Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - oprymea

Document Subject

Generated Narrative: MedicinalProductDefinition mpb44aec4025bf7e6a7ad2808694b3bfd0

identifier: http://ema.europa.eu/identifier/20 tablets: EU/1/08/469/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Oprymea 0.088 mg tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-b44aec4025bf7e6a7ad2808694b3bfd0

identifier: http://ema.europa.eu/identifier/20 tablets: EU/1/08/469/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - oprymea

Attesters

What is in this leaflet

1. What Oprymea is and what it is used for
2. What you need to know before you take Oprymea
3. How to take Oprymea
4. Possible side effects
5. How to store Oprymea
6. Contents of the pack and other information

Oprymea 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. Oprymea is used to:

treat the symptoms of primary Parkinson's disease in adults. 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 in adults.

Do not take Oprymea

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 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 up-titration of Oprymea

Dystonia (inability of keeping your body and neck straight and upright (axial dystonia)). In particular, you may experience forward flexion of the head and neck (also called antecollis), forward bending of the lower back (also called camptocormia) or sidewards bending of the back (also called pleurothotonus or Pisa Syndrome). If this happens, your doctor may want to change your medication.

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 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).

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 preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose. Tell your doctor if you or your family/carer notices that you are developing mania (agitation, feeling elated or over-excited) or delirium (decreased awareness, confusion or loss of reality). Your doctor may need to adjust or stop your dose. Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your Oprymea treatment. If the problems persist more than a few weeks, your doctor may need to adjust your treatment. Children and adolescents Oprymea is not recommended for use in children or adolescents under 18 years. Other medicines and Oprymea 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 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 are drinking alcohol. In these cases Oprymea may affect your ability to drive and operate machinery. Oprymea with food, drink and alcohol You should be cautious while drinking alcohol during treatment with Oprymea. Oprymea 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 or pharmacist for advice before taking this medicine. 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 should not be used 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 use of Oprymea is unavoidable, breast-feeding should be stopped. Ask your doctor or pharmacist for advice before taking any medicine. 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 this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The doctor will advise you on the right dosing. 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.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) 0.1.1 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 1 tablet Oprymea 1.1 mg three three times a day times a day Total daily dose (mg) 0.3.3 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. 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 Oprymea 0.088 mg once a day (equivalent to 0.088 mg daily): 1st week Number of tablets 1 tablet Oprymea 0.088 mg Total daily dose (mg) 0.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 Oprymea 0.18 mg OR 2 tablets Oprymea 0.088 mg 1 tablet Oprymea 0.35 mg OR 2 tablets Oprymea 0.18 mg OR 4 tablets Oprymea 0.088 mg 1 tablet Oprymea 0.35 mg and 1 tablet Oprymea 0.18 mg OR 3 tablets Oprymea 0.18 mg OR 6 tablets Oprymea 0.088 mg Total daily dose (mg) 0.0.0.The daily dose should not exceed 6 tablets Oprymea 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, Oprymea may not be a suitable treatment for you. If you take more Oprymea 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 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 try to make up for the missed dose. 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 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 stop or reduce Oprymea you may also develop a medical condition called dopamine agonist withdrawal syndrome. The symptoms include depression, apathy, anxiety, fatigue, sweating or pain. If you experience these symptoms you should contact your physician. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Evaluation of these side effects is based on the following frequencies: Very common may affect more than 1 in 10 people Common may affect up to 1 in 10 people Uncommon may affect up to 1 in 100 people Rare may affect up to 1 in 1,000 people Very rare may affect up to 1 in 10,000 people 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

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)

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)* - Delirium (decreased awareness, confusion, loss of reality) Rare:

Mania (agitation, feeling elated or over-excited) Not known:

After stopping or reducing your Oprymea treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS). Tell your doctor if you experience any of these behaviours; he will discuss ways of managing or reducing the symptoms. 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 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:

Urge to behave in an unusual way* - 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)* - 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)* - Mania (agitation, feeling elated or over-excited)* - Delirium (decreased awareness, confusion, loss of reality)* Not known:

After stopping or reducing your Oprymea treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS). Tell your doctor if you experience any of these behaviors; he will discuss ways of managing or reducing the symptoms. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 packaging after EXP. The expiry date refers to the last day of that month. Store in the original package in order to protect from light. 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.

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 Oprymea 0.088 mg tablets are white, round, with bevelled edges and imprint "P6" on one side of the tablet. Oprymea 0.18 mg tablets 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 doses. Oprymea 0.35 mg tablets 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 doses. Oprymea 0.7 mg tablets 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 doses. Oprymea 1.1 mg tablets are white, round, with bevelled edges, both sides scored. The tablet can be divided into equal doses. 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-Stra e 5, 27472 Cuxhaven, Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien KRKA Belgium, SA. T l/Tel: + 32 (0) 487 50 73 Lietuva UAB KRKA Lietuva Tel: + 370 5 236 27

Te .: + 359 (02) 962 34 Luxembourg/Luxemburg KRKA Belgium, SA. T l/Tel: + 32 (0) 487 50 73 62 (BE) esk republika KRKA R, s.r.o. Tel: + 420 (0) 221 115 Magyarorsz g KRKA Magyarorsz g Kereskedelmi Kft. Tel.: + 36 (1) 355 8Danmark KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) Malta E. J. Busuttil Ltd. Tel: + 356 21 445 Deutschland TAD Pharma GmbH Tel: + 49 (0) 4721 606-0 Nederland KRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 Norge KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE)

QUALIA PHARMA S.A. : + 30 210 6256 sterreich KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 Espa a KRKA Farmac utica, S.L. Tel: + 34 911 61 03 Polska KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7France KRKA France Eurl T l: + 33 (0)1 57 40 82 Portugal KRKA Farmac utica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 Hrvatska KRKA - FARMA d.o.o. Tel: + 385 1 6312 Rom nia KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 Ireland KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3Slovenija KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 sland LYFIS ehf. S mi: + 354 534 3Slovensk republika KRKA Slovensko, s.r.o. Tel: + 421 (0) 2 571 04 Italia KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8Suomi/Finland KRKA Finland Oy Puh/Tel: + 358 20 754 5 KI.PA. (PHARMACAL) LIMITED : + 357 24 651 Sverige KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE) Latvija KRKA Latvija SIA Tel: + 371 6 733 86 United Kingdom (Northern Ireland) KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3This leaflet was last revised in. Detailed information on this medicine is available on the European Medicines Agency web site: