0.26 mg & 0.52 mg & 1.05 mg & 1.57 mg & 2.10 mg & 2.62 mg & 3.15 mg prolonged-release tablets are
pramipexole
What Pramipexole STADA is and what it is used for
Pramipexole Stada 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 Stada 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 ).
Pramipexole contained in Pramipexole Stada 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 you use Pramipexole STADA
Do not take Pramipexole STADA
- 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 Stada. 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 titration period with Pramipexole Stada
- dystonia (inability to keep body and neck straight and upright ( axial dystonia )). In particular, you may experience a forward flexion of the head and neck (also called Nate Collis), forward flexion of the lumbar spine (also known as combat tachormia), or lateral back flexion (also known as pleurototone or Pisa syndrome).
- drowsiness and episodes of sudden drowsiness
- psychosis (eg comparable to symptoms of schizophrenia)
- visual impairment. Your eyes should be examined regularly during treatment with Pramipexole Stada
- for 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 you 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 overexciting) or delirium (decreased consciousness, confusion, 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 Stada. 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 Stada 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 Stada is not recommended for children and adolescents under 18 years of age.
Other medicines and Pramipexole STADA
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 Pramipexole Stada with antipsychotic drugs.
Tell your doctor 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 Stada.
Be careful when using drugs that have a sedative effect or when consuming alcoholic beverages.
In these cases, Pramipexole Stada may affect your ability to drive and use machines.
Pramipexole STADA with food, drink, and alcohol
Be careful with alcoholic beverages during treatment with Pramipexole Stada.
Pramipexole Stada 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 or pharmacist for advice before taking this medicine. Your doctor will then discuss with you whether you should continue to use Pramipexole Stada.
The effect of Pramipexole Stada on the unborn baby is unknown. Therefore, you should not use Pramipexole Stada if you are pregnant unless your doctor advises you to do so.
Pramipexole Stada should not be used during breastfeeding. Pramipexole Stada may reduce breast milk production. It can also pass to the breast milk and reach your baby. If the use of Pramipexole Stada is necessary, breastfeeding should be discontinued.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Pramipexole Stada can cause hallucinations (seeing, hearing, or perceiving things that do not exist). If this happens to you, do not drive or use machines.
Pramipexole Stada 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 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 STADA
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.
When and how to take Pramipexole Stada
Take Pramipexole Stada prolonged-release tablets only once a day at about the same time each day.
You can take Pramipexole Stada 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.
Dosage
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 Stada prolonged-release tablets | ||
| Week | Daily dose (mg) | Number of tablets |
| 1 | 0.26 | 1 Pramipexole Stada 0.26 mg prolonged-release tablet |
| 2 | 0.52 | 1 Pramipexole Stada 0.52 mg prolonged-release tabletor2 Pramipexole Stada 0.26 mg prolonged-release tablet is |
| 3 | 1.05 | 1 Pramipexole Stada 1.05 mg prolonged-release tabletor2 Pramipexole Stada 0.52 mg prolonged-release tablet isor4 Pramipexole Stada 0.26 mg prolonged-release tablet is |
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 a Pramipexole Stada 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 pramipexole tablets (with immediate-release )
Your doctor will base your dose of Pramipexole Stada prolonged-release tablet on the dose you took of pramipexole tablets (immediate-release ).
Take your pramipexole tablets (immediate release ) as usual the day before you change. Then take your Pramipexole Stada prolonged-release tablet the next morning but no more pramipexole tablets (immediate-release ).
If you take more Pramipexole STADA 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.
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 take Pramipexole STADA
If you forget to take a dose of Pramipexole Stada, 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 taking Pramipexole STADA
Do not stop taking Pramipexole Stada 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 Stada 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 Pramipexole Stada 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)
- dyskinesia (abnormal involuntary movements)
- somnolence
- dizziness
- nausea.
Common (may affect up to 1 in 10 people):
- strong need to behave in an unusual way
- hallucinations (abnormal visions, sounds, or sensations)
- confusion
- fatigue
- 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 (may affect up to 1 in 100 people):
- paranoia (eg excessive concern for their health)
- abnormal perception of reality
- excessive sleepiness during the day and suddenly falling asleep
- 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 or family consequences
- altered or increased sexual interest or behavior, of significant inconvenience to you or others, e.g. 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 (may affect up to 1 in 1,000 people):
- mania (feeling upset, elated, or becoming overexcited).
Has been reported (occurs in an unknown number of users):
- after discontinuation or reduction of treatment with Pramipexole Stada: depression, apathy, anxiety, fatigue, sweating or pain may occur (withdrawal syndrome after treatment with dopamine agonist).
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 2,762 patients treated with pramipexole.
The frequency is probably not higher than “less common”.
How to store Pramipexole STADA
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 and blister after EXP. The expiration date is the last day of the specified month.
No special temperature instructions.
Store in the original package. Moisture sensitive.
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, 1.57 mg, 2.1 mg, 2.62 mg or 3.15 mg pramipexole in the form of 0.375 mg, 0.75 mg, 1 , 5 mg, 2.25 mg, 3 mg, 3.75 mg and 4.5 mg pramipexole dihydrochloride monohydrate, respectively.
The other ingredients are: hypromellose, calcium hydrogen phosphate, magnesium stearate, anhydrous colloidal silica
What the medicine looks like and the contents of the pack
0.26 mg: The 9 mm tablets are white or off-white, round, with a flat surface, beveled edges, and embossed with 026 on one side.
0.52 mg: The 10 mm tablets are white or off-white, round, biconvex, and debossed with 052 on one side.
1.05 mg: The 10 mm tablets are white or off-white, round, biconvex, and debossed with 105 on one side.
1.57 mg: The 10 mm tablets are white or off-white, round, biconvex, and embossed with 157 on one side.
2.10 mg: The 10 mm tablets are white or off-white, round, biconvex, and debossed with 210 on one side.
2.62 mg: The 10 mm tablets are white off-white, round, biconvex, and debossed with 262 on one side.
3.15 mg: The 11 mm tablets are white or off-white, round, with a flat surface, beveled edges, and embossed with 315 on one side.
0.26 mg, 0.52 mg, 1.05 mg, 2.10 mg and 2.62 mg: Al / OPA-Al-PVC blisters: 10, 30 and 100 prolonged-release tablets .
1.57 mg and 3.15 mg: Al / OPA-Al-PVC blisters: 30 and 100 prolonged-release tablets .
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Ferrer Internacional, SA
Joan Buscallà 1-9
Sant Cugat del Vallès
08173 Barcelona
Spain
Laboratorios Normon SA
Ronda Valdecarrizo 6
Tres Cantos
28760 Madrid
Spanien
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark