Requip 1mg Tablets

Ropinirole is a non-ergoline dopamine agonist that selectively stimulates D2 and D3 dopamine receptors in the brain. The precise mechanism of action in Parkinson's disease is thought to be related to its ability to stimulate postsynaptic D2-type receptors in the caudate-putamen, thereby mimicking dopamine. For Restless Legs Syndrome, the mechanism is unknown but is presumed to involve dopaminergic pathways in the central nervous system.

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 or seek medical attention immediately:

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 or 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 eating, gambling, sex, or spending money)
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 that are not normal
Memory problems or loss
Fever
Muscle stiffness

Some people have experienced sudden, uncontrollable sleepiness while taking this medication, even up to 1 year after starting treatment. This can occur during activities like driving, eating, or talking, and may happen without feeling sleepy beforehand. 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 only mild 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:

Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Dizziness, drowsiness, tiredness, or weakness
Headache
Excessive sweating
Dry mouth
Joint pain
Feeling nervous or excitable
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, its components, or other substances. 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 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 medication. Your doctor will help determine whether it is safe to take this medication with your other medications and health conditions.

Important Warnings and Cautions

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, get up slowly from a sitting or lying 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 taking this 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.

Smoking and Medication Dosage
If you start or stop smoking, discuss this with your doctor, as your medication dosage may need to be adjusted.

Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult your doctor.

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

Neuroleptic Malignant Syndrome (NMS)
Be aware of the risk of NMS, a potentially life-threatening condition that can occur when medications like this one are stopped abruptly or when the dosage 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 for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to you and your baby.

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

• CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine): Can significantly increase ropinirole plasma levels, requiring dose reduction of ropinirole.
• Dopamine antagonists (e.g., neuroleptics like phenothiazines, butyrophenones, thioxanthenes; metoclopramide): May reduce the efficacy of ropinirole.
• Estrogens (e.g., hormone replacement therapy): May decrease ropinirole clearance, leading to increased plasma levels. Dose adjustment of ropinirole may be needed.

• CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics): May enhance the sedative effects of ropinirole.
• Other drugs metabolized by CYP1A2 (e.g., theophylline): Potential for competitive inhibition, though clinical significance is generally low for ropinirole.

• Orthostatic hypotension (dizziness, lightheadedness, fainting)
• Somnolence/drowsiness
• Sudden sleep attacks
• Nausea/vomiting
• Dyskinesia (in PD patients)
• Hallucinations
• Confusion
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Peripheral edema
• Worsening of RLS symptoms (augmentation)

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on fetal development at doses higher than human therapeutic doses.

Ropinirole is excreted in rat milk and is expected to be excreted in human milk. It 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 have not been established in pediatric patients for either Parkinson's disease or Restless Legs Syndrome. Use is not recommended.

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, monitoring closely for adverse effects, particularly orthostatic hypotension and CNS effects.

• **Titration is Key:** Ropinirole requires slow, gradual dose titration to minimize common side effects like nausea, dizziness, and somnolence. Patients should be educated on the importance of this process.
• **Sudden Sleep Attacks:** Warn patients about the potential for sudden onset of sleep, even during activities like driving. Advise caution with activities requiring mental alertness.
• **Impulse Control Disorders (ICDs):** Educate patients and their caregivers about the risk of ICDs (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating). These can be severe and may require dose reduction or discontinuation.
• **Orthostatic Hypotension:** Advise patients to rise slowly from sitting or lying positions to reduce the risk of dizziness or fainting.
• **Augmentation in RLS:** In RLS, monitor for augmentation (worsening of RLS symptoms, earlier onset, or spread to other body parts) which can occur with long-term dopamine agonist use. This may require dose adjustment or switching therapy.
• **Withdrawal Symptoms:** Do not discontinue abruptly, especially in PD patients, 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)
• Levodopa/carbidopa (for Parkinson's Disease)
• MAO-B inhibitors (e.g., selegiline, rasagiline - for Parkinson's Disease)
• COMT inhibitors (e.g., entacapone, tolcapone - for Parkinson's Disease)
• Amantadine (for Parkinson's Disease)
• Gabapentin/Pregabalin (for Restless Legs Syndrome)
• Opioids (for severe, refractory RLS, with caution)

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, the amount, and the time it happened.