Ibured

Package Leaflet: Information for the Patient

Ibured

50 mg/g (5%), 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, consult a 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, consult a doctor.

Table of Contents of the Leaflet

• 1. What is Ibured and what is it 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 pack and other information

1. What is Ibured and what is it used for

Ibured is a gel for topical application to the skin. 1 g of gel contains 50 mg of ibuprofen, which belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). When applied topically to the skin, it relieves pain and reduces swelling. This medicine is intended for the rapid symptomatic treatment of muscle pain, back pain, 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 you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• if you have previously been diagnosed with hypersensitivity (allergy) to acetylsalicylic acid or other pain-relieving medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs),
• if you have previously experienced hypersensitivity reactions, such as asthma, bronchospasm, rhinitis, angioedema, or urticaria in response to ibuprofen, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs (NSAIDs),
• if you are in the third trimester of pregnancy,
• if you have skin damage.

Warnings and precautions

Before starting to use Ibured, discuss it with your doctor or pharmacist.
If the symptoms of the disease worsen or persist after 2 weeks of treatment, consult a doctor. Do not use for more than 14 days without consulting a doctor.
In patients using ibuprofen, who have previously had asthma or allergic disease, bronchospasm may occur.
Patients with asthma who have not previously taken acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs should be advised to consult a doctor before using Ibured in the form of a gel.
A link between the use of topical NSAIDs and renal failure has been suggested.
Patients with a history of kidney disease should be advised to consult a doctor before using Ibured in the form of a gel.
Ibuprofen used topically may potentially cause gastrointestinal side effects. Although the risk of such side effects is much lower than with oral ibuprofen, patients with disorders such as active or history of stomach ulcers, inflammatory bowel disease, or bleeding disorders should be advised to consult a doctor before using Ibured in the form of a gel.
Although systemic absorption of topically applied ibuprofen is significantly lower than with oral forms, in rare cases, complications may occur. Therefore, patients with active or history of stomach ulcers, inflammatory bowel disease, or bleeding disorders should consult a doctor before using this product.
For external use only. Ibured in the form of a gel should be gently rubbed in. The medicine should not be applied to damaged or inflamed skin. Avoid contact with the eyes and the mucous membrane of the mouth. If a rash occurs, discontinue use.
To reduce the risk of photosensitivity, during treatment with ibuprofen, protect the treated area from strong natural or artificial light sources.
The medicine is not intended for use under occlusive dressings.
After applying the medicine, wash your hands.

Children

Do not use Ibured in the form of a gel in children under 12 years of age without consulting a doctor.

Ibured and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Nonsteroidal anti-inflammatory drugs may interact with antihypertensive drugs and may enhance the effects of anticoagulant drugs. However, with proper use, the absorption of ibuprofen into the body is small, so the occurrence of interactions associated with oral ibuprofen is unlikely.
Concomitant use of acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs may increase the frequency of side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before using this medicine.
Pregnancy
Use of the medicine should be avoided in the first and second trimester of pregnancy. In the third trimester of pregnancy, use of the medicine is contraindicated.
Breastfeeding
Ibuprofen passes into breast milk in very small amounts and is unlikely to affect the breastfed infant. Given that the bioavailability of topically applied ibuprofen is about 5% of the bioavailability of an oral dose, it is considered that the amount of medicine taken by the breastfed infant is negligible.
Fertility
No effect on fertility has been observed after topical application.

Driving and using machines

Unknown side effects that may affect the ability to drive and use machines.

3. How to use Ibured

This medicine should always be used exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.
Before first opening the tube, check that the protective foil on the opening is not damaged. To break it, press on it with the reverse side of the cap. After squeezing out the desired amount of gel, close the tube with the cap.
For topical application to the skin. Only for short-term use.

Adults and children over 12 years of age:

Squeeze 4 to 10 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, then wash your hands.
Do not apply the medicine to the same area more often than every 4 hours.
Do not apply the medicine more than 4 times a day.
Do not apply the medicine to damaged skin, the mucous membrane of the mouth (mouth), or the eye area.
If a rash occurs, discontinue use.
If after 2 weeks of using the medicine the symptoms do not improve or worsen, consult a doctor.

Elderly

No special dose adjustment is necessary.

Overdose of Ibured

Overdose after topical application is unlikely.
Symptoms of ibuprofen overdose include dizziness, nausea, vomiting, drowsiness, headache, and hypotension.
In case of accidental ingestion of the gel by a child, immediately consult a doctor.
In case of ingestion of the gel by an adult, rinse your mouth. Swallowed gel may cause stomach upset. If necessary, consult a doctor.

Discontinuation of Ibured

If you have any doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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, please tell your doctor or pharmacist.
Rare (may affect up to 1 in 1,000 people)

• toxic epidermal necrolysis, erythema multiforme

Frequency not known: cannot be estimated from the available data

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

Reporting of side effects
If you experience any side effects, including any possible side effects not listed in this leaflet, please tell your doctor or pharmacist. 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
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail:
[email protected].
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

Do not store above 25°C. Do not freeze.
Keep out of sight and reach of children.
Do not use Ibured in the form of a gel after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Shelf life after first opening the packaging: 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 contains

1 gram of Ibured in the form of a gel contains:
Active substance: ibuprofen 50 mg
Excipients: hydroxyethyl cellulose, sodium hydroxide, benzyl alcohol, isopropyl alcohol, purified water.

What Ibured 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. Pack size 20g, 25g, 30g, 35g, 50g, 100g.

Marketing authorization holder and manufacturer

Zakład Farmaceutyczny „Amara” Sp. z o.o.
Stacyjna 5 Street
30-851 Kraków
Phone: 12 657 40 40
Fax: 12 657 40 40 ext. 34
e-mail: [email protected]

Date of last revision of the leaflet: