Ibured forte

Package leaflet: Information for the patient

IBURED FORTE
100 mg/g (10%), gel
Ibuprofen
Please read the entire 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 patient leaflet or as
recommended by the doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 14 days, or if you feel worse, consult your doctor.

Contents of the leaflet

1. What Ibured Forte is and what it is 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 package and other information

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

Ibured Forte is a topical gel for application to the skin. Each gram of gel contains 100 mg of ibuprofen, which
belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). This medicine relieves pain, reduces
inflammation, and lowers high temperature.
This medicine is intended for the treatment of various painful conditions affecting 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
nerve pain (neuralgia).

2. Important information before using Ibured Forte

When not to use Ibured Forte

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• if the patient has been diagnosed with an allergy (hypersensitivity) to acetylsalicylic acid or other pain-relieving medicines known as non-steroidal anti-inflammatory drugs (NSAIDs),
• if the patient has asthma, nasal inflammation, or hives,
• if the patient has damaged, broken skin or a skin infection.

Warnings and precautions
Before starting to use Ibured Forte, discuss this with your doctor or pharmacist.
Exercise particular caution when using Ibured Forte in the following situations:

• protect the areas where the gel is applied from direct exposure to sunlight in order to avoid hypersensitivity reactions (e.g. rash);
• if the patient has a stomach or duodenal ulcer or other gastrointestinal disorders;
• in patients suffering from asthma or wheezing (or if asthma has occurred in the patient in the past);
• in patients with kidney problems;
• if skin changes occur at the site of application, discontinue use of the medicine;
• the medicine should not be used more frequently than every 4 hours and no more than 3 times a day;
• in patients who have been diagnosed with asthma or allergic conditions.

Ibured Forte is intended for external use only.
Children
Ibured Forte gel should not be used in children under 14 years of age without medical advice.
Ibured Forte and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
Using this medicine may affect the action of other medicines when taken at the same time:

• medicines that lower blood pressure (e.g. atenolol)
• medicines used to thin the blood (e.g. warfarin)
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs used to treat pain and inflammatory conditions.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Ibured Forte should not be used during pregnancy or breastfeeding.
Driving and operating machinery
No adverse effects affecting the ability to drive motor vehicles or operate machinery are known.

3. How to use Ibured Forte

This medicine should always be used as described in the patient information leaflet or according to the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Before first opening the tube, check that the protective seal covering its opening is intact. To pierce the seal, press the reverse side of the cap against it. After squeezing out the desired amount of gel, the tube should be closed with the cap.

Adults and children over 14 years of age: Squeeze 2 to 5 cm of gel from the tube 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 fully absorbed. Do not reapply to the same site within 4 hours.

Do not use the medicine more than 4 times a day.
Do not apply the medicine to broken or damaged skin, mucous membranes of the mouth, or around the eyes.
If the gel comes into contact with the eyes, immediately rinse thoroughly with water and consult a doctor.
Do not apply the gel under dressings (e.g. plasters).
If hands are not being treated, wash them thoroughly after each application.
Do not apply the gel to the genital area.

If symptoms do not improve or worsen after 2 weeks of treatment, consult a doctor.

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

Use of a higher than recommended dose of Ibured Forte
In case of accidental ingestion of the gel, rinse the mouth and seek immediate medical advice from a doctor or the nearest hospital. Swallowed gel may cause disturbances in stomach function.

Missed dose of Ibured Forte
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everyone will experience them.
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
When using Ibured Forte gel, the following adverse reactions may occur in some patients:

• skin itching or redness,
• burning sensation,
• painful skin lesions,
• abdominal pain (stomach ache) or other unusual gastrointestinal symptoms,
• kidney problems (especially in patients with a history of kidney disease).

If sudden onset of wheezing, difficulty breathing, facial swelling, swelling of the eyelids or lips, rash or itching (especially affecting the whole body) occurs, consult a doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. 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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected].
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of this medicinal product.

5. How to store Ibured Forte

Do not store above 25°C. Do not freeze.
Keep out of sight and reach of children.
Do not use Ibured Forte gel after the expiry date stated on the immediate packaging. The expiry date refers to the last day of the month indicated.
Shelf-life after first opening of the container: 6 months.
Medicines must not be disposed of via sewage or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Ibured Forte contains
1 gram of Ibured Forte gel contains:
Active substance: ibuprofen 100 mg
Excipients: hydroxyethylcellulose, sodium hydroxide, benzyl alcohol, isopropyl alcohol, purified water.

What Ibured Forte looks like and contents of the pack
Aluminium tube with external print, fitted with a membrane and a polyethylene cap with a piercing device, packed in a cardboard box with patient information leaflet. Package sizes: 20 g, 25 g, 30 g, 35 g, 50 g, 100 g.

Marketing Authorisation 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: [email protected]