Ropinirole 4mg 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 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
New or worsening trouble controlling body movements
Swelling
Burning, numbness, or tingling sensations that are not normal
Memory problems or loss
Fever
Muscle stiffness
Sudden sleepiness, including falling asleep during activities like driving, eating, or talking, even if you feel alert beforehand

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 this side effect 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. However, 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, 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 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 you avoid potential interactions and ensure that it is safe 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 alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and be cautious when climbing stairs.

Stopping the Medication
Do not stop taking this medication without consulting your doctor, as this may lead to withdrawal symptoms. If you need to stop taking this medication, follow your doctor's instructions. Be aware of the following potential withdrawal symptoms, and contact your doctor immediately if you experience: fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain.

Smoking and Medication Dosage
If you start or stop smoking, inform your doctor, as your medication 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 if this medication is stopped abruptly or if the dosage is lowered. Seek immediate medical attention if you experience any of the following symptoms: fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered mental status, rapid or abnormal heartbeat, or excessive sweating.

Special Considerations for Older Adults
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 significantly increase ropinirole plasma concentrations, leading to increased adverse effects.

• Estrogens (e.g., oral contraceptives): May reduce ropinirole clearance, leading to increased plasma levels. Dose adjustment of ropinirole may be needed.
• CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics): May potentiate the sedative effects of ropinirole, increasing risk of somnolence and sudden sleep attacks.

• Not available

• Orthostatic hypotension (dizziness, lightheadedness upon standing)
• Somnolence or excessive daytime sleepiness
• Sudden onset of sleep without warning
• Hallucinations (visual, auditory)
• Delusions or paranoid ideation
• Impulse control disorders (pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Dyskinesia (involuntary movements)
• Nausea and vomiting
• Dizziness
• Syncope (fainting)
• Augmentation (worsening of RLS symptoms, earlier onset, increased intensity, spread to other body parts)

Ropinirole is classified as Pregnancy Category C. It 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 may inhibit lactation due to its dopamine agonist activity. It is excreted into breast milk in rats, and human data are limited. 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 efficacy have not been established in pediatric patients for either Parkinson's Disease or Restless Legs Syndrome.

Elderly patients may be more sensitive to the effects of ropinirole, particularly regarding hallucinations, orthostatic hypotension, and other adverse events. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

• Ropinirole requires slow and gradual dose titration to minimize common side effects such as nausea, dizziness, and somnolence.
• Patients should be warned about the potential for sudden onset of sleep without warning, even without prior somnolence, and advised to avoid driving or operating machinery if this occurs.
• Counsel patients and caregivers about the risk of impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) and to report any new or worsening compulsive behaviors.
• Take with food to help reduce nausea.
• Do not stop ropinirole abruptly, as this can lead to a neuroleptic malignant syndrome-like syndrome or withdrawal symptoms (e.g., apathy, anxiety, depression, fatigue, sweating, pain). Doses should be tapered gradually.
• For RLS, augmentation (worsening of symptoms, earlier onset, increased intensity, spread to other body parts) can occur with long-term use, especially at higher doses.

• For Parkinson's Disease: Levodopa/carbidopa, pramipexole, rotigotine, safinamide, rasagiline, selegiline, entacapone, tolcapone, amantadine, benztropine, trihexyphenidyl.
• For Restless Legs Syndrome: Pramipexole, rotigotine, gabapentin enacarbil, pregabalin, iron supplementation (if iron deficient), opioids (for severe refractory cases), benzodiazepines (for sleep disturbance).

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 your 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.