Akineton Sr 4 mg

Leaflet attached to the packaging: patient information

AKINETON SR 4 mg, 4 mg, prolonged-release tablets

Biperideni hydrochloridum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• -Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 SR 4 mg and what is it used for
• 2. Important information before taking Akineton SR 4 mg
• 3. How to take Akineton SR 4 mg
• 4. Possible side effects
• 5. How to store Akineton SR 4 mg
• 6. Contents of the packaging and other information

1. What is Akineton SR 4 mg and what is it used for

Akineton SR 4 mg is an anticholinergic medicine with a strong effect on the central nervous system, used to treat 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 SR 4 mg is used:

• to treat muscle stiffness, tremors, and movement slowing in Parkinson's disease;
• to treat 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, compulsive need to be in constant motion (akathisia), and symptoms similar to Parkinson's disease (parkinsonian symptoms);
• to treat 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 affect 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 SR 4 mg

When not to take Akineton SR 4 mg:

• 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;
• in children.

Warnings and precautions

Before starting treatment with Akineton SR 4 mg, discuss it with your doctor or pharmacist. Particular caution should be exercised:

• in patients with prostatic hyperplasia (enlargement of the 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 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 used 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").

Regularly check intraocular pressure (see section 4 "Possible side effects"). Single cases of abuse and dependence on Akineton SR 4 mg have been observed. This may be due to the occasionally observed improvement in mood and unnatural liveliness (euphoria) associated with the use of the medicine. In addition to life-threatening cases, it is recommended to avoid sudden withdrawal of the medicine due to the risk of relapse.

Akineton SR 4 mg and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take. The use of Akineton SR 4 mg with other medicines that have anticholinergic effects, 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.

Taking Akineton SR 4 mg with food, drink, and alcohol

Akineton SR 4 mg tablets should not be divided. They should be taken (without chewing) preferably during or after meals, with a large amount of liquid (e.g., a glass of water). Taking the medicine without food reduces the undesirable effect on the gastrointestinal tract. During treatment with Akineton, the effect of alcohol may be increased, and the consequences of their concurrent use may be unpredictable; therefore, during treatment with Akineton SR 4 mg, you should not drink alcohol. 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, consult your 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 in pregnancy, particular caution should be exercised, especially in the first trimester. There are no data on penetration through the placenta. 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 stop breastfeeding.

Driving and using machines

Akineton SR 4 mg has a negative effect on the ability to drive and use machines. The side effects of Akineton SR 4 mg 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 that require special caution, such as driving, using machines, or working at heights, may be dangerous. These abilities may be further reduced if biperiden is used concurrently with other medicines that affect the central nervous system, anticholinergic agents, and especially alcohol.

Akineton SR 4 mg contains lactose

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

Akineton SR 4 mg contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Akineton SR 4 mg

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The dose of the medicine should be determined individually. 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. 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 with Akineton SR 4 mg should be started with the administration of 2 mg tablets of another form of the medicine (Akineton) and then gradually increased, individually for each patient. After determining the optimal daily dose of biperiden in tablets, the treatment can be switched to the administration of biperiden in prolonged-release tablets (Akineton SR 4 mg). The recommended daily dose of Akineton SR 4 mg for adults is from 1 to 3 prolonged-release tablets (which corresponds to 4-12 mg of biperiden hydrochloride). The maximum daily dose is 4 prolonged-release tablets (which corresponds to 16 mg of biperiden hydrochloride). The tablets should be taken at equal intervals during the day, with the first tablet of Akineton SR 4 mg taken in the morning. Note: In situations where rapid action of the medicine is necessary, the injectable form should be used.

Taking a higher dose of Akineton SR 4 mg 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, 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 symptoms, it may be necessary to support circulation and respiration (oxygen therapy), reduce body temperature in case of fever, and catheterize the bladder. In case of taking a higher dose of the medicine than recommended, immediately inform your doctor or pharmacist, or go to the nearest hospital. Take the leaflet and packaging of Akineton SR 4 mg with you.

Missing a dose of Akineton SR 4 mg

Always take the medicine every day at the same time (at the same times) as recommended by your doctor, which helps in regular administration. If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Akineton SR 4 mg

Always follow your doctor's instructions, who will tell you how long to take the medicine. In case of sudden discontinuation of biperiden treatment, there may be a relapse of previous symptoms that occurred before the start of treatment. Therefore, do not stop treatment abruptly. The dose should be gradually reduced by the doctor. If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects may occur mainly at the beginning of treatment and in case of too rapid dose increase. To assess the frequency of side effects, the following classification was used: Rare(may occur less frequently than in 1 in 1,000 people): in case of higher doses, excitement, agitation, anxiety, disorientation, psychotic delusions (delirium 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 of fatigue, dizziness, and memory disorders; accelerated pulse (palpitations); dryness in the mouth (if this symptom is severe, 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 people): hypersensitivity; nervousness, unnaturally elevated mood (euphoria); headache, involuntary movements, coordination disorders, and speech disorders, increased tendency to seizures and epileptic seizures; vision disorders, pupil dilation with increased sensitivity to light. Glaucoma (with closed-angle glaucoma) may occur. Therefore, intraocular pressure should be regularly monitored; slowed heart rate; constipation; reduced sweating, allergic skin rash; difficulty in emptying the bladder, especially in patients with prostatic hyperplasia (prostate enlargement). In case of complete urinary retention, 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 estimated from the 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 this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Akineton SR 4 mg

Keep the medicine out of the sight and reach of children. Store in a temperature not exceeding 25°C. Do not use this medicine after the expiry date stated on the carton and blister after "Expiry date" or "EXP". The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Akineton SR 4 mg contains

The active substance of the medicine is biperiden hydrochloride. One tablet contains 4 mg of biperiden hydrochloride, which corresponds to 3.6 mg of biperiden. The other ingredients are: lactose monohydrate, corn starch, povidone, microcrystalline cellulose, hypromellose, magnesium stearate, purified water; coating: hypromellose (type 2910; 6 mPa x s), hypromellose (type 2910; 15 mPa x s), hydroxypropylcellulose, macrogol 400, macrogol 6000, sodium dokuzate, talc, anhydrous colloidal silica, titanium dioxide (E 171), yellow iron oxide (E 172), carnauba wax.

What Akineton SR 4 mg looks like and contents of the pack

The packaging (carton box) contains 30, 60, or 100 prolonged-release tablets (3, 6, or 10 blisters).

Marketing authorization holder:

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

Manufacturer:

Laboratorio Farmaceutico S.I.T. Srl, Via Cavour, 70 27035 Mede (PV), Italy For more detailed information, contact the local representative of the marketing authorization holder.

Date of last revision of the leaflet: 15.04.2024