Ibum Forte 400 mg capsules are no longer over-the-counter. Decision No. UR/ZD/2070/26 by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL), effective from 16 October, renamed them Ibum Med and changed their availability category to Rp.
What the URPL decision changed
The decision of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerns marketing authorisation No. 10864 for soft capsules containing 400 mg of ibuprofen. The product name was changed from Ibum Forte to Ibum Med, and the availability category from OTC (over the counter) to Rp (prescription only). According to the decision text, cited by pharmaceutical industry outlets, it was issued at the request of the marketing authorisation holder, Hasco-Lek.
In practice, a pharmacy may now dispense Ibum Med only on a doctor’s prescription. Previously, the capsules could be bought without consulting a doctor.
New pack size
Alongside the name change, a larger pack was approved. Until now the medicine was available in packs of 6, 12, 24 and 36 capsules, and a pack of 60 capsules will now be added. It has the same availability category, so it also requires a prescription.
Which Ibum products are still available without a prescription
The change covers one specific product, not ibuprofen 400 mg in general. The decision does not apply to other products from this manufacturer, which have separate authorisations:
- Ibum Express Forte 400 mg (soft capsules), available without a prescription;
- Ibum Sprint 200 mg, available without a prescription;
- Ibum and Ibum Forte oral suspensions for children, still OTC;
- Ibum Forte SR tablets, which are also not covered by this decision.
Note the name: the word “Forte” is still used by products available without a prescription, including the children’s suspensions. Only the 400 mg capsules, now sold as Ibum Med, require a prescription.
Why the category was changed
The available information does not indicate that the reason is a new risk associated with ibuprofen. No justification for the change in availability category was given in the publicly described parts of the decision.
Ibuprofen belongs to the non-steroidal anti-inflammatory drugs (NSAIDs). It is used for pain and fever. According to the product characteristics, adults and adolescents over 12 years (weighing at least 40 kg) take 400 mg every 4–6 hours, with a maximum of 1200 mg per day. Ibuprofen should not be used, among others, by people with liver, kidney or heart failure, peptic ulcer disease, or by women in the last trimester of pregnancy.
