Patient Medication Information: uses, side effects, how to take - Ropinirole Tablets
ABOUT THIS MEDICATION
What the medication is used for:
Ropinirole Tablets, also known as ropinirole, is used to treat the signs and symptoms of Parkinson's disease.
You may receive Ropinirole Tablets on its own but it may also be given with another drug used to treat Parkinson's disease.
What it does:
Ropinirole Tablets belongs to the family of medicines called dopamine agonists. Ropinirole Tablets 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 Ropinirole Tablets if you are allergic to it or any of the components of its formulation (see list below). Ropinirole Tablets is not recommended for children under 18 years of age.
What the medicinal ingredient is:
ropinirole hydrochloride
What the nonmedicinal ingredients are:
Non-medicinal ingredients include: cellulose microcrystalline, croscarmellose sodium, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, macrogol/polyethylene glycol 400, titanium dioxide, iron oxide yellow (0.5 and 1.0 mg tablets), iron oxide red (2.0 mg), iron oxide black (1.0 mg), FD & C Blue No. 2/lake colour of indigo carmine (1.0 and 5.0 mg tablets), macrogol/polyethylene glycol 4000 (5.0 mg), talc (0.25 and 5.0 mg tablets)
For a full listing of nonmedical ingredients, talk to your pharmacist or physician.
What dosage forms it comes in:
Ropinirole Tablets is available as 0.25 mg (white), 0.5 mg (yellow), 1.0 mg (green), 2.0 mg (pink) and 5.0 mg (blue) tablets.
| WARNING AND PRECAUTIONS |
You are warned of a sudden onset of sleep condition which may occur without warning, while taking Ropinirole Tablets. 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 anti-Parkinson drugs.
What should I know before taking Ropinirole Tablets:
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. Ropinirole Tablets is one of the drugs used to treat Parkinson’s disease, therefore, patients treated with Ropinirole Tablets should have periodic skin examinations.
BEFORE you use Ropinirole Tablets talk to your doctor or pharmacist:
- if you have any health problem, especially any heart, liver or kidney condition.
- if you have previously taken Ropinirole Tablets and became unwell.
- if you have any allergies or reactions to foods or drugs.
if you are pregnant or think you may be pregnant, or if you are breast feeding. You should not be taking Ropinirole Tablets if you are pregnant or breast feeding.
- if you are taking any other medications, including any drugs you can buy without a prescription.
- if you have experienced any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour).
| INTERACTION WITH THIS MEDICATION |
Other medications may be affected by Ropinirole Tablets or may affect how Ropinirole Tablets 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 Ropinirole Tablets.
Drugs that may interact with Ropinirole Tablets 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
- 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 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 Ropinirole Tablets, 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 Ropinirole Tablets three times a day. You should not change the dose or discontinue treatment with Ropinirole Tablets 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 Ropinirole Tablets.
You should swallow the tablets whole with water. Do not chew. Ropinirole Tablets 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 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 there are no tablets left.
Missed Dose
If you have forgotten to take Ropinirole Tablets, do not take extra doses to make up for forgotten individual
doses. When you do remember to take Ropinirole Tablets, take your next dose of Ropinirole Tablets at the usual time. If you have missed taking Ropinirole Tablets for more than a few days consult your doctor for advice on restarting Ropinirole Tablets.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medications 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 Ropinirole Tablets are:
- Feeling or being sick
- Stomach ache
- Dizziness or lightheadedness
- Sleepiness
- Headache
- Some leg swelling
- Tiredness
- Viral infection
Other side effects include:
Some patients taking Ropinirole Tablets have shown urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and/or behaviours. If you or your family notices that you are developing any unusual behaviours, talk to you doctor.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom/effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
Only if severe | In all cases | |||
Very common | Sleepiness | 9 | ||
Very common | Fainting | 9 | ||
Very common | Uncontrollable movements (dyskinesias) | 9 | ||
| Common | Hallucinations | 9 | ||
| Common | Feeling confused | 9 | ||
| Common | Feeling dizzy or faint when standing up | 9 | ||
| Uncommon | Having irrational ideas or feeling irrational | 9 | ||
| suspiciousness | ||||
| Uncommon | Impulse control symptoms, increased libido including hypersexuality, pathological gambling | 9 | ||
| Very rare | Allergic reactions (red, itchy swellings on the skin, swelling of the face, lips, mouth, tongue or throat, difficulty swallowing or breathing, rash or intense itching) | 9 | ||
| Very rare | Extreme sleepiness | 9 | ||
| Very rare | Falling asleep without warning | 9 |
This is not a complete list of side effects. For any unexpected effects while taking Ropinirole Tablets, contact your doctor or pharmacist.
HOW TO STORE IT
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 kept at room temperature (between 15-30oC). Close container tightly after each use.
Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax: 866-678-6789
Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. 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 at: www.ranbaxy.ca or by contacting the sponsor, Ranbaxy Pharmaceuticals Canada Inc. at: 1.866.840.1340.