PATIENT INFORMATION
Ropinirole Tablets, USP
(roe pin’ i role”)
Ropinirole Extended-Release Tablets
(roe pin’ i role”)
Dispense with Patient Information available at:
www.solcohealthcare.com/medguide/ropinirole-er-tablets.pdf
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 have not been studied in RLS and are not approved for the treatment of RLS. However, an immediate-release form of ropinirole is approved for the treatment of moderate to severe primary RLS (see other side of this leaflet).
What is the most important information I should know about ropinirole tablets and ropinirole extended-release tablets?
Ropinirole tablets and ropinirole extended-release tablets can cause serious side effects including:
- •
-
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 tablets or 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 tablets or 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 tablets or 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 tablets or ropinirole extended-release tablets or your dose is increased. Tell your healthcare provider if you faint, feel dizzy, or feel light-headed.
- •
-
Decrease in blood pressure. Ropinirole tablets and ropinirole extended-release tablets can decrease your blood pressure (hypotension), especially when you start taking ropinirole tablets or 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 tablets and ropinirole extended-release tablets can decrease or increase your heart rate.
- •
-
Hallucinations and other psychotic-like behavior. Ropinirole tablets and 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 tablets or 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 tablets and 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 tablets or 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.
- •
-
Withdrawal Symptoms. Ropinirole tablets and ropinirole extended-release tablets are dopamine agonist medicines. Dopamine agonist medicines, including ropinirole tablets and ropinirole extended-release tablets, can cause withdrawal symptoms as your dose is slowly lowered (tapered) or when treatment with ropinirole tablets or ropinirole extended-release tablets is stopped. Tell your doctor right away if you get any of the following withdrawal symptoms:
- •
- fever
|
- •
- fatigue
|
- •
- confusion
|
- •
- sweating
|
- •
- severe muscle stiffness
|
- •
- pain
|
- •
- insomnia
|
- •
- feeling like you do not care about things you usually care about (apathy)
|
- •
- depression
|
- •
- anxiety
|
After you have stopped taking ropinirole tablets or ropinirole extended-release tablets, your healthcare provider may need to restart you at a low dose of ropinirole tablets or ropinirole extended-release tablets if you get severe withdrawal symptoms.
What are ropinirole tablets and ropinirole extended-release tablets?
- •
- Ropinirole tablets are a short-acting prescription medicine containing ropinirole (usually taken 3 times a day) that is used to treat Parkinson’s disease. It is also used to treat a condition called Restless Legs Syndrome (RLS).
- •
- Ropinirole extended-release tablets are a 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 tablets and ropinirole extended-release tablets are safe and effective for use in children younger than 18 years of age.
Do not take ropinirole tablets or ropinirole extended-release tablets if you:
- •
- are allergic to ropinirole or any of the ingredients in ropinirole tablets or ropinirole extended-release tablets. See the end of this page for a complete list of the ingredients in ropinirole tablets and ropinirole extended-release tablets.
- •
- Get help right away if any of the symptoms of an allergic reaction cause problems swallowing or breathing. Call your healthcare provider if you have any of the symptoms of an allergic reaction. Symptoms of an allergic reaction may include:
- •
- hives
- •
- rash
- •
- swelling of the face, lips, mouth, tongue, or throat
- •
- itching
Before taking ropinirole tablets or ropinirole extended-release tablets, tell your healthcare provider about all of your medical conditions, including if you:
- •
- have daytime sleepiness from a sleep disorder or have unexpected or unpredictable sleepiness or periods of sleep.
- •
- start or stop taking other medicines while you are taking ropinirole tablets or ropinirole extended-release tablets. This may increase your chances of getting side effects.
- •
- start or stop smoking while you are taking ropinirole tablets or ropinirole extended-release tablets. Smoking may decrease the treatment effect of ropinirole tablets or ropinirole extended-release tablets.
- •
- feel dizzy, nauseated, sweaty, or faint when you stand up from sitting or lying down.
- •
- drink alcoholic beverages. This may increase your chances of becoming drowsy or sleepy while taking ropinirole tablets or ropinirole extended-release tablets.
