Package Insert: Information for the User

AKINETÓN RETARD 4 mg prolonged-release tablets

Biperiden, hydrochloride

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Akinetón Retard contains biperiden as its active ingredient, which is an anticholinergic agent.

Akinetón Retard is indicated for:

• Treatment of Parkinson's disease, mainly in patients with muscular rigidity and tremor,

Treatment of extrapyramidal symptoms (characterized by involuntary and slow movements, muscle weakness, tremor, excessive saliva production, and sweating), caused by some medications.

Do not take Akinetón Retard:

• If you are allergic to biperideno or any of the other components of this medication (listed in section 6).
• If you have intestinal problems such as mechanical stenosis (narrowing of the intestines), megacolon (enlargement of the colon), and ileus (interruption of intestinal transit).
• Closed-angle glaucoma (increase in internal eye pressure).

Warnings and precautions

Consult your doctor before starting to take Akinetón Retard:

• Enlargement of the prostate (prostatic hypertrophy).
• Irregular heartbeats (cardiac arrhythmias).
• Epilepsy (seizures of part or all of the body).

Do not stop treatment abruptly, as this may cause a worsening of your disease.

In elderly patients, the effect of this medication may be increased, causing mental confusion, dizziness, agitation, balance problems, and euphoria.

Antiparkinsonian medications such as levodopa may increase involuntary movements (tardive dyskinesia) when administered concurrently with Akinetón Retard. Additionally, this type of movement, sometimes caused by neuroleptic medications, may also increase with concomitant administration of Akinetón Retard.

In all cases, your doctor will evaluate the maintenance of treatment with Akinetón Retard.

Elderly population

The elderly population has a special susceptibility to medications affecting the central nervous system. In these patients, the administration of anticholinergic medications may cause mental confusion, dizziness, agitation, behavioral changes, and euphoria.

Use of Akinetón Retard with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medication.

Consult with your doctor if you are taking these other medications:

• Antihistamines (allergy medications), as they may potentiate its activity.
• Spasmolytics (for treating spasms) because they may potentiate its activity.
• Antiparkinsonian medications such as levodopa (for treating Parkinson's disease).
• Pethidine (opioid medication for acute pain), as it may increase the risk of delirium.
• Quinidine (heart medication), as it may cause cardiac arrhythmias.
• Metoclopramide (for nausea and vomiting), as it may decrease its effect.
• Potassium supplements, as they may potentiate gastrointestinal lesions.

Taking Akinetón Retard with food, drinks, and alcohol

To minimize possible gastrointestinal discomfort, it is recommended to take Akinetón Retard with some liquid, preferably during or after meals.

It is recommended to avoid the consumption of alcoholic beverages during treatment with Akinetón Retard, as it may increase the effect of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The effects of biperideno on the fetus are unknown when administered to pregnant women, or if it may affect reproductive capacity. Biperideno should not be administered to pregnant women except if your doctor indicates that it is clearly necessary.

Breastfeeding

The excretion of biperideno in breast milk is unknown. Therefore, caution should be exercised when administering biperideno during lactation.

Driving and operating machinery

Akinetón Retard reduces the ability to drive vehicles and operate machinery, especially when combined with other medications affecting the central nervous system.

Akinetón Retard contains lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide on the dosage, which will be adjusted individually for you.

Patients of advanced age may need a lower dose.

The treatment with Akinetón Retard is usually initiated with low doses that are increased, depending on the efficacy and tolerability of the patient, therapeutic action, and adverse reactions.

Akinetón Retard is administered orally.

The recommended dose is:

Parkinsonian Syndromes:

The recommended dose is 1 to 2 tablets of Akinetón Retard per day (4-8 mg of biperideno hydrochloride/day). The total daily dose may be increased up to a maximum of 3 tablets of Akinetón Retard (12 mg of biperideno hydrochloride/day) as determined by your doctor.

If, in exceptional cases, three prolonged-release tablets per day are to be taken, the single dose should not exceed two tablets (corresponding to 8 mg of biperideno hydrochloride).

Medication-induced extrapyramidal symptomatology

The recommended dose is 4 mg of biperideno hydrochloride per day (1 tablet of Akinetón Retard). The daily dose required may vary from 2 mg to 6 mg per day of hydrochloride of biperideno, depending on the individual needs of the patient and the judgment of the doctor.

Change of treatment from Akinetón immediate-release tablets

To achieve a more comfortable dosing regimen, patients treated with immediate-release tablets of Akinetón may be switched to prolonged-release tablets of Akinetón Retard. Your doctor will decide which option is most suitable for you. Your doctor will first adjust the dose of biperideno with Akinetón 2 mg tablets for approximately 20 days before switching you to Akinetón Retard. Your doctor will evaluate the dose that you should be prescribed if you make this change.

Use in children and adolescents

Akinetón Retard is not recommended for use in children or adolescents under 18 years of age, due to the lack of efficacy and safety data in this population.

Use in elderly patients

Elderly patients, especially those with a higher susceptibility to seizures, are more sensitive to anticholinergic medication, so caution is required in dosing.

If you take more Akinetón Retard than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, go to the nearest hospital, or call the Toxicological Information Service, phone 91 562 0420, indicating the medication and the amount ingested.

You may feel drowsiness, confusion, lack of coordination of movements, dizziness, dry mouth, nausea, vomiting, dilated pupils, blurred vision, redness, increased heart rate, urinary and intestinal retention, increased body temperature. Sometimes anxiety, hallucinations. In severe intoxication, muscle cramps, respiratory depression, and risk of circulatory collapse.

If you forgot to take Akinetón Retard

Do not take a double dose to compensate for the missed doses. Follow the next usual dose as you normally do.

If you interrupt treatment with Akinetón Retard

Brusque suspension of treatment is not advisable due to the risk of exacerbation of symptoms, except in cases of vital complications.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects primarily occur when starting treatment or when the dose is increased rapidly.

Rare adverse effects (may affect up to 1 in 1,000 people)

• excitement, agitation, fear, confusion, delirium, hallucinations, insomnia, and sleep disturbances
• fatigue, dizziness, and memory disturbances
• rapid heart rate
• dry mouth, nausea, and gastrointestinal disturbances
• muscle spasms
• drowsiness

Very rare adverse effects (may affect up to 1 in 10,000)

• hypersensitivity (allergic reaction)
• nervousness and euphoria
• headache, involuntary and uncontrolled movements, speech disturbances, increased predisposition to cerebral crises and convulsions
• difficulty focusing vision, dilated pupils, light sensitivity, glaucoma (increased intraocular pressure)
• slow heart rate
• constipation
• decreased sweating
• difficulty urinating or urinary retention

Adverse effects of unknown frequency (cannot be estimated from available data)

diarrhea

• diarrhea

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Akinetón Retard

• The active ingredient is biperiden hydrochloride. Each Akinetón Retard tablet contains 4 mg of biperiden hydrochloride.
• The other components (excipients) are: lactose monohydrate, cornstarch, microcrystalline cellulose, povidone K30, hypromellose, magnesium stearate, purified water, hydroxypropylcellulose, macrogol 400, macrogol 6000, sodium docusate, titanium dioxide (E-171), yellow iron oxide (E-172), talc, anhydrous colloidal silica, carnauba wax.

Appearance of the product and contents of the packaging

Akinetón Retard prolonged-release tablets are oval-shaped, coated tablets with a white color and a groove. The groove should not be used to split the tablet.

Each package contains 20 or 50 tablets in an Aluminio/PVC/PVDC blister.

Holder of the marketing authorization and responsible manufacturer

Laboratorio Farmaceutico S.I.T., Srl

Via Cavour, 70

27035 Mede (PV)

Italy

For further information about this medication, please contact the local representative of the marketing authorization holder:

Desma Laboratorio Farmacéutico SL

Paseo de la Castellana 121, escalera Izquierda 3ºB

28046 Madrid – Spain

Last review date of this leaflet:May 2024

Other sources of information

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/