AKINETON 5mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Akinetón 5mg/ml Solution for Injection

Biperiden, Lactate

Read all of this leaflet carefully before you start using 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 is Akinetón and what is it used for
2. What you need to know before you use Akinetón
3. How to use Akinetón
4. Possible side effects
5. Storing Akinetón
6. Contents of the pack and other information

1. What is Akinetón and what is it used for

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

Akinetón is 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) caused by some medications that affect the nervous system.

2. What you need to know before you use Akinetón

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

Warnings and precautions

Consult your doctor before starting treatment 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, resulting in mental confusion, dizziness, agitation, behavioral changes, and euphoria.

Antiparkinsonian medications, such as levodopa (a medication that affects the nervous system), may increase involuntary movements (tardive dyskinesia) when administered concomitantly 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.

Elderly population

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

Other medications and Akinetón

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medications.

Consult your doctor if you are taking these other medications:

• Antihistamines (medications for allergies), as they may potentiate their activity.
• Spasmolytics (for treating spasms), as they may potentiate their activity.
• Antiparkinsonian medications, such as levodopa (for treating Parkinson's disease).
• Neuroleptics, as they may potentiate their activity.
• Pethidine (an opioid medication for acute pain), as it may increase the risk of delirium.
• Quinidine (a medication for the heart), 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.

Using Akinetón with food, drinks, and alcohol

Consumption of alcoholic beverages 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

Physical and chemical data suggest that biperiden is excreted in breast milk. Breastfeeding should be discontinued during treatment with Akinetón.

Fertility

It is not known if biperiden can affect reproductive capacity.

Driving and using machines

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

Akinetón contains sodium

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

3. How to use Akinetón

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 and adjust it individually for you.

Treatment with Akinetón should normally be started with low doses that can be increased, depending on the therapeutic effect and adverse effects.

For continuation of treatment by oral route, biperiden tablets are available.

The recommended dose is:

Parkinsonian syndromes:

In severe cases or in cases of oculogyric crises (involuntary eye movements), treatment should be started with 10-20 mg of biperiden lactate solution for injection (2-4 ml of the solution for injection) divided into several doses throughout the day.

Extrapyramidal symptomatology induced by medications:

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

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

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

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

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

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

Method of administration:

• Intramuscular route
• Intravenous route: by slow intravenous injection to avoid the appearance of 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, 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 retention, and increased body temperature. Sometimes, anxiety states and hallucinations may occur. In severe intoxication, convulsions, respiratory depression, and risk of circulatory collapse may occur.

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

If you forget to use Akinetón

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

If you stop using Akinetón

Abrupt discontinuation of treatment is not recommended due to the risk of exacerbation of symptoms, except when life-threatening complications occur.

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.

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

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 (increased internal eye pressure)
• slow heart rate (bradycardia)
• decreased blood pressure
• constipation
• decreased sweating, allergic rash
• 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 and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Akinetón

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 refers to the last day of the month shown.

Do not store above 25°C.

Store in the original package to protect from moisture.

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

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

• The active substance is biperiden lactate. Each 1 ml ampoule of Akinetón contains 5 mg of biperiden lactate, equivalent to 3.88 mg of biperiden.
• The other ingredients (excipients) are: lactic acid, sodium hydroxide (E-524), and water for injections.

Appearance and pack contents

Package with five 1 ml glass ampoules type I.

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 Healthcare Products (AEMPS): http://www.aemps.gob.es/