Requip XL 8mg Tablets

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

Urgent Side Effects: Seek Medical Help Right Away

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 immediate medical attention:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure: severe headache, dizziness, fainting, or changes in vision
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain
Confusion, difficulty focusing, or changes in behavior
Strong, uncontrollable urges (such as excessive eating, gambling, sex, or spending)
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Shortness of breath
Trouble controlling body movements (new or worsening)
Swelling
Burning, numbness, or tingling sensations (unusual or unexplained)
Memory problems or loss
Fever
Muscle stiffness

Some people have experienced sudden, unexplained sleepiness, even while engaging in activities like driving, eating, or talking. This can occur up to 1 year after starting the medication. If you experience excessive sleepiness or fall asleep during activities, do not drive or perform tasks that require alertness. Contact your doctor immediately if you experience these symptoms.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Dizziness, drowsiness, tiredness, or weakness
Headache
Excessive sweating
Dry mouth
Joint pain
Feeling nervous, excitable, or anxious
Shakiness
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 symptoms you experienced as a result of the allergy.
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 and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any existing health problems that may affect your ability to take this medication safely.

Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug. Your doctor and pharmacist will help determine whether it is safe to take this medication in combination with your other medications and health conditions.

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

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, such as standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.

Do not discontinue this medication without consulting your doctor, as stopping it abruptly may lead to withdrawal symptoms. If you need to stop taking this medication, follow the guidance provided by your doctor. Monitor yourself for signs of withdrawal, 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 when reducing the dose or stopping the medication.

If you start or stop smoking, consult your doctor, as this may necessitate an adjustment in your medication dosage. Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may impair your reactions, discuss this with your doctor.

As directed by your doctor, regularly monitor your blood pressure and heart rate. Be aware of the risk of neuroleptic malignant syndrome (NMS), a potentially life-threatening condition that may occur when medications like this one are stopped suddenly or when the dose is lowered. If you experience symptoms such as fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered mental status, rapid or abnormal heartbeat, or excessive sweating, contact your doctor immediately.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.

• Dopamine antagonists (e.g., antipsychotics like haloperidol, chlorpromazine, metoclopramide): May reduce the efficacy of ropinirole.
• CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine): May significantly increase ropinirole plasma concentrations, leading to increased adverse effects.

• Estrogens (e.g., hormone replacement therapy, oral contraceptives): May decrease ropinirole clearance, leading to increased plasma levels.
• Other CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics): May potentiate the sedative effects of ropinirole.

• Smoking: Induces CYP1A2, potentially increasing ropinirole clearance and reducing its efficacy. Dose adjustment may be needed in patients who start or stop smoking.

• Dizziness
• Lightheadedness
• Syncope
• Nausea
• Vomiting
• Abdominal pain
• Constipation
• Headache
• Peripheral edema
• Hallucinations
• Confusion
• Delusions
• Excessive daytime sleepiness
• Sudden onset of sleep
• Uncontrollable urges (gambling, hypersexuality, shopping, eating)
• Dyskinesia (in advanced Parkinson's)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on embryo-fetal development at doses higher than clinical exposure.

Ropinirole is expected to be excreted in human milk and may 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.

The safety and effectiveness of ropinirole extended-release in pediatric patients have not been established. It is not indicated for use in this population.

Elderly patients (over 65 years) may be more susceptible to the adverse effects of ropinirole, particularly hallucinations, orthostatic hypotension, and somnolence. Start with the lowest effective dose and titrate slowly. Monitor closely for adverse reactions.

• Ropinirole XL is specifically formulated for once-daily dosing, providing continuous dopaminergic stimulation, which may help reduce 'off' times in Parkinson's disease.
• Patients should be warned about the risk of sudden onset of sleep, even without prior warning signs of drowsiness. This can occur at any time during treatment.
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) have been reported in patients treated with dopamine agonists, including ropinirole. Patients and caregivers should be regularly monitored for these behaviors.
• Orthostatic hypotension is a common side effect, especially during initiation and dose titration. Advise patients to rise slowly and be aware of symptoms.
• Hallucinations are more common in elderly patients and those with advanced Parkinson's disease or cognitive impairment.
• Do not discontinue ropinirole abruptly, as this can lead to a neuroleptic malignant syndrome-like syndrome (fever, rigidity, altered mental status, autonomic instability).

• Other dopamine agonists (e.g., pramipexole, rotigotine)
• Levodopa/carbidopa
• MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
• COMT inhibitors (e.g., entacapone, opicapone)
• Amantadine
• Anticholinergics (for tremor, e.g., trihexyphenidyl, benztropine)

If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.