0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg prolonged-release tablets
pramipexole
What Oprymea is and what it is used for
Oprymea contains the active substance pramipexole and belongs to a group of medicines called dopamine agonists, which stimulate the dopamine receptors in the brain. By stimulating dopamine receptors, nerve impulses are triggered in the brain that can help control the body’s movements.
Oprymea is used to treat the symptoms of Parkinson’s disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson’s disease ).
What you need to know before you use Oprymea
Do not use Oprymea
- if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before taking Oprymea. Tell your doctor if you have (have had) or have any symptoms, especially any of the following:
- kidney disease
- hallucinations (seeing, hearing or perceiving things that do not exist). Most hallucinations are visual hallucinations.
- dyskinesia (eg abnormal, uncontrolled movements of the arms and legs). If you have advanced Parkinson’s disease and are also taking levodopa , you may develop dyskinesia during the titration period with Oprymea.
- dystonia (inability to keep body and neck straight and upright ( axial dystonia )). In particular, you may experience forward bending of the head and neck (also known as antecollis), forward bending of the lumbar spine (also known as camptochormia) or lateral bending of the back (also known as pleurototonus or Pisa syndrome). If this happens, your doctor may want to change your medication.
- drowsiness and episodes of sudden drowsiness
- psychosis (eg comparable to symptoms of schizophrenia)
- visual impairment. Your eyes should be examined regularly during treatment with Oprymea.
- severe cardiovascular disease. You will need to check your blood pressure regularly, especially at the beginning of treatment. The reason is that you want to avoid a drop in blood pressure when you stand up.
Tell your doctor if you or your family/caregiver notices that you are developing impulses or want to behave in a way that is unusual for you and that you cannot resist the impulse, the drive, or the temptation to perform activities that may harm yourself or others. This is called impaired impulse control and can include behavior such as gambling addiction, excessive eating or buying behavior, abnormally high sex drive, or increased preoccupation with constant thoughts of sex or sexual feelings. Your doctor may need to adjust your dose or stop your medication.
Tell your doctor if you or your family/caregiver notices that you are developing mania (feeling upset, elated, or overexcited) or delirium (decreased consciousness, confusion, or loss of reality). Your doctor may need to adjust your dose or stop your medication.
Tell your doctor if you get symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping taking or reducing the dose of Oprymea. If the problems persist for 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 substance is gradually released after the tablet has been swallowed. Parts of the tablets can sometimes pass and be seen in the stool ( feces ) and may look like whole tablets. Tell your doctor if you find parts of tablets in your stool.
Children and young people
Oprymea is not recommended for use in children and adolescents below 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 also applies to medicines, herbal medicines, health foods, or dietary supplements that you have received without a prescription.
Avoid taking Oprymea with antipsychotic drugs.
Be careful if you are taking any of the following medicines:
- cimetidine (for the treatment of excess stomach acid and ulcers )
- amantadine (which can be used to treat Parkinson’s disease )
- mexiletine (for the treatment of irregular heartbeat, a condition called ventricular arrhythmia)
- zidovudine (which can be used to treat HIV , an immunodeficiency disease)
- cisplatin (for the treatment of various types of cancer)
- quinine (which can be used to prevent painful nocturnal calf cramps and to treat a type of malaria known as falciparum malaria)
- procainamide (for the treatment of irregular heartbeats)
If you are taking levodopa, the dose of one of levodopa should be reduced when you start treatment with Oprymea.
Be careful when using drugs that have a sedative effect or when consuming alcoholic beverages. In these cases, Oprymea may affect your ability to drive and use machines.
Oprymea with food, drink and alcohol
Be careful with alcoholic beverages during treatment with Oprymea.
Oprymea can be taken with or without food.
Pregnancy, breastfeeding and fertility
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 whether to continue using Oprymea.
The effect of Oprymea on the unborn baby is unknown. Therefore, you should not take Oprymea if you are pregnant unless your doctor advises you to do so.
