PRAMIPEXOLE 0.18MG TABLET

Active substance: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Package leaflet: Information for the user
Pramipexole Ranbaxy 0.18 mg Tablets
Pramipexole Ranbaxy 0.35mg Tablets
Pramipexole Ranbaxy 0.7mg 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.
2.
3.
4.
5.
6.

What Pramipexole Ranbaxy is and what it is used for
What you need to know before you take Pramipexole Ranbaxy
How to take Pramipexole Ranbaxy
Possible side effects
How to store Pramipexole Ranbaxy
Contents of the pack and other information.

1. What Pramipexole Ranbaxy is and what it is used for
Pramipexole Ranbaxy 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 Ranbaxy 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).
 treat the symptoms of moderate to severe primary Restless Legs Syndrome in adults.

2. What you need to know before you take Pramipexole Ranbaxy
Do not take Pramipexole Ranbaxy tablets
 If you are allergic to pramipexole or any of the other ingredients of this medicine (listed
in section 6).

Warnings and precautions
Talk to your doctor before taking Pramipexole Ranbaxy. 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 up titration 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).
Augmentation. You may experience that symptoms start earlier than usual, be more
intense and involve other limbs.

Children and adolescents
Pramipexole Ranbaxy is not recommended for use in children or adolescents under 18 years.
Other medicines and Pramipexole Ranbaxy
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 Ranbaxy 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 types 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 Ranbaxy.

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 Ranbaxy may affect your ability to
drive and operate machinery.
Pramipexole Ranbaxy with food, drink and alcohol
You should be cautious while drinking alcohol during treatment with Pramipexole Ranbaxy.
Pramipexole Ranbaxy 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 Ranbaxy.
The effect of Pramipexole Ranbaxy on the unborn child is not known. Therefore, do not take
Pramipexole Ranbaxy if you are pregnant unless your doctor tells you to do so.
Pramipexole Ranbaxy should not be used during breast-feeding. Pramipexole Ranbaxy can
reduce the production of breast milk. Also, it can pass into the breast milk and can reach your
baby. If use of Pramipexole Ranbaxy is unavoidable, breast-feeding should be stopped.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Pramipexole Ranbaxy can cause hallucinations (seeing, hearing or feeling things that are not
there). If affected, do not drive or use machines.
Pramipexole Ranbaxy 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 Ranbaxy

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 Ranbaxy 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 0.088 mg three times a day
(equivalent to 0.264 mg daily).

Number of tablets
Total daily dose (mg)

1st week
1 tablet Pramipexole 0.088 mg 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

Total daily dose (mg)

2nd week
1 tablet Pramipexole
Ranbaxy 0.18 mg three
times a day
OR
2 tablets Pramipexole
0.088 mg three times a day
0.54

3rd week
1 tablet Pramipexole
Ranbaxy 0.35 mg three
times a day
OR
2 tablets Pramipexole
Ranbaxy 0.18 mg three
times a day
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.

Number of tablets
Total daily dose (mg)

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

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

Patients with renal impairment:
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.
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 0.088 mg once a day (equivalent
to 0.088 mg daily):

Number of tablets
Total daily dose (mg)

1st week
1 tablet pramipexole 0.088 mg
0.088

This will be increased every 4-7 days as directed by your doctor until your symptoms are controlled
(maintenance dose).

Number of
tablets

2nd week
1 tablet Pramipexole
Ranbaxy 0.18 mg
OR
2 tablets pramipexole
0.088 mg

3rd week
1 tablet Pramipexole
Ranbaxy 0.35 mg
OR
2 tablets Pramipexole
Ranbaxy 0.18 mg
OR
4 tablets pramipexole

4th week
1 tablet Pramipexole
Ranbaxy 0.35 mg and
1 tablet Pramipexole
Ranbaxy 0.18 mg
OR
3 tablets Pramipexole
Ranbaxy 0.18 mg

0.088 mg

Total daily
dose (mg)

