Akineton

Package leaflet: Information for the patient

Warning! Please keep the leaflet. Information on the immediate packaging is in a foreign language.
Akineton
2 mg, tablets
Biperideni hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. 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. Contents of the pack and other information

1. What Akineton is and what it is used for

Akineton 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 rigidity, involuntary muscle tremors, bradykinesia, and involuntary movements.
Biperiden is recommended as an adjunctive treatment during therapy with levodopa or similar
medicines that have stronger effects on motor disturbances in Parkinson's disease.
Akineton is used:

• in the treatment of muscular rigidity, tremor, and bradykinesia in Parkinson's disease;
• in the treatment of movement disorders (extrapyramidal symptoms) caused by certain neurological medicines (neuroleptics or other drugs with similar action); such as tongue spasms, spasms of the throat muscles, and attacks of forced upward gaze (early dyskinesias); motor restlessness and the compulsion to keep moving (akathisia), as well as 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).

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 gastrointestinal obstruction;
• if the patient has megacolon (dilation of the large intestine);
• if the patient has intestinal obstruction.

Warnings and precautions
Before starting treatment with Akineton, discuss this with your doctor or pharmacist. Special caution is required:

• 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 bladder emptying disorders, the bladder should be emptied before each dose;
• in patients with myasthenia gravis (a chronic disease characterized by rapid fatigue and muscle weakness);
• in patients with conditions that may lead to severe tachycardia (accelerated heart rate);
• when used in elderly patients, especially those with organic brain disorders (specific brain function disorders, e.g. vascular or degenerative), due to frequent excessive sensitivity even to normal doses of the drug and increased risk of adverse effects;
• in patients with increased susceptibility to seizures;
• in pregnant women (see section "Pregnancy, breastfeeding and fertility").

Regular monitoring of intraocular pressure is recommended (see section 4, "Possible adverse effects").
Isolated cases of Akineton misuse and dependence have been reported. This may be due to the occasionally observed improvement in mood and unnatural excitement (euphoria) associated with the use of the drug.
Except in life-threatening situations, abrupt discontinuation of Akineton 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 drugs).

Akineton with other medicines
Inform your doctor about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
Concomitant use of Akineton with other anticholinergic drugs, such as psychotropic drugs, first-generation antihistamines (antiallergic drugs), drugs used in Parkinson's disease, and antispasmodics, may enhance adverse effects on the central and peripheral nervous systems.
When quinidine (a medicine used to treat cardiac arrhythmias) is used concomitantly, adverse effects on the coronary circulation (particularly atrioventricular conduction) may be enhanced.
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 or 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 effectiveness 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 drugs such as Akineton.
Anticholinergic drugs may enhance the adverse effects of pethidine (a strong analgesic) on the central nervous system.

Taking Akineton with food, drink and alcohol
Akineton tablets may be divided. They should preferably be taken during or after a meal, with a large amount of fluid (e.g. a glass of water). Taking the medicine immediately after a meal reduces its undesirable effects on the gastrointestinal tract.
During treatment with Akineton, the effects of alcohol may be enhanced and the consequences of concomitant use may be unpredictable; therefore, alcohol should not be consumed during treatment with Akineton.
Biperiden may enhance 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 baby, 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 is required, especially during the first trimester. There are no data on placental transfer. The drug 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 drugs may inhibit lactation.
Biperiden passes into breast milk, reaching concentrations similar to those in plasma. Breastfeeding is not recommended during treatment with biperiden.

Driving and operating machinery
Akineton has a negative effect on the ability to drive and operate machinery. Adverse effects of Akineton on the central and peripheral nervous systems, such as fatigue, dizziness and lethargy, may impair concentration and reaction speed to such an extent—even when the drug is used correctly 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 impaired if biperiden is used concomitantly with other drugs affecting the central nervous system, anticholinergic agents, and especially with alcohol.

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

3. How to use Akineton

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
The dosage of the medicine should be individually adjusted.
The duration of treatment depends on the type and course of the disease: from short-term therapy, e.g. in
the case of drug-induced extrapyramidal symptoms (especially in children), to long-term treatment (e.g. in
Parkinson's disease).
Treatment should be initiated 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.

Recommended doses of Akineton
Parkinson's disease
The recommended initial dose in the treatment of Parkinson's disease is half a tablet twice daily (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, administered 3 or 4 times daily (corresponding to 3 to 16 mg of biperiden hydrochloride
per day). The maximum daily dose is 16 mg of biperiden hydrochloride (equivalent to 8 tablets per day).

Extrapyramidal symptoms caused by other medicines
In the treatment of extrapyramidal symptoms induced by other medicines, used concomitantly with
neuroleptics, half to 2 tablets 1 to 4 times daily (corresponding to 1 to 16 mg of biperiden hydrochloride
per day) should be administered, depending on the severity of symptoms.

Other extrapyramidal movement disorders
Dose adjustment should be performed slowly, by gradually increasing the initial dose of 2 mg at weekly
intervals 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 years)
In the treatment of drug-induced extrapyramidal symptoms, used concomitantly with neuroleptics, half to
1 tablet should be administered 1 to 3 times daily (corresponding to 1 to 6 mg of biperiden hydrochloride
per day).

Note:
If rapid action is required, the medicine should be administered in the form of an injection.

Use of a higher than recommended dose of Akineton
Symptoms of overdose include: dilated, "lazy" pupils, dry mucous membranes, facial flushing,
tachycardia, intestinal and bladder atony, increased body temperature (especially in children),
excitation, 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
Acetylcholinesterase inhibitors are recommended as antidotes, including physostigmine in exceptional
cases, 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), reduction of body temperature 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 packaging with you.

Missed dose of Akineton
The medicine should always be taken daily at the same time(s) 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 treatment
Always follow the physician's instructions regarding how long the medicine should be taken.
Abrupt discontinuation of biperiden treatment may lead to recurrence of previous symptoms present
before starting therapy. Therefore, treatment should not be stopped abruptly. The dose should be
gradually reduced by the physician.

If you have any further questions concerning 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 will experience them.
Side effects may occur primarily at the beginning of treatment and when the dose is 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: excitation, agitation, anxiety, disorientation, mental hallucinations (delirious states 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, gastrointestinal 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 disorders, increased tendency to seizures and epileptic fits;
• visual disturbances, dilated pupils with increased sensitivity to light. Glaucoma (with closed drainage angle) may occur. Therefore, intraocular pressure should be monitored regularly;
• slowing of the heartbeat;
• constipation;
• reduced sweating, allergic skin rash;
• difficulty in emptying the urinary bladder, particularly in patients with enlarged prostate (prostatic adenoma). In case of complete urinary retention,
  the doctor should be informed immediately, as it may be necessary to reduce the dose of the medicine or administer an antidote (carbachol) to the patient.

Frequency not known (cannot be estimated from available data):

• swelling or inflammation of the parotid salivary glands.

Reporting of side effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department for Monitoring 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) 4921301
Fax: +48 (22) 4921309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Akineton

Keep the 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. 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 helps protect the environment.

6. Contents of the packaging and other information

What Akineton contains
The active substance is biperiden hydrochloride. One tablet contains 2 mg of biperiden hydrochloride, equivalent to 1.8 mg of biperiden.
The other ingredients are: maize starch, potato starch, monohydrate lactose, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, copovidone, talc, magnesium stearate, purified water.

What Akineton looks like and contents of the pack
The pack contains 50 tablets (5 blisters in a cardboard box).
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation 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
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing authorisation number in Spain, the country of export: 803817.6
859892.2
Parallel import authorisation number: 19/07