Brand Name
Ropinirole
View Brand InformationFDA approval date: February 25, 2010
Classification: Nonergot Dopamine Agonist
Form: Tablet
What is Ropinirole?
Parkinson’s Disease Ropinirole tablets are indicated for the treatment of Parkinson’s disease.
Approved To Treat
Save this treatment for later
Not sure about your diagnosis?
Tired of the same old research?
Related Clinical Trials
Gene Expression Changes on Extended Use of Dopamine Agonists in Restless Legs Syndrome (RLS)
Summary: The study aims to observe changes in dopaminergic genes expression in peripheral tissue upon prolonged dopamine agonist treatment on patients with Restless Legs Syndrome (RLS). Similar studies in Parkinson's disease have shown changes in alpha-synuclein expression, which might offer insights into the dopaminergic gene regulation seen in RLS. The dopamine agonist drugs to be included in this study ...
Gait Pattern Analysis in Neurological Disease
Summary: The purpose of this study is to investigate whether speed-dependent measures of gait can be identified in patients with neurological conditions that affect gait, particularly in subjects with parkinsonian disorders.
Related Latest Advances
Brand Information
Ropinirole (Ropinirole)
1DOSAGE FORMS AND STRENGTHS
- 0.5 mg, pale yellow coloured, modified oval shaped, biconvex, film-coated tablet debossed with “106” on one side and “RH” on the other side
2CONTRAINDICATIONS
Ropinirole is contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients.
3ADVERSE REACTIONS
The following adverse reactions are described in more detail in other sections of the label:
• Hypersensitivity [
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug (or of another development program of a different formulation of the same drug) and may not reflect the rates observed in practice.
Parkinson's Disease
During the premarketing development of ropinirole, patients received ropinirole either without L-dopa (early Parkinson's disease trials) or as concomitant therapy with L-dopa (advanced Parkinson's disease trials). Because these 2 populations may have differential risks for various adverse reactions, this section will in general present adverse reaction data for these 2 populations separately.
During the premarketing development of ropinirole, patients received ropinirole either without L-dopa (early Parkinson's disease trials) or as concomitant therapy with L-dopa (advanced Parkinson's disease trials). Because these 2 populations may have differential risks for various adverse reactions, this section will in general present adverse reaction data for these 2 populations separately.
Early Parkinson's Disease (without L-dopa):
In the double-blind, placebo-controlled trials in patients with early-stage Parkinson's disease, the most commonly observed adverse reactions in patients treated with ropinirole (incidence at least 5% greater than placebo) were nausea, somnolence, dizziness, syncope, asthenic condition (i.e., asthenia, fatigue, and/or malaise), viral infection, leg edema, vomiting, and dyspepsia.
In the double-blind, placebo-controlled trials in patients with early-stage Parkinson's disease, the most commonly observed adverse reactions in patients treated with ropinirole (incidence at least 5% greater than placebo) were nausea, somnolence, dizziness, syncope, asthenic condition (i.e., asthenia, fatigue, and/or malaise), viral infection, leg edema, vomiting, and dyspepsia.
Approximately 24% of patients treated with ropinirole who participated in the double-blind, placebo-controlled early Parkinson's disease (without L-dopa) trials discontinued treatment due to adverse reactions compared with 13% of patients who received placebo. The most common adverse reactions in patients treated with ropinirole (incidence at least 2% greater than placebo) of sufficient severity to cause discontinuation were nausea and dizziness.
Table 3 lists treatment-emergent adverse reactions that occurred in at least 2% of patients with early Parkinson's disease (without L-dopa) treated with ropinirole participating in the double-blind, placebo-controlled trials and were numerically more common than the incidence for placebo-treated patients. In these trials, either ropinirole or placebo was used as early therapy (i.e., without L-dopa).
aPatients may have reported multiple adverse reactions during the trial or at discontinuation; thus, patients may be included in more than one category.
bAsthenic condition (i.e., asthenia, fatigue, and/or malaise).
Advanced Parkinson's Disease (with L-dopa):
In the double-blind, placebo-controlled trials in patients with advanced-stage Parkinson's disease, the most commonly observed adverse reactions in patients treated with ropinirole (incidence at least 5 % greater than placebo) were dyskinesia, somnolence, nausea, dizziness, confusion, hallucinations, increased sweating, and headache.
In the double-blind, placebo-controlled trials in patients with advanced-stage Parkinson's disease, the most commonly observed adverse reactions in patients treated with ropinirole (incidence at least 5 % greater than placebo) were dyskinesia, somnolence, nausea, dizziness, confusion, hallucinations, increased sweating, and headache.
Approximately 24% of patients who received ropinirole in the double-blind, placebo-controlled advanced Parkinson's disease (with L-dopa) trials discontinued treatment due to adverse reactions compared with 18% of patients who received placebo. The most common adverse reaction in patients treated with ropinirole (incidence at least 2% greater than placebo) of sufficient severity to cause discontinuation was dizziness.
Table 4 lists treatment-emergent adverse reactions that occurred in at least 2% of patients with advanced Parkinson's disease (with L-dopa) treated with ropinirole who participated in the double-blind, placebo-controlled trials and were numerically more common than the incidence for placebo-treated patients. In these trials, either ropinirole or placebo was used as an adjunct to L-dopa.
aPatients may have reported multiple adverse reactions during the trial or at discontinuation; thus, patients may be included in more than one category.
Restless Legs Syndrome
In the double-blind, placebo-controlled trials in patients with RLS, the most commonly observed adverse reactions in patients treated with ropinirole (incidence at least 5% greater than placebo) were nausea, vomiting, somnolence, dizziness, and asthenic condition (i.e., asthenia, fatigue, and/or malaise).
In the double-blind, placebo-controlled trials in patients with RLS, the most commonly observed adverse reactions in patients treated with ropinirole (incidence at least 5% greater than placebo) were nausea, vomiting, somnolence, dizziness, and asthenic condition (i.e., asthenia, fatigue, and/or malaise).
Approximately 5% of patients treated with ropinirole who participated in the double-blind, placebo-controlled trials in the treatment of RLS discontinued treatment due to adverse reactions compared with 4% of patients who received placebo. The most common adverse reaction in patients treated with ropinirole (incidence at least 2% greater than placebo) of sufficient severity to cause discontinuation was nausea.
Table 5 lists treatment-emergent adverse reactions that occurred in at least 2% of patients with RLS treated with ropinirole participating in the 12 week, double-blind, placebo-controlled trials and were numerically more common than the incidence for placebo-treated patients.
aPatients may have reported multiple adverse reactions during the trial or at discontinuation; thus, patients may be included in more than one category.
bAsthenic condition (i.e., asthenia, fatigue, and/or malaise).
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of ropinirole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General Disorders and Administration Site Conditions
Withdrawal symptoms [ see Warnings and Precautions (5.8)]
Withdrawal symptoms [ see Warnings and Precautions (5.8)]
4OVERDOSAGE
The symptoms of overdose with ropinirole are related to its dopaminergic activity. General supportive measures are recommended. Vital signs should be maintained, if necessary.
In clinical trials, there have been patients who accidentally or intentionally took more than their prescribed dose of ropinirole. The largest overdose reported with ropinirole in clinical trials was 435 mg taken over a 7 day period (62.1 mg/day). Of patients who received a dose greater than 24 mg/day, reported symptoms included adverse events commonly reported during dopaminergic therapy (nausea, dizziness), as well as visual hallucinations, hyperhidrosis, claustrophobia, chorea, palpitations, asthenia, and nightmares. Additional symptoms reported in cases of overdose included vomiting, increased coughing, fatigue, syncope, vasovagal syncope, dyskinesia, agitation, chest pain, orthostatic hypotension, somnolence, and confusional state.
