PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER GLEPARK 0.088mg tablets GLEPARK 0.18mg tablets GLEPARK 0.35mg tablets GLEPARK 0.7mg tablets (pramipexole)

Read all of 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 further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their sings of ilness are the same as yours.

If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What GLEPARK is and what it is used for

2.    Before you take GLEPARK

3.    How to take GLEPARK

4.    Possible side effects

5.    How to store GLEPARK

Contents of the pack and other information

1. WHAT GLEPARK IS AND WHAT IT IS USED FOR

GLEPARK 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.

GLEPARK 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).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLEPARK

DO NOT take GLEPARK

-    if you are allergic (hypersensitive) to pramipexole or to any of the other ingredients of the tablets (listed insection 6).

Warnings and precautions

Talk to your doctor before taking GLEPARK.

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 dyskinesias during the uptitration of GLEPARK.

-    sleepiness and episodes of suddenly falling asleep

-    psychosis, (e.g. comparable with symptoms of schizophrenia)

-    Vision impairment

You should have regular eye examinations during treatment with GLEPARK

-    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).

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.

Tell your doctor if you or your family/carer notices that you are developing mania (agitation, feeling elated or over-excited) or delirium (decreased awareness, confusion, loss of reality). Your doctor may need to adjust or stop your dose.

Children and adolescents

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

Other medicines and Glepark

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.

You should avoid taking GLEPARK 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 nighttime 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 GLEPARK.

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 GLEPARK may affect your ability to drive and operate machinery.

GLEPARK with food and drink and alcohol

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

GLEPARK can be taken with or without food. Swallow the tablets with water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will then discuss with you if you should continue to take GLEPARK .

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

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

Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines

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

Always take GLEPARK exactly as your doctor has told you. Check with your doctor if you are not sure. The doctor will advise you on the right dosing.

You can take GLEPARK with or without food. Swallow the tablets with water.

Parkinson’s disease

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

During the first week, the usual dose is 1 tablet GLEPARK 0.088 mg tablet three times a day (equivalent to 0.264 mg daily):

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 GLEPARK 0.088 mg twice a day. In severe kidney disease, the usual starting dose is just 1 tablet

GLEPARK 0.088 mg a day.

If you take more GLEPARK 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 GLEPARK

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 GLEPARK

Do not stop taking GLEPARK 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 GLEPARK 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

If you suffer from Parkinson’s disease you may experience the following side effects:

Very common:

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

-    Sleepiness

-    Dizziness

-    Nausea (sickness)

Common:

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

-    Confusion

-    Tiredness (fatigue)

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

-    Headache

-    Abnormal dreams

-    Constipation

-    Sleeplessness (insomnia)

-    Urge to behave in an unusual way

-    Visual impairment

-    Vomiting (being sick)

-    Weight loss including decreased appetite

-    Hypotension (low blood pressure)

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

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

-    Fainting

-    Dyspnoea (difficulties to breathe)

-    Pneumonia (infection of lungs)

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

-    Inappropriate antidiuretic hormone secretion*

-    Restlessness

-    Hiccups

-    Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, 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)*.

-    Delirium (decreased awareness, confusion, loss of reality)

Rare:

- Mania (agitation, feeling elated or over-excited)

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

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”. Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet. You can also report side effects directly via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE GLEPARK

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

Do not use GLEPARK after the expiry date which is stated on the carton and blister after <EXP>.

The expiry date refers to the last day of that month.

Store in the original package to protect the tablets from light. This medicinal product does not require any special temperature storage conditions.

Do not throw away any medicines 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 GLEPARK contains

The active substance is pramipexole.

Each 0.088mg tablet contains 0.088mg of pramipexole base (as 0.125mg of pramipexole dihydrochloride monohydrate)

Each 0.18mg tablet contains 0.18mg of pramipexole base (as 0.25mg of pramipexole dihydrochloride monohydrate Each 0.35 mg tablet contains 0.35mg of pramipexole base (as 0.5mg of pramipexole dihydrochloride monohydrate)

Each 0.7mg tablet contains 0.7mg of pramipexole base (as 1.0mg of pramipexole dihydrochloride monohydrate)

The other ingredients are:

mannitol (E 421); maize starch; povidone K 30 (E 1201); silica, colloidal anhydrous; magnesium stearate (E470b)

What GLEPARK looks like and contents of the pack

0.088mg tablets: circular, white, flat bevelled tablets engraved with ‘PX” on one side and plain on the other side 0.18mg tablets: oval, white, flat bevelled uncoated tablets engraved with ‘PX' and ‘1' on either side of score line on one side and score line on the other side. The tablet can be divided into equal halves. 0.35mg tablets: oval white, flat bevelled uncoated tablets engraved with ‘PX' and ‘2' on either side of score line on one side and score line on other side. The tablet can be divided into equal halves. 0.7mg tablets: oval, white, flat bevelled uncoated tablets engraved with ‘PX' and ‘3' on either side of score line on one side and score line on other side. The tablet can be divided into equal halves. GLEPARK 0.088mg, 0.18mg, 0.35mg, 0.7mg tablets are available in aluminium/aluminium blisters of 30,100 tablets Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Glenmark Pharmaceuticals Europe Ltd, Laxmi House, 2-B Draycott Avenue, Kenton, Harrow,

Middx, HA3 0BU. United Kingdom

Manufacturer

Glenmark Pharmaceuticals Europe Limited, Building 2, Croxley Green Business Park, Croxley Green, Hertfordshire, WD18 8YA, United Kingdom

Glenmark Pharmaceuticals s.r.o., Hv zdova 1716/2b, 140 78 Praha 4, Czech Republic

PL 25258/0004-7

This medicinal product is authorised in the Member States of the EEA under the following names:

Czech Republic, Denmark, Finland, Germany, Greece, Romania,

Slovak Republic, The Netherlands, UK

Glepark

This leaflet was last revised in June 2014