Ibured Forte

Package Leaflet: Information for the Patient

IBURED FORTE

100 mg/g (10%), gel
Ibuprofen

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient or as advised by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 14 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

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

1. What is Ibured forte and what is it used for

Ibured forte is a gel for topical application to the skin. 1 g of gel contains 100 mg of ibuprofen, which belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). This medicine relieves pain, reduces inflammation, and lowers high temperature.

This medicine is intended for the treatment of various pain syndromes affecting the joints and muscles, such as back pain, sprains, strains, and other sports injuries. It is also used to relieve pain caused by mild joint disorders and neuralgia.

2. Important information before using Ibured forte

When not to use Ibured forte

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• if you have been diagnosed with an allergy (hypersensitivity) to acetylsalicylic acid or other painkillers classified as nonsteroidal anti-inflammatory drugs (NSAIDs),
• if you have been diagnosed with asthma, rhinitis, or urticaria,
• if you have damaged, broken skin or a skin infection.

Warnings and precautions

Before starting to use Ibured forte, discuss it with your doctor or pharmacist.

Be particularly careful when using Ibured forte in the following situations:

• protect the application site from direct sunlight to avoid hypersensitivity reactions (e.g., rash);
• if you have stomach or duodenal ulcers or other gastrointestinal disorders;
• in patients with asthma or wheezing (or if asthma has occurred in the past);
• in patients with kidney problems;
• if skin changes occur at the application site, the medicine should be discontinued;
• the medicine should not be used more frequently than every 4 hours and no more than 3 times a day;
• in patients with asthma or allergic diseases;

Ibured forte is intended for use on the skin only.

Children

Ibured forte should not be used in children under 14 years of age without a doctor's recommendation.

Ibured forte and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Using this medicine may affect the action of other medicines if taken at the same time:

• blood pressure-lowering medicines (e.g., atenolol)
• blood-thinning medicines (e.g., warfarin)
• acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs used to treat pain and inflammation.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Ibured forte should not be used during pregnancy and breastfeeding.

Driving and using machines

There are no known side effects that affect the ability to drive vehicles or operate machinery.

3. How to use Ibured forte

This medicine should always be used exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist.

Before opening the tube for the first time, check that the protective foil on the opening is not damaged. To break it, press the reverse side of the cap. After squeezing out the desired amount of gel, close the tube with the cap.

Adults and children over 14 years: Squeeze 2 to 5 cm of gel onto the affected area (this amount corresponds to a dose of 50 to 125 mg of ibuprofen). Gently rub the gel into the skin until it is absorbed. Do not apply the medicine to the same area more often than every 4 hours.

Do not use the medicine more than 4 times a day.

Do not use the medicine on damaged skin, mucous membranes of the mouth (mouth) or eyes.

If the gel gets into your eyes, rinse them immediately with water and consult a doctor.

Do not use the gel under bandages (e.g., plasters).

If there is no need to apply the medicine to your hands for therapeutic purposes, wash your hands after each use.

Do not use the medicine in the genital area.

If after 2 weeks of using the medicine the symptoms do not disappear or worsen, consult a doctor.

Children under 14 years: Ibured forte is not intended for use in children under 14 years of age.

Using more than the recommended dose of Ibured forte

In case of accidental ingestion of the gel, rinse your mouth and contact a doctor or the nearest hospital immediately. Swallowed gel may cause stomach upset.

Missing a dose of Ibured forte

Do not use a double dose to make up for a missed dose.

4. Possible side effects

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

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

During the use of Ibured forte in the form of a gel, some patients may experience the following side effects:

In case of sudden, wheezing breathing, difficulty breathing, swelling of the face, eyelids, or lips, rash, or itching (especially all over the body), consult a doctor immediately.

Other side effects include:

• itching or redness of the skin,
• a burning sensation,
• painful spots on the skin,
• stomach pain (stomachache) or other unusual symptoms from the stomach,
• kidney problems (especially in patients with a history of kidney disease).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibured forte

Do not store above 25°C. Do not freeze.

Keep out of the sight and reach of children.

Do not use Ibured forte 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: 6 months.

Medicines should 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 Ibured forte contains

1 g of Ibured forte gel contains:

Active substance: ibuprofen 100 mg

Excipients: hydroxyethyl cellulose, sodium hydroxide, benzyl alcohol, isopropyl alcohol, purified water.

What Ibured forte looks like and contents of the pack

Aluminum tube with printing on the outside, with a membrane and a cap with a puncture device made of polyethylene, in a cardboard box with patient information.

Package sizes: 20g, 25g, 30g, 35g, 50g, 100g.

Marketing authorization holder and manufacturer

Zakład Farmaceutyczny "Amara" Sp. z o.o.

ul. Stacyjna 5

30-851 Kraków

Tel.: 12 657 40 40

Fax: 12 657 40 40 ext. 34

e-mail: amara@amara.pl

Date of last revision of the leaflet: