Package Leaflet: Information for the User

Akinetón 2 mg Tablets

Biperideno, hydrochloride

Read this leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isAkinetónand what it is used for

2. What you need to know before takingAkinetón

3. How to takeAkinetón

4. Possible side effects

5. Storage ofAkinetón

6. Contents of the pack and additional information

Akinetón contains biperideno as its active ingredient, which is a medication

anticholinergic and is used for:

• Treatment of Parkinson's disease, mainly in patients who have 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

• 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 the internal pressure of the eyes).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Akinetón.

Be especially careful with Akinetón if you have:

• 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 could lead to a worsening of your

disease.

In elderly patients, the effect of this medication may be increased, resulting in

mental confusion, dizziness, agitation, balance problems, and euphoria.

Antiparkinsonian medications such as levodopa may increase involuntary movements

(tardive dyskinesia) when administered concurrently with Akinetón. Additionally, this

type of movement, sometimes caused by neuroléptics, may also increase with concomitant

administration of Akinetón.

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

Taking Akinetón with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to

take any other medication.

Consult your doctor if you are taking these other medications:

• Antihistamines (allergy medications), as they may potentiate its activity.

activity.

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

Taking Akinetón with food, drinks, and alcohol

To minimize possible gastrointestinal discomfort, it is recommended to take Akinetón with

something to drink, preferably during or after meals.

It is recommended to avoid the consumption of alcoholic beverages during treatment with

Akinetón, as it may increase the effect of alcohol.

Pregnancy, breastfeeding, and fertility

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 the breastfeeding period.

Driving and operating machinery

Akinetón reduces the ability to drive vehicles and operate machinery, especially when

combined with other medications that affect the Central Nervous System.

Akinetón contains lactose

This medication contains lactose. If your doctor has indicated that you have an

intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your

doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

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

Patients of advanced age may need a lower dose.

Akinetón tablets are administered orally

The recommended dose is:

Generally, your doctor will initially prescribe low doses of Akinetón for you to

gradually increase them as you respond to the treatment.

Parkinsonian Syndromes:

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

Subsequently, 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 you have reached your optimal dose, your doctor may evaluate the possibility of

switching to a more comfortable dose by changing from immediate-release tablets to

extended-release tablets (Akinetón retard).

Medication-induced extrapyramidal symptoms:

The dose adjustment will depend on the severity of the symptoms. It is recommended to

administer half a tablet to one tablet, administered two or three times a day (2 – 6 mg biperideno hidrocloruro/day).

Use in children and adolescents

Akinetón 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

In elderly patients, especially those with a higher susceptibility to seizures, the

treatment will start with the lowest dose. The dose should be increased gradually, 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, 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 forget to take Akinetón

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

Briskly stopping treatment is not recommended due to the risk of an increase in symptoms of your disease.

If you have any other doubts about the use of this medication, 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 seizures and convulsions

• difficulty focusing vision, dilated pupils, light sensitivity, glaucoma
• slow heart rate
• constipation
• decreased sweating
• difficulty urinating or urinary retention

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

• 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 Medicines for

Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute

to providing more information about 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.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and

the medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your

pharmacist how to dispose of the containers and medications you no longer need.

By doing so, you will help protect the environment.

Composition of Akinetón

• The active principle is biperideno. Each Akinetón tablet contains 2 mg of

biperideno hydrochloride.

• The other components (excipients) are: lactose monohydrate, cornstarch,

microcrystalline cellulose, dihydrated calcium hydrogen phosphate, copovidone, talc,

magnesium stearate, potato starch, and purified water.

Appearance of the product and contents of the packaging

Akinetón is presented in the form of white, round, flat tablets with a cross-shaped groove on one of its faces.

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

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

Holder of the marketing authorization and responsible manufacturer

Laboratorio Farmaceutico S.I.T., Srl

Via Cavour, 70

27035 Mede (PV)

Italy

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

Desma Laboratorio Farmacéutico SL

Paseo de la Castellana 121, left staircase 3rd floor

28046 Madrid, Spain

Last review date of this leaflet: May 2024

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS).

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