Dear Healthcare Professional Letter on placing on the market of new medicinal products Silapen K 1 000 000 IU film-coated tablets and Silapen K 1 500 000 IU film-coated tablets
22.05.2014
Belupo, medicines & cosmetics d.d. has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals of placing on the market of new medicines: Silapen K 1 000 000 IU film-coated tablets and Silapen K 1 500 000 film-coated tablets. This medicines will replace Silapen 1 000 000 IU tablets and Silapen 1 500 000 IU tablets, and therefore it might be possible for some time that all of these medicines will be on the market.
The medicinal product Silapen K film-coated tablets contain the salt phenoxymethylpenicillinum potassium, whereas Silapen tablets contain the salt phenoxymethylpenicillinum benzathyne. The phenoxymethylpenicillinum potassium doses expressed in international units (IU) equal to doses of phanoxymethylpenicilline in form of phenoxymethylpenicillinum benzathyne expressed in IU, and the results of the bioequivalence study have proven the essential similarity with the reference product.
In addition, the colour and appearance tablets have been changed: white to yellowish white tablets have been changed with film -coated tablets white to slightly cream colour, oblong or oval shape with a partition slot on both sides, with weak odour to peppermint.
Here you may view the Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