- •
- have high or low blood pressure.
- •
- have or have had heart problems.
- •
- are pregnant or plan to become pregnant. It is not known if ropinirole tablets or ropinirole extended-release tablets can harm your unborn baby.
- •
- are breastfeeding or plan to breastfeed. It is not known if ropinirole passes into your breast milk. The amount of breast milk you make may be decreased while taking ropinirole tablets or ropinirole extended-release tablets. Talk to your healthcare provider to decide if you should breastfeed while taking ropinirole tablets or ropinirole extended-release tablets.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of these medicines may increase your chances of getting side effects while taking ropinirole tablets or ropinirole extended-release tablets.
How should I take ropinirole tablets or ropinirole extended-release tablets?
- •
- Take ropinirole tablets or ropinirole extended-release tablets exactly as directed by your healthcare provider.
- •
- Take ropinirole tablets or ropinirole extended-release tablets with or without food.
- •
-
Do not suddenly stop taking ropinirole tablets or ropinirole extended-release tablets without talking to your healthcare provider. If you stop this medicine, you may develop withdrawal symptoms (See “What is the most important information I should know about ropinirole tablets or ropinirole extended-release tablets?”).
- •
- Before starting ropinirole tablets or 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 tablets or 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 your symptoms.
- •
- Contact your healthcare provider if you stop taking ropinirole tablets or ropinirole extended-release tablets for any reason. Do not restart without talking with your healthcare provider.
- •
- Your healthcare provider may prescribe ropinirole tablets or ropinirole extended-release tablets alone, or add ropinirole tablets or 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.
If you are taking ropinirole tablets:
- •
- Ropinirole tablets are usually taken 3 times a day for Parkinson’s disease.
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.
What are the possible side effects of ropinirole tablets and ropinirole extended-release tablets?
Ropinirole tablets and ropinirole extended-release tablets can cause serious side effects, including:
- •
-
See “What is the most important information I should know about ropinirole tablets and ropinirole extended-release tablets?”
The most common side effects of ropinirole tablets and ropinirole extended-release tablets include:
- •
- fainting
- •
- sleepiness or drowsiness
- •
- hallucinations (seeing or hearing things that are not real)
- •
- dizziness
- •
- nausea or vomiting
- •
- uncontrolled sudden movements
- •
- upset stomach, abdominal pain or discomfort
- •
- fatigue, tiredness, or weakness
- •
- confusion
- •
- headache
- •
- leg swelling
- •
- increased sweating
- •
- constipation
- •
- suddenly falling asleep
- •
- high blood pressure (hypertension)
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all of the possible side effects with ropinirole tablets and ropinirole extended-release tablets. 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 tablets or ropinirole extended-release tablets?
- •
- Store ropinirole tablets or ropinirole extended-release tablets at room temperature between 68°F to 77°F (20°C to 25°C).
- •
- Keep ropinirole tablets or ropinirole extended-release tablets in a tightly closed container and out of direct sunlight.
Keep ropinirole tablets or ropinirole extended-release tablets and all medicines out of the reach of children.
General information about the safe and effective use of ropinirole tablets or ropinirole extended-release tablets:
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ropinirole tablets or ropinirole extended-release tablets for a condition for which it was not prescribed. Do not give ropinirole tablets or ropinirole extended-release tablets to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about ropinirole tablets or ropinirole extended-release tablets that is written for health professionals.
What are the ingredients in ropinirole tablets and ropinirole extended-release tablets?
The following ingredients are in ropinirole tablets:
Active ingredient: ropinirole (as ropinirole hydrochloride)
Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Inactive ingredients of the film coats are slightly different among the 7 strengths of tablets and are tabulated below:
|
Strength
|
Inactive ingredients of the film coat
|
|
0.25 mg
|
polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide and lecithin (soya).
|
|
0.5 mg
|
polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide and iron oxide yellow.
|
|
1 mg
|
polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, FD&C Blue No. 2 aluminum lake and iron oxide yellow.
|
|
2 mg
|
polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, lecithin (soya) and iron oxide red.
|
|
3 mg
|
polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, carmine and FD&C Blue No. 1 aluminum lake.
|
|
4 mg
|
polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, iron oxide yellow and iron oxide red.
|
|
5 mg
|
polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, FD&C Blue No. 2 aluminum lake and lecithin (soya).
|
The following ingredients are in ropinirole extended-release tablets:
Active ingredient: ropinirole (as ropinirole hydrochloride, USP)
Inactive ingredients: carboxymethylcellulose sodium, hypromellose, lactose monohydrate, colloidal silicon dioxide, magnesium stearate, yellow ferric oxide. Inactive ingredients of the film coats are slightly different among the 5 strengths of tablets and are tabulated below:
|
Strength
|
Inactive ingredients of the film coat
|
|
2 mg
|
polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide, polyethylene glycol, D&C red #27 aluminum lake and FD&C blue #1 aluminum lake
|
|
4 mg
|
polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide, polyethylene glycol, D&C yellow #10 aluminum lake and red ferric oxide
|
|
6 mg
|
polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide and polyethylene glycol
|
|
8 mg
|
polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide, polyethylene glycol and red ferric oxide
|
|
12 mg
|
polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide, polyethylene glycol, yellow ferric oxide and FD&C blue #2 aluminum lake
|
PATIENT INFORMATION
Ropinirole Tablets, USP
(roe pin’ i role”)
If you have Restless Legs Syndrome (RLS), read this side.
If you have Parkinson’s disease, read the other side.
Important Note: Ropinirole extended-release tablets have not been studied in RLS and are not approved for the treatment of RLS.
People with RLS should take ropinirole tablets differently than people with Parkinson’s disease (see “How should I take ropinirole tablets for RLS?” for the recommended dosing for RLS). A lower dose of ropinirole tablets is generally needed for people with RLS, and is taken once daily before bedtime.
What is the most important information I should know about ropinirole tablets?
Ropinirole tablets can cause serious side effects including:
- •
-
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 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 tablets are greater if you take other medicines that cause drowsiness. Tell your healthcare provider right away if this happens. Before starting ropinirole 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 tablets or your dose is increased. Tell your healthcare provider if you faint, feel dizzy, or feel light-headed.
- •
-
Decrease in blood pressure. Ropinirole tablets can decrease your blood pressure (hypotension), especially when you start taking ropinirole 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.
- •
-
Hallucinations and other psychotic-like behavior. Ropinirole 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 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 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 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.
- •
-
Withdrawal Symptoms. Ropinirole tablets are dopamine agonist medicines. Dopamine agonist medicines, including ropinirole tablets, can cause withdrawal symptoms as your dose is slowly lowered (tapered) or when treatment with ropinirole tablets is stopped. Tell your doctor right away if you get any of the following withdrawal symptoms:
- o
- fever
|
- o
- fatigue
|
- o
- confusion
|
- o
- sweating
|
- o
- severe muscle stiffness
|
- o
- pain
|
- o
- insomnia
|
- o
- feeling like you do not care about things you usually care about (apathy)
|
- o
- depression
|
- o
- anxiety
|
-
- After you have stopped taking ropinirole tablets, your healthcare provider may need to restart you at a low dose of ropinirole tablets or ropinirole extended-release tablets if you get severe withdrawal symptoms
- •
-
Changes in RLS symptoms. Ropinirole tablets may cause RLS to come back in the morning (rebound), happen earlier in the evening, or even happen in the afternoon.
What are ropinirole tablets?
Ropinirole tablets are a prescription medicine containing ropinirole used to treat moderate-to-severe primary RLS. It is also used to treat Parkinson’s disease.
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 tablets are safe and effective for use in children younger than 18 years of age.
Do not take ropinirole tablets if you:
- •
- are allergic to ropinirole or any of the ingredients in ropinirole tablets. See the end of this page for a complete list of the ingredients in ropinirole tablets.
