Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Valproate semisodium
Lupin Healthcare (UK) Ltd
N03AG01
Valproate semisodium
250mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020300; GTIN: 5060346430416
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SYONELL 250MG GASTRO-RESISTANT TABLETS SYONELL 500MG GASTRO-RESISTANT TABLETS valproate semisodium This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects, you may get. See the end of section 4 for how to report side effects. WARNING Syonell, valproate semisodium, can seriously harm an unborn child when taken during pregnancy. If you are a female able to have a baby, you must use effective method of birth control (contraception) without interruptions during your entire treatment with Syonell. Your doctor will discuss this with you, but you must also follow the advice in section 2 of this leaflet. Schedule an urgent appointment with your doctor if you want to become pregnant or if you think you are pregnant. Do not stop taking Syonell unless your doctor tells you to as your condition may become worse. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you . Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Syonell is and what it is used for 2. What you need to know before you take Syonell 3. How to take Syonell 4. Possible side effects 5. How to store Syonell 6. Contents of the pack and other information 1. WHAT SYONELL IS AND WHAT IT IS USED FOR What Syonell is The name of your medicine is Syonell 250mg Gastro-Resistant tablets or 500mg Gastro-Resistant tablets. Syonell tablets contains a medicine called valproate semisodium. This belongs to a group of medicines called mood stabilisers. It works by stabilising the leve Preberite celoten dokument
OBJECT 1 SYONELL 250MG GASTRO-RESISTANT TABLETS Summary of Product Characteristics Updated 07-Sep-2022 | Lupin Healthcare (UK) Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product Syonell 250 mg Gastro-Resistant Tablets 2. Qualitative and quantitative composition Containing 269.06mg of valproate semisodium* per tablet (equivalent to 250mg of valproic acid). *Valproate semisodium is a stable coordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. It is also known as divalproex sodium (USAN. Excipient(s) with known effect: Sodium 18.51 mg (see section 4.4). For a full list of excipients, see section 6.1 3. Pharmaceutical form Gastro-resistant tablet. 250mg: Pink, oval shaped, bicon Preberite celoten dokument