Voltadvance - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Diclofenac (Diclofenac sodium)

VOLTADVANCE 25 mg film-coated tablets
VOLTADVANCE 25 mg powder for oral solution

Indications Why is Voltadvance used? What is it for?

Voltadvance contains the active substance diclofenac sodium, which belongs to the class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Voltadvance works by reducing pain and inflammation.

Voltadvance is indicated for the treatment of pain of various origins and nature, such as:

  • joint pain
  • back pain (lumbago)
  • pain in the muscles, including a stiff neck
  • headache
  • toothache
  • menstrual cramps

Talk to your doctor if you do not feel better or if you feel worse after 2 - 3 days of treatment.

Contraindications When Voltadvance should not be used

Do not take Voltadvance

  • if you are allergic to diclofenac sodium or any of the other ingredients of this medicine (listed in section 6)
  • if you have an ongoing ulcer, bleeding or perforation of the stomach or intestines
  • if you have ever had stomach or bowel bleeding (haemorrhage) or perforation after previous NSAID treatment
  • if you have ever had bleeding or ulcer that occurred repeatedly (two or more distinct episodes of proven ulceration or bleeding)
  • if you have severe liver or kidney failure
  • if you have overt heart disease and / or cerebral vascular disease, eg have had a heart attack, stroke, mini-stroke (TIA) or "blockage of blood vessels to the heart or brain or surgery to eliminate or avoid such obstructions
  • if you have or have suffered from blood circulation problems (peripheral arterial disease)
  • if you have had attacks of asthma, hives, acute rhinitis or severe allergic reactions, which occurred after taking acetylsalicylic acid or other NSAIDs
  • if you have an "alteration in the production of blood cells
  • if you are taking high doses of medicines that increase urine production (diuretics) (see "Other medicines and Voltadvance")
  • if your stools are dark or contain blood
  • if you are breast-feeding (see section "Pregnancy, breast-feeding and fertility")
  • if you are in the last three months of pregnancy (see section "Pregnancy, breast-feeding and fertility")
  • if you are under the age of 14.

Precautions for use What you need to know before taking Voltadvance

Talk to your doctor or pharmacist before taking Voltadvance.

Before taking Voltadvance make sure your doctor knows:

  • if you have asthma
  • if you have an allergic seasonal cold (allergic rhinitis), swelling of the nasal mucosa (e.g. nasal polyps)
  • if you have chronic obstructive pulmonary disease or chronic respiratory tract infections
  • if you have liver or kidney problems, unless you have severe liver or kidney failure because in these latter cases you should not take Voltadvance (see section 2 "Do not take Voltadvance"). If you are unsure, ask your doctor.
  • if you have liver porphyria
  • if you have ulcerative colitis or Crohn's disease as these conditions may get worse
  • if you are using medicines that increase urine production (diuretics) or other medicines that can affect the way your kidneys work
  • if you have a low volume of body fluids (for example before or after major surgery)
  • if you are due to undergo or have had major surgery
  • if you have blood clotting defects (haemostasis defects)
  • if you have or have had heart problems
  • if you smoke
  • if you have diabetes
  • if you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
  • if you experience any signs or symptoms of heart or blood vessel problems such as chest pain, shortness of breath, weakness or slurred speech, contact your doctor immediately
  • if you have stomach or bowel problems, unless you have one or more conditions that you should not take Voltadvance (see section "Do not take Voltadvance")
  • if you are taking medicines that may increase the risk of bleeding, ulceration and perforation such as acetylsalicylic acid (e.g. aspirin) and other NSAIDs, corticosteroids given by mouth, by injection or rectally (e.g. cortisone), medicines to thin the blood ( anticoagulants and antiplatelet agents), selective serotonin reuptake inhibitors (antidepressants) (see section "Other medicines and Voltadvance").

In these cases, your doctor will monitor you closely and periodically re-evaluate the need for treatment with Voltadvance. In addition, your doctor may have you have periodic tests (such as monitoring your kidney or liver function) to evaluate your condition during treatment with Voltadvance.

