Ropinirole 0.5mg Tablets

Ropinirole is a non-ergoline dopamine agonist with high affinity for D2 and D3 dopamine receptors. It stimulates postsynaptic dopamine D2-type receptors in the caudate-putamen in the brain, mimicking the effects of dopamine and thereby improving motor symptoms in Parkinson's disease and reducing the urge to move in Restless Legs Syndrome.

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 experience 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
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 onset of sleep during activities (e.g., driving, eating, or talking), even if you feel alert beforehand. If this occurs, do not drive or engage in activities that require alertness while taking this medication. Contact your doctor immediately if you experience excessive sleepiness or sudden sleep episodes.

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 are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dizziness
Drowsiness
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 safe use, disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems, to your doctor and pharmacist.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.

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, rise 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 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. You and your doctor will need to discuss the potential benefits and risks to you and your baby.

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

• CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine): May increase ropinirole plasma levels, requiring dose reduction.
• Dopamine antagonists (e.g., neuroleptics like phenothiazines, butyrophenones, thioxanthenes, metoclopramide): May reduce the efficacy of ropinirole.

• Estrogens (e.g., hormone replacement therapy, oral contraceptives): May decrease ropinirole clearance, potentially increasing plasma levels. Dose adjustment may be needed.
• Smoking: Induces CYP1A2, potentially increasing ropinirole clearance and reducing efficacy. Dose adjustment may be needed in smokers or those who stop smoking.

• Alcohol: May increase risk of somnolence and sudden sleep attacks.

• Dizziness or lightheadedness upon standing (orthostatic hypotension)
• Excessive daytime sleepiness or sudden onset of sleep
• Hallucinations or delusions
• Unusual urges or behaviors (e.g., gambling, increased sexual urges, compulsive shopping, binge eating)
• Nausea or vomiting
• Swelling in ankles or feet (peripheral edema)
• Involuntary movements (dyskinesia) in Parkinson's patients

Ropinirole is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Ropinirole is excreted in rat milk. It is not known whether ropinirole is excreted in human milk. Dopamine agonists can inhibit lactation. 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 recommended for use in this population.

Elderly patients may be more sensitive to the effects of ropinirole, particularly orthostatic hypotension and hallucinations. Initiate at the lowest dose and titrate slowly. Monitor closely for adverse effects.

• Ropinirole is a potent D2/D3 agonist; slow titration is crucial to minimize side effects like nausea, dizziness, and somnolence.
• Patients should be warned about the risk of sudden sleep attacks and impulse control disorders (ICDs) and advised to report these immediately.
• For RLS, timing of dose (1-3 hours before bedtime) is important for optimal efficacy.
• Augmentation (worsening of RLS symptoms, earlier onset, or spread to other body parts) can occur with long-term use in RLS patients; consider dose adjustment or alternative therapy if this occurs.
• Smoking cessation can increase ropinirole levels due to CYP1A2 inhibition, requiring dose adjustment.

• 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, opicapone) (for Parkinson's Disease)
• Gabapentin enacarbil (for Restless Legs Syndrome)
• Alpha-2 delta ligands (e.g., gabapentin, pregabalin) (for Restless Legs Syndrome)
• Opioids (for severe, refractory Restless Legs Syndrome, last resort)

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 discuss them with 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.