0.088 mg; 0.18 mg; 0.35 mg; respectively 0.7 mg tablets
pramipexole
What SIFROL is and what it is used for
SIFROL 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.
SIFROL is used to:
- treat symptoms of Parkinson’s disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson’s disease ).
- treat symptoms of moderate to severe primary restless legs syndrome in adults (ant crawls in the legs).
What you need to know before taking SIFROL
Do not take SIFROL
-if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to a doctor before taking SIFROL. Tell your doctor if you have (have had) or have had any medical 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 SIFROL.
- 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 tachormy), or lateral flexion 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 SIFROL.
- 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.
- Exacerbated symptoms. You may find that the symptoms start earlier than usual, become more intense, and affect other parts of the body.
Tell your doctor if you or your family/caregiver notice 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 the dose one or stop the medication.
Tell your doctor if you or your family / caregiver notice that you are developing mania (feeling upset, excited or overexcited) or delirium (decreased consciousness, confusion or loss of reality). Your doctor may need to adjust the dose one or stop the medication.
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after you have stopped taking or reduced the dose of SIFROL. 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.
Children and young people
SIFROL is not recommended for children and adolescents under 18 years of age.
Other medicines and SIFROL
Tell your doctor or pharmacist if you 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 SIFROL with antipsychotic medicines.
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 AIDS (acquired immune deficiency syndrome), 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 SIFROL.
Be careful when using drugs that have a sedative effect or when consuming alcoholic beverages. In these cases, SIFROL may affect your ability to drive and use machines.
SIFROL with food, drink, and alcohol
Be careful with alcoholic beverages during treatment with SIFROL.
SIFROL can be taken with or without food.
Pregnancy and breastfeeding
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 take SIFROL.
The effect of SIFROL on the unborn baby is unknown. Therefore, you should not take SIFROL if you are pregnant unless your doctor advises you to do so.
SIFROL should not be used during breast-feeding. SIFROL may reduce the production of breast milk. It can also pass to the breast milk and reach your baby. If the use of SIFROL is necessary, breastfeeding should be discontinued.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
SIFROL can cause hallucinations (seeing, hearing, or perceiving things that do not exist). If this happens to you, do not drive or use machines.
SIFROL has been 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.
How to take SIFROL
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.
You can take SIFROL with or without food. The tablets should be swallowed with water.
Parkinson’s disease
The daily dose should always be divided into 3 equal doses.
During the first week, the usual dose of 1 tablet of SIFROL is 0.088 mg three times daily (equivalent to 0.264 mg per day).
| The first week | |
|---|---|
| Number of tablets | 1 tablet SIFROL 0.088 mg3 times daily |
| Total daily dose (mg) | 0.264 |
The dose is increased every 5 to 7 days according to your doctor’s instructions until the symptoms are checked (maintenance dose).
| Second week | Third week | |
|---|---|---|
| Number of tablets | 1 tablet SIFROL 0.18 mg3 times dailyOR2 tablets SIFROL 0.088 mg3 times daily | 1 tablet SIFROL 0.35 mg3 times dailyOR2 tablets SIFROL 0.18 mg3 times daily |
| Total daily dose (mg) | 0.54 | 1.1 |
The usual maintenance dose is 1.1 mg per day. However, your doctor may need to increase the dose one further. If necessary, your doctor may increase your dose up to a maximum of 3.3 mg per day. A lower maintenance dose of 3 0.088 mg SIFROL tablets is also possible.
| Minimum maintenance dose | Maximum maintenance dose | |
|---|---|---|
| Number of tablets | 1 tablet SIFROL 0.088 mg3 times daily | 1 tablet SIFROL 0.7 mg and 1 tablet SIFROL 0.35 mg 3 times daily |
| Total daily dose (mg) | 0.264 | 3.15 |
Patients with kidney disease
If you have moderate or severe kidney disease, your doctor will prescribe a lower dose. In this case, you will take the tablets only once or twice daily. If you have moderate kidney disease, the usual starting dose is 1 tablet of SIFROL 0.088 mg twice daily. In severe kidney disease, the usual starting dose is only 1 tablet of SIFROL 0.088 mg per day.
Restless legs syndrome
Dose one is usually taken once a day, 2-3 hours before bedtime.
During the first week, the usual dose of 1 tablet SIFROL is 0.088 mg once daily (equivalent to 0.088 mg daily):
| The first week | |
|---|---|
| Number of tablets | 1 tablet SIFROL 0.088 mg |
| Total daily dose (mg) | 0.088 |
The dose is increased every 4 to 7 days according to your doctor’s instructions, until the symptoms are checked (maintenance dose).
| Second week | Third week | Fourth week | |
|---|---|---|---|
| Number of tablets | 1 tablet SIFROL 0.18 mgOR2 tablets SIFROL 0.088 mg | 1 tablet SIFROL 0.35 mgOR2 tablets SIFROL 0.18 mgOR4 tablets SIFROL 0.088 mg | 1 tablet SIFROL 0.35 mg and 1 tablet SIFROL 0.18 mgOR3 tablets SIFROL 0.18 mgOR6 tablets SIFROL 0.088 mg |
| Total daily dose (mg) | 0.18 | 0.35 | 0.54 |
The daily dose should not exceed 6 tablets SIFROL 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).