Stop treatment and tell your doctor if you develop during treatment with Voltadvance:

  • gastrointestinal bleeding or ulceration
  • skin reactions, as severe skin reactions which can be fatal have been reported very rarely (see section 4.8)
  • mucosal lesions or any other signs of an allergic reaction
  • fluid retention and swelling from fluid accumulation (edema)
  • signs and symptoms of liver problems or if your liver function parameters are abnormal (visible in blood tests)
  • unusual symptoms in the stomach and intestines
  • worsening of headache because prolonged use of medicines to reduce the headache can in some cases make it worse
  • symptoms of an "infection (eg headache, fever) or if you notice an infection worsening" as Voltadvance may hide the signs and symptoms of the infection.

In these cases, your doctor will consider whether to continue or stop treatment with Voltadvance.

Other important information:

  • During treatment with NSAIDs, including diclofenac, bleeding from the gastrointestinal tract, ulceration or perforation, which can even cause death, can occur. The risk of gastrointestinal bleeding is higher with high doses of NSAIDs and in patients who have had an ulcer, especially if complicated with bleeding or perforation. You should take the lowest effective dose of diclofenac to reduce the risk of gastrointestinal toxicity and your doctor he may also prescribe medicines (for example misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
  • Medicines such as Voltadvance may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses or prolonged treatment.
  • Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary (see section 3 "How to take Voltadvance")
  • Avoid the use of diclofenac during treatment with other NSAIDs given by mouth, by injection and rectally, including selective cyclo oxygenase-2 inhibitors, as it increases the chance that you will have side effects.

Children and adolescents

Voltadvance is contraindicated in children and adolescents under 14 years of age.

Elderly patients

Elderly patients are more likely to experience adverse reactions, especially stomach or bowel bleeding and perforation, which are usually more serious and can be fatal.

If you are elderly you should take the lower dose of Voltadvance. As a precaution, your doctor may have you check your kidney function and prescribe medicines that work by protecting the gastrointestinal mucosa such as misoprostol or proton pump inhibitors.

Tell your doctor about any unusual stomach and bowel symptoms.

Interactions Which drugs or foods can change the effect of Voltadvance

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are using any of the medicines listed below before taking Voltadvance:

  • lithium (medicine for mood disorders)
  • digoxin (heart medicine)
  • methotrexate (cancer medicine)
  • phenytoin (anti-epilepsy medicine)
  • diuretics, including potassium-sparing, and blood pressure lowering medicines (ACE inhibitors, beta blockers and angiotensin II antagonists), particularly if you have kidney problems
  • anti-inflammatory medicines (NSAIDs and corticosteroids)
  • medicines to thin the blood (anticoagulant or antiplatelet medicines)
  • serotonin reuptake inhibitors (medicines for depression)
  • medicines for diabetes
  • cyclosporine, interferon alpha (immunosuppressants used to change the response of the body's immune system)
  • medicines to fight bacterial infections of the quinolone class
  • colestipol and cholestyramine (medicines to lower cholesterol)
  • sulfinpyrazone (used for gout) and voriconazole (used for fungal infections)
  • intrauterine devices, as their effectiveness may decrease
  • medicines that increase the levels of potassium in the blood (potassium-sparing diuretics, cyclosporine, tacrolimus or trimethoprim), as in this case your doctor will have you have frequent blood tests.

Warnings It is important to know that:

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Conception, first and second trimester of pregnancy

Diclofenac should not be used during the first and second trimester of pregnancy unless clearly needed. Your doctor will consider whether the benefits to you clearly outweigh the risks to the fetus.

If you want to get pregnant or are in the first or second trimester of pregnancy and need to use diclofenac, take the lowest dose of diclofenac for the shortest possible time.

Third trimester of pregnancy

Diclofenac is contraindicated during the third trimester of pregnancy because it can cause serious harm to the mother and baby.

Feeding time

Diclofenac passes into breast milk in small quantities, therefore Voltadvance is contraindicated during breastfeeding.

Fertility

As with other NSAIDs, Voltadvance is not recommended in women planning to become pregnant because this medicine can affect a woman's fertility. Your doctor will consider the need to stop treatment with Voltadvance if you have difficulty getting pregnant or need to have fertility tests.

Driving and using machines

Avoid driving or operating machines if you have or have had in the past with the use of diclofenac disturbed vision, dizziness, vertigo, somnolence or other central nervous system disorders.

Dose, Method and Time of Administration How to use Voltadvance: Posology

Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.

