Akineton vials

Package leaflet: Information for the patient

Akineton vials 5 mg/ml injectable solution

biperiden lactate
Please read this leaflet carefully before using 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Akineton vials are and what they are used for
2. What you need to know before using 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 Akineton vials is and what it is used for

Akineton vials contain biperiden lactate, which belongs to a group of medicines called
"anticholinergics".
This medicine is indicated, in combination with other therapies, for the treatment of all forms
of parkinsonism (Parkinson's disease, post-encephalitic parkinsonian syndrome, arteriosclerotic
parkinsonian syndrome, extrapyramidal syndrome due to neuroleptic drugs),
particularly in severe cases or emergency situations.

2. What you need to know before using Akineton ampoules

Do not use Akineton ampoules

• if you are allergic to the active substance 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 in the stomach or intestines, which may be characterized by abdominal cramps, vomiting, constipation (mechanical obstruction of the gastrointestinal tract or intestinal atony);
• if you have a colon disorder characterized by excessive enlargement of the colon (megacolon);
• if you have difficulty urinating (urinary retention).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Akineton ampoules:

• if you have recently had a heart attack or if you suffer from heart rhythm disorders, as this medicine may cause an increase in heart rate. Your doctor will monitor your heart rate;
• if you have a prostate disorder characterized by enlargement of the gland (prostatic hypertrophy), as this medicine may cause difficulty in urination; in such case, your doctor may reduce your dose;
• if you are prone to seizures, as the risk of seizures may increase.

Children
This medicine is not recommended for use in children.
Other medicines and Akineton ampoules
Inform 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 psychiatric disorders such as anxiety, depression, mania, etc. (psychotropic medicines);
• other medicines belonging to the same group as Akineton ampoules (anticholinergic medicines);
• other medicines used to treat Parkinson's disease, such as levodopa, as they may increase involuntary muscle movements;
• medicines used to treat involuntary muscle contractions known as spasms (antispastic medicines);
• quinidine: a medicine used to treat heart rhythm disorders, as it may enhance the effect of Akineton ampoules;
• pethidine: a medicine used to treat pain, as its side effects may be intensified;
• medicines used to treat gastrointestinal disorders (e.g. metoclopramide), as their effect may be reduced when taken concomitantly with Akineton ampoules.

Akineton ampoules are incompatible with chlorprothixene and promazine.
Akineton ampoules and alcohol
Do not drink alcohol while taking this medicine.
Pregnancy and breastfeeding
Avoid taking this medicine if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding. Always consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Do not drive or operate machinery requiring special attention while taking this medicine.
Akineton ampoules contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically 'sodium-free'.

3. How to take Akineton ampoules

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Your doctor will determine the most appropriate dose for you.

For the treatment of parkinsonism:
In severe cases, the recommended dose is 2–4 ampoules per day.
Maintenance therapy is administered orally by taking ½–2 tablets of Akineton 2 mg tablets, 3–4 times daily.

For the treatment of drug-induced parkinsonism:
The recommended dose is ½–2 ampoules per day.

Method of administration
The ampoule can be injected either slowly into a vein (intravenous slow injection) by a doctor or nurse, or into a muscle (intramuscular injection).

If you take more Akineton ampoules than you should
If you have taken more Akineton ampoules than prescribed, contact your doctor immediately or go to the nearest hospital. Bring this leaflet and the medicine carton with you, even if it is empty.
If you have taken an excessive dose of this medicine, you may experience: dilated pupils or pupils that have difficulty dilating normally, dry mouth, flushing, increased heart rate (tachycardia), intestinal obstruction, increased bladder muscle tone, elevated body temperature (especially in children), agitation, confusion, disorientation, and/or hallucinations. If the dose taken is very high, a dangerous reduction in respiratory and heart rate may occur.

If you forget to take Akineton ampoules
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may particularly occur at the beginning of treatment and if the dose 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, disconnection from reality), hallucinations (seeing or hearing things that are not there), sleep disturbances;
• fatigue, dizziness;
• memory disturbances;
• 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 sense 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), light sensitivity (photosensitivity), increased pressure in the eye (glaucoma);
• decreased heart rate;
• drop in blood pressure (following injection);
• constipation;
• reduced sweating, allergic skin rash;
• muscle contractions;
• difficulty emptying the bladder (particularly in patients with prostate tumour), difficulty urinating (urinary retention).

Not known (frequency cannot be estimated from the available data)

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

Administration of Akineton injection solution together with medicines used to treat psychiatric disorders, at high doses, may lead to the development of delirium with visual hallucinations.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 ampoules

This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.": The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Akineton ampoules contains

• The active substance is biperidenum lactate. One 1 ml ampoule contains 5 mg of biperidenum lactate.
• The other components are water for injections and sodium lactate.

Description of the appearance of Akineton ampoules and contents of the pack
Akineton 5 mg/ml solution for injection is presented in a box containing 5 ampoules of 1 ml each.
Marketing Authorization 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)