Metafen gel forte

Patient Information Leaflet

Metafen Gel Forte, 100 mg/g (10%), gel
Ibuprofenum lysinum
Please read the following carefully before using this medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if you feel worse, consult your doctor.

Table of Contents

1. What Metafen Gel Forte is and what it is used for
2. Important information before using Metafen Gel Forte
3. How to use Metafen Gel Forte
4. Possible side effects
5. How to store Metafen Gel Forte
6. Contents of the pack and other information

1. What Metafen Gel Forte is and what it is used for

The active substance in Metafen Gel Forte is ibuprofen. Ibuprofen belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) with analgesic and anti-inflammatory properties. Its mechanism of action involves inhibition of prostaglandin synthesis in inflamed tissues. The product is formulated as a gel intended for topical application to the skin.

Indications
Conditions requiring local analgesic and anti-inflammatory action:

• Pain associated with musculoskeletal disorders;
• Back pain;
• Neuralgia;
• Traumatic pain;
• Pain in mild forms of arthritis.

2. Important information before using Metafen gel Forte

When not to use Metafen gel Forte

• if the patient is allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has allergic skin diseases;
• if the patient has infectious diseases accompanied by skin lesions;
• if the patient has skin burns;
• if the patient has skin injuries;
• if the patient previously experienced bronchospasm, rhinitis, or urticaria after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• if the patient is in the last 3 months of pregnancy.

Do not use in children under 12 years of age without medical advice.

Warnings and precautions

Before starting treatment with Metafen gel Forte, consult a doctor or pharmacist.

Severe skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with the use of ibuprofen. If any of the symptoms associated with these severe skin reactions described in section 4 occur, Metafen gel Forte must be discontinued immediately and medical help should be sought.

Special caution is advised when using Metafen gel Forte in the following cases:

• if the patient has impaired liver or kidney function;
• if the patient has gastric or duodenal ulcer disease;
• asthmatic patients, even if they have not previously taken acetylsalicylic acid or other NSAIDs, should consult a doctor before using Metafen gel Forte;
• topically applied ibuprofen may potentially cause adverse effects related to the gastrointestinal tract. Although the risk of such adverse effects is significantly lower than with oral ibuprofen, patients with gastrointestinal disorders should consult a doctor before using Metafen gel Forte;
• avoid contact of the medicine with eyes and mucous membranes;
• avoid excessive exposure of treated areas to sunlight due to the risk of phototoxic reactions;
• if skin changes occur at the application site, discontinue use of the medicine;
• during prolonged skin massage, it is recommended to wear protective gloves;
• the medicine should not be used more frequently than every 4 hours and no more than 3 times daily;
• after applying the gel, hands should be washed unless the hands themselves are the treated area;
• if symptoms do not improve or worsen after 2 weeks of treatment, consult a doctor;
• after topical application of the gel, less ibuprofen enters the bloodstream than after oral administration. However, since orally administered ibuprofen may worsen existing renal impairment, patients with kidney disease should consult a doctor before using Metafen gel Forte. Consult a doctor even if the above warnings refer to conditions that occurred in the past.

Metafen gel Forte and other medicines

Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

No interactions are known between topically administered ibuprofen and other medicines. However, such interactions cannot be ruled out due to known interactions following oral administration of ibuprofen.

Like other non-steroidal anti-inflammatory drugs, orally administered ibuprofen may interfere with antihypertensive medicines.

Concomitant use of acetylsalicylic acid and other non-steroidal anti-inflammatory drugs may increase the frequency of adverse effects.

Ibuprofen may irreversibly reduce the antiplatelet effect of acetylsalicylic acid, thereby limiting its cardioprotective effect in patients at risk of myocardial infarction.

Concomitant use of corticosteroids and non-steroidal anti-inflammatory drugs may increase the risk of gastrointestinal ulceration.

Ibuprofen may inhibit platelet aggregation in patients taking anticoagulants (e.g. warfarin, acenocoumarol) or thrombolytic agents (e.g. streptokinase), potentially leading to gastrointestinal bleeding and prolonged blood clotting time.

Ibuprofen increases serum lithium levels, enhances the toxic effects of methotrexate, and reduces the efficacy of diuretics.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Do not use Metafen gel Forte during the last 3 months of pregnancy.

Do not use Metafen gel Forte during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is necessary during this period, the lowest effective dose should be used for the shortest possible duration.

Oral formulations of ibuprofen-containing medicines (e.g. Metafen Ibuprofen tablets) may cause adverse effects in the unborn child. It is unknown whether the same risk applies to Metafen gel Forte when applied to the skin.

Driving and operating machinery

No adverse effects affecting the ability to drive or operate machinery are known.

Metafen gel Forte contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

This medicine may cause allergic reactions (including delayed-type reactions) and, rarely, bronchospasm.

3. How to use Metafen żel Forte

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Apply the medicine topically to the skin.
Use in adults and adolescents over 12 years of age:
Squeeze out approximately 3 cm of gel and gently massage it into the affected area until completely absorbed.
Do not exceed the recommended dose.
Use of more than the recommended dose of Metafen żel Forte
Overdose with topically applied ibuprofen is unlikely. If too much gel has been applied to the skin, wash off the excess with water.
If someone, for example a child, accidentally swallows the medicine, contact a doctor or pharmacist immediately.
Missed dose of Metafen żel Forte
If a dose is missed, continue treatment as before by applying and massaging the same amount of gel into the skin.
Do not apply a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur in a patient, ibuprofen use should be stopped immediately and medical help should be sought:

• red, flat, ring-shaped or circular skin lesions on the trunk, often with blisters in the center, peeling skin, and mucosal ulcers in the mouth, throat, nose, genital organs, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) – very rare (occurring in fewer than 1 in 10,000 people);
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome) – frequency unknown (cannot be estimated from available data);
• red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) – frequency unknown.

Other adverse reactions:

• asthma, worsening of asthma, bronchospasm, or shortness of breath
• abdominal pain
• indigestion
• various types of skin rash
• itching
• urticaria
• angioedema
• skin reactions (e.g. redness) and skin tingling at the site of application
• non-specific allergic and anaphylactic reactions
• skin becomes sensitive to light (frequency unknown).

With prolonged use over large areas of the body, additional adverse reactions may occur: headaches, dizziness, changes in blood parameters (granulocytopenia, agranulocytosis), hyperuricemia, and gastrointestinal symptoms: nausea, vomiting, loss of appetite, recurrence of gastric and duodenal ulcer disease. Renal impairment may also occur during ibuprofen treatment, particularly in patients with pre-existing kidney disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Metafen gel Forte

Store below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Expiry date after first opening the container: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What the medicine Metafen żel Forte contains

• The active substance is ibuprofen. Each gram of gel contains 100 mg (10%) of ibuprofen lysine salt.
• Other ingredients are: macrogol 200, trolamine, carbomer 980, methyl parahydroxybenzoate, propyl parahydroxybenzoate, bitter orange oil, purified water.

What Metafen żel Forte looks like and contents of the pack
An aluminium tube in a cardboard box containing 50 g or 100 g of gel.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
Władysława Łokietka Street 10, 98-200 Sieradz