If you stop taking your tablets for more than a few days and want to resume treatment, you will need to start again with the lowest dose. You can then step up dose one again, as you did the first time. Ask your doctor for advice.
Your doctor will evaluate the treatment after 3 months to decide if you should continue with the treatment or not.
Patients with kidney disease:
If you have severe kidney disease, SIFROL may not be a suitable treatment for you.
If you take more SIFROL 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 take SIFROL
Do not worry. Simply skip the current dose one completely and then take the next dose at the right time. Do not try to compensate for missed doses.
If you stop taking SIFROL
Do not stop taking SIFROL 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 treatment with SIFROL abruptly. A sudden interruption can cause you to develop a disease condition called 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 SIFROL 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:
| Name | A number of users affected: |
|---|---|
| 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 |
| Has been reported: | occurs in an unknown number of users |
If you have Parkinson’s disease, you can get the following side effects:
Very common:
- Dyskinesia (eg abnormal involuntary movements of the arms and legs)
- 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 sleepiness during the day and suddenly falling asleep
- Memory loss ( amnesia )
- Hyperkinesia (increased movement and 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
- Altered 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) *
- Delirium (decreased consciousness, confusion, loss of reality)
Rare:
- Mania (feeling upset, elated or overexcited)
Has been reported:
- After discontinuation or reduction of treatment with SIFROL: 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, and he will discuss how to manage or reduce the symptoms.
For side effects marked with *, an exact frequency estimate is not possible as these side effects have not been seen in clinical trials in 2762 patients treated with pramipexole. The frequency is probably not higher than “less common”.
If you have restless legs syndrome, you can get the following side effects:
Very common:
- Nausea
Usual:
- Altered sleep habits, such as insomnia and drowsiness
- Fatigue
- Headache
- Abnormal dreams
- Constipation
- Dizziness
- Vomiting
Uncommon:
- Strong need to behave unusually *
- Heart failure (heart problems that can cause shortness of breath and swollen ankles) *
- Altered secretion of antidiuretic hormone *
- Dyskinesia (eg abnormal, involuntary movements of the arms and legs)
- Hyperkinesia (increased movement and inability to stand still) *
- Paranoia (eg excessive concern for their health) *
- Abnormal perception of reality *
- Memory loss ( amnesia ) *
- Hallucinations (abnormal vision, sound, or sensations)
- Confusion
- Excessive sleepiness during the day and suddenly falling asleep
- Weight gain
- Low blood pressure ( hypotension )
- Excess fluid, usually in the legs (peripheral edema )
- Allergic reactions (eg skin rash, itching , hypersensitivity)
- Fainting
- Restlessness
- Visual impairment
- Weight loss including decreased appetite
- 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 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) *
- Mania (feeling upset, elated, or overexcited) *
- Delirium (decreased consciousness, confusion, loss of reality) *
Has been reported:
- After discontinuation or reduction of treatment with SIFROL: 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, and he will discuss how to manage or reduce the symptoms.
For side effects marked with *, an exact frequency estimate is not possible as these side effects have not been seen in clinical trials in 1395 patients treated with pramipexole. The frequency is probably not higher than “less common”.
How to store SIFROL
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.
Do not store above 30 ° C.
Store in the original package. Sensitive to light.
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 packaging and other information
Content declaration
The active substance is pramipexole.
Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg or 0.7 mg pramipexole as 0.125 mg, 0.25 mg, 0.5 mg and 1 mg pramipexole dihydrochloride monohydrate respectively.
The other ingredients are mannitol, corn starch, anhydrous colloidal silica, povidone K 25, and magnesium stearate.
What the medicine looks like and the contents of the pack
SIFROL 0.088 mg tablets are white, round, flat, and not scored.
SIFROL 0.18 mg tablets and SIFROL 0.35 mg tablets are white, oval and flat. The tablets have a notch on both sides and can be divided into two equal parts.
SIFROL 0.7 mg tablets are white, round and flat. The tablets have a notch on both sides and can be divided into two equal parts.
All tablets are marked with the Boehringer Ingelheim company symbol on one side and the codes P6, P7, P8, or P9 on the other side, which represent the tablet strengths 0.088 mg, 0.18 mg, 0.35 mg, and 0.7 mg respectively.
All strengths of SIFROL are available in aluminum blister cards with 10 tablets in each card, in cartons containing 3 or 10 blister cards (30 or 100 tablets). Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim France
100-104 avenue de France
75013 Paris
France
Contact the representative of the marketing authorization holder to find out more about this medicine:
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