PRAMIPEXOLE 1.1 MG TABLETS

Active substance: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Pramipexole 0.088mg tablets
Pramipexole 0.18mg tablets
Pramipexole 0.35mg tablets
Pramipexole 0.7mg tablets
Pramipexole 1.1mg tablets
Pramipexole
Read all of this leaflet carefully before you start taking
this medicine.
- 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
as yours.
- If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor
or pharmacist.
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
6.Further information
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
information”).
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
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)
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
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)
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
with Pramipexole.
Pramipexole can be taken with or without food. Swallow the tablets
with water.
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
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 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
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):

Number of tablets
Total daily dose (mg)

1st week
1 tablet Pramipexole 0.088mg three times a day
0.264

This will be increased every 5 - 7 days as directed by your doctor until
your symptoms are controlled (maintenance dose).

Number of
tablets

2nd week
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
1 tablet Pramipexole 0.35mg
three times a day
OR
2 tablets Pramipexole 0.18mg
three times a day
1.1

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.

Number of
tablets
Total daily
dose (mg)

Lowest maintenance dose
1 tablet Pramipexole 0.088mg
three times a day
0.264

Highest maintenance dose
1 tablet Pramipexole 1.1mg
three times a day
3.3

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
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:
- loss of muscle movement (akinesia)
- rigid muscles
- fever
- unstable blood pressure
- increased heart rate (tachycardia)
- confusion
- 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)
- Sleepiness
- Dizziness
- 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
not there)
- Confusion
- Tiredness (fatigue)
- Sleeplessness (insomnia)
- Excess of fluid, usually in the legs (peripheral oedema)
- Headache
- Abnormal dreams
- Constipation
- Restlessness
- 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)
- Delusion
- 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)
- Fainting
- Pathological gambling, especially when taking high doses
of Pramipexole
- Hypersexuality
- Compulsive shopping
- Difficulties to breathe (dyspnoea)
- Infections of the lungs (pneumonia)
Unknown frequency:
- 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
or pharmacist.
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
storage conditions.
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
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 0.5 mg of pramipexole
dihydrochloride monohydrate).
For 0.70mg: Each Pramipexole 0.7 mg tablet contains
0.7 mg of pramipexole base (as 1.0 mg of pramipexole
dihydrochloride monohydrate).
For 1.1mg: Each Pramipexole 1.1mg tablet contains
1.1mg of pramipexole base (as 1.5 mg of pramipexole
dihydrochloride monohydrate).
- 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
Pharmathen S.A.
6, Dervenakion str.,
15351 Pallini Attiki, Greece
Manufacturer
Pharmathen S.A. Dervenakion 6, 15351, Pallini, Attiki , Greece
Distributor
Aspire Pharma Ltd.
Antrobus House Business Centre,
18 College Street,
Petersfield,
Hants, GU31 4AD,
U.K.
This leaflet was last approved in 08/2010
1010040-P2

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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