Requip XL 12mg 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 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 fall asleep during activities or feel extremely sleepy, do not drive or engage in tasks that require alertness. Contact your doctor immediately if this happens.

Other Possible Side Effects

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

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 symptoms you experienced.
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:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ 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 medication. Your doctor and pharmacist need to be aware of all your medications and health conditions to verify the safe use of this medication.

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

When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and exercise caution when climbing 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 your doctor's instructions for tapering off the dose. 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.

If you start or stop smoking, notify your doctor, as this may affect your dosage. Additionally, consult your doctor before consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness.

Regularly 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 irregular 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.

If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

• Dopamine antagonists (e.g., antipsychotics like haloperidol, phenothiazines, butyrophenones, thioxanthenes, 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.
• Other CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics): May potentiate somnolence and sedation.

• Antihypertensives: May increase risk of orthostatic hypotension.

• Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
• Excessive daytime sleepiness or sudden sleep attacks
• Hallucinations, delusions, confusion
• Nausea, vomiting
• Dyskinesia (involuntary movements)
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Peripheral edema

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women.

Ropinirole is excreted into human milk and is known to inhibit lactation due to its dopamine agonist activity. It is generally not recommended for use in nursing mothers due to potential harm to the infant and inhibition of milk production.

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

Elderly patients may be more sensitive to the effects of ropinirole, particularly psychiatric adverse events (e.g., hallucinations) and orthostatic hypotension. Initiate at the lowest dose and titrate slowly, monitoring closely for adverse effects.

• 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 onset of sleep and advised to avoid driving or operating machinery if they experience somnolence.
• Impulse control disorders (ICDs) are a known class effect of dopamine agonists. Screen patients for new or worsening compulsive behaviors regularly.
• Orthostatic hypotension is common, especially during initiation and dose titration. Advise patients to rise slowly and ensure adequate hydration.
• Switching from immediate-release ropinirole to extended-release: The total daily dose of immediate-release ropinirole should be converted to the same total daily dose of extended-release ropinirole, taken once daily.
• Avoid abrupt discontinuation, as this can lead to a neuroleptic malignant syndrome-like syndrome or withdrawal symptoms (e.g., apathy, anxiety, depression, fatigue, sweating, pain).

• Other dopamine agonists (e.g., pramipexole, rotigotine, apomorphine)
• 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'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.