Akineton

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Akineton

2 mg, tablets

Biperideni hydrochloridum

Before taking the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one 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 inform 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 taking Akineton
• 3. How to take Akineton
• 4. Possible side effects
• 5. How to store Akineton
• 6. Contents of the package 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 symptoms such as muscle stiffness, involuntary muscle tremors, movement slowing, or involuntary movements. It is recommended to use biperiden 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 episodes of forced staring with eye rotation upwards (early dyskinesias); motor agitation, forced movement (akathisia), and symptoms similar to Parkinson's disease (parkinsonian symptoms);
• in the treatment of other extrapyramidal movement disorders, e.g., involuntary movements causing twisting and bending of different body parts, resulting in the patient often taking an unnatural posture, which may involve the entire body (generalized dystonia) or individual body parts (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 taking Akineton

When not to take 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 colonic obstruction (enlargement of the large intestine);
• if the patient has intestinal obstruction.

Warnings and precautions

Before starting treatment with Akineton, the patient should discuss it with their doctor or pharmacist. Particular caution should be exercised:

• 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 presence of disorders related to bladder emptying, the patient should empty their bladder before each administration 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").

The patient should regularly check their intraocular pressure (see section 4, "Possible side effects"). Single cases of Akineton abuse and dependence 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. In addition to life-threatening cases, the patient should avoid sudden withdrawal of the medicine due to the risk of disease relapse.

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

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The use of Akineton with other anticholinergic medicines, e.g., psychotropic medicines, antihistamines (first-generation antiallergic medicines), 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 concomitantly with quinidine (a medicine used to treat heart rhythm disorders), there may be an increase in side effects on coronary circulation (especially concerning 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, the occurrence of general movement disorders resembling restlessness or dance (choreoathetoid movements) has 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 pain reliever) 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 directly 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; therefore, the patient should not drink alcohol during treatment with Akineton. Biperiden may increase the effect of alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking 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, particular caution should be exercised, especially in the first trimester. There are no data on placental transfer. The medicine may be used during pregnancy only in cases where 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 plasma. During treatment with biperiden, it is recommended to discontinue breastfeeding.

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., fatigue, dizziness, and lethargy, may change the ability to concentrate and react to such an extent 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 alcohol.

Akineton contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Akineton

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their 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 for 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 (corresponding to 3 to 16 mg of biperiden hydrochloride per day). The maximum daily dose is 16 mg of biperiden hydrochloride (corresponding 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 (corresponding to 1 to 16 mg of biperiden hydrochloride per day), depending on the severity of symptoms. Other extrapyramidal movement disorders The dose should be adjusted 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) 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 (corresponding to 1 to 6 mg of biperiden hydrochloride per day). Note: In situations 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, hallucinations, disorientation, and (or) confusion. 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 symptoms, it may be necessary to support circulation and respiration (oxygen therapy), reduce body temperature in the case of fever, and catheterize the bladder. In the case of taking a higher dose of the medicine than recommended, the patient should immediately inform their doctor or pharmacist or go to the nearest hospital. The patient should bring the leaflet and packaging of Akineton with them.

Missing a dose of Akineton

The medicine should always be taken daily at the same time (at the same times) according to the doctor's recommendation, which helps in regular use. If a dose of the medicine is missed, the next dose should be taken at the normal time. A double dose should not be taken to make up for the missed dose.

Stopping treatment with Akineton

The patient should always follow the doctor's recommendations, who will say how long to take the medicine. In the case of sudden cessation of biperiden treatment, there may be a relapse of previous symptoms that occurred before the start of treatment. Therefore, the patient 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, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Akineton can cause side effects, although they may not occur in every patient. 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 patients):

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

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

• hypersensitivity;
• nervousness, abnormally elevated mood (euphoria);
• headache, involuntary movements, coordination disorders, and speech disorders, increased susceptibility to seizures and epileptic fits;
• vision disorders, pupil dilation with increased sensitivity to light. Glaucoma (with closed-angle glaucoma) may occur. Therefore, the patient should regularly check their intraocular pressure;
• slow heart rate;
• constipation;
• reduced sweat secretion, allergic skin rash;
• difficulty in emptying the bladder, especially in patients with prostate enlargement (prostatic hyperplasia). In the case of complete urinary retention, the patient should immediately inform their 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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, Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +48 (22) 49 21 301, fax: +48 (22) 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Akineton

The medicine should be stored in a place invisible and inaccessible to children. Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the package 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: cornstarch, potato starch, lactose monohydrate, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, copolyvidone, talc, magnesium stearate, purified water.

What Akineton looks like and what the package contains

The package contains 50 tablets (5 blisters in a cardboard box). For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export:

Laboratorio Farmaceutico S.I.T., Srl, Via Cavour, 70, 27035 Mede (PV), Italy

Manufacturer:

Laboratorio Farmaceutico S.I.T., Srl, Via Cavour, 70, 27035 Mede (PV), Italy

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Spanish export authorization number: 803817.6

• 859892.2

Parallel import authorization number: 19/07 Date of approval of the leaflet: 26.04.2022

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