Ropinirole ER 6mg 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 notice 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

Some people have experienced sudden, uncontrollable sleepiness while taking this medication, even up to 1 year after starting treatment. If you fall asleep during activities like driving, eating, or talking, do not drive or engage in tasks that require alertness. Contact your doctor immediately if you experience excessive sleepiness or fall asleep unexpectedly.

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 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, any of 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 safe use, disclose all of 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 altering the dose of any drug. Your doctor and pharmacist need to be aware of all your medications and health conditions to verify that it is safe for you to take this medication in conjunction with your other treatments.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, such as standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.

Do not discontinue this medication without consulting your doctor, as stopping it abruptly may lead to withdrawal symptoms. If you need to stop taking this medication, follow the guidance provided by your doctor. Monitor for signs of withdrawal, 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 when reducing the dose or stopping the medication.

If you start or stop smoking, consult your doctor, as this may necessitate an adjustment in your medication dosage. Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may impair your reactions, discuss the potential risks with your doctor.

Regularly monitor your blood pressure and heart rate as directed by your doctor. Be aware of the risk of neuroleptic malignant syndrome (NMS), a 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 symptoms such as fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered mental status, rapid or irregular heartbeat, or excessive sweating.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the benefits and risks of this medication with their doctor to make an informed decision.

• 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 levels, 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.
• Other CNS depressants (e.g., alcohol, sedatives, hypnotics): May potentiate sedative effects of ropinirole.
• Smoking: Induces CYP1A2, potentially increasing ropinirole clearance and decreasing plasma levels. Dose adjustment may be needed in smokers who start or stop smoking.

• Orthostatic hypotension (dizziness, lightheadedness, fainting)
• Nausea
• Somnolence/excessive daytime sleepiness
• Sudden onset of sleep
• Hallucinations
• Dyskinesia (in Parkinson's Disease)
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Augmentation (worsening of RLS symptoms)
• Peripheral edema
• Confusion

Category C. Animal studies have shown adverse effects on fetal development. Use only if the potential benefit justifies the potential risk to the fetus.

L3 (Moderately Safe). Ropinirole is known to inhibit prolactin secretion and may inhibit lactation. It is unknown if ropinirole is excreted in human milk. Use with caution; consider risks to infant (e.g., somnolence, poor feeding) and impact on milk supply.

Safety and efficacy have not been established in pediatric patients. Not recommended for use in children.

Increased incidence of hallucinations, somnolence, and orthostatic hypotension in elderly patients. Start with lower doses and titrate slowly. Monitor closely for adverse effects.

• Ropinirole ER is designed for once-daily dosing, providing sustained dopamine stimulation.
• Patients should be warned about the potential for sudden onset of sleep and impulse control disorders, even without prior warning signs.
• Titration is crucial to minimize side effects, especially nausea and orthostatic hypotension.
• For RLS, augmentation (worsening of symptoms with earlier onset, increased intensity, or spread) is a known complication of long-term dopamine agonist use.
• Discontinuation should be gradual to avoid a dopamine agonist withdrawal syndrome (e.g., apathy, anxiety, depression, fatigue, pain, sweating).

• Other non-ergoline 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, pregabalin (for Restless Legs Syndrome)
• Iron supplementation (if iron deficiency is present for RLS)

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 taken, the amount, and the time it happened.