Package leaflet: Information for the user Pramipexole 88 micrograms Tablets Pramipexole 180 micrograms Tablets Pramipexole 350 micrograms Tablets Pramipexole 700 micrograms Tablets

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 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 Pramipexole Tablets are and what they are used for

2.    What you need to know before you take Pramipexole Tablets

3.    How to take Pramipexole Tablets

4.    Possible side effects

5.    How to store Pramipexole Tablets

6.    Contents of the pack and other information

1. What Pramipexole Tablets are and what they are used for

Pramipexole Tablets contains the active substance pramipexole and belong 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 Tablets are used to:

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

Pramipexole which is contained in Pramipexole Tablets 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 Tablets

Do not take Pramipexole Tablets

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

Warnings and precautions

Talk to your doctor before taking Pramipexole Tablets. 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 up-titration of Pramipexole Tablets

•    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 Tablets

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

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.

Children and adolescents

Pramipexole Tablets are not recommended for

use in children or adolescents under 18 years.

Other medicines and Pramipexole Tablets

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 Pramipexole Tablets 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 Tablets.

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 Tablets may affect your ability to drive and operate machinery.

Pramipexole Tablets with food, drink and alcohol

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

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

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

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

Driving and using machines

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

Pramipexole Tablets have 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 Tablets

Always take this medicine 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 Pramipexole Tablets with or without food. Swallow the tablets with water.

Parkinson's disease

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

The usual maintenance dose is 1,100 micrograms 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 3,300 micrograms of pramipexole a day. A lower maintenance dose of three Pramipexole 88 micrograms 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 one Pramipexole 88 micrograms Tablet twice a day. In severe kidney disease, the usual starting dose is just one Pramipexole 88 micrograms Tablet a day.

If you take more Pramipexole Tablets 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 Tablets

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 Tablets

Do not stop taking Pramipexole Tablets 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.

105437/5

If you suffer from Parkinson's disease you should not stop treatment with Pramipexole Tablets 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 medicine, 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:

•    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:

•    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.

•    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

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

•    inappropriate antidiuretic hormone secretion*

•    restlessness

•    dyspnoea (difficulties to breathe)

•    hiccups

•    pneumonia (infection of the lungs)

•    delirium (decreased awareness, confusion, loss of reality).

Rare:

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

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 another indication, 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:

•    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.

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

•    inappropriate antidiuretic hormone secretion*

•    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

•    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)*

•    delirium (decreased awareness, confusion, loss of reality

•    mania (agitation, feeling elated or over-excited).

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”.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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 Tablets

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. 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 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 Tablets contain

The active substance is pramipexole.

Each tablet contains 88 micrograms,

180 micrograms, 350 micrograms or 700 micrograms pramipexole as 125 micrograms, 250 micrograms,

500 micrograms or 1,000 micrograms pramipexole dihydrochloride monohydrate, respectively.

The other ingredients are mannitol, maize starch, citric acid monohydrate, colloidal anhydrous silica, povidone K 30 and magnesium stearate.

What Pramipexole Tablets look like and contents of the pack

Pramipexole 88 micrograms Tablets are white to off white, round uncoated tablets, debossed ” ^W6 ” on one side and plain on the other.

Pramipexole 180 micrograms Tablets are white to off white, oval shaped uncoated tablets, debossed "W” on one side and "117” on the other side of score line and plain on either side of the score line on the reverse side.

Pramipexole 350 micrograms Tablets are white to off white, oval shaped uncoated tablets, debossed "W” on one side and "118” on the other side of score line and plain on either side of the score line on the reverse side.

Pramipexole 700 micrograms Tablets are white to off white, round shaped uncoated tablets, debossed "W” on one side and "119” on the other side of score line and plain on either side of the score line on the reverse side.

The 180 micrograms, 350 micrograms and 700 micrograms tablets can be divided into equal halves.

Pramipexole Tablets are available in Alu/Alu blister packs of ten tablets per strip.

Pramipexole 88 micrograms Tablets are available in cartons containing three blister strips (30 tablets) and Pramipexole 180 micrograms, 350 micrograms and 700 micrograms Tablets are available in cartons containing three or ten blister strips (30 or 100 tablets). Not all pack sizes may be marketed.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.

Manufacturer

CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK.

This leaflet was last revised in 03/2016.

fwOCKHARDT