Ropinirole ER 2mg 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 pass urine
+ 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, especially during activities like driving, eating, or talking. 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.

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
Drowsiness
Fatigue
Weakness
Headache
Excessive sweating
Dry mouth
Joint pain
Nervousness or excitability
Shakiness
Anxiety
Nose or throat irritation
Back pain

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. 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 adjusting 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 combination 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 yourself for signs of withdrawal, which may include 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 cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, discuss this with your doctor.

As directed by your doctor, regularly monitor your blood pressure and heart rate. Be aware of the risk of neuroleptic malignant syndrome (NMS), a potentially life-threatening condition that may occur if this medication is stopped suddenly or if the dose is reduced. 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.

• Ciprofloxacin (CYP1A2 inhibitor): May increase ropinirole exposure. Dose adjustment of ropinirole may be needed.
• Fluvoxamine (CYP1A2 inhibitor): May significantly increase ropinirole exposure. Dose adjustment of ropinirole may be needed.
• Dopamine antagonists (e.g., antipsychotics like haloperidol, metoclopramide): May reduce the efficacy of ropinirole.

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

• Smoking: Induces CYP1A2, potentially decreasing ropinirole exposure. Dose adjustment may be needed in patients who start or stop smoking.

• Excessive daytime sleepiness or sudden sleep attacks
• Dizziness or lightheadedness (especially upon standing)
• Nausea, vomiting
• Hallucinations, delusions, confusion
• Compulsive behaviors (e.g., gambling, hypersexuality, compulsive shopping, binge eating)
• Dyskinesia (in Parkinson's Disease)
• Augmentation or rebound (in Restless Legs Syndrome)

Ropinirole is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use 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. It may inhibit lactation due to its dopamine agonist activity. 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 indicated for use in children.

Elderly patients may be more sensitive to the effects of ropinirole and may require lower doses or slower titration due to decreased clearance. Increased risk of hallucinations and orthostatic hypotension.

• Ropinirole ER should be swallowed whole and not crushed, chewed, or divided, as this will alter its extended-release properties.
• Patients should be warned about the potential for sudden sleep attacks without prior warning, even at therapeutic doses. Advise caution with driving or operating machinery.
• Monitor for impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) which can develop or worsen during treatment. Dose reduction or discontinuation may be necessary.
• Titrate dose slowly to minimize side effects, especially nausea and orthostatic hypotension.
• For Restless Legs Syndrome, if augmentation (earlier onset, increased intensity, or spread of symptoms) occurs, consider dose adjustment or alternative therapy.
• Discontinuation should be gradual to avoid withdrawal symptoms (e.g., akinesia, insomnia, anxiety, depression, sweating, pain).

• 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)
• Amantadine (for Parkinson's Disease)
• 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 occurred.