Akineton ® Tablets

AKINETON contains the active substance biperiden hydrochloride. Biperiden is an anticholinergic medicine that exhibits effects on the central nervous system (CNS).

AKINETON can be used to treat Parkinson’s disease by relaxing muscle spasms and controlling muscle twitching. It can also be used to control muscle twitching and spasms caused by some medicines.

Do not take AKINETON if:

• you are hypersensitive (allergic) to biperiden or any of the other ingredients of this medicine (listed in section 6);
• you are lactose intolerant;
• you are suffering from an eye disorder called narrow angle glaucoma;
• you have been told that you have a narrow stomach or bowels, or any other bowel problem;
• you are suffering from abnormal dilation of the colon (also called the large bowel);
• you are suffering from a disease, injury or physical disorder that causes impaired brain function;
• you are pregnant or breast feeding (see section 3);
• you suffer from myasthenia gravis

Do not take AKINETON if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before using AKINETON.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking AKINETON if:

• you have a disease, injury or physical disorder that causes decreased brain function;
• you have low tolerance to the medicine (e.g., patients with cerebral arteriosclerosis (thickening and hardening of the walls of the arteries in the brain);
• you have an enlarged prostate;
• you are suffering from heart failure or fast-heart beat or fits;
• you are an alcoholic;
• you have glaucoma. Your doctor may check the pressure in your eye at regular intervals;

AKINETON can cause addiction if used for longer durations than prescribed. If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking AKINETON.

Other medicines and AKINETON

Always tell your healthcare provider if you are taking any other medicines (This includes all complementary or traditional medicines). Combining AKINETON with other medicines having similar effects may increase its undesirable effects. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines used for the treatment of movement disorders and Parkinson’s disease (e.g. levodopa, carbidopa)
• medicines used for the treatment for nervous disorders and depression (e.g., tricyclic antidepressants, amitriptyline, imipramine);
• medicines used to treat irregular heartbeats (e.g., quinidine);
• medicines that treat indigestion and stomach pains caused by muscle spasms, or medicines used to treat nausea and vomiting (e.g., metoclopramide)
• antihistamines (sometimes used to treat allergies such as hay fever and skin rashes)

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking AKINETON.

Pregnancy and Breastfeeding

Pregnancy
The safety and efficacy of AKINETON in pregnant women has not been established. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking AKINETON.

Breastfeeding
The safety and efficacy of AKINETON in breastfeeding has not been established. Do not take AKINETON if you are breastfeeding.

Do not share medicines prescribed for you with another person. Your doctor will tell you how long your treatment with AKINETON will last. Do not stop treatment early, even if you start to feel better. Withdrawal should be done gradually.

If you have the impression that the effect of AKINETON is too strong or too weak, tell your doctor or pharmacist.

Using this medicine

Tablets
Always take AKINETON tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist is you are unsure. The tablets may be broken into the desired dose from the break line. Tablets may be taken at any time of the day, with or without food.

Parkinsonism:
Adults: The usual dose for adults is one ½ a tablet (1 mg) to 2 tablets (4 mg) three to four times a day. The total daily dose should be spread evenly throughout the day.

Drug-induced extrapyramidal symptoms:
Adults: Take orally, concomitant with the neuroleptic medicines, 1 mg (½ a tablet) to 4 mg (2 tablets) one to four times daily, increased as required, to maximum of 18 mg (9 tablets) daily.

Children (aged between 3 to 15 years):
The usual dose for adults is one ½ a tablet (1 mg) to 1 tablet (2 mg) three times a day. The total daily dose should be spread evenly throughout the day.

If you take more AKINETON than you should
If you take more than the prescribed dose (an overdose), you should contact a doctor immediately or go to the nearest hospital casualty department.

If you forget to take AKINETON
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop using AKINETON
It is important that you keep taking these tablets until your doctor tells you to stop. Don’t stop just because you feel better. If you stop taking the tablets without your doctor’s advice, your condition may get worse. Withdrawal of this product should be gradual. Abrupt withdrawal may lead to feeling sick, sweating, and urinary urgency.

AKINETON can have side effects. Not all side effects reported for AKINETON are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your health care provider for advice.

If any of the following happens, stop using AKINETON and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Hypersensitivity (allergic reactions, which may include difficulty in breathing, swelling of the lips or face, rash or itching).
• Increased tendency to suffer from convulsions and seizures
• Involuntary disorders of movement
• Disturbed coordination of movement and speech disturbances
• An increase in the pressure within the eye, called glaucoma (closed-angle glaucoma), is possible. The value of this pressure should be checked regularly by a specialist.
• Slowing of the heart rate
• Difficulties emptying the urinary bladder, in particular in patients with an enlarged prostate gland (prostate adenoma)

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

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

• excitement
• agitation
• fear
• confusion
• mental delusions (delirious syndromes and hallucinations)
• sleeplessness
• influence on sleep phases
• fatigue
• dizziness and disturbance of memory
• accelerated pulse (palpitations, tachycardia).
• dryness of mouth
• gastric disorder
• nausea.
• muscle twitching.
• drowsiness.

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

• hypersensitivity
• nervousness, unnaturally elevated mood (euphoria)
• headache
• involuntary, erratic, writhing movements of the face, arms, legs or trunk (dyskinesia)
• loss in muscle control (ataxia)
• visual disturbances
• pupil dilatation with sensitivity to light
• slower than normal heart rate (bradycardia)
• constipation
• reduced perspiration
• allergic skin rash
• difficulty in passing urine (urinary retention)

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

• swelling or inflammation of the salivary glands

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of AKINETON.

Store in a dry place at or below 25 °C. AKINETON must be stored in the original package and in the outer carton until required for use. AKINETON should not be used after the expiry date shown on the container. Store out of reach of children.