Active ingredient
- pramipexole dihydrochloride monohydrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL17277/0048 .
Pramipexole 0.088mg tablets, Pramipexole 0.18mg tablets, Pramipexole 0.35mg tablets, Pramipexole 0.7mg tablets
Package Leaflet: Information for the user
Pramipexole 0.088mg tablets
Pramipexole 0.18mg tablets
Pramipexole 0.35mg tablets
Pramipexole 0.7mg tablets
Pramipexole
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Pramipexole is and what it is used for
2. What you need to know before you take Pramipexole
3. How to take Pramipexole
4. Possible side effects
5. How to store Pramipexole
6. Contents of the pack and other information
1. What Pramipexole is and what it is used for
This medicine contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists which stimulate dopamine receptors in the brain. Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.
Pramipexole is used to:
2. What you need to know before you take Pramipexole
Do not take this medicine:
Warnings and precautions
Talk to your doctor before taking Pramipexole. Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:
Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.
Tell your doctor if you or your family/carer notices that you are developing mania (agitation, feeling elated or over-excited) or delirium (decreased awareness, confusion, loss of reality). Your doctor may need to adjust or stop your dose.
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your Pramipexole treatment. If the problems persist more than a few weeks, your doctor may need to adjust your treatment.
Children and adolescents
Pramipexole is not recommended for use in children or adolescents under 18 years.
Other medicines and Pramipexole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.
You should avoid taking pramipexole together with antipsychotic medicines.
Take care if you are taking the following medicines:
If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with Pramipexole.
Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol. In these cases Pramipexole may affect your ability to drive and operate machinery.
Pramipexole with food, drink and alcohol
You should be cautious while drinking alcohol during treatment with Pramipexole.
Pramipexole can be taken with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will then discuss with you if you should continue to take Pramipexole.
The effect of Pramipexole on the unborn child is not known. Therefore, do not take Pramipexole if you are pregnant unless your doctor tells you to do so.
Pramipexole should not be used during breast-feeding. Pramipexole can reduce the production of breast milk. Also, it can pass into the breast milk and can reach your baby. If use of Pramipexole is unavoidable, breast-feeding should be stopped.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Pramipexole can cause hallucinations (seeing, hearing or feeling things that are not there). If affected, do not drive or use machines.
Pramipexole has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson’s disease. If you experience these side effects, you must not drive or operate machinery. You should tell your doctor if this occurs.
3. How to take Pramipexole
Always take this medicine exactly as your doctor has told you.
Check with your doctor if you are not sure. The doctor will advise you on the right dosing.
You can take Pramipexole with or without food. Swallow the tablets with water.
Parkinson’s disease
The daily dose is to be taken divided into 3 equal doses.
During the first week, the usual dose is 1 tablet Pramipexole 0.088mg three times a day (equivalent to 0.264mg daily):
1st week
Number of tablets: 1 tablet Pramipexole 0.088mg three times a day
Total daily dose (mg): 0.264
This will be increased every 5 - 7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
2nd week
Number of tablets: 1 tablet Pramipexole 0.18mg three times a day OR 2 tablets Pramipexole 0.088mg three times a day
Total daily dose (mg): 0.54
3rd week
Number of tablets: 1 tablet Pramipexole 0.35mg three times a day OR 2 tablets Pramipexole 0.18mg three times a day
Total daily dose (mg): 1.1
The usual maintenance dose is 1.1mg per day. However, your dose may have to be increased further. If necessary, your doctor may increase your dose up to a maximum of 3.3mg of Pramipexole a day. A lower maintenance dose of three Pramipexole 0.088mg tablets a day is also possible.
Lowest maintenance dose
Number of tablets: 1 tablet Pramipexole 0.088mg three times a day.
Total daily dose (mg): 0.264
Highest maintenance dose
Number of tablets: 1 tablet Pramipexole 1.1mg three times a day.
Total daily dose (mg): 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 have to take the tablets only once or twice a day. If you have moderate kidney disease, the usual starting dose is 1 tablet Pramipexole 0.088mg twice a day.
In severe kidney disease, the usual starting dose is just 1 tablet Pramipexole 0.088mg a day.
Restless Legs Syndrome
The dose is usually taken once a day, in the evening, 2-3 hours before bedtime.
