SIFROL 0.7 mg tablets

SIFROL 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.

SIFROL 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).
• treat the symptoms of moderate to severe primary Restless Legs Syndrome.

Do not take SIFROL

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

Take special care with SIFROL

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 SIFROL.
• 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 SIFROL.
• 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.

Children and adolescents

SIFROL 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 SIFROL 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 SIFROL.

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 SIFROL may affect your ability to drive and operate machinery.

Taking SIFROL with food and drink

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

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

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

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

Driving and using machines

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

SIFROL 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.

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

You can take SIFROL 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 SIFROL 0.088 mg three times a day (equivalent to 0.264 mg daily):

1st week Number of tablets 1 tablet SIFROL 0.088 mg three times a day Total daily dose mg 0.264

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

2nd week 3rd week Number of tablets 1 tablet SIFROL 0.18 mg three times a day OR 2 tablets SIFROL 0.088 mg three times a day 1 tablet SIFROL 0.35 mg three times a day OR 2 tablets SIFROL 0.18 mg three times a day Total daily dose mg 0.54 1.1

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 SIFROL 0.088 mg tablets a day is also possible.

Lowest maintenance dose Highest maintenance dose Number of tablets 1 tablet SIFROL 0.088 mg three times a day 1 tablet SIFROL 1.1 mg three times a day Total daily dose mg 0.264 3.3

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

Restless Legs Syndrome

The dose is usually taken once a day, in the evening, 2-3 hours before bedtime.

During the first week, the usual dose is 1 tablet SIFROL 0.088 mg once a day (equivalent to 0.088 mg daily):

1st week Number of tablets 1 tablet SIFROL 0.088 mg Total daily dose mg 0.088

This will be increased every 4-7 days as directed by your doctor until your symptoms are controlled (maintenance dose).

2nd week 3rd week 4th week Number of tablets 1 tablet SIFROL 0.18 mg OR 2 tablets SIFROL 0.088 mg 1 tablet SIFROL 0.35 mg OR 2 tablets SIFROL 0.18 mg OR 4 tablets SIFROL 0.088 mg 1 tablet SIFROL 0.35 mg and 1 tablet SIFROL 0.18 mg OR 3 tablets SIFROL 0.18 mg OR 6 tablets SIFROL 0.088 mg 0.18 0.35 0.54 Total daily dose mg

The daily dose should not exceed 6 tablets SIFROL 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).

If you stop taking your tablets for more than a few days and want to restart the treatment, you must start again at the lowest dose. You can then build up the dose again, as you did the first time. Ask your doctor for advice.

Your doctor will review your treatment after 3 months to decide whether or not to continue the treatment.

Patients with kidney disease

If you have severe kidney disease, SIFROL may not be a suitable treatment for you.

If you take more SIFROL 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 SIFROL

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 SIFROL

Do not stop taking SIFROL 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 SIFROL 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.

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

Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Rare affects 1 to 10 users in 10,000 Very rare affects less than 1 user in 10,000 Not known frequency cannot be estimated from the available data

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:

• 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 SIFROL
• Hypersexuality
• Increased eating (binge eating, hyperphagia)
• Restlessness
• Compulsive shopping
• Dyspnoea (difficulties to breathe)
• Hiccups
• Pneumonia (infection of the lungs)

If you suffer from Restless Legs Syndrome, 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 SIFROL
• Hypersexuality
• Compulsive shopping
• Urge to behave in an unusual way
• 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)

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.

Keep out of the reach and sight of children.

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

Do not store above 30°C.
Store in the original package to protect the tablets from light.

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.

What SIFROL contains

The active substance is pramipexole.

Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg, or 1.1 mg pramipexole as 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 1.5 mg pramipexole dihydrochloride monohydrate, respectively.

The other ingredients are mannitol, maize starch, anhydrous colloidal silica, povidone K 25 and magnesium stearate.

What SIFROL looks like and contents of the pack

SIFROL 0.088 mg tablets are white, round, flat, embossed with a code, without scoring.

SIFROL 0.18 mg tablets and SIFROL 0.35 mg tablets are white, oval, flat, and embossed with a code. Tablets are scored and breakable in halves.

SIFROL 0.7 mg tablets and SIFROL 1.1 mg tablets are white, round, flat, embossed with a code. Tablets are scored and breakable in halves.

All strengths of SIFROL are available in 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

Boehringer Ingelheim International GmbH
D-55216 Ingelheim am Rhein
Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG
D-55216 Ingelheim am Rhein
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien SCS Boehringer Ingelheim Comm.V TélTel 32 2 773 33 11 LuxembourgLuxemburg SCS Boehringer Ingelheim Comm.V TélTel 32 2 773 33 11

- 359 2 958 79 98 Magyarország Boehringer Ingelheim RCV GmbH Co KG Magyarországi Fióktelepe Tel. 36 1 299 8900

eská republika Boehringer Ingelheim spol. s r.o. Tel 420 234 655 111 Malta Boehringer Ingelheim Ltd. Tel 44 1344 424 600

Danmark Boehringer Ingelheim Danmark AS Tlf 45 39 15 88 88 Nederland Boehringer Ingelheim b.v. Tel 31 0 800 22 55 889

Deutschland Boehringer Ingelheim Pharma GmbH Co. KG Tel 49 0 800 77 90 900 Norge Boehringer Ingelheim Norway KS Tlf 47 66 76 13 00

Österreich Boehringer Ingelheim RCV GmbH Co KG Tel 43 1 80 105-0 Eesti Boehringer Ingelheim RCV GmbH Co KG Eesti filiaal Tel 372 60 80 940

Boehringer Ingelheim Ellas A.E. T 30 2 10 89 06 300 Polska Boehringer Ingelheim Sp.zo.o. Tel. 48 22 699 0 699

España Boehringer Ingelheim España S.A. Tel 34 93 404 58 00 Portugal Boehringer Ingelheim, Lda. Tel 351 21 313 53 00

France Boehringer Ingelheim France S.A.S. Tél 33 3 26 50 45 33 România Boehringer Ingelheim RCV GmbH Co KG Viena - Sucursala Bucuresti Tel 40 21 302 2800

Ireland Boehringer Ingelheim Ireland Ltd. Tel 353 1 295 9620 Slovenija Boehringer Ingelheim RCV GmbH Co KG, Podrunica Ljubljana Tel 386 1 586 40 00

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Boehringer Ingelheim RCV GmbH Co KG, organizaná zloka Tel 421 2 5810 1211

Italia Boehringer Ingelheim Italia S.p.A. Tel 39 02 5355 1 SuomiFinland Boehringer Ingelheim Finland Ky PuhTel 358 10 3102 800

Boehringer Ingelheim Ellas A.E. T 30 2 10 89 06 300 Sverige Boehringer Ingelheim AB Tel 46 8 721 21 00

United Kingdom Boehringer Ingelheim Ltd. Tel 44 1344 424 600 Latvija Boehringer Ingelheim Pharma GmbH Prstvniecba Latvij Tel 371 67 240 068

Lietuva

Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel.: +370 37 473922

This leaflet was last approved in {MM/YYYY}.