Oprymea SR prolonged-release tablets – pramipexole for the symptoms of Parkinson’s disease

Oprymea SR contains pramipexole, a medicine from the group of dopamine agonists. It stimulates dopamine receptors in the brain, triggering nerve impulses that help control body movements, and thereby relieves the symptoms of Parkinson’s disease.

The medicine comes as prolonged-release tablets (manufacturer Krka, Slovenia): the tablet releases the active substance gradually, so it is taken only once a day. In Serbia, the name Oprymea is currently used only for the prolonged-release form (Oprymea SR) – according to the Summary of Product Characteristics, immediate-release Oprymea tablets are not authorised in the Republic of Serbia.

What is Oprymea SR used for and how should it be taken correctly?

Key facts about the medicine

What is Oprymea SR used for?

According to the package leaflet, Oprymea SR is used to treat the symptoms of primary Parkinson’s disease in adults. It can be taken alone or in combination with levodopa (another medicine for Parkinson’s disease).

How is it used and dosed?

Take the tablet once a day, at about the same time each day, with or without food. Swallow it whole with water – do not chew, divide or crush it, as the medicine could then be released too quickly (risk of overdose). The dose is increased every 5–7 days, as instructed by your doctor, until your symptoms are controlled:

• The usual maintenance dose is 1.05 mg a day. If necessary, the doctor may increase the dose further (according to the SmPC by 0.52 mg at weekly intervals) up to a maximum of 3.15 mg pramipexole a day. A lower maintenance dose of 0.26 mg a day is also possible.
• Switching from immediate-release pramipexole tablets: take your usual tablet on the day before switching, then start Oprymea SR the next morning at the dose set by your doctor.
• If you take levodopa, its dose is usually reduced when you start Oprymea SR.
• Treatment lasts as long as your doctor decides; do not change the dose on your own.

Special patient groups

• Kidney disease: your doctor may advise a starting dose of 0.26 mg every other day during the first week, then every day; further increases are made in steps of 0.26 mg (according to the SmPC, a maximum of 1.57 mg a day at a creatinine clearance of 30–50 mL/min). Prolonged-release tablets are not recommended at a clearance below 30 mL/min. If your kidney problems get worse, contact your doctor as soon as possible.
• Liver impairment: dose adjustment is probably not needed, as about 90% of the medicine is excreted by the kidneys (SmPC).
• Children and adolescents under 18 years: use is not recommended.
• Heart or blood vessel disease: regular blood pressure checks are needed, especially at the start of treatment (risk of a drop in blood pressure on standing up).

Contraindications – when the medicine must not be used

Do not take Oprymea SR if you are allergic (hypersensitive) to pramipexole or to any of the excipients of the medicine.

Warnings and precautions

Tell your doctor if you have or have had: kidney disease; hallucinations (mostly visual); dyskinesia (uncontrolled limb movements – may occur while the dose is increased together with levodopa); dystonia (bending of the head and neck forward, or of the lower back forward or to the side); sleepiness and episodes of suddenly falling asleep; excessive use of and craving for the medicine; psychosis; visual disturbances (regular eye examinations are needed); more serious heart or blood vessel disease.

Your doctor may need to adjust the dose or stop treatment if impulse control disorders (pathological gambling, binge eating, excessive spending, abnormally increased sex drive), symptoms of mania or delirium, or axial dystonia occur. After the dose is reduced or treatment is stopped, depression, apathy, anxiety, fatigue, sweating or pain may appear (dopamine agonist withdrawal syndrome). Parts of the tablet may sometimes pass through the digestive tract and be visible in the stool – tell your doctor if you notice this.

Interactions with other medicines, food and drink

• avoid taking it together with antipsychotics;
• caution with cimetidine, amantadine, mexiletine, zidovudine, cisplatin, quinine and procainamide;
• levodopa – its dose is usually reduced at the start of Oprymea SR treatment;
• sedative medicines and alcohol – may further affect your ability to drive;
• also tell your doctor about herbal products, health foods and supplements you take without a prescription.

The medicine can be taken with or without meals; be careful with alcohol during treatment.

Pregnancy and breast-feeding

• Pregnancy: the effect on the unborn child is not known – do not take the medicine if you are pregnant unless your doctor prescribes it.
• Breast-feeding: the medicine should not be taken while breast-feeding; it may reduce breast milk production and passes into breast milk. If its use is necessary, breast-feeding should be stopped.

Driving and using machines

Oprymea SR can cause hallucinations, sleepiness and episodes of suddenly falling asleep, especially in patients with Parkinson’s disease. If this happens, you must not drive or use machines, and you should tell your doctor.