Use in adults and adolescents over 14 years of age

1-3 coated tablets or sachets per day, with meals, even 2 in a single administration.

The maximum daily dose is 75 mg.

Take Voltadvance preferably on a full stomach.

Voltadvance tablets should be taken whole with some water or some other liquid.

Voltadvance sachets must be dissolved in a glass of water before being taken.

Take care not to exceed the recommended doses without your doctor's advice. If you are elderly you should use the lowest possible dose above.

Do not use for more than 3 days.

Talk to your doctor if you do not feel better or if you feel worse after 2-3 days of treatment.

Use in children and adolescents under 14 years of age

Voltadvance should not be used in children and adolescents under 14 years of age.

Use in the elderly

The dose of diclofenac may need to be reduced in the elderly. If you are elderly you should use the lowest possible dose above.

Use in patients with kidney problems

Voltadvance must not be used in patients with severe renal insufficiency. The medicinal product should be used with caution in patients with mild to moderate renal insufficiency.

Use in patients with liver problems

Voltadvance must not be used in patients with severe phage insufficiency.

The medicine should be used with caution in patients with mild to moderate liver failure.

Overdose What to do if you have taken too much Voltadvance

If you take more Voltadvance than you should

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

If you take an overdose of diclofenac you may have

  • He retched
  • bleeding from the stomach and intestines
  • diarrhea
  • dizziness
  • ringing or ringing in the ears
  • convulsions.

In severe cases, severe kidney and liver damage can also occur.

Your doctor will treat acute poisoning with non-steroidal anti-inflammatory drugs, including diclofenac, based on your symptoms.

If you forget to take Voltadvance

Do not take a double dose to make up for a forgotten dose.

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 Voltadvance

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

If any of these effects appear during treatment with Voltadvance, we recommend that you stop the medicine and consult your doctor.

Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary.

Common side effects (may affect up to 1 in 10 people)

  • headache, dizziness, vertigo
  • nausea, vomiting
  • diarrhea, gas (flatulence)
  • problems with digestion (dyspepsia), pain in the abdomen
  • lack or reduced appetite (anorexia)
  • changes in tests to evaluate liver function (increased transaminases)
  • rash on the skin

Uncommon side effects (may affect up to 1 in 100 people)

These effects occurred after treatment for a long time and with a high dose (150 mg per day).

  • heart attack
  • heart problems (heart failure)
  • perception of one's heartbeat (palpitations)
  • chest pain

Rare side effects (may affect up to 1 in 1,000 people)

  • allergic reactions, severe allergic reactions even after the first use of the medicine (anaphylactic and anaphylactoid reactions) including hypotension and collapse (shock)
  • drowsiness
  • asthma, difficulty in breathing (dyspnoea)
  • inflammation of the stomach (gastritis), bleeding from the stomach or intestines, vomiting with blood (haematemesis), stomach or intestinal ulcer with or without bleeding and perforation
  • diarrhea accompanied by bleeding, dark bloody stools (melaena)
  • dryness of the mouth and mucous membranes
  • inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorder
  • urticaria
  • swelling from fluid accumulation (edema).

Very rare side effects (may affect up to 1 in 10,000 people)

  • abnormal values ​​in blood tests; reduction in the number of platelets (thrombocytopenia), reduction in the number of white blood cells (leukopenia, agranulocytosis), anemia (including haemolytic and plastic anemia)
  • abnormal values ​​in urinalysis: presence of blood in the urine (haematuria), presence of proteins in the urine (proteinuria)
  • swelling of the skin and mucous membranes (angioneurotic edema) including face edema
  • disorientation, depression, insomnia, nightmares, irritability, severe mental changes (psychotic reactions)
  • worsening of memory, seizures, anxiety, tremors
  • changes in the sensitivity of the limbs or other parts of the body (paraesthesia)
  • changes in taste
  • inflammation of the membranes that line the brain and spinal cord (aseptic meningitis), damage to the blood vessels of the brain (cerebrovascular accidents)
  • visual disturbances, blurred vision, double vision (diplopia)
  • ringing or ringing in the ears (tinnitus), impaired hearing
  • high blood pressure (hypertension)
  • inflammation of blood vessels (vasculitis)
  • pneumonia
  • inflammation of the colon (colitis) including colitis accompanied by bleeding and worsening of ulcerative colitis or Crohn's disease
  • constipation (constipation)
  • inflammation of the lining of the mouth (stomatitis) including stomatitis with ulcers
  • inflammation of the tongue (glossitis)
  • problems with the esophagus, narrowing of the intestine (diaphragmatic intestinal stenosis)
  • inflammation of the pancreas (pancreatitis)
  • very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (liver failure)
  • skin reactions ranging from mild to life-threatening (bullous rashes, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis)
  • appearance of red-brown spots on the skin (purpura), allergic purpura, itching
  • hair loss
  • appearance of spots or redness on the skin following exposure to sunlight or sunlamps
  • impaired kidney functions (acute renal failure), nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

