Ropinirole Hcl

Dosage Forms And Strengths

• 0.25 mg, white, film-coated tablet, imprinted with “SB” and “4890”
• 0.5 mg, yellow, film-coated tablet, imprinted with “SB” and “4891”
• 1 mg, green, film-coated tablet, imprinted with “SB” and “4892”
• 2 mg, pale yellowish-pink, film-coated tablet, imprinted with “SB” and “4893”
• 3 mg, pale to moderate reddish-purple, film-coated tablet, imprinted with “SB” and “4895”
• 4 mg, pale brown, film-coated tablet, imprinted with “SB” and “4896”
• 5 mg, blue, film-coated tablet imprinted with “SB” and “4894”

Storage And Handling

Each pentagonal film-coated TILTAB® tablet with beveled edges contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows:

0.25 mg: white tablets imprinted with “SB” and “4890” in bottles of 100 (NDC 0007-4890- 20)

0.5 mg: yellow tablets imprinted with “SB” and “4891” in bottles of 100 (NDC 0007-4891- 20)

1 mg: green tablets imprinted with “SB” and “4892” in bottles of 100 (NDC 0007-4892-20)

2 mg: pale yellowish-pink tablets imprinted with “SB” and “4893” in bottles of 100 (NDC 0007-4893-20)

3 mg: pale to moderate reddish-purple tablets, imprinted with “SB” and “4895” in bottles of 100 (NDC 0007-4895-20)

4 mg: pale brown tablets imprinted with “SB” and “4896” in bottles of 100 (NDC 0007- 4896-20)

5 mg: blue tablets imprinted with “SB” and “4894” in bottles of 100 (NDC 0007-4894-20)

Store at controlled room temperature 20° - 25°C (68° - 77°F) [see USP]. Protect from light and moisture. Close container tightly after each use.

GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: August 2014

Included as part of the PRECAUTIONS section.

Ropinirole may cause you to fall asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. If you are unsure of how this medicine will affect you, be careful if you drive or do anything that requires you to be awake and alert.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking ropinirole.

Do not share this medication with another person, even if they have the same symptoms you do.

Avoid drinking alcohol, which can increase some of the side effects of ropinirole.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by ropinirole. Tell your doctor if you regularly use any of these other medicines.

Ropinirole may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you experience hallucinations.

Do not stop using ropinirole or change your dose without first talking to your doctor. You may have side effects such as fever, muscle stiffness, and confusion if you stop the medication suddenly or if you change doses.

Some people taking medicines for Parkinson's disease have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk than most people for developing melanoma. Talk to your doctor about your specific risk and what skin symptoms to watch for. You may need to have regular skin exams.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Ropinirole can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid smoking, which can make ropinirole less effective.

Avoid drinking alcohol. It can increase some of the side effects of ropinirole.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

The following adverse reactions are described in more detail in other sections of the label:

• Hypersensitivity [see CONTRAINDICATIONS]
• Falling Asleep during Activities of Daily Living and Somnolence [see WARNINGS AND PRECAUTIONS]
• Syncope [see WARNINGS AND PRECAUTIONS]
• Hypotension/Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
• Hallucinations/Psychotic-like Behavior [see WARNINGS AND PRECAUTIONS]
• Dyskinesia [see WARNINGS AND PRECAUTIONS]
• Impulse Control/Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]
• Withdrawal-emergent Hyperpyrexia and Confusion [see WARNINGS AND PRECAUTIONS]
• Melanoma [see WARNINGS AND PRECAUTIONS]
• Augmentation and Early-morning rebound in RLS [see WARNINGS AND PRECAUTIONS]
• Fibrotic Complications [see WARNINGS AND PRECAUTIONS]

Clinical 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 REQUIP, patients received REQUIP either without L-dopa (early Parkinson's disease trials) or as concomitant therapy with L-dopa (advanced Parkinson's 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.

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 REQUIP (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 REQUIP 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 REQUIP (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 REQUIP participating in the doubleblind, placebo-controlled trials and were numerically more common than the incidence for placebo-treated patients. In these trials, either REQUIP 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 Parkinson's Disease (without L-dopa) Trials (Events ≥ 2% of Patients Treated with REQUIP and Numerically More Frequent than the Placebo Group)a

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 REQUIP (incidence at least 5 % greater than placebo) were dyskinesia, somnolence, nausea, dizziness, confusion, hallucinations, increased sweating, and headache.

Approximately 24% of patients who received REQUIP 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 REQUIP (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 REQUIP 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 REQUIP or placebo was used as an adjunct to L-dopa.

Table 4: Treatment-emergent Adverse Reaction Incidence in Double-blind, Placebocontrolled Advanced Parkinson's Disease (with L-dopa) Trials (Events ≥ 2% of Patients Treated with REQUIP and Numerically More Frequent than the Placebo Group)a

Restless Legs Syndrome

In the double-blind, placebo-controlled trials in patients with RLS, the most commonly observed adverse reactions in patients treated with REQUIP (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 REQUIP 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 REQUIP (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 REQUIP 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, Placebocontrolled RLS Trials (Events ≥ 2% of Patients Treated with REQUIP and Numerically More Frequent than the Placebo Group)a

Read the entire FDA prescribing information for Requip (Ropinirole Hcl)