Ropinirole 5mg 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 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, even during activities like driving, eating, or talking, up to 1 year after starting this medication. If you fall asleep during activities or feel extremely sleepy, do not drive or engage in tasks that require alertness. Contact your doctor immediately if you experience sudden 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, contact your doctor or seek medical attention if they bother you or do not go away:

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.
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 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, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

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 understand how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, 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, follow your doctor's instructions. Be aware of potential withdrawal signs, 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, discuss this with 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)
Be aware of the risk of NMS, a severe and potentially life-threatening condition that may occur when medications like this one are stopped abruptly or 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, as you will need to discuss the 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 levels, requiring dose reduction.

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

• Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
• Excessive daytime sleepiness or sudden sleep attacks
• Hallucinations or confusion
• Nausea, vomiting, abdominal pain
• Dyskinesia (involuntary movements)
• Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
• Peripheral edema

Ropinirole is classified as Pregnancy Category C. Studies in animals have shown adverse effects on fetal development. 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 into breast milk in rats and is known to inhibit lactation due to its dopamine agonist activity. It is not known whether ropinirole is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants and the inhibition of 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. Ropinirole is not recommended for use in children.

Elderly patients may be more sensitive to the effects of ropinirole, particularly orthostatic hypotension, hallucinations, and somnolence. Dose titration should be done cautiously, and patients should be closely monitored for adverse effects.

• Ropinirole should be titrated slowly to minimize side effects, especially nausea, dizziness, and somnolence.
• Patients should be warned about the potential for sudden onset of sleep and impulse control disorders, and advised to report these symptoms immediately.
• Take with food to reduce gastrointestinal upset.
• Orthostatic hypotension is common, especially during initiation and dose escalation; advise patients to rise slowly.
• Concomitant use with dopamine antagonists (e.g., antipsychotics, metoclopramide) should generally be avoided as they can reduce ropinirole's effectiveness.
• Smoking cessation may require a dose adjustment of ropinirole, as smoking induces CYP1A2, which metabolizes ropinirole.

• Other dopamine agonists (e.g., pramipexole, rotigotine, bromocriptine)
• 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)
• Gabapentin (for Restless Legs Syndrome)
• Pregabalin (for Restless Legs Syndrome)

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.