Xamamina - Package Leaflet

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

Active ingredients: Dimenhydrinate

XAMAMINE 50 mg soft capsules
XAMAMINE Children 25 mg soft capsules
XAMAMINE 25 mg medicated chewing gum

Why is Xamamina used? What is it for?

XAMAMINE contains the active substance dimenhydrinate which belongs to the category of anti-emetic (against vomiting) and anti-nausea medicines.

XAMAMINA is used for seasickness, air, car and train sickness.

Contact your doctor if you do not notice any improvement or if you notice worsening of your symptoms after a short period of treatment

Contraindications When Xamamina should not be used

Do not take XAMAMINA

  • if you are allergic to dimenhydrinate, other antihistamines or any of the other ingredients of this medicine
  • in case of pregnancy and lactation.

Xamamina is contraindicated in children under 2 years of age.

Precautions for use What you need to know before taking Xamamina

Talk to your doctor or pharmacist before taking XAMAMINE.

If you are being treated with ototoxic drugs (which cause damage to the ear) you should take this medicine with caution as it may mask the symptoms of ear toxicity.

If you have narrow-angle glaucoma (increased pressure inside the eye), prostatic hypertrophy (enlarged prostate), urinary retention (difficulty urinating), slowed intestinal transit (constipation), bronchial asthma, epilepsy , porphyria (rare hereditary disease) you should take this medicine with caution.

Children

Do not use in children under 2 years of age.

Interactions Which drugs or foods can modify the effect of Xamamina

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Take care in case of concomitant administration of:

  • other CNS depressants, such as alcohol, barbiturates (drugs against depression), other hypnotics (drugs that induce sleep), sedatives or tranquilizers, as concomitant intake may increase the sedative effects.
  • other anticholinergic drugs, including antidepressants as it may increase their effects.
  • aminoglycoside antibiotics or other ototoxic drugs, as dimenhydrinate can mask the first symptoms of ear toxicity which can only reveal itself when the damage is irreversible (see section "Warnings and precautions").

XAMAMINA with alcohol

The medicine may increase the effects of alcohol. In such cases, be careful if you experience increased sedative effects.

Warnings It is important to know that:

Pregnancy and breastfeeding

XAMAMINA is contraindicated in pregnancy and during lactation.

Driving and using machines

This medicine, like other antihistamines, can cause sedation which can manifest as sleepiness as an undesirable effect. If you experience these side effects, you should be careful s in carrying out tasks that require vigilance such as driving cars and using machines.

XAMAMINA contains:

  • soft capsules, medicated chewing gums and chewable tablets contain sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
  • Medicated chewing gums also contain aspartame. This medicine contains a source of phenylalanine. It can be harmful to you if you have phenylketonuria.
  • The soft capsules also contain sodium ethyl parahydroxybenzoate (E215) and sodium propyl parahydroxybenzoate (E217). They can cause allergic reactions (even delayed).

Dosage and method of use How to use Xamamina: Dosage

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

XAMAMINE 50 mg soft capsules

The recommended dose is:

  • Adults: 1 soft capsule half an hour before the trip; if necessary repeat the dose after 3-4 hours, up to a maximum of 4 soft capsules in 24 hours.

The soft capsule should not be chewed, but swallowed even without water

XAMAMINE Children 25 mg soft capsules

The recommended dose is:

  • Children aged between 2-6 years: 1 soft capsule of XAMAMINE Children half an hour before travel up to a maximum of 3 times in 24 hours.
  • Children aged 7-12 years: 1-2 soft capsules of XAMAMINA Children half an hour before the trip, up to a maximum of 2-3 times in 24 hours.

The soft capsule should not be chewed, but swallowed even without water.

Xamamina Children 25 mg soft capsules should not be used in children under 2 years of age.

XAMAMINE 25 mg medicated chewing gum

The recommended dose is:

  • Adults: 1 medicated chewing gum at the first symptoms of nausea; the effect lasts about 4 hours. If necessary, repeat the dose after 3-4 hours, up to a maximum of 4 medicated chewing gums in 24 hours.
  • Children between the ages of 4 and 12: 1 medicated chewing gum half an hour before the trip or at the first symptoms of nausea and vomiting and if necessary repeat the dose after 6-8 hours, up to a maximum of 2 medicated chewing gums in 24 hours.

The medicated chewing gum should be chewed without swallowing it. Xamamina Children 25 mg medicated chewing gum should not be used in children under 4 years of age.

Do not exceed the prescribed dose unless recommended by your physician.

Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.

Use only for short periods of treatment.

Overdose What to do if you have taken too much Xamamina

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

The most common symptom of overdose is sleepiness. Toxic doses can cause seizures, coma and breathing problems.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Side Effects What are the side effects of Xamamina

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

With the use of antihistamines, sedation, drowsiness, dry mouth, sensitivity to light, visual disturbances, disturbances in the ability to urinate, headaches, anorexia, nausea, allergic skin reactions may occur.

Less frequently dizziness, feeling of weakness, insomnia (especially in children), euphoria, tremors, convulsions (especially in children), decreased blood pressure, increased heart rate.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 the safety of this medicine.

Expiry and Retention

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

Do not use this medicine after the expiry date which is stated on the carton after EXP.

XAMAMINA soft capsules: Store at a temperature not exceeding 25 ° C.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

What XAMAMINA contains

XAMAMINE 50 mg soft capsules

  • The active ingredient is dimenhydrinate. One soft capsule contains: 50 mg of dimenhydrinate.
  • The other ingredients are: macrogol 400. Capsule shell: gelatin; partially dehydrated liquid sorbitol; ethyl sodium-parahydroxybenzoate (E215); propyl sodium parahydroxybenzoate (E 217).

XAMAMINE Children 25 mg soft capsules

  • The active ingredient is dimenhydrinate. One soft capsule contains: 25 mg of dimenhydrinate.
  • The other ingredients are: macrogol 400. Capsule shell: gelatin; partially dehydrated liquid sorbitol; ethyl sodium-parahydroxybenzoate (E215); propyl sodium parahydroxybenzoate (E 217).

XAMAMINE 25 mg medicated chewing gum

  • The active ingredient is dimenhydrinate. One medicated chewing gum contains: 25 mg of dimenhydrinate.
  • The other ingredients are: Core: Type A methacrylic acid copolymer, sorbitol, mint flavor, magnesium stearate, gum base, levomenthol, aspartame, talc, colloidal silica, anhydrous tricalcium phosphate. Coating: hypromellose, macrogol 6000, titanium dioxide, yellow quinoline (E104), patent blue V (E131).

Description of what XAMAMINA looks like and contents of the pack

It comes in the form of soft capsules and medicated chewing gum.

XAMAMINE 50 mg soft capsules: Carton containing 2, 6, 10 capsules

XAMAMINE Children 25 mg soft capsules: Box containing 6 capsules

XAMAMINE 25 mg medicated chewing gum: Box containing 6 gums

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 Xamamina 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, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

XAMAMINA

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

XAMAMINE 50 mg soft capsules

One soft capsule contains:

active ingredient: dimenhydrinate 50 mg

Excipients: sorbitol, parabens

XAMAMINE Children 25 mg soft capsules

One soft capsule contains:

active ingredient: dimenhydrinate 25 mg

Excipients: sorbitol, parabens

XAMAMINE 25 mg medicated chewing gum

A medicated chewing gum contains:

active ingredient: dimenhydrinate 25 mg

Excipients: Aspartame, sorbitol

For the full list of excipients, see section 6.1

03.0 PHARMACEUTICAL FORM

Soft capsules

Medicated chewing gum

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Sea, plane, car and train sickness.

04.2 Posology and method of administration

XAMAMINE 50 mg soft capsules

In adults 1 soft capsule half an hour before the trip; if necessary repeat the dose after 3-4 hours, up to a maximum of 4 soft capsules in 24 hours.

XAMAMINE Children 25 mg soft capsules

In children aged 2-6 years 1 soft capsule of Xamamina Children half an hour before travel up to a maximum of 3 times in 24 hours. In children aged 7-12 years 1-2 soft capsules of Xamamina Children half an hour "hour before the trip, up to a maximum of 2-3 times in 24 hours.

