Pramipexole Tablets (Pramipexole Dihydrochloride)– Product Information
Pramipexole (Pramipexole Dihydrochloride)is used to treat symptoms of Parkinson’s disease, such as stiffness, tremors, muscle spasms, and poor muscle control. Pramipexole is also used to treat restless legs syndrome (RLS).
We also stock Aripiprazole tablets (Asprito tablets) are used for treating schizophrenia and certain symptoms of bipolar disorder.
Name of Drug
Pramipexole Dihydrochloride Tablets: We supply Pramipex manufactured by SUN Pharmaceuticals. Pramipexole Tablets are more well known as Generic Mirapex®.
(Sometimes Pramipexole is also referred to as: Pramipexolein and Sifrol).
Manufacturer of Pramipexole Dihydrochloride Tablets
SUN Pharmaceuticals Ltd.
Website: www.sunpharma.com
Active Pharmaceutical Ingredient
The active pharmaceutical ingredient contained in Pramipexole Tablets is Pramipexole Dihydrochloride.
Uses Of Pramipexole Tablets
Pramipexole has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson’s disease.
Pramipexole is used to treat symptoms of Parkinson’s disease, such as stiffness, tremors, muscle spasms, and poor muscle control. Pramipexole Tablets are also used to treat restless legs syndrome (RLS).
Pramipexole may also be used for other purposes not listed in this medication guide.
Warnings and Precautions to be taken when using Pramipexole Tablets
Before using Pramipexole Dihydrochloride please inform your doctor all the medicines that you take including no prescription medications, over the counter medicines and herbal remedies. Some people taking Pramipexole have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. If you are unsure of how this medicine will affect you, be careful if you drive or do anything that requires you to be awake and alert.
You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking Pramipexole.
If you are taking this medication for RLS, tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.
Do not stop using Pramipexole Tablets without first talking to your doctor. You may need to use less and less before you stop the medication completely.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Pramipexole. Tell your doctor if you regularly use any of these other medicines. Avoid drinking alcohol, which can increase some of the side effects of Pramipexole.
Pramipexole may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you have hallucinations.
Before taking Pramipexole Tablets
Some people taking Pramipexole Dihydrochloride Tablets have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. If you are unsure of how this medicine will affect you, be careful if you drive or do anything that requires you to be awake and alert. Do not use Pramipexole Tablets if you are allergic to pramipexole.
If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before you take Pramipexole, tell your doctor if you are allergic to any drugs, or if you have:
- narcolepsy (a sleep disorder);
- kidney disease; or
- tremors (dyskinesia) or uncontrolled muscle movements.
You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking Pramipexole. It is not known whether the medicine actually causes this effect. Talk with your doctor if you believe you have any intense or unusual urges while taking Pramipexole.
Some people using medicines for Parkinson’s disease have developed skin cancer (melanoma). However, people with Parkinson’s disease may have a higher risk than most people for developing melanoma. Talk to your doctor about your specific risk and what skin symptoms to watch for. You may need to have regular skin exams.
FDA pregnancy category C. It is not known whether Pramipexole is harmful to an unborn baby. Before you take Pramipexole, tell your doctor if you are pregnant or plan to become pregnant during treatment. Pramipexole may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Pramipexole Tablets may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you have hallucinations.
What should I avoid while taking Pramipexole?
Pramipexole can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which can increase some of the side effects of Pramipexole.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Pramipexole Tablets – Dosage
Take Pramipexole exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results from this medication.
The dose and timing of Pramipexole in treating Parkinson’s disease is different from the dose and timing in treating RLS. Follow the directions on your prescription label. For the treatment of Parkinson’s Disease in Patients with Normal Renal Function the dosage should be increased gradually from a recommended starting dose of 0.375 mg/day given in three divided doses. The dose should not be increased more frequently than every 5 to 7 days.
Take each dose with a full glass of water. Pramipexole can be taken with or without food. Take the medication with food if it upsets your stomach.
If you are taking this medication for RLS, tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.
Do not stop using Pramipexole without first talking to your doctor. You may need to use less and less before you stop the medication completely. Store Pramipexole at room temperature away from moisture and heat.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
Symptoms of a Pramipexole overdose are not known.
Missed Dose
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Possible Side Effects of Pramipexole Tablets
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Pramipexole and call your doctor at once if you have any of these serious side effects:
- extreme drowsiness, falling asleep suddenly, even after feeling alert;
- hallucinations;
- fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
- nausea, sweating, feeling light-headed, fainting; or
- restless muscle movements in your eyes, tongue, jaw, or neck.
Less serious Pramipexole side effects may include:
- constipation, upset stomach, loss of appetite;
- dry mouth, trouble swallowing;
- urinating more often than usual;
- mild drowsiness or sleepiness;
- sleep problems (insomnia), unusual dreams;
- amnesia, forgetfulness, thinking problems;
- headache, confusion, weakness;
- blurred vision;
- joint pain, muscle weakness;
- swelling in your hands or feet;
- runny or stuffy nose;
- weight loss; or
- impotence, loss of interest in sex, or trouble having an orgasm.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Pramipexole?
Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Pramipexole. Tell your doctor if you regularly use any of these medicines, or any other medicines for Parkinson’s disease.
Before taking Pramipexole, tell your doctor if you are using any of the following drugs:
• amantadine (Symmetrel);
• cimetidine (Tagamet);
• diltiazem (Cardizem, Cartia, Dilacor, Tiazac);
• ranitidine (Zantac);
• quinidine (Quinaglute, Quinidex);
• quinine(Qualaquin);
• triamterene (Dyrenium); or
• verapamil (Calan, Covera, Isoptin).
This list is not complete and there may be other drugs that can interact with Pramipexole. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
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