AKINETON Tablets Ref.[6740] Active ingredients: Biperiden

Biperiden has to be dosed individually.

Treatment should begin with the lowest dose and then be increased to the most favourable dose for the patient.

Posology

Adults

Parkinson syndrome

Initially 2 times ½ tablet (2 mg Biperiden hydrochloride/day) distributed over the day. The dose can be increased daily by 2 mg. As maintenance dose, 3–4 times daily ½–2 tablets (corresponding to 3–16 mg/day) are administered. The maximum daily dose amounts to 16 mg Biperiden hydrochloride (corresponding to 8 tablets/day).

Drug-related extrapyramidal symptoms:

For the treatment of drug-related extrapyramidal symptoms, ½–1 tablet is administered 2–3 times daily concomitantly with the neuroleptic (corresponding to 2–6 mg Biperiden hydrochloride/day), depending on the severity of the symptoms.

Children and adolescents (up to 18 years)

For the treatment of drug-induced extrapyramidal symptoms, children from 3 to 15 years receive 1– 3 times daily 1/2–1 tablet (equivalent to 1–6 mg biperiden hydrochloride/ day).

Older patients

Caution with dosing is necessary! The lowest possible dose should be used initially and the dose should then be slowly increased, depending on the response of the patient (see also section 5.2).

Patients with impaired liver or renal function

No pharmacokinetic data is available in patients with impaired liver or renal function. For this reason, caution is necessary when dosing. Start with the lowest possible dose and, depending upon the response of the patient, the dose should be increased slowly.

Remarks

In patients requiring a quick onset of action, an injection solution is available.

Method of administration

The total daily dose should be divided into several single administrations and taken uniformly distributed over the day.

The tablets can be divided into two equal doses and should be taken with sufficient liquid preferably during or after a meal.

Undesired effects on the gastro-intestinal tract can be avoided by taking the tablets immediately after meals.

Duration of treatment

The duration of treatment depends on the type and extent of the disease and can range from short-term administration to long-term medication. Treatment with this medication should not be discontinued abruptly, but in steps.

Symptoms of overdose

Symptoms of an intoxication resemble in principle that of atropine poisoning with peripheral anticholinergic symptoms (wide, slow-reacting pupils; dryness of the membranes; redness of the face; increased cardiac rate; intestinal and bladder atony; raised temperature) and central nervous disturbances (such as excitation, delirium, confusion, clouding of consciousness and/or hallucinations).

In severe intoxications, there is a risk of circulatory collapse and central respiratory paralysis.

Therapeutic measures in overdose

Acetylcholinesterase inhibitors, particularly physostigmine, which can pass into the cerebrospinal fluid, are recommended as antidotes, which can also influence centrally triggered symptoms (and/or physostigmine salicylate, in case of a positive physostigmine test). If necessary, support of the cardiovascular and respiratory functions (artificial respiration with oxygen), heat dissipation in case of febrile temperatures and the application of a bladder catheter should be used, depending on the type of symptoms.

Furthermore, gastric lavage or measures which reduce the absorption from the gastro-intestinal tract may be undertaken, if necessary.

Shelf life: 5 years.

This drug should no longer be used after the expiry date.

This medicinal product does not require any special storage conditions.

PVC/Al-blister pack with 30, 50, 60, 100 and 200 (5x40) tablets.

Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with local requirements.