0.18, 0.35 and 0.7 mg pramipexole tablets
1. What Derinik is and what it is used for
Derinik contains the active substance pramipexole and Derinik 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.
Derinik 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 ).
Pramipexole contained in Derinik may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Derinik
Do not use Derinik
– 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 using Derinik.
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 also use levodopa, you may develop dyskinesia during the titration period (habituation period) with Derinik.
- 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 antecollis), forward flexion of the lumbar spine (also known as camptocormia), or lateral flexion 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 suddenly falling asleep
- psychosis (eg comparable to symptoms of schizophrenia).
- visual impairment. Your eyes should be examined regularly during treatment with Derinik.
- 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.
- worsening 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 develop a strong desire or desire to behave in ways that are unusual for you, or if you can not resist the impulse, drive, or temptation to perform certain activities. which may harm you or others. These behaviors are called impaired impulse control and may include gambling addiction, compulsive eating, compulsive buying, an abnormally high sex drive, or an increase in sexual thoughts and feelings. Your doctor may need to adjust your dose or discontinue treatment.
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 get symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping taking or reducing the dose of Derinik. If the problems persist for more than a few weeks, your doctor may need to adjust your treatment.
Children and young people
Derinik is not recommended for children and adolescents under 18 years.
Other medicines and Derinik
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid using Derinik with antipsychotic drugs.
Be careful if you are taking any of the following medicines:
cimetidine (used to treat stomach acid and stomach ulcers ).
amantadine (to treat Parkinson’s disease ).
mexiletine (for the treatment of irregular heartbeat, a condition called ventricular arrhythmia).
zidovudine (can be used to treat acquired immune deficiency syndrome ( AIDS ), a disease of the human immune system).
cisplatin (for the treatment of various types of cancer).
– quinine (can be used to prevent painful nocturnal leg cramps and for the treatment of a type of malaria known as falciparum malaria ( malignant malaria ).
– procainamide (to treat irregular heartbeats).
If you use levodopa should the dose of levodopa is reduced when you start treatment with Derinik.
Be careful when using medicines that have a sedative effect or when drinking alcoholic beverages. In these cases, Derinik may affect your ability to drive and use machines.
Derinik with food, drink, and alcohol
Be careful with alcoholic beverages during treatment with Derinik.
Derinik can be taken with or without food. Swallow the tablet with water.
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 you should continue to use Derinik.
The effect of Derinik on the unborn baby is unknown. Therefore, you should not use Derinik if you are pregnant unless your doctor advises you to do so.
Derinik should not be used during breast-feeding. Derinik can reduce the production of breast milk. It can also pass to breast milk and reach your baby. If the use of Derinik is necessary, breast-feeding should be discontinued.
Driving and using machines
Derinik 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.
Derinik 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 increased 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.
3. How to use Derinik
Always use 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.
Derinik can be taken 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 recommended dose is 1 tablet Derinik 0.088 mg * (or ½ tablet 0.18 mg) three times daily (equivalent to 0.264 mg per day).
| The first week | |
|---|---|
| Number of tablets | 1 tablet Derinik 0.088 mg * 3 times daily (or ½ tablet 0.18 mg 3 times daily) |
| Total daily dose (mg) | 0.264 |
The dose is increased every 5 – 7 days according to your doctor’s instructions until the symptoms are checked (maintenance dose).
| Second week | Third week | |
|---|---|---|
| Number of tablets | 1 tablet Derinik 0.18 mg 3 times dailyor2 tablets Derinik 0.088 mg * 3 times daily | 1 tablet Derinik 0.35 mg 3 times dailyor2 tablets Derinik 0.18 mg 3 times daily |
| Total daily dose (mg) | 0.54 | 1.1 |
The recommended maintenance dose is 1.1 mg per day. However, your doctor may need to increase the dose further. If necessary, your dose can be increased to a maximum of 3.3 mg per day. A lower maintenance dose of 3 tablets Derinik 0.088 mg * (or 1½ tablet 0.18 mg) per day is also possible.
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| Minimum maintenance dose | Maximum maintenance dose | |
|---|---|---|
| Number of tablets | 1 tablet Derinik 0.088 mg * 3 times daily (or ½ tablet Derinik 0.18 mg 3 times daily) | 1 tablet Derinik 1.1 mg * 3 times daily * (or 3 tablets 0.35 mg three times daily) |
| Total daily dose (mg) | 0.264 | 3.3 |
Patients with kidney disease
If you have kidney problems, you will receive a lower dose. In this case, you will take the tablets only once or twice daily. If you have moderate kidney problems, the recommended starting dose is 1 tablet Derinik 0.088 mg * twice daily (or ½ tablet 0.18 mg twice daily). In case of severe kidney problems, the recommended starting dose is only 1 tablet Derinik 0.088 mg * per day (or ½ tablet 0.18 mg per day).
If you use more Derinik then you should
If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine immediately contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
You may experience vomiting, inability to stand still, or any of the other side effects described in section “4. Possible side effects”.
If you forget to use Derinik
Do not worry. Skip the missed dose one whole and take the next dose as usual at the allotted time. Do not take a double dose to make up for a forgotten dose.