XAMAMINE 25 mg medicated chewing gum

In adults 1 medicated chewing gum at the first symptoms of nausea; the effect lasts about 4 hours. If necessary, repeat the dose after 3-4 hours, up to a maximum of 4 medicated chewing gums in 24 hours.

In children aged between 4 and 12 years 1 medicated chewing gum half an hour before the trip or at the first symptoms of nausea and vomiting and if necessary repeat the dose after 6-8 hours, up to a maximum of 2 gum chew medicated within 24 hours.

Do not exceed the recommended dose.

04.3 Contraindications

Hypersensitivity to the active substance, to other antihistamines or to any of the excipients.

Contraindicated in children under 2 years of age.

Contraindicated during pregnancy and breastfeeding.

04.4 Special warnings and appropriate precautions for use

The product should be administered with caution in subjects suffering from narrow-angle glaucoma, prostatic hypertrophy, urinary retention, slowing of intestinal transit, bronchial asthma, epilepsy, porphyria.

The product may mask the symptoms of ototoxicity and therefore should be administered with caution to patients receiving ototoxic drugs.

Soft capsules and medicated chewing gums contain sorbitol: Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Soft capsules contain parabens which can cause allergic reactions (including delayed).

Medicated chewing gums contain aspartame, a source of phenylalanine. It can be harmful to you if you have phenylketonuria.

04.5 Interactions with other medicinal products and other forms of interaction

The product may enhance the effects of other CNS depressants, such as alcohol, barbiturates, other hypnotics, sedatives or tranquilizers. In case of concomitant intake of these substances, attention must be paid in order to avoid additive phenomena of sedation.

The product may potentiate the effects of other anticholinergic drugs, including antidepressants. If administered concomitantly with aminoglycoside antibiotics or other ototoxic drugs, dimenhydrinate can mask the first symptoms of ototoxicity, which can only be detected when the damage is irreversible (see also section 4.4).

04.6 Pregnancy and breastfeeding

Pregnancy. In reproduction studies in rats and rabbits doses 20-25 times higher than those normally used in therapy in humans did not show teratogenic effects or reduced fertility. However, no data are available on the use of the product in pregnant women. Therefore, although the teratogenicity of the product appears unlikely, the use of dimenhydrinate in pregnancy is contraindicated.

Feeding time. Small amounts of dimenhydrinate pass into breast milk. Given the possible adverse events of the product in infants, the use of dimenhydrinate during lactation is contraindicated.

04.7 Effects on ability to drive and use machines

Since the most frequent secondary effect of antihistamines is sedation which can manifest itself as drowsiness, this must be taken into account by those who carry out operations requiring integrity of the degree of vigilance (driving vehicles, operating machinery).

04.8 Undesirable effects

The following side effects have been reported following treatment with Xamamina:


System organ class More frequent side effects Frequent side effects Less frequent side effects Disorders of metabolism and nutrition Anorexia Psychiatric disorders Insomnia (especially in children), euphoria Disorders of the nervous system Sedation, sleepiness Headache Vertigo, tremors, convulsions (especially in children) Disorders of vision Disorders of accommodation Cardiac disorders Tachycardia Vascular disorders Hypotension Gastrointestinal disorders Dry mouth, nausea Disorders of the skin and subcutaneous tissue Photosensitivity, skin reaction on an allergic basis Renal and urinary disorders Disorders of urination General Disorders and Administration Site Conditions Asthenia

"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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse".

04.9 Overdose

In case of overdose consult your doctor immediately.

Sleepiness is the most usual symptom of overdosing. Toxic doses can produce: convulsion, coma and respiratory depression. If necessary, implement symptomatic therapy.

When needed, respiratory assistance.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: antiemetics and antinauseants

ATC code A04AD49

The pharmacodynamic properties of dimenhydrinate consist of antiemetic, antihistamine and anticholinergic activity. Dimenhydrinate also has a depressive activity on the central nervous system. Although the exact mechanism of its antiemetic action has not been fully understood, it has been shown that dimenhydrinate inhibits labyrinth stimulation, acting first on the otolith system and, for higher doses, also on the semicircular canals of the auricular labyrinth.

Dimenhydrinate has an anticholinergic action and this activity is considered by some authors to be the main mechanism of action, since the cholinergic stimulation of the vestibular and reticular systems could be responsible for nausea and vomiting resulting from movement.