5DESCRIPTION
Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C
The structural formula is:
Ropinirole hydrochloride, USP is a pale cream to yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water.
Each modified oval shaped, biconvex film-coated tablet contains 0.29 mg, 0.57 mg, 1.14 mg, 2.28 mg, 3.42 mg, 4.56 mg, or 5.70 mg ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of microcrystalline cellulose, lactose monohydrate, citric acid monohydrate, croscarmellose sodium, magnesium stearate.
0.25 mg tablet contains opadry white. The components of opadry white are hypromellose, titanium dioxide, polyethylene glycol 6000 and polysorbate 80.
0.5 mg tablet contains opadry yellow. The components of opadry yellow are hypromellose, titanium dioxide, polyethylene glycol 6000, iron oxide yellow and polysorbate 80.
1 mg tablet contains opadry green. The components of opadry green are hypromellose, titanium dioxide, triacetin, iron oxide yellow and FD&C Blue No. 2.
2 mg tablet contains opadry pink. The components of opadry pink are hypromellose, titanium dioxide, polyethylene glycol 6000, iron oxide red and polysorbate 80.
3 mg tablet contains opadry purple. The components of opadry purple are hypromellose, titanium dioxide, carmine, polyethylene glycol 400, polysorbate 80 and FD&C Blue No. 1.
4 mg tablet contains opadry brown. The components of opadry brown are hypromellose, titanium dioxide, iron oxide red, polyethylene glycol 400, FD&C Blue No. 2, polysorbate 80 and iron oxide black. Also contains FD&C yellow No. 6 as a color additive.
5 mg tablet contains opadry blue. The components of opadry blue are hypromellose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 and polysorbate 80.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Dosing Instructions
Instruct patients to take ropinirole tablets only as prescribed. If a dose is missed, advise patients not to double their next dose. Ropinirole tablets can be taken with or without food [see Dosage and Administration (2.1)].
Instruct patients to take ropinirole tablets only as prescribed. If a dose is missed, advise patients not to double their next dose. Ropinirole tablets can be taken with or without food [see Dosage and Administration (2.1)].
Ropinirole is the active ingredient in ropinirole tablets (the immediate-release formulation). Ask your patients if they are taking another medication containing ropinirole.
Hypersensitivity/Allergic Reactions
Advise patients about the potential for developing a hypersensitivity/allergic reaction including manifestations such as urticaria, angioedema, rash, and pruritus when taking any ropinirole product. Inform patients who experience these or similar reactions to immediately contact their healthcare professional [see Contraindications (4)].
Advise patients about the potential for developing a hypersensitivity/allergic reaction including manifestations such as urticaria, angioedema, rash, and pruritus when taking any ropinirole product. Inform patients who experience these or similar reactions to immediately contact their healthcare professional [see Contraindications (4)].
Falling Asleep during Activities of Daily Living and Somnolence
Alert patients to the potential sedating effects caused by ropinirole tablets, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Because somnolence is a frequent adverse reaction with potentially serious consequences, patients should not drive a car, operate machinery, or engage in other potentially dangerous activities until they have gained sufficient experience with ropinirole tablets to gauge whether or not it adversely affects their mental and/or motor performance. Advise patients that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., conversations, eating, driving a motor vehicle) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician.
Alert patients to the potential sedating effects caused by ropinirole tablets, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Because somnolence is a frequent adverse reaction with potentially serious consequences, patients should not drive a car, operate machinery, or engage in other potentially dangerous activities until they have gained sufficient experience with ropinirole tablets to gauge whether or not it adversely affects their mental and/or motor performance. Advise patients that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., conversations, eating, driving a motor vehicle) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician.
