Document: leaflet MAH GENERIC_PL 16363-0297 change

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• leaflet MAH GENERIC_PL 17277-0048
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PACKAGE LEAFLET: INFORMATION FOR THE USER

Pramipexole 0.088 mg tablets Pramipexole 0.18 mg tablets Pramipexole 0.7 mg tablets

Pramipexole

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Pramipexole is and what it is used for

2.    What you need to know before you take Pramipexole

3.    How to take Pramipexole

4.    Possible side effects

5.    How to store Pramipexole

6.    Contents of the pack and other information

1. WHAT PRAMIPEXOLE IS AND WHAT IT IS USED FOR

Pramipexole belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.

Pramipexole is used to:

treat the symptoms of primary Parkinson’s disease. It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).

Pramipexole may also be authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRAMIPEXOLE

Do not take Pramipexole

if you are allergic to pramipexole or to any of the other ingredients of this medicine (see Section 6).

Warnings and precautions

Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:

Kidney disease

Hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visual.

Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) If you have advanced Parkinson's disease and are also taking levodopa, you might develop dyskinesia during the uptitration of Pramipexole.

Sleepiness and episodes of suddenly falling asleep

Behavioural changes (e. g. pathological gambling, compulsive shopping),

increased libido (e.g. increased sexual desire), binge eating.

Psychosis, (e.g. comparable with symptoms of schizophrenia)

Vision impairment you should have regular eye examinations during treatment with Pramipexole.

Severe heart or blood vessels disease you will need to have your blood pressure checked regularly, especially at the beginning of treatment. This is to avoid postural hypotension (a fall in blood pressure on standing up) Augmentation

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

You may experience that symptoms start earlier than usual, be more intense and involve other limbs.

Children and adolescents

Pramipexole is not recommended for use in children or adolescents under 18 years.

Other medicines and Pramipexole

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

You should avoid taking Pramipexole together with antipsychotic medicines.

Take care if you are taking the following medicines:

cimetidine (to treat excess stomach acid and stomach ulcers) amantadine (which can be used to treat Parkinson’s disease) mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia);

zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system); cisplatin (to treat various types of cancers);

quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria)); procainamide (to treat irregular heart beat).

If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with Pramipexole.

Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol. In these cases Pramipexole may affect your ability to drive and operate machinery.

Pramipexole with food and drink

You should be cautious while drinking alcohol during treatment with Pramipexole.

Pramipexole can be taken with or without food.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you might be pregnant or if you intend to become pregnant.

Your doctor will then discuss with you if you should continue to take Pramipexole.

The effect of Pramipexole on the unborn child is not known. Therefore, do not take Pramipexole if you are pregnant unless your doctor tells you to do so.

Pramipexole should not be used during breast-feeding. Pramipexole can reduce the production of breast milk. Also, it can pass into the breast milk and can reach your baby. If use of Pramipexole is unavoidable, breast-feeding should be stopped.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Pramipexole can cause hallucinations (seeing, hearing or feeling things that are not there). If affected, do not drive or use machines.

Pramipexole has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson's disease. If you experience these side effects, you must not drive or operate machinery. You should tell your doctor if this occurs.

3. HOW TO TAKE PRAMIPEXOLE

Always take Pramipexole exactly as your doctor has told you. The doctor will advice you on the right dosing.

You can take Pramipexole with or without food. Swallow the tablets with water. Parkinson’s disease

The daily dose is to be taken divided into 3 equal doses.

This will be increased every 5-7 days as directed by your doctor until your symptoms are controlled (maintenance dose).

The usual maintenance dose is 1.1 mg per day. However, your dose may have to be increased even further. If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of pramipexole a day. A lower maintenance dose of three Pramipexole 0.088 mg tablets a day is also possible.

Patients with kidney disease

If you have moderate or severe kidney disease, your doctor will prescribe a lower dose. In this case, you will have to take the tablets only once or twice a day. If you have moderate kidney disease, the usual starting dose is 1 tablet Pramipexole 0.088 mg twice a day. In severe kidney disease, the usual starting dose is just 1 tablet Pramipexole 0.088 mg a day.

If you take more Pramipexole than you should

If you accidentally take too many tablets,

Contact your doctor or nearest hospital casualty department immediately for advice.

You may experience vomiting, restlessness, or any of the side effects as described in chapter 4 “Possible side effects”.

If you forget to take Pramipexole

Do not worry. Simply leave out that dose completely and then take your next dose at the right time.

Do not try to make up for the missed dose.

If you stop taking Pramipexole

Do not stop taking Pramipexole without first talking to your doctor. If you have to stop taking this medicine, your doctor will reduce the dose gradually. This reduces the risk of worsening symptoms.