Medicines such as Voltadvance may be associated with a small increased risk of heart attack (heart attack) or stroke (see "Warnings and precautions" above).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. 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.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the package after

Expiration. The expiry date refers to the last day of that month.

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.

Composition and pharmaceutical form

What Voltadvance contains

Voltadvance 25 mg film-coated tablets

  • The active ingredient is diclofenac sodium. Each film-coated tablet contains 25 mg of diclofenacsodium.
  • The other ingredients are potassium bicarbonate, mannitol, sodium lauryl sulfate, crospovidone, megnesium stearate, glycerol dibeenate, Clear Opadry (hypromellose, macrogol).

Voltadvance 25 mg powder for oral solution

  • The active ingredient is diclofenac sodium. Each sachet contains 25 mg of diclofenac sodium.
  • The other ingredients are potassium bicarbonate, mannitol, acesulfame potassium, glycerol dibeenate, mint flavor, anise flavor.

Description of the appearance of Voltadvance and contents of the package

Voltadvance 25 mg film-coated tablets

Each pack contains 10 or 20 film-coated tablets for oral use, in blister packs.

Voltadvance 25 mg powder for oral solution

Each pack contains 10 or 20 sachets of powder for oral solution.

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 Voltadvance can be found in the "Summary of Features" 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 interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the primary packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER CIO 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

VOLTADVANCE

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

One film-coated tablet contains: active ingredient diclofenac sodium 25 mg.

One sachet of powder for oral solution contains: active ingredient diclofenac sodium 25 mg.

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

Film-coated tablets.

Powder for oral solution.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Pain of various kinds such as, for example, pain in the joints, lumbago, muscle pain, headache and toothache, menstrual pain. As an adjuvant in the therapy of influenza and in feverish states.

04.2 Posology and method of administration

Adults and adolescents over 14 years: 1-2 coated tablets or sachets of powder for oral solution, for single administration, 1-2 times a day.

Do not exceed the recommended dose; in particular elderly patients must follow the minimum dosages indicated above.

The coated tablets should be swallowed whole, with water or other liquid; the sachets of powder should be dissolved in a glass of water before taking.

We recommend taking the product preferably on a full stomach.

As an antifebrile use the product for a maximum of 3 days. As an analgesic, do not exceed 5 days of treatment.

Undesirable effects can be minimized by administering the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 "Special warnings and precautions for use").

04.3 Contraindications

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

• Active gastrointestinal ulcer, bleeding or perforation.

• History of gastrointestinal bleeding or perforation related to previous NSAID treatment or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

• Last trimester of pregnancy and during lactation (see section 4.6).

• Severe hepatic insufficiency, severe renal insufficiency or severe heart failure (see section 4.4).

• Like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients who have experienced asthma attacks, acute urticaria or rhinitis, anaphylactic or anaphylactoid reactions after taking acetylsalicylic acid or other NSAIDs (see section 4.4).

• The product must not be used in case of alterations of hematopoiesis.

• In case of intensive diuretic therapy.

• The product should not be taken in case of dark or bloody stools.

• Overt congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral arterial disease and / or cerebral vascular disease.

Voltadvance should not be given to children under the age of 14.

04.4 Special warnings and appropriate precautions for use

After 2-3 days of treatment without noticeable results, consult your doctor.

General informations

Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2 and the paragraphs below on gastrointestinal and cardiovascular risks).

The use of diclofenac concomitantly with other systemic NSAIDs, including selective cyclo-oxygenase-2 inhibitors, should be avoided due to the lack of any evidence showing synergistic benefits and based on potential additive side effects.

On a basic medical level, caution is required in the elderly. Particularly in frail elderly patients or in those with a low body weight, the use of the lowest effective dose is recommended.

As with other NSAIDs, allergic reactions, including anaphylactic / anaphylactoid reactions, may also occur in rare cases without prior exposure to diclofenac. Like other NSAIDs, diclofenac can mask the signs and symptoms of infections due to its pharmacodynamic properties.

Prolonged use of any type of pain reliever for headaches can make them worse. If this has been experienced or suspected, medical advice should be sought and treatment should be discontinued. Diagnosis of drug overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite regular use of headache medications.

Gastrointestinal effects

During treatment with all NSAIDs, including diclofenac, they have been reported and may appear at any time, with or without warning symptoms or a previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration or perforation, which can be fatal.

They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the medicinal product should be discontinued.

As with all NSAIDs, including diclofenac, close medical surveillance is mandatory and particular caution should be used when prescribing diclofenac to patients with symptoms indicative of gastrointestinal (GI) disorders or with a history indicative of gastric or intestinal ulceration, bleeding or perforation. chronic inflammatory bowel diseases (see section 4.8). The risk of GI bleeding is higher with increased doses of NSAIDs and in patients with a history of ulcer, especially if complicated with haemorrhage or perforation. The elderly have a higher frequency of adverse reactions, especially gastrointestinal bleeding and perforation which can be fatal.

To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, treatment should be initiated and maintained at the lowest effective dose.

Concomitant use of protective agents (proton pump inhibitors or misoprostol) should be considered for these patients and also for patients requiring concomitant use of medicinal products containing low doses of acetylsalicylic acid (ASA) or other medicinal products that may increase the risk gastrointestinal.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is advised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, antiplatelet agents or selective serotonin reuptake inhibitors (see section 4.5).

Close medical surveillance and caution should also be exercised in patients with ulcerative colitis or Crohn's disease as these conditions may be exacerbated (see section 4.8).

Hepatic effects

Close medical surveillance is required when prescribing diclofenac to patients with hepatic insufficiency as their condition may be exacerbated.

As with other NSAIDs, including diclofenac, the values ​​of one or more liver enzymes may increase. During prolonged treatment with diclofenac, regular checks of liver function are indicated as a precautionary measure. If liver function parameters are persistently altered or worsened, if clinical signs or consistent symptoms of liver disease develop, or if other manifestations (e.g. eosinophilia, rash) occur, diclofenac treatment should be discontinued. A "hepatitis with the use of diclofenac" can occur without prodromal symptoms.

Particular caution should be exercised in the use of diclofenac in patients with hepatic porphyria, as they can trigger an attack.

Kidney effects

Since fluid retention and edema have been reported in association with NSAID therapy, including diclofenac, special caution is required in cases of renal insufficiency, history of hypertension, in the elderly, in patients receiving concomitant diuretics or medicinal products that may significantly affect on renal function and in those patients with substantial extracellular volume depletion due to any cause (e.g. before or after major surgery) (see section 4.3). In such cases, monitoring of renal function is recommended as a precaution when administering diclofenac. Discontinuation of therapy is usually followed by a return to pre-treatment conditions.

Skin effects

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy, patients appear to be at highest risk for these reactions: the onset of the reaction occurs in most cases within the first month of treatment. Voltadvance should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.

Cardiovascular and cerebrovascular effects

Caution is required (consultation with doctor or pharmacist) before initiating treatment in patients with a history of hypertension as fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs.

Clinical trials and epidemiological data consistently indicate an increased risk of arterial thrombotic events (eg, myocardial infarction or stroke) associated with the use of diclofenac, especially at high doses (150 mg / day) and with long-term treatment.

Available data do not suggest an increased risk with the use of low dose diclofenac 25 mg up to 100 mg / day.

Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.

Since the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest possible duration and the lowest effective daily dose should be used. The response to therapy and the need for symptom improvement should be reassessed periodically.

Hematological effects

During prolonged treatment with diclofenac, as with other NSAIDs, blood count checks are recommended.

Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with haemostatic defects should be carefully monitored.

