Imigran - Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life

Active ingredients: Sumatriptan (sumatriptan succinate)

IMIGRAN 6 mg / 0.5 ml Solution for injection for subcutaneous use
IMIGRAN 50 mg Film-coated tablets
IMIGRAN 100 mg Film-coated tablets

Imigran package inserts are available for packs:
  • IMIGRAN 6 mg / 0.5 ml Solution for injection for subcutaneous use, IMIGRAN 50 mg Film-coated tablets, IMIGRAN 100 mg Film-coated tablets
  • Imigran 25 mg Suppositories
  • Imigran 10 mg and 20 mg Nasal Spray

Indications Why is Imigran used? What is it for?

PHARMACOTHERAPEUTIC CATEGORY

Anti-migraine selective 5-HT1 receptor agonists

THERAPEUTIC INDICATIONS

IMIGRAN injectable and tablets are indicated for the treatment of acute migraine attack with or without aura, including acute migraine attacks associated with the menstrual period. IMIGRAN injectable is also indicated for the treatment of cluster headache.

Contraindications When Imigran should not be used

Hypersensitivity to the active substance or to any of the excipients.

Sumatriptan should not be used in patients who have had myocardial infarction or who have ischemic heart disease, coronary vasospasm (Prinzmetal's angina), peripheral vascular disease or with signs or symptoms related to ischemic heart disease.

Sumatriptan should not be given to patients with a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA).

Sumatriptan must not be administered to patients with severe hepatic impairment. The use of sumatriptan is contraindicated in patients with moderate and severe hypertension and mild uncontrolled hypertension.

Concomitant administration of ergotamine or ergotamine derivatives (including methysergide) or any triptan / 5-hydroxytryptamine1 (5-HT1) receptor agonist is contraindicated (see section "Interactions").

Concomitant administration of monoamine oxidase inhibitors (MAOIs) and sumatriptan is contraindicated.

Sumatriptan should not be used within two weeks of stopping monoamine oxidase inhibitor therapy.

Precautions for use What you need to know before taking Imigran

Film-coated tablets

Sumatriptan should only be used after a clear diagnosis of migraine has been made.

Solution for injection for subcutaneous use

Sumatriptan should only be used after a clear diagnosis of migraine or cluster headache has been made. Sumatriptan solution for injection must not be used intravenously.

All pharmaceutical forms

The use of sumatriptan is not indicated in the treatment of hemiplegic, basilar or ophthalmoplegic migraine. Before starting treatment with sumatriptan, care should be taken to exclude potentially serious neurological conditions (e.g. cerebrovascular accidents (CVA), transient ischemic attacks (TIA)) if patients have atypical symptoms or if they have not had an appropriate diagnosis. use of sumatriptan.

Administration of sumatriptan may be accompanied by transient symptoms, including chest pain and tightness, which may be intense and affect the throat (see section "Undesirable effects"). If such symptoms are believed to be indicative of ischemic heart disease, no further doses of sumatriptan should be given and appropriate evaluation made. Sumatriptan should be administered with caution in patients with mild controlled hypertension as in a small proportion transient increases in blood pressure and peripheral vascular resistance have been observed in patients (see section "Contraindications").

There have been rare post-marketing reports of patients with serotonin syndrome (which included altered mental status, autonomic instability and neuromuscular abnormalities) following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. The serotonin syndrome has been reported following concomitant treatment with triptans and serotonin and norepinephrine reuptake inhibitors (SNRIs).

If concomitant treatment of sumatriptan with an SSRI / SNRI is clinically justified, "appropriate observation of the patient" is advised (see section "Interactions").

Sumatriptan should be administered with caution to patients with conditions that can significantly alter the absorption, metabolism and excretion of the drug, such as in the case of hepatic (Child Pugh grade A or B) or renal insufficiency.

Sumatriptan should be used with caution in patients with epilepsy and / or a history of seizures or other risk factors that lower the seizure threshold level, as seizures have been reported in association with sumatriptan (see section "Undesirable effects").

Patients with known hypersensitivity to sulfonamides may exhibit an allergic reaction after administration of sumatriptan. Reactions can range from cutaneous hypersensitivity to “anaphylaxis.” Evidence of cross-reactivity is limited, however caution should be exercised before using sumatriptan in these patients.

Undesirable effects may occur more commonly during concomitant use of triptans and preparations based on St. John's Wort (Hypericum perforatum).

Prolonged use of any type of pain reliever for headache can make it worse. If this occurs or is suspected, medical advice should be sought and treatment discontinued.

A diagnosis of headache from overuse of headache medications should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of headache medications.

Sumatriptan should not be given to patients with risk factors for ischemic heart disease, including those patients who are heavy smokers or using nicotine replacement therapies, without first conducting a cardiovascular evaluation (see section "Contraindications"). Particular consideration must be given to postmenopausal women and men over the age of 40 in whom these risk factors are present. However, these assessments may not identify every patient who has cardiac disease and, in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease.

Interactions Which drugs or foods can change the effect of Imigran

Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription

There is no evidence of interactions with propranolol, flunarizine, pizotifen or alcohol.

Preparations containing ergotamine or other triptans / 5-HT1 receptor agonists may give prolonged vasospastic reactions. Data relating to interactions with these drugs are limited. There is a theoretical possibility of an increased risk of coronary vasospasm, therefore concomitant administration is contraindicated (see section "Contraindications").