0.18

0.35

OR
6 tablets pramipexole
0.088 mg
0.54

The daily dose should not exceed 6 tablets pramipexole 0.088 mg or a dose of 0.54 mg (0.75
mg 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 Ranbaxy may not be a suitable treatment for
you.
If you take more Pramipexole Ranbaxy than you should
If you accidentally take 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 Ranbaxy
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 Ranbaxy
Do not stop taking Pramipexole Ranbaxy 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.
Evaluation of these side effects is based on the following frequencies:
If you suffer from Parkinson’s disease, you may experience the following side effects:
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 impairment
 Vomiting (being sick)
 Weight loss including decreased appetite.
Uncommon (may affect up to 1 in 10 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)*
 Increased eating (binge eating, hyperphagia)*
 Inappropriate antidiuretic hormone secretion*
 Restlessness
 Compulsive shopping
 Dyspnoea (difficulties to breathe)
 Hiccups
 Pneumonia (infection of the lungs)

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)
 Nausea (sickness)
Common (may affect up to 1 in 10 people)
 Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness
 Tiredness (fatigue)
 Headache
 Abnormal dreams
 Constipation
 Dizziness
 Vomiting (being sick).
Uncommon (may affect up to 1 in 100 people)
 Pathological gambling, especially when taking high doses of pramipexole *
 Hypersexuality*
 Compulsive shopping*
 Urge to behave in an unusual way*
 Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*
 Increased eating (binge eating, hyperphagia)*
 Inappropriate antidiuretic hormone secretion*
 Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)
 Hyperkinesia (increased movements and inability to keep still)*
 Paranoia (e.g. excessive fear for one’s own well-being)*
 Delusion*
 Amnesia (memory disturbance)*
 Hallucinations (seeing, hearing or feeling things that are not there)
 Confusion
 Excessive daytime sleepiness and suddenly falling asleep
 Weight increase
 Increased sexual desire (e.g. increased libido)
 Hypotension (low blood pressure)
 Excess of fluid, usually in the legs (peripheral oedema)
 Allergic reactions (e.g. rash, itching, hypersensitivity)
 Fainting
 Restlessness
 Visual impairment
 Weight loss including decreased appetite
 Dyspnoea (difficulties to breathe)
 Hiccups
 Pneumonia (infection of the lungs)*.

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”.
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 RANBAXY TABLETS



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 {Exp.}. The
expiry date refers to the last day of that month.



Store in the original package in order to protect from light.



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 Ranbaxy tablet contains
 The active substance is pramipexole dihydrochloride monohydrate.
 The other ingredients are Mannitol, maize starch, silica colloidal anhydrous, povidone,
magnesium stearate

What Pramipexole Ranbaxy tablets look like and contents of the pack
 Pramipexole Ranbaxy 0.18 mg tablets are white, oblong, 9 mm x 4.5 mm, uncoated
tablets with score line on one side.
 Pramipexole Ranbaxy 0.35 mg tablets are white, circular, 9.5 mm diameter, uncoated
tablets with score line on one side and embossed with “PM” in the both halves in one side
and the other side plain.
 Pramipexole Ranbaxy 0.7 mg tablets are white, circular, 9.5 mm diameter, uncoated
tablets with score line on one side and embossed with “PA” in the both halves in one side
and the other side plain.
Pramipexole Ranbaxy tablets are available in blister packs of 30 and 100 tablets. Not all pack
sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ranbaxy (UK) Limited, Building 4, Chiswick Park, 566 Chiswick High Road, London, W4 5YE
United Kingdom

Manufacturer
Ranbaxy Ireland Limited
Spafield, Cork Road, Cashel, Co-Tipperary, Ireland
Terapia S.A.,124 Fabricii Street, 400 632 Cluj Napoca, Romania
Ranbaxy Pharmacie Génériques
11-15, quai de Dion Bouton, 92800 Puteaux, France
Basics GmbH
Hemmelrather Weg 201, D-51377 Leverkusen, Germany

This leaflet was last approved in January/2013.

Expand view ⇕

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.

Hide
(web1)