AKINETON 5 mg /Ml Injectable Solution

Зміст інструкції

1. Akineton vials 5 mg/ml injectable solution
   1. What is Akineton ampoules and what is it used for
   2. What you need to know before you take Akineton vials
   3. How to take Akineton vials
   4. Possible side effects
   5. How to store Akineton vials
   6. Contents of the pack and other information

Akineton vials 5 mg/ml injectable solution

biperiden lactate

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Akineton vials is and what it is used for
• 2. What you need to know before you use Akineton vials
• 3. How to use Akineton vials
• 4. Possible side effects
• 5. How to store Akineton vials
• 6. Contents of the pack and other information

1. What is Akineton ampoules and what is it used for

Akineton ampoules contains biperiden lactate which belongs to the group of drugs called
“anticholinergics”.
This medicine is indicated, together with other therapies, for the treatment of all forms
of parkinsonism (Parkinson's disease, post-encephalitic parkinsonian syndrome, arteriosclerotic parkinsonian syndrome, drug-induced extrapyramidal syndrome from neuroleptic drugs)
especially if severe or in emergency cases.

2. What you need to know before you take Akineton vials

Do not take Akineton vials

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you have high eye pressure (glaucoma);
• if you have a blockage at the level of the stomach or intestines which may be characterised by abdominal cramps, vomiting, constipation (mechanical stenosis of the gastrointestinal tract or intestinal atony);
• if you have a malformation of the colon, characterised by an excessive dilation of this organ (megacolon);
• if you have difficulty urinating (urinary retention).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Akineton vials:

• if you have recently had a heart attack or if you suffer from heart rhythm disturbances, because this medicine can cause an increase in heart rate. Your doctor will monitor your heart rate;
• if you have a prostate disease characterised by swelling of this organ (prostatic hypertrophy), because this medicine may cause problems with urination; in this case your doctor will reduce the dose;
• if you are prone to seizures as the risk of a seizure may increase.

Children
This medicine is not recommended for children.

Other medicines and Akineton vials
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
It is particularly important that you tell your doctor or pharmacist if you are taking or have
recently taken:

• medicines used to treat mental disorders such as anxiety, depression, mania etc. (psychotropic medicines);
• other medicines belonging to the same group as Akineton vials (anticholinergic medicines);
• other medicines for treating Parkinson's disease, such as levodopa, as they may increase involuntary muscle movements;
• medicines used to treat involuntary muscle contractions called spasms (antispastic medicines);
• quinidine: a medicine used to treat heart rhythm disturbances, as it may increase the effect of Akineton vials;
• pethidine: a medicine used to treat pain, as its side effects may be accentuated;
• medicines used to treat disorders of the gastrointestinal tract (e.g. metoclopramide), as their effect may be reduced by concomitant intake of Akineton vials.

Akineton vials is incompatible with chlorprothixene and promazine.

Akineton vials and alcohol
Do not drink alcoholwhile taking this medicine.

Pregnancy and breastfeeding
Avoid taking this medicine if you are pregnant, suspect you might be
pregnant, or are planning a pregnancy, or if you are breastfeeding. Always ask your
doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Do not drive and do not use machines that require particular attention while taking
this medicine.

Akineton vials containsless than 1mmol (23 mg) of sodium per dose, i.e. it is practically
‘sodium-free’.

3. How to take Akineton vials

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. The doctor will establish what is the most appropriate dose for you.

For the treatment of parkinsonism:
In severe cases, the recommended dose is 2-4 vials per day.
Maintenance therapy is administered orally by taking ½ - 2 tablets of Akineton 2

mg tablets,3-4 times a day.

For the treatment of parkinsonism caused by taking certain medications:
The recommended dose is ½ - 2 vials per day.

Method of use
The vial can be injected either directly into a vein, very slowly, (slow intravenous route) by a doctor or nurse, or into a muscle (intramuscular route).

If you take more Akineton vials than you should
If you have taken a dose of Akineton vials higher than that prescribed immediately inform your doctoror go to the nearest hospital. Bring with you this leaflet and the medicine packaging even if it is empty.
If you have taken an excessive dose of this medicine, you may experience: dilated pupils or difficulty dilating as usual, dry mouth, redness, increased heart rate (tachycardia), intestinal blockage, increased volume of the bladder muscles, increased body temperature (especially in children), agitation, confusion, disorientation and/or hallucinations. If the dose taken is very high, a dangerous decrease in respiratory and heart rate may occur.

If you forget to take Akineton vials
Do not take a double dose to make up for a missed dose.
If you have any doubts about 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.
Side effects can occur particularly at the beginning of treatment and if the
dosage is increased too quickly.

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

• at high doses: excitement, agitation, confusion, fear, delirium (loss of awareness of the surrounding environment, confusion, detachment from reality), hallucinations (seeing or hearing things that are not there), sleep disorders;
• fatigue, dizziness;
• memory disorders;
• increased heart rate (tachycardia);
• dry mouth, nausea, stomach problems;
• drowsiness.

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

• Hypersensitivity (allergic reactions);
• nervousness, exaggerated feeling of well-being (euphoria);
• headache;
• abnormal involuntary movements (dyskinesia); loss of muscle coordination (ataxia), difficulty speaking, increased likelihood of having epileptic seizures and convulsions;
• vision disorders (e.g. difficulty focusing), dilation of the pupils (mydriasis), sensitivity to light (photosensitivity), increased eye pressure (glaucoma);
• decreased heart rate;
• lowering of blood pressure (following injection);
• constipation;
• reduced sweating, allergic rash;
• muscle contraction;
• difficulty emptying the bladder (particularly in patients with prostate cancer), difficulty urinating (urinary retention).

Not known (frequency cannot be estimated from available data)

• Inflammation of the salivary glands located near the ears (parotitis).

The administration of Akineton vials with drugs used to treat mental disorders, at high
doses, can lead to the development of a form of delirium with visual hallucinations.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Akineton vials

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the pack after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Akineton vials contain

• The active ingredient is biperiden lactate. One 1 ml vial contains 5 mg of biperiden lactate.
• The other ingredients are water for injections and sodium lactate.

Description of the appearance of Akineton vials and contents of the pack
Akineton vials 5 mg/ml injectable solution is presented in a box containing 5 vials of 1
ml.

Marketing authorisation holder
Laboratorio Farmaceutico SIT S.r.l. – Via Cavour, 70 – 27035 Mede (PV)

Manufacturer
Sirton Pharmaceuticals S.p.A. – Piazza XX Settembre, 2 – 22079 Villa Guardia (CO)