0.26 mg, 0.52 mg, 1.05 mg, 2.1 mg, 2.62 mg, 3.15 mg prolonged-release tablets are
pramipexole
What Pramipexole Orion is and what it is used for
Pramipexole Orion 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.
Pramipexole Orion is used to treating the symptoms of Parkinson’s disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson’s disease ).
Pramipexole contained in Pramipexole Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Pramipexole Orion
Do not use Pramipexole Orion
- 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 Pramipexole Orion. Tell your doctor if you have (have had) or have had 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 dose increase period with Pramipexole Orion.
- 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 camptocormia), or lateral bending of the back (also known as pleurototonus or Pisa syndrome).
- Sleepiness and episodes of suddenly falling asleep
- Psychosis (eg comparable to symptoms of schizophrenia)
- Visual impairment. Your eyes should be examined regularly during treatment with Pramipexole Orion.
- 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 notice 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 experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing the dose of Pramipexole Orion. If the problems persist for more than a few weeks, your doctor may need to adjust your treatment.
Tell your doctor if you develop an inability to keep your body and neck straight and upright ( axial dystonia ). If this happens, your doctor may want to change your medication.
Pramipexole Orion 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
Pramipexole Orion is not recommended for children and adolescents under 18 years of age.
Other medicines and Pramipexole Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to medicines, natural remedies, health foods, or supplements that you have received without a prescription.
Avoid taking this medicine 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 Pramipexole Orion.
Be careful when using drugs that have a sedative effect or when consuming alcoholic beverages. In these cases, Pramipexole Orion may affect your ability to drive and use machines.
Pramipexole Orion with food, drink, and alcohol
Be careful with alcoholic beverages during treatment with Pramipexole Orion.
The tablets can be taken with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Your doctor will then discuss with you whether you should continue to use this medicine.
The effect of this medicine on the unborn baby is unknown. Therefore, you should not take this medicine if you are pregnant unless your doctor advises you to do so.
This medicine should not be used during breastfeeding. This medicine may reduce the production of breast milk. It can also pass to the breast milk and reach your baby. If the use of this medicine is necessary, breastfeeding should be stopped.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Pramipexole Orion 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.
This medicine 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.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Pramipexole Orion
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure. Your doctor will inform you about the correct dosage.
Take Pramipexole Orion prolonged-release tablets only once a day at about the same time each day.
You can take Pramipexole Orion 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 into 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).
| Dosage schedule for Pramipexole Orion prolonged-release tablets | ||
| Week | Daily dose (mg) | Number of tablets |
| 1 | 0.26 | A 0.26 mg prolonged-release tablet . |
| 2 | 0.52 | A 0.52 mg prolonged-release tabletORtwo 0.26 mg prolonged-release tablets . |
| 3 | 1.05 | A 1.05 mg prolonged-release tabletORtwo 0.52 mg prolonged-release tabletsORfour 0.26 mg prolonged-release tablets . |
The usual maintenance dose is 1.05 mg daily. However, 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 one 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 switch from tablets (with immediate-release )
Your doctor will base your dose of Pramipexole Orion prolonged-release tablet on the dose of pramipexole you took (immediate-release ) tablets.
Take your pramipexole tablets (immediate release ) as usual the day before you change. Then take your Pramipexole Orion prolonged-release tablets the next morning but no more Pramipexole Orion tablets (immediate-release ).
If you use more Pramipexole Orion than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you accidentally take too many tablets, 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 Pramipexole Orion
If you forget to take a dose of Pramipexole Orion, 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 Pramipexole Orion
Do not stop taking this medicine 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 Pramipexole Orion abruptly. A sudden interruption can cause you to develop a disease condition called a malignant neuroleptic syndrome, which can pose a major health risk. Symptoms include akinesia (loss of muscle mobility), stiff muscles, fever, varying blood pressure, tachycardia (increased heart rate), confusion, and decreased level of consciousness (eg coma ).
If you stop taking Pramipexole Orion 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.
You may experience the following side effects:
Very common (may affect more than 1 user in 10)
- Drowsiness, dizziness, dyskinesia (abnormal involuntary movements)
- Nausea
Common (may affect up to 1 in 10 people)
- Insomnia (hallucinations), hallucinations (abnormal visions, sounds, or sensations), abnormal dreams, confusion, strong need to behave in an unusual way
- Fatigue, excess fluid, usually in the legs (peripheral edema )
- Headache
- Low blood pressure ( hypotension )
- Constipation, vomiting
- Visual impairment
- Weight loss including decreased appetite
Uncommon (may affect up to 1 in 100 people)
- Abnormal perception of reality, paranoia (eg excessive concern for one’s health), restlessness, delirium (decreased consciousness, confusion, loss of reality)
- Excessive daytime sleepiness and sudden drowsiness, memory loss ( amnesia ), hyperkinesia (inability to stand still), fainting
- Weight gain
- Allergic reactions (eg rash, itching, hypersensitivity)
- Heart failure (heart problems that can cause shortness of breath and swollen ankles) *
- Altered secretion of antidiuretic hormone *
- Dyspnoea (difficulty breathing), hiccups
- 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 inconvenience to 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). *
Rare (may affect up to 1 in 1,000 people)
- Mania (feeling upset, elated, or over-excited).
Has been reported (occurs in an unknown number of users)
- After discontinuation or reduction of treatment with Pramipexole Orion: 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/she 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 Pramipexole Orion
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.
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 tablet contains 0.26 mg, 0.52 mg, 1.05 mg, 2.1 mg, 2.62 mg or 3.15 mg of pramipexole in the form of 0.375 mg, 0.75 mg, 1.5 mg, 3 mg, 3.75 mg and 4.5 mg pramipexole dihydrochloride monohydrate, respectively.
The other ingredients are hypromellose, calcium hydrogen phosphate, magnesium stearate, and anhydrous colloidal silica.
What the medicine looks like and the contents of the pack
Pramipexole Orion 0.26 mg and 3.15 mg prolonged-release tablets are white to off-white, round tablets with a smooth surface and beveled edges.
Pramipexole Orion 0.52 mg, 1.05 mg, 2.1 mg, and 2.62 mg prolonged-release tablets are white to off-white, round, and biconvex tablets.
The tablets are marked with 026, 052, 105, 210, 262 or 315 on one side, which corresponds to the strength of the tablet 0.26 mg, 0.52 mg, 1.05 mg, 2.10 mg, 2.62 mg or 3, 15 mg.
Pack sizes: 10, 30, and 100 prolonged-release tablets in blisters. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
Laboratorios Normon, SA
Ronda de Valdecarrizo, 6
Tres Cantos
28760 Madrid
Spain