LAMITOR Tablet

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

LAMITOR–25 (tablet). LAMITOR–50 (tablet). LAMITOR–100 (tablet). LAMITOR–200 (tablet).

2. Qualitative and quantitative composition

LAMITOR–25: Each tablet contains lamotrigine 25 mg. LAMITOR–50: Each tablet contains lamotrigine 50 mg. LAMITOR–100: Each tablet contains lamotrigine 100 mg. LAMITOR–200: Each ...

3. Pharmaceutical form

LAMITOR–25: Light yellow coloured, round, flat uncoated tablets, with bisecting line on one side. LAMITOR–50: Light yellow coloured, round, flat uncoated tablets, with bisecting line on one ...

4.1. Therapeutic indications

Adults and children over 12 years LAMITOR is indicated as monotherapy or add-on treatment of partial epilepsy with or without secondary generalised tonic-clonic seizures and in primary generalised tonic-clonic ...

4.2. Posology and method of administration

It is important to adhere to the recommended dosages especially in combination therapy with valproate where one-tenth of the normal dose is used. Do not exceed the maximum dosage (see WARNINGS). To ensure ...

4.3. Contraindications

LAMITOR is contraindicated in the following circumstances: Individuals with known hypersensitivity to lamotrigine. The safety of LAMITOR in pregnancy and lactation has not been established. Renal and hepatic ...

4.4. Special warnings and precautions for use

WARNINGS Severe convulsive seizures including status epilepticus may lead to rhabdomyolysis, multiorgan dysfunction and disseminated intravascular coagulation, usually with fatal outcome. Similar cases ...

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

Enzyme-inducing agents (such as phenytoin, carbamazepine, phenobarbitone and primidone) enhance the metabolism of LAMITOR leading to an increased clearance and subsequent reduction of the elimination halflife ...

4.6. Pregnancy and lactation

The safety of LAMITOR in pregnancy and lactation has not been established.

4.8. Undesirable effects

Side-effects Very common (>1/10), Common (>1/100 and ≤1/10), Uncommon (>1/1000 and ≤1/100), Rare (>1/10 000 and ≤1/1000), Very rare (≤1/10 000). Blood and lymphatic system disorders Very rare: Blood ...

4.9. Overdose

Symptoms and signs Acute ingestion of doses in excess of 10 – 20 times the maximum therapeutic doses has been reported. Overdose has resulted in symptoms including nystagmus, ataxia, impaired consciousness ...

5.1. Pharmacodynamic properties

A 2.5 Antiepileptics Pharmacological action Lamotrigine blocks voltage-sensitive sodium channels, thereby stabilising neuronal membranes and inhibiting neurotransmitter release, principally that of glutamate, ...

5.2. Pharmacokinetic properties

Lamotrigine is rapidly and completely absorbed from the gut. The absorption is unaffected by food. The time to peak concentration is 1,4 to 4,8 hours. The mean elimination half-life is 25 ± 10 hours and ...

6.4. Special precautions for storage

Store at or below 25ºC in a dry place. Keep tablets in the original blister packs until a dose is to be taken. KEEP OUT OF REACH OF CHILDREN.

6.5. Nature and contents of container

LAMITOR–25: 60 tablets, as six PVC/Aluminium foil blister strips of 10 tablets each, in a carton. LAMITOR–50: 60 tablets, as six PVC/Aluminium foil blister strips of 10 tablets each, in a ...

7. Marketing authorization holder

Dr Reddys Laboratories (Pty) Limited, The Place, 1 Sandton Drive, Sandton, 2196

8. Marketing authorization number(s)

LAMITOR–25: 37/2.5/0051 LAMITOR-50: 37/2.5/0052 LAMITOR-100: 37/2.5/0053 LAMITOR-200: 41/2.5/0375

9. Date of first authorization / renewal of the authorization

December 2008

10. Date of revision of the text

December 2008

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