During the first week, the usual dose is 1 tablet Pramipexole 0.088mg once a day (equivalent to 0.088mg daily):
1st week
Number of tablets: 1 tablet Pramipexole 0.088mg
Total daily dose (mg): 0.088
This will be increased every 4 - 7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
2nd week
Number of tablets: 1 tablet Pramipexole 0.18mg OR 2 tablets Pramipexole 0.088mg
Total daily dose (mg): 0.18
3rd week
Number of tablets: 1 tablet Pramipexole 0.35mg OR 2 tablets Pramipexole 0.18mg OR 4 tablets Pramipexole 0.088mg
Total daily dose (mg): 0.35
4th week
Number of tablets: 1 tablet Pramipexole 0.35mg and 1 tablet Pramipexole 0.18mg OR 3 tablets Pramipexole 0.18mg OR 6 tablets Pramipexole 0.088mg
Total daily dose (mg): 0.54
The daily dose should not exceed 6 tablets Pramipexole 0.088mg or a dose of 0.54mg (0.75mg pramipexole salt).
If you stop taking your tablets for more than a few days and want to restart the treatment, you must start again at the lowest dose. You can then build up the dose again, as you did the first time. Ask your doctor for advice.
Your doctor will review your treatment after 3 months to decide whether or not to continue the treatment.
Patients with kidney disease:
If you have severe kidney disease, Pramipexole may not be a suitable treatment for you.
Parkinson's disease and Restless Legs Syndrome
If you take more Pramipexole than you should
If you accidentally take too many tablets,
If you forget to take Pramipexole
Do not worry. Simply leave out that dose completely and then take your next dose at the right time. Do not try to make up for the missed dose.
If you stop taking Pramipexole
Do not stop taking Pramipexole without first talking to your doctor.
If you have to stop taking this medicine, your doctor will reduce the dose gradually. This reduces the risk of worsening symptoms.
If you suffer from Parkinson’s disease you should not stop treatment with Pramipexole abruptly. A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk. The symptoms include:
If you stop or reduce Pramipexole you may also develop a medical condition called dopamine agonist withdrawal syndrome. The symptoms include depression, apathy, anxiety, fatigue, sweating or pain. If you experience these symptoms you should contact your physician.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop taking Pramipexole if you experience swelling of the face, lips, tongue or throat and difficulty breathing, as these may be signs of a serious allergic reaction.
If you suffer from Parkinson’s disease, you may experience the following side effects:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Not known (frequency cannot be estimated from the available data):
Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 2,762 patients treated with pramipexole. The frequency category is probably not greater than ‘uncommon’.
If you suffer from Restless Legs Syndrome, you may experience the following side effects:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Not known (frequency cannot be estimated from the available data):
For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 1,395 patients treated with pramipexole. The frequency category is probably not greater than “uncommon”.
You may experience the inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store).
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Pramipexole
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 expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. Contents of the pack and other information
What this medicine contains
For 0.088mg:
Each Pramipexole 0.088mg tablet contains 0.088mg of pramipexole base (as 0.125mg of pramipexole dihydrochloride monohydrate).
For 0.18mg:
Each Pramipexole 0.18mg tablet contains 0.18mg of pramipexole base (as 0.25mg of pramipexole dihydrochloride monohydrate).
For 0.35mg:
Each Pramipexole 0.35mg tablet contains 0.35mg of pramipexole base (as 0.5mg of pramipexole dihydrochloride monohydrate).
For 0.7mg:
Each Pramipexole 0.7mg tablet contains 0.7mg of pramipexole base (as 1.0mg of pramipexole dihydrochloride monohydrate).
What Pramipexole looks like and contents of the pack
0.088mg White, round tablets, marked on one side with a ‘0’ (zero).
0.18mg White, round tablets, marked on one side with a ‘1’ (one), scored on the other side.
0.35mg White, round tablets, marked on one side with a ‘2’ (two), scored on the other side.
0.70mg White, round tablets, marked on one side with a ‘3’ (three), scored on the other side.
Pramipexole is available in aluminium/aluminium blister strips of 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Distributor
This leaflet was last revised in 04/2020
1010040-P11.2
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
+44 (0)1730 231148
+44 (0)1730 231148