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AKINETON Tablets

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Akineton 2 mg tablets

Qualitative and quantitative composition

Active substance: Biperiden Hydrochloride. 1 tablet contains 2 mg Biperiden Hydrochloride equivalent to 1.8 mg Biperiden. Excipient with known effect: Lactose monohydrate 38 mg. For the full list of excipients, ...

Pharmaceutical form

White, biplanar tablet, cross-scored on one side. The tablet can be divided into equal doses.

Therapeutic indications

All forms of parkinsonism. Drug-induced extrapyramidal symptoms excito-motor phenomena, parkinsonoid, akinesia, rigidity, akathisia, acute dystonia.

Posology and method of administration

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 ...

Contraindications

Akineton should not be used in case of: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Untreated narrow angle glaucoma. Mechanical stenoses in the gastro-intestinal ...

Special warnings and precautions for use

Anti-cholinergic drugs, such as Biperiden, with a central mode of action can lead to an increased tendency to cerebral seizures. In patients with an increased tendency to convulsions, Akineton is to be ...

Interaction with other medicinal products and other forms of interaction

Combination with other anti-cholinergic drugs, e.g. psycho-pharmaceuticals, antihistamines, antiParkinson drugs and spasmolytics, can lead to an increase in central and peripheral side-effects. Taking ...

Pregnancy and lactation

Pregnancy Akineton should be administered during pregnancy only after a careful risk-benefit analysis, as no experience is available with its use in pregnancy. Breastfeeding Anti-cholinergic drugs can ...

Effects on ability to drive and use machines

Due to central nervous and peripheral side-effects, such as e.g. tiredness, dizziness and drowsiness, even when used correctly this drug can also change the ability to react to such an extent that – independent ...

Undesirable effects

Summary of the safety profile Side-effects may occur particularly at the beginning of treatment and if the dosage is increased too quickly. Central excitation effects are frequently seen in patients with ...

Overdose

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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-parkinson drugs, anticholinergic agents, biperiden ATC code: N04AA02 Biperiden is a predominantly centrally acting anti-cholinergic. It has a peripheral effect, which is ...

Pharmacokinetic properties

Absorption Biperiden hydrochloride is quickly absorbed after 4 mg are taken orally with a lag-time of 27min. The maximum plasma concentration of 4-7 ng/ml is attained after 1-2 h. Bioavailability The bioavailability ...

Preclinical safety data

Chronic toxicity Investigations on the chronic toxicity in rats and dogs gave no indication of organ toxicity. Mutagenic and tumourigenic potential In-vivo and in-vitro investigations with Biperiden gave ...

List of excipients

Calcium hydrogen phosphate dihydrate Copovidone Purified water Potato starch Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Talc

Incompatibilities

Not applicable.

Shelf life

Shelf life: 5 years. This drug should no longer be used after the expiry date.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC/Al-blister pack with 30, 50, 60, 100 and 200 (5x40) tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

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

Marketing authorization holder

Desma GmbH, Peter-Sander-Str. 41b, 55252, Mainz-Kastel, Germany, Tel: +49 (0) 6134 21079 0, Fax: +49 (0) 6134 21079 24

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