Pramipexole 0.35 Mg Tablets
Package leaflet: Information for the user
Pramipexole 0.088 mg tablets Pramipexole 0.18 mg tablets Pramipexole 0.35 mg tablets Pramipexole 0.7 mg tablets
Pramipexole
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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
Pramipexole 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 treat the symptoms of primary Parkinson’s disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson’s disease).
2. What you need to know before you take Pramipexole Do not take Pramipexole
• if you are allergic (hypersensitive) to pramipexole or to any of the other ingredients of this medicine (listed in section 6).
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:
- kidney disease.
- hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visual.
- dyskinesia (e.g. abnormal, uncontrolled movements of the limbs). If you have advanced Parkinson’s disease and are also taking levodopa, you might develop dyskinesia during the uptitration of Pramipexole.
- sleepiness and episodes of suddenly falling asleep.
- behavioural changes (e. g. pathological gambling, compulsive shopping), increased libido (e.g. increased sexual desire), binge eating.
- psychosis, (e.g. comparable with symptoms of schizophrenia).
- vision impairment.
You should have regular eye examinations during treatment with Pramipexole.
- severe heart or blood vessels disease.
You will need to have your blood pressure checked regularly, especially at the beginning of treatment. This is to avoid postural hypotension (a fall in blood pressure on standing up).
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 an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.
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.
You should avoid taking Pramipexole together with antipsychotic medicines.
Take care if you are taking the following medicines:
- cimetidine (to treat excess stomach acid and stomach ulcers)
- amantadine (which can be used to treat Parkinson’s disease)
- mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia)
- zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system)
- cisplatin (to treat various type of cancers)
- quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria))
- procainamide (to treat irregular heart beat)
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. The tablets should be taken with water.
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 or pharmacist 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, breastfeeding 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 a glass of water. Tablets with scored line can be divided for ease of swallowing but not to divide into equal doses.
Parkinson’s disease
The daily dose is to be taken divided into 3 equal doses.
During the first week, the usual dose is one Pramipexole 0.088 mg tablet three times a day (a daily dose of 0.264 mg).
|
1st week | |
|
Number of tablets |
1 tablet Pramipexole 0.088 mg 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 |
3rd week | |
|
Number of tablets |
1 tablet Pramipexole 0.18 mg three times a day OR 2 tablets Pramipexole 0.088 mg three times a day |
1 tablet Pramipexole 0.35 mg three times a day OR 2 tablets Pramipexole 0.18 mg three times a day |
|
Total daily dose (mg) |
0.54 |
1.1 |
The usual maintenance dose is 1.1 mg per day. However, your dose may have to be increased even further. If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of pramipexole a day. A lower maintenance dose of three Pramipexole 0.088 mg tablets a day is also possible.
|
Lowest maintenance dose |
Highest maintenance dose | |
|
Number of tablets |
1 tablet Pramipexole 0.088 mg three times a day |
1.1 mg of Pramipexole three times a day |
|
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 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 0.088 mg twice a day. In severe kidney disease, the usual starting dose is just 1 tablet Pramipexole 0.088 mg a day.
If you take more Pramipexole than you should
If you accidentally took too many tablets
- contact your doctor or nearest hospital casualty department immediately for advice.
- you may experience vomiting, restlessness, or any of the side effects as described in section 4 (Possible side effects).
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:
- akinesia (loss of muscle movement)
- rigid muscles
- fever
- unstable blood pressure
- tachycardia (increased heart rate)
- confusion
- depressed level of consciousness (e.g. coma)
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.
You may experience the following side effects:
• inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
- Strong impulse to gamble excessively despite serious personal or family consequences.
- Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
- Uncontrollable excessive shopping or spending
- binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms
Very common: may affect more than 1 in 10 people
- Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)
- Sleepiness
- Dizziness
- Nausea (sickness)
Common: may affect up to 1 in 10 people
- Urge to behave in an unusual way
- Hallucinations (seeing, hearing or feeling things that are not there)
- Confusion
- Tiredness (fatigue)
- Sleeplessness (insomnia)
- Excess of fluid, usually in the legs (peripheral oedema)
- Headache
- Hypotension (low blood pressure)
- Abnormal dreams
- Constipation
- Visual disturbance
- Vomiting (being sick)
- Weight loss including decreased appetite
Uncommon: may affect up to 1 in 100 people
- Paranoia (e.g. excessive fear for one’s own well-being)
- Delusion
- Excessive daytime sleepiness and suddenly falling asleep
- Amnesia (memory disturbance)
- Hyperkinesia (increased movements and inability to keep still)
- Weight increase
- Increased sexual desire (e.g. increased libido)
- Allergic reactions (e.g. rash, itching, hypersensitivity)
- Fainting
- Pathological gambling, especially when taking high doses of Pramipexole
- Hypersexuality
- Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*
- Restlessness
- Compulsive shopping
- Dyspnoea (difficulties to breathe)
- Hiccups
- Pneumonia (infection of the lungs)
- Increased eating (binge eating, hyperphagia)*
- Inappropriate antidiuretic hormone secretion*
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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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 blister and the carton after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
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 Pramipexole contains
- The active substance is pramipexole. Pramipexole 0.088 mg tablets contain 0.088 mg of pramipexole (as 0.125 mg of pramipexole dihydrochloride monohydrate).Pramipexole 0.18 mg tablets contain 0.18 mg of pramipexole (as 0.25 mg of pramipexole dihydrochloride monohydrate).Pramipexole 0.35 mg tablets contain 0.35 mg of pramipexole (as 0.5 mg of pramipexole dihydrochloride monohydrate).Pramipexole 0.7 mg tablets contain 0.7 mg of pramipexole (as 1.0 mg of pramipexole dihydrochloride monohydrate).
- The other ingredients are: mannitol (E 421), maize starch, povidone K29/32, pregelatinised maize starch, silica, colloidal anhydrous, magnesium stearate.
What Pramipexole looks like and contents of the pack
Pramipexole 0.088 mg tablets are round, white, 6 mm diameter, no score, marked with PX on one side.
Pramipexole 0.18 mg tablets are oval, white, 8 x 5.7 mm, scores on both sides, marked with PX02 on one side._The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Pramipexole 0.35 mg tablets are oval, white, 10.8 x 7.7 mm, scores on both sides, marked with PX05 on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Pramipexole 0.7 mg tablets are round, white, 9 mm diameter, scores on both sides, marked with PX10 on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Pack sizes:
OPA-AL-PVC/AL blister 30 and 100 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Aptil Pharma Limited
9th Floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL
Manufacturer
Actavis Limited
Bulebel Industrial Estate, Zejtun, Malta
This leaflet was last revised in 01/2013.
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