Leaflet: information for the user

Akinetón 5mg/ml injectable solution

Biperideno, lactate

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Akinetón is and for what it is used

2. What you need to know before starting to use Akinetón

3. How to use Akinetón

4. Possible adverse effects

5. Storage of Akinetón

6. Contents of the pack and additional information

Akinetón contains the active ingredient lactate of biperiden, which is an anticholinergic agent.

Akinetón 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), caused by some medications that act on the nervous system.

Do not use 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 intestine), megacolon (enlargement of the colon), and ileus (interruption of intestinal transit).
• If you have closed-angle glaucoma (increased internal eye pressure).

Warnings and precautions

Consult your doctor before starting to use Akinetón if you have:

• Prostatic hypertrophy (enlargement of the prostate).
• 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 condition.

In elderly patients, this medication may increase its effect, causing mental confusion, dizziness, agitation, behavioral changes, and euphoria.

Antiparkinsonian medications, such as levodopa (medication acting on the nervous system), may increase involuntary movements (tardive dyskinesia) when administered concurrently with Akinetón. Additionally, this type of movement, sometimes caused by neuroleptic medications, may also increase with concurrent administration of Akinetón.

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

Elderly population

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

Other medications and Akinetón

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication.

Consult your doctor if you are taking these other medications:

• Antihistamines (allergy medications), as they may potentiate its activity.
• Spasmolytics (for treating spasms) as they may potentiate its activity.
• Antiparkinsonian medications such as levodopa (for treating Parkinson's disease).
• Neuroleptics, as they may potentiate its activity.
• 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.

Use of Akinetón with food, drinks, and alcohol

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.Biperideno should not be administered to pregnant women except if your doctor indicates that it is clearly necessary.

Breastfeeding

The physicochemical data suggest that biperideno is excreted in breast milk.Discontinue breastfeeding during treatment with Akinetón.

Fertility

The effects of biperideno on fertility are unknown.

Driving and operating machinery

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

Akinetón contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per 1 ml ampoule; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor.

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

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

Akinetón treatment usually starts with low doses that can be increased, depending on the therapeutic effect and adverse effects.

For oral continuation treatment, there are biperideno tablets available.

The recommended dose is:

Parkinsonian Syndromes:

In severe cases or in cases of oculogyric crisis (involuntary eye movements), it is recommended to start treatment with 10-20 mg of biperideno lactate injectable solution (2-4 ml of injectable solution) divided into several doses throughout the day.

Medication-induced extrapyramidal symptoms:

To achieve a rapid therapeutic response, 2.5-5 mg of biperideno lactate (0.5-1 ml of injectable solution) can be administered in a single dose. If necessary, the same dose can be repeated after 30 minutes. The maximum daily total dose is 10-20 mg of biperideno lactate injectable solution (2-4 ml of injectable solution).

Symptoms may disappear during the injection. In these cases, the injection should be interrupted.

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

Elderly patients, and especially those with a higher susceptibility to seizures, are more sensitive to anticholinergic medication, so caution is required in dosing.This group of patients may require a lower dose.

Patients with liver (hepatic disorders) or kidney (renal disorders) impairment

No data are available for these patients, but this medication should be dosed individually in these patient groups. Treatment should start with the lowest dose and then be increased to the most suitable dose for the patient.

Administration form:

• Intramuscular route
• Intravenous route: via slow intravenous injection to avoid adverse effects.

Once the ampoule is opened, discard the unused portion of the solution.

If you use 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.

In patients with a lower tolerance to biperideno, such as patients with cerebral atherosclerosis, psychotic alterations may appear.

If you forget to use Akinetón

Do not use a double dose to compensate for the missed doses. Follow the next regular dose as usual.

If you interrupt treatment with Akinetón

Briskly stopping treatment is not recommended due to the risk of exacerbating symptoms, except in cases of vital complications.

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.

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 (tachycardia)
• dry mouth, nausea, and gastrointestinal disturbances
• muscle spasms
• fatigue

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 seizures
• difficulty focusing vision, dilated pupils, light sensitivity, glaucoma (increased intraocular pressure)
• slow heart rate (bradycardia)
• decreased blood pressure
• constipation
• decreased sweating, allergic rash
• 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 Medicines 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 above25 °C.

Store in the original packaging to protect it from moisture.

Once the vial is opened, discard the unused portion of the solution.

Medicines should not be disposed of through drains or inthe trash. Depositthe containers and medicines that you no longer need at the SIGREcollection pointat the pharmacy. Askyour pharmacist how to dispose of the containers and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Akinetón

• The active principle is lactate of biperideno.Each ampoule of 1 ml of Akinetón contains 5 mg oflactate of biperideno, equivalent to 3.88 mg of biperideno.
• The other components (excipients) are:lactic acid, sodium hydroxide (E-524) and water for injectable preparations.

Appearance of the product and contents of the packaging

Container with five glass type I ampoules of 1 ml.

Holder of the marketing authorization and responsible for manufacturing

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 holder of the marketing authorization:

Desma Laboratorio Farmacéutico SL

Paseo de la Castellana 121, escaleraIzquierda 3ºB

28046 Madrid – Spain

Date of the last review of this leaflet: May 2024

Other sources of information

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