AKINETON RETARD 4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

AKINETÓN RETARD 4 mg prolonged-release tablets

Biperiden, hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Akinetón Retard and what is it used for
2. What you need to know before you take Akinetón Retard
3. How to take Akinetón Retard
4. Possible side effects
5. Storage of Akinetón Retard

Contents of the pack and other information

1. What is Akinetón Retard and what is it used for

Akinetón Retard contains the active substance biperiden, which is an anticholinergic agent.

Akinetón Retard is indicated:

• Treatment of Parkinson's disease, mainly in patients with muscle rigidity and tremors,

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

2. What you need to know before you take Akinetón Retard

Do not take Akinetón Retard:

• If you are allergic to biperiden or any of the other ingredients of this medicine (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).
• Angle-closure glaucoma (increased pressure inside the eyes).

Warnings and precautions

Consult your doctor before starting to take Akinetón Retard:

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

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

In elderly patients, the effect of this medicine 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 concomitantly 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 assess the continuation of treatment with Akinetón Retard.

Elderly population

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

Use of Akinetón Retard with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

Consult your doctor if you are taking these other medications:

• Antihistamines (medications for allergies), as they may enhance their activity.
• Spasmolytics (for treating spasms), as they may enhance their 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 (medication for the heart), as it may cause cardiac disorders.
• Metoclopramide (for nausea and vomiting), as it may decrease its effect.
• Potassium supplements, as they may enhance 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.

Consumption of alcoholic beverages during treatment with Akinetón Retard should be avoided, as it may increase the effect of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

It is not known if biperiden can cause fetal harm when administered to pregnant women or if it can affect reproductive capacity. Biperiden should not be administered to pregnant women unless your doctor indicates that it is clearly necessary.

Breastfeeding

It is not known if biperiden is excreted in breast milk. Therefore, caution should be exercised when administering biperiden during breastfeeding.

Driving and using machines

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

Akinetón Retard contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Akinetón Retard

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

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

Elderly patients may need a lower dose.

Treatment with Akinetón Retard should normally be started 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 biperiden hydrochloride/day). The total daily dose may be increased up to a maximum of 3 tablets of Akinetón Retard (12 mg of biperiden hydrochloride per day) as estimated by your doctor.

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

Drug-induced extrapyramidal symptoms

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

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 biperiden with Akinetón 2 mg tablets for approximately 20 days before switching to Akinetón Retard. Your doctor will assess the dose to be prescribed if this change is made.

Use in children and adolescents

Akinetón Retard is not recommended for use in children and 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 greater 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, or go to the nearest hospital or call the Toxicology Information Service, phone 91 562 0420, indicating the medication and the amount ingested.

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

If you forget to take Akinetón Retard

Do not take a double dose to make up for forgotten doses. Continue with the next scheduled dose as usual.

If you stop taking Akinetón Retard

Abrupt cessation of treatment is not recommended due to the risk of exacerbation of symptoms, except when vital complications appear.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects usually occur when starting treatment or when the dose is rapidly increased.

Rare side 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 disorders
• muscle spasms
• drowsiness

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

• hypersensitivity (allergic reaction)
• nervousness and euphoria
• headache, involuntary and uncontrolled movements, speech disorders, increased tendency to suffer from seizures and convulsions
• difficulty focusing, dilated pupils, sensitivity to light, glaucoma (increased pressure inside the eyes)
• slow heart rate
• constipation
• decreased sweating
• difficulty urinating or urinary retention

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

• mumps

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Akinetón Retard

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Akinetón Retard

• The active substance is biperiden hydrochloride. Each tablet of Akinetón Retard contains 4 mg of biperiden hydrochloride.
• The other ingredients (excipients) are: lactose monohydrate, corn starch, 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 pack contents

Akinetón Retard prolonged-release tablets are presented in the form of oval, white, scored tablets. The score line is not intended to break the tablet.

Each pack contains 20 or 50 tablets in aluminum/PVC/PVDC blisters.

Marketing authorization holder and manufacturer

Laboratorio Farmaceutico S.I.T., Srl

Via Cavour, 70

27035 Mede (PV)

Italy

You can obtain further information on this medicine from the local representative of the marketing authorization holder:

Desma Laboratorio Farmacéutico SL

Paseo de la Castellana 121, escalera Izquierda 3ºB

28046 Madrid – Spain

Date of last revision of this leaflet:May 2024

Other sources of information

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/