Advise patients of possible additive effects when patients are taking other sedating medications, alcohol, or other central nervous system depressants (e.g., benzodiazepines, antipsychotics, antidepressants) in combination with ropinirole tablets or when taking a concomitant medication (e.g., ciprofloxacin) that increases plasma levels of ropinirole
Syncope and Hypotension/Orthostatic Hypotension
Advise patients that they may experience syncope and may develop hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating while taking ropinirole tablets, especially if they are elderly. Hypotension and/or orthostatic symptoms may occur more frequently during initial therapy or with an increase in dose at any time (cases have been seen after weeks of treatment). Postural/orthostatic symptoms may be related to sitting up or standing. Accordingly, caution patients against standing rapidly after sitting or lying down, especially if they have been doing so for prolonged periods and especially at the initiation of treatment with ropinirole tablets [see Warnings and Precautions (5.2, 5.3)].
Advise patients that they may experience syncope and may develop hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating while taking ropinirole tablets, especially if they are elderly. Hypotension and/or orthostatic symptoms may occur more frequently during initial therapy or with an increase in dose at any time (cases have been seen after weeks of treatment). Postural/orthostatic symptoms may be related to sitting up or standing. Accordingly, caution patients against standing rapidly after sitting or lying down, especially if they have been doing so for prolonged periods and especially at the initiation of treatment with ropinirole tablets [see Warnings and Precautions (5.2, 5.3)].
Hallucinations/Psychotic-Like Behavior
Inform patients that they may experience hallucinations (unreal visions, sounds, or sensations), and that other psychotic-like behavior can occur while taking ropinirole tablets. In patients with Parkinson’s disease, the elderly are at greater risk than younger patients. This risk is greater in patients who are taking ropinirole tablets with L-dopa or taking higher doses of ropinirole tablets and may also be further increased in patients taking any other drugs that increase dopaminergic tone. Tell patients to report hallucinations or psychotic-like behavior to their healthcare provider promptly should they develop [
Dyskinesia
Inform patients that ropinirole tablets may cause and/or exacerbate pre-existing dyskinesias [ see Warnings and Precautions (5.5)].
Inform patients that ropinirole tablets may cause and/or exacerbate pre-existing dyskinesias [ see Warnings and Precautions (5.5)].
Impulse Control/Compulsive Behaviors
Advise patients that they may experience impulse control and/or compulsive behaviors while taking ropinirole tablets. Advise patients to inform their physician or healthcare provider if they develop new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while being treated with ropinirole tablets. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking ropinirole tablets [ see Warnings and Precautions (5.6)].
Advise patients that they may experience impulse control and/or compulsive behaviors while taking ropinirole tablets. Advise patients to inform their physician or healthcare provider if they develop new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while being treated with ropinirole tablets. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking ropinirole tablets [ see Warnings and Precautions (5.6)].
Withdrawal-Emergent Hyperpyrexia and Confusion
Advise patients to contact their healthcare provider if they wish to discontinue ropinirole tablets or decrease the dose of ropinirole tablets. Advise patients who have been prescribed a lower dose or who have been withdrawn from the drug to notify their healthcare provider if they present with fever, muscular rigidity, or altered consciousness [ see Warnings and Precautions (5.7)].
Advise patients to contact their healthcare provider if they wish to discontinue ropinirole tablets or decrease the dose of ropinirole tablets. Advise patients who have been prescribed a lower dose or who have been withdrawn from the drug to notify their healthcare provider if they present with fever, muscular rigidity, or altered consciousness [ see Warnings and Precautions (5.7)].
Withdrawal Symptoms
Advise patients that withdrawal symptoms may occur during or after discontinuation or dose reduction of ropinirole tablets. Advise patients who have been prescribed a lower dose or who have been withdrawn from the drug to notify their healthcare provider if they have withdrawal symptoms such as apathy, anxiety, depression, fatigue, insomnia, sweating, or pain. Notify patients that in case of severe withdrawal symptoms, a trial re-administration of a dopamine agonist at the lowest effective dose may be considered [ see Warnings and Precautions (5.8)].
