Pramipex Er 0.375 Mg Tablet (10 Tab)

PRAMIPEX ER 0.375 MG TABLET (10 TAB)

PRAMIPEX ER 0.375 MG TABLET, manufactured by SUN PHARMA LABORATORIES LTD., is an extended-release medication used to manage neurological conditions.

• Composition

  • Active Ingredient: Each extended-release tablet contains 0.375 mg of Pramipexole (as pramipexole dihydrochloride monohydrate, equivalent to 0.352 mg pramipexole dihydrochloride).

• Uses PRAMIPEX ER 0.375 MG TABLET is prescribed for adults to treat:

  • Parkinson's Disease: It helps alleviate symptoms such as tremors, stiffness, slowed movement, and poor muscle control by mimicking the action of dopamine in the brain.
  • Willis-Ekbom Disease (Restless Legs Syndrome - RLS): It helps relieve the uncomfortable urge to move the legs, particularly at night.

• Dosage and Administration

  • PRAMIPEX ER 0.375 MG TABLET is an extended-release formulation taken orally once daily, with or without food. Taking it with food may help reduce nausea.
  • Tablets must be swallowed whole and should not be crushed, chewed, or broken.
  • For Parkinson's disease, the starting dose is typically 0.375 mg once per day, gradually increased not more frequently than every 5 to 7 days, up to a maximum recommended dose of 4.5 mg per day, based on efficacy and tolerability.
  • For Restless Legs Syndrome, the usual starting dose is 0.125 mg once daily, taken 2-3 hours before bedtime. Doses may be increased every 4-7 days up to a maximum of 0.75 mg/day.
  • Do not discontinue the medication suddenly; a gradual tapering off is necessary to avoid withdrawal symptoms.
  • Dosage adjustments may be required for patients with kidney impairment. It is not recommended for children under 18 years of age.

• Side Effects

  • Common Side Effects: Sleepiness, nausea, constipation, dizziness, fatigue, dry mouth, muscle spasms, peripheral oedema (leg swelling), headache, insomnia, and confusion.
  • Serious Side Effects: Hallucinations (seeing or hearing things that are not real), agitation, aggressive behavior, abnormal thoughts, vision changes, abnormal body movements (dyskinesia), uncontrolled posture changes, sudden onset of sleep, orthostatic hypotension (a sudden drop in blood pressure when standing up), and intense urges (such as increased gambling, sexual urges, or compulsive spending).

• Precautions

  • Avoid if allergic to pramipexole or any other components of the tablet.
  • Caution is advised for patients with kidney problems, low blood pressure, heart conditions, mental/mood disorders, sleep disorders, dyskinesia, dystonia, or vision impairment.
  • This medicine can cause drowsiness, dizziness, and sudden sleep episodes; therefore, avoid driving or operating machinery until you know how it affects you.
  • Alcohol consumption should be avoided as it can increase drowsiness and dizziness.
  • Pregnant or breastfeeding individuals should consult their doctor before use.
  • Rise slowly from a sitting or lying position to minimize the risk of dizziness due to orthostatic hypotension.
  • Inform your doctor if you experience new or worsening mental status or behavioral changes, including psychotic-like behavior or impulse control disorders.
  • Interactions may occur with certain medications, including antipsychotics, cimetidine, metoclopramide, and levodopa.

• Storage

  • Store at room temperature, between 20° to 25°C (68° to 77°F), with excursions permitted to 15° to 30°C (59° to 86°F).
  • Protect from high humidity.
  • Keep out of reach of children and pets.

PRAMIPEX ER 0.375 MG TABLET, containing pramipexole extended-release, is a medication primarily used to manage symptoms of Parkinson's disease. It is also sometimes used for moderate to severe restless legs syndrome. Below are frequently asked questions regarding this medicine.

What is Pramipex ER 0.375 mg Tablet used for?

Pramipex ER 0.375 mg Tablet is used to treat the symptoms of Parkinson's disease, a progressive neurological disorder affecting movement, muscle control, and balance. It can help alleviate tremors, stiffness, and slowed movements. It may also be used to treat moderate to severe restless legs syndrome (Willis-Ekbom disease), a condition causing an uncontrollable urge to move the legs, especially at night.

How does Pramipex ER 0.375 mg Tablet work?

