Pronunciation:

roe-PIN-i-role

Brand Names:

• Requip
• Requip XL

Dosage Forms:

• Tablet, Extended Release
• Tablet

Classifications:

Therapeutic—

Antiparkinsonian

Pharmacologic—

Dopamine Agonist

Uses of This Medicine:

Ropinirole is used alone or with other medicines to treat Parkinson's disease.

Ropinirole tablets are also used to treat a condition called Restless Legs Syndrome (RLS). RLS is a neurologic disorder that affects sensation and movement in the legs and causes the legs to feel uncomfortable. This results in an overwhelming feeling of wanting to move your legs to make them comfortable.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ropinirole in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ropinirole in the elderly. However, elderly patients are more likely to have age-related liver problems or to develop hallucinations (seeing, hearing, or feeling things that are not there), which may require caution in patients receiving ropinirole.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Sulpiride

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Haloperidol
• Metoclopramide
• Olanzapine
• Risperidone
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ciprofloxacin
• Kava

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dyskinesia (trouble controlling your muscles) or
• Heart or heart rhythm problems or
• Hypertension (high blood pressure) or
• Hypotension (low blood pressure) or
• Mental illness (eg, hallucinations, psychosis) or
• Postural hypotension (lightheadedness, or fainting when getting up from a lying or sitting position)—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Sleep disorders or
• Sleepiness, history of—May cause side effects to be worse.

Proper Use of This Medicine:

Take this medicine every day exactly as ordered by your doctor in order to improve your condition as much as possible. Do not take more of it or less of it, and do not take it more or less often than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine may be taken with or without food, or on an empty or full stomach. Taking this medicine with food may reduce nausea.

The extended-release tablets work differently from the regular tablets, even at the same dose. Do not switch from one form to the other unless your doctor tells you to.

Swallow the extended-release tablet whole. Do not split, crush, or chew it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release tablets):
  • For Parkinson's disease:
    • Adults—At first, 2 milligrams (mg) once a day for 1 to 2 weeks. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 24 mg per day.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (tablets):
  • For Parkinson's disease:
    • Adults—At first, 0.25 milligram (mg) 3 times a day. Your doctor will adjust your dose as needed and tolerated. However, the dose is usually not more than 24 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For Restless Legs Syndrome:
    • Adults—At first, 0.25 milligrams (mg) once a day, 1 to 3 hours before bedtime. Your doctor will adjust your dose as needed and tolerated. However, the dose is usually not more than 4 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to allow changes in your dose and to check for any unwanted effects.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. Stopping this medicine suddenly may cause fever, confusion, or severe muscle stiffness.

People taking ropinirole have reported falling asleep without warning during activities of daily living, including driving, which sometimes resulted in accidents. This may happen as late as one year after taking the medicine. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Check with your doctor right away if you have confusion, trouble breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, or severe muscle stiffness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. Getting up slowly may help. If you should have this problem, check with your doctor.

Hallucinations (seeing, hearing, or feeling things that are not there) may occur in some patients. This is more common with elderly patients. If you have hallucinations, check with your doctor.

Smoking may decrease the treatment effects of this medicine. It is best to avoid smoking while you are using it. If you have any questions about this, check with your doctor.

This medicine may increase your risk for skin cancer, including melanoma. It is important that your doctor check your skin regularly if you have Parkinson's disease. Check your doctor right away if you have a new mole, change in size, shape, or color of existing mole, or mole that leaks fluid or bleeds.

Some people who have used this medicine had unusual changes in their behavior, including an urge to gamble, spend money, binge eat, or an increased sex drive. Talk with your doctor if this is a concern for you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

falling

nausea

seeing, hearing, or feeling things that are not there (hallucinations)

sleepiness or unusual drowsiness

swelling of the legs

twisting, twitching, or other unusual body movements

unusual tiredness or weakness

worsening of parkinsonism

Less common

Bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine

blurred vision

burning, pain, or difficulty in urinating

chest pain or tightness

chills

cold sweats

cough

double vision or other eye or vision problems

fainting

fear or nervousness

feeling of constant movement of self or surroundings

high or low blood pressure

irregular or pounding heartbeat

loss of memory

mental depression

pain in the arms or legs

pounding in the ears

rapid weight gain

sensation of spinning

slow or fast heartbeat

sore throat

stomach pain

sweating

tingling of the hands or feet

tingling, numbness, or prickly feelings

trouble in concentrating

trouble breathing

unusual weight gain or loss

vomiting

Rare

Anxiety

buzzing or ringing in the ears

changes in vision

fever

headache

joint pain

loss of bladder control

muscle cramps, pain, or spasms

runny or stuffy nose

sneezing

trouble with swallowing

unusual urges

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

chest pain

chills

cold sweats

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from lying or sitting position

fast, irregular, pounding, or racing heartbeat or pulse

grogginess

increase in unusual body movements, especially of the face or mouth

increased coughing

increased sweating

lack or loss of strength

nightmares

sleepiness or unusual drowsiness

twitching, twisting, uncontrolled repetitive movements of tongue, lips, face, arms, or legs

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Abnormal dreams

acid or sour stomach

back pain

belching

decrease in sexual desire or performance

difficulty having a bowel movement (stool)

dryness of mouth

flushing

general feeling of discomfort or illness

heartburn or gas

hot flashes

indigestion

loss of appetite

tremor

weight loss

yawning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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