PRAMIPEXOLE 0.35MG 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 Parkinsons 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 Parkinsons 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 Parkinsons 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 Parkinsons 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). 1st week 1 tablet Pramipexole 0.088 mg three times a day 0.264
Number of tablets Total daily dose (mg)
This will be increased every 5 - 7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
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
Number of tablets
Total daily dose (mg)
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 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
Number of tablets Total daily dose (mg)
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):
1st week 1 tablet pramipexole 0.088 mg 0.088
Number of tablets Total daily dose (mg)
This will be increased every 4-7 days as directed by your doctor until your symptoms are controlled (maintenance dose). 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
Number of tablets
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 Parkinsons 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 Parkinsons 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 ones 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 ones 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 Gnriques 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.
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 Parkinsons 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 Parkinsons 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 Parkinsons 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 Parkinsons 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). 1st week 1 tablet Pramipexole 0.088 mg three times a day 0.264
Number of tablets Total daily dose (mg)
This will be increased every 5 - 7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
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
Number of tablets
Total daily dose (mg)
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 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
Number of tablets Total daily dose (mg)
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):
1st week 1 tablet pramipexole 0.088 mg 0.088
Number of tablets Total daily dose (mg)
This will be increased every 4-7 days as directed by your doctor until your symptoms are controlled (maintenance dose). 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
Number of tablets
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 Parkinsons 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 Parkinsons 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 ones 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 ones 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 Gnriques 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.
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
