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• leaflet ASPIRE PHARMA_PL 17277-0047
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• leaflet MAH GENERIC_PL 36687-0016
• leaflet MAH GENERIC_PL 40378-0105

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Package Leaflet: Information for the user Pramipexole 0.088mg tablets Pramipexole 0.18mg tablets Pramipexole 0.35mg tablets Pramipexole 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 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 of these 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 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 contains the active substance pramipexole and 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).

2.    What you need to know before you take Pramipexole

DO NOT take Pramipexole

-    if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before taking Pramipexole. 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 notthere). Most hallucinations are visual.

-    Abnormal, uncontrolled movements of the limbs (dyskinesia). If you have advanced Parkinson's disease and are also taking levodopa, you might develop dyskinesia during the up-titration of Pramipexole.

-    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 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)

Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These behaviours are called impulse control disorders and can include 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 the dose.

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 or have recently taken any other medicines. This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription. 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, drink and alcohol You should be cautious while drinking alcohol during treatment with Pramipexole.

Pramipexole can betaken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may 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 Pramipexole.

The effect of Pramipexole on the unborn child is not known. Therefore, do nottake Pramipexole ifyou 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 notthere). 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. Ifyou 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 this medicine exactly as your doctor has told you. Check with your doctor ifyou are not sure. The doctor will advise you on the rightdosing.

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.

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

Patients with kidney diseases:

Ifyou 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. Ifyou have moderate kidney disease, the usual starting dose is 1 tablet Pramipexole 0.088mg twice a day. In severe kidney disease, the usual starting dose is just 1 tablet Pramipexole 0.088mg a day.

If you take more Pramipexole than you should

If you accidentally took 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 reducesthe 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:

-    loss of muscle movement (akinesia)

-    rigid muscles

-    fever

-    unstable blood pressure

-    increased heart rate (tachycardia)

-    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, Pramipexole can cause side effects, although not everybody gets them.

Tell your doctor immediately and stop taking Pramipexole if you experience swelling of the face, lips, tongue or throat and difficulty breathing, as these may be signs of a serious allergic reaction.

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

Very common (may affect more than 1 in 10 people):

-    Abnormal, uncontrolled movements of the limbs (dyskinesia)

-    Sleepiness

-    Dizziness

-    Sickness (nausea)

Common (may affect up to 1 in 10 people):

-    Urge to behave in an unusual way

-    Hallucinations (seeing, hearing or feeling things that are notthere)

-    Confusion

-    Tiredness (fatigue)

-    Sleeplessness (insomnia)

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

-    Headache

-    Low blood pressure (hypotension)

-    Abnormal dreams

-    Constipation

-    Visual impairment

-    Vomiting (being sick)

-    Weight loss including decreased appetite Uncommon (may affect up to 1 in 100 people):

-    Excessive fear for one's own well-being (paranoia)

-    Delusion

-    Excessive daytime sleepiness and suddenly falling asleep

-    Memory disturbance (amnesia)

-    Increased movements and inability to keep still (hyperkinesia)

-    Weight increase

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

-    Fainting

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

-    Inappropriate antidiuretic hormone secretion*

-    Restlessness

-    Difficulties to breathe (dyspnoea)

-    Hiccups

-    Infections of the lungs (pneumonia)

-    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)*.

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms. For the side effects marked with * a precise frequency 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 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 this 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 Pramipexole

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

Do not use Pramipexole after the expiry date, which is stated on the pack. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist howto throw away medicines you no longer use. These measures will help to protect the environment.

6.    Contents of the pack and other information

What Pramipexole contains

-    The active substance is pramipexole.

For 0.088mg: Each Pramipexole 0.088mg tablet contains 0.088mg of pramipexole base (as0.125mg of pramipexole dihydrochloride monohydrate).

For 0.18mg: Each Pramipexole 0.18mg tablet contains 0.18mg of pramipexole base (as0.25mg of pramipexole dihydrochloride monohydrate).

For 0.35mg: Each Pramipexole 0.35mg tablet contains 0.35mg of pramipexole base (as 0.5 mg of pramipexole dihydrochloride monohydrate).

For 0.70mg: Each Pramipexole 0.7mg tablet contains 0.7mg of pramipexole base (as 1.0mg of pramipexole dihydrochloride monohydrate).

-    The other ingredients are Starch, pregelatinised (Starch maize 1500), Mannitol, Cellulose, microcrystalline, Povidone (27.0-32.4), Talc and Magnesium stearate.

What Pramipexole looks like and contents of the pack 0.088mg White, round tablets, marked on one side with a'0'(zero)

0.18mg White, round tablets, marked on one side with a'1'(one), scored on the other side

0.35mg White, round tablets, marked on one side with a'2'(two), scored on the other side

0.70mg White, round tablets, marked on one side with a'3'(three), scored on the other side

Pramipexole is available in aluminium/aluminium blister strips of 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Pharmathen S.A.

6, Dervenakion str.

15351 Pallini Attiki,

Greece Distributor Aspire Pharma Ltd.

Bellamy House,

Winton Road,

Petersfield,

Hants, GU32 3HA,

U.K.

This leaflet was last approved in 01/2014

1010040-P6.1