Oprymea should not be used during breast-feeding. Oprymea may reduce the production of breast milk. It can also pass to the breast milk and reach your baby. If the use of Oprymea is necessary, breast-feeding should be discontinued.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Oprymea can cause hallucinations (seeing, hearing, or perceiving things that do not exist). If you experience this, do not drive or use any tools or machines.
Oprymea is associated with drowsiness and episodes of sudden drowsiness, especially in patients with Parkinson’s disease. If you experience these side effects, do not drive or use any tools or machines. You should tell your doctor if this happens.
How to use Oprymea
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will inform you about the correct dosage.
Take Oprymea prolonged-release tablet only once a day at about the same time each day.
You can take Oprymea with or without food. The tablets should be swallowed whole with water.
Prolonged-release tablets must not be chewed, divided, or crushed. If this should still happen, there is a risk of overdose because the drug can be released too quickly in your body.
During the first week, the normal daily dose is 0.26 mg pramipexole. Your doctor will increase the dose every five to seven days until your symptoms are under control (maintenance dose).
| Dose escalation schedule for Oprymea prolonged-release tablets | ||
|---|---|---|
| Week | Daily dose (mg) | Number of tablets |
| 1 | 0.26 | An Oprymea 0.26 mg prolonged-release tablet. |
| 2 | 0.52 | An Oprymea 0.52 mg prolonged-release tabletORtwo Oprymea 0.26 mg prolonged-release tablets are. |
| 3 | 1.05 | An Oprymea 1.05 mg prolonged-release tabletORtwo Oprymea 0.52 mg prolonged-release tabletsORfour Oprymea 0.26 mg prolonged-release tablets . |
The usual maintenance dose is 1.05 mg daily. However, does one may need to be increased further. Your doctor may increase the dose by up to a maximum of 3.15 mg pramipexole per day, if necessary. A lower maintenance dose of an Oprymea 0.26 mg prolonged-release tablet per day is also possible.
Patients with kidney disease
If you have any kidney disease, your doctor may recommend that you take the usual starting dose of 0.26 mg prolonged-release tablet, only every other day for the first week. After that, your doctor may increase the dosing frequency to a 0.26 mg prolonged-release tablet every day. If further dose escalation is required, your doctor may adjust the dose one step at a time with 0.26 mg pramipexole with each increase.
In severe kidney disease, your doctor may need to switch to another medicine with pramipexole. If your kidney problems worsen during treatment, you should contact a doctor as soon as possible.
If you are switching from Oprymea tablets (with immediate-release )
Your doctor will base your dose of Oprymea prolonged-release tablet on the dose you took of Oprymea tablets (immediate-release ).
Take your Oprymea tablets (immediate release ) as usual the day before you change. Then take your Oprymea prolonged-release tablets the next morning but no more Oprymea tablets (with immediate-release ).
If you use more Oprymea than you should
If you accidentally take too many tablets,
- contact your doctor or nearest emergency department immediately for advice
- you may experience vomiting, inability to stand still, or any of the side effects described in section 4 (Possible side effects )
If you forget to use Oprymea
If you forget to take a dose of Oprymea, but remember within 12 hours, take your tablet at once and then take the next one at the usual time.
If you miss a dose for more than 12 hours, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop using Oprymea
Do not stop taking Oprymea without talking to your doctor first. If you need to stop treatment, your doctor will reduce the dose gradually. This reduces the risk of worsening symptoms.
