Package leaflet: Information for the patient

AKINETON SR 4 mg, 4 mg, prolonged-release tablets
Biperideni hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Akineton SR 4 mg is and what it is used for
Important information before taking Akineton SR 4 mg
How to take Akineton SR 4 mg
Possible side effects
How to store Akineton SR 4 mg
Contents of the pack and other information

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

Akineton SR 4 mg is an anticholinergic medicine 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 medicine reduces the severity of symptoms such as muscle stiffness, involuntary tremors, bradykinesia (slowness of movement), and involuntary movements.
Biperiden is recommended as an additional treatment alongside levodopa or similar medicines that have a stronger effect on motor disturbances in Parkinson's disease.
Akineton SR 4 mg 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 medicines (neuroleptics or other medicines with similar effects), such as tongue spasms, spasms of the throat muscles, and sudden attacks of forced upward gaze (early dyskinesias); motor restlessness, a 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 contorting 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).

2. Important information before using Akineton SR 4 mg

When not to use 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 megacolon (dilation of the colon);
if the patient has intestinal obstruction;
in children.

Warnings and precautions
Before starting treatment with Akineton SR 4 mg, discuss this with your doctor or pharmacist.
Exercise particular caution:

in patients with benign prostatic hyperplasia (enlarged prostate) with residual urine in the bladder;
in patients with urinary retention (inability to naturally empty the bladder through the urethra); In patients with existing voiding disorders, the bladder should be emptied before each dose 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 brain function disorders, 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, breastfeeding and fertility").

Regular monitoring of intraocular pressure is recommended (see section 4. "Possible side effects").
Isolated cases of misuse and dependence on Akineton SR 4 mg have been reported.
This may be due to the occasionally observed improvement in mood and unnatural excitement (euphoria) associated with the use of the medicine.
Except in life-threatening situations, abrupt discontinuation of the medicine should be avoided due to the risk of disease recurrence.

Akineton SR 4 mg and other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use.
Concomitant use of Akineton SR 4 mg 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 SR 4 mg may exacerbate involuntary movements (dyskinesias). When biperiden and levodopa or carbidopa are administered simultaneously to patients with Parkinson's disease, general movement disorders resembling restlessness or chorea (choreiform movements) have been observed.
Involuntary movements (tardive dyskinesias) caused by neuroleptics (medicines used in the treatment of psychiatric disorders) may be intensified by Akineton SR 4 mg. Occasionally, Parkinsonian symptoms in the presence of 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 effects on the gastrointestinal tract may be reduced by anticholinergic medicines such as Akineton SR 4 mg.
Anticholinergic medicines may intensify the adverse effects of pethidine (a strong analgesic) on the central nervous system.
During treatment with Akineton SR 4 mg, the effect of alcohol may be enhanced, and the consequences of their combined use may be unpredictable; therefore, alcohol should not be consumed during treatment with Akineton SR 4 mg.

Taking Akineton SR 4 mg with food, drink, and alcohol
Akineton SR 4 mg tablets must not be divided. They should be taken whole (without chewing), preferably during or after meals, with a large amount of liquid (e.g. a glass of water). Taking the medicine immediately after meals helps reduce unwanted effects on the gastrointestinal tract.
During treatment with Akineton, the effect of alcohol may be enhanced, and the consequences of their combined use may be unpredictable; therefore, alcohol should not be consumed during treatment with Akineton.
Biperiden may intensify the effects of alcohol.

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

Pregnancy
There are no data indicating that biperiden use may be associated with teratogenic effects. However, due to the lack of experience with biperiden use during pregnancy, particular caution should be exercised, 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 is not recommended during biperiden treatment.

Driving and operating machinery
Akineton SR 4 mg has a negative impact on the ability to drive and operate machinery.
Adverse effects of Akineton SR 4 mg 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 caution, such as driving vehicles, operating machinery, or working at heights, may be dangerous. These abilities may be further reduced if biperiden is used concomitantly with other medicines affecting the central nervous system, anticholinergic agents, and especially with alcohol.

