Ropinirole Hydrochloride (Ropinirole Hydrochloride)

Trade Name

ROPINIROLE HYDROCHLORIDE

Active Ingredient

Power

0.25 mg/1

Type / form

Tablets

Status

Manufacturer

Major Pharmaceuticals

Storage and handling for ROPINIROLE HYDROCHLORIDE

ROPINIROLE HYDROCHLORIDE Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ropinirole Hydrochloride (Ropinirole Hydrochloride) which is also known as ROPINIROLE HYDROCHLORIDE and Manufactured by Major Pharmaceuticals. It is available in strength of 0.25 mg/1 per ml. Read more

Ropinirole Hydrochloride (Ropinirole Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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  • No data
  • Dosage and Administration (2.3)u00a0u00a0u00a0u00a0u00a0u00a0 9/2016
  • Warnings and Precautions (5.7, 5.9)u00a0u00a0 9/2016
  • Ropinirole Tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinsonu2019s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS) (1.1, 1.2).u00a0
  • u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Ropinirole tablets u00a0can be taken with or without u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 food (2.1)
  • u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Retitration of ropinirole tablets may be warranted if therapy u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 is interrupted (2.1)
  • Parkinsonu2019s Disease:
  • u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 The recommended starting dose is 0.25 mg taken three times daily; titrate to a maximum daily dose of 24 mg (2.2)
  • u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Renal Impairment: The maximum recommended dose is 18 mg/day in patients with end-stage renal disease on hemodialysis u00a0u00a0 (2.2)
  • Restless Legs Syndrome:
  • u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 The recommended starting dose is 0.25 mg once daily, 1 to 3 hours before bedtime, titrate to a maximum recommended dose of 4 mg daily (2.3)
  • u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Renal Impairment: The maximum recommended dose is 3 mg/day in patients with end-stage renal disease on hemodialysis (2.3)
  • Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, and 5 mg (3)
  • Ropinirole tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients.
  • History of hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients (4)
  • u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Sudden onset of sleep and somnolence may occur (5.1)
  • u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Syncope may occur (5.2)
  • u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Hypotension, including orthostatic hypotension may occur (5.3)
  • u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 May cause hallucinations and psychotic-like behaviors (5.4)
  • u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 May cause or exacerbate dyskinesia (5.5)
  • u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 May cause problems with impulse control or compulsive behaviors u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 (5.6)
  • The following adverse reactions are described in more detail in other sections of the label:
  • 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.
  • Parkinsonu2019s Disease
  • During the premarketing development of ropinirole tablets, patients received ropinirole tablets either without L-dopa (early Parkinsonu2019s disease trials) or as concomitant therapy with L-dopa (advanced Parkinsonu2019s disease trials). Because these two populations may have differential risks for various adverse reactions, this section will in general present adverse reaction data for these two populations separately.
  • Early Parkinsonu2019s Disease (without L-dopa)
  • In the double-blind, placebo-controlled trials in patients with early-stage Parkinsonu2019s disease, the most commonly observed adverse reactions in patients treated with ropinirole tablets (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 tablets who participated in the double-blind, placebo-controlled early Parkinsonu2019s 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 tablets (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 Parkinsonu2019s disease (without L-dopa) treated with ropinirole tablets 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 tablets or placebo was used as early therapy (i.e., without L-dopa).
  • Table 3. Treatment-Emergent Adverse Reaction Incidence in Double-blind, Placebo-Controlled Early Parkinsonu2019s Disease (without L-dopa) Trials (Events u22652% of Patients Treated with ropinirole tablets and Numerically More Frequent than the Placebo Group)n
  • Advanced Parkinsonu2019s Disease (with L-dopa)