Pre-existing asthma

In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (eg, nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially when linked to symptoms similar to allergic rhinitis), are more common than in others patients reactions to NSAIDs such as asthma exacerbations (so-called analgesic intolerance / analgesic asthma), Quincke's edema or urticaria. Special precaution is therefore recommended in such patients (preparing for emergency). This also applies to patients allergic to other substances, eg. with skin reactions, itching or hives.

04.5 Interactions with other medicinal products and other forms of interaction

Before using the product, if you are taking other drugs, it is advisable to inform your doctor as it may be necessary to change the dosage or stop treatment.

The following interactions include those seen with diclofenac gastro-resistant tablets and / or other pharmaceutical forms of diclofenac.

Lithium: when administered concomitantly, diclofenac can elevate plasma lithium concentrations. Monitoring of serum lithium levels is recommended.

Digoxin: When administered concomitantly, diclofenac can elevate plasma digoxin concentrations. Monitoring of serum digoxin levels is recommended.

Diuretics and antihypertensive agents: Patients undergoing treatment with such drugs should consult their physician before taking the product.

Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (eg beta blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination must be taken with caution and patients, especially the elderly, should receive periodic monitoring of their blood pressure.

Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to an increased risk of nephrotoxicity. Concomitant treatment with potassium-sparing drugs it may be associated with increased serum potassium levels which should therefore be monitored frequently (see section 4.4).

Other NSAIDs and corticosteroids: Concomitant use of diclofenac and other systemic non-steroidal anti-inflammatory drugs or corticosteroids may increase the incidence of gastrointestinal side effects (see section 4.4).

Anticoagulants and antiplatelet agents: Caution is recommended as concomitant administration may increase the risk of bleeding (see section 4.4). Although there is no indication from clinical trial data of an "influence of diclofenac on the effect of anticoagulants", there have been isolated reports of an increased risk of haemorrhage in patients receiving diclofenac concomitantly with anticoagulants. Careful monitoring is therefore recommended for these patients.

Selective Serotonin Reuptake Inhibitors (SSRIs): Co-administration of systemic NSAIDs, including diclofenac, and SSRIs may increase the risk of gastrointestinal bleeding (see section 4.4).

Antidiabetics: Clinical studies have shown that diclofenac can be administered together with oral antidiabetic agents without affecting their clinical effect. However, isolated cases of both hypo- and hyperglycemic effects have been reported, with the need to modify the dosage of antidiabetic agents. administered during treatment with diclofenac For this reason, monitoring of blood glucose levels is recommended as a precautionary measure in case of concomitant therapy.

Methotrexate: diclofenac can inhibit renal tubular release of methotrexate by increasing its levels. Caution is advised when administering NSAIDs, including diclofenac, 24 hours before or after methotrexate treatment as blood concentrations of methotrexate and consequently the toxicity of this substance may increase.

Ciclosporin: Due to its effect on renal prostaglandins, diclofenac, like other NSAIDs, may increase the nephrotoxicity of cyclosporine. Therefore, diclofenac should be administered at lower dosages than those used in patients not on cyclosporine therapy.

Quinolone antibacterials: isolated cases of convulsions have been reported, probably due to the concomitant use of quinolones and NSAIDs.

Phenytoin: When using phenytoin together with diclofenac, monitoring of phenytoin plasma concentrations is recommended.

Colestipol and cholestyramine: These agents may induce a delay or decrease in the absorption of diclofenac. Therefore, it is recommended that diclofenac be administered at least one hour before or 4-6 hours after colestipol / cholestyramine administration.

Potent CYP2C9 inhibitors: Caution is advised when prescribing diclofenac together with potent CYP2C9 inhibitors (such as sulfinpyrazone and voriconazole); this can lead to a significant increase in peak plasma concentrations and exposure to diclofenac due to inhibition of its metabolism.

Diclofenac may also decrease the efficacy of intrauterine devices and the risk of inhibition of Interferon alfa has been reported.

04.6 Pregnancy and breastfeeding

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Results from epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%.

The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality.

In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.

During the first and second trimester of pregnancy, diclofenac should not be administered except in strictly necessary cases. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low as possible and the duration of treatment should be as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose

- the fetus to:

- cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);

- renal dysfunction, which can progress to renal failure with oligo-hydroamnios;

- the mother and the newborn, at the end of pregnancy, to:

- possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses;

- inhibition of uterine contractions resulting in delayed or prolonged labor.

Consequently, diclofenac is contraindicated during the third trimester of pregnancy.

Feeding time

Like other NSAIDs, diclofenac passes into breast milk in small amounts. Therefore, diclofenac should not be administered during breastfeeding to avoid undesirable effects in the infant.

Fertility

As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women wishing to conceive. Discontinuation of diclofenac in women who have difficulty conceiving or are undergoing investigation of infertility should be considered.

04.7 Effects on ability to drive and use machines

Patients who have experienced visual disturbances, dizziness, vertigo, somnolence or other central nervous system disorders with the use of diclofenac should refrain from driving or operating machinery.

04.8 Undesirable effects

Undesirable effects (Table 1) are listed below by organ, organ / system, and MedDRA frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 y

The following side effects include those reported with short or long term use.

Should any of these effects appear during treatment with Voltadvance, it is advisable to discontinue the drug and consult your doctor.

Table 1


Disorders of the blood and lymphatic system Very rare thrombocytopenia, leukopenia, anemia (including haemolytic and aplastic anemia), agranulocytosis. Disorders of the immune system Rare hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock). Very rare angioneurotic edema (including face edema). Psychiatric disorders Very rare disorientation, depression, insomnia, nightmares, irritability, psychotic reactions. Nervous system disorders common headache, dizziness. Rare drowsiness. Very rare paraesthesia, memory impairment, convulsions, anxiety, tremors, aseptic meningitis, taste disturbances, cerebrovascular accidents. Eye disorders Very rare vision disturbances, blurred vision, diplopia. Ear and labyrinth disorders common dizziness. Very rare tinnitus, hearing impairment. Cardiac pathologies Very rare palpitations, chest pain, heart failure, myocardial infarction. Vascular pathologies Very rare hypertension, vasculitis. Respiratory, thoracic and mediastinal disorders Rare asthma (including dyspnoea). Very rare pneumonia. Gastrointestinal disorders common nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia. Rare gastritis, gastrointestinal haemorrhage, haematemesis, haemorrhagic diarrhea, melaena, gastrointestinal ulcer (with or without bleeding or perforation), dry mouth and mucous membranes. Very rare colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorders, diaphragm-like intestinal strictures, pancreatitis, constipation. Hepatobiliary disorders common increased transaminases. Rare hepatitis, jaundice, liver disorders. Very rare fulminant hepatitis, hepatic necrosis, hepatic failure. Skin and subcutaneous tissue disorders common rash. Rare urticaria. Very rare bullous rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, hair loss, photosensitivity reaction, purpura, allergic purpura, pruritus. Renal and urinary disorders Very rare acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis. General disorders and administration site conditions Rare edema.

Clinical trials and epidemiological data consistently indicate an increased risk of arterial thrombotic events (for example, myocardial infarction or stroke) associated with the use of diclofenac, especially at high doses (150 mg / day) and with long-term treatment ( for contraindications and special warnings and precautions for use see sections 4.3 and 4.4).

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions that occur after authorization of the medicine is important as it allows for continuous monitoring of the benefit / risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: www.agenziafarmaco.gov.it/it/responsabili.

04.9 Overdose

In case of overdose contact your doctor.

Symptoms

There is no typical clinical picture resulting from diclofenac overdose. Overdose can cause symptoms such as vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus or convulsions. In the case of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures

Treatment of acute NSAID poisoning, including diclofenac, essentially consists of supportive measures and symptomatic treatment. In case of complications such as hypotension, renal failure, seizures, gastrointestinal disturbances and respiratory depression, supportive measures and symptomatic treatment should be adopted.

After ingestion of a potentially toxic overdose, the use of activated charcoal may be considered, while gastric emptying (eg vomiting, gastric lavage) may be considered after ingestion of a potentially life-threatening overdose.

Specific therapies, such as forced diuresis, dialysis or haemoperfusion, are unlikely to help eliminate NSAIDs, including diclofenac, due to their high plasma protein binding and extensive metabolism.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: non-steroidal antirheumatic anti-inflammatory drugs.

ATC code: M01AB05.

Voltadvance contains, as the active ingredient, the sodium salt of diclofenac, a non-steroidal molecule with marked analgesic, anti-inflammatory and antipyretic characteristics. The inhibition of prostaglandin biosynthesis, experimentally demonstrated, plays a fundamental role for its mechanism of action since prostaglandins are among the main causes of inflammation, pain and fever.