The length of time that must elapse between the use of sumatriptan and preparations containing ergotamine or other triptans / 5-HT1 receptor agonists is not known. This will also depend on the doses and types of products used. The effects may be addictive. Yes. advised to wait at least 24 hours after using preparations containing ergotamine or other triptan / 5-HT1 receptor agonists before administering sumatriptan. Conversely, it is recommended to wait at least six hours after using sumatriptan before administering an ergotamine-containing product and at least 24 hours before administering another triptan / 5-HT1 receptor agonist.

An "interaction between sumatriptan and MAOIs may occur, and concomitant administration is contraindicated (see section" Contraindications ").

There have been rare post-marketing reports of patients with serotonin syndrome (which included altered mental status, autonomic instability and neuromuscular abnormalities) following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. The serotonin syndrome has been also reported following concomitant treatment with triptans and selective norepinephrine reuptake inhibitors (see section "Precautions for use").

Warnings It is important to know that:

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

There are post-marketing data on the use of sumatriptan during the first trimester of pregnancy in over 1,000 women. Although these data do not contain sufficient information to draw firm conclusions, they did not reveal an increase in the risk of congenital defects.

Experience with the use of sumatriptan in the second and third trimesters is limited.

Experimental animal studies do not indicate teratogenic or dangerous effects in peri- or postnatal development. However, embryonic and fetal death can occur in the rabbit. Administration of sumatriptan should only be considered if the benefit to the mother is greater than the possible risk to the fetus.

Feeding time

Following subcutaneous administration, sumatriptan has been shown to be excreted in human milk. Infants' exposure to the drug can be minimized by avoiding breastfeeding during the 12 hours following treatment, during which time the amount of breast milk produced must be eliminated.

Effects on ability to drive and use machines

No studies on the ability to drive or use machines have been performed.

Migraine or treatment with sumatriptan may cause drowsiness. This may affect the ability to drive or use machines.

Caution is advised in patients performing such activities.

Important information about some of the ingredients

IMIGRAN contains less than 1 mmol (23 mg) sodium per dose, ie essentially "sodium-free".

Dosage and method of use How to use Imigran: Dosage

All pharmaceutical forms

Sumatriptan should not be used in prophylaxis.

The recommended dose of sumatriptan should not be exceeded.

Film-coated tablets

Sumatriptan is recommended as monotherapy for the treatment of acute migraine attack and should not be administered concomitantly with ergotamine or ergotamine derivatives (including methysergide) (see section "Contraindications").

It is recommended that sumatriptan be taken as soon as possible after the onset of the migraine attack. The medicine is equally effective whenever it is taken during the attack.

Solution for injection for subcutaneous use

It is recommended that sumatriptan be taken as soon as possible after the onset of the migraine attack or associated symptoms such as nausea, vomiting or photophobia. The medicine is equally effective whenever it is taken during the attack.

The efficacy of sumatriptan is independent of the time elapsed between the onset of the attack and the start of treatment.

Administration during the aura phase before other symptoms occur may not prevent the onset of headache.

Populations

Film-coated tablets

  • Adults

The recommended dose of oral sumatriptan is one 50 mg tablet. Some patients may require 25 mg or 100 mg.

If the patient does not respond to the first dose of sumatriptan, a second dose should not be taken for the same attack.In these cases the attack can be treated with paracetamol, acetylsalicylic acid, or non-steroidal anti-inflammatory drugs. Sumatriptan tablets can be taken for subsequent attacks. If the patient has responded to the first dose but symptoms recur, a second dose it can be administered as long as there is an interval of at least 2 hours between the two doses.No more than 300 mg should be taken in any 24 hour period.

The tablets should be swallowed whole with water. Patients with swallowing difficulties may choose to disperse the sumatriptan tablet in a small amount of water before taking. Sumatriptan tablets dispersed in water have a bitter taste.

  • Pediatric population

The efficacy and safety of sumatriptan tablets (film-coated) in children aged less than 10 years have not been established. No clinical data are available in this age group.

The efficacy and safety of sumatriptan tablets (film-coated) in children and adolescents aged 10 to 17 years have not been demonstrated in clinical studies conducted in this age group. Therefore the use of sumatriptan tablets (film-coated) in children and adolescents 10 to 17 years of age is not recommended.

  • Elderly (over 65 years of age)

There is limited experience with the use of sumatriptan tablets in patients over 65 years of age. Pharmacokinetics do not differ significantly from that of the younger population, but until further clinical data become available, the use of sumatriptan tablets in patients over 65 years of age is not recommended.

Solution for injection for subcutaneous use

Sumatriptan injectable should be administered subcutaneously using the auto-injector.

Patients should be advised to strictly observe the instructions for use of the sumatriptan auto-injector, especially regarding the safe disposal of syringes and needles.

  • Adults

Migraine

The recommended dose of sumatriptan solution for injection is a single 6 mg subcutaneous injection. If the patient does not respond to the first dose of sumatriptan, a second dose for the same attack cannot be taken. In these cases the attack can be treated with paracetamol, acetylsalicylic acid or non-steroidal anti-inflammatory drugs. Sumatriptan solution for injection can be taken for subsequent attacks. If the patient has responded to the first dose but symptoms recur, a second dose can be taken. administered over the next 24 hours, provided there is a minimum interval of one hour between the two doses.