  • In the double-blind, placebo-controlled trials in patients with advanced-stage Parkinsonu2019s disease, the most commonly observed adverse reactions in patients treated with ropinirole tablets (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 tablets in the double-blind, placebo-controlled advanced Parkinsonu2019s 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 tablets (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 Parkinsonu2019s disease (with L-dopa) treated with ropinirole tablets u00a0who 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 tablets or placebo was used as an adjunct to L-dopa.
  • Table 4. Treatment-Emergent Adverse Reaction Incidence in Double-blind, Placebo-Controlled Advanced Parkinsonu2019s Disease (with L-dopa) Trials (Events u22652% of Patients Treated with ropinirole tablets and Numerically More Frequent than the Placebo Group)n
  • 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 tablets (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 tablets 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 tablets (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 tablets participating in the 12-week, double-blind, placebo-controlled trials and were numerically more common than the incidence for placebo-treated patients.
  • Table 5. Treatment-Emergent Adverse Reaction Incidence in Double-blind, Placebo- Controlled RLS Trials (Events u22652% of Patients Treated with ropinirole tablets and Numerically More Frequent than the Placebo Group)n
  • thus, patients may be included in more than one category.
  • Most common adverse reactions (incidence with ropinirole tablets at least 5% greater than placebo) in the respective indications were:
  • To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Inhibitors or inducers of CYP1A2: May alter the clearance of u00a0u00a0u00a0 ropinirole tablets; dose adjustment of ropinirole tablets may be required (7.1,u00a012.3)
  • u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Hormone replacement therapy(HRT): Starting or stopping HRTu00a0may require dose adjustment of ropinirole tablets u00a0(7.2, 12.3)
  • u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Dopamine antagonists (e.g., neuroleptics, metoclopramide): Mayu00a0reduce efficacy of ropinirole tablets (7.3)
  • Pregnancy: Based on animal data, may cause fetal harm. (8.1)
  • The symptoms of overdose with ropinirole tablets are related to its dopaminergic activity. General supportive measures are recommended. Vital signs should be maintained, if necessary.
  • In the 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 casesu00a0of overdoseu00a0included vomiting, increased coughing, fatigue, syncope, vasovagal syncope, dyskinesia, agitation, chest pain, orthostatic hypotension, somnolence, and confusional state.
  • Ropinirole tablets contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-oneu00a0 and the empirical formula is CHNOu2022HCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is:n n
  • Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243u00b0 to 250u00b0C and a solubility of 133 mg/mL in water. Each circular, biconvex, film-coated tablets contains ropinirole hydrochloride USP equivalent to ropinirole free base, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg, respectively. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake, hypromellose, iron oxides (iron oxide yellow, iron oxide red and iron oxide black), polyethylene glycol, polysorbate 80, titanium dioxide.
  • No data
  • Carcinogenesis
  • Two-year carcinogenicity studies of ropinirole were conducted in mice at oral doses of 0, 5, 15, and 50 mg/kg/day and in rats at oral doses of 0, 1.5, 15, and 50 mg/kg/day.
  • In rats, there was an increase in testicular Leydig cell adenomas at all doses tested. The lowest dose tested (1.5 mg/kg/day) is less than the MRHD for Parkinsonu2019s disease (24 mg/day) on a mg/mbasis. The endocrine mechanisms believed to be involved in the production of these tumors in rats are not considered relevant to humans.
  • In mice, there was an increase in benign uterine endometrial polyps at a dose of 50 mg/kg/day. The highest dose not associated with this finding (15 mg/kg/day) isu00a03 times the MRHD on a mg/mbasis.
  • Mutagenesis
  • Ropinirole was not mutagenic or clastogenic in (Ames, chromosomal aberration in human lymphocytes, mouse lymphoma ) assays, or in the mouse micronucleus test.
  • Impairment of Fertility
  • When administered to female rats prior to and during mating and throughout pregnancy, ropinirole caused disruption of implantation at oral doses of 20 mg/kg/day (8 times the MRHD on a mg/mbasis) or greater. This effect in rats is thought to be due to the prolactin-lowering effect of ropinirole. In rat studies using a low oral dose (5 mg/kg) during the prolactin-dependent phase of early pregnancy (gestation days 0 to 8), ropinirole did not affect female fertility at oral doses up to 100 mg/kg/day (40 times the MRHD on a mg/mbasis). No effect on male fertility was observed in rats at oral doses up to 125 mg/kg/day (50 times the MRHD on a mg/mbasis).