Advise patients that withdrawal symptoms may occur during or after discontinuation or dose reduction of ropinirole tablets. Advise patients who have been prescribed a lower dose or who have been withdrawn from the drug to notify their healthcare provider if they have withdrawal symptoms such as apathy, anxiety, depression, fatigue, insomnia, sweating, or pain. Notify patients that in case of severe withdrawal symptoms, a trial re-administration of a dopamine agonist at the lowest effective dose may be considered [ see Warnings and Precautions (5.8)].
Augmentation and Rebound
Inform patients with RLS that augmentation and/or rebound may occur after starting treatment with ropinirole tablets [ see Warnings and Precautions (5.9)].
Inform patients with RLS that augmentation and/or rebound may occur after starting treatment with ropinirole tablets [ see Warnings and Precautions (5.9)].
Nursing Mothers
Because of the possibility that ropinirole may be excreted in breast milk, discuss the developmental and health benefits of breastfeeding along with the mother’s clinical need for ropinirole tablets and any potential adverse effects on the breastfed child from ropinirole or from the underlying maternal condition [ see Use in Specific Populations (8.2)].
Because of the possibility that ropinirole may be excreted in breast milk, discuss the developmental and health benefits of breastfeeding along with the mother’s clinical need for ropinirole tablets and any potential adverse effects on the breastfed child from ropinirole or from the underlying maternal condition [ see Use in Specific Populations (8.2)].
Advise patients that ropinirole tablets could inhibit lactation because ropinirole inhibits prolactin secretion.
Pregnancy
Because experience with ropinirole in pregnant women is limited and ropinirole has been shown to have adverse effects on embryofetal development in animals, including teratogenic effects, advise patients of this potential risk. Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy [ see Use in Specific Populations (8.1)].
Because experience with ropinirole in pregnant women is limited and ropinirole has been shown to have adverse effects on embryofetal development in animals, including teratogenic effects, advise patients of this potential risk. Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy [ see Use in Specific Populations (8.1)].
Repackaged By / Distributed By: RemedyRepack Inc.
625 Kolter Drive, Indiana, PA 15701
(724) 465-8762
7PATIENT INFORMATION
Ropinirole (roe-PIN-ih-role) Tablets, USP
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?
Ropinirole tablets can cause serious side effects including:
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.
- Increase in blood pressure.Ropinirole extended-release tablets may increase your blood pressure.
- Changes in heart rate (decrease or increase).Ropinirole tablets can decrease or increase your heart rate.
- 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 tablet is a dopamine agonist medicine. 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:
• 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, your healthcare provider may need to restart you at a low dose of ropinirole tablets if you get severe withdrawal symptoms.
What are ropinirole 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
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.
- Take ropinirole tablets with or without food.
- Do notsuddenly 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?”).
- Before starting ropinirole 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,
- Your healthcare provider will start you on a low dose of ropinirole tablets. Your healthcare provider will change the dose until you are taking the right amount of medicine to control your symptoms.
- Contact your healthcare provider if you stop taking ropinirole tablets for any reason. Do not restart without talking with your healthcare provider.
- Your healthcare provider may prescribe ropinirole tablets alone, or add ropinirole 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.
What are the possible side effects of ropinirole tablets?
Ropinirole tablets can cause serious side effects, including:
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:
- 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. 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 20°C and 25°C (68°F and 77°F).
- 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 they were not prescribed. Do not give ropinirole tablets to other people, even if they have the same symptoms that you have. They may harm them. You can ask your pharmacist or healthcare provider for information about ropinirole tablets that is written for health professionals.
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 they were not prescribed. Do not give ropinirole tablets to other people, even if they have the same symptoms that you have. They 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?
The following ingredients are in ropinirole tablets:
Active ingredient:ropinirole (as ropinirole hydrochloride)
Inactive ingredients:microcrystalline cellulose, lactose monohydrate, citric acid monohydrate, croscarmellose sodium, magnesium stearate.
