Ibument

Package Leaflet: Information for the Patient

Ibument, 50 mg/g + 30 mg/g, Gel

Ibuprofen + Levomenthol

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 this package leaflet for the patient, or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact a doctor.

Table of Contents of the Package Leaflet

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

1. What is Ibument and what is it used for

Ibument is a locally acting analgesic and anti-inflammatory gel containing ibuprofen (50 mg in 1 g of gel) and levomenthol (30 mg in 1 g of gel).
Ibuprofen belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs), which reduce inflammation at the site of the disease, relieve pain, and reduce swelling.
Levomenthol acts locally as an anesthetic, also causing local hyperemia of the tissues.
The combined action of both components causes very rapid pain relief after applying the gel to the skin, lasting for several hours.

Indications for Use

Ibument can be used without a doctor's recommendation for the treatment of:

• pain and swelling due to overexertion injuries, joint sprains with ligament sprains (joint sprains), sports injuries.

Only after consulting a doctor can it also be used for the treatment of:

• rheumatic pains, including joint pain caused by inflammatory and degenerative changes;
• back pain, lumbago, muscle pain, pain in the fibrous tissue, tendons, and ligaments.

If after 7 days there is no improvement or you feel worse, you should consult a doctor.

2. Important Information Before Using Ibument

When Not to Use Ibument

• if you are allergic to ibuprofen, levomenthol, other nonsteroidal anti-inflammatory drugs, or any of the other components of this medicine (listed in section 6),
• in people with asthma who have had shortness of breath, rash, or rhinitis after using acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs,
• if you are in the last three months of pregnancy.

Warnings and Precautions

Before starting to use Ibument, you should discuss it with your doctor or pharmacist:

• if you have kidney disease,
• if you are taking acetylsalicylic acid or other medicines,
• if you have active peptic ulcer disease. The gel should not be applied to mucous membranes, damaged or inflamed skin, or the eye area. Do not use under occlusive dressings. Stop using the medicine if you experience hives and consult a doctor.

Children and Adolescents

It is not recommended to use in children under 12 years of age.

Ibument and Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Taking this medicine at the same time as acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs may increase the frequency of side effects characteristic of this group of medicines.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
If you become pregnant during treatment with this medicine, tell your doctor. Ibument should not be used during the last three months of pregnancy. In the first and second trimester of pregnancy, this medicine can only be used on the advice of a doctor.

• In the first and second trimester of pregnancy, the doctor will prescribe this medicine only if it is absolutely necessary due to the potential risk of miscarriage or birth defects. In such cases, the dose should be as small as possible, and the duration of treatment as short as possible.
• In the third trimester of pregnancy, the use of this medicine is contraindicated: you should neveruse this medicine, as it may have a serious or even fatal effect on the baby, especially on its heart, lungs, and/or kidneys, even after a single use.

If you used this medicine during pregnancy, you should talk to your doctor or midwife immediately so that appropriate monitoring can be considered.
Ibuprofen passes into breast milk in small amounts and is not expected to affect the baby's body. Ibuprofen used on the skin can be used during breastfeeding. However, there is insufficient information about the penetration of levomenthol, the second active substance of Ibument, into breast milk. Due to the lack of sufficient data, it is not recommended to use Ibument during breastfeeding.

Driving and Using Machines

Ibument has no effect on the ability to drive vehicles and operate machines.

Ibument Contains Propylene Glycol (E 1520) and Ethanol 96%

This medicine contains 100 mg of propylene glycol (E 1520) per gram of gel. Propylene glycol may cause skin irritation.
This medicine contains 300 mg of alcohol (ethanol 96%) per gram of gel. It may cause a burning sensation on damaged skin.

3. How to Use Ibument

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.
Recommended dose

Adults and Children Over 12 Years Old

Apply the gel to the painful area and gently massage until the medicine is absorbed. Use 1 to 4 cm of gel at a time. If necessary, repeat, up to 3 times a day. Do not use the gel more often than every 4 hours.
After using the gel, wash your hands unless they are the area being treated.
Do not cover the application site with dressings, such as bandages or plasters.
The maximum treatment duration is two weeks. If after 7 days there is no improvement or you feel worse, you should contact a doctor.

Use in Children

It is not recommended to use in children under 12 years of age.

Using More Than the Recommended Dose of Ibument

Overdose of the medicine after local application is unlikely.
Symptoms of ibuprofen overdose include headache, vomiting, drowsiness, and decreased blood pressure.
Severe electrolyte disturbances should be corrected.

Missing a Dose of Ibument

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported side effects are local reactions after application, such as redness, itching, and hives.
Rarely reported side effects include gastrointestinal disorders, such as abdominal pain and indigestion.
In people prone to asthma or allergic diseases, bronchospasm may occur.
Skin sensitization to light - frequency not known.

Reporting Side Effects

If you experience any side effects, including those not listed in this package 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
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Ibument

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Shelf life after first opening the tube: 18 months.
Do not use this medicine after the expiry date stated on the packaging after: "EXP".
The expiry date refers to the last day of the month stated.
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 Package and Other Information

What Ibument Contains

• The active substances are ibuprofen and levomenthol. 1 gram of gel contains 50 mg of ibuprofen and 30 mg of levomenthol.
• The other ingredients are: ethanol 96%, carbomer 980, propylene glycol (E 1520), diisopropanolamine 85%, purified water.

What Ibument Looks Like and Contents of the Package

Ibument is a clear, colorless to slightly yellowish gel with a characteristic menthol smell.
Packaging: aluminum tube with a membrane, internally coated with epoxy-phenolic lacquer, with a PE cap, containing 50 g or 100 g of gel, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder

ZIAJA Ltd Pharmaceutical Production Plant sp. z o.o.
ul. Jesienna 9
80-298 Gdańsk
Poland
Phone: +48 58 521 34 00

Manufacturer

ZIAJA Ltd Pharmaceutical Production Plant sp. z o.o.
ul. Przemysłowa 12
83-050 Kolbudy
Poland
Date of last revision of the package leaflet:07/2025