If you suffer from Parkinson’s disease you should not stop treatment with Pramipexole abruptly. A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk. The symptoms include:

akinesia (loss of muscle movement)

rigid muscles

fever

unstable blood pressure tachycardia (increased heart rate) confusion

depressed level of consciousness (e.g. coma)

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.

Very common:

Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)

Sleepiness

Dizziness

Nausea (sickness)

Common:

Urge to behave in an unusual way

Hallucinations (seeing, hearing or feeling things that are not there)

Confusion

Tiredness (fatigue)

Sleeplessness (insomnia)

Excess of fluid, usually in the legs (peripheral oedema)

Headache

Hypotension (low blood pressure)

Abnormal dreams Constipation Visual impairment Vomiting (being sick)

Weight loss including decreased appetite

Uncommon:

Paranoia (e.g. excessive fear for one’s own well-being)

Delusion

Excessive daytime sleepiness and suddenly falling asleep Amnesia (memory disturbance)

Hyperkinesia (increased movements and inability to keep still)

Weight increase

Increased sexual desire (e.g. increased libido)

Allergic reactions (e.g.rash, itching, hypersensitivity)

Fainting

Pathological gambling, especially when taking high doses of Pramipexole Hypersexuality

Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*

Increased eating (binge eating, hyperphagia)*

Restlessness Compulsive shopping Dyspnoea (difficulties to breathe)

Hiccups

Pneumonia (infection of the lungs)

For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 2,762 patients treated with pramipexole. The frequency category is probably not greater than “uncommon”.

If you suffer from other indication treated with Pramipexole, you may experience the following side effects:

Very common:

Nausea (sickness)

Common:

Changes in sleep pattern, such as sleeplessness (insomnia) and

sleepiness

Tiredness (fatigue)

Headache Abnormal dreams Constipation Dizziness

Vomiting (being sick)

Uncommon:

Pathological gambling, especially when taking high doses of Pramipexole* Hypersexuality*

Compulsive shopping*

Urge to behave in an unusual way*

Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*

Increased eating (binge eating, hyperphagia)*

Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) Hyperkinesia (increased movements and inability to keep still)*

Paranoia (e.g. excessive fear for one's own well-being)*

Delusion*

Amnesia (memory disturbance)*

Hallucinations (seeing, hearing or feeling things that are not there) Confusion

Excessive daytime sleepiness and suddenly falling asleep Weight increase

Increased sexual desire (e.g. increased libido)

Hypotension (low blood pressure)

Excess of fluid, usually in the legs (peripheral oedema)

Allergic reactions (e.g. rash, itching, hypersensitivity)

Fainting Restlessness Visual impairment

Weight loss including decreased appetite

Dyspnoea (difficulties to breathe)

Hiccups

Pneumonia (infection of the lungs)*

For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 1,395 patients treated with pramipexole. The frequency category is probably not greater than “uncommon”.

You may experience the following side effects:

inability to resist the impulse to perform an action that could be harmful, which may include:

-    Strong impulse to gamble excessively despite serious personal or family consequences.

-    Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.

-    uncontrollable excessive shopping or spending

-    binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)

Tell your doctor if you experience any of these behaviors; they will discuss ways of managing or reducing the symptoms

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE PRAMIPEXOLE

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister foil after EXP. The expiry date refers to the last day of the month.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Pramipexole contains

The active substance is pramipexole.

Each tablet contains 0.125 mg of pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.

Each tablet contains 0.25 mg of pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.

Each tablet contains 1.0 mg of pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.

The other ingredients are: Mannitol (E421), maize starch, povidone K30, povidone K90, silica, colloidal anhydrous, magnesium stearate.

What Pramipexole looks like and contents of the pack

Tablet

Pramipexole 0.088 mg Tablets:

White to off-white, round, flat, beveled edge, uncoated tablets, debossed with ‘Y’ on one side ‘41’ on other side.

Pramipexole 0.18 mg Tablets:

White to off-white, oval, biconcave, beveled edge, uncoated tablets, debossed with ‘Y’ and ‘42’ separated by score line on one side and plain with score line on other side.

The tablet can be divided into equal halves.

Pramipexole 0.7mg Tablets:

White to off-white, round, flat, beveled edge, uncoated tablets, debossed with ‘Y’ and ‘45’ separated by score line on one side and plain with score line on other side.

The tablet can be divided into equal halves.

Pramipexole tablets are available in Polyamide/Aluminium foil /PVC - Aluminium foil blister and HDPE bottle with polypropylene cap containing cotton.

Pack sizes

Blister pack: 10, 20, 30, 50, 60, 90, 100 & 200 tablets HDPE bottle pack: 90, 100 & 1000 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

or

Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom

This leaflet was last approved in 11/2012.