Ropinirole Hydrochloride Tablets - Consumer Medicine Information
|Manufacture:||Dr. Reddy's Laboratories, Inc.|
|Condition:||Parkinson's Disease, Periodic Limb Movement Disorder, Restless Legs Syndrome|
|Class:||Dopaminergic antiparkinsonism agents|
|Ingredients:||ropinirole (as ropinirole hydrochloride USP), anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide, triethyl citrate|
If you have Parkinson's disease, read this side.
If you have Restless Legs Syndrome (RLS), read the other side.
|Important Note:Ropinirole extended-release tablets has not been studied in Restless Legs Syndrome (RLS) and is not approved for the treatment of RLS. However, an immediate-release form of ropinirole is approved for the treatment of RLS.|
What is the Most Important Information I Should Know About Ropinirole Extended-release Tablets
Ropinirole extended-release tablets can cause serious side effects, including:
- Hypersensitivity/allergic reactions . You may experience a hypersensitivity/allergic reaction characterized by hives, rash, itching, and/or swelling of the face, lips, mouth, tongue, or throat, which may cause problems in swallowing or breathing. If you experience any of these reactions, you should not take ropinirole extended-release tablets again until you talk to a healthcare provider and seek their advice.
- Falling asleep during normal activities . You may fall asleep while doing normal activities such as driving a car, doing physical tasks, or using hazardous machinery while taking ropinirole extended-release tablets. You may suddenly fall asleep without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while doing normal activities while taking ropinirole extended-release tablets are greater if you take other medicines that cause drowsiness. Tell your healthcare provider right away if this happens. Before starting ropinirole extended-release tablets, be sure to tell your healthcare provider if you take any medicines that make you drowsy.
- Fainting. Fainting can happen, and sometimes your heart rate may be decreased. This can happen especially when you start taking ropinirole extended- release tablets or your dose is increased. Tell your healthcare provider if you faint or feel dizzy or light headed.
- Decrease in blood pressure. Ropinirole extended-release tablets can decrease your blood pressure. Decreases in your blood pressure (hypotension) can happen, especially when you start taking ropinirole extended- release tablets or when your dose is changed. If you faint or feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down (orthostatic hypotension), this may mean that your blood pressure is decreased. When you change position from lying down or sitting to standing up, you should do it carefully and slowly. Call your healthcare provider if you have any of the symptoms of decreased blood pressure listed above.
- Increase in blood pressure. Ropinirole extended-release tablets may increase your blood pressure.
- Changes in heart rate (decrease or increase). Ropinirole extended-release tablets can decrease or increase your heart rate.
- Hallucinations and other psychotic-like behavior. Ropinirole extended-release tablets can cause or worsen psychotic-like behavior including hallucinations (seeing or hearing things that are not real), confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs (believing things that are not real), and disorganized thinking. The chances of having hallucinations or these other psychotic-like changes are higher in people with Parkinson’s disease who are taking ropinirole extended-release tablets or taking higher doses of these drugs. If you have hallucinations or any of these other psychotic-like changes, talk with your healthcare provider.
- Uncontrolled sudden movements . Ropinirole extended-release tablets may cause uncontrolled sudden movements or make such movements you already have worse or more frequent. Tell your healthcare provider if this happens. The doses of your anti-Parkinson’s medicine may need to be changed.
- Unusual urges . Some patients taking ropinirole extended-release tablets get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble, increased sexual urges and behaviors, or an uncontrollable urge to shop, spend money, or eat. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider.
- Increased chance of skin cancer (melanoma). People with Parkinson’s disease may have a higher chance of getting melanoma. It is not known if ropinirole extended-release tablets increase your chances of getting melanoma. You and your healthcare provider should check your skin on a regular basis. Tell your healthcare provider right away if you notice any changes in your skin such as a change in the size, shape, or color of moles on your skin.
What are Ropinirole Extended-release Tablets
- Ropinirole extended-release tablets are long-acting prescription medicine containing ropinirole (taken 1 time a day) that is used only to treat Parkinson’s disease but not to treat RLS.
Having one of these conditions does not mean you have or will develop the other condition.
You should not be taking more than 1 medicine containing ropinirole. Tell your healthcare provider if you are taking any other medicine containing ropinirole.
It is not known if ropinirole extended-release tablets are safe and effective for use in children younger than 18 years of age.
Who Should not Take Ropinirole Extended-release Tablets
Do not take ropinirole extended-release tablets if you:
- are allergic to ropinirole or any of the ingredients in ropinirole extended-release tablets. See the end of this page for a complete list of the ingredients in ropinirole extended-release tablets.
Call your healthcare provider and get help right away if you have any of the following symptoms of an allergic reaction. Symptoms of an allergic reaction may include:
- swelling of the face, lips, mouth, tongue, or throat
What Should I Tell My Healthcare Provider Before Taking Ropinirole Extended-release Tablets
Before you take ropinirole extended-release tablets, tell your healthcare provider if you:
- have daytime sleepiness from a sleep disorder or have unexpected or unpredictable sleepiness or periods of sleep.
- are taking any other prescription or over-the-counter medicines. Some of these medicines may increase your chances of getting side effects while taking ropinirole extended-release tablets.
- start or stop taking other medicines while you are taking ropinirole extended-release tablets. This may increase your chances of getting side effects.
- start or stop smoking while you are taking ropinirole extended-release tablets. Smoking may decrease the treatment effect of ropinirole extended-release tablets.
- feel dizzy, nauseated, sweaty, or faint when you first stand up from sitting or lying down.
- drink alcoholic beverages. This may increase your chances of becoming drowsy or sleepy while taking ropinirole extended-release tablets.
- have high or low blood pressure. have or have had heart problems.
- are pregnant or plan to become pregnant. Ropinirole extended-release tablets should only be used during pregnancy if needed.
- are breastfeeding. It is not known if ropinirole extended-release tablets passes into your breast milk. Talk to your healthcare provider to decide whether you will breastfeed or take ropinirole extended-release tablets.
- have any other medical conditions
How Should I Take Ropinirole Extended-release Tablets For Parkinson's Disease
- Take ropinirole extended-release tablets exactly as directed by your healthcare provider.
- Do not suddenly stop taking ropinirole extended- release tablets without talking to your healthcare provider. If you stop this medicine suddenly, you may develop fever, confusion, or severe muscle stiffness.
- Before starting ropinirole extended- release tablets, you should talk to your healthcare provider about what to do if you miss a dose. If you have missed the previous dose and it is time for your next dose, do not double the dose.
- Your healthcare provider will start you on a low dose of ropinirole extended-release tablets. Your healthcare provider will change the dose until you are taking the right amount of medicine to control your symptoms. It may take several weeks before you reach a dose that controls yoursymptoms .
If you are taking ropinirole extended-release tablets:
- Take ropinirole extended-release tablets 1 time each day for Parkinson’s disease, preferably at or around the same time of day.
- Swallow ropinirole extended-release tablets whole. Do not chew, crush, or split ropinirole extended-release tablets.
- Ropinirole extended-release tablets release drug over a 24-hour period. If you have a condition where medicine passes through your body too quickly, such as diarrhea, the tablet(s) may not dissolve completely and you may see tablet residue in your stool. If this happens, let your healthcare provider know as soon as possible.
If you are taking ropinirole extended-release tablets:
- Contact your healthcare provider if you stop taking ropinirole extended-release tablets for any reason. Do not restart without talking with your healthcare provider.
- Your healthcare provider may prescribe ropinirole extended-release tablets alone, or add ropinirole extended-release tablets to medicine that you are already taking for Parkinson's disease.
- You should not substitute ropinirole tablets for ropinirole extended-release tablets or ropinirole extended-release tablets for ropinirole tablets without talking with your healthcare provider.
- You can take ropinirole extended-release tablets with or without food.
What are the Possible Side Effects of Ropinirole Extended-release Tablets
Ropinirole extended-release tablets can cause serious side effects including:
- See “What is the most important information I should know about ropinirole extended-releasetablets?”
The most common side effects of ropinirole extended-release tablets include:
- sleepiness or drowsiness
- hallucinations (seeing or hearing things that are not real)
- nausea or vomiting
- uncontrolled sudden movements
- leg swelling
- fatigue, tiredness, or weakness
- upset stomach, abdominal pain or discomfort
- increased sweating
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
This is not a complete list of side effects and should not take the place of talking with your healthcare provider. Your healthcare provider or pharmacist can give you a more complete list of possible side effects.
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 Ropinirole Extended-release Tablets
- Store ropinirole extended-release tablets at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature].
- Keep ropinirole extended-release tablets in a tightly closed container and out of direct sunlight.
Keep ropinirole extended-release tablets and all medicines out of the reach of children.
General Information About the Safe and Effective Use of Ropinirole Extended-release Tablets
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take ropinirole extended-release tablets for a condition for which it was not prescribed. Do not give ropinirole extended-release tablets to other people, even if they have the same symptoms you have. It may harm them.
This side of the patient information leaflet summarizes the most important information about ropinirole extended-release tablets for Parkinson’s disease. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about ropinirole extended-release tablets that is written for healthcare professionals. For more information call 1-888-375-3784 (toll free).
What are the Ingredients in Ropinirole Extended-release Tablets
The following ingredients are in ropinirole extended-release tablets:
Active ingredient: ropinirole (as ropinirole hydrochloride USP)
Inactive ingredients: anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet).
To reorder additional Patient Information contact Dr. Reddy’s Customer Service at 1-866-733-3952.
Dr. Reddy’s Laboratories Limited
Bachepalli - 502 325 INDIA