Oprymea – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Oprymea, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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, askyour 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Oprymea is and what it is used for
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).
⚠️ 2. What you need to know before you take Oprymea
Do not take Oprymea
- 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 Oprymea. 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 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).
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 tocarry 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 increasein 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.
Oprymea prolonged-release tablet is a specially designed tablet from which the active ingredient is gradually released, once the tablet has been ingested. Parts of tablets may occasionallybe passed and seen in the stool (faeces) and may look like whole tablets. Inform your doctor if you find tablet pieces in your faeces.
Children and adolescents
Oprymea is not recommended for use in children or adolescents under 18 years.
Other medicinesand 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. You should tell your doctor if this occurs.
💊 3. How to take Oprymea
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.
Take Oprymea prolonged-release tablets only once a day and each day at about the same time.
You can take Oprymea with or without food. Swallow the tablets whole with water.
Do not chew, divide or crush the prolonged-release tablets. If you do, there is a danger you could overdose, because the medicine may be released into your body too quickly.
During the first week, the usual daily dose is 0.26mg pramipexole. The dose will be increased every 5-7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
The Oprymea treatment initiation pack is only to be used for the beginning of the treatment with Oprymea.
The Oprymea treatment initiation packcontains three blister strips of tablets – one strip for each of the first three weeks of your treatment. The three strips are marked with “Week1”, “Week2” and “Week3”.
The daily dose you take of Oprymea increases each week.
Ascending dose schedule of Oprymea prolonged-release tablets Week Daily dose (mg) Number of tablets 1 0.26 One Oprymea 0.26mg prolonged-release tablet on blister “Week1”.
2 0.52 One Oprymea 0.52mg prolonged-release tablet on blister “Week2”.
3 1.05 One Oprymea 1.05mg prolonged-release tablet on blister “Week3”.
The usual maintenance dose is 1.05mg per day. However, your dose may have to be increased even further. If necessary, your doctor may increase your dose up to a maximum of 3.15mg of pramipexole a day. A lower maintenance dose of one Oprymea 0.26mg prolonged-release tablet a day is also possible.
Patients with kidney disease If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26mg prolonged-release tablets only every other day for the first week. After that, your doctor may increase the dosing frequency to one 0.26mg prolonged-release tablet every day. If a further dose increase is necessary, your doctor may adjust it in steps of 0.26mg pramipexole.
If you have serious kidney problems, your doctor may need to switch you to a different pramipexole medicine. If during treatment your kidney problems get worse, you should contact your doctor as soon as possible.
If you are switching from Oprymea (immediate release) tablets Your doctor will base your dose of Oprymea prolonged-release tablets on the dose of Oprymea (immediate release) tablets you were taking.
Take your Oprymea (immediate release) tablets as normal the day before you switch. Then take your Oprymea prolonged-release tablets next morning and do not take any more Oprymea (immediate release)tablets.
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 chapter 4 “Possible side effects”.
If you forget to take Oprymea
If you forget to take a dose of Oprymea, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for a forgotten tablet dose.
If you stop taking Oprymea
Do not stop taking Oprymea without first talking to your doctor. If you have tostop 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 symptomsyou should contact your physician.
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.
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 1000 people Very rare may affect up to 1 in 10000 people Not known frequency cannot be estimated from the available data 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 lossincluding decreased appetite
Uncommon
- Paranoia (e.g. excessive fear for one’s own well-being)
- Delusion
- Excessive daytime sleepiness and suddenly fallingasleep
- 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 ofreality)
Rare
- Mania (agitation, feeling elated or over-excited)
- Spontaneous penile erection
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 ofmanaging 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 2762 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.
🌡️ 5. How tostore Oprymea
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 moisture.
This medicine does not require any special temperature 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 measureswill help protect the environment.
📦 6. Contents of the pack and other information
What Oprymea contains
- The active substance is pramipexole. Each prolonged-release tablet contains 0.26mg, 0.52mg or 1.05mg pramipexole as 0.375mg, 0.75mg or 1.5mg pramipexole dihydrochloride monohydrate, respectively.
- The other ingredients are hypromellose, maize starch, colloidal anhydrous silica and magnesium stearate.
What Oprymea looks like and contents of the pack
Oprymea 0.26 mg prolonged-release tablets are white or almost white, round (diameter 10mm), slightly biconvex tablets engraved with P1 on one side, with bevelled edges and possible spots.
Oprymea 0.52 mg prolonged-release tablets are white or almost white, round (diameter 10mm), slightly biconvex tablets engraved with P2 on one side, with bevelled edges and possible spots.
Oprymea 1.05 mg prolonged-release tablets are white or almost white, round (diameter 10mm), slightly biconvex tablets engraved with P3 on one side, with bevelled edges and possiblespots.
3-week treatmentinitiation packcontains 21prolonged-release tablets in 3 packages:
- the package marked “Week 1” contains 1 blister of 7 tablets of 0.26mg,
- the package marked “Week 2” contains 1 blister of 7 tablets of 0.52mg,
- the package marked “Week 3” contains 1 blister of 7 tablets of 1.05mg.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka 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:
België/Belgique/Belgien KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 Lietuva UAB KRKA Lietuva Tel: + 370 5 236 27 40 България КРКА БългарияЕООД Teл.: + 359 (02) 962 34 50 Luxembourg/Luxemburg KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62(BE) Česká republika KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150 Magyarország KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490 Danmark KRKA Sverige AB Tlf.: + 46 (0)8 643 67 66 (SE) Malta E. J. Busuttil Ltd.
Tel: + 356 21 445 885 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) 6 671 658 Norge KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) Ελλάδα KRKA ΕΛΛΑΣΕΠΕ Τηλ: + 30 2100101613 Österreich KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 300 España KRKAFarmacéutica, S.L.
Tel: + 34 911 61 03 80 Polska KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500 France KRKA France Eurl Tél: + 33 (0)1 57 40 82 25 Portugal KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650 Hrvatska KRKA – FARMAd.o.o.
Tel: + 385 1 6312 101 România KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05 Ireland KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710 Slovenija KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 100 Ísland LYFIS ehf.
Sími: + 354 534 3500 Slovenská republika KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501 Italia KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841 Suomi/Finland KRKA Finland Oy Puh/Tel: + 358 20 754 5330 Κύπρος KI.PA. (PHARMACAL) LIMITED Τηλ: + 357 24 651 882 Sverige KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE) Latvija KRKA Latvija SIA Tel: + 371 6 733 86 10
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Oprymea (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/08/469).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.