Consumer Information for: TEVA-ROPINIROLE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

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

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

What it does

TEVA-ROPINIROLE belongs to the family of medicines called dopamine agonists. TEVA-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 TEVA-ROPINIROLE if you are allergic to it or any of the components of its formulation (see list below). TEVAROPINIROLE is not recommended for children under 18 years of age.

What the medicinal ingredient is

Ropinirole hydrochloride

What the non-medicinal ingredients are

croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, FD&C Blue #2 (1mg and 2mg), iron oxide yellow (1mg, 2mg and 5mg), FD&C yellow #6 (2mg), iron oxide red (5mg) and iron oxide black (5mg)

What dosage form it comes in

TEVA-ROPINIROLE is available as 0.25 mg (white), 1 mg (green), 2 mg (pink) and 5 mg (blue) tablets.

Warnings and precautions

You are warned of a sudden onset of sleep condition which may occur without warning, while taking TEVAROPINIROLE. 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 TEVA-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. TEVAROPINIROLE is one of the drugs used to treat Parkinson’s disease, therefore, patients treated with TEVAROPINIROLE should have periodic skin examinations.

Drop in Blood Pressure

While taking TEVA-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,

TEVA-ROPINIROLE taken with L-dopa

TEVA-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 TEVAROPINIROLE compared to people without albinism. Therefore, you should take TEVA-ROPINIROLE only under an ophthalmologist’s (doctor who specializes in eye disorders) care.

Hallucinations

While taking TEVA-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 TEVA-ROPINIROLE.

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

  • have any health problem, especially any heart, liver or kidney condition.
  • have previously taken 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 TEVAROPINIROLE 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 TEVA-ROPINIROLE or may affect how TEVA-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 TEVAROPINIROLE.

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

  • a drug used to help with breathing difficulties called theophylline
  • an antibiotic called ciprofloxacin
  • any hormone replacement therapy (HRT)
  • other dopamine agonists, e.g. L-dopa: TEVAROPINIROLE may make some of the side effects of Ldopa 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:

  • TEVA-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 TEVA-ROPINIROLE affects you.
  • Because TEVA-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 TEVA-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 TEVA-ROPINIROLE three times a day. You should not change the dose or discontinue treatment with TEVA-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 TEVA-ROPINIROLE.

You should swallow the tablets whole with water. Do not chew. TEVA-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 think you have taken too much TEVA-ROPINIROLE, contact your healthcare professional, 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 TEVA-ROPINIROLE, do not take extra doses to make up for the forgotten individual doses. When you do remember to take TEVA-ROPINIROLE, take your next dose of TEVA-ROPINIROLE at the usual time. If you have missed taking TEVA-ROPINIROLE for one day or more consult your doctor for advice on restarting TEVA-ROPINIROLE.

Side effects and what to do about them

Like all medications, TEVA-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 light-headedness, fainting
  • Sleepiness
  • Headache
  • Some leg swelling
  • Tiredness
  • Viral infection
  • Feeling full and bloated or experiencing heartburn
Serious side effects 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 TEVA-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 kept at room temperature (between 15 to 30°C). Close container tightly after each use.

Keep out of the reach and sight 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 leaflet was prepared by: Teva Canada Limited 30 Novopharm Court, Toronto, Ontario Canada M1B 2K9

www.tevacanada.com

Last Revised: May 19, 2020

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