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Ibutop Gel – Fast Relief for Muscle and Joint Pain
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- Stock: Zabrana online prodaje
- Brand: DR. THEISS NATURWAREN-EN
- Model: 2016
Ibutop Gel is a non-prescription medicine containing ibuprofen 50 mg/g, an active substance from the group of non-steroidal anti-inflammatory drugs (NSAIDs). It is applied to the skin and is used to relieve back and muscle pain, pain from sprains, strains and sports injuries, and pain associated with less serious rheumatic conditions.
In Serbia it is authorised as a gel in tubes of 50 g and 100 g, and the same manufacturer also offers Ibutop Cream 50 mg/g (tubes of 20 g and 50 g). All information on this page is taken from the package leaflet (PIL) and the summary of product characteristics (SmPC) approved by the Medicines and Medical Devices Agency of Serbia (ALIMS).
Read the package leaflet before use. If your symptoms last longer than 3 days, see a doctor; ask a doctor or pharmacist about use with chronic illness, during pregnancy and in children.
Important warning
- For use on the skin only. Do not apply to open wounds, inflamed or infected skin, eczema or mucous membranes, and do not use under an occlusive (airtight) dressing. Do not swallow.
- Do not use in the last (third) trimester of pregnancy.
- Not intended for children and adolescents under 14 years of age.
- People with asthma, hay fever, nasal polyps or chronic obstructive pulmonary disease have a higher risk of asthma attacks, swelling of the skin and mucous membranes (Quincke's oedema) and hives – they should use the medicine only with caution and under medical supervision.
Ibutop Gel 50 mg/g – ibuprofen gel for the skin
Key facts about the medicine
| Name of the medicine | Ibutop Gel 50 mg/g, gel |
|---|---|
| Active substance (INN) | ibuprofen |
| Composition | 1 g of gel contains 50 mg of ibuprofen |
| Pharmaceutical form | gel – clear and colourless, with a characteristic smell |
| Pharmacotherapeutic group | topical products for joint and muscular pain; NSAIDs for topical use |
| ATC code | M02AA13 |
| Packs | 1 tube of 50 g or 100 g |
| Dispensing | without a medical prescription (OTC), in pharmacies only |
| Marketing authorisation holder | Dr. Theiss d.o.o. Beograd (Zemun) |
| First authorisation / renewal | 09.03.2016 / 21.08.2023 |
Authorised forms and packs of Ibutop in Serbia
Two forms of the same strength (50 mg of ibuprofen per 1 g) are authorised in Serbia under the name Ibutop. They differ in their base and excipients, while the dosing is the same.
| Medicine | Strength and form | Pack | Marketing authorisation holder | Dispensing | Authorisation no. | Source |
|---|---|---|---|---|---|---|
| Ibutop® Cream | 50 mg/g, cream | 1 tube 20 g | Dr. Theiss d.o.o. Beograd | without prescription | 515-01-04178-20-002 | package leaflet (PIL) |
| Ibutop® Cream | 50 mg/g, cream | 1 tube 50 g | Dr. Theiss d.o.o. Beograd | without prescription | 515-01-04179-20-002 | package leaflet (PIL) |
| Ibutop® Gel | 50 mg/g, gel | 1 tube 50 g | Dr. Theiss d.o.o. Beograd | without prescription | 515-01-04180-20-002 | package leaflet (PIL) |
| Ibutop® Gel | 50 mg/g, gel | 1 tube 100 g | Dr. Theiss d.o.o. Beograd | without prescription | 515-01-04181-20-002 | package leaflet (PIL) |
Agree on the choice of form and the duration of use with your doctor or pharmacist.
What it is used for
According to the approved package leaflet, Ibutop Gel is used to relieve:
- back and muscle pain;
- pain from sprains, strains and sports injuries;
- pain associated with less serious rheumatic conditions.
Ibuprofen blocks the production of prostaglandins, substances involved in pain and inflammation. After application to the skin the medicine is retained in the skin and the tissue beneath it, from where it gradually acts on the painful area; only about 5% of the amount that would be absorbed after oral intake reaches the bloodstream.
How to use it
The medicine is intended for adults and children over 14 years of age.
- Apply 3–4 times a day.
- Depending on the size of the painful area, squeeze out a strip of gel 2 to 5 cm long, which corresponds to 50–125 mg of ibuprofen.
- The interval between two applications must not be shorter than 4 hours, and no more than 4 doses may be applied within 24 hours.
- Apply the medicine to the skin and rub in gently; wash your hands after each application.
- If symptoms last longer than 3 days, see a doctor. The need for treatment should be reassessed after 2 weeks, especially if symptoms persist or get worse.
The package leaflet for Ibutop Gel states that use for 1–2 weeks is usually sufficient; a therapeutic effect of longer use has not been demonstrated.
If you have applied more of the medicine than you should, remove it and rinse with water. If a much larger amount has been applied or the medicine has been swallowed by accident, contact a doctor; there is no specific antidote.
When the medicine must not be used
- if you are allergic to ibuprofen, other painkillers or antirheumatics (NSAIDs) or to any of the excipients (including the fragrance components);
- on open wounds, inflammation or infections of the skin, eczema and mucous membranes;
- under an occlusive dressing;
- in the last trimester of pregnancy.
Warnings and precautions
- In patients with asthma, hay fever, nasal polyps, chronic obstructive pulmonary disease and hypersensitivity to painkillers and antirheumatics there is an increased risk of an asthma attack (analgesic asthma), Quincke's oedema or hives. Such patients should use the medicine with caution and under medical supervision; the same applies to people prone to allergic skin reactions, itching or hives.
- Make sure that children do not come into contact with skin to which the medicine has been applied.
- The medicine contains a fragrance (lavender oil and bitter orange flower oil – neroli) with benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, limonene and linalool, which may cause allergic reactions.
Interactions with other medicines
No interactions with other medicines have been reported so far when the medicine is used as directed. Nevertheless, tell your doctor or pharmacist about all medicines you are using, have recently used or might use.
Pregnancy, breast-feeding and driving
- Pregnancy: in the first and second trimester the medicine is used only on a doctor's advice, after weighing benefits and risks. In the third trimester it is contraindicated, because it may affect uterine contractions, the course of labour and the baby's heart, lungs and kidneys.
- Breast-feeding: only small amounts of ibuprofen pass into breast milk; with short-term use there is no need to stop breast-feeding, but 3–4 applications of 2 to 5 cm a day should not be exceeded. Do not apply the medicine to the breasts. With long-term use, earlier weaning should be considered.
- Driving: the medicine has no influence on the ability to drive and use machines.
Possible side effects
Frequencies are taken from the table in section 4.8 of the summary of product characteristics (ALIMS):
| Frequency | Side effect |
|---|---|
| Common (1 to 10 in 100 patients) | local skin reactions: redness (erythema), itching, burning, rash (exanthema), pustular exanthema or hives |
| Uncommon (1 to 10 in 1,000 patients) | hypersensitivity reactions such as local allergic reactions (contact dermatitis) |
| Very rare (fewer than 1 in 10,000 patients) | narrowing of the airways (bronchospasm) |
| Not known | sensitivity of the skin to sunlight (photosensitivity) |
If the medicine is applied to large areas of skin over a long period, side effects affecting certain organs or the whole body, such as those seen after taking ibuprofen by mouth, cannot be ruled out. The fragrance components may cause allergic reactions. Report any suspected side effect to your doctor, pharmacist or ALIMS.
When to seek medical help immediately
- difficulty breathing, wheezing or a feeling of tightness in the chest after applying the medicine;
- swelling of the face, lips, tongue or throat, or hives spreading over the body;
- a severe or worsening skin reaction at the application site;
- accidental swallowing of the medicine or application of a much larger amount than recommended.
Pharmacist's advice
Apply Ibutop in a thin layer only to the painful area, on clean and intact skin, and rub it in gently. Adjust the length of the strip (2–5 cm) to the size of the area – a larger amount does not mean a stronger effect, but it increases the risk of side effects. Wash your hands immediately after application so that the medicine does not get into your eyes or onto mucous membranes.
The gel is clear and does not leave a greasy film, but it must not be used under an occlusive (airtight) dressing. Because sensitivity of the skin to sunlight has also been reported, protect the treated area from strong sun and sunbeds.
If the pain does not ease after 3 days, if the injury is accompanied by marked swelling, deformity or inability to bear weight, or if the pain comes with fever, see a doctor. If you have asthma or have ever reacted to aspirin or other painkillers, ask a pharmacist for advice before use.
Availability and price
Ibutop is dispensed without a medical prescription, in pharmacies only. This page is for information purposes only and is not an offer to sell the medicine online.
For questions about use and the choice of form, ask the pharmacist at your pharmacy or your doctor.
Storage
- Keep out of the sight and reach of children; store below 25 °C.
- Shelf life: 30 months; after the tube is first opened, the medicine can be used for 3 months (stored below 25 °C).
- Do not throw away unused medicine via household waste or wastewater – return it to a pharmacy.
Frequently asked questions
Can children use Ibutop?
Not children under 14 years of age, because there are not enough data on use in this age group. Adults and children over 14 use the medicine 3–4 times a day, with no more than 4 doses in 24 hours.
What is the difference between Ibutop Cream and Ibutop Gel?
Both contain 50 mg of ibuprofen per 1 g and are dosed the same way. The cream is an oil-in-water emulsion (it contains propylene glycol and a paraben), while the gel is clear and free of these excipients. At the start of treatment of severe bruises and sprains the cream may be used under an occlusive dressing, but the gel must not.
Can I put the gel under a dressing?
No. Use of Ibutop Gel under an occlusive (airtight) dressing is contraindicated.
Can Ibutop be used during pregnancy?
Not in the last trimester of pregnancy. In the first and second trimester only on a doctor's advice, after weighing benefits and risks. While breast-feeding, do not apply the medicine to the breasts.
Sources
- ALIMS – Package leaflet Ibutop Gel
- ALIMS – Summary of product characteristics Ibutop Gel
- ALIMS – Package leaflet Ibutop Cream
Text prepared from ALIMS documents (text revision August 2023), November 2026.
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