CONVULEX Gastro-resistant capsule (2019)

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Περιεχόμενα

1. Name of the medicinal product

Convulex 150 mg Capsules.

2. Qualitative and quantitative composition

1 capsule contains: Valproic Acid 150.00 mg For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Gastro-resistant capsule, soft. Old-rose coloured, oblong gelatine capsules with enteric coating.

4.1. Therapeutic indications

Treatment of generalised, partial or other epilepsy.

4.2. Posology and method of administration

Convulex capsules are for oral administration. Daily dosage requirements vary according to age and body weight. Convulex capsules may be given twice daily. Female children and women of childbearing potential ...

4.3. Contraindications

Convulex is contraindicated in the following situations: Hypersensitivity to the active substance or any of the excipients Active liver disease Personal or family history of severe hepatic dysfunction, ...

4.4. Special warnings and precautions for use

Pregnancy Prevention Programme Valproate has a high teratogenic potential and children exposed in utero to valproate have a high risk for congenital malformations and neurodevelopmental disorders (see ...

4.5. Interaction with other medicinal products and other forms of interaction

Effects of Valproate on other drugs Neuroleptics, MAO inhibitors, antidepressants and benzodiazepines Valproate may potentiate the effect of other psychotropics such as neuroleptics, MAO inhibitors, antidepressants ...

4.6. Fertility, pregnancy and lactation

Pregnancy Valproate is contraindicated as treatment for epilepsy during pregnancy unless there is no suitable alternative to treat epilepsy. Valproate is contraindicated for use in women of childbearing ...

4.7. Effects on ability to drive and use machines

Use of Convulex may provide seizure control such that the patient may be eligible to hold a driving licence. Patients should be warned of the risk of transient drowsiness, especially in cases of anticonvulsant ...

4.8. Undesirable effects

Hepato-biliary disorders Rare cases of liver dysfunction (see section 4.4.1 Warnings). Severe liver damage, including hepatic failure sometimes resulting in death, has been reported (see also sections ...

4.9. Overdose

Cases of accidental and deliberate valproate overdosage have been reported. At plasma concentrations of up to 5-6 times the maximum therapeutic levels, there are unlikely to be any symptoms other than ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: antiepileptics, fatty acid derivates ATC code: N03AG01 The most likely mode of action for valproate is potentiation of the inhibitory action of gamma amino butyric ...

5.2. Pharmacokinetic properties

Absorption The half-life of valproate is usually reported to be within the range of 8-20 hours. It is usually shorter in children. In patients with severe renal insufficiency it may be necessary to alter ...

5.3. Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to those already stated in other sections of the SmPC.

6.1. List of excipients

Gelatine Glycerol 85% Dry substance of Karion 83 (70%) Titanium dioxide Red ferric oxide (E 172) Hydrochloric acid Methacrylic acid-ethylacrylate copolymer (1:1)-dispersion 30% Triethyl citrate Macrogol ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze. Keep in the original package in order to protect from light and moisture.

6.5. Nature and contents of container

Blister packs: Upper: PVC/PVDC or PVC-foil Lower: aluminium foil Outer box: carton folding box Pack size: 100, 30

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

8. Marketing authorization number(s)

PL 21597/0004

9. Date of first authorization / renewal of the authorization

11 October 1991 / 16 October 1998 / 2 July 2004

10. Date of revision of the text

11/01/2019

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