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SPC, UK: LAMOTRIGINE / MYLAN Dispersible tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Lamotrigine Mylan 100 mg Dispersible Tablets.

Qualitative and quantitative composition

Each tablet contains 100 mg lamotrigine. For the full list of excipients, see section 6.1.

Pharmaceutical form

Dispersible Tablet. Lamotrigine Mylan 100 mg tablets are white to off white, round, flat faced, bevelled edge tablets marked LY over 100 on one side and plain on the other side.

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 ...

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 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Skin rash There have been reports of adverse skin reactions, which have generally occurred within the first eight weeks after initiation of lamotrigine treatment. The majority of rashes are mild and self-limiting, ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. UDP glucuronyl transferases have been identified as the enzymes responsible for metabolism of lamotrigine. Drugs that induce or inhibit glucuronidation ...

Fertility, pregnancy and lactation

Risk related to antiepileptic medicines 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 ...

Effects on ability to drive and use machines

As there is individual variation in response to all AED therapy, patients taking lamotrigine to treat epilepsy should consult their physician on the specific issues of driving and epilepsy. No studies ...

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 ...

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, ...

Pharmacodynamic properties

Pharmacotherapeutic group: other antiepileptics ATC code: N03AX09 Mechanism of action The results of pharmacological studies suggest that lamotrigine is a use- and voltage dependent blocker of voltage ...

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. ...

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 ...

List of excipients

Cellulose, microcrystalline Sodium starch glycolate (Type A) Povidone Silica, colloidal anhydrous Saccharin sodium Mannitol Magnesium stearate Artificial blackcurrant flavouring containing glyceryl triacetate ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Lamotrigine Mylan Dispersible Tablets will be packed in PVdC/PVC/Aluminium blister strips. Pack sizes: 14, 21, 28, 30, 46, 56, 100 tablets. * Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Generics [UK] Limited t/a Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization number(s)

PL 04569/1210

Date of first authorization / renewal of the authorization

28/10/2005 / 03/03/2010

Date of revision of the text

11/06/2019

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