AKINETON 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

Akinetón 2 mg 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:

1. What Akinetón is and what it is used for
2. What you need to know before you take Akinetón
3. How to take Akinetón
4. Possible side effects
5. Storage of Akinetón
6. Contents of the pack and other information

1. What Akinetón is and what it is used for

Akinetón contains the active substance biperiden, which is an anticholinergic medicine used for:

• 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 some medications.

2. What you need to know before you take Akinetón

Do not take Akinetón

• 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).

• Narrow-angle glaucoma (increased pressure inside the eyes).

Warnings and precautions

Consult your doctor or pharmacist before taking Akinetón.

Be particularly careful with Akinetón if you have:

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

Do not stop treatment abruptly, as this may worsen your condition.

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

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

In all cases, your doctor will assess the need to continue treatment with Akinetón.

Taking Akinetón with other medicines

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

Consult your doctor if you are taking these other medicines:

• Antihistamines (medicines for allergies), as they may enhance their activity.

• Spasmolytics (for treating spasms) because they may enhance their activity.
• Antiparkinsonian medications like levodopa (for treating Parkinson's disease).
• Pethidine (an opioid medication for acute pain), as it may increase the risk of delirium.

• Quinidine (a heart medication), as it may cause cardiac alterations.

• Metoclopramide (for nausea and vomiting), as it may decrease its effect.
• Potassium supplements, as they may enhance gastrointestinal lesions.

Taking Akinetón with food, drinks, and alcohol

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

Alcohol consumption should be avoided during treatment with Akinetón, as it may increase the effect of alcohol.

Pregnancy, breastfeeding, and fertility

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 whether biperiden can cause harm to the fetus when administered to pregnant women or whether 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 whether biperiden is excreted in breast milk. Therefore, caution should be exercised when administering biperiden during breastfeeding.

Driving and using machines

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

Akinetón 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

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

Your doctor will decide the dose and adjust it individually for you.

Elderly patients may need a lower dose.

Akinetón tablets are administered orally.

The recommended dose is:

Generally, your doctor will initially prescribe low doses of Akinetón and gradually increase them according to your response to treatment.

Parkinsonian syndromes:

The initial dose for adults is half a tablet twice a day (2 mg/day).

Later, your doctor may increase the dose to one tablet three or four times a day.

The maximum daily dose is 16 mg per day (8 tablets).

Once the optimal dose is reached, your doctor may consider switching from immediate-release tablets to prolonged-release tablets (Akinetón retard) to achieve a more convenient dose.

Extrapyramidal symptoms induced by medications:

Dose adjustment will depend on the severity of symptoms. It is recommended to administer half a tablet to 1 tablet, given two or three times a day (2-6 mg biperiden hydrochloride/day).

Use in children and adolescents

Akinetón 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

In elderly patients, especially those with a higher susceptibility to seizures, treatment will start with the lowest dose. The dose should be increased slowly, depending on the patient's response.

If you take more Akinetón 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 medicine 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, and increased body temperature. Sometimes, anxiety and hallucinations may occur. In severe poisoning, convulsions, respiratory depression, and risk of circulatory collapse may occur.

If you forget to take Akinetón

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

Abruptly stopping treatment is not recommended due to the risk of worsening your condition.

If you have any further questions on the use of this medicine, 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 gastric 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 susceptibility to seizures and convulsions

• difficulty focusing, dilated pupils, sensitivity to light, glaucoma
• 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 they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Akinetón

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Akinetón

• The active substance is biperiden. Each Akinetón tablet contains 2 mg of biperiden hydrochloride.

• The other ingredients (excipients) are: lactose monohydrate, cornstarch, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, copovidone, talc, magnesium stearate, potato starch, and purified water.

Appearance of the product and pack contents

Akinetón is presented as white, round, flat tablets with a cross-shaped notch on one side.

The tablet can be divided into two equal doses (halves).

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

Marketing authorization holder and manufacturer

Laboratorio Farmaceutico S.I.T., Srl

Via Cavour, 70

27035 Mede (PV)

Italy

For more information about this medicine, contact 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

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS).

http://www.aemps.gob.es/