Ibum Sport

Package Leaflet: Information for the Patient

IBUM SPORT

(50 mg + 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 the package leaflet for the patient or as directed by a doctor or pharmacist.

• 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 or pharmacist. See section 4.
• If after a few days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Leaflet:

• 1. What is IBUM Sport gel and what is it used for
• 2. Important information before using IBUM Sport gel
• 3. How to use IBUM Sport gel
• 4. Possible side effects
• 5. How to store IBUM Sport gel
• 6. Package contents and other information

1. What is IBUM Sport gel and what is it used for

IBUM Sport gel is a medicine with anti-inflammatory and analgesic effects. It has a combined effect of the active substances it contains: ibuprofen and levomenthol. Ibuprofen (a non-steroidal anti-inflammatory drug), whose action is based on inhibiting the synthesis of prostaglandins, has analgesic and anti-inflammatory properties. At the same time, levomenthol contained in the medicine causes a feeling of coolness at the site of application and has a mild anesthetic effect.

Indications for use

IBUM Sport gel is intended for the symptomatic treatment of muscle pain, back pain, pain associated with musculoskeletal system diseases, such as mild forms of arthritis, sprains, sports injuries, and neuralgia.

2. Important information before using IBUM Sport gel

When not to use IBUM Sport gel:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• if the patient has or has had bronchial asthma, rhinitis, or urticaria associated with the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• if the patient is in the last three months of pregnancy.

Warnings and precautions

Before starting to use IBUM Sport gel, discuss it with your doctor or pharmacist.
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Avoid contact with eyes and mucous membranes.
The medicine should not be applied to damaged or inflamed skin.
If a rash occurs, discontinue use of the medicine.
Caution should be exercised when administering the medicine and concomitantly using acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
The medicine should be used with caution in patients with gastric or duodenal ulcer disease.
If there is no need to apply the medicine to the hands for therapeutic purposes, wash your hands after each application.

Children and adolescents

Do not use in children under 12 years of age without a doctor's recommendation.

IBUM Sport gel and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Non-steroidal anti-inflammatory drugs may interact with blood pressure-lowering medicines, although the possibility of such interactions with topical medicines is very small.
When using the medicine concomitantly with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, there is an increased risk of adverse reactions characteristic of this group of medicines.

Using IBUM Sport gel in patients with kidney or liver function disorders

Although ibuprofen is absorbed through the skin to a much lesser extent than when taken orally, caution should be exercised when using the medicine in patients with kidney or liver failure.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to have a baby, consult your doctor before using this medicine.
If you become pregnant while using the medicine, inform your doctor. Do not use IBUM Sport gel in the last three months of pregnancy. In the first and second trimester of pregnancy, the medicine can only be used on the advice of a doctor.
Avoid using the medicine during pregnancy. Although no teratogenic effect of ibuprofen has been observed, it should not be used during pregnancy due to the risk of delayed delivery and prolonged labor.
Ibuprofen passes into breast milk in small amounts and is not expected to affect the baby. Ibuprofen used on the skin can be used during breastfeeding. However, there is insufficient information about the passage of levomenthol, the second active substance of IBUM Sport gel, into breast milk. Due to the lack of sufficient data, the use of IBUM Sport gel during breastfeeding is not recommended.

IBUM Sport gel contains propylene glycol

The medicine may cause allergic reactions.

3. How to use IBUM Sport gel

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is intended for topical use on the skin.
Adults and adolescents (over 12 years of age):
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apply 5 cm to 12 cm of gel (an amount equivalent to approximately 50 mg to 125 mg of ibuprofen) up to 3 times a day to the painful area. The gel should be gently rubbed in until completely absorbed. After applying the medicine, wash your hands thoroughly.
Children under 12 years of age:
There is no appropriate indication for the use of IBUM Sport gel in this age group. The medicine should not be used without a doctor's recommendation.
Do not use the gel more often than every 4 hours within a 24-hour period and not for more than 2 weeks, unless otherwise directed by a doctor.
If there is no need to apply the medicine to the hands for therapeutic purposes, wash your hands after each application.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

Using a higher dose of IBUM Sport gel than recommended

Overdose of the medicine when applied topically is unlikely.
Symptoms of ibuprofen overdose are: headache, vomiting, drowsiness, hypotension.
In case of using a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately.

Missing a dose of IBUM Sport gel

Do not use a double dose to make up for a missed dose.
In case of any further doubts about the use of 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.

Rare (occurring in less than 1 in 1,000 patients):

edema
dermatitis (necrotizing dermatitis and erythema multiforme).

Very rare (occurring in less than 1 in 10,000 patients):

hypersensitivity, anaphylaxis
rash, itching, urticaria, redness
asthma, bronchospasm, dyspnea
abdominal pain and nausea.

Frequency not known (frequency cannot be estimated from the available data):

skin becomes sensitive to light.

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
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 IBUM Sport gel

Store at a temperature below 25°C. Store in the original packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What IBUM Sport gel contains

• The active substances of the medicine are ibuprofen, levomenthol. 1 g of gel contains 50 mg of ibuprofen and 30 mg of levomenthol.
• The other ingredients (excipients) are: propylene glycol, ethanol 96%, polysorbate 20, carbomer EZ-2, aminomethylpropanol, purified water.

What IBUM Sport gel looks like and what the package contains

IBUM Sport gel is a colorless gel with a strong minty smell.
One package contains 50 g or 100 g of gel.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information about the medicine
tel. +48 (22) 742 00 22
e-mail: [email protected]

Date of last update of the leaflet: 04/2022

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