The maximum dose in 24 hours is two 6 mg injections (12 mg).

Cluster headache

The recommended dose of sumatriptan solution for injection is a single 6 mg subcutaneous injection for each cluster headache attack. The maximum dose in 24 hours is two 6 mg (12 mg) injections, with a minimum interval of one "hour between the two doses.

  • Children and adolescents (under 18 years of age)

The use of sumatriptan solution for injection is not recommended in children and adolescents due to insufficient data on safety and efficacy.

  • Elderly (over 65 years of age)

There is limited experience with the use of sumatriptan in patients over 65 years of age. Pharmacokinetics do not differ significantly from that of the younger population, but until further clinical data become available, the use of sumatriptan in patients over 65 years of age is not recommended.

Instructions for Use

Follow the instructions at the end of the package leaflet.

Overdose What to do if you have taken too much Imigran

Symptoms and signs

Film-coated tablets

Doses up to 100 mg orally were not associated with side effects other than those mentioned below.

Solution for injection for subcutaneous use

Patients received single subcutaneous injections of up to 12 mg with no significant adverse effects. Doses up to 16 mg subcutaneously were not associated with side effects other than those listed below.

Treatment

All pharmaceutical forms In the event of an overdose, the patient should be monitored for at least ten hours and appropriate supportive care initiated if necessary. The effects of hemodialysis or peritoneal dialysis on plasma concentrations of sumatriptan are unknown. .

In case of accidental ingestion / intake of an excessive dose of IMIGRAN, notify your doctor immediately or go to the nearest hospital.

If you have any questions about the use of IMIGRAN, ask your doctor or pharmacist.

Side Effects What are the side effects of Imigran

Like all medicines, IMIGRAN can cause side effects, although not everybody gets them.

Undesirable effects are listed below by system organ class and frequency. Frequencies are defined as: very common (> 1/10), common (> 1/100 to 1 / 1,000 to 1 / 10,000 to

All pharmaceutical forms

Disorders of the immune system

Not known: hypersensitivity reactions, which can range from skin hypersensitivity (such as hives) to anaphylaxis.

Nervous system disorders

Common: dizziness, somnolence, sensory disturbances including paraesthesia and hypoesthesia.

Not known: seizures, although some of these cases have occurred in patients with a history of seizures or concomitant conditions predisposing to seizures. There are also reports in patients for whom such predisposing factors are not evident. Tremor, dystonia, nystagmus, scotoma.

Eye disorders

Not known: vision flickering, diplopia, impaired vision. Loss of vision, including cases of permanent defects. However, eye disorders can also occur during the migraine attack itself.

Cardiac pathologies

Not known: bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischemic ECG changes, coronary vasospasm, angina, myocardial infarction (see sections "Contraindications", "Precautions for use" and "Interactions").

Vascular pathologies

Common: transient increase in blood pressure occurring soon after administration. Redness.

Not known: hypotension, Raynaud's phenomenon.

Respiratory, thoracic and mediastinal disorders

Common: dyspnoea.

Gastrointestinal disorders

Common: Nausea and vomiting have been reported in some patients, but it is unclear whether this is related to sumatriptan or pre-existing conditions.

Not known: ischemic colitis. Not known: diarrhea.

Musculoskeletal and connective tissue disorders

Common: feeling of heaviness (usually transient, can be intense and can affect any part of the body, including the chest and throat). Myalgia.

Not known: neck stiffness.

Not known: arthralgia.

General disorders and administration site conditions

Common: pain, sensation of heat or cold, pressure or tightness (these events are usually transient, can be intense and can affect any part of the body including the chest and throat); feelings of weakness, fatigue (both of these events are largely mild to moderate in intensity and transient).

Diagnostic tests

Very rare: Mild changes in liver function tests have occasionally been observed.

Psychiatric disorders

Not known: anxiety.

Skin and subcutaneous tissue disorders

Not known: hyperhidrosis.

Solution for injection only for subcutaneous use

The most common side effects associated with subcutaneous sumatriptan treatment are:

General disorders and administration site conditions

Very common: transient pain at the injection site.

Very common: Burning sensation, edema, erythema, ecchymosis and bleeding have also been reported at the injection site.

Although no direct comparison data are available, redness, paraesthesia, warmth, feeling of pressure and heaviness may be more common after administration of injectable sumatriptan. Conversely, nausea, vomiting, fatigue appear to be less frequent after administration of injectable sumatriptan than tablets.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

If you get any side effects, including any possible side effects not listed in this leaflet, contact your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on safety of this medicine.

Expiry and Retention

Expiry: see the expiry date indicated on the package.

The expiry date refers to the product in intact packaging, correctly stored. Warning: do not use the medicine after the expiry date indicated on the package.

Conservation rules

Film-coated tablets: store at a temperature not exceeding 30 ° C. Pre-filled syringes: store in the original packaging to protect the product from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Keep this medicine out of the sight and reach of children.

COMPOSITION

IMIGRAN 6 mg / 0.5 ml solution for injection for subcutaneous use

Each pre-filled syringe contains:

Active principle:

sumatriptan succinate 8.4 mg

equal to sumatriptan 6 mg.

Excipients: sodium chloride, water for injections.

The pre-filled syringes contain 6 mg of sumatriptan base as succinate salt in an isotonic solution (total volume: 0.5 ml). Pre-filled syringes are available with PENKIT auto-injector.

IMIGRAN 100 mg film-coated tablets

Each film-coated tablet contains:

Active principle:

sumatriptan succinate 140.0 mg

equal to sumatriptan 100 mg.

Excipients: anhydrous dibasic calcium phosphate, microcrystalline cellulose, sodium bicarbonate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E 171), glycerol triacetate.

IMIGRAN 50 mg film-coated tablets

Each film-coated tablet contains:

Active principle:

sumatriptan succinate 70.0 mg

equal to sumatriptan 50 mg

Excipients: anhydrous dibasic calcium phosphate, microcrystalline cellulose, sodium bicarbonate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E 171), glycerol triacetate, red iron oxide (E 172).

PHARMACEUTICAL FORM AND CONTENT

Solution for injection for subcutaneous use:

  • 2 pre-filled 6 mg syringes with PENKIT auto-injector.

Film-coated tablets:

  • 100 mg film-coated tablets
  • 4 film-coated tablets of 50 mg

METHOD OF USING THE PENKIT SELF-INJECTOR

Read carefully and strictly follow the instructions.

Description of the parts

The PENKIT auto-injector contains the spring mechanism to automatically inject the drug and should only be used after being loaded with a syringe.

1 - PENKIT auto-injector

2 - Case

3 - Syringe container

A - Blue button

B - White plunger

C - Gray section

D - Blue section

How to use the PENKIT auto-injector

Open the pouch. Remove the seal from one of the two syringe containers.

Note: the removed seal indicates that this dose has been used.

Open the syringe container cap by lifting it up.

Remove the PENKIT auto-injector from the case, taking great care not to press the blue button.

Please note: the spring mechanism inside the PENKIT auto-injector is loaded, ready for use as soon as it is removed from its case, so the white plunger should not protrude from the lower edge of the PENKIT auto-injector.

To load the PENKIT auto-injector, insert it into the syringe container and screw clockwise (approximately half a turn).

NB: also during this operation, be careful not to push the button so as not to release the spring mechanism located inside the PENKIT auto-injector.

Pull out the charged PENKIT auto-injector keeping it in a straight line. You may need to pull hard to do this, so you still need to be careful not to press the blue button.

The device is equipped with a safety device in order to prevent accidental injections.

In fact, the PENKIT auto-injector only works when the gray section is slid against the blue part, thus disengaging the safety device (position B in the photo).

A - By pressing the blue button the device does not work.

B - By pressing the blue button the device works.

To give the injection, press the loaded PENKIT auto-injector against the skin, preferably on the external part of the thigh (see illustration), until the gray part slides against the blue section; firmly holding the PENKIT auto-injector, press the blue button firmly, until you hear the clicking sound, keeping the pen immobile for at least 5 seconds.

After 5 seconds remove the PENKIT auto-injector carefully without bending it, paying attention to the needle that comes out.

Immediately return the used syringe to its empty container by pushing the PENKIT auto-injector all the way into the container. Then unscrew the PENKIT auto-injector counterclockwise (approximately half a turn) until the used syringe is left inside the container.

With the empty PENKIT auto-injector removed, close the container lid on the used syringe.

Please note: after the device has been used the white plunger will protrude from the lower edge of the PENKIT auto-injector.

Put the PENKIT auto-injector back into the case and push it down until it stops with a clicking noise in the right position (be careful once again not to press the blue button).

NB: this operation allows the loading of the spring mechanism inside the PENKIT auto-injector for the next injection. (The white piston will go back to being inside the PENKIT auto-injector).

The lid of the case cannot be closed if the spring has not been loaded.

After use, do not dispose of empty containers in the environment.

Needles and syringes can be dangerous and should be disposed of properly and safely.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

More information about Imigran can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

IMIGRAN

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

IMIGRAN 6 mg / 0.5 ml Solution for injection for subcutaneous use

Each pre-filled syringe contains:

Active principle:

sumatriptan succinate 8.4 mg

equal to sumatriptan 6 mg

IMIGRAN 100 mg Film-coated tablets

Each film-coated tablet contains:

Active principle:

sumatriptan succinate 140.0 mg

equal to sumatriptan 100 mg

IMIGRAN 50 mg Film-coated tablets

Each film-coated tablet contains:

Active principle:

sumatriptan succinate 70.0 mg

equal to sumatriptan 50 mg

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

- injectable solution for subcutaneous use;

- film-coated tablets.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

IMIGRAN for injection and tablets is indicated for the treatment of acute migraine attack with or without aura, including acute migraine attacks associated with the menstrual period.

IMIGRAN injectable is also indicated for the treatment of cluster headache.

04.2 Posology and method of administration

All pharmaceutical forms

Sumatriptan should not be used in prophylaxis.

Film-coated tablets

Sumatriptan is recommended as monotherapy for the treatment of acute migraine attack and should not be administered concomitantly with ergotamine or ergotamine derivatives (including methysergide) (see section 4.3).

It is recommended that sumatriptan be taken as soon as possible after the onset of the migraine attack. The medicine is equally effective whenever it is taken during the attack.

Solution for injection for subcutaneous use

It is recommended that sumatriptan be taken as soon as possible after the onset of the migraine attack or associated symptoms such as nausea, vomiting or photophobia. The medicine is equally effective whenever it is taken during the attack.

The efficacy of sumatriptan is independent of the time elapsed between the onset of the attack and the start of treatment.

