AKINETON

Package leaflet: Information for the user

AKINETON
5 mg/ml, solution for injection
Biperideni lactas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Akineton is and what it is 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 pack and other information

1. What Akineton is and what it is used for

Akineton is an anticholinergic agent with strong effects on the central nervous system,
used in the treatment of Parkinson's disease and extrapyramidal disorders characterized by
involuntary, abnormal movements.
By binding to certain receptors in the brain (muscarinic receptors), the drug reduces the severity
of symptoms such as muscle rigidity, involuntary muscle tremors, bradykinesia, and involuntary movements.
Biperiden is recommended as an adjunctive treatment during therapy with levodopa or similar
medicines that have a stronger effect on motor disturbances in Parkinson's disease.
Akineton solution for injection is used:

• in the treatment of muscle rigidity, tremor, and bradykinesia in Parkinson's disease;
• in the treatment of movement disorders (extrapyramidal symptoms) caused by certain neurological drugs (neuroleptics or other drugs with similar effects), such as tongue spasms, spasms of the throat muscles, and attacks of forced upward eye deviation (early dyskinesias); motor restlessness and the compulsion to keep moving (akathisia); and Parkinson-like symptoms (parkinsonism);
• in the treatment of other extrapyramidal movement disorders, e.g. involuntary movements causing twisting and contortions of various body parts, often resulting in unnatural postures, which may affect the whole body (generalized dystonia) or individual body parts (segmental dystonia), particularly movement disorders affecting the head (Meige’s syndrome), blepharospasm (Blepharospasmus), or spasmodic torticollis (Torticollis spasmodicus);
• in the treatment of nicotine poisoning or poisoning with organophosphorus compounds.

Note:
The solution for injection is particularly indicated when rapid action is required or in initial therapy of severe cases of parkinsonism.

2. Important information before using Akineton

When not to use Akineton:

• if the patient is allergic to the active substance or to 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 megacolon (dilation of the colon);
• if the patient has intestinal obstruction.

Warnings and precautions
Before starting treatment with Akineton, discuss this with your doctor, pharmacist, or
nurse. Exercise caution:

• in patients with benign prostatic hyperplasia (enlarged prostate) with residual urine in the bladder;
• in patients with urinary retention (inability to empty the bladder physiologically through the urethra). In patients with existing voiding disorders, the bladder should be emptied before each administration of the medicine;
• in patients with myasthenia gravis (a chronic disease characterized by rapid muscle fatigue and weakness);
• in patients with conditions that may lead to severe tachycardia (accelerated heart rate);
• when administering to elderly patients, especially those with organic brain disorders (specific disturbances in brain function, e.g. vascular or degenerative in origin), due to frequent excessive sensitivity even to normal doses of the medicine and increased risk of adverse effects;
• in patients with an increased tendency to seizures;
• in pregnant women (see section **"**Pregnancy and breastfeeding").

Regularly monitor intraocular pressure (see section 4. "Possible adverse effects").
Except in life-threatening situations, abrupt discontinuation of the medicine should be avoided due to the risk of disease recurrence.

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

Akineton with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Concomitant use of Akineton with other anticholinergic medicines, such as psychotropic drugs, first-generation antihistamines (antiallergic agents), medicines used in Parkinson's disease, and antispasmodics, may intensify adverse effects on the central and peripheral nervous system.
When quinidine (a medicine used to treat cardiac arrhythmias) is used concomitantly, adverse effects on the coronary circulation (particularly atrioventricular conduction) may be intensified.
Concomitant use of levodopa (a medicine used in the treatment of Parkinson's disease) and Akineton may exacerbate involuntary movements (dyskinesias). Cases of generalized movement disorders resembling restlessness or chorea (choreiform movements) have been observed in patients with Parkinson's disease receiving biperiden together with levodopa/carbidopa.
Involuntary movements (tardive dyskinesias) caused by neuroleptics (medicines used in the treatment of psychiatric disorders) may be intensified by Akineton. Occasionally, Parkinsonian symptoms associated with existing tardive dyskinesias are so severe that anticholinergic treatment becomes necessary.
The efficacy of metoclopramide (a medicine used to treat nausea and other gastrointestinal disorders) and drugs with similar gastrointestinal effects may be reduced by anticholinergic medicines such as Akineton.
Anticholinergic medicines may intensify the adverse effects of pethidine (a strong analgesic) on the central nervous system.
Biperiden may enhance the effects of alcohol.

Akineton, food, drink, and alcohol
During treatment with Akineton, the effects of alcohol may be intensified, and the consequences of concomitant use may be unpredictable. Therefore, alcohol should not be consumed during treatment with Akineton.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
There are no data suggesting that biperiden may have teratogenic effects. However, due to the lack of experience with biperiden use during pregnancy, particular caution is required, especially during the first trimester. There are no data on placental transfer.

The medicine may be used during pregnancy only if, in the opinion of the physician, the benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding
Anticholinergic medicines may inhibit lactation.
Biperiden passes into breast milk, reaching concentrations similar to those in plasma. Breastfeeding should be discontinued during biperiden treatment.

Driving and operating machinery
Akineton has a negative effect on the ability to drive motor vehicles and operate machinery.
Adverse effects of Akineton on the central and peripheral nervous system, such as fatigue, dizziness, and lethargy, may impair concentration and reaction speed to such an extent—even with proper use of the medicine and regardless of limitations caused by the underlying condition requiring treatment—that performing activities requiring special vigilance, such as driving vehicles, operating machinery, 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 sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml ampoule, meaning the medicine is considered "sodium-free".