- •
- Get help right away if any of the symptoms of an allergic reaction cause problems swallowing or breathing. Call your healthcare provider if you have any of the symptoms of an allergic reaction. Symptoms of an allergic reaction may include:
- •
- hives
- •
- rash
- •
- swelling of the face, lips, mouth, tongue, or throat
- •
- itching
Before taking ropinirole tablets, tell your healthcare provider about all of your medical conditions, including if you:
- •
- have daytime sleepiness from a sleep disorder or have unexpected or unpredictable sleepiness or periods of sleep.
- •
- start or stop taking other medicines while you are taking ropinirole tablets. This may increase your chances of getting side effects.
- •
- start or stop smoking while you are taking ropinirole tablets. Smoking may decrease the treatment effect of ropinirole tablets.
- •
- feel dizzy, nauseated, sweaty, or faint when you stand up from sitting or lying down.
- •
- drink alcoholic beverages. This may increase your chances of becoming drowsy or sleepy while taking ropinirole tablets.
- •
- have high or low blood pressure.
- •
- have or have had heart problems.
- •
- are pregnant or plan to become pregnant. It is not known if ropinirole tablets can harm your unborn baby.
- •
- are breastfeeding or plan to breastfeed. It is not known if ropinirole passes into your breast milk. The amount of breast milk you make may be decreased while taking ropinirole tablets. Talk to your healthcare provider to decide if you should breastfeed while taking ropinirole tablets.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of these medicines may increase your chances of getting side effects while taking ropinirole tablets.
How should I take ropinirole tablets?
- •
- Take ropinirole tablets exactly as directed by your healthcare provider.
- •
- Ropinirole tablets are usually taken once in the evening, 1 to 3 hours before bedtime.
- •
- Take ropinirole tablets with or without food.
- •
-
Do not suddenly stop taking ropinirole tablets without talking to your healthcare provider. If you stop this medicine, you may develop withdrawal symptoms (See “What is the most important information I should know about ropinirole tablets?”).
- •
- Your healthcare provider will start you on a low dose of ropinirole tablets. Your healthcare provider may change the dose until you are taking the right amount of medicine to control your symptoms.
- •
-
If you miss your dose, do not double your next dose. Take only your usual dose 1 to 3 hours before your next bedtime.
- •
- Contact your healthcare provider if you stop taking ropinirole tablets for any reason. Do not restart without talking with your healthcare provider.
What are the possible side effects of ropinirole tablets?
Ropinirole tablets can cause serious side effects, including:
- •
- See “What is the most important information I should know about ropinirole tablets?”
The most common side effects of ropinirole tablets include:
- •
- nausea or vomiting
- •
- drowsiness or sleepiness
- •
- dizziness
- •
- fatigue, tiredness, or weakness
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all of the possible side effects with ropinirole tablets. 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 tablets?
- •
- Store ropinirole tablets at room temperature between 68°F and 77°F (20°C and 25°C).
- •
- Keep ropinirole tablets in a tightly closed container and out of direct sunlight.
Keep ropinirole tablets and all medicines out of the reach of children.
General information about the safe and effective use of ropinirole tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ropinirole tablets for a condition for which it was not prescribed. Do not give ropinirole tablets to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about ropinirole tablets that is written for health professionals.
What are the ingredients in ropinirole tablets?
Active ingredient: ropinirole (as ropinirole hydrochloride)
Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Inactive ingredients of the film coats are slightly different among the 7 strengths of tablets and are tabulated below:
|
Strength
|
Inactive ingredients of the film coat
|
|
0.25 mg
|
polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide and lecithin (soya).
|
|
0.5 mg
|
polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide and iron oxide yellow.
|
|
1 mg
|
polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, FD&C Blue No. 2 aluminum lake and iron oxide yellow.
|
|
2 mg
|
polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, lecithin (soya) and iron oxide red.
|
|
3 mg
|
polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, carmine and FD&C Blue No. 1 aluminum lake.
|
|
4 mg
|
polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, iron oxide yellow and iron oxide red.
|
|
5 mg
|
polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, FD&C Blue No. 2 aluminum lake and lecithin (soya).
|
Distributed by:
Solco Healthcare US, LLC
Somerset, NJ 08873, USA
Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China
For more information call 1-866-257-2597.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 05/2022