Ropinirole 3mg Tablets

Ropinirole is a non-ergoline dopamine agonist with high affinity for D2 and D3 dopamine receptors. It is believed to exert its effects by stimulating postsynaptic D2-type dopamine receptors in the caudate-putamen in the brain, thereby mimicking the effects of dopamine.

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 before falling asleep
+ This can occur up to 1 year after starting the medication; if it happens, do not drive or engage in activities that require alertness, and contact your doctor right away

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only 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

Reporting Side Effects

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 your other medications and health conditions. To avoid any potential risks, do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.

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 activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position. Be cautious when climbing stairs.

Discontinuing the Medication
Do not stop taking this medication without consulting your doctor. Stopping the medication abruptly may lead to withdrawal symptoms. If you need to stop taking this medication, follow your doctor's instructions. Monitor yourself for signs of withdrawal, such as 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.

Lifestyle Changes
If you start or stop smoking, consult your doctor, as your 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, discuss the potential risks with your doctor.

Monitoring Your Condition
Regularly check your blood pressure and heart rate as directed by your doctor.

Neuroleptic Malignant Syndrome (NMS)
NMS is a rare but potentially life-threatening condition that can occur when medications like this one are stopped suddenly 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
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. Your doctor will help you weigh the benefits and risks of taking this medication.

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., antipsychotics like haloperidol, chlorpromazine; metoclopramide): May reduce the efficacy of ropinirole.
• Estrogens (e.g., hormone replacement therapy, oral contraceptives): May decrease ropinirole clearance, leading to increased plasma levels. Ropinirole dose adjustment may be needed.

• Alcohol: May potentiate the sedative effects of ropinirole.
• Other CNS depressants (e.g., sedatives, hypnotics, anxiolytics): Additive CNS depression.
• Smoking: Induces CYP1A2, potentially increasing ropinirole clearance and reducing its efficacy. Patients who start or stop smoking while on ropinirole may require dose adjustment.

• Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
• Somnolence/drowsiness (including sudden sleep attacks)
• Hallucinations (visual, auditory)
• Dyskinesia (in Parkinson's patients, especially with concomitant levodopa)
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Nausea, vomiting, abdominal pain
• Peripheral edema
• Augmentation or rebound (in RLS patients)

Category C. Use during pregnancy 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 into breast milk in rats and may inhibit lactation in humans due to its dopamine agonist activity. It is generally not recommended for use in breastfeeding mothers.

Safety and effectiveness in pediatric patients have not been established for either Parkinson's disease or restless legs syndrome. Use is not recommended.

Elderly patients may be more sensitive to the effects of ropinirole, particularly orthostatic hypotension and hallucinations. Start with lower doses and titrate more slowly. Monitor closely for adverse effects.

• Titration is critical: Ropinirole requires slow, gradual dose titration to minimize side effects, especially nausea, dizziness, and somnolence.
• Sudden sleep attacks: Patients should be warned about the potential for sudden onset of sleep during daily activities and advised to avoid driving or operating machinery if this occurs.
• Impulse control disorders: Counsel patients and caregivers about the risk of developing impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) and to report any new or unusual behaviors.
• Orthostatic hypotension: Advise patients to rise slowly to minimize dizziness and lightheadedness.
• Augmentation in RLS: For RLS patients, monitor for augmentation, where symptoms worsen, occur earlier in the day, or spread to other body parts. This may require dose adjustment or switching therapy.
• Withdrawal symptoms: Do not discontinue abruptly, especially in Parkinson's patients, 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 (for Parkinson's Disease)
• MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide - for Parkinson's Disease)
• COMT inhibitors (e.g., entacapone, opicapone - for Parkinson's Disease)
• Amantadine (for Parkinson's Disease dyskinesia)
• Gabapentin or pregabalin (for Restless Legs Syndrome)
• Iron supplementation (if iron deficiency is present for RLS)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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.