Ibured

Package leaflet: Information for the patient

Ibured
50 mg/g (5%), gel
Ibuprofenum
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 according
to the instructions given by the doctor, pharmacist or nurse.

• Keep this leaflet, as you may need to read it again.
• 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 or if you feel worse after 14 days, you should contact your doctor.

Table of contents

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

1. What Ibured is and what it is used for

Ibured is a topical gel for application to the skin. Each 1 g of gel contains 50 mg of ibuprofen, which belongs
to the group of non-steroidal anti-inflammatory drugs (NSAIDs). When applied topically to the skin, it relieves
pain and reduces swelling. This medicine is intended for rapid symptomatic treatment of muscular pain, back pain, and pain associated with musculoskeletal disorders, such as: mild forms of arthritis, sprains, sports injuries, fibromyalgia and neuralgia.

2. Important information before using Ibured

When not to use Ibured

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• if the patient has previously experienced hypersensitivity (allergy) to acetylsalicylic acid or other pain-relieving medicines known as non-steroidal anti-inflammatory drugs (NSAIDs),
• if the patient has previously experienced allergic reactions such as bronchial asthma, bronchospasm, rhinitis, angioedema or urticaria in response to ibuprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• if the patient is in the third trimester of pregnancy,
• if the patient has skin lesions.

Warnings and precautions
Before starting to use Ibured, consult a doctor or pharmacist.
If symptoms worsen or persist after 2 weeks of treatment, medical advice should be sought.
Do not use for longer than 14 days without consulting a doctor.
In patients who have previously experienced bronchial asthma or allergic conditions while using ibuprofen, bronchospasm may occur.
Patients with asthma who have not previously taken acetylsalicylic acid or other non-steroidal anti-inflammatory drugs should consult a doctor before using Ibured gel.
There is evidence suggesting an association between the topical use of NSAIDs and renal impairment.
Patients with a history of kidney disease should consult a doctor before using Ibured gel.
Topically applied ibuprofen may potentially cause gastrointestinal adverse effects. Although the risk of such adverse effects is significantly lower than with oral ibuprofen, patients with conditions such as active or past peptic ulcer disease, inflammatory bowel disease, or bleeding disorders should consult a doctor before using Ibured gel.
Although systemic absorption of topically applied ibuprofen is significantly lower than with oral formulations, complications may rarely occur. Therefore, patients with active or past peptic ulcer disease, inflammatory bowel disease, or bleeding disorders should seek medical advice before using this product.
For external use only. Ibured gel should be gently massaged into the skin. Do not apply on damaged or inflamed skin. Avoid contact with eyes and oral mucous membranes. Discontinue use if a rash occurs.
To reduce the risk of photosensitivity, protect the treated area from strong sources of natural or artificial light during treatment with ibuprofen.
This medicine is not intended for use under occlusive dressings.
After applying the medicine, wash your hands.

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

Ibured and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Non-steroidal anti-inflammatory drugs may interact with antihypertensive medicines and may potentially enhance the effect of anticoagulant medicines. However, with correct use, systemic absorption of ibuprofen is low, making such interactions—common with orally administered ibuprofen—unlikely.
Concomitant use of acetylsalicylic acid and other non-steroidal anti-inflammatory drugs may increase the frequency of adverse effects.

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

Pregnancy
Avoid using this medicine during the first and second trimesters of pregnancy. Use of the medicine is contraindicated during the third trimester of pregnancy.

Breastfeeding
Ibuprofen passes into breast milk in very low concentrations and is unlikely to adversely affect the breastfed infant. Since the bioavailability of topically administered ibuprofen is approximately 5% of the oral dose, the amount of medicine transferred to the breastfed infant is considered negligible.

Fertility
No effect on fertility has been observed following topical application to the skin.

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

3. How to use Ibured

This medicine should always be used as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Before first opening the tube, check whether the protective seal covering its opening is intact. To pierce it, press the reverse side of the cap against the seal. After squeezing out the desired amount of gel, close the tube with the cap.
For topical application on the skin only. For short-term use only.
Adults and children over 12 years of age:
Squeeze 4 to 10 cm of gel (corresponding to a dose of 50 to 125 mg of ibuprofen) onto the affected area. Gently massage the gel into the skin until fully absorbed, then wash your hands.
Do not reapply the medicine to the same site earlier than 4 hours after the previous application.
Do not use the medicine more than 4 times per day.
Do not apply the medicine to damaged skin, mucous membranes of the oral cavity (mouth), or around the eyes.
If a rash develops, discontinue use of the medicine.
If symptoms persist or worsen after 2 weeks of treatment, consult a doctor.
Elderly patients
No special dose adjustment is necessary.
Use of a higher than recommended dose of Ibured
Overdose following topical administration does not seem likely.
Symptoms of ibuprofen overdose include: dizziness, nausea, vomiting, drowsiness, headache, and hypotension.
If the gel is accidentally swallowed by a child, contact a doctor immediately.
If the gel is swallowed by an adult, rinse the mouth thoroughly. Swallowed gel may cause gastrointestinal disturbances. If necessary, contact a doctor.
Discontinuation of Ibured
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur,
inform your doctor or pharmacist.

Rare (may occur in 1 out of 1000 people):

• toxic epidermal necrolysis, erythema multiforme

Frequency not known: cannot be estimated from the available data

• hypersensitivity
• abdominal pain, dyspepsia
• renal function impairment
• reactions at the site of administration, skin changes (e.g. redness) and tingling at the site of administration, non-specific allergic and anaphylactic reactions
• bronchial asthma, exacerbation of bronchial asthma and bronchospasm
• various rashes, urticaria, angioedema

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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: [email protected].
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ibured

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

6. Contents of the pack and other information

What Ibured contains
1 gram of Ibured gel contains:
Active substance: ibuprofen 50 mg
Excipients: hydroxyethylcellulose, sodium hydroxide, benzyl alcohol, isopropyl alcohol, purified water.

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

Marketing Authorisation Holder and Manufacturer
Pharmaceutical Company „Amara” Sp. z o.o.
Stacyjna 5 Street
30-851 Kraków
Phone: +48 12 657 40 40
Fax: +48 12 657 40 40 ext. 34
e-mail: [email protected]