Ropinirole 0.25mg 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 symptoms of Parkinson's disease and Restless Legs Syndrome.

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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:

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

If you experience sudden sleepiness, do not drive or engage in activities that require alertness while taking this medication. Contact your doctor immediately if you experience sudden sleepiness or feel extremely sleepy.

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 experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

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, 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 your safety, disclose all of your medications, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any existing health problems that may be relevant to your treatment.

Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug. This will help ensure that it is safe for you to take this medication in combination 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 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.

Stopping 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, inform 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, consult your doctor.

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

Neuroleptic Malignant Syndrome (NMS)
NMS is a rare but potentially life-threatening condition that may occur when medications like this one are stopped suddenly or when the dose is lowered. Seek medical attention immediately 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 years 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): May significantly increase ropinirole plasma levels, requiring dose reduction of ropinirole.
• Dopamine antagonists (e.g., neuroleptics/antipsychotics like haloperidol, phenothiazines, metoclopramide): May reduce the efficacy of ropinirole due to antagonistic effects on dopamine receptors.

• Estrogens (e.g., hormone replacement therapy, oral contraceptives): May decrease ropinirole clearance, leading to increased plasma levels. Dose adjustment of ropinirole may be needed.
• Alcohol: May potentiate the sedative effects of ropinirole and increase the risk of orthostatic hypotension.
• Other CNS depressants (e.g., sedatives, hypnotics, anxiolytics): May increase the risk of somnolence and sudden sleep onset.

• Not available

• Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
• Somnolence/sleep attacks (sudden onset of sleep during daily activities)
• Hallucinations (visual, auditory, tactile)
• Dyskinesia (involuntary movements, especially in PD patients also on levodopa)
• Impulse control disorders (pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Nausea, vomiting, abdominal pain
• Peripheral edema

Pregnancy Category C. Ropinirole should be used 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 and its metabolites are excreted in rat milk. It is not known whether ropinirole is excreted in human milk. Dopamine agonists can inhibit lactation. Therefore, 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 for either Parkinson's disease or Restless Legs Syndrome. Use is not recommended.

Elderly patients (over 65 years) may be more sensitive to the effects of ropinirole, particularly regarding hallucinations and orthostatic hypotension. Start with lower doses and titrate slowly. Monitor closely for adverse effects.

• Ropinirole requires careful titration to minimize adverse effects, especially nausea, dizziness, and somnolence.
• Patients should be warned about the potential for sudden onset of sleep during daily activities, even without prior warning signs of drowsiness.
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) are a known class effect of dopamine agonists. Patients and caregivers should be counselled on these risks.
• Orthostatic hypotension is common, especially during initiation and dose escalation. Advise patients to rise slowly from a sitting or lying position.
• In Parkinson's disease, ropinirole can be used as monotherapy or as an adjunct to levodopa. When used with levodopa, it may allow for a reduction in levodopa dose and help manage 'wearing-off' phenomena.
• For Restless Legs Syndrome, ropinirole should be taken 1-3 hours before bedtime. Augmentation (worsening of RLS symptoms with earlier onset or spread to other body parts) can occur with long-term use, especially at higher doses.

• Other dopamine agonists (e.g., pramipexole, rotigotine, bromocriptine)
• Levodopa/carbidopa (for Parkinson's Disease)
• MAO-B inhibitors (e.g., selegiline, rasagiline - for Parkinson's Disease)
• COMT inhibitors (e.g., entacapone, opicapone - for Parkinson's Disease)
• Amantadine (for Parkinson's Disease, dyskinesia)
• Gabapentin enacarbil (for Restless Legs Syndrome)
• Alpha-2 delta ligands (e.g., gabapentin, pregabalin - for Restless Legs Syndrome)

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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.