If you have Parkinson’s disease, do not stop taking Oprymea abruptly. A sudden interruption can cause you to develop a disease condition called a malignant neuroleptic syndrome, this condition can pose a major health risk. Symptoms include:
- akinesia (loss of muscle mobility)
- stiff muscles
- fever
- varying blood pressure
- tachycardia (increased heart rate)
- confusion
- decreased level of consciousness (eg coma )
If you stop taking Oprymea or reduce your dose, you may also develop a medical condition called withdrawal syndrome after treatment with a dopamine agonist. Symptoms include depression, apathy, anxiety, fatigue, sweating, or pain. If you get these symptoms, consult a doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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: Show larger
| Very common: | may occur in more than 1 in 10 users |
| Usual: | may affect up to 1 in 10 users |
| Uncommon: | may affect up to 1 in 100 users |
| Rare: | can occur in up to 1 in 1,000 users |
| Very rare: | may affect up to 1 in 10,000 users |
| No known frequency | can not be calculated from available data |
You may experience the following side effects:
Very common:
- Dyskinesia (abnormal involuntary movements)
- Somnolence
- Dizziness
- Nausea
Usual:
- Strong need to behave in an unusual way
- Hallucinations (abnormal vision, sound or sensations)
- Confusion
- Fatigue
- Insomnia (insomnia)
- Excess fluid, usually in the legs (peripheral edema )
- Headache
- Low blood pressure ( hypotension )
- Abnormal dreams
- Constipation
- Visual impairment
- Vomiting
- Weight loss including decreased appetite
Uncommon:
- Paranoia (eg excessive concern for their health)
- Abnormal perception of reality
- Excessive daytime sleepiness and sudden drowsiness
- Memory loss ( amnesia )
- Hyperkinesia (inability to stand still)
- Weight gain
- Allergic reactions (eg rash, itching , hypersensitivity)
- Fainting
- Heart failure (heart problems that can cause shortness of breath and swollen ankles) *
- Altered secretion of antidiuretic hormone *
- Restlessness
- Dyspnoea (difficulty breathing)
- Hiccup
- Pneumonia ( pneumonia )
- Inability to resist the impulse, drive or desire to perform an act that may be harmful to yourself and others, which may include:
- Strong impulse to play excessively despite serious personal consequences or consequences for the family.
- Changed or increased sexual interest and behavior of significant problems for you or others, such as increased sexual drive.
- Uncontrollable excessive buying behavior or wasting money.
- Binge eating (eating large amounts of food for a short time) or compulsive eating (eating larger amounts of food than normal and more than is needed to satisfy hunger). *
- Delirium (decreased consciousness, confusion, loss of reality)
Rare:
- Mania (feeling upset, elated or overexcited)
No known frequency:
- After discontinuation or reduction of Oprymea: depression, apathy , anxiety, fatigue, sweating or pain may occur (withdrawal syndrome after dopamine agonist treatment).
Tell your doctor if you experience any of the above behaviors, he will discuss how to manage or reduce the symptoms.
For adverse reactions marked with *, an exact frequency estimate is not possible as these adverse reactions have not been observed in clinical trials in 2762 patients treated with pramipexole. The frequency is probably not higher than “less common”.
How to store 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 carton after EXP. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive.
No special temperature instructions.
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.
Contents of the pack and other information
Content declaration
– The active substance is pramipexole. Each prolonged-release tablet contains 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg or 3.15 mg pramipexole each corresponding to 0.375 mg, 0.75 mg, 1, 5 mg, 2.25 mg, 3 mg, 3.75 mg or 4.5 mg pramipexole dihydrochloride monohydrate.
– The other ingredients are hypromellose, corn starch, colloidal anhydrous silicon, and magnesium stearate.
What the medicine looks like and contents of the pack
Oprymea 0.26 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets marked with P1 on one side, with beveled edges and any spots.
Oprymea 0.52 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets marked with P2 on one side, with beveled edges and any spots.
Oprymea 1.05 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets marked with P3 on one side, with beveled edges and any spots.
Oprymea 1.57 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets marked with P12 on one side, with beveled edges and any spots.
Oprymea 2.1 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets marked with P4 on one side, with beveled edges and any spots.
Oprymea 2.62 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets marked with P13 on one side and 262 on the other side, with beveled edges and any spots.
Oprymea 3.15 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets marked with P5 on one side and 315 on the other side, with beveled edges and any spots.
Cartons of 10, 30, 90, or 100 tablets in blister cards are available.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
KRKA Sverige AB
Göta Ark 175
118 72 Stockholm
Tel: + 46 (0) 8 643 67 66 (SE)