Administration during the aura phase before other symptoms occur may not prevent the onset of headache.

Populations

Film-coated tablets

§ Adults

The recommended dose of oral sumatriptan is a single 50 mg tablet. Some patients may require 100 mg.

If the patient does not respond to the first dose of sumatriptan, a second dose should not be taken for the same attack. In these cases the attack can be treated with paracetamol, acetylsalicylic acid or non-steroidal anti-inflammatory drugs. Sumatriptan tablets can be taken for subsequent attacks.

If the patient has responded to the first dose but symptoms recur, a second dose may be given over the next 24 hours, provided there is an interval of at least 2 hours between the two doses. No more than 300 should be taken. mg during 24 hours.

The tablets should be swallowed whole with water. Patients with swallowing difficulties may choose to disperse the sumatriptan tablet in a small amount of water before taking. Sumatriptan tablets dispersed in water have a bitter taste.

§ Pediatric population

The efficacy and safety of sumatriptan tablets (film-coated) in children aged less than 10 years have not been established. No clinical data are available in this age group.

The efficacy and safety of sumatriptan tablets (film-coated) in children and adolescents aged 10 to 17 years have not been demonstrated in clinical studies conducted in this age group. Therefore the use of sumatriptan tablets (film-coated) in children and adolescents 10 to 17 years of age is not recommended (see section 5.1).

§ Elderly (over 65 years of age)

There is limited experience with the use of sumatriptan tablets in patients over 65 years of age. Pharmacokinetics do not differ significantly from that of the younger population, but until further clinical data become available, the use of sumatriptan tablets in patients over 65 years of age is not recommended.

Solution for injection for subcutaneous use

Sumatriptan injectable should be administered subcutaneously using the auto-injector.

Patients should be advised to strictly observe the instructions for use of the sumatriptan auto-injector, especially regarding the safe disposal of syringes and needles.

§ Adults

MIGRAINE

The recommended dose of sumatriptan for injection is a single 6 mg subcutaneous injection.

If the patient does not respond to the first dose of sumatriptan, a second dose for the same attack cannot be taken. In these cases the attack can be treated with paracetamol, acetylsalicylic acid or non-steroidal anti-inflammatory drugs. Injectable sumatriptan can be taken for subsequent attacks.

If the patient has responded to the first dose but symptoms recur, a second dose may be given over the next 24 hours, provided there is an interval of at least 1 hour between the two doses.

The maximum dose in 24 hours is two 6 mg injections (12 mg).

CLUSTER HEADACHE

The recommended dose of sumatriptan for injection is a single 6 mg subcutaneous injection for each cluster headache attack. The maximum dose in 24 hours is two 6 mg injections (12 mg), with a minimum interval of 1 hour between the two doses.

§ Children and adolescents (under 18 years of age)

The use of injectable sumatriptan is not recommended in children and adolescents due to insufficient data on safety and efficacy.

§ Elderly (over 65 years of age)

There is limited experience with the use of sumatriptan in patients over 65 years of age. Pharmacokinetics do not differ significantly from that of the younger population, but until further clinical data become available, the use of sumatriptan in patients over 65 years of age is not recommended.

04.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Sumatriptan must not be used in patients who have had myocardial infarction or who have ischemic heart disease, coronary vasospasm (Prinzmetal's angina), peripheral vascular disease or signs or symptoms related to ischemic heart disease.

Sumatriptan should not be given to patients with a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA).

Sumatriptan must not be administered to patients with severe hepatic impairment.

The use of sumatriptan is contraindicated in patients with moderate and severe hypertension and mild uncontrolled hypertension.

Concomitant administration of ergotamine or ergotamine derivatives (including methysergide) or any triptan / 5-hydroxytryptamine (5-HT1) receptor agonist is contraindicated (see section 4.5).

Concomitant administration of monoamine oxidase inhibitors (MAOIs) and sumatriptan is contraindicated.

Sumatriptan should not be used within 2 weeks of stopping monoamine oxidase inhibitor therapy.

04.4 Special warnings and appropriate precautions for use

Film-coated tablets

Sumatriptan should only be used after a clear diagnosis of migraine has been made.

Solution for injection for subcutaneous use

Sumatriptan should only be used after a clear diagnosis of migraine or cluster headache has been made.

Sumatriptan injectable should not be used intravenously.

All pharmaceutical forms

The use of sumatriptan is not indicated in the treatment of hemiplegic, basilar or ophthalmoplegic migraine.

As with other therapies for the treatment of acute migraine attack, care should be taken to exclude other potentially serious neurological conditions.

It should be borne in mind that migraineurs may present an increased risk for some cerebrovascular events (e.g. CVA, TIA).

Administration of sumatriptan may be accompanied by transient symptoms, including chest pain and tightness, which may be intense and affect the throat (see section 4.8). If these symptoms are believed to be indicative of ischemic heart disease, no further doses of sumatriptan should be given and appropriate evaluation made.

Sumatriptan should be administered with caution in patients with mild controlled hypertension as transient increases in blood pressure and peripheral vascular resistance have been observed in a small proportion of patients (see section 4.3).

There have been rare post-marketing reports of patients with serotonin syndrome (which included altered mental status, autonomic instability and neuromuscular abnormalities) following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. The serotonin syndrome has been reported following concomitant treatment with triptans and serotonin and norepinephrine reuptake inhibitors (SNRIs).

If concomitant treatment of sumatriptan with an SSRI / SNRI is clinically warranted, appropriate observation of the patient is advised (see section 4.5).

Sumatriptan should be administered with caution to patients with conditions that can significantly alter the absorption, metabolism and excretion of the drug, such as in the case of hepatic or renal insufficiency.

Sumatriptan should be used with caution in patients with epilepsy and / or a history of seizures or other risk factors that lower the seizure threshold level, as seizures have been reported in association with sumatriptan (see section 4.8).

Patients with known hypersensitivity to sulfonamides may exhibit an allergic reaction after administration of sumatriptan. Reactions can range from skin hypersensitivity to anaphylaxis.

Evidence of cross-reactivity is limited, however caution should be exercised before using reasumatriptan in these patients.

Undesirable effects may occur more commonly during concomitant use of triptans and St. John's wort preparations (Hypericum perforatum).

Prolonged use of any type of pain reliever for headache can make it worse. If this occurs or is suspected, medical advice should be sought and treatment discontinued.

A diagnosis of headache from overuse of headache medications should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of headache medications.

The recommended dose of sumatriptan should not be exceeded.

Sumatriptan should not be given to patients with risk factors for ischemic heart disease, including those patients who are heavy smokers or using nicotine replacement therapies, without first conducting a cardiovascular evaluation (see section 4.3). Particular consideration must be given to postmenopausal women and men over the age of 40 in whom these risk factors are present. However, these assessments may not identify every patient who has cardiac disease and, in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease.

04.5 Interactions with other medicinal products and other forms of interaction

There is no evidence of interactions with propranolol, flunarizine, pizotifen or alcohol.

Data on interactions with ergotamine-containing preparations or other triptans / 5-HT1 receptor agonists are limited. There is a theoretical possibility of an increased risk of coronary vasospasm, therefore concomitant administration is contraindicated (see section 4.3).

The length of time that must elapse between the use of sumatriptan and preparations containing ergotamine or other triptans / 5-HT1 receptor agonists is not known. This will also depend on the doses and types of products used. The effects may be addictive. We recommend to wait at least 24 hours after using preparations containing ergotamine or other triptan / 5-HT1 receptor agonists before administering sumatriptan. Conversely, it is recommended to wait at least 6 hours after using sumatriptan before administering an ergotamine-containing product and at least 24 hours before administering another triptan / 5-HT1 receptor agonist.

An interaction between sumatriptan and MAOIs may occur, and concomitant administration is contraindicated (see section 4.3).

There have been rare post-marketing reports of patients with serotonin syndrome (which included altered mental status, autonomic instability and neuromuscular abnormalities) following the use of SSRIs and sumatriptan. Serotonin syndrome has also been reported following concomitant treatment with triptans. and SNRIs (see section 4.4).

04.6 Pregnancy and lactation

Pregnancy

There are post-marketing data on the use of sumatriptan during the first trimester of pregnancy in over 1,000 women. Although these data do not contain sufficient information to draw firm conclusions, they did not reveal an increased risk of birth defects. Experience with the use of sumatriptan in the second and third trimesters is limited.

Experimental animal studies do not indicate direct teratogenic effects or dangerous effects in peri or postnatal development. However, embryonic and fetal death may occur in rabbits (see section 5.3).

Administration of sumatriptan should only be considered if the benefit to the mother is greater than the possible risk to the fetus.

Feeding time

Following subcutaneous administration, sumatriptan has been shown to be excreted in human milk. Infants' exposure to the drug can be minimized by avoiding breastfeeding during the 12 hours following treatment, during which time the amount of breast milk produced must be eliminated.

04.7 Effects on ability to drive and use machines

No studies on the ability to drive or use machines have been performed.

Migraine or its treatment with sumatriptan may cause drowsiness. This may affect the ability to drive or use machines.

04.8 Undesirable effects

Undesirable effects are listed below by system organ class and frequency. Frequencies are defined as: very common (> 1/10), common (> 1/100, 1/1000, 1/10000,

All pharmaceutical forms:

Disorders of the immune system

Not known: hypersensitivity reactions, which can range from skin hypersensitivity (such as hives) to anaphylaxis.

Nervous system disorders

Common: dizziness, somnolence, sensory disturbances including paraesthesia and hypoesthesia.

Not known: seizures, although some of these cases have occurred in patients with a history of seizures or concomitant conditions predisposing to seizures. There are also reports in patients for whom such predisposing factors are not evident.

Tremor, dystonia, nystagmus, scotoma.

Eye disorders

Not known: vision flickering, diplopia, impaired vision. Loss of vision, including cases of permanent defects. However, eye disorders can also occur during the migraine attack itself.

Cardiac pathologies

Not known: bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischemic-type ECG changes, coronary vasospasm, angina, myocardial infarction (see sections 4.3 and 4.4).

Vascular pathologies

Common: transient increase in blood pressure occurring soon after administration. Redness.

Not known: hypotension, Raynaud's phenomenon.

Respiratory, thoracic and mediastinal disorders

Common: dyspnoea.

Gastrointestinal disorders

Common: Nausea and vomiting have been reported in some patients, but it is unclear whether this is related to sumatriptan or to pre-existing conditions.

Not known: ischemic colitis.

Not known: diarrhea.

Musculoskeletal and connective tissue disorders

Common: feeling of heaviness (usually transient, can be intense and can affect any part of the body, including the chest and throat). Myalgia.

Not known: neck stiffness.

Not known: arthralgia.

General disorders and administration site conditions

Common: pain, sensation of heat or cold, pressure or tightness (these events are usually transient and can be intense and can affect any part of the body including the chest and throat);

feelings of weakness, fatigue (both of these events are largely mild to moderate in intensity and transient).

Diagnostic tests

Very rare: Mild changes in liver function tests have occasionally been observed.

Psychiatric disorders

Not known: anxiety.

Skin and subcutaneous tissue disorders

Not known: hyperhidrosis.

Solution for injection only for subcutaneous use :

The most common side effects associated with subcutaneous sumatriptan treatment are:

General disorders and administration site conditions

Very common: transient pain at the injection site.

Very common: Burning sensation, edema, erythema, ecchymosis and bleeding have also been reported at the injection site.

Although no direct comparison data are available, redness, paraesthesia, warmth, feeling of pressure and heaviness may be more common after administration of injectable sumatriptan.

In contrast, nausea, vomiting and fatigue appear to be less frequent after administration of injectable sumatriptan than tablets.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: http://www.agenziafarmaco.gov.it/it/responsabili.

04.9 Overdose

Symptoms and signs

Film-coated tablets

Doses up to 100 mg orally were not associated with side effects other than those mentioned above.

Solution for injection for subcutaneous use

There have been reports of overdose with injectable sumatriptan.

Patients received single subcutaneous injections of up to 12 mg with no significant adverse effects. Doses up to 16 mg subcutaneously were not associated with side effects other than those mentioned above.

Treatment

All pharmaceutical forms

In the event of an overdose, the patient should be monitored for at least ten hours and appropriate supportive care initiated if necessary. The effects of hemodialysis or peritoneal dialysis on plasma concentrations of sumatriptan are unknown.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: anti-migraine selective 5HT1 receptor agonists.

ATC code: N02CC01.

Mechanism of action

Sumatriptan is a selective vascular agonist of serotonin 5HT1 D receptors, thus devoid of interference with the other subtypes of serotonergic receptors (5HT2 - 5HT7). The 5HT1D receptor has been identified mainly in the cerebral vessels and mediates vasoconstriction. Animal pharmacology studies have shown that sumatriptan acts by selectively forcing the circulation of the arterial carotids without modifying the cerebral blood flow. The carotid circulation irrigates the extra and intracranial tissues such as the meninges and it is believed that the dilation of these vessels and / or the formation of edema is the basis of the pathogenetic mechanism of migraine in humans.

Furthermore, experimental evidence from animal studies suggests that sumatriptan may inhibit trigeminal nerve activity. Both of these actions (cranial vasoconstriction and inhibition of trigeminal nerve activation) may contribute to the anti-migraine action of sumatriptan in humans.

Pharmacodynamic effects

Clinical response begins 10-15 minutes after a 6 mg subcutaneous injection, 15 minutes after a 20 mg intranasally administered dose, and approximately 30 minutes following a 25 mg rectal dose.

Following administration of the 50 mg or 100 mg film-coated tablets, the onset of pain relief occurred after 30 and 20 minutes, respectively, in a small percentage of subjects and the percentage of subjects responding to therapy, with relief from pain over 2 hours, progressively increased up to 67% and 72% of subjects, compared to 42% of subjects treated with placebo. In a small percentage of patients, complete freedom from pain began after 33 and 26 minutes, respectively, and the percentage continued to increase to 40% and 47% of pain-free subjects over 2 hours, compared with 15. % of subjects treated with placebo.

A few placebo-controlled clinical trials have been conducted to define the tolerability and efficacy of oral sumatriptan in 600 adolescents 12 to 17 years with migraine. These studies have shown no relevant differences between placebo and any dose of sumatriptan in the relief of headache 2 hours post dose The undesirable effect profile of oral sumatriptan in adolescents aged 12 to 17 years was similar to that reported in studies in the adult population.

05.2 Pharmacokinetic properties

The pharmacokinetic profile of sumatriptan does not appear to be significantly affected by migraine attacks.

Absorption

Solution for injection for subcutaneous use

After subcutaneous administration, sumatriptan has a high average bioavailability (96%); peak serum concentrations are reached in 25 minutes.

After a subcutaneous dose of 6 mg, the mean peak concentrations are 72 ng / mL.

Film-coated tablets

After a dose of 100 mg the mean peak plasma concentrations are 54 ng / ml. The mean absolute bioavailability, following oral administration, is 14%; this is partly due to presystemic metabolism and partly to incomplete absorption.

Sumatriptan Cmax increased by 15% following administration of the film-coated tablets taken with a high-fat meal.

Distribution

Plasma protein binding is low (14-21%); the mean total volume of distribution is 170 liters.

Metabolism

The major metabolite, the indole acetic acid derivative analog of sumatriptan, is excreted mainly in the urine, in which it is present in both free acid and conjugated glucuronide form. It has no known 5HT1 or 5HT2 activity. No minor metabolites were identified.

Elimination

The elimination half-life is approximately 2 hours.

The mean total plasma clearance is approximately 1160 mL / min, the mean renal plasma clearance is approximately 260 mL / min.

Non-renal clearance is approximately 80% of total clearance. Sumatriptan is eliminated primarily through monoamine oxidase A mediated oxidative metabolism.

