Requip XL

DRUG DESCRIPTION

REQUIP (ropinirole) is an orally administered non-ergoline dopamine agonist. It is supplied as the hydrochloride salt of ropinirole 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and has an empirical formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base).

The structural formula is:

REQUIP XL
  (ropinirole) Structural Formula Illustration

Ropinirole hydrochloride is a white to yellow solid with a melting range of 243 to 250C and a solubility of 133 mg/mL in water. REQUIP XL (ropinirole extended release tablets) Extended-Release Tablets are formulated as a three-layered tablet with a central, active-containing, slow-release layer, and 2 placebo outer layers acting as barrier layers which control the surface area available for drug release. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, glyceryl behenate, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mannitol, povidone, and one or more of the following: FD&C Yellow No. 6 aluminum lake, FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 400, titanium dioxide.

What are the possible side effects of ropinirole (Requip, Requip XL)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling like you might pass out;
  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats (especially if you stop taking ropinirole or use a lower dose);
  • hallucinations;
  • tremors (uncontrolled shaking); or
  • tight feeling in your...

Read All Potential Side Effects and See Pictures of Requip XL

What are the precautions when taking ropinirole extended release tablets (Requip XL)?

Before taking ropinirole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease, low blood pressure, sleep disorder (such as sleep apnea, narcolepsy), mental/mood disorder, liver problems.

Some people taking ropinirole have reported falling asleep suddenly during usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without feelings of drowsiness beforehand. This effect may occur at any time during treatment, including up to 1 year after...

Read All Potential Precautions of Requip XL


Requip XL Consumer (continued)

SIDE EFFECTS: Nausea, drowsiness, dizziness, abdominal pain/discomfort, or headache may occur. If these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

You may develop a sudden drop in blood pressure, which can cause dizziness, nausea, and fainting. This is more likely when you are first starting the medication, when your dose is increased, or when you get up suddenly. To lower your risk, get up slowly from a sitting or lying position.

Tell your doctor immediately if any of these unlikely but serious side effects occur: new or worsening uncontrolled movements (dyskinesia), mental/mood changes (such as hallucinations), unusual urges (such as increased gambling or sexual urges).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ropinirole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease, low blood pressure, sleep disorder (such as sleep apnea, narcolepsy), mental/mood disorder, liver problems.

Some people taking ropinirole have reported falling asleep suddenly during usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without feelings of drowsiness beforehand. This effect may occur at any time during treatment, including up to 1 year after starting this medication. Therefore, do not drive or take part in other possibly dangerous activities until you are certain that this medication will not cause drowsiness or sudden sleep. This risk is increased with the use of alcohol or other medications that can make you drowsy (see Drug Interactions section). Consult your doctor for more details.

Older adults may be more sensitive to the side effects of this drug, especially mental/mood changes (such as hallucinations).

This drug should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Requip XL Patient Information Including Side Effects

Brand Names: Requip, Requip XL

Generic Name: ropinirole (oral) (Pronunciation: roe PIN i role)

  • What is ropinirole (Requip XL)?
  • What are the possible side effects of ropinirole (Requip XL)?
  • What is the most important information I should know about ropinirole (Requip XL)?
  • What should I discuss with my healthcare provider before taking ropinirole (Requip XL)?
  • How should I take ropinirole (Requip XL)?
  • What happens if I miss a dose (Requip XL)?
  • What happens if I overdose (Requip XL)?
  • What should I avoid while taking ropinirole (Requip XL)?
  • What other drugs will affect ropinirole (Requip XL)?
  • Where can I get more information?

What is ropinirole (Requip XL)?

Ropinirole has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson's disease.

Ropinirole is used to treat symptoms of Parkinson's disease, such as stiffness, tremors, muscle spasms, and poor muscle control. Ropinirole is also used to treat restless legs syndrome (RLS).

Ropinirole may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ropinirole (Requip XL)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling like you might pass out;
  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats (especially if you stop taking ropinirole or use a lower dose);
  • hallucinations;
  • tremors (uncontrolled shaking); or
  • tight feeling in your chest, trouble breathing.

Call your doctor promptly if you fall asleep during a daily activity, if you faint, or if you have hallucinations (hearing or seeing something that is not there). Your doctor may want you to stop taking ropinirole, or take a lower dose.

Less serious side effects may occur, such as:

  • mild nausea, vomiting, stomach pain, or loss of appetite;
  • worsened RLS symptoms early in the morning;
  • diarrhea or constipation;
  • dry mouth, sweating;
  • headache;
  • dizziness, drowsiness;
  • sleep problems (insomnia); or
  • agitation or anxiety.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ropinirole (Requip XL)?

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.

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