Source: European Medicines Agency (EU) Publisher: Desma GmbH, Peter-Sander-Str. 41b, 55252, Mainz-Kastel, Germany, Tel: +49 (0) 6134 21079 0, Fax: +49 (0) 6134 21079 24
Akineton should not be used in case of:
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 dosed carefully (see side-effects).
In the case of urinary retention, patients should empty the bladder before taking the respective dose of Biperiden.
Biperiden can lead sporadically to difficulties in micturition, in particular in patients with prostate hypertrophy, more seldom to urinary retention.
The intraocular pressure should be controlled regularly (see side-effects). Caution should also be taken in cases of existing glaucoma.
Akineton may only be used with particular caution in patients with Myasthenia gravis.
In patients who suffer from diseases which can lead to tachycardia, Akineton should be used with caution.
If marked dryness of the mouth occurs, this can be improved by frequently drinking small amounts of liquid or by chewing sugar-free chewing gum.
In older patients, in particular those with cerebro-organic symptoms, careful dosing is necessary.
Older patients, especially those with organo-cerebral changes of a vascular or degenerative nature, frequently show an increased sensitivity towards therapeutic doses of the active substance.
Experience with Biperiden in children and adolescents up to 18 years of age is limited and extends primarily to the use for a limited period of time in cases of drug-induced dystonia (e.g. due to neuroleptics or metoclopramide and analogous compounds), which can arise as sideeffects or symptoms of an intoxication.
Patients during pregnancy and lactation period see section 4.6. Impaired memory may arise while taking Biperiden (see also section 4.8 Side-effects).
Reports of misuse and dependency upon taking Biperiden have been reported in isolated cases, due to occasionally observed mood-enhancing and euphoric effects.
Other than in the case of vital complications, abrupt discontinuation of the drug is to be avoided due to the danger of excessive counter-regulation.
Akineton 5 mg – solution for injection contains sodium.
This medicine contains less than 1 mmol sodium (23 mg) per 1 ampoule of 1 ml solution for injection, that is to say essentially ‘sodium-free’.
Combination with other anti-cholinergic drugs, e.g. psycho-pharmaceuticals, antihistamines, antiParkinson drugs and spasmolytic, can lead to an increase in central and peripheral side-effects.
Taking quinidine concomitantly can lead to an enhancement of anti-cholinergic cardio-vascular effects (in particular to AV-conduction).
Levodopa and the concomitant administration of Akineton can enhance dyskinesia. Generalised choreiform disturbances of movement have been observed with the concomitant use of Biperiden and Levodopa/Carbidopa preparations in patients with Parkinson’s disease.
Tardive dyskinesia induced by neuoleptics may be enhanced by Akineton. Occasionally, Parkinson symptoms in existing delayed dyskinesia may be so serious, that anti-cholinergic treatment becomes necessary.
An increase in the effects of alcohol under Akineton may occur (avoid alcohol).
The effect of metoclopramide and compounds with similar effects on the gastro-intestinal tract is antagonised by anti-cholinergic drugs such as Akineton.
Anti-cholinergics can increase the central-nervous side-effects of pethidine.
Akineton should be administered during pregnancy only after a careful risk-benefit analysis, as no experience is available with its use in pregnancy.
Anti-cholinergic drugs can inhibit lactation. Due to the chemical structure of the active substance, it can be assumed that Biperiden passes into breast milk. For this reason, weaning is recommended.
No data are available on the effects of Akineton on fertility.
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 of the limitation due to the underlying disease to be treated – the ability to actively participate in road traffic or operate electrically or motor-driven tools and machines is further impaired. This is particularly true with the concomitant use of other centrally active drugs, anticholingeric drugs and especially in connection with alcohol.
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 symptoms of a cerebral deficiency and can necessitate a decrease in the dosage.
The following frequencies are used as the basis in the evaluation of side-effects:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data
Not known: Parotitis.
Very rare: Hypersensitivity.
Rare: In higher doses excitement, agitation, fear, confusion, delirious syndromes, hallucinations, sleeplessness.
Very rare: Nervousness, euphoria.
Rare: Fatigue, dizziness and disturbance of memory.
Very rare: Headache, dyskinesia, ataxia and speaking disorder, increased disposition to cerebral seizures and convulsions.
Very rare: Disturbance of accommodation, mydriasis, photosensitivity. Closed-angle glaucoma might occur (controlling of intraocular pressure).
Rare: Tachycardia.
Very rare: Bradycardia. A fall in blood pressure may occur following parenteral administration.
Rare: Dryness of mouth, nausea, gastric disorder.
Very rare: Constipation.
Very rare: Reduced perspiration, allergic rash.
Rare: Muscle twitching.
Very rare: Voiding disorders, especially in patients with prostate adenoma (dose reduction), more seldom: urinary retention.
Rare: Drowsiness.
There have been reports of temporarily reduced REM sleep (sleeping phase with rapid eye movements), characterised by an increase in the time needed to reach this stage and a percentage decrease in the length of this phase in the total sleep.
The safety profile in the Paediatric population is similar to that in adults.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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