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Details for: RAN-ROPINIROLE

Company: RANBAXY PHARMACEUTICALS CANADA INC.

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02314037RAN-ROPINIROLEROPINIROLE (ROPINIROLE HYDROCHLORIDE)0.25 MGTABLETORAL
02314053RAN-ROPINIROLEROPINIROLE (ROPINIROLE HYDROCHLORIDE)1.0 MGTABLETORAL
02314061RAN-ROPINIROLEROPINIROLE (ROPINIROLE HYDROCHLORIDE)2.0 MGTABLETORAL
02314088RAN-ROPINIROLEROPINIROLE (ROPINIROLE HYDROCHLORIDE)5.0 MGTABLETORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

RAN-ROPINIROLE, also known as ropinirole, is used to treat the signs and symptoms of Parkinson's disease.

You may receive RAN-ROPINIROLE on its own, but it may also be given with another drug used to treat Parkinson's disease.

What it does

RAN-ROPINIROLE belongs to the family of medicines called dopamine agonists. RAN-ROPINIROLE improves some of the chemical imbalance in the part of the brain affected by Parkinson’s disease.

When it should not be used

Do not use RAN-ROPINIROLE if you are allergic to it or any of the components of its formulation (see list below). RAN-ROPINIROLE is not recommended for children under 18 years of age.

What the medicinal ingredient is

ropinirole hydrochloride

What the non-medicinal ingredients are

Non-medicinal ingredients include: croscarmellose sodium, FD & C Blue #2 (1.0 mg and 5.0 mg tablets), hypromellose, iron oxide black (1.0 mg), iron oxide red (2.0 mg), iron oxide yellow (0.5 mg and 1.0 mg tablets), lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 4000 (5.0 mg), talc (0.25 mg and 5.0 mg tablets), titanium dioxide.

What dosage form it comes in

RAN-ROPINIROLE is available as 0.25 mg, 0.5 mg, 1.0 mg, 2.0 mg and 5.0 mg tablets.

Warnings and precautions

You are warned of a sudden onset of sleep condition which may occur without warning, while taking RAN-ROPINIROLE. You should not operate machinery or engage in activities that require alertness, as you may put yourself and others at risk of serious injury or death. This sudden onset of sleep condition has also been reported in patients taking other similar antiParkinson drugs.

What should I know before taking RAN-ROPINIROLE:
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 drugs used to treat Parkinson’s disease. RAN-ROPINIROLE is one of the drugs used to treat Parkinson’s disease, therefore, patients treated with RAN-ROPINIROLE should have periodic skin examinations.

Drop in Blood Pressure
While taking RAN-ROPINIROLE, you may experience a drop in blood pressure that may make you feel dizzy or faint especially when standing up from a sitting or lying position.

Neurological Disorder
Symptoms resembling a neurological disorder (Neuroleptic Malignant Syndrome) characterized by fever, muscle stiffness, stupor and unstable involuntary actions have been reported in relation to changes in treatment, reduction of treatment dose and stopping treatment.

RAN-ROPINIROLE taken with L-dopa
RAN-ROPINIROLE may amplify the side effects of L-dopa (also called levodopa) and may cause or worsen pre-existing uncontrolled jerky movements (dyskinesia). Tell your doctor if this happens as the dose of your medicines may need adjusting.

Eye Disorders
If you have albinism (lack of pigmentation in skin or hair), you may have an increased risk of eye disorders while taking RAN-ROPINIROLE compared to people without albinism. Therefore, you should take RAN-ROPINIROLE only under an ophthalmologist’s (doctor who specializes in eye disorders) care.

Hallucinations
While taking RAN-ROPINIROLE, you may experience hallucinations, such as seeing or hearing things that aren’t really there.

Psychiatric Disorders
Impulse control symptoms including compulsive behaviours, e.g. feeling an urge to gamble, hypersexuality, compulsive shopping, or binge eating, as well as aggression have been reported with the use of RAN-ROPINIROLE.

BEFORE you use RAN-ROPINIROLE talk to your doctor or pharmacist if you:

  • have any health problem, especially any heart, liver or kidney condition.
  • have previously taken RAN-ROPINIROLE and became unwell.
  • have any allergies or reactions to foods or drugs.
  • are pregnant or think you may be pregnant, or if you are breast feeding. You should not be taking RAN-ROPINIROLE if you are pregnant or breast feeding.
  • are taking any other medications, including any drugs you can buy without a prescription.
  • have experienced any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour). (See SIDE EFFECTS AND WHAT TO DO ABOUT THEM)

Interactions with this medication

Other medications may be affected by RAN-ROPINIROLE or may affect how RAN-ROPINIROLE works. Do not take any other medication, including any drugs or herbal products you can buy without a prescription. Tell any other doctor, dentist or pharmacist that you talk to that you are taking RAN-ROPINIROLE.

Drug-drug Interaction:
Drugs that may interact with RAN-ROPINIROLE include:

  • a drug used to help with breathing difficulties called theophylline
  • an antibiotic called ciprofloxacin
  • any hormone replacement therapy (HRT)EASE A
  • other dopamine agonists, e.g. L-dopa: RAN-ROPINIROLE may make some of the side effects of L-dopa worse, e.g. jerky movement.
  • certain medicines called neuroleptics used to treat schizophrenia and other serious mental illnesses
  • digoxin, a heart medicine that is used to treat congestive heart failure or certain heartbeat irregularities
Drug-lifestyle Interaction:
  • RAN-ROPINIROLE may affect your ability to remain alert while doing normal daily activities. You should refrain yourself from doing activities such as driving a car, doing physical tasks or using hazardous machinery until you know how RAN-ROPINIROLE affects you.
  • Because RAN-ROPINIROLE can make you feel sleepy, tell your doctor or pharmacist if you are planning to drink alcohol.
Before making any change to other medications you are taking, or stopping them, talk to your doctor first.
Proper use of this medication

Usual dose

Follow the doctor's instructions about how and when you should take your tablets. Your doctor will decide how many tablets you need to take each day and you should always follow his/her instructions. When you first start taking RAN-ROPINIROLE, the amount you take will be increased gradually.

Your doctor may adjust the amount that you are taking. You will usually be told to take RAN-ROPINIROLE three times a day. You should not change the dose or discontinue treatment with RAN-ROPINIROLE without the recommendation of your doctor.

If you are taking other medicines for Parkinson's disease, the doctor may adjust the dose of these medicines while you are taking RAN-ROPINIROLE.

You should swallow the tablets whole with water. Do not chew. RAN-ROPINIROLE can be taken with or without food.

You should continue to take your medicine even if you do not feel better, as it may take a number of weeks for the medicine to work.

REMEMBER: THIS MEDICINE IS FOR THE PERSON NAMED BY THE DOCTOR. DO NOT GIVE IT TO ANYBODY ELSE.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you or someone you know have taken too many tablets all at once, you should get medical help immediately, either by calling your doctor, the Regional Poison Control Centre, or the nearest hospital (do not drive yourself). Always take the labelled medicine container with you even if there are no tablets left.

Missed Dose

If you have forgotten to take RAN-ROPINIROLE, do not take extra doses to make up for forgotten individual doses. When you do remember to take RAN-ROPINIROLE, take your next dose of RAN-ROPINIROLE at the usual time. If you have missed taking RAN-ROPINIROLE for one day or more consult your doctor for advice on restarting RAN-ROPINIROLE.

Side effects and what to do about them

Like all medications, RAN-ROPINIROLE tablets can cause some side effects. You may not experience any of them. For most patients these side effects are likely to be minor and temporary. However, some may be serious. Consult your doctor if you experience these or other side effects.
Some of the most commonly reported side effects of RAN-ROPINIROLE tablets are:

  • Feeling or being sick
  • Stomach ache
  • Dizziness or light-headedness, fainting
  • Sleepiness
  • Headache
  • Some leg swelling
  • Tiredness
  • Viral infection
  • Feeling full and bloated or experiencing heartburn
Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist right away Only if severe Talk with your doctor or pharmacist right away In all cases Stop taking drug and seek immediate emergency assistance
Very common
Uncontrollable movements (dyskinesias)   ✔  
Common
Hallucinations, feeling confused   ✔  
Uncommon
Having severe confusion, irrational ideas or feeling irrational suspiciousness, other psychotic reactions, impulse control (symptoms like increased libido, feeling the urge to gamble, to shop or eat, acting in an aggressive manner)   ✔  
Very rare
Allergic reactions (symptoms like red, itchy swellings on the skin, swelling of the face, lips, mouth, tongue or throat, difficulty swallowing or breathing, rash or intense itching)     ✔
Extreme sleepiness, falling asleep without warning   ✔  

This is not a complete list of side effects. For any unexpected effects while taking RAN-ROPINIROLE, contact your doctor or pharmacist.
How to store

The expiry date of this medicine is printed on the label. Do not use the medicine after this date.

Keep your tablets in their original pack in a dry place away from light and moisture. They should be stored between 15 and 30°C. Close container tightly after each use.

Keep out of reach of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor: Ranbaxy Pharmaceuticals Canada Inc., at: 1-866-840-1340.

RANBAXY

This leaflet was prepared by:
Ranbaxy Pharmaceuticals Canada Inc.
Brampton, ON L6T 1C1

Last revised: June 29, 2017

Date modified: