Syonell 500mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Valproate semisodium

Available from:

Lupin Healthcare (UK) Ltd

ATC code:

N03AG01

INN (International Name):

Valproate semisodium

Dosage:

500mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020300; GTIN: 5060346430423

Patient Information leaflet

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

Summary of Product characteristics

OBJECT 1
SYONELL 500MG 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 500 mg Gastro-Resistant Tablets
2. Qualitative and quantitative composition
Containing 538.12mg of valproate semisodium* per tablet (equivalent to
500mg 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 37.03 mg (see section 4.4).
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Gastro-resistant tablet.
500mg: Pink, oval shaped, bico