Akineton

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Akineton (Акинетон), 2 mg, tablets

Biperideni hydrochloridum
Akineton and Акинетон are the same trade names for the same drug written in Polish and Bulgarian.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Akineton and what is it used for
• 2. Important information before using Akineton
• 3. How to use Akineton
• 4. Possible side effects
• 5. How to store Akineton
• 6. Contents of the packaging and other information

1. What is Akineton and what is it used for

Akineton is an anticholinergic medicine with a strong effect on the central nervous system, used in the treatment of Parkinson's disease and extrapyramidal disorders, in the form of involuntary, abnormal movements.
The medicine, by binding to certain receptors in the brain (muscarinic receptors), reduces the severity of such symptoms as muscle stiffness, involuntary muscle tremors, movement slowing or involuntary movements.
Biperiden is recommended as an additional medicine during treatment with levodopa or similar medicines that have a stronger effect on movement disorders in Parkinson's disease.

Akineton is used:

• in the treatment of muscle stiffness, tremors, and movement slowing in Parkinson's disease;
• in the treatment of movement disorders (extrapyramidal symptoms) caused by the action of certain neurological medicines (neuroleptics or other medicines with similar effects), such as: tongue spasms, muscle spasms of the throat and attacks of forced staring with eye rotation upwards (early dyskinesias); motor agitation, compulsion to be in constant motion (akathisia) and symptoms similar to Parkinson's disease (parkinsonoid symptoms);
• in the treatment of other extrapyramidal movement disorders, e.g. involuntary movements causing twisting and bending of different parts of the body, resulting in the patient often taking an unnatural posture, which may affect the entire body (generalized dystonia) or individual parts of the body (segmental dystonia), in particular movement disorders in the head area (Meige's syndrome), eyelid spasms (Blepharospasmus) or spastic torticollis (Torticollis spasmodicus).

2. Important information before using Akineton

When not to use Akineton:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the patient has narrow-angle glaucoma;
• if the patient has mechanical obstruction of the gastrointestinal tract;
• if the patient has colon enlargement (colonic dilatation);
• if the patient has intestinal obstruction.

Warnings and precautions

Before starting to use Akineton, you should discuss it with your doctor or pharmacist. You should be particularly careful:

• in patients with prostate enlargement (prostate) with residual urine in the bladder;
• in patients with urinary retention (inability to physiologically empty the bladder through the urethra); In the case of existing disorders related to bladder emptying, the patient should empty the bladder before each use of the medicine;
• in patients with myasthenia (a chronic disease characterized by rapid fatigue and muscle weakness);
• in patients with conditions that may lead to severe tachycardia (heart rate acceleration);
• when using in elderly patients, especially with organic brain disorders (certain brain function disorders, e.g. of vascular or degenerative origin) due to frequent, excessive sensitivity even to normal doses of the medicine and increased risk of side effects;
• in patients with an increased tendency to seizures;
• in pregnant women (see "Pregnancy, breastfeeding, and fertility").

You should regularly check the intraocular pressure (see section 4, "Possible side effects").
Single cases of Akineton abuse and dependence on it have been observed. This may be due to the occasionally observed improvement in mood and unnatural stimulation (euphoria) associated with the use of the medicine.
Except in life-threatening cases, you should avoid sudden withdrawal of the medicine due to the risk of relapse of the disease.

Children and adolescents

Experience with the use of biperiden in children is limited and mainly concerns short-term treatment of dystonia caused by other medicines (e.g. caused by neuroleptics or metoclopramide and similar medicines).

