Package leaflet: Information for the user

IBUM SPORT
(50 mg + 30 mg)/g, gel
Ibuprofenum + Levomentholum
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 directed by a
physician or pharmacist.

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

Table of contents of the leaflet:

What IBUM SPORT, gel is and what it is used for
Important information before using IBUM SPORT, gel
How to use IBUM SPORT, gel
Possible side effects
How to store IBUM SPORT, gel
Contents of the pack and other information

1. What IBUM SPORT, gel is and what it is used for

IBUM SPORT, gel is a medicine with anti-inflammatory and analgesic properties. It exerts a combined effect of its active ingredients: ibuprofen and levomenthol. Ibuprofen (a non-steroidal anti-inflammatory drug), which acts by inhibiting prostaglandin synthesis, has analgesic and anti-inflammatory properties. At the same time, levomenthol contained in the medicine produces a cooling sensation at the site of application and has a mild local anesthetic effect.
Indications
IBUM SPORT, gel is intended for symptomatic treatment of muscular pain, back pain, and pain associated with disorders of the musculoskeletal system, 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 to 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 experienced or ever experienced bronchospasm, rhinitis, or urticaria after taking 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 this with your doctor or pharmacist.
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Avoid contact with eyes and mucous membranes.
Do not apply the medicine to damaged or inflamed skin.
If a rash occurs, discontinue use of the medicine.
Exercise caution when using the medicine concurrently with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
Use with caution in patients with gastric or duodenal ulcer disease.
If there is no need to treat the hands therapeutically, wash hands after each application of the medicine.

Children and adolescents
Do not use in children under 12 years of age without medical advice.

IBUM Sport gel 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.
Non-steroidal anti-inflammatory drugs may interact with antihypertensive medicines, although the possibility of such interactions with topically applied medicines is very low.
When used concomitantly with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, there is an increased risk of adverse effects typical of this group of medicines.

Use of IBUM Sport gel in patients with renal and/or hepatic impairment
Although ibuprofen is absorbed through the skin to a much lesser extent than after oral administration, caution should be exercised when using the medicine in patients with renal or hepatic insufficiency.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
If the patient becomes pregnant while using the medicine, she should inform her doctor. Do not use IBUM Sport during the last three months of pregnancy. During the first and second trimesters of pregnancy, the medicine should be used only on medical advice.
Avoid using the medicine during pregnancy. Although teratogenic effects of ibuprofen have not been observed, it should not be used during pregnancy due to the risk of delayed onset of labour and prolonged duration of delivery.
Ibuprofen passes into human milk in small amounts and no effect on the breastfed infant is expected. Topical ibuprofen alone may be used during breastfeeding. However, there is insufficient information regarding the passage of levomenthol, the second active substance in IBUM Sport, 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
This medicine may cause allergic reactions.

3. How to use IBUM Sport, gel

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is for topical application to the skin.
Adults and adolescents (over 12 years of age):
Apply 5 cm to 12 cm of gel (corresponding to approximately 50 mg to 125 mg of ibuprofen) up to 3 times daily to the affected area. The gel should be gently rubbed in until completely absorbed. After application, hands should be thoroughly washed.
Children under 12 years of age:
There is no appropriate indication for the use of IBUM Sport gel in children in this age group. Use without medical advice is not recommended.
Do not apply the gel more frequently than every 4 hours during the day or for longer than 2 weeks, unless otherwise advised by a doctor.
If hands do not require therapeutic treatment, wash hands after each application of the medicine.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.
Use of a higher than recommended dose of IBUM Sport, gel
Overdose following topical application is unlikely.
Symptoms of ibuprofen overdose include: headache, vomiting, drowsiness, hypotension.
If a larger than recommended dose has been used, seek immediate medical advice from a doctor or pharmacist.
Missed dose of IBUM Sport, gel
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Rare (affects less than 1 in 1,000 patients):
swelling
dermatosis (epidermal necrosis and erythema multiforme).
Very rare (affects less than 1 in 10,000 patients):
hypersensitivity, anaphylaxis
rash, itching, urticaria, redness
asthma, bronchospasm, dyspnoea
abdominal pain and indigestion.
Frequency not known (frequency cannot be estimated from the available data):
skin becomes sensitive to light.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of the medicine can be collected.
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5. How to store IBUM Sport, gel

Store below 25°C. Keep 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 stated month.
Medicines must 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 package and other information

What the medicine Ibum Sport, gel contains

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

What Ibum Sport, gel looks like and contents of the pack
Ibum Sport, gel is a colourless gel with a strong minty odour.
Each pack contains 50 g or 100 g of gel.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel. + 48 (22) 742 00 22
e-mail: [email protected]
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