החמרה לעלון 30.11.2021.pdf

Sanofi Aventis Israel, 10 Bnei Gaon St, Poleg Industrial Area, POB 8090, Netanya 42504: Tel 09-8633700, Fax 09-8851444, December 2021.

SOLIAN 100mg tablets, SOLIAN 400mg film coated tablets: Active ingredient - Amisulpride 100mg, Amisulpride 400mg.

Approved indication: Treatment of schizophrenia.

Sanofi Aventis is updating the information for healthcare professionals and consumers. There is no change in the appearance of the tablets. The main updates appear in the following sections:

For healthcare professionals: 4.4 Special warnings and precautions for use - the medicine contains less than 1 mmol sodium per tablet, 4.8 Undesirable effects - fall as a consequence of adverse reactions compromising body balance.

For consumers: 2. Before using the medicine - important information about some of the ingredients, 3. How to use the medicine - do not crush or chew the tablets, swallow with water.

4. Side effects - rare (affecting up to 1 in 1000 people): fatigue, weakness, confusion, muscle stiffness, falls as a consequence of adverse reactions compromising body balance.

5. How to store the medicine - do not use if the color of the tablets has changed, do not throw away medicines via wastewater or household waste.

6. Further information - what the medicine looks like and what the pack contains: SOLIAN 100mg - white to off-white round flat tablets, SOLIAN 400mg - white film-coated tablets with a score line.

The updated label will be published on the Ministry of Health's website and can be obtained by contacting Sanofi Aventis Israel.