Akineton

Leaflet accompanying the packaging: information for the user

AKINETON

5 mg/ml, solution for injection
Biperideni lactas

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.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What Akineton is and what it is used for
• 2. Important information before taking Akineton
• 3. How to take Akineton
• 4. Possible side effects
• 5. How to store Akineton
• 6. Package contents and other information

1. What Akineton is and what it is used for

Akineton 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 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 in the form of a solution for injection 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, a compulsion 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 various body parts, resulting in the patient often taking an unnatural posture, which can 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);
• to treat nicotine poisoning or poisoning with organic phosphorus compounds.

Note:

The solution for injection is particularly indicated in situations where rapid action is required, or in initial therapy in severe cases of parkinsonism.

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 colon enlargement (megacolon);
• if the patient has intestinal obstruction.

Warnings and precautions

Before starting treatment with Akineton, discuss it with your doctor, pharmacist, or nurse. Be cautious:

• 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 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 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 section "Pregnancy and breastfeeding").

Regularly check intraocular pressure (see section 4 "Possible side effects").
Except in life-threatening cases, avoid sudden withdrawal of the medicine due to the risk of relapse of the disease.

Children and adolescents

Experience with 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

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Taking Akineton with other medicines that have anticholinergic effects, e.g., psychotropic medicines, antihistamines (first-generation antiallergic medicines), medicines used in Parkinson's disease, and muscle relaxants, may increase the risk of side effects in the central and peripheral nervous system.
When taking quinidine (a medicine used to treat heart rhythm disorders) together, there may be an increased risk of side effects on coronary circulation (especially regarding atrioventricular conduction).
Taking levodopa (a medicine used to treat Parkinson's disease) and Akineton together may increase involuntary movements (dyskinesias). In cases of concurrent administration of biperiden and levodopa/carbidopa in patients with Parkinson's disease, general movement disorders resembling restlessness or dancing (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 pain reliever) on the central nervous system.
Biperiden may enhance the effect of alcohol.

Akineton with food, drink, and alcohol

During treatment with Akineton, the effect of alcohol may be increased, and the consequences of concurrent use may be unpredictable. Therefore, do not drink alcohol during treatment with Akineton.

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 suggesting that biperiden may have a teratogenic effect. However, due to the lack of experience with biperiden in pregnancy, special caution is advised, especially in the first trimester. There are no data on placental passage.
The medicine may be used in pregnancy only when 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, breastfeeding is not recommended.

Driving and using machines

Akineton has a negative effect on the ability to drive vehicles and operate machinery.
The side effects of Akineton related to the central and peripheral nervous system, e.g., fatigue, dizziness, and lethargy, may change concentration and reaction speed to such an extent that performing tasks requiring special caution, such as driving, operating machinery, or working at heights, may be dangerous. These abilities may be further impaired if biperiden is taken concurrently with other medicines affecting the central nervous system, anticholinergic agents, and especially alcohol.

Akineton contains sodium

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

3. How to take Akineton

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Akineton, solution for injection, is administered intramuscularly, slowly intravenously, or in intravenous infusion. After opening the packaging, any unused medicine should be discarded.
Dosage should be determined individually.
Treatment should be started with the smallest effective dose, and then increased gradually 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. Treatment may be short-term (especially in children) or long-term, until it is possible to continue treatment with oral forms of the medicine or until treatment can be discontinued.
Recommended dosage of Akineton
Parkinson's disease
In severe cases and in cases of eyelid spasms, initial treatment may involve intramuscular or slow intravenous administration of up to 10 to 20 mg (2 to 4 ml of solution for injection) of biperiden lactate per day, in divided doses.
Extrapyramidal symptoms caused by other medicines and other extrapyramidal movement disorders
Adults:
To achieve a rapid therapeutic effect, 2.5 to 5 mg (0.5 to 1 ml of solution for injection) of biperiden lactate is administered once, intramuscularly or slowly intravenously. If necessary, the same dose can be repeated after 30 minutes.
The maximum daily dose is 10 to 20 mg (2 to 4 ml of solution for injection) of biperiden lactate.
For chronic treatment, Akineton in the form of tablets is recommended.

Use in children and adolescents

up to 1 year of age:
1 mg of biperiden lactate (0.2 ml of solution for injection)
up to 6 years of age:
2 mg of biperiden lactate (0.4 ml of solution for injection)
up to 10 years of age:
3 mg of biperiden lactate (0.6 ml of solution for injection)
The medicine is administered in slow intravenous injection.
If symptoms disappear during administration, administration should be stopped. If necessary, the same dose can be repeated after 30 minutes.
Nicotine poisoning
5 to 10 mg of biperiden lactate (1 to 2 ml of solution for injection) is administered intramuscularly.
In severe cases, in addition to standard treatment, 5 mg of biperiden lactate (1 ml of solution for injection) is administered intravenously.
Poisoning caused by organic phosphorus compounds
The dose of biperiden should be determined individually. Depending on the degree of poisoning, 1 ampoule (5 mg of solution for injection) of biperiden lactate is administered slowly intravenously, repeating the dose several times until the symptoms of poisoning disappear.

Using a higher dose of Akineton than recommended

Symptoms
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 cases 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 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 using a higher dose of the medicine than recommended, immediately inform your doctor, pharmacist, or go to the nearest hospital. Take the leaflet and packaging of Akineton with you.

Missing a dose of Akineton

Always take the medicine daily 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 normal time. Do not take a double dose to make up for the missed dose. Administration of Akineton, solution for injection, 5 mg/ml may be continued until it is possible to switch to oral forms of the medicine or until treatment can be discontinued.

Stopping treatment with Akineton

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 starting treatment. Therefore, do not stop treatment abruptly. The dose should be gradually reduced by your doctor.
If you have any further doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Akineton can cause side effects, although not everybody gets them.
Side effects may occur mainly at the beginning of treatment and in cases of too rapid dose increase.
Rare(may occur in less than 1 in 1,000 people):
in cases of higher doses, excitement, agitation, anxiety, disorientation, psychotic episodes (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;
fatigue, dizziness, and memory disturbances;
accelerated pulse (palpitations);
dry mouth (if this symptom is severe, drink small amounts of fluid or chew sugar-free gum), nausea, gastrointestinal disorders;
muscle tremors;
drowsiness.
Very rare(may occur in less than 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 fits;
vision disturbances, pupil dilation with increased sensitivity to light. Glaucoma (with closed-angle glaucoma) may occur. Therefore, intraocular pressure should be regularly monitored;
slow heart rate;
constipation;
reduced sweating, allergic skin rash;
difficulty in emptying the bladder, especially in patients with prostate enlargement (prostate adenoma). 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 available data)
swelling or inflammation of the parotid glands.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging 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 needed. This will help protect the environment.

6. Package contents and other information

What Akineton contains

The active substance of the medicine is biperiden lactate. One 1 ml ampoule contains 5 mg of biperiden lactate, which corresponds to 3.9 mg of biperiden.
Other ingredients are: sodium lactate, purified water.

What Akineton looks like and what the package contains

Ampoules made of colorless glass, 1 ml each, in a cardboard box.
The package contains 5 ampoules.

Marketing authorization holder:

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

Manufacturer:

Sirton Pharmaceuticals S.p.A. Piazza XX Settembre 2, 22079 Villa Guardia (Como), Italy
To obtain more detailed information, contact the representative of the marketing authorization holder.

Date of last revision of the leaflet: 15.04.2024