3. How to use Akineton

This medicine should always be used as directed by the physician. In case of doubts, consult a
physician or pharmacist.
Akineton injection solution is administered intramuscularly, slowly intravenously, or by intravenous
infusion. After opening the package, any unused portion of the medicine should be discarded.
Dosage should be individually adjusted.
Treatment should begin with the lowest effective dose, which should then be gradually increased
until the optimal dose for the patient is reached, depending on the therapeutic effect and adverse
reactions.
The duration of treatment depends on the type and course of the disease. Treatment may be short-term
(particularly in children) or long-term, until oral formulations of the medicine can be used to continue
treatment, or until treatment can be discontinued.
Recommended dosage of Akineton
Parkinson's disease
In severe cases and in blepharospasm, during initial treatment, up to 10 to 20 mg (2 to 4 ml of injection solution) of biperiden lactate per day may be administered intramuscularly or slowly intravenously, in divided doses.
Extrapyramidal symptoms caused by other medicines and other extrapyramidal movement disorders
Adults:
To achieve a rapid therapeutic effect, a single dose of 2.5 to 5 mg (0.5 to 1 ml of injection solution) of biperiden lactate should be administered intramuscularly or slowly intravenously. If necessary, the same dose may be repeated after 30 minutes.
The maximum daily dose is 10 to 20 mg (2 to 4 ml of injection solution) of biperiden lactate.
For chronic treatment, Akineton tablets are recommended.
Use in children and adolescents
up to 1 year of age: 1 mg of biperiden lactate (0.2 ml of injection solution)
up to 6 years: 2 mg of biperiden lactate (0.4 ml of injection solution)
up to 10 years: 3 mg of biperiden lactate (0.6 ml of injection solution)
The medicine should be administered by slow intravenous injection.
If symptoms subside during administration, the injection should be stopped. If necessary, the same dose may be repeated after 30 minutes.
Nicotine poisoning
Administer 5 to 10 mg of biperiden lactate (1 to 2 ml of injection solution) intramuscularly.
In severe cases, in addition to standard procedures, administer 5 mg of biperiden lactate (1 ml of injection solution) intravenously.
Poisoning caused by organophosphorus compounds
The dose of biperiden should be individually adjusted. Depending on the severity of poisoning, administer slowly intravenously one ampoule (5 mg of injection solution) of biperiden lactate, repeating the dose several times until symptoms of poisoning resolve.
Use of a higher than recommended dose of Akineton
Symptoms
Symptoms of overdose include: dilated, "lazy" pupils, dry mucous membranes, facial flushing, tachycardia, intestinal and bladder atony, increased body temperature (especially in children), agitation, delirium, disorientation, disturbances of consciousness and/or hallucinations. In severe poisoning, there is a risk of circulatory collapse and respiratory arrest.
Management in case of overdose
Antidotes recommended are acetylcholinesterase inhibitors, 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, circulatory and respiratory support (oxygen therapy), body temperature reduction in case of fever, and urinary catheterization may be necessary.
In case of administration of a dose higher than recommended, contact a physician or pharmacist immediately or go to the nearest hospital. Bring the package leaflet and the Akineton packaging with you.
Missed dose of Akineton
The medicine should always be taken daily at the same time (or times), as directed by the physician, which helps ensure regular use. If a dose is missed, take the next dose at the usual time. Do not take a double dose to make up for a missed dose. Administration of Akineton injection solution, 5 mg/ml, may continue until oral formulations of the medicine can be used to continue treatment or until treatment can be discontinued.
Stopping Akineton treatment
Always follow the physician's instructions regarding how long the medicine should be used.
Sudden discontinuation of biperiden treatment may lead to recurrence of previous symptoms that occurred before starting treatment. Therefore, treatment should not be abruptly stopped. The dose should be gradually reduced by the physician.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects may occur mainly at the beginning of treatment and in case of too rapid dose escalation.

Rare (may occur in fewer than 1 in 1,000 people):
at higher doses – excitation, agitation, anxiety, disorientation, psychiatric hallucinations (delirious syndromes and hallucinations), insomnia. Central nervous system stimulation is common in patients with impaired brain function and may require dose reduction;
influence on sleep phases;
feeling of fatigue, dizziness, and memory disturbances;
rapid heartbeat (palpitations);
dry mouth (if this symptom is pronounced, drink small amounts of fluids frequently or chew sugar-free chewing gum), nausea, gastric disturbances;
muscle tremors;
drowsiness.

Very rare (may occur in fewer than 1 in 10,000 people):
hypersensitivity;
nervousness, abnormally elevated mood (euphoria);
headache, involuntary movements, disturbances in motor coordination and speech, increased tendency to seizures and epileptic fits;
visual disturbances, pupil dilation with increased sensitivity to light. Glaucoma (with closed-angle glaucoma) may occur. Therefore, intraocular pressure should be monitored regularly;
slowing of heart rate;
constipation;
reduced sweating, allergic skin rash;
difficulty in emptying the urinary bladder, especially in patients with enlarged prostate (benign prostatic hyperplasia). In case of complete urinary retention, inform the doctor immediately, 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 of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects allows the collection of additional information on the safety of the medicine.

5. How to store Akineton

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Akineton contains
The active substance is biperiden lactate. Each 1 ml ampoule contains 5 mg of biperiden lactate, equivalent to 3.9 mg of biperiden.
The other ingredients are: sodium lactate, water for injections.

What Akineton looks like and contents of the pack
Ampoules made of colourless glass, 1 ml, packed in a cardboard carton.
The pack contains 5 ampoules.

Marketing Authorisation 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

For further information, please contact the marketing authorisation holder.