Requip XL 4mg Tablets

Ropinirole is a non-ergoline dopamine agonist that has 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.

Serious 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 immediately or seek medical attention:

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
Trouble controlling body movements (new or worsening)
Swelling
Burning, numbness, or tingling sensations that are not normal
Memory problems or loss
Fever
Muscle stiffness
Sudden, unexplained sleepiness, including:
+ Falling asleep during activities like driving, eating, or talking
+ Feeling extremely sleepy or alert right before falling asleep
+ If you experience sudden sleepiness, do not drive or engage in activities that require alertness while taking this medication. Contact your doctor immediately.

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 unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

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

Reporting Side Effects

This list is not exhaustive, and you may experience other 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 and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any existing health problems, as they may affect the safety of taking this medication.

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 you verify that it is safe to take this medication 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. 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 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 cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, discuss this with your doctor.

Monitor your blood pressure and heart rate as directed by your doctor. 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. Seek immediate medical attention 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.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the benefits and risks of this medication with their doctor to make an informed decision.

• Dopamine antagonists (e.g., antipsychotics like haloperidol, phenothiazines, metoclopramide): May reduce the efficacy of ropinirole.
• CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine): May increase ropinirole exposure, requiring dose reduction.

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

• Dizziness or lightheadedness upon standing
• Excessive daytime sleepiness or sudden sleep attacks
• Hallucinations (visual, auditory)
• Unusual urges or behaviors (e.g., compulsive gambling, increased sexual urges, uncontrolled spending, binge eating)
• New or worsening uncontrolled movements (dyskinesia)
• Nausea or vomiting
• Swelling in legs or feet

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects.

Ropinirole is excreted into human milk and can inhibit lactation due to its dopamine agonist activity. Avoid use during breastfeeding or discontinue breastfeeding.

Safety and effectiveness in pediatric patients have not been established. Not recommended for use in this population.

Increased incidence of hallucinations and orthostatic hypotension in elderly patients. Initiate with caution and titrate slowly. No overall differences in effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

• Requip XL is an extended-release formulation, designed for once-daily dosing, which can improve adherence compared to immediate-release formulations.
• Patients should be warned about the potential for sudden sleep attacks without warning, even during normal activities. This risk persists even after stable dosing.
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) can occur with dopamine agonists, including ropinirole. Patients and caregivers should be monitored for these behaviors.
• Orthostatic hypotension is a common side effect, especially during initiation and dose titration. Advise patients to rise slowly.
• Do not crush, chew, or divide Requip XL tablets, as this will disrupt the extended-release mechanism and lead to rapid drug release.

• Other dopamine agonists (e.g., pramipexole, rotigotine, apomorphine)
• Levodopa/carbidopa (e.g., Sinemet, Rytary, Duopa)
• 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'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 your 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.