AKINETON 2 mg Tablet

Зміст інструкції

1. Akineton 2 mg tablets, 4 mg prolonged-release tablets
   1. What is Akineton and what is it used for
   2. What you need to know before you take Akineton
   3. How to take Akineton
   4. Possible side effects
   5. How to store Akineton
   6. Contents of the pack and other information

Akineton 2 mg tablets, 4 mg prolonged-release tablets

biperiden hydrochloride

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of this leaflet:

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

1. What is Akineton and what is it used for

Akineton contains biperiden hydrochloride 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).

2. What you need to know before you take Akineton

Do not take Akineton

• 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 intestine 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 or pharmacist before taking Akineton:

• if you have recently had a heart attack or if you suffer from irregular heartbeat, 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 enlargement 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.

The transition from another medicine to Akineton must occur gradually and
progressively, i.e. by slowly decreasing the dose of the previously used medicine and
gradually increasing that of Akineton.

Children
This medicine is not recommended for children.

Other medicines and Akineton
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
It is particularly important that you inform 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 (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 irregular heartbeat, as it may increase the effect of Akineton;
• pethidine: a medicine used to treat pain, as its side effects may be accentuated;
• medicines used to treat gastrointestinal disorders (e.g. metoclopramide), as their effect may be reduced by the concomitant use of Akineton.

Akineton is incompatible with chlorprothixene and promazine.

Akineton and alcohol
Do not drink alcoholwhile taking this medicine.

Pregnancy and breastfeeding
Avoid taking this medicine if you are pregnant, suspect you are 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 contains

• lactose:if your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. How to take Akineton

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.

Akineton 2 mg tablets
The optimal dose must be established by the doctor and varies from: half a tablet 3 times a day to 2 tablets 5 times a day.
The doctor will help you establish your optimal dose, following the following procedure: they will start you on treatment with half a tablet 2 times a day and then gradually increase the dose to 1 tablet 3 times a day. After a few days they will increase the dose again until further improvement of the symptoms can no longer be obtained.
Afterwards you will be asked to decrease the dose gradually until your symptoms worsen again.
The optimal dose for you will be the one between the maximum reached and the dose that caused your symptoms to worsen again.

Akineton 4 mg prolonged-release tablets
You should start treatment with Akineton 2 mg tablets and gradually increase the dose until a more favourable dosage is reached, as directed by your doctor. Subsequently, you may switch to taking Akineton 4 mg prolonged-release tablets. Generally, the average dose is 1-2 prolonged-release tablets per day, but it is also possible to reach up to 3 tablets per day distributed throughout the day.

Method of administration
Take the tablets after meals. If you suffer from excessive saliva production in the mouth (sialorrhea), take the tablets during meals. Correct administration of the medicine will also help to reduce the onset of gastric disorders.

If you take more Akineton than you should
If you have ingested a dose of Akineton higher than that prescribed immediately notify your
doctor or pharmacist, even if it is empty. If you have taken an excessive dose of this medicine, you may experience: dilated pupils or difficulty in dilating as usual, dry mouth, redness, increased heart rate (tachycardia), intestinal blockage, increased volume of the bladder musculature, 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
Do not take a double dose to make up for a missed dose.

If you stop taking Akineton
Do not stop treatment with Akineton without your doctor's advice. Discontinuation of treatment with Akineton must occur gradually.
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 epileptic seizures and convulsions;
• visual disturbances (e.g. difficulty focusing), pupil dilation (mydriasis), sensitivity to light (photosensitivity), increased eye pressure (glaucoma);
• decreased heart rate;
• 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).

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

This medicine does not require any particular storage conditions.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated 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 contains
Akineton 2 mg tablets

• The active ingredient is biperiden hydrochloride. One tablet contains 2 mg of biperiden hydrochloride.
• The other ingredients are corn starch, dibasic calcium phosphate dihydrate, microcrystalline cellulose, vinylpyrrolidone vinyl acetate copolymer, lactose, magnesium stearate, talc.

Akineton 4 mg prolonged-release tablets

• The active ingredient is biperiden hydrochloride. One tablet contains 4 mg of biperiden hydrochloride.
• The other ingredients are corn starch, microcrystalline cellulose, carnauba wax, hydroxypropyl cellulose, lactose, magnesium stearate, methylhydroxypropyl cellulose, yellow iron oxide (E 172), polyethylene glycol 400, polyethylene glycol 6000, povidone, anhydrous colloidal silica, sodium lauryl sulfate, talc, titanium dioxide (E 171).

Description of the appearance of Akineton and contents of the pack
Akineton 2 mg tabletsare presented in a box containing 60 tablets in blisters.

Akineton 4 mg prolonged-release tabletsare presented in a box containing 50
prolonged-release tablets in blisters.

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