Pramipexole Dihydrochloride (Page 7 of 8)

16.2 Storage and Handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light.

Store in a safe place out of the reach of children.

17 PATIENT COUNSELING INFORMATION


Advise the patient to read the FDA-approved patient labeling (Patient Information).

Dosing Instructions

Instruct patients to take pramipexole dihydrochloride tablets only as prescribed. If a dose is missed, advise patients not to double their next dose.

Pramipexole dihydrochloride tablets can be taken with or without food. If patients develop nausea, advise that taking pramipexole dihydrochloride tablets with food may reduce the occurrence of nausea.

Pramipexole is the active ingredient that is in both pramipexole dihydrochloride tablets and extended-release pramipexole tablets. Ensure that patients do not take both extended-release pramipexole and pramipexole dihydrochloride.

Sedating Effects

Alert patients to the potential sedating effects associated with pramipexole dihydrochloride tablets, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Since somnolence is a frequent adverse reaction with potentially serious consequences, patients should neither drive a car nor engage in other potentially dangerous activities until they have gained sufficient experience with pramipexole dihydrochloride tablets to gauge whether or not it affects their mental and/or motor performance adversely. Advise patients that if increased somnolence or new episodes of falling asleep during activities of daily living (e.g., conversations or eating) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Because of possible additive effects, advise caution when patients are taking other sedating medications or alcohol in combination with pramipexole dihydrochloride tablets and when taking concomitant medications that increase plasma levels of pramipexole (e.g., cimetidine) [see Warnings and Precautions (5.1) ].

Impulse Control Symptoms Including Compulsive Behaviors

Alert patients and their caregivers to the possibility that they may experience intense urges to spend money uncontrollably, intense urges to gamble, increased sexual urges, binge eating and/or other intense urges and the inability to control these urges while taking pramipexole dihydrochloride [see Warnings and Precautions (5.3) ].

Hallucinations and Psychotic-like Behavior

Inform patients that hallucinations and other psychotic-like behavior can occur and that the elderly are at a higher risk than younger patients with Parkinson’s disease [see Warnings and Precautions (5.4) ].

Postural (Orthostatic) Hypotension

Advise patients that they may develop postural (orthostatic) hypotension, with or without symptoms such as dizziness, nausea, fainting or blackouts, and sometimes, sweating. Hypotension may occur more frequently during initial therapy. Accordingly, caution patients against rising rapidly after sitting or lying down, especially if they have been doing so for prolonged periods and especially at the initiation of treatment with pramipexole dihydrochloride tablets [see Warnings and Precautions (5.2) ].

Pregnancy

Because the teratogenic potential of pramipexole has not been completely established in laboratory animals, and because experience in humans is limited, advise women to notify their physicians if they become pregnant or intend to become pregnant during therapy [see Use in Specific Populations (8.1) ].

Nursing Mothers

Because of the possibility that pramipexole may be excreted in breast milk, advise women to notify their physicians if they intend to breast-feed or are breast-feeding an infant [see Use in Specific Populations (8.3) ].
Distributed by:
Citron Pharma LLC
Suite -1101
2 Tower Center Blvd
East Brunswick NJ 08816
Code No.: DRUGS/AP/22/2009
Made in IndiaRevised: 03/2016

PATIENT INFORMATION

Pramipexole Dihydrochloride Tablets
(pram” i pex’ ole dye hye” droe klor’ ide)
Read this Patient Information before you start taking pramipexole dihydrochloride tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.


What are pramipexole dihydrochloride tablets?
Pramipexole dihydrochloride tablets are a prescription medicine used to treat:

  • signs and symptoms of Parkinson’s disease (PD)

It is not known if pramipexole dihydrochloride tablets are safe and effective in children.
What should I tell my doctor before taking pramipexole dihydrochloride tablets?

  • Before taking pramipexole dihydrochloride tablets, tell your doctor 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 sitting or lying down
    • have trouble controlling your muscles (dyskinesia)
    • have kidney problems
    • drink alcohol. Alcohol can increase the chance that pramipexole dihydrochloride tablets will make you feel sleepy or fall asleep when you should be awake.
    • have any other medical conditions
    • are pregnant or plan to become pregnant. It is not known if pramipexole dihydrochloride tablets will harm your unborn baby.
    • are breastfeeding or plan to breastfeed. It is not known if pramipexole dihydrochloride passes into your breast milk. You and your doctor should decide if you will take pramipexole dihydrochloride tablets or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
The combination of pramipexole dihydrochloride tablets and other medicines may affect each other and may cause side effects. Pramipexole dihydrochloride tablets may affect the way other medicines work, and other medicines may affect how pramipexole dihydrochloride tablet works.
Especially tell your doctor if you take:

  • medicines called neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide. Pramipexole dihydrochloride tablets may not work as well if you take these medicines.
  • pramipexole dihydrochloride extended-release tablets. Pramipexole is the active ingredient in both pramipexole dihydrochloride tablets and pramipexole dihydrochloride extended-release tablets. If you are taking pramipexole dihydrochloride extended-release tablets, you should not take pramipexole dihydrochloride tablets.
  • any other medicines that make you sleepy or may increase the effects of pramipexole dihydrochloride tablets, such as cimetidine (Tagamet).