Akineton SR 4 mg contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Akineton SR 4 mg contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Akineton SR 4 mg

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
The dosage of this medicine should be individually adjusted.
Treatment should be initiated with the lowest effective dose, which should then be gradually increased
according to the therapeutic response and occurrence of adverse effects, until the optimal dose for the patient is achieved.
The duration of treatment depends on the type and course of the disease: from short-term therapy, e.g.
in cases of drug-induced extrapyramidal symptoms (especially in children), to long-term treatment (e.g. in Parkinson's disease).
Treatment with Akineton SR 4 mg should be initiated by administering 2 mg tablets of another formulation
of the drug (Akineton), followed by gradual dose escalation, individually tailored for each patient.
Once the optimal daily dose of biperiden in tablet form has been established, treatment may be switched
to biperiden in extended-release tablets (Akineton SR 4 mg).
The recommended daily dose of Akineton SR 4 mg for adults is 1 to 3 extended-release tablets
(corresponding to 4–12 mg of biperiden hydrochloride). The maximum daily dose is 4 extended-release tablets
(corresponding to 16 mg of biperiden hydrochloride).
Tablets should be taken at regular intervals throughout the day, with the first dose of Akineton SR 4 mg taken in the morning.
Note:
In situations where rapid onset of action is required, the injectable formulation should be used.
Use of a higher than recommended dose of Akineton SR 4 mg
Symptoms of overdose include: dilated, "lazy" pupils, dry mucous membranes, facial flushing,
tachycardia, intestinal and bladder atony, elevated body temperature, excitation, delirium, disorientation,
disturbances of consciousness and (or) hallucinations. In severe poisoning, circulatory collapse and respiratory arrest may occur.
Management of overdose
Antidotal treatment includes acetylcholinesterase inhibitors; in exceptional cases physostigmine, which crosses the blood-brain barrier and reduces central nervous system 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 ingestion of a dose higher than recommended, contact a doctor or pharmacist immediately, or go to the nearest hospital. Bring the package leaflet and the Akineton SR 4 mg packaging with you.
Missed dose of Akineton SR 4 mg
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.
Stopping Akineton SR 4 mg
Always follow the doctor's instructions regarding how long the medicine should be taken.
Abrupt discontinuation of biperiden therapy may result in recurrence of previous symptoms that occurred before treatment initiation. Therefore, treatment should not be stopped suddenly. The dose should be gradually reduced under medical supervision.
If you have any further questions 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 when doses are increased too quickly.
The following classification has been used to assess the frequency of occurrence of side effects:

Rare (may affect fewer than 1 in 1,000 people):
at higher doses – excitement, agitation, anxiety, disorientation, mental hallucinations (delirious episodes 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 gum), nausea, gastric disturbances;
muscle tremors;
drowsiness.

Very rare (may affect 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 filtration angle) may occur. Therefore, intraocular pressure should be monitored regularly;
slowed heart rate;
constipation;
reduced sweating, allergic skin rash;
difficulty in emptying the urinary bladder, especially in patients with enlarged prostate (prostatic adenoma). In case of complete urinary retention, inform the doctor immediately, as it may be necessary to reduce the dose or administer an antidote (carbachol) to the patient.

Frequency not known (cannot be estimated from available data):
swelling or inflammation of the parotid glands.

Reporting of side effects
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Akineton SR 4 mg

Keep this medicine out of the sight and reach of children.
Store at 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 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 SR 4 mg contains
The active substance is biperiden hydrochloride. One tablet contains 4 mg of biperiden hydrochloride, equivalent to 3.6 mg of biperiden.
The other ingredients are: monohydrate lactose, 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, polyethylene glycol 400, polyethylene glycol 6000, sodium lauryl sulfate, talc, colloidal anhydrous silica, titanium dioxide (E 171), iron oxide yellow (E 172), Carnauba wax.

What Akineton SR 4 mg looks like and contents of the pack
The pack (cardboard box) contains 30, 60 or 100 prolonged-release tablets (3, 6 or 10 blisters).

Marketing Authorisation 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 further information, please contact the local representative of the marketing authorisation holder.