… ).
Paediatric population
Long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are not available (see section 4.2).
Lactose
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Identical in both labels. Surrounding text shown from Brown & Burk UK Ltd.
… ointestinal symptoms.
If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.
Warnings about excipients
Amitriptyline Hydrochloride Film-coated Tablet contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Severe cutaneous reactions
Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been re …
Identical in both labels. Surrounding text shown from Flamingo Pharma (UK) Ltd.
… in children and adolescents concerning growth, maturation and cognitive and behavioural development are not available (see section 4.2).
Excipients
Amitriptyline hydrochloride contains lactose
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine.
Amitriptyline hydrochloride contains Sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.