Special patient populations

Film-coated tablets

Following oral administration, pre-systemic clearance is reduced in patients with hepatic insufficiency, resulting in increased plasma levels of sumatriptan.

Clinical studies

Film-coated tablets

The time to onset of therapeutic effect of sumatriptan 50 mg and 100 mg film-coated tablets was evaluated in adults in two randomized, double-blind, placebo-controlled studies, identical in design. Data from these studies were combined to obtain individual results for each endpoint. Overall, time to pain relief and time to complete pain freedom were reported in 2696 subjects with moderate to severe migraine pain in the sumatriptan 50 mg, 100 mg and placebo groups. Time-to-pain relief curves (defined as a reduction in pain severity from moderate or severe to mild or absent) were generated for sumatriptan and placebo for a period of 2 hours after treatment intake. L "Time interval of onset of pain relief was defined as the earliest time when statistical significance, compared with placebo, was reached and subsequently maintained at all subsequent times on the 0 to 2 hour curve.

Pain freedom (defined as reduction in pain intensity from severe or moderate to no pain) was assessed using the same methodology.

The percentage of subjects achieving pain relief or pain freedom within 2 hours of treatment was significantly higher in subjects who received sumatriptan (50 mg or 100 mg) compared to those who received placebo (p

From the pooled data analysis, the time interval for pain relief for sumatriptan 50 mg and 100 mg film-coated tablets was 30 minutes and 20 minutes, respectively. From this point on, the percentage of responding subjects continued to increase, up to 67% and 72% of subjects achieving pain relief, for 50 mg and 100 mg, respectively, 2 hours after treatment, in comparison. to 42% of subjects in the placebo group.

From the pooled data analysis, the time interval to onset of pain freedom for sumatriptan 50 mg and 100 mg film-coated tablets was 33 minutes and 26 minutes, respectively. From this point on, the percentage of responding subjects continued to increase, reaching 40% and 47% of pain-free subjects for 50 mg and 100 mg, respectively, at 2 hours after treatment. , compared to 15% of the subjects in the placebo group.

05.3 Preclinical safety data

Carcinogenesis, mutagenesis

Sumatriptan in studies in vitro and in the animal it was found devoid of genotoxic and carcinogenic activity.

Reproductive toxicity

Tablets

In a rat fertility study, oral doses of sumatriptan, which resulted in plasma levels approximately 200 times higher than those observed in humans after a 100 mg oral dose, were associated with a reduction in insemination success.

This effect did not occur in a subcutaneous study, where maximum plasma levels were approximately 150 times those in humans by the oral route.

Solution for injection for subcutaneous use

In a rat fertility study, oral doses of sumatriptan which resulted in plasma levels approximately 150 times higher than those observed in humans after a 6 mg subcutaneous dose were associated with a reduction in insemination success.

This effect did not occur in a subcutaneous study, where maximum plasma levels were approximately 100 times those in humans by the oral route.

Pregnancy and breastfeeding

No teratogenic effects were observed in rats or rabbits, and sumatriptan did not affect postnatal development in the rat.

Administered to pregnant rabbits throughout the period of organogenesis, sumatriptan occasionally resulted in embryolethality at doses high enough to induce toxicity in the mothers.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Pre-filled syringes: sodium chloride, water for injections

100 mg film-coated tablets: anhydrous dibasic calcium phosphate, microcrystalline cellulose, sodium bicarbonate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E 171), glycerol triacetate

50 mg film-coated tablets: anhydrous dibasic calcium phosphate, microcrystalline cellulose, sodium bicarbonate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E 171), glycerol triacetate, red iron oxide (E 172).

06.2 Incompatibility

Not relevant.

06.3 Period of validity

Solution for injection: 2 years.

Film-coated tablets: 2 years.

06.4 Special precautions for storage

Film-coated tablets: store at a temperature not exceeding 30 ° C

Pre-filled syringes: keep in the original packaging to protect the product from light.

After use, do not dispose of empty containers in the environment.

06.5 Nature of the immediate packaging and contents of the package

Solution for injection for subcutaneous use:

- 2 pre-filled 6 mg syringes with PENKIT auto-injector

Film-coated tablets

- 4 film-coated tablets of 100 mg in OPA-Al-PVC / Al blisters

- 4 film-coated tablets of 50 mg in OPA-Al-PVC / Al blisters

06.6 Instructions for use and handling

Needles and syringes can be dangerous and must be disposed of properly and safely.

07.0 MARKETING AUTHORIZATION HOLDER

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 - Verona.

08.0 MARKETING AUTHORIZATION NUMBER

IMIGRAN 6 mg / 0.5 ml Solution for injection for subcutaneous use -

2 pre-filled syringes with PENKIT A.I.C .: 027975061 auto-injector

IMIGRAN 100 mg Film-coated tablets - 4 tablets A.I.C .: 027975059

IMIGRAN 50 mg Film-coated tablets - 4 tablets A.I.C .: 027975073

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

IMIGRAN 6 mg Solution for injection for subcutaneous use - 2 pre-filled syringes with auto-injector PENKIT: 27 July 1993 / December 2006

IMIGRAN 100 mg Film-coated tablets: November 28, 1991 / December 2006

IMIGRAN 50 mg Film-coated tablets: 11 July 2001 / December 2006

10.0 DATE OF REVISION OF THE TEXT

December 2013

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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