Epsylam DT

Epsylam DT Side Effects

lamotrigine

Manufacturer:

Aurobindo Pharma

Distributor:

Unimed
Full Prescribing Info
Side Effects
The undesirable effects have been divided into epilepsy and bipolar specific sections based on the data currently available. However, both sections should be consulted when considering the overall safety profile of Lamotrigine. Adverse reactions identified through post-marketing surveillance are included in the Epilepsy as follows.
Epilepsy: Skin and subcutaneous tissue disorders: Very common: Skin rash.
Rare: Stevens Johnson syndrome.
Very Rare: Toxic epidermal necrolysis.
The rash, usually maculopapular in appearance, generally within eight weeks of starting treatment and resolves on withdrawal of Lamotrigine (see Precautions).
Rarely, serious potentially life-threatening skin rashes, including Stevens Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome) have been reported. Although the majority recover on drug withdrawal, some patients experience irreversible scaring and there have been rare cases of associated death (see Precautions).
The overall risk of rash, appearance to be strongly associated with: High initial doses of Lamotrigine and exceeding the recommended dose escalation of Lamotrigine therapy (see Dosage & Administration); Concomitant use of valproate (see Dosage & Administration).
Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms (see Immune system disorders** as follows).
Blood and lymphatic system disorders: Very rare: Haematological abnormalities (including neutropenia, leucopenia, anaemia, thrombocytopenia, pancytopenia, aplastic anaemia, agranulocytosis, lymphadenopathy.
Haematological abnormalities and lymphadenopathy may or may not be associated with the hypersensitivity syndrome (see Immune system disorders** as follows).
Immune system disorders: Very rare: Hypersensitivity syndrome** (including such symptoms as fever, lymphadenopathy, facial oedema, abnormalities of the blood and liver, disseminated intravascular coagulation (DIC) multi-organ failure).
**Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms including fever, lymphadenopathy, facial oedema and abnormalities of the blood and liver. The syndrome shows a wide spectrum of clinical severity and may, rarely, lead to disseminated intravascular coagulation (DIC) and multiorgan failure. It is important to note that early manifestations of hypersensitivity (e.g. fever, lymphadenopathy) may be present even though rash is not evident. If such signs and symptoms are present the patient should be evaluated immediately and Lamotrigine discontinued if an alternative aetiology cannot be established.
Psychiatric disorders: Common: Aggression, irritability.
Very rare: Tics, hallucinations, confusion.
Nervous system disorders: Very common: Somnolence, ataxia, headache, dizziness.
Common: Nystagmus, tremor, insomnia.
Very rare: Aseptic meningitis, agitation, unsteadiness, movement disorders, worsening of Parkinson's disease, extrapyramidal effects, choreoathetosis, increase in seizure frequency.
Eye disorders: Very common: Diplopia, blurred vision.
Rare: Conjunctivitis.
Gastrointestinal disorders: Very common: Nausea, vomiting.
Common: Diarrhoea.
Hepatobiliary disorders: Very rare: Increased liver function tests, hepatic dysfunction, hepatic failure.
Hepatic dysfunction usually occurs in association with hypersensitivity reactions but isolated cases have been reported without overt signs of hypersensitivity.
Musculoskeletal and connective tissue disorders: Very rare: Lupus-like reactions.
General disorders and administration site conditions: Common: Tiredness.
Bipolar Disorder: The undesirable effects as follows should be considered alongside those seen in epilepsy for an overall safety profile of Lamotrigine.
Skin and subcutaneous tissue disorders: Very common: Skin rash.
Rare: Stevens Johnson syndrome.
Nervous system disorders: Very common: Headache.
Common: Agitation, somnolence, dizziness.
Musculoskeletal and connective tissue disorders: Common: Arthralgia.
General disorders and administration site conditions: Common: pain, back pain.
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