Metafen zhel Forte

Package Leaflet: Information for the Patient

Metafen Gel Forte, 100 mg/g (10%), Gel

Ibuprofen Lysinate

Read the Package Leaflet Carefully Before Using the Medication, as it Contains

Important Information for the Patient.
This medication should always be used exactly as described in this patient information leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 14 days, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Metafen Gel Forte and What is it 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 Package and Other Information

1. What is Metafen Gel Forte and What is it Used For

The active substance of Metafen Gel Forte is ibuprofen. Ibuprofen belongs to a group of nonsteroidal anti-inflammatory and analgesic drugs. Its mechanism of action involves inhibiting the synthesis of prostaglandins in inflamed tissue. The medication is in the form of a gel, intended for topical application to the skin.

Indications for Use

Conditions requiring local analgesic and anti-inflammatory action:

• pains associated with musculoskeletal system diseases;
• back pain;
• neuralgia;
• traumatic pain;
• pains in mild forms of arthritis.

2. Important Information Before Using Metafen Gel Forte

When Not to Use Metafen Gel Forte

• if the patient is hypersensitive to ibuprofen, other nonsteroidal anti-inflammatory drugs, or any of the other ingredients of this medication (listed in section 6);
• if the patient has allergic skin diseases;
• if the patient has infectious diseases with skin changes;
• if the patient has skin burns;
• if the patient has skin damage;
• if the patient has a history of bronchospasm, rhinitis, and urticaria associated with the use of acetylsalicylic acid or other nonsteroidal 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 a doctor's recommendation.

Warnings and Precautions

Before starting to use Metafen Gel Forte, the patient should discuss it with their doctor or pharmacist.
Severe skin reactions, such as 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 the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should immediately discontinue Metafen Gel Forte and seek medical attention.
Particular caution should be exercised when using Metafen Gel Forte in the following cases:

• if the patient has liver or kidney function disorders;
• if the patient has stomach or duodenal ulcer disease;
• patients with asthma who have not previously taken acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs should consult their doctor before using Metafen Gel Forte;
• topically applied ibuprofen may potentially cause gastrointestinal side effects. Although the risk of such side effects is much lower than with oral ibuprofen, patients with gastrointestinal disorders should consult their doctor before using Metafen Gel Forte;
• the eyes and mucous membranes should be protected from contact with the medication;
• excessive exposure to sunlight of the treated area should be avoided due to the possibility of phototoxic reactions;
• if skin changes occur at the application site, the medication should be discontinued;
• during prolonged rubbing into the skin, it is recommended to wear protective gloves;
• the medication should not be used more frequently than every 4 hours and not more than 3 times a day;
• after applying the gel, hands should be washed, unless the treatment concerns the hands themselves;
• if symptoms do not improve or worsen after 2 weeks of using the medication, the patient should consult their doctor;
• after topical application of the gel, less ibuprofen is absorbed into the blood than after oral administration. However, since oral ibuprofen may worsen existing kidney failure, patients with kidney diseases should consult their doctor before using Metafen Gel Forte. The patient should consult their doctor, even if the above warnings concern past situations.

Metafen Gel Forte and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
No interactions between topically applied ibuprofen and other medications are known.
Such interactions cannot be ruled out, given the occurrence of interactions after oral ibuprofen administration.
Like other nonsteroidal anti-inflammatory drugs, oral ibuprofen may interact with blood pressure-lowering medications.
Concomitant use of acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs may increase the frequency of side effects.
Ibuprofen may irreversibly inhibit the antiplatelet aggregation effect of acetylsalicylic acid, limiting the protective effect of this medication on the heart in patients at risk of myocardial infarction.
Concomitant administration of corticosteroids and nonsteroidal anti-inflammatory drugs may increase the risk of gastrointestinal ulcer disease.
There is a possibility of inhibiting platelet aggregation by ibuprofen in patients concomitantly using anticoagulant medications (e.g., warfarin, acenocoumarol) or thrombolytic agents (e.g., streptokinase), which may lead to gastrointestinal bleeding and prolonged blood coagulation time.
Ibuprofen increases lithium levels in the blood, enhances the toxic effects of methotrexate, and reduces the effectiveness of diuretics.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medication.
Metafen Gel Forte should not be used during the last 3 months of pregnancy.
Metafen Gel Forte should not be used during the first 6 months of pregnancy, unless it is absolutely necessary and advised by a doctor. If treatment is necessary during this period, the smallest dose should be used for the shortest possible time.
Oral forms of medications (e.g., Metafen Ibuprofen tablets) containing ibuprofen may cause side effects in the unborn child. It is not known if the same risk applies to Metafen Gel Forte when used on the skin.

Driving and Operating Machinery

No side effects that could affect the ability to drive or operate machinery are known.

Metafen Gel Forte Contains Methyl Parahydroxybenzoate and Propyl Parahydroxybenzoate

The medication may cause allergic reactions (possible late reactions) and, exceptionally, bronchospasm.

3. How to Use Metafen Gel Forte

This medication should always be used exactly as described in this patient information leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medication should be applied topically to the skin.
Use in adults and adolescents over 12 years of age:
About 3 cm of gel should be squeezed out and gently rubbed into the affected area until completely absorbed.
The recommended dose should not be exceeded.

Using a Larger Than Recommended Dose of Metafen Gel Forte

Overdose of topically applied ibuprofen is unlikely. If too much gel is applied to the skin, the excess should be washed off with water.
If someone, e.g., a child, accidentally ingests the medication, they should immediately contact a doctor or pharmacist.

Missing a Dose of Metafen Gel Forte

If a dose is missed, the treatment should be continued by applying and rubbing in the usual amount of gel into the skin.
A double dose should not be used to make up for a missed dose.
In case of any further doubts about using this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Metafen Gel Forte can cause side effects, although not everybody gets them.
If the patient experiences any of the following symptoms, they should immediately stop using ibuprofen and seek medical attention:

• red, flat, target-like, or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, 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 less than 1 in 10,000 people);
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome) - frequency not known (cannot be estimated from the available data);
• red, peeling rash with nodules under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) - frequency not known.

Other side effects:

• asthma, worsening of asthma, bronchospasm, or shortness of breath
• abdominal pain
• indigestion
• various rashes
• itching
• hives
• angioedema
• skin disorders (e.g., redness) and tingling of the skin at the application site
• non-specific allergic and anaphylactic reactions
• skin becomes sensitive to light (frequency not known).

In the case of long-term use on large areas of the body, additional side effects may occur: headaches and dizziness, changes in blood counts (granulocytopenia, agranulocytosis), hyperuricemia, and gastrointestinal disorders such as nausea, vomiting, loss of appetite, and recurrence of stomach and duodenal ulcers. During ibuprofen treatment, kidney damage may also occur, especially in patients with kidney diseases.

Reporting Side Effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Metafen Gel Forte

Store at a temperature below 25°C.
The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the packaging.The expiry date refers to the last day of the month stated.
Shelf life after first opening the package: 6 months.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Metafen Gel Forte Contains

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

What Metafen Gel Forte Looks Like and What the Package Contains

An aluminum tube in a cardboard box, containing 50 g or 100 g of gel.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz

Date of the Last Update of the Leaflet: