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AMANTADINE tablets
COMPOSITION:
Each capsule contains: Amantadine (INN) hydrochloride
100 mg.
Excipients: Dicalcium phosphate dihydrate, Magnesium stearate and Carboxymethylcellulose sodium,
q.s.
The gelatin capsule is made of: gelatin, indigo carmine (E 132), quinoline yellow (E 104) and titanium dioxide (E 171).
ACTIVITY
Amantadine Level is an anti-viral agent. The mechanism of action of amantadine appears to be the inhibition of viral penetration into the host cell, with which it prevents the replication and spread of the viral infection.
INDICATIONS
Prophylaxis and treatment of symptoms of influenza caused by Type A influenza virus, especially in patients at high risk where vaccination is not indicated. Parkinson's disease. Drug-induced, toxic or traumatic extrapyramidal symptoms.
Herpes Zoster.
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CONTRAINDICATIONS
History of hypersensitivity to amantadine. Pregnancy. Lactation. Convulsions. A history of gastric ulceration. Severe renal disease.
PRECAUTIONS
Amantadine Level should be used with great caution in patients with renal and hepatic insufficiency because this medication is excreted unchanged by the kidneys.
It should also be used with caution in patients with a history of epilepsy, psychiatric disorders (especially those characterized by confusional or hallucinatory states), in patients with congestive heart failure or peripheral oedema.
Patients with Parkinson's disease should avoid abrupt discontinuation of amantadine.
Amantadine may occasionally cause insomnia. Dosage should be adjusted so that the last dose is not taken late in the afternoon or at night.
Patients receiving Amantadine Level should be warned that blurred vision or other central nervous symptoms may occur and impair the reaction of the patient, in which case they should be carfeul when driving or operating machinery.
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INTERACTIONS
Amantadine may potentiate the effects of anticholinergic agents, especially psychiatric adverse effects. If the unwanted effects of anticholinergic drugs increase due to the concomitant use of amantadine, the dose of one of the two medications should be decreased. Caution should be applied when taking amantadine concurrently with substances acting on the central nervous system.
POSOLOGY
Parkinson's disease: Initially 100 mg. (1 capsule) a day for the first week, then increasing to 1 capsule twice a day. A higher dose may be administered, only if indicated by your doctor, in such cases careful surveillance of the patient is recommended.
Prophylaxis of influenza:
Adults: One capsule twice a day.
Children aged 10 - 15 years: One capsule once a day.
The administration to children under 10 years of age is not recommended.
Treatment of influenza:
The same dosage as for prophylaxis should be used. The duration of treatment should be determined by your doctor.
Herpes Zoster:
One capsule (100 mg.) twice a day for 14 days.
If the symptoms persist treatment can be continued for a further 14 days.
OVERDOSE
In case of accidental ingestion, gastric lavage or induction of vomiting should be carried out immediately.
There is no specific antidote. Acidification of the urine to favour its excretion should be carried out and symptomatic therapy should be employed, including, if necessary the administration of sedatives and anticonvulsants.
ADVERSE REACTIONS
Insomnia, oedema of the legs (with or without livedo reticularis), psychiatric disorders (depression, agitation, vertigo, headache, hallucinations or confusion).
Rarely you may experience convulsions, visual disturbances, orthostatic hypotension, congestive heart failure, anorexia, urinary retention, palpitations, nausea, constipation, skin rash or myalgia.
All these side effects subside after termination of therapy and most also disappear after a few days of continued therapy.
If you notice any side effects not mentioned in this leaflet please inform your doctor or pharmacist.
EXPIRY
Do not use this medication after the expiry date stated on the pack
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