Symmetrel Capsules (2011)

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης	Alliance Pharmaceuticals
Διεύθυνση	Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB

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Qualitative and quantitative composition

Amantadine hydrochloride PhEur 100mg.

Contraindications

Known hypersensitivity to amantadine or any of the excipients. Individuals subject to convulsions. A history of gastric ulceration. Severe renal disease. Pregnancy.

Therapeutic indications

Parkinsons disease. Herpes zoster. It is recommended that Symmetrel be given to elderly or debilitated patients in whom the physician suspects that a severe and painful rash could occur. Symmetrel can ...

Posology and method of administration

Parkinsons disease: Initially 100mg daily for the first week, increasing to 100mg twice daily. The dose can be titrated against signs and symptoms. Doses exceeding 200mg daily may provide some additional ...

Pharmaceutical form

Brownish-red, hard gelatin capsules imprinted SYMM in white on both cap and body.

Name of the medicinal product

Symmetrel capsules 100mg.

Effects on ability to drive and use machines

Patients should be warned of the potential hazards of driving or operating machinery if they experience side effects such as dizziness or blurred vision.

Overdose

Overdose with Symmetrel can lead to fatal outcome. Signs and symptoms: Neuromuscular disturbances and symptoms of acute psychosis are prominent. Central nervous system: Hyperreflexia, motor restlessness, ...

Incompatibilities

None known.

Pharmacokinetic properties

Absorption: Amantadine is absorbed slowly but almost completely. Peak plasma concentrations of approximately 250ng/ml and 500ng/ml are seen 3 to 4 hours after single oral administration of 100mg and 200mg ...

Pregnancy and lactation

Amantadine-related complications during pregnancy have been reported. Symmetrel is contra-indicated during pregnancy and in women trying to become pregnant. Amantadine passes into breast milk. Undesirable ...

Marketing authorization number(s)

PL16853/0015

Undesirable effects

Amantadines undesirable effects are often mild and transient, usually appearing within the first 2 to 4 days of treatment and promptly disappearing 24 to 48 hours after discontinuation. A direct relationship ...

Date of first authorization / renewal of the authorization

26 June 1998

Pharmacodynamic properties

Pharmacotherapeutic group: Antiparkinsonian agent ATC code: N04BB01 Parkinsons disease: Symmetrel has been shown to be a low affinity antagonist at the N-methyl-D-aspartate (NMDA) subtype of glutamate ...

Special precautions for disposal and other handling

None.

Shelf life

Five years.

Special precautions for storage

Protect from moisture. Medicines should be kept out of reach of children.

Date of revision of the text

11th November 2011

List of excipients

Lactose Polyvinylpyrrolidone Magnesium stearate Red iron oxide (E172) Titanium dioxide (E171) Gelatin Monogramming ink S1-7085 White containing Titanium Dioxide (E171), Ammonium Hydroxide 28%, Propylene ...

Special warnings and precautions for use

Symmetrel should be used with caution in patients with confusional or hallucinatory states or underlying psychiatric disorders, in patients with liver or kidney disorders, and those suffering from, or ...

Nature and contents of container

Aluminium/PVdC blister packs of 56 capsules.

Preclinical safety data

Reproductive toxicity studies were performed in rats and rabbits. In rat oral doses of 50 and 100 mg/kg proved to be teratogenic. The maximum recommended dose of 400mg is less than 6mg/kg. There are no ...

Interaction with other medicinal products and other forms of interaction

Concurrent administration of amantadine and anticholinergic agents or levodopa may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects (see ...

Marketing authorization holder

Alliance Pharmaceuticals Ltd Avonbridge House Bath Road Chippenham Wiltshire SN15 2BB