Possible side effects

• Very common (more than 1 in 10): dyskinesia, sleepiness, dizziness, nausea.
• Common (up to 1 in 10): urge to behave in an unusual way, hallucinations, confusion, tiredness, insomnia, excess fluid in the legs (peripheral oedema), headache, low blood pressure, abnormal dreams, constipation, impaired vision, vomiting, weight loss and reduced appetite.
• Uncommon (up to 1 in 100): paranoia, delusions, excessive daytime sleepiness and suddenly falling asleep, memory disturbance, hyperkinesia, weight gain, allergic reactions (rash, itching), fainting, heart failure, inappropriate secretion of antidiuretic hormone, restlessness, difficulty breathing, hiccups, pneumonia, impulse control disorders (gambling, sexual behaviour, shopping, binge eating), delirium.
• Rare (up to 1 in 1,000): mania.
• Frequency not known: dopamine agonist withdrawal syndrome after stopping or reducing the dose.

Report any suspected side effect to your doctor, pharmacist or the Medicines and Medical Devices Agency of Serbia (ALIMS).

Overdose, missed dose and stopping treatment

• Overdose: contact your doctor or the nearest emergency service immediately; vomiting, restlessness or other side effects may occur.
• Missed dose: if you remember within 12 hours of your usual time, take the tablet straight away and the next one at the usual time; if more than 12 hours have passed, take the next dose at the usual time. Do not take a double dose.
• Stopping treatment: do not stop the medicine without talking to your doctor – the dose is reduced gradually. Stopping abruptly in Parkinson’s disease can cause neuroleptic malignant syndrome (loss of movement, muscle rigidity, high temperature, unstable blood pressure, fast heart rate, confusion, reduced consciousness).

Related information

For home blood pressure checks, recommended especially at the start of treatment, see also the category Blood pressure monitors – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substance: pramipexole – 0.26 mg, 0.52 mg, 1.05 mg or 2.1 mg per prolonged-release tablet (as 0.375 / 0.75 / 1.5 / 3 mg pramipexole dihydrochloride monohydrate).
• Excipients: hypromellose 100,000 mPa.s (type 2208) (E464); maize starch; colloidal anhydrous silica; magnesium stearate (E572).
• Appearance: white to almost white, round, slightly biconvex tablets marked P1 (0.26 mg), P2 (0.52 mg), P3 (1.05 mg) or P4 (2.1 mg).
• Pack: blister (OPA/Al/desiccant/PE-Al foil) with 10 tablets; carton with 3 blisters (30 tablets) and a package leaflet.
• Marketing authorisation holder: KRKA-FARMA d.o.o. Beograd, Jurija Gagarina 26/V/II, Belgrade; manufacturer: KRKA, d.d., Novo mesto, Šmarješka cesta 6, Novo mesto, Slovenia.

Storage

• The medicine does not require any special temperature storage conditions.
• Store in the original package to protect from moisture.
• Shelf life: 3 years (according to the 2021 SmPC).
• Keep out of the sight and reach of children; do not use after the expiry date, and return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Can I split an Oprymea SR tablet?

No. Prolonged-release tablets are swallowed whole – if they are chewed, divided or crushed, the medicine may be released too quickly and cause an overdose.

What is the difference between Oprymea and Oprymea SR?

SR means that the tablet releases the medicine gradually, so it is taken once a day. According to the Summary of Product Characteristics, immediate-release Oprymea tablets are not authorised in Serbia; if you previously took immediate-release pramipexole, your doctor will set the dose for switching to Oprymea SR.

Why is the dose increased gradually?

According to the leaflet, treatment starts at 0.26 mg a day and the dose is increased every 5–7 days until symptoms are controlled (usually 1.05 mg, at most 3.15 mg a day). A gradual increase helps reduce side effects such as nausea, dizziness and a drop in blood pressure.

What if I forget to take a tablet?

If you remember within 12 hours, take it straight away and the next one at the usual time. If more than 12 hours have passed, skip the missed dose and take the next one at the usual time; never take a double dose.

Sources

• ALIMS – Oprymea® SR prolonged-release tablets, package leaflet (PIL, August 2021, Serbian)
• ALIMS – Oprymea® SR, Summary of Product Characteristics (SmPC, 2021, Serbian)
• ALIMS – Oprymea® SR, package leaflet (PIL, 0.26 mg licence, November 2019, Serbian)
• ALIMS – Oprymea® SR 0.26 mg, Summary of Product Characteristics (SmPC, Serbian)

Date sources checked: 25.10.2026.