The central nervous system depressant effects usually subside after a few days of treatment. After prolonged use, there may be a slight reduction in antiemetic activity.

05.2 Pharmacokinetic properties

After administration, as a single oral dose, diphenhydramine appears in the blood within 15 minutes and peak plasma concentrations are obtained between 1 and 4 hours. The concentration remains high for a similar period and then runs exponentially so that the plasma half-life is 6-7 hours.

The drug is uniformly distributed in the different tissues of the body, including the CNS and almost all of the drug is eliminated in the urine in the form of metabolites.

The main site of metabolic transformation is in the liver.

Diphenhydramine crosses the placenta and has been found in breast milk.

05.3 Preclinical safety data

The LD50 values ​​obtained after oral administration, in a single dose, in mice and rats, are respectively 150 and 600 times the human DTeS per kg.

Repeated oral administration for 3 months in rats of both sexes and in dogs, did not cause any weight alteration in the animals treated with the low dose while it caused a weight loss, related to the decrease in feed consumption, in those treated with the high dose. The chemical-clinical, haematological examinations, the weight of the organs and the histological examination did not show any difference with respect to the controls.

Daily oral administration of Xamamina to rats did not cause alterations in any parameter relating to the mothers and did not show teratogenic action.

Xamamina did not cause any change in fertility in either male or female.

The administration of 35 and 70 mg / kg of Xamamine orally to rats, for the entire duration of pregnancy and lactation, also did not determine changes in the weight parameters relating to the mothers in both periods, neither in the duration of gestation nor the number and weight of those born.

The teratogenic study performed by administering Xamamine to pregnant rabbits did not show the presence of toxic effects either on the mother or on the organogenesis level.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

XAMAMINE 50 mg soft capsules and XAMAMINE Children 25 mg soft capsules

macrogol 400.

Casing:

jelly; partially dehydrated liquid sorbitol; ethyl sodium-parahydroxybenzoate (E215); propyl sodium parahydroxybenzoate (E 217).

XAMAMINE 25 mg medicated chewing gum

Core: copolymer of Type A methacrylic acid, sorbitol, mint flavor, magnesium stearate, gum base, levomentol, aspartame, talc, colloidal silica, anhydrous tricalcium phosphate;

Coating: hypromellose, macrogol 6000, titanium dioxide, quinoline yellow (E104), patent blue V (E131).

06.2 Incompatibility

None known

06.3 Period of validity

XAMAMINA 50 mg soft capsules and XAMAMINA Children 25 mg soft capsules: 5 years.

XAMAMINE 25 mg medicated chewing gum: 3 years.

06.4 Special precautions for storage

Xamamina soft capsules: store at a temperature not exceeding 25 ° C

06.5 Nature of the immediate packaging and contents of the package

Opaque white PVC / PVDC blister sealed with coupled aluminum and heat-sealing plastic material.

XAMAMINE 50 mg soft capsules Box of 2, 6, 10 capsules

XAMAMINE Children 25 mg soft capsules Box of 6 capsules

XAMAMINE 25 mg medicated chewing gum Box of 6 gums

06.6 Instructions for use and handling

The soft capsule should not be chewed, but swallowed even without water.

The medicated chewing gum goes to chew it without swallowing it.

07.0 MARKETING AUTHORIZATION HOLDER

BRACCO S.p.A.

Via E. Folli, 50

MILAN 20134

08.0 MARKETING AUTHORIZATION NUMBER

XAMAMINE 50 mg soft capsules

Box of 2 A.I.C. capsules 002955058

Box of 6 A.I.C. capsules 002955060

Box of 10 A.I.C. capsules 002955072

XAMAMINE Children 25 mg soft capsules

Box of 6 A.I.C. capsules 002955108

XAMAMINE 25 mg medicated chewing gum

Box of 6 A.I.C. 002955134

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

XAMAMINE 50 mg soft capsules

First authorization: December 1986. Renewal 2010

XAMAMINE Children 25 mg soft capsules

First authorization: February 1988. Renewal 2010

XAMAMINE 25 mg medicated chewing gum

First authorization: July 2000. Renewal 2010

10.0 DATE OF REVISION OF THE TEXT

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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