Document: leaflet ACTAVIS_PL 17277-0045 change

• leaflet ACTAVIS_PL 17277-0045
• leaflet ASPIRE PHARMA_PL 17277-0045
• leaflet MAH GENERIC_PL 16363-0295
• leaflet MAH GENERIC_PL 17277-0045
• leaflet MAH GENERIC_PL 36687-0014
• leaflet MAH GENERIC_PL 40378-0103

---

Pramipexole 0.18 mg tablets Pramipexole 0.35 mg tablets Pramipexole 0.7 mg tablets Pramipexole 1.1 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    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. See section 4.

In this leaflet:

J What Pramipexole is and what it is used for

Before you take Pramipexole

^ How to take Pramipexole Possible side effects

_5| How to store Pramipexole

^1 Further information

3 WHAT PRAMIPEXOLE IS AND WHAT IT IS USED FOR

Pramipexole tablets 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 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).

^ BEFORE YOU TAKE PRAMIPEXOLE

DO NOT take Pramipexole

•    if you are allergic (hypersensitive) to pramipexole or any of the other ingredients of the tablets (See Section 6, "Further information").

Take special care with 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 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)

Children and adolescents

Pramipexole is not recommended for use in

children or adolescents under 18 years.

Taking other medicines

Please 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).

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.

Continued top of next column

AAAG4992

Taking Pramipexole with food and drink

You should be cautious while drinking alcohol during treatment with Pramipexole. Pramipexole can be taken with or without food. Swallow the tablets with water.

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, breastfeeding 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.

^ HOW TO TAKE PRAMIPEXOLE

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

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

Parkison'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 0.088 mg three times a day (equivalent to 0.264 mg daily):

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 diseases:

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

Continued over page

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 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 effect".

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.

3 POSSIBLE SIDE EFFECTS

Like all medicines, Pramipexole can cause side effects, although not everybody gets them. Evaluation of these side effects is based on the following frequencies:

Tell your doctor immediately and stop taking Pramipexole if you experience swelling of the face, lips, tongue or throat, difficulty breathing or develop a rash or itching, 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:

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

•    Sleepiness

•    Dizziness

•    Nausea (sickness)

•    Hypotension (low blood pressure)

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

•    Abnormal dreams

•    Constipation

•    Restlessness

•    Amnesia (memory disturbance)

•    Visual disturbance

•    Vomiting (being sick)

•    Weight loss

Uncommon:

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

•    Delusion

•    Excessive daytime sleepiness and suddenly falling asleep

•    Hyperkinesia (increased movements and inability to keep still)

•    Weight increase

•    Increased sexual desire (e.g. increased libido)

•    Fainting

•    Pathological gambling, especially when taking high doses of Pramipexole

•    Hypersexuality

•    Compulsive shopping

•    Dyspnoea (difficulties to breathe)

•    Pneumonia (infections of the lungs)

Unknown frequency:

•    Increased eating (binge eating, hyperphagia)

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: HYPERLINK "http://www.mhra.gov.uk/ yellowcard" www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

^ HOW TO STORE PRAMIPEXOLE

Keep out of the reach and sight of children.

Do not take 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

^ FURTHER INFORMATION

What Pramipexole contains

•    The active substance is pramipexole.

For 0.088 mg:

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

For 0.18 mg:

Each Pramipexole 0.18 mg tablet contains 0.18 mg of pramipexole base (as 0.25 mg of pramipexole dihydrochloride monohydrate).

For 0.35 mg:

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

For 0.70 mg:

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

For 1.1 mg:

Each Pramipexole 1.1 mg tablet contains

1.1    mg of pramipexole base (as 1.5 mg 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

0.088 mg White, round tablets, marked on one side with a "0" (zero), with no defects and dimensions 6.0 ± 0.1mm in diameter and 3.0 mm ± 0.2 mm in thickness 0.18 mg White, round tablets, marked on one side with a "1" (one), scored on the other side with no defects and dimensions

6.0    ± 0.1 mm in diameter and

3.0    mm ± 0.2 mm in thickness 0.35 mg White, round tablets, marked

on one side with a "2" (two), scored on the other side with no defects and dimensions

6.0    ± 0.1 mm in diameter and

3.0    mm ± 0.2 mm in thickness 0.70 mg White, round tablets, marked

on one side with a "3" (three), scored on the other side with no defects and dimensions 6.0 ± 0.1 mm in diameter and 3.0 mm ± 0.2 mm in thickness

1.1    mg White, round tablets, marked

on one side with a "4" (four), scored on the other side with no defects and dimensions

6.0    ± 0.1mm in diameter and

3.0    mm ± 0.2 mm in thickness

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

Pharmathen S.A.

6, Dervenakion str.,

15351 Pallini Attiki, Greece

Manufacturer

Pharmathen S.A., Dervenakion 6, 15351, Pallini, Attiki , Greece

This leaflet was last approved in

06/08/2010

^actavis

Continued top of next column AAAG4992

Pramipexole 0.088mg, 0.18mg, 0.35mg, 0.7mg & l.lmg Tablets PIL - UK			colours/plates:
			1. Black
^actavis cresting value In pharmaceuticals t 00441271 311400 f 00441271311449	item no: AAAG4992	dimensions: 170 x 500	2.
	print proof no: 1	pharmacode:	3.
			4.
	origination date: 27.01.14	min pt size:	5.
@ artworkstudio@actavis.co.uk	originated by: S.Anson		6.
approved for print/date	revision date:	Technical Approval	Non Printing Colours
			1.
	revised by:	date sent: 27.01.14
			2.
	supplier: Pharmathen	technically app. date: 27.01.14	3.