Ask your doctor for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How should I take pramipexole dihydrochloride tablets?

  • Take pramipexole dihydrochloride tablets exactly as your doctor tells you to take them.
  • Your doctor will tell you how much pramipexole dihydrochloride to take and when to take it. Do not take more or less pramipexole dihydrochloride tablets than your doctor tells you to.
  • Your doctor may change your dose if needed.
  • Pramipexole dihydrochloride tablets can be taken with or without food. Taking pramipexole dihydrochloride tablets with food may lower your chances of getting nausea.
  • If you take more pramipexole dihydrochloride tablets than your doctor recommends, call your doctor or go to the nearest hospital emergency room right away.
  • If you miss a dose, do not double your next dose. Skip the dose you missed and take your next regular dose.
  • If you have Parkinson’s disease and your doctor tells you to stop taking pramipexole dihydrochloride tablets, you should stop pramipexole dihydrochloride tablets slowly as directed by your doctor. If you stop pramipexole dihydrochloride tablets too quickly you may have withdrawal symptoms such as:
    • fever
    • confusion
    • severe muscle stiffness

Do not stop taking pramipexole dihydrochloride tablets without talking to your doctor.
What should I avoid while taking pramipexole dihydrochloride tablets?

  • Do not drink alcohol while taking pramipexole dihydrochloride tablets. It can increase your chance of having serious side effects. See “What are the possible side effects of pramipexole dihydrochloride tablets ?
  • Do not drive a car, operate a machine, or do other dangerous activities until you know how pramipexole dihydrochloride tablets affect you. Sleepiness caused by pramipexole dihydrochloride tablets can happen as late as 1 year after you start your treatment.

What are the possible side effects of pramipexole dihydrochloride tablets?
Pramipexole dihydrochloride tablets may cause serious side effects, including:

  • falling asleep during normal daily activities . Pramipexole dihydrochloride tablets may cause you to fall asleep while you are doing daily activities such as driving, talking with other people, or eating.
    • Some people taking the medicine in pramipexole dihydrochloride tablets 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.

Tell your doctor right away if you fall asleep while you are doing activities such as talking, eating, driving, or if you feel sleepier than normal for you.

  • low blood pressure when you sit or stand up quickly. You may have:
    • dizziness
    • nausea
    • fainting
    • sweating

Sit and stand up slowly after you have been sitting or lying down.

  • unusual urges. Some people who take certain medicines to treat Parkinson’s disease, including pramipexole dihydrochloride tablets, have reported problems, such as gambling, compulsive eating, compulsive buying, and increased sex drive.

If you or your family members notice that you are developing unusual urges or behaviors, talk to your doctor.

  • hallucinations and other psychotic-like behavior (seeing visions, hearing sounds or feeling sensations that are not real, confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs and disorganized thinking). Your chance of having hallucinations and other psychotic-like behavior is higher if you are elderly (age 65 or older).

If you have hallucinations or other psychotic-like changes, talk with your doctor right away.

  • uncontrolled sudden movements (dyskinesia).

If you have new dyskinesia or your existing dyskinesia gets worse tell your doctor.

  • skin cancer (melanoma). Some people with Parkinson’s disease may have a higher chance of having melanoma than people who do not have Parkinson’s disease. It is not known if the chance of having melanoma is higher because of the medicines to treat Parkinson’s disease, like pramipexole dihydrochloride tablets, or from the Parkinson’s disease. People who take pramipexole dihydrochloride tablets should have regular skin examinations to check for melanoma.

The most common side effects in people taking pramipexole dihydrochloride tablets for Parkinson’s disease are:

  • nausea
  • dizziness
  • insomnia
  • constipation
  • muscle weakness
  • abnormal dreams
  • confusion
  • memory problems (amnesia)
  • urinating more often than normal

These are not all the possible side effects of pramipexole dihydrochloride tablets. Tell your doctor if you have any side effect that bothers you.
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 tablets?

  • Store pramipexole dihydrochloride tablets at 20° to 25°C (68° to 77°F).
  • Keep pramipexole dihydrochloride tablets out of the light.
  • Keep pramipexole dihydrochloride tablets and all medicines out of the reach of children.

General Information about the safe and effective use of pramipexole dihydrochloride tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use pramipexole dihydrochloride tablets for a condition for which it was not prescribed. Do not give pramipexole dihydrochloride tablets to other people, even if they have the same symptoms that you have. They may harm them.

This Patient Information leaflet summarizes the most important information about pramipexole dihydrochloride tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about pramipexole dihydrochloride tablets that is written for healthcare professionals.

For more information, call Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766).

What are the ingredients in pramipexole dihydrochloride tablets?

Active Ingredient: pramipexole dihydrochloride
Inactive Ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, mannitol, and povidone
This Patient Information has been approved by the U.S. Food and Drug Administration.
All brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.
Distributed by:
Citron Pharma LLC
Suite -1101
2 Tower Center Blvd
East Brunswick NJ 08816
Code No.: DRUGS/AP/22/2009
Made in India
Revised: 03/2016

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