Oprymea 0.088 mg tablets

Oprymea 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.

Oprymea 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).

DO NOT take Oprymea

• If you are allergic (hypersensitive) to pramipexole or any of the other ingredients of Oprymea (see section 6. "Further information").

Take special care with Oprymea

Tell your doctor if you have or 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 Oprymea.
• 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 Oprymea.
• 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

Oprymea 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 Oprymea 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 Oprymea.

Take care if you are using any medicines that calm you down (have a sedative effect) or if you drink alcohol. In this cases Oprymea may effect your ability to drive and operate machinery.

Taking Oprymea with food and drink
You should be cautious while drinking alcohol during treatment with Oprymea.
Oprymea can be taken with or without food.

Pregnancy and breast-feeding

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

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

Oprymea is not recommended during breast-feeding. Oprymea can reduce the production of breast milk. Also, it can pass into the breast milk and can reach your baby. If treatment with Oprymea is unavoidable, breast-feeding must be stopped.

Driving and using machines
Oprymea can cause hallucinations (seeing, hearing or feeling things that are not there). If affected, do not drive or use machines.
Oprymea 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. Please tell your doctor if this occurs.

Always take Oprymea exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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

1st week Number of tablets 1 tablet Oprymea 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 Oprymea 0.18 mg three times a day OR 2 tablets Oprymea 0.088 mg three times a day 1 tablet Oprymea 0.35 mg three times a day OR 2 tablets Oprymea 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 Oprymea 0.088 mg tablets a day is also possible.

Lowest maintenance dose Highest maintenance dose Number of tablets 1 tablet Oprymea 0.088 mg three times a day 1 tablet Oprymea 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 Oprymea 0.088 mg twice a day. In severe kidney disease, the usual starting dose is just 1 tablet Oprymea 0.088 mg a day.

If you take more Oprymea 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 section 4. "Possible side effects".

If you forget to take Oprymea
Do not worry. Simply leave out that dose completely and then take your next dose at the right time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Oprymea

Do not stop taking Oprymea 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 Oprymea abruptly. A sudden stop could cause you to develop a medicinal 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, Oprymea 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 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)
• Sleepines
• 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 Oprymea
• Hypersexuality
• Increased eating (binge eating, hyperphagia)
• Restlessness
• Compulsive shopping
• Dyspnoea (difficulties to breathe)
• Hiccups
• Pneumonia (infection of the lungs)

If you suffer from other 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:
• Pathological gambling, especially when taking high doses of MIRAPEXIN
• 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 use Oprymea after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.

Store in the original package in order to protect 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 Oprymea 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, pregelatinised maize starch, povidone K25, colloidal anhydrous silica and magnesium stearate.

What Oprymea looks like and contents of the pack

Tablets of 0.088 mg are white, round, with bevelled edges and imprint "P6" on one side of the tablet. Tablets of 0.18 mg are white, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet. The tablet can be divided into equal halves.
Tablets of 0.35 mg are white, oval, with bevelled edges, both sides scored, with imprint "P8" on both halves of one side of the tablet. The tablet can be divided into equal halves.
Tablets of 0.70 mg are white, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet. The tablet can be divided into equal halves.
Tablets of 1.1 mg are white, round, with bevelled edges, both sides scored. The tablet can be divided into equal halves.
Boxes of 20, 30, 60, 90 and 100 tablets in blisters of 10 tablets are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

KRKA, d. d., Novo mesto, ?marje?ka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d. d., Novo mesto, ?marje?ka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

BelgiëBelgiqueBelgien KRKA, d.d., Novo mesto TélTel 32 03 321 63 52 LuxembourgLuxemburg KRKA, d.d., Novo mesto TélTel 32 03 321 63 52

KRKA Te. 359 02 962 34 50 Magyarország KRKA Magyarország Kereskedelmi Kft. Tel. 361 0 355 8490

eská republika KRKA R, s.r.o. Tel 420 0 221 115 150 Malta KRKA Pharma Dublin, Ltd. Tel 46 8 643 67 66

Danmark KRKA Sverige AB Tlf 46 08 643 67 66 SE Nederland KRKA, d.d., Novo mesto Tel 32 3 321 63 52 BE

Deutschland TAD Pharma GmbH Tel 49 0 4721 6060 Norge KRKA Sverige AB Tlf 46 08 643 67 66 SE

Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel 372 06 671 658 Österreich KRKA Pharma GmbH, Wien Tel 43 01 66 24 300

QUALIA PHARMA S.A. 30 0210 2832941 Polska KRKA-POLSKA Sp. z o.o. Tel. 48 022 573 7500

España KRKA, d.d., Novo mesto Tel 34 061 5089 809 Portugal KRKA Farmacêutica, Unipessoal Lda. Tel 351 021 46 43 650

France KRKA, d.d., Novo mesto Tél 32 3 321 63 52 BE România KRKA Romania S.R.L., Bucharest Tel 402 01 310 66 05

Ireland KRKA Pharma Dublin, Ltd. Tel 46 8 643 67 66 Slovenija KRKA, d.d., Novo mesto Tel 386 0 1 47 51 100

Ísland KRKA Sverige AB Sími 46 08 643 67 66 SE Slovenská republika KRKA Slovensko, s.r.o., Tel 421 0 2 571 04 501

Italia KRKA, d.d., Novo mesto Tel 39 069448827 SuomiFinland KRKA Sverige AB PuhTel 46 08 643 67 66 SE

Kipa Pharmacal Ltd. 357 24 651 882 Sverige KRKA Sverige AB Tel 46 08 643 67 66 SE

Latvija KRKA, d.d., Novo mesto Tel 371 6 733 86 10 United Kingdom Consilient Health UK Ltd. Tel 44 02089562310

Lietuva

UAB KRKA Lietuva
Tel: + 370 5 236 27 40

This leaflet was last approved in .