Details for: RAN-ROPINIROLE
Company: RANBAXY PHARMACEUTICALS CANADA INC.
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02314037 | RAN-ROPINIROLE | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) | 0.25 MG | TABLET | ORAL |
02314053 | RAN-ROPINIROLE | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) | 1.0 MG | TABLET | ORAL |
02314061 | RAN-ROPINIROLE | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) | 2.0 MG | TABLET | ORAL |
02314088 | RAN-ROPINIROLE | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) | 5.0 MG | TABLET | ORAL |
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:
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
- 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.
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
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
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:
- Visiting the Web page on Adverse Reaction Reporting (www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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