Akineton and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Using Akineton with other anticholinergic medicines, e.g. psychotropic medicines, antihistamines (antiallergic) of the first generation, medicines used in Parkinson's disease, and antispasmodic medicines, may cause an increase in side effects in the central and peripheral nervous system.
When used together with quinidine (a medicine used to treat heart rhythm disorders), there may be an increase in side effects on coronary circulation (especially in terms of atrioventricular conduction).
Concomitant use of levodopa (a medicine used to treat Parkinson's disease) and Akineton may increase involuntary movements (dyskinesias). In the case of concomitant administration of biperiden and levodopa or carbidopa in patients with Parkinson's disease, general movement disorders resembling restlessness or dance (choreoathetoid movements) have been observed.
Involuntary movements (late dyskinesias) caused by neuroleptics (medicines used to treat mental illnesses) may be exacerbated by Akineton. Sometimes, the symptoms of Parkinson's disease with existing late dyskinesias are so severe that anticholinergic treatment is necessary.
The effectiveness of metoclopramide (a medicine used to treat nausea and other gastrointestinal disorders) and medicines with similar effects on the gastrointestinal tract may be reduced due to the action of anticholinergic medicines, such as Akineton.
Anticholinergic medicines may increase the side effects of pethidine (a strong painkiller) on the central nervous system.

Using Akineton with food, drink, and alcohol

Akineton tablets can be divided. They should be taken preferably during or after a meal, with a large amount of liquid (e.g. a glass of water). Taking the medicine immediately after a meal reduces the undesirable effect on the gastrointestinal tract.
During treatment with Akineton, the effect of alcohol may be increased, and the consequences of concomitant use may be unpredictable, so you should not drink alcohol during treatment with Akineton.
Biperiden may increase the effect of alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
There are no data indicating that the use of biperiden may be associated with a teratogenic effect.
However, due to the lack of experience with the use of biperiden during pregnancy, you should be particularly careful, especially during the first trimester. There are no data on placental passage.
The medicine may be used during pregnancy only in cases where, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding
Anticholinergic medicines may inhibit lactation.
Biperiden passes into breast milk, reaching the same concentration as in serum. During treatment with biperiden, breastfeeding is not recommended.

Driving and using machines

Akineton has a negative effect on the ability to drive vehicles and operate machines.
The side effects of Akineton related to the central and peripheral nervous system, e.g. feeling tired, dizziness, and lethargy, may change the ability to concentrate and react to such an extent, even with proper use of the medicine and regardless of the limitations caused by the underlying disease requiring treatment, that performing activities requiring special caution, such as driving vehicles, operating machines, or working at heights, may be dangerous.
These abilities may be further impaired if biperiden is used concomitantly with other medicines affecting the central nervous system, anticholinergic agents, and especially with alcohol.

Akineton contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to use Akineton

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
The dosage of the medicine should be determined individually.
The duration of treatment depends on the type and course of the disease: from short-term therapy, e.g. in the case of extrapyramidal symptoms caused by other medicines (especially in children), to long-term treatment (e.g. in the case of Parkinson's disease).
Treatment should be started with the smallest effective dose, and then the dose should be gradually increased to achieve the most beneficial dose for the patient, depending on the therapeutic effect and side effects.
Recommended doses of Akineton:
Parkinson's disease
The recommended initial dose in the treatment of Parkinson's disease is 2 times half a tablet per day (2 mg of biperiden hydrochloride per day). The dose may be increased by 2 mg per day. The maintenance dose is half to 2 tablets, taken 3 or 4 times a day (which corresponds to 3 to 16 mg of biperiden hydrochloride per day). The maximum daily dose is 16 mg of biperiden hydrochloride (which corresponds to 8 tablets per day).
Extrapyramidal symptoms caused by other medicines
In the treatment of extrapyramidal symptoms caused by other medicines, in combination therapy with neuroleptics, half to 2 tablets are used, 1 to 4 times a day (which corresponds to 1 to 16 mg of biperiden hydrochloride per day), depending on the severity of the symptoms.
Other extrapyramidal movement disorders
Dose adjustment should be done slowly, through gradual, weekly increases in the initial dose of 2 mg until the maximum tolerated daily dose is reached, which may be several times higher than the maximum daily doses used in other indications.
Use in children and adolescents (aged 3 to 15 years)
In the treatment of extrapyramidal symptoms caused by other medicines, in combination therapy with neuroleptics, half to 1 tablet is administered 1 to 3 times a day (which corresponds to 1 to 6 mg of biperiden hydrochloride per day).
Warning:
In a situation where rapid action is necessary, the medicine should be used in the form of an injection.

Using a higher dose of Akineton than recommended

Symptoms of overdose are: dilated, "lazy" pupils, dryness of mucous membranes, facial flushing, accelerated heart rate, intestinal and bladder atony, increased body temperature, especially in children, excitement, delirium, disorientation, disturbances of consciousness, and (or) hallucinations. In the case of severe poisoning, there is a risk of circulatory collapse and respiratory arrest.
Procedure in case of overdose
As an antidote, acetylcholinesterase inhibitors are recommended, including, in exceptional cases, physostigmine, which penetrates into the cerebrospinal fluid and reduces central symptoms (e.g. physostigmine salicylate in the case of a positive physostigmine test). Depending on the severity of the symptoms, it may be necessary to support circulation and breathing (oxygen therapy), lower body temperature in case of fever, and catheterize the bladder.
In the case of taking a dose of the medicine higher than recommended, you should immediately inform your doctor or pharmacist, or go to the nearest hospital. You should take the leaflet and packaging of Akineton with you.

Missing a dose of Akineton

The medicine should always be taken daily at the same time (at the same times) in accordance with the doctor's recommendation, which helps in regular use. In the case of missing a dose of the medicine, you should take the next dose at the normal time. You should not take a double dose to make up for the missed dose.

Stopping the use of Akineton

You should always follow the doctor's recommendations, who will say how long you should take the medicine.
In the case of sudden cessation of biperiden treatment, there may be a relapse of the previous symptoms that occurred before the start of treatment. Therefore, you should not abruptly stop treatment. The dose should be gradually reduced by the doctor.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like any medicine, this medicine can cause side effects, although they may not occur in everyone.
Side effects may occur mainly at the beginning of treatment and in the case of too rapid dose increases.
To assess the frequency of side effects, the following classification has been used:
Rare(may occur less frequently than in 1 in 1,000 people):

• in the case of higher doses, excitement, agitation, anxiety, disorientation, psychotic delusions (delirious syndromes and hallucinations), insomnia. Central nervous system stimulation is common in patients with brain function disorders and may require dose reduction;
• effect on sleep phases;
• feeling tired, dizziness, and memory disturbances;
• accelerated pulse (palpitations);
• dryness in the mouth (if this symptom is severe, you should drink small amounts of liquid or chew sugar-free gum), nausea, gastrointestinal disturbances;
• muscle tremors;
• drowsiness.

Very rare(may occur less frequently than in 1 in 10,000 people):

• hypersensitivity;
• nervousness, abnormally elevated mood (euphoria);
• headache, involuntary movements, coordination disorders, and speech disturbances, increased tendency to seizures and epileptic seizures;
• vision disturbances, pupil dilation with increased sensitivity to light. Glaucoma (with closed-angle glaucoma) may occur. Therefore, you should regularly check the intraocular pressure;
• slowed heart rate;
• constipation;
• decreased sweat production, allergic skin rash;
• difficulty in emptying the bladder, especially in patients with prostate enlargement (prostate adenoma). In the case of complete urinary retention, you should immediately inform your doctor, as it may be necessary to reduce the dose of the medicine or administer an antidote (carbachol).

Frequency not known(cannot be determined based on available data):

• swelling or inflammation of the parotid glands.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Akineton

The medicine should be stored in a place invisible and inaccessible to children.
There are no special recommendations for storage.
You should not use this medicine after the expiry date stated on the packaging.
The expiry date indicates the last day of the given month.
Medicines should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Akineton contains

The active substance of the medicine is biperiden hydrochloride.
One tablet contains 2 mg of biperiden hydrochloride, which corresponds to 1.8 mg of biperiden.
The other ingredients are: corn starch, potato starch, lactose monohydrate, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, copovidone K 28, talc, magnesium stearate.

What Akineton looks like and what the packaging contains

The packaging (cardboard box) contains 50 tablets (5 blisters).
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Desma GmbH, Peter-Sander-Str. 41B, D-55252 Mainz-Kastel, Germany

Manufacturer:

Laboratorio Farmaceutico SIT Srl, Via Cavour, 70, 27035 Mede (PV), Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20020915

Parallel import authorization number: 91/22 Date of leaflet approval: 16.02.2022

[Information about the trademark]