Pramipex ER 0.375 mg Tablet contains pramipexole, which is a dopamine agonist. It works by mimicking the action of dopamine, a natural chemical in the brain essential for controlling movement. By stimulating dopamine receptors in the brain, it helps to restore balance and improve motor control, thereby relieving the symptoms of Parkinson's disease and restless legs syndrome.

What is the usual dosage for Pramipex ER 0.375 mg Tablet?

For Parkinson's disease, the typical starting dose for Pramipex ER (extended-release) is 0.375 mg, taken once daily. Your doctor may gradually increase the dose, usually not more frequently than every 5 to 7 days, up to a maximum recommended dose of 4.5 mg per day, based on your response and tolerability. It is crucial to swallow the extended-release tablet whole; do not chew, crush, or divide it. Pramipex ER is generally not used for restless legs syndrome; an immediate-release form of pramipexole is typically prescribed for that condition.

What are the possible side effects of Pramipex ER 0.375 mg Tablet?

Common side effects can include nausea, dizziness, drowsiness (which may include suddenly falling asleep during daily activities), weakness, constipation, dry mouth, headache, difficulty sleeping, abnormal dreams, and swelling in the hands or feet.

More serious side effects, though less common, require immediate medical attention. These include hallucinations, confusion, aggressive behavior, agitation, unusual thoughts, changes in vision, uncontrolled body movements (dyskinesia), unusual posture changes (like your neck bending forward), and muscle pain or weakness that could indicate a severe muscle condition (rhabdomyolysis). Some individuals may also experience intense urges such as increased gambling or sexual urges.

Is Pramipex ER 0.375 mg Tablet safe during pregnancy or breastfeeding?

Pregnancy: There is insufficient data on the effects of pramipexole in pregnant women. Animal studies have suggested potential harm to the fetus at higher doses, though its relevance to humans is uncertain. It is generally advised to avoid pramipexole during pregnancy. If you are pregnant or plan to become pregnant, discuss this with your doctor.

Breastfeeding: It is not known if pramipexole passes into human breast milk. Pramipexole can inhibit prolactin secretion, which may interfere with lactation. Therefore, you should discuss with your doctor whether to take this medicine or breastfeed.

Can Pramipex ER 0.375 mg Tablet be taken with other medications?

Pramipex ER can interact with several medications. It is important to inform your doctor and pharmacist about all prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Medications that block dopamine, such as certain antipsychotics (e.g., neuroleptics like phenothiazines) and anti-nausea drugs (like metoclopramide), may make pramipexole less effective. Antacids, cimetidine, and ranitidine may also interact.

Additionally, alcohol and other medications that cause drowsiness (e.g., antihistamines, sleep medications, certain pain medications like opioids, gabapentin, or tramadol) should be used with caution or avoided, as they can increase the risk of drowsiness and impaired judgment. Your doctor may adjust doses if you are also taking levodopa.

What precautions should be taken while taking Pramipex ER 0.375 mg Tablet?

• Pramipex ER can cause extreme drowsiness or sudden sleep attacks without warning during daily activities, including driving. You should not drive or operate machinery until you know how this medication affects you.
• It may cause dizziness, lightheadedness, or fainting, especially when standing up too quickly from a sitting or lying position (orthostatic hypotension). To minimize this, rise slowly.
• Report any new or increased compulsive behaviors, such as unusual urges to gamble, increased sexual urges, or excessive eating, to your doctor.
• Inform your doctor if you have kidney problems, mental illness, or any sleep disorder other than restless legs syndrome.
• Do not stop taking Pramipex ER suddenly, as this can lead to withdrawal symptoms such as fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, insomnia, sweating, or pain. Your doctor will provide instructions on how to gradually reduce the dose if discontinuation is necessary.
• Swallow the extended-release tablet whole; do not crush, chew, or split it.

What happens if a dose of Pramipex ER 0.375 mg Tablet is missed?

If you miss a dose of Pramipex ER (extended-release) tablet, take it as soon as you remember, but only if it is within 12 hours of your regularly scheduled time. If more than 12 hours have passed since the missed dose, skip it and continue with your regular dosing schedule the next day. Do not take a double dose to make up for a missed one.

How should Pramipex ER 0.375 mg Tablet be stored?

Store Pramipex ER 0.375 mg Tablet at room temperature, typically between 68ºF to 77ºF (20ºC to 25ºC). Keep the medication away from high humidity or moisture and protect it from light. Always keep this and all medicines out of the reach of children.