0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg, 1.1 mg tablets
pramipexole
What Pramipexole Accord is and what it is used for
Pramipexole Accord 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 Accord 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 ).
What you need to know before using Pramipexole Accord
Do not take Pramipexole Accord
- 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 Accord. 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 Accord. - 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). If this happens, your doctor may want to change your medication.
- drowsiness and episodes of sudden drowsiness
- psychosis (eg comparable to symptoms of schizophrenia).
- visual disturbance
Your eyes should be examined regularly during treatment with Pramipexole Accord. - severe cardiovascular disease
You will need to have your blood pressure checked regularly, especially at the beginning of treatment. The reason is that you want to avoid a drop in blood pressure when you stand up. - Augmentation. You may notice that signs of illness appear earlier than usual, are more intense, and affect other body parts.
Tell a 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 urge, 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 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 a Pramipexole Accord. If the problems persist for more than a few weeks, your doctor may need to adjust your treatment.
Children and young people
Pramipexole Accord is not recommended for children and adolescents under 18 years of age.
Other medicines and Pramipexole Accord
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 Accord 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 Accord. Be careful when using drugs that have a sedative effect or when consuming alcoholic beverages. In these cases, Pramipexole Accord may affect your ability to drive and use machines.
Pramipexole Accord with food, drink, and alcohol
Be careful with alcoholic beverages during treatment with Pramipexole Accord. Pramipexole Accord 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 Pramipexole Accord.
The effect of the Pramipexole Accord on the unborn baby is unknown. Therefore, you should not take Pramipexole Accord if you are pregnant unless your doctor advises you to do so.
Pramipexole Accord should not be used during breastfeeding. Pramipexole Accord may reduce breast milk production. It can also pass to the breast milk and reach your baby. If the use of Pramipexole Accord is necessary, breastfeeding should be discontinued.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Pramipexole Accord 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.
Pramipexole Accord 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.
How to take Pramipexole Accord
Use for children and adolescents
Always take Pramipexole Accord exactly as your doctor has told you. Consult a doctor if you are unsure. Your doctor will inform you about the correct dosage.
Pramipexole Accord 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 usual dose is 1 tablet of Pramipexole Accord 0.088 mg three times daily (equivalent to 0.264 mg per day).
| The first week | |
| Number of tablets | 1 Pramipexole Accord tablet 0.088 mg 3 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 Pramipexole Accord tablet 0.18 mg 3 times daily or 2 Pramipexole Accord tablets 0.088 mg 3 times daily | 1 Pramipexole Accord tablet 0.35 mg 3 times daily or 2 Pramipexole Accord tablets 0.18 mg 3 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 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 Pramipexole Accord tablets 0.088 mg is also possible.
| Minimum maintenance dose | Maximum maintenance dose | |
| Number of tablets | 1 Pramipexole Accord tablet 0.088 mg 3 times daily | 1 Pramipexole Accord tablet 1.1 mg 3 times daily |
| Total daily dose (mg) | 0.264 | 3.3 |
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 Pramipexole Accord tablet 0.088 mg twice daily. In severe kidney disease, the usual starting dose is only 1 Pramipexole Accord tablet 0.088 mg per day.
If you use more Pramipexole Accord 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 Pramipexole Accord
Do not worry. Simply skip the current dose completely and then take the next dose at the right time. Do not try to compensate for a missed dose.
If you stop taking Pramipexole Accord
Do not stop taking Pramipexole Accord 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 Accord 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 have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Pramipexole Accord can cause side effects, although not everybody gets them. Evaluation of these side effects is based on the following frequencies:
| 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: | may affect up to 1 in 1,000 users |
| Very rare: | may affect up to 1 in 10,000 users |
| No known frequency | can not be calculated from available data |
If you have Parkinson’s disease, you can get the following side effects:
Very common:
- Dyskinesia (abnormal involuntary movements)
- 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 daytime sleepiness and sudden drowsiness
- 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) *
- Increased food intake (binge eating, voracious eating behavior) *
- 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.
- Changed or increased sexual interest and behavior of significant problems for 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)
No known frequency:
- After discontinuation or reduction of treatment with Pramipexole Accord: 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 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”.
If you have any other indication, you may experience 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) *
- Inappropriate secretion of antidiuretic hormone
- Dyskinesia (abnormal involuntary movements)
- Hyperkinesia (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 daytime sleepiness and sudden drowsiness
- Weight gain
- Increased sexual drive (eg increased libido )
- Low blood pressure ( hypotension )
- Excess fluid, 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 ( 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 problems for 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 being overexcited) *
- Delirium (decreased consciousness, confusion, loss of reality) *
No known frequency:
- After discontinuation or reduction of treatment with Pramipexole Accord: 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 adverse reactions marked with *, an exact frequency estimate is not possible as the adverse reaction did not occur in the clinical database which included 1395 patients with other indications treated with pramipexole. The frequency is probably not higher than “less common”.
How to store Pramipexole Accord
Keep out of 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 pack and other information
Content declaration
The active ingredient is pramipexole.
Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.
Each tablet contains 0.25 mg of pramipexole dihydrochloride monohydrate equivalent to 0.18 mg of pramipexole.
Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole.
Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.1 mg pramipexole.
The other ingredients are mannitol, microcrystalline cellulose, corn starch, anhydrous colloidal silica, povidone K 30, and magnesium stearate.
What the medicine looks like and the contents of the pack
Pramipexole Accord 0.088 mg tablets are white to off-white, round, flat, slanted, and have “I1” imprinted on one side and are smooth on the other side.
Pramipexole Accord 0.18 mg tablets are white to off-white, round, flat, slanted, and have “I” and “2” imprinted on each side of the breaker on one side and a breaker on the other side.
Pramipexole Accord 0.35 mg tablets are white to off-white, round, flat, slanted, and have “I” and “3” imprinted on each side of the breaker on one side and a breaker on the other side.
Pramipexole Accord 0.7 mg tablets are white to off-white, round, flat, slanted, and have “I” and “4” imprinted on each side of the breaker on one side and a breaker on the other side.
Pramipexole Accord 1.1 mg tablets are white to off-white, round, flat, slanted, and have “I” and “5” imprinted on each side of the breaker on one side and a breaker on the other side.
All strengths of Pramipexole Accord tablets are available in alu-all blisters of 10 tablets per card in cartons containing 3 or 10 blister cartons (30 or 100 tablets).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s / n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF,
UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare BV,
Winthontlaan 200,
3526 VK Utrecht,
Netherlands