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PRAMIPEXOLE 1.1 MG TABLETS
Pramipexole 0.088mg tablets
Pramipexole 0.18mg tablets
Pramipexole 0.35mg tablets
Pramipexole 0.7mg tablets
Pramipexole 1.1mg tablets
Read all of this leaﬂet carefully before you start taking
- 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
- If any of the side eﬀects gets serious, or if you notice any side
eﬀects not listed in this leaﬂet, please tell your doctor
In this leaﬂet:
1.What Pramipexole is and what it is used for
2.Before you take Pramipexole
3.How to take Pramipexole
4.Possible side eﬀects
5.How to store Pramipexole
1. WHAT PRAMIPEXOLE IS AND WHAT IT IS USED FOR
Pramipexole tablets belong 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. It can be used alone or in combination with levodopa
(another medicine for Parkinson's disease).
2. BEFORE YOU TAKE PRAMIPEXOLE
DO NOT take Pramipexole
- if you are allergic (hypersensitive) to pramipexole or any of the
other ingredients of the tablets (See Section 6, “Further
Take special care with 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.
- abnormal, uncontrolled movements of the limbs (dyskinesia)
If you have advanced Parkinson’s disease and are also taking
levodopa, you might develop dyskinesia during the uptitration
- sleepiness and episodes of suddenly falling asleep
- behavioural changes (e. g. pathological gambling, compulsive
shopping), increased libido (e.g. increased sexual desire),
- psychosis, (e.g. comparable with symptoms of schizophrenia)
- vision impairment
You should have regular eye examinations during treatment
- 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)
Children and adolescents
Pramipexole is not recommended for use in children or adolescents
under 18 years.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken 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
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
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.
Taking Pramipexole with food and drink
You should be cautious while drinking alcohol during treatment
Pramipexole can be taken with or without food. Swallow the tablets
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you might be pregnant or
if you intend to become pregnant. 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
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 Pramipexole exactly as your doctor has told you.
The doctor will advise you on the right dosing.
You can take Pramipexole with or without food. Swallow the tablets
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):
Number of tablets
Total daily dose (mg)
1 tablet Pramipexole 0.088mg three times a day
This will be increased every 5 - 7 days as directed by your doctor until
your symptoms are controlled (maintenance dose).
1 tablet Pramipexole 0.18mg
three times a day
2 tablets Pramipexole 0.088mg
three times a day
1 tablet Pramipexole 0.35mg
three times a day
2 tablets Pramipexole 0.18mg
three times a day
The usual maintenance dose is 1.1mg 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 3.3mg of pramipexole
a day. A lower maintenance dose of three Pramipexole 0.088mg
tablets a day is also possible.
Lowest maintenance dose
1 tablet Pramipexole 0.088mg
three times a day
Highest maintenance dose
1 tablet Pramipexole 1.1mg
three times a day
Patients with kidney diseases:
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 chapter 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
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:
- loss of muscle movement (akinesia)
- rigid muscles
- unstable blood pressure
- increased heart rate (tachycardia)
- depressed level of consciousness (e.g. coma)
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pramipexole 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 (aﬀects more than 1 user in 10):
- Abnormal, uncontrolled movements of the limbs (dyskinesia)
- Sickness (nausea)
- Low blood pressure (hypotension)
Common (aﬀects 1 to 10 users in 100):
- Urge to behave in an unusual way
- Hallucinations (seeing, hearing or feeling things that are
- Tiredness (fatigue)
- Sleeplessness (insomnia)
- Excess of ﬂuid, usually in the legs (peripheral oedema)
- Abnormal dreams
- Memory disturbance (amnesia)
- Visual disturbance
- Vomiting (being sick)
- Weight loss
Uncommon (aﬀects 1 to 10 users in 1,000):
- Excessive fear for one’s own well-being (paranoia)
- Excessive daytime sleepiness and suddenly falling asleep
- Increased movements and inability to keep still (hyperkinesia)
- Weight increase
- Increased sexual desire (e.g. increased libido)
- Allergic reactions (e.g. rash, itching, hypersensitivity)
- Pathological gambling, especially when taking high doses
- Compulsive shopping
- Diﬃculties to breathe (dyspnoea)
- Infections of the lungs (pneumonia)
- Increased eating (binge eating, hyperphagia)
If any of the side eﬀects gets serious, or if you notice any
side eﬀects not listed in this leaﬂet, please tell your doctor
5. HOW TO STORE PRAMIPEXOLE
Keep out of the reach and sight of children.
Do not take Pramipexole after the expiry date, which is stated on the
pack. The expiry date refers to the last day of that month.
This medicinal product does not require any special
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. FURTHER INFORMATION
What Pramipexole contains
- The active substance is pramipexole.
For 0.088mg: Each Pramipexole 0.088mg tablet contains
0.088mg of pramipexole base (as 0.125mg of pramipexole
For 0.18mg: Each Pramipexole 0.18mg tablet contains
0.18mg of pramipexole base (as 0.25mg of pramipexole
For 0.35mg: Each Pramipexole 0.35mg tablet contains
0.35mg of pramipexole base (as 0.5 mg of pramipexole
For 0.70mg: Each Pramipexole 0.7 mg tablet contains
0.7 mg of pramipexole base (as 1.0 mg of pramipexole
For 1.1mg: Each Pramipexole 1.1mg tablet contains
1.1mg of pramipexole base (as 1.5 mg of pramipexole
- The other ingredients are Starch, pregelatinised (Starch maize
1500), Mannitol, Cellulose, microcrystalline, Povidone (27.0-32.4),
Talc and Magnesium stearate.
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
1.1mg White, round tablets, marked on one side
with a “4” (four), 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
6, Dervenakion str.,
15351 Pallini Attiki, Greece
Pharmathen S.A. Dervenakion 6, 15351, Pallini, Attiki , Greece
Aspire Pharma Ltd.
Antrobus House Business Centre,
18 College Street,
Hants, GU31 4AD,
This leaﬂet was last approved in 08/2010