Requip 0.5mg Tablets

Ropinirole is a non-ergoline dopamine agonist with high affinity for D2 and D3 dopamine receptors. It stimulates postsynaptic D2-type dopamine receptors in the caudate-putamen in the brain, thereby mimicking the effects of dopamine and alleviating symptoms of Parkinson's disease and restless legs syndrome.

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain or pelvic pain
Confusion, difficulty focusing, or changes in behavior
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Changes in eyesight
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Shortness of breath
New or worsening trouble controlling body movements
Swelling
Burning, numbness, or tingling sensations that are not normal
Memory problems or loss
Fever
Muscle stiffness

Some people have experienced sudden sleepiness during activities like driving, eating, or talking, even if they felt alert beforehand. This can occur up to 1 year after starting the medication. If you experience sudden sleepiness, do not drive or engage in activities that require alertness. Contact your doctor immediately if you experience sudden sleepiness or excessive sleepiness.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dizziness
Sleepiness
Fatigue
Weakness
Headache
Excessive sweating
Dry mouth
Joint pain
Nervousness or excitability
Shakiness
Anxiety
Nose or throat irritation
* Back pain

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking another medication that contains the same active ingredient as this drug.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all of your medications, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Any existing health problems, as they may affect the safety of taking this medication.

To minimize potential risks, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in combination with all of your other medications and health conditions. Your doctor and pharmacist will work together to ensure that all of your medications are compatible and safe for use.

Important Warnings and Precautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and be cautious when climbing stairs.

Stopping the Medication
Do not stop taking this medication without consulting your doctor, as this may lead to withdrawal symptoms. If you need to stop the medication, follow your doctor's instructions. Be aware of potential withdrawal symptoms, including fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain, and contact your doctor immediately if you experience any of these symptoms.

Lifestyle Changes
If you start or stop smoking, inform your doctor, as your dosage may need to be adjusted. Before consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.

Monitoring Your Condition
Follow your doctor's instructions for monitoring your blood pressure and heart rate.

Neuroleptic Malignant Syndrome (NMS)
NMS is a rare but potentially life-threatening condition that can occur when medications like this one are stopped abruptly or when the dose is lowered. Seek immediate medical attention if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, rapid or abnormal heartbeat, or excessive sweating.

Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women should discuss the benefits and risks of this medication with their doctor.

Restless Leg Syndrome
If your symptoms worsen or occur earlier in the day, inform your doctor.

• Ciprofloxacin (strong CYP1A2 inhibitor): May increase ropinirole exposure significantly. Dose reduction of ropinirole may be needed.
• Fluvoxamine (strong CYP1A2 inhibitor): May increase ropinirole exposure significantly. Dose reduction of ropinirole may be needed.
• Other strong CYP1A2 inhibitors (e.g., enoxacin, mexiletine): Potential for increased ropinirole levels.

• Dopamine antagonists (e.g., neuroleptics like phenothiazines, butyrophenones, thioxanthenes, metoclopramide): May reduce the efficacy of ropinirole.
• Estrogens (e.g., hormone replacement therapy, oral contraceptives): May decrease ropinirole clearance, leading to increased exposure. Dose adjustment of ropinirole may be needed.
• Smoking (CYP1A2 inducer): May increase ropinirole clearance, leading to decreased exposure. Dose adjustment of ropinirole may be needed in smokers or those who stop smoking.

• CNS depressants (e.g., alcohol, sedatives, hypnotics): Additive sedative effects.
• Antihypertensives: Potential for additive hypotensive effects, especially orthostatic hypotension.

• Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
• Excessive daytime sleepiness or sudden sleep attacks
• Hallucinations or confusion
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Nausea, vomiting
• Dyskinesia (in Parkinson's disease)
• Augmentation or rebound (in Restless Legs Syndrome)

Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies showed developmental toxicity at doses higher than human therapeutic doses.

Ropinirole is excreted into breast milk in rats. It is not known whether ropinirole is excreted in human milk. Ropinirole can inhibit lactation due to its dopamine agonist activity. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients have not been established for either Parkinson's disease or restless legs syndrome. Not recommended for use in this population.

Elderly patients may be more sensitive to the effects of ropinirole, particularly regarding hallucinations, orthostatic hypotension, and somnolence. Dose titration should be done cautiously. Renal function should be considered.

• Ropinirole requires slow dose titration to minimize side effects, especially nausea, dizziness, and somnolence.
• Patients should be warned about the potential for sudden onset of sleep, even without prior warning signs of drowsiness, and advised to avoid driving or operating machinery if this occurs.
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) are a known class effect of dopamine agonists. Patients and caregivers should be specifically questioned about these behaviors.
• Orthostatic hypotension is common, especially during initiation and dose escalation. Advise patients to rise slowly.
• In Parkinson's disease, ropinirole can be used as monotherapy in early disease or as adjunct therapy with levodopa in advanced disease to reduce 'off' time and levodopa-induced dyskinesia.
• For Restless Legs Syndrome, augmentation (worsening of RLS symptoms, or symptoms occurring earlier in the day or involving other limbs) can occur with long-term use of dopamine agonists. If augmentation occurs, consider dose reduction, drug holiday, or switching to an alternative therapy.
• Do not discontinue ropinirole abruptly, as this can lead to a dopamine agonist withdrawal syndrome (DAWS) characterized by symptoms such as apathy, anxiety, depression, fatigue, sweating, and pain. Taper gradually over several days to weeks.

• Other non-ergoline dopamine agonists (e.g., pramipexole, rotigotine)
• Levodopa/carbidopa (for Parkinson's disease)
• MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide - for Parkinson's disease)
• COMT inhibitors (e.g., entacapone, opicapone - for Parkinson's disease, adjunct to levodopa)
• Amantadine (for Parkinson's disease, especially dyskinesia)
• Gabapentin or pregabalin (for Restless Legs Syndrome)
• Iron supplementation (if iron deficiency is present for RLS)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.