Akineton 5 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Akinetón 5mg/ml injectable solution

Biperiden, lactate

Read the entire leaflet carefully before you start using 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Akinetón is and what it is used for
2. What you need to know before using Akinetón
3. How to use Akinetón
4. Possible adverse 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 lactate, which is an anticholinergic agent.

Akinetón is used for:

• Treatment of Parkinson's disease, primarily in patients who have muscle rigidity and tremor,
• Treatment of extrapyramidal symptoms (characterized by involuntary and slow movements, muscle weakness, tremor) caused by certain medications acting on the nervous system.

2. What you need to know before using Akinetón.

Do not use Akinetón:

• If you are allergic to biperiden or to any of the other components 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), or 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:

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

You should not stop treatment abruptly, as this could lead to a worsening of your condition.

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

Antiparkinson agents such as levodopa (a medicine acting on the nervous system) may increase involuntary movements (tardive dyskinesia) when administered concomitantly with Akinetón. Furthermore, such movements, sometimes caused by neuroleptic medicines, may also increase with concomitant administration of Akinetón.

In all cases, your doctor will assess whether continued treatment with Akinetón is appropriate.

Elderly population

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

Other medicines and Akinetón

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

Consult your doctor if you are taking any of the following medicines:

• Antihistamines (medicines for allergies), as they may enhance its activity.
• Spasmolytics (used to treat spasms), as they may enhance its activity.
• Antiparkinson agents such as levodopa (used to treat Parkinson's disease).
• Neuroleptics, as they may enhance its activity.
• Pethidine (an opioid medicine for acute pain), as it may increase the risk of delirium.
• Quinidine (a medicine for heart conditions), as it may cause cardiac disturbances.
• Metoclopramide (for nausea and vomiting), as it may reduce its effect.
• Potassium supplements, as they may enhance gastrointestinal injury.

Use of 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

It is unknown whether biperiden may cause fetal harm when administered to pregnant women. Biperiden should not be given to pregnant women unless your doctor clearly determines it is necessary.

Breastfeeding

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

Fertility

It is unknown whether biperiden may affect reproductive capacity.

Driving and use of machines

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

Akinetón contains sodium

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

3. How to use Akineton

Follow exactly the administration instructions for this medicine as indicated by your doctor.

If in doubt, consult your doctor or pharmacist again.

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

Treatment with Akineton should normally begin with low doses, which may be increased depending on the therapeutic effect and adverse reactions.

For continuation of oral treatment, biperiden tablets are available.

The recommended dose is:

Parkinsonian syndromes:

In severe cases or during oculogyric crises (involuntary eye movements), treatment should be initiated with 10–20 mg of biperiden lactate injectable solution (2 to 4 ml of the injectable solution), divided into several doses throughout the day.

Drug-induced extrapyramidal symptoms:

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

Symptoms may disappear during the injection. In such cases, the injection should be stopped.

Use in children and adolescents

Akineton is not recommended for use in children or adolescents under 18 years of age due to lack of efficacy and safety data in this population.

Use in elderly patients

Elderly patients, and particularly those with increased susceptibility to seizures, are more sensitive to anticholinergic medication; therefore, caution is required in dosing. This patient group may require a lower dose.

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

Data in these patients are lacking; however, this medicine should be individually dosed in these patient groups. Treatment should be initiated at the lowest dose and then gradually increased to the most appropriate dose for the patient.

Method of administration:

• Intramuscular route
• Intravenous route: by slow intravenous injection to avoid the occurrence of adverse effects.

After opening the ampoule, discard any unused portion of the solution.

If you use more Akineton than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at telephone number 91 562 0420, indicating the medicine and the amount ingested.

You may experience drowsiness, confusion, lack of motor coordination, dizziness, dry mouth, nausea, vomiting, pupil dilation, blurred vision, flushing, increased heart rate, urinary and intestinal retention, elevated body temperature. Sometimes anxiety states and hallucinations may occur. In severe intoxication, muscle cramps, respiratory depression, and risk of circulatory collapse may occur.

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

If you forget to use Akineton

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

If you stop treatment with Akineton

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone 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 impairment
• rapid heart rate (tachycardia)
• dry mouth, nausea, and gastric disturbances
• muscle spasms
• tiredness

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

• hypersensitivity (allergic reaction)
• restlessness and euphoria
• headache, involuntary and uncontrolled movements, speech disorders, increased tendency to suffer cerebral crises and seizures
• difficulty focusing vision, dilated pupils, light sensitivity, glaucoma (increased internal pressure of the eyes)
• slow heart rate (bradycardia)
• decreased blood pressure
• constipation
• reduced sweating, allergic rash
• difficulty urinating or urinary retention

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

• mumps

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Akineton

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

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

Do not store above 25 °C.

Keep in the original packaging to protect from moisture.

After opening the ampoule, discard any unused portion of the solution.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Akinetón

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

Appearance of the product and contents of the pack

Pack containing five 1 ml type I glass ampoules.

Marketing Authorization Holder and Manufacturer

Laboratorio Farmaceutico S.I.T., Srl
Via Cavour, 70
27035 Mede (PV)
Italy

Further information about this medicinal product is available 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 latest revision of the leaflet: May 2024

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/