Pramipexole Dihydrochloride Tablets - Consumer Medicine Information
|Manufacture:||Endo Pharmaceuticals Inc.|
|Condition:||Parkinson's Disease, Periodic Limb Movement Disorder, Restless Legs Syndrome|
|Class:||Dopaminergic antiparkinsonism agents|
|Ingredients:||pramipexole dihydrochloride monohydrate,betacyclodextrin (betadex), corn starch, colloidal silicon dioxide, povidone, magnesium stearate and microcrystalline cellulose.|
What is the Most Important Information I Should Know About Pramipexole Dihydrochloride
Pramipexole dihydrochloride may cause you to fall asleep while you are doing daily activities such as driving, talking with other people, watching TV, or eating.
- Some people taking pramipexole dihydrochloride have had car accidents because they fell asleep while driving.
- Some patients did not feel sleepy before they fell asleep while driving. You could fall asleep without any warning.
Do not drive a car, operate a machine, or do anything that needs you to be alert until you know how pramipexole dihydrochloride affects you.
Tell your doctor right away if you fall asleep while you are doing activities such as talking with people, watching TV, eating, or driving, or if you feel sleepier than is normal for you.
What is Pramipexole Dihydrochloride
Pramipexole dihydrochloride is a prescription medicine to treat signs and symptoms of Parkinson's disease.
Pramipexole dihydrochloride has not been studied in children.
Who Should not Take Pramipexole Dihydrochloride
Do not take pramipexole dihydrochloride if you are allergic to pramipexole or any of the inactive ingredients of pramipexole dihydrochloride. See the end of this leaflet for a complete list of ingredients in pramipexole dihydrochloride.
What Should I tell my Doctor Before Taking Pramipexole Dihydrochloride
Tell your doctor about all of your medical conditions, including if you
- feel sleepy during the day from a sleep problem.
- have low blood pressure, or if you feel dizzy or faint, especially when getting up from a lying or sitting position.
- have trouble controlling your muscles (dyskinesia)
- have kidney problems.
- are pregnant or plan to become pregnant. It is not known if pramipexole dihydrochloride will harm your unborn baby.
- are breast feeding. It is not known if pramipexole dihydrochloride will pass into your breast milk. You and your doctor should decide if you will take – pramipexole dihydrochloride or breastfeed.You should not do both.
- drink alcohol. Alcohol can increase the chance that pramipexole dihydrochloride will make you feel sleepy or fall asleep when you should be awake.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements . Especially tell your doctor if you take any other medicines that make you sleepy. Pramipexole dihydrochloride and other medicines may interact with each other causing side effects. Pramipexole dihydrochloride may affect the way other medicines work, and other medicines may affect how pramipexole dihydrochloride works.
How Should I Take Pramipexole Dihydrochloride
- Take pramipexole dihydrochloride exactly as your doctor tells you to. Your doctor will tell you how many pramipexole dihydrochloride Tablets to take and when to take them.
- Your doctor may change your dose until you are taking the right amount of medicine to control your symptoms. Do not take more or less pramipexole dihydrochloride than your doctor tells you to.
- Pramipexole dihydrochloride can be taken with or without food. Taking pramipexole dihydrochloride with food may lower your chances of getting nausea.
- If you miss a dose, do not double your next dose. Skip the dose you missed and take your next regular dose.
- Be sure to tell your doctor right away if you stop taking pramipexole dihydrochloride for any reason. Do not start taking pramipexole dihydrochloride again before speaking with your doctor. If you have Parkinson’s disease and are stopping pramipexole dihydrochloride, you should stop pramipexole dihydrochloride slowly over 7 days.
What Should I Avoid While Taking Pramipexole Dihydrochloride
- Do not drive a car, operate a machine, or do anything that needs you to be alert until you know how pramipexole dihydrochloride affects you. See “What is the most important information I should know about pramipexole dihydrochloride?” at the beginning of this leaflet.
- Do not drink alcohol while taking pramipexole dihydrochloride. It can increase your chances of feeling sleepy or falling asleep when you should be awake.
What are the Possible Side Effects of Pramipexole Dihydrochloride
Pramipexole dihydrochloride can cause serious side effects, including
- falling asleep during normal daily activities . See “What is the most important information I should know about pramipexole dihydrochloride?”
- low blood pressure when you sit or stand up quickly. You may have dizziness, nausea, fainting, or sweating. Sit and stand up slowly after you have been sitting or lying down for a while.
- hallucinations . You may see, hear, feel, or taste something that isn’t there. You have a higher chance of having hallucinations if you are over 65 years old.
The most common side effects in people taking pramipexole dihydrochloride for Parkinson’s Disease are nausea, dizziness, sleepiness, constipation, hallucinations, insomnia, muscle weakness, confusion, and abnormal movements.
These are not all the possible side effects of pramipexole dihydrochloride. For more information ask your doctor or pharmacist.
Be sure to talk to your doctor about any side effects that bother you or that do not go away.
Other Information About Pramipexole Dihydrochloride
Studies of people with Parkinson’s disease show that they may be at an increased risk of developing melanoma, a form of skin cancer, when compared to people without Parkinson’s disease. It is not known if this problem is associated with Parkinson’s disease or the medicines used to treat Parkinson’s disease. Pramipexole dihydrochloride is one of the medicines used to treat Parkinson’s disease, therefore, patients being treated with pramipexole dihydrochloride should have periodic skin examinations.
There have been reports of patients taking certain medicines to treat Parkinson’s disease, including pramipexole dihydrochloride tablets, that have reported problems with gambling, compulsive eating, and increased sex drive. It is not possible to reliably estimate how often these behaviors occur or to determine which factors may contribute to them. If you or your family members notice that you are developing unusual behaviors, talk to your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How Should I Store Pramipexole Dihydrochloride
- Store pramipexole dihydrochloride at room temperature at 59ºF to 86ºF (15ºC to 30ºC).
- Keep pramipexole dihydrochloride out of light.
- Keep pramipexole dihydrochloride and all medicines out of the reach of children.
General Information About Pramipexole Dihydrochloride
Medicines are sometimes prescribed for purposes other than those listed in this Patient Information leaflet. Do not take pramipexole dihydrochloride for a condition for which it was not prescribed. Do not share pramipexole dihydrochloride with other people, even if they have the same symptoms you do. It may harm them.
This Patient Information leaflet summarizes the most important information about pramipexole dihydrochloride. For more information, talk with your doctor or pharmacist.
They can give you information about pramipexole dihydrochloride that is written for health care professionals.
What are the Ingredients in Pamipexole Dihydrochloride
Active Ingredient: pramipexole dihydrochloride monohydrate
Inactive Ingredients : betacyclodextrin (betadex), corn starch, colloidal silicon dioxide, povidone, magnesium stearate and microcrystalline cellulose.
Endo Pharmaceuticals Inc.
Chadds Ford, PA 19317
Alembic Pharmaceuticals Limited (Formulation Division),
Village Panelav, P. O. Tajpura, Near Baska,
Taluka-Halol, Panchmahal, Gujarat, India.