Voltadvance's coated tablets and powder perform their action quickly, which makes them particularly suitable for treating acute painful and inflammatory states.

Diclofenac sodium, in vitro, at concentrations equivalent to those reached in man, does not inhibit the biosynthesis of proteoglycans in cartilage.

05.2 Pharmacokinetic properties

Absorption

Diclofenac is rapidly and completely absorbed from the coated tablets and diclofenac sodium powder. After oral administration of Voltadvance the peak serum levels (Cmax) of diclofenac are approximately 800 ng / ml at 10 minutes (powder, Tmax) and 20 minutes (tablets, Tmax) after dosing.

Distribution

99.7% of diclofenac is bound to plasma proteins, mainly albumin (99.4%). The calculated apparent volume of distribution is 0.12-0.17 l / kg.

Diclofenac penetrates the synovial fluid, where maximum concentrations are measured 2-4 hours after reaching the plasma peak. The apparent half-life for elimination from the synovial fluid is 3-6 hours.

Two hours after reaching peak plasma values, concentrations of the active substance are already higher in the synovial fluid than in the plasma and remain so for up to 12 hours.

Biotransformation

The biotransformation of diclofenac occurs partially by glucuronidation of the molecule as such but mainly by hydroxylation and single and multiple methoxylation giving rise to phenolic metabolites (diclofenac 3 "-hydroxy-4" -hydroxy-5-hydroxy-4 ", 5-dihydroxy and 3 "-hydroxy-4" -methoxy-diclofenac), most of which are converted to glucuronic conjugates.Two of these phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.

Elimination

Total systemic clearance of diclofenac from plasma is 263 ± 56 ml / min (mean value ± standard deviation); the terminal plasma half-life is 1-2 hours.

Four of the metabolites, including the two pharmacologically active, have a "short plasma half-life of 1-3 hours. One metabolite, 3" -hydroxy-4 "-methoxy-diclofenac, has a much longer" plasma half-life; however, this metabolite is virtually inactive.

About 60% of the administered dose is excreted in the urine in the form of glucuronic conjugate of the intact molecule and as metabolites, most of which are also converted to glucuronic conjugates; less than 1% is excreted as unchanged substance. The remainder of the administered dose is excreted as metabolites with the bile in the faeces.

05.3 Preclinical safety data

Preclinical data from acute and repeated dose toxicity studies as well as those from genotoxicity, mutagenicity and carcinogenicity studies with diclofenac showed no specific risk for humans at usual therapeutic doses.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Film-coated tablets: potassium bicarbonate; mannitol; sodium lauryl sulfate; crospovidone; magnesium stearate; glycerol dibeenate; Clear Opadry (hypromellose; macrogol).

Powder for oral solution: potassium bicarbonate; mannitol; acesulfame potassium; glycerol dibeenate; mint flavor; anise aroma.

06.2 Incompatibility

None known.

06.3 Period of validity

5 years.

06.4 Special precautions for storage

This medicine does not require any special storage conditions.

06.5 Nature of the immediate packaging and contents of the package

Film-coated tablets: OPA / Al / PVC blister, sealed on aluminum backing.

Box of 10 and 20 coated tablets.

Sachets of powder for oral solution: paper / Al / PE sachets.

Box of 10 and 20 sachets.

Not all pack sizes may be marketed.

06.6 Instructions for use and handling

No special instructions.

07.0 MARKETING AUTHORIZATION HOLDER

Novartis Consumer Health S.p.A., Largo U. Boccioni 1 - Origgio (VA)

08.0 MARKETING AUTHORIZATION NUMBER

VOLTADVANCE 25 mg film-coated tablets, 10 tablets - A.I.C. n. 035500014

VOLTADVANCE 25 mg film-coated tablets, 20 tablets - A.I.C. n. 035500026

VOLTADVANCE 25 mg powder for oral solution, 10 sachets - A.I.C. n. 035500038

VOLTADVANCE 25 mg powder for oral solution, 20 sachets - A.I.C. n. 035500040

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

March 2005

10.0 DATE OF REVISION OF THE TEXT

AIFA determination of 7 January 2014.

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

none:  hair genetic-diseases posture