Ropinirole Hydrochloride, Oral

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KEY POINTS

• This medicine is taken by mouth to treat the symptoms of Parkinson's disease or restless legs syndrome. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause you to suddenly fall asleep without warning, have unusual urges, or cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: anti-Parkinson's; dopamine agonist

Generic and brand names: ropinirole hydrochloride, oral; Requip; Requip XL

What is this medicine used for?

This medicine is taken by mouth to treat the symptoms of Parkinson's disease. It is also used to treat restless legs syndrome.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A sleep disorder such as sleep apnea or narcolepsy
• Heart disease
• Liver or kidney disease
• Low or high blood pressure
• Mental health problems such as schizophrenia or hallucinations

Tell your healthcare provider if you currently smoke cigarettes, or if you start or stop smoking while you are taking this medicine. It can change how this medicine works.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Your healthcare provider may change your dosage until you reach one that works well and causes as few side effects as possible. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less than prescribed. Do not stop taking this medicine without your healthcare provider's approval. You need to reduce your dosage gradually.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine comes in regular or sustained-release forms. Do not crush or chew sustained release tablets. If you do not know which product you have, check with your pharmacist.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

If you take this medicine for restless legs syndrome, take it 1 to 3 hours before bedtime.

What if I miss a dose?

For Parkinson's disease: If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

For Restless Legs Syndrome: If you miss a dose, take it as soon as you can if it is still the same day. If it is the next day, do not double your next dose. Take only your usual dose 1 to 3 hours before your next bedtime. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: dizziness, lightheadedness, nausea, vomiting, weakness, fainting, restlessness, confusion, hallucinations, muscle twitching, tingling, chest pain.

What should I watch out for?

This medicine may cause you to fall asleep without warning during daily activities including driving a car. If you have drowsiness that continues or becomes severe, you may need to stop taking this medicine. Do not drive or operate machinery if you feel the least bit drowsy or dizzy. These reactions may become more severe if you drink alcohol or take sedatives (narcotics, muscle relaxants or some allergy medicines) while you are taking this medicine. Talk to your healthcare provider about this.

This medicine may cause strong urges, such as to gamble, or have sex. Talk with your healthcare provider if you have unusual urges while taking this medicine.

Some people taking medicines for Parkinson's disease have developed skin cancer (melanoma). Talk to your healthcare provider about this and what to watch for.

You will need to have checkups regularly to see how this medicine affects you. Keep all appointments.

Adults over the age of 65 have a greater risk for hallucinations (seeing and hearing things that are not there).

You may become dizzy or nauseous, sweat heavily, or pass out if you get up too quickly from sitting or lying down. This may happen more often when you first start taking this medicine. Getting up slowly may help.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

Tell your provider if your symptoms do not improve, get worse, or come back between doses.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Feeling dizzy or drowsy most of the time; fainting; high fever; rigid muscles; severe confusion; chest pain; swelling in the feet; ankles; or legs; vision changes; falling asleep without warning; abnormal movements of the body; trouble urinating; painful urination; hallucinations; unusual urges or behavior; very fast or slow heartbeat.

Other: Tiredness, weakness, dry mouth, trouble sleeping, nausea, vomiting, headache, dizziness, drowsiness, abnormal dreams, constipation, diarrhea, heavy sweating, muscle or joint pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone) and mexiletine
• Antibiotics such as ciprofloxacin (Cipro), ofloxacin, and rifampin (Rifadin)
• Antidepressants such as amitriptyline, citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antipsychotic medicines such as aripiprazole (Abilify), chlorpromazine, haloperidol (Haldol), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), ethosuximide (Zarontin), lamotrigine (Lamictal), methsuximide (Celontin), phenobarbital, phenytoin (Dilantin, Phenytek), and valproic acid (Depacon, Depakene, Depakote)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cimetidine (Tagamet)
• Doxepin (Silenor)
• Hormonal birth control pills, implants, shots, patches, vaginal rings, and IUDs, and hormones such as conjugated estrogens (Premarin), estradiol (Climara, Estrace, Estraderm, Vivelle), medroxyprogesterone (Depo-Provera, Provera), and norethindrone (Aygestin, Micronor)
• Levodopa/carbidopa (Duopa, Rytary, Sinemet)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Methoxsalen (8-MOP, Oxsoralen Ultra, Uvadex)
• Metoclopramide (Metozolv, Reglan)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), meperidine (Demerol), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), and pentazocine (Talwin)
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Omeprazole (Prilosec)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Primaquine
• Sleeping pills such as butabarbital (Butisol), flurazepam, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Warfarin (Coumadin)

Do not drink alcohol unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.