Ropinirole 1mg 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.

Urgent 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 immediate 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 while urinating
+ 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

Some people have experienced sudden sleepiness during activities like driving, eating, or talking, even if they felt alert beforehand. This can occur up to 1 year after starting the medication. 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 do not experience side effects or 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 or seek medical help:

Constipation
Diarrhea
Stomach pain
Upset stomach
Nausea or 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, as this may increase the risk of adverse effects.
Potential interactions with other medications or health conditions. To ensure safe treatment, disclose all of your:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Any existing health problems, as these may affect the safety and efficacy of 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. This will help prevent potential interactions and ensure your safety while taking 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 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 withdrawal symptoms may occur. If you need to stop the 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.

Lifestyle Changes
If you start or stop smoking, consult your doctor, as your medication dosage may need to be adjusted.

Interactions with Other Substances
Before consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, discuss the potential risks with 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 the dosage 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.

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, 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.

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

• Estrogens (e.g., hormone replacement therapy, oral contraceptives): May decrease ropinirole clearance, leading to increased plasma levels. Dose adjustment may be needed.
• CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics): May potentiate the sedative effects of ropinirole.

• Orthostatic hypotension (dizziness, lightheadedness, fainting)
• Somnolence, sudden sleep attacks
• Nausea, vomiting, abdominal pain
• Dyskinesia (in Parkinson's disease patients, especially with levodopa co-administration)
• Hallucinations, delusions, confusion
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Peripheral edema
• Syncope

Ropinirole is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown adverse effects on fetal development at doses higher than human therapeutic doses. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Ropinirole is known to inhibit prolactin secretion in humans, which could potentially inhibit lactation. It is unknown if ropinirole is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, 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. Ropinirole is not indicated for use in pediatric populations.

Elderly patients may be more sensitive to the effects of ropinirole, particularly orthostatic hypotension, somnolence, and hallucinations. Dose titration should be done cautiously. Renal function should be considered, as clearance may be reduced in older adults with impaired renal function.

• Always titrate ropinirole slowly to minimize side effects, especially nausea, dizziness, and somnolence.
• Educate patients about the risk of sudden sleep attacks and impulse control disorders (ICDs) and advise them to report these symptoms immediately.
• Advise patients to take ropinirole with food if they experience nausea.
• Monitor for orthostatic hypotension, especially during initial titration and dose increases.
• For RLS, ensure patients take the dose 1-3 hours before bedtime, as taking it too early or too late can reduce efficacy or cause daytime somnolence.
• In Parkinson's disease, ropinirole can be used as monotherapy in early disease or as adjunct therapy with levodopa in advanced disease to reduce 'off' time and dyskinesia.

• Other dopamine agonists (e.g., pramipexole, rotigotine)
• Levodopa/carbidopa (for Parkinson's disease)
• MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
• COMT inhibitors (e.g., entacapone, opicapone)
• Amantadine
• For RLS: Gabapentin enacarbil, pregabalin, iron supplementation (if iron deficient)

If your symptoms or health issues persist or worsen, it is 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 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 medication taken, the amount, and the time it happened.