LAMOTRIX Tablet (2023)
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Περιεχόμενα
1. Name of the medicinal product
Lamotrix, 25 mg, tablets. Lamotrix, 50 mg, tablets. Lamotrix, 100 mg, tablets. Lamotrix, 200 mg, tablets.
2. Qualitative and quantitative composition
Lamotrix 25 mg tablets: each tablet contains 25 mg of lamotrigine. Lamotrix 50 mg tablets: each tablet contains 50 mg of lamotrigine. Lamotrix 100 mg tablets: each tablet contains 100 mg of lamotrigine. ...
3. Pharmaceutical form
Tablet. Lamotrix 25 mg tablets are beige coloured, round, flat, marked MC at one side and have a diameter of 6 mm. Lamotrix 50 mg tablets are beige coloured, round, flat and scored and have a diameter ...
4.1. Therapeutic indications
Epilepsy Adults and adolescents aged 13 years and above Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including tonic-clonic seizures. Seizures associated with Lennox-Gastaut ...
4.2. Posology and method of administration
Posology If the calculated dose of lamotrigine (for example for treatment of children with epilepsy or patients with hepatic impairment) does not equate to whole tablets, the dose to be administered is ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Brugada-type ECG and other cardiac rhythm and conduction abnormalities Arrhythmogenic ST-T abnormality and typical Brugada ECG pattern has been reported in patients treated with lamotrigine. Based on in ...
4.5. Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Uridine 5'-diphospho (UDP)-glucuronyl transferases (UGTs) have been identified as the enzymes responsible for metabolism of lamotrigine. Drugs that ...
4.6. Fertility, pregnancy and lactation
Risk related to antiepileptic drugs in general Specialist advice should be given to women who are of childbearing potential. The antiepileptic treatment should be reviewed when a woman is planning to become ...
4.7. Effects on ability to drive and use machines
As there is individual variation in response to all AED therapy, patients taking Lamotrix to treat epilepsy should consult their physician on the specific issues of driving and epilepsy. No studies on ...
4.8. Undesirable effects
The undesirable effects for epilepsy and bipolar disorder indications are based on available data from controlled clinical studies and other clinical experience and are listed in the table below. Frequency ...
4.9. Overdose
Symptoms and signs Acute ingestion of doses in excess of 10 to 20 times the maximum therapeutic dose has been reported, including fatal cases. Overdose has resulted in symptoms including nystagmus, ataxia, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> other antiepileptics <b>ATC code:</b> N03AX09 Mechanism of action The results of pharmacological studies suggest that lamotrigine is a use- and voltage-dependent blocker ...
5.2. Pharmacokinetic properties
Absorption Lamotrigine is rapidly and completely absorbed from the gut with no significant first-pass metabolism. Peak plasma concentrations occur approximately 2.5 hours after oral administration of lamotrigine. ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. In reproductive and developmental toxicity ...
6.1. List of excipients
All strengths of lamotrigine tablets contain lactose monohydrate, cellulose microcrystalline, sodium starch glycolate, povidone, magnesium stearate and iron oxide yellow (E172) as the inactive ingredients. ...
6.2. Incompatibilities
No known incompatibilities.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
All strengths are packed in PVC-Al blisters of 10 tablets in packs of 20, 30, 50, 100 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
Lamotrix 25mg tablets: 18540 Lamotrix 50mg tablets: 18538 Lamotrix 100mg tablets: 18541 Lamotrix 200mg tablets: 18539
9. Date of first authorization / renewal of the authorization
Lamotrix 25mg tablets: 12.01.2000 / 20.12.2010 Lamotrix 50mg tablets: 12.01.2000 / 20.12.2010 Lamotrix 100mg tablets: 12.01.2000 / 20.12.2010 Lamotrix 200mg tablets: 12.01.2000 / 20.12.2010
10. Date of revision of the text
19/10/2023
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