  • No data
  • Ropinirole Tablets:
  • Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6373-61u00a0
  • 1 mg: green tablets debossed with u201cHu201d on one side and u201c123u201d on other side
  • Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6374-61u00a0
  • STORAGE: Protect from light and moisture. Close container tightly after each use.
  • Store at controlled room temperature 20u00b0-25u00b0C (68u00b0-77u00b0F) [see USP].
  • Advise the patient to read the FDA-approved patient labeling (Patient Information). n n 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 n 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 n- [see Contraindications (4)].
  • Falling Asleep during Activities of Daily Living and Somnolence n- [see Warnings and Precautions (5.1)].
  • Syncope and Hypotension/Orthostatic Hypotension n- [see Warnings and Precautions (5.2, 5.3)].
  • Hallucinations/Psychotic-like Behavior n- [see Warnings and Precautions (5.4)].
  • Dyskinesia n- [see Warnings and Precautions (5.5)].
  • Impulse Control/Compulsive Behaviors n- [see Warnings and Precautions (5.6)]. n- Withdrawal-Emergent Hyperpyrexia and Confusion n- [see Warnings and Precautions (5.7)].
  • Melanoma n- [see Warnings and Precautions (5.8)].
  • Augmentation and Rebound n- [see Warnings and Precautions (5.9)].
  • Nursing Mothers n- [see Use in Specific Populations (8.2n- ].
  • Pregnancy n- [see Use in Specific Populations (8.1)].n- http://www.alembicusa.com/medicationguide.aspxn- Alembic Pharmaceuticals Limitedn- Alembic Pharmaceuticals, Inc.
  • Revised: 01/2019n PHARMACIST DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
  • Ropinirole (roe PIN i role) Tablets USP
  • If you have Parkinsonu2019s disease, read this side. n- If you have Restless Legs Syndrome (RLS), read the other side.
  • What is the most important information I should know about ropinirole tablets?
  • Ropinirole tablets can cause serious side effects including: u2022u00a0 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. u2022u00a0 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,u00a0 feel dizzy, or light-headed. u00a0 Ropinirole tablets can decrease your blood pressureu00a0u00a0(hypotension)u00a0 especially when u00a0you u00a0start taking ropinirole tablets or when your dose is changed. If you faint or feel dizzy, u00a0nauseated, or sweaty when you stand up from sitting or lying u00a0down (orthostatic u00a0hypotension), this may mean that your blood pressure is decreased. When you change u00a0position from lying down or sitting to standing up, you should do it u00a0carefully and u00a0slowly. Call your healthcare provider if you have any of the symptoms of u00a0decreased u00a0blood pressure listed above. u2022u00a0 Ropinirole tablets can decrease or increase your heart rate. u2022u00a0 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 Parkinsonu2019s disease who are taking ropinirole tablets taking higher doses of these drugs. If you have hallucinations or any of these other psychotic-like changes, talk with your healthcare provider. u2022u00a0 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-Parkinsonu2019s medicine may need to be changed. u2022u00a0 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. u2022u00a0 People with Parkinsonu2019s disease may have a higher chance of getting melanoma. It is not known if ropinirole 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 is ropinirole tablet?
  • 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.
  • Who should not take ropinirole tablets? n- Do not take ropinirole tablet if you:
  • 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 theu00a0 symptoms of an allergic reaction. Symptoms of an allergic reaction may include: u2022u00a0hives u2022rash u2022u00a0swelling of the face, lips, mouth, tongue, or throat u2022itching
  • Before taking ropinirole tablet, tell your healthcare provider about all of your medical conditions, including if you: n- How should I take ropinirole tablets?u00a0 n- Do notn- do not double the dose.n- It may take several weeks before you reach a dose that controls your symptoms.
  • If you are taking ropinirole tablets:
  • What are the possible side effects of ropinirole tablets? n- Ropinirole tablets can cause serious side effects, including: n- See u201cWhat is the most important informationu00a0I should know about ropinirole tablets?u201d
  • These are not all the 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?
  • Keep ropinirole tablets and all medicines out of the reach of children. n- General information about the safe and effective use of ropinirole tablets:
  • You can ask your pharmacist or healthcare provider for information about ropinirole tabletsu00a0 that is written for health professionals.u00a0 For more information call Alembic Pharmaceuticals Limited at 1-866-210-9797.u00a0
  • Whatu00a0are u00a0the ingredients in ropinirole tablets? n- The following ingredients are in ropinirole tablets: n- Active ingredient:n- Inactive ingredients:n- http://www.alembicusa.com/medicationguide.aspx
  • Manufactured by: Aln (Formulation Division), Panelav 389350, Gujarat, Indian n Manufactured for:n n 750 Route 202, Bridgewater, NJ 08807 USA
  • Revised: 01/2019n PHARMACIST DETACH HERE AND GIVE INSTRUCTIONS TO PATIENTn n n n n n n n u00a0
  • People with RLS should take ropinirole tablets differently than people with parkinsonu2019s disease (see u201c for the recommended dosing forRLS).u00a0A lower dose of ropinirole tabletu00a0 is generally needed for people with RLS, and is taken once daily before bedtime. n n Ropinirole tablets can cause serious side effects, including:
  • . 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. u2022u00a0 Fainting can happen, and sometimes your heart rate may be decreased. This can happen especially when you start taking ropinirole tabletsu00a0 or your dose is increased. Tell your healthcare provider if you faint,u00a0feel dizzy, or light-headed. u2022u00a0 Ropinirole tablet can decrease your blood pressure (hypotension), especially when you start taking ropinirole tablet or when your dose is changed. If youu00a0faint 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. u2022u00a0 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 Parkinsonu2019s 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. u2022u00a0. 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-Parkinsonu2019s medicine may need to be changed. n u2022u00a0 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. u2022u00a0 It is not known if ropinirole tablets increases your chance 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. u2022u00a0 Ropinirole tablets may cause restless legs symptoms to come back in the morning (rebound), happen earlier in the evening, or even happen in the afternoon.
  • What is ropinirole tablet? n- Do not take ropinirole tablets if you:
  • 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 theu00a0 symptoms of an allergic reaction. Symptoms of an allergic reaction may include: u2022u00a0hives u2022u00a0rash u2022u00a0swelling of the face, lips, mouth, tongue, or throat u2022itching
  • Before taking ropinirole tablet, tell your healthcare provider about all your medical conditions, including if you:
  • 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. u00a0n n n u2022u00a0Take ropinirole tablets exactly as directed by your healthcare provider. u2022u00a0Ropinirole tablets are usually taken once in the evening, 1 to 3 hours before bedtime. u2022u00a0Take ropinirole tablets with or without food. u2022u00a0Do not suddenly stop taking ropinirole tablets without talking to your healthcare provider. If you stop this medicine suddenly, you may develop fever, confusion, or severe muscle stiffness. u2022u00a0Your 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. n u2022u00a0 Take only your usual dose 1 to 3 hours before your next bedtime. u2022u00a0Contact your healthcare provideru00a0if you stop taking ropinirole tablets for any reason. Do not restart withoutu00a0talking with u00a0your healthcare provider. u2022u00a0You can take ropinirole tablets with or without food. n n n n u2022u00a0n The most common side effects of ropinirole tablets include: u2022u00a0nausea or vomiting u2022u00a0drowsiness or sleepiness u2022u00a0dizziness u2022u00a0fatigue, tiredness, or weakness
  • Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the 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. n n n u2022u00a0Store ropinirole tabletsu00a0 at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F), [See USP]. Protect from light and moisture.
  • Keep ropinirole tablet and all medicines out of the reach of children. n- 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 youru00a0 pharmacistu00a0 or healthcare provideru00a0for information about ropinirole tablets that is written for health professionals.u00a0 n For more information call Alembic Pharmaceuticals Limited at 1-866-210-9797.n n n n ropinirole (as ropinirole hydrochloride) n croscarmellose sodium, hydrous lactose, magnesium stearate, microcrystalline cellulose, and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake, hypromellose, iron oxides, polyethylene glycol, polysorbate 80, titanium dioxide.
  • This Patient Information has been approved by the U.S. Food and Drug Administration. Medication Guide available at or call 1-866-210-9797.
  • Manufactured by:n n (Formulation Division), Panelav 389350, Gujarat, India
  • Manufactured for:n n 750 Route 202, Bridgewater, NJ 08807 USA
  • Revised: 01/2019
  • rOPINIRole Tablets, USP
  • 0.25 mg*
  • 100 Tablets
  • rOPINIRole Tablets, USP
  • 1 mg*
  • 100 Tablets

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