Requip XL 6mg 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.

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
Sudden, unexplained sleepiness, including falling asleep during activities like driving, eating, or talking. If this happens, do not drive or engage in tasks that require alertness while taking this medication. Contact your doctor immediately if you experience 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 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 your safety, disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems.
You must verify that it is safe to take this medication in conjunction with all of your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.

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 getting up from a sitting or lying down position, rise slowly to minimize the risk of dizziness or fainting. Be cautious when climbing stairs to prevent accidents.

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 instructions provided by your doctor. Be aware of potential withdrawal signs, 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, notify 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, consult 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. If you experience 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. 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 significantly increase ropinirole plasma levels, increasing risk of adverse effects.

• 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): May potentiate sedative effects.

• Orthostatic hypotension (dizziness, lightheadedness upon standing)
• Somnolence/sudden sleep attacks
• Hallucinations (visual, auditory)
• Dyskinesia (involuntary movements)
• Nausea/vomiting
• Peripheral edema
• Impulse control disorders (pathological gambling, hypersexuality, compulsive shopping/eating)
• Confusion/psychosis

Category C. Use 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 human therapeutic doses.

Ropinirole is 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.

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

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and titrate slowly due to increased risk of hallucinations and orthostatic hypotension.

• Ropinirole ER is typically taken once daily. Emphasize not to crush, chew, or divide the tablets.
• Warn patients about the potential for sudden sleep attacks without warning, even during daily activities. Advise caution with driving or operating machinery.
• Educate patients and caregivers about impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping/eating) and to report any new or worsening behaviors.
• Orthostatic hypotension is a common side effect, especially during initiation and dose titration. Advise patients to rise slowly from a sitting or lying position.
• Hallucinations are more common in elderly patients and those with advanced Parkinson's disease. Monitor for these symptoms.
• Nausea can be managed by taking the medication with food, though it's not strictly required.
• Dose titration is crucial for managing efficacy and minimizing side effects. Patients should be advised to follow the prescribed titration schedule carefully.

• 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'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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, including the amount and time of ingestion.