If you stop using Derinik
You should not stop using Derinik without talking to your doctor first. If you need to stop treatment, your doctor will reduce the dose gradually. This reduces the risk of side effects.
If you have Parkinson’s disease, do not stop taking Derinik quickly. A sudden interruption can cause you to develop a disease condition called a malignant neuroleptic syndrome, this condition can be serious. The symptoms can be:
- decreased muscle mobility ( akinesia ),
- muscle stiffness,
- fever,
- varying blood pressure,
- increased heart rate ( tachycardia ),
- confusion and decreased level of consciousness (eg coma ).
If you stop taking Derinik or reduce your dose, you may also develop a medical condition called withdrawal syndrome after treatment with a dopamine agonist. Symptoms include depression, lethargy, 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.
4. 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:
If you have Parkinson’s disease, you can get the following side effects:
Very common (may affect more than 1 user in 10):
- Dyskinesia (uncontrolled involuntary movements)
- Somnolence
- Dizziness
- Nausea
Common (may affect up to 1 in 10 people):
- Deviant compulsive behavior
- Hallucinations (seeing, hearing, or feeling things that do not exist)
- Confusion
- Fatigue
- Insomnia
- Fluid retention, usually in the legs (peripheral edema )
- HeadacheLow blood pressure
- 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)
- Delusions
- Excessive daytime sleepiness and sudden drowsinessMemory loss
- 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 or swelling of the ankles) *
- Altered secretion of antidiuretic hormone *
- Restlessness
- Dyspnoea (difficulty breathing)Hiccup
- 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). *
- Delirium (decreased consciousness, confusion, loss of reality)
Rare (may affect up to 1 in 1,000 people):
- Mania (feeling upset, elated, or being overexcited)
Has been reported (occurs in an unknown number of users):
- After discontinuation or reduction of Derinik treatment: 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 side effects marked with *, an exact frequency estimate is not possible, as these side effects have not been observed in clinical trials in 2762 patients treated with pramipexole. The frequency category is probably not higher than “less common”.
If you get Derinik for diseases other than Parkinson’s disease, you can get the following side effects:
Very common (may affect more than 1 user in 10):
- Nausea
Common (may affect up to 1 in 10 people):
- Altered sleep, e.g. insomnia and drowsiness
- Fatigue
- Headache
- Abnormal dreams
- Constipation
- Dizziness
- Vomiting
Uncommon (may affect up to 1 in 100 people):
- Deviant compulsive behavior *
- Heart failure (heart problem which can cause shortness of breath and ankle swelling) *
- Altered secretion of antidiuretic hormone *
- Dyskinesia (uncontrolled involuntary movements)
- Hyperkinesias (increased body movements and inability to stand still) *
- Paranoia (eg excessive concern for their health) *
- Delusions*
- Memory loss *
- Hallucinations (seeing, hearing, or feeling things that do not exist)
- Confusion
- Excessive daytime sleepiness and suddenly falling asleep
- Weight gain
- Low blood pressure
- Fluid retention, usually in the legs (peripheral edema)
- Allergic reactions (eg rash, itching, hypersensitivity)
- Fainting
- Restlessness
- Visual impairment
- Weight loss including decreased appetite
- Dyspnoea (difficulty breathing)
- Hiccup
- 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 (occurs in an unknown number of users):
- After discontinuation or reduction of Derinik treatment: 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 side effects marked with *, an exact frequency estimate is not possible, as these side effects have not been observed in clinical trials in 1395 patients treated with pramipexole. The frequency category is probably not higher than “less common”.
5. How to store Derinik
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.
This medicine does not require any special storage 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.
6. Contents of the packaging and other information
Content declaration
The active substance is pramipexole.
Each tablet contains 0.18 mg, 0.35 mg or 0.7 mg pramipexole (as 0.25 mg, 0.5 mg or 1 mg pramipexole dihydrochloride monohydrate)
The other ingredients are Pregelatinized starch (corn starch 1500), mannitol, microcrystalline cellulose, talc, Povidone (27.0-32.4), and magnesium stearate.
What the medicine looks like and the contents of the pack
0.18 mg
White, round tablets marked with “1” (one) on one side and with a notch on the other side and with the dimensions 6.0 ± 0.1 mm in diameter and 3.0 mm ± 0.2 mm in thickness. The tablets can be divided into two equal parts.
0.35 mg
White, round tablets marked with “2” (two) on one side and with a notch on the other side and with the dimensions 6.0 ± 0.1 mm in diameter and 3.0 mm ± 0.2 mm in thickness. The tablets can be divided into two equal parts.
0.70 mg
White, round tablets marked with “3” (three) on one side and with a notch on the other side and with the dimensions 6.0 ± 0.1 mm in diameter and 3.0 mm ± 0.2 mm in thickness. The tablets can be divided into two equal parts.
Derinik is 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
Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavikurvegur 76-78, IS-220 Hafnarfjordur, Iceland
Manufacturer
Pharmathen SA, Dervenakion 6, 15351, Pallini, Attiki, Greece