5 mg / ml injection solution 
biperidenlaktat

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Akineton is and what it is used for 
2. What you need to know before you use Akineton 
3. How to use Akineton 
4. Possible side effects 
5. How to store Akineton 
6. Contents of the packaging and other information 

1. What Akineton is and what it is used for

Akineton is a so-called anticholinergic drug used to treat Parkinson’s disease. The drug can also be used for so-called extrapyramidal symptoms that have arisen due to other drug use.

2. What you need to know before using Akineton

Do not use Akineton

  • if you are allergic to biperiden lactate or any of the other ingredients of this medicine (listed in section 6).
  • If you have stone formation ( stenosis ) of the gastrointestinal tract, the risk of acute glaucoma ( glaucoma ) or if you suffer from tardive dyskinesia (a delayed movement disorder).

Warnings and cautions

Talk to your doctor or pharmacist before using Akineton.

Take special care with Akineton if you have an enlarged prostate, an increased risk of cramps and palpitations.

Elderly people may be more sensitive to this type of medicine and the dose may need to be adjusted by a doctor.

Other medicines and Akineton

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

Concomitant use of Akineton and other anticholinergic drugs such as neuroleptics(medicines for nervous system diseases), antihistamines (medicines for allergies ), antiparkinsonian medicines, antispasmodics (antispasmodics), quinidine (heart medicine), and levodopa (medicines for Parkinson’s disease ) may strengthen side effects of the drugs.

Akineton with alcohol

You should avoid drinking alcohol during treatment with Akineton.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Limited experience of use during pregnancy.

Breast-feeding

Biperiden passes into breast milk and may affect the breast-feeding baby. Breast-feeding is not recommended when using Akineton.

Driving and using machines

Akineton may reduce the reactivity of some patients and may therefore affect your ability to drive or use tools or machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Akinetone contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per ampoule, ie essentially ‘sodium-free’.

3. How to use Akineton

This medicine is given to you by a doctor or other healthcare professional.

Dose one is determined by the doctor, who adjusts it individually for you.

Older people may need a lower dose.

Akinetone 5 mg/ml solution for injection is injected into a muscle or given slowly intravenously.

If you have any further questions on the use of this product, 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 can occur especially at the beginning of treatment and if the dose is increased too quickly.

Rare (may affect up to 1 in 1,000 people):

  • Dry mouth, nausea, stomach upset
  • Memory disorders, fatigue, dizziness
  • Drowsiness
  • Temporarily reduced REM sleep ( sleep phase with rapid eye movements)
  • High heart rate ( tachycardia )
  • Muscle twitching.

In higher doses, the following side effects may occur upset mood, anxiety, fear, confusion, hallucinations, and insomnia. Central stimulant effects are common in patients with symptoms of mental retardation and may require a dose reduction.

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

  • Hypersensitivity
  • Allergic skin rash, reduced sweating
  • Headache, difficulty controlling movements ( dyskinesia ), difficulty coordinating movements ( ataxia ), speech difficulties, increased tendency to seizures
  • Nervousness, euphoria
  • Difficulty urinating (especially in patients with an enlarged prostate, dose reduction is recommended), inability to empty the bladder,
  • Constipation
  • Slow heart rate ( bradycardia ), decrease in blood pressure (after intravenous administration)
  • Inability to adjust the eye to different distances (ackommodationsbesvär), enlarged pupils, photophobia, glaucoma ( glaucoma ).

No known frequency (cannot be calculated from the available data):

  • Inflammation of the parotid gland (parotitis).

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala


Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Akineton

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 expiration date is the last day of the specified month.

No special storage instructions.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is biperiden lactate.
  • The other ingredients are sodium lactate (see section 2, “Akinetone contains sodium”) and water for injections.

What the medicine looks like and the contents of the pack

Pack sizes: 5×1 ml, glass ampoule

Marketing Authorization Holder and Manufacturer

Laboratorio Farmaceutico SIT, Srl

Via Cavour, 70

27035 Co (PV)

Italy

Information provided by:

POA Pharma Scandinavia AB

Box 24026

400 22 Gothenburg

Tel. 031-788 05 99

info@poaab.com

This leaflet was last amended on 2018-08-24

The following information is intended for healthcare professionals only:

Dosage and route of administration

Parkinsonism: In severe cases, 2 (–4) ampoules [10 (–20) mg] intramuscularly or slowly intravenously, distributed throughout the day.

Drug-induced extrapyramidal symptoms ( acute dystonia and initial dyskinesia ):

In acute dystonia, ½ – 1 ampoule (2.5–5 mg) is given intramuscularly or slowly intravenously. The extrapyramidal symptoms may disappear already during injection one. In these cases, the injection should be stopped. If necessary, the prescribed dose can be given again after 30 minutes.

Incompatibilities

The solution for injection should not be mixed with other medicines, as miscibility studies are not available

Muhammad Nadeem

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