Inactive ingredients:microcrystalline cellulose, lactose monohydrate, citric acid monohydrate, croscarmellose sodium, magnesium stearate.
0.25 mg tablet contains opadry white. The components of opadry white are hypromellose, titanium dioxide, polyethylene glycol 6000 and polysorbate 80.
0.5 mg tablet contains opadry yellow. The components of opadry yellow are hypromellose, titanium dioxide, polyethylene glycol 6000, iron oxide yellow and polysorbate 80.
1 mg tablet contains opadry green. The components of opadry green are hypromellose, titanium dioxide, triacetin, iron oxide yellow and FD&C Blue No. 2.
2 mg tablet contains opadry pink. The components of opadry pink are hypromellose, titanium dioxide, polyethylene glycol 6000, iron oxide red and polysorbate 80.
3 mg tablet contains opadry purple. The components of opadry purple are hypromellose, titanium dioxide, carmine, polyethylene glycol 400, polysorbate 80 and FD&C Blue No. 1.
4 mg tablet contains opadry brown. The components of opadry brown are hypromellose, titanium dioxide, iron oxide red, polyethylene glycol 400, FD&C Blue No. 2, polysorbate 80 and iron oxide black. Also contains FD&C yellow No. 6 as a color additive.
5 mg tablet contains opadry blue. The components of opadry blue are hypromellose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 and polysorbate 80.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Distributed by:
MADE IN INDIA
Revised: 5/2023
Revised: 5/2023
PATIENT INFORMATION
Ropinirole (roe-PIN-ih-role) Tablets, USP
Ropinirole (roe-PIN-ih-role) Tablets, USP
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 "
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. If you have hallucinations or any of these other psychotic-like changes, talk with your healthcare provider.
- 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 tablet is a dopamine agonist medicine. 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:
• 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, your healthcare provider may need to restart you at a low dose of ropinirole tablets if you get severe withdrawal symptoms. - Changes in RLS symptoms.Ropinirole tablets may cause RLS symptoms 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.
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 notsuddenly 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:
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 20°C and 25°C (68°F and 77°F).
- 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 they were not prescribed. Do not give ropinirole tablets to other people, even if they have the same symptoms that you have. They may harm them. You can ask your pharmacist or healthcare provider for information about ropinirole tablets that is written for health professionals.
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 they were not prescribed. Do not give ropinirole tablets to other people, even if they have the same symptoms that you have. They 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:microcrystalline cellulose, lactose monohydrate, citric acid monohydrate, croscarmellose sodium, magnesium stearate.
Active ingredient:ropinirole (as ropinirole hydrochloride)
Inactive ingredients:microcrystalline cellulose, lactose monohydrate, citric acid monohydrate, croscarmellose sodium, magnesium stearate.
0.25 mg tablet contains opadry white. The components of opadry white are hypromellose, titanium dioxide, polyethylene glycol 6000 and polysorbate 80.
0.5 mg tablet contains opadry yellow. The components of opadry yellow are hypromellose, titanium dioxide, polyethylene glycol 6000, iron oxide yellow and polysorbate 80.
1 mg tablet contains opadry green. The components of opadry green are hypromellose, titanium dioxide, triacetin, iron oxide yellow and FD&C Blue No. 2.
2 mg tablet contains opadry pink. The components of opadry pink are hypromellose, titanium dioxide, polyethylene glycol 6000, iron oxide red and polysorbate 80.
3 mg tablet contains opadry purple. The components of opadry purple are hypromellose, titanium dioxide, carmine, polyethylene glycol 400, polysorbate 80 and FD&C Blue No. 1.
4 mg tablet contains opadry brown. The components of opadry brown are hypromellose, titanium dioxide, iron oxide red, polyethylene glycol 400, FD&C Blue No. 2, polysorbate 80 and iron oxide black. Also contains FD&C yellow No. 6 as a color additive.
5 mg tablet contains opadry blue. The components of opadry blue are hypromellose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 and polysorbate 80.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762