Pramipex 0.125 Mg Tablet (10 Tab)

PRAMIPEX 0.125 MG TABLET, manufactured by SUN PHARMA LABORATORIES LTD., is a medication primarily used to manage symptoms of Parkinson's disease and moderate to severe restless legs syndrome (RLS) in adults. It is a prescription-only medicine.

Name

• Brand Name: Pramipex 0.125 Tablet
• Common Name: Pramipexole

Composition

PRAMIPEX 0.125 MG TABLET contains Pramipexole (0.125 mg) as its active ingredient. It works by mimicking the action of dopamine, a natural substance in the brain essential for controlling body movement, by stimulating dopamine receptors.

Uses

• Parkinson's Disease: It helps improve symptoms such as tremors, stiffness, slowed movement, and poor muscle control. It can be used alone or in combination with levodopa.
• Restless Legs Syndrome (RLS): It relieves the uncontrollable urge to move the legs, especially at night, thereby improving sleep quality.
• Other uses: It may also be used for fibromyalgia, though this is not listed in the approved professional labeling.

Dosage and Administration

PRAMIPEX 0.125 MG TABLET is for oral administration and can be taken with or without food; taking it with food may help reduce nausea. For RLS, it is typically taken once daily, 2 to 3 hours before bedtime. The dosage for Parkinson's disease usually starts at 0.125 mg taken three times per day and may be gradually increased by a doctor. Do not crush, break, or chew the tablet. It is important not to suddenly stop the medication without consulting a doctor, as symptoms may worsen or withdrawal symptoms may occur.

Side Effects

Common Side Effects:

• Sleepiness, drowsiness, or sudden onset of sleep
• Nausea, vomiting, constipation
• Dizziness, lightheadedness, or fatigue
• Headache
• Hallucinations (seeing or hearing things that are not real)
• Dry mouth
• Muscle spasms, muscle weakness
• Peripheral oedema (leg swelling due to fluid overload)
• Trouble sleeping or unusual dreams

Serious Side Effects (report to your doctor immediately):

• Fainting or sudden drop in blood pressure upon standing (orthostatic hypotension)
• Mental/mood changes (e.g., confusion, agitation, aggressive behavior, abnormal thoughts, psychosis)
• Unusual strong urges (e.g., increased gambling, sexual urges, overeating)
• Increased difficulty moving/walking, abnormal body movements, dyskinesia (uncontrollable, involuntary movements)
• Muscle injury (unusual weakness or fatigue, muscle pain, dark urine)
• Unusual posture changes (e.g., neck bending forward)

Precautions

• Allergies: Inform your doctor if you are allergic to pramipexole or any of its components.
• Pregnancy and Breastfeeding: Consult your doctor if you are pregnant or breastfeeding. It may be unsafe during pregnancy, and it is unknown if it passes into breast milk.
• Alcohol: Avoid consuming alcohol as it can increase drowsiness and dizziness.
• Driving and Operating Machinery: This medicine may cause drowsiness and dizziness; avoid driving or operating heavy machinery until you know how it affects you.
• Medical Conditions: Inform your doctor about any pre-existing medical conditions, especially kidney problems, heart problems (e.g., irregular heartbeat, low blood pressure), liver impairment, mental/mood disorders (e.g., hallucinations, psychosis), or sleep disorders (e.g., sleep apnea). Dose adjustments may be necessary for patients with kidney impairment.
• Interactions: Tell your doctor about all medications you are taking, including prescription, non-prescription, and herbal products, as some drugs can interact with pramipexole (e.g., antipsychotics, cimetidine, metoclopramide, other medications that cause drowsiness).
• Orthostatic Hypotension: Rise slowly from sitting or lying positions to reduce the risk of dizziness or fainting due to sudden lowering of blood pressure.

Storage

Store PRAMIPEX 0.125 MG TABLET at room temperature, ideally between 68°F and 77°F (20°C and 25°C), away from light and moisture. Do not store it in the bathroom. Keep all medications out of reach and sight of children and pets.PRAMIPEX 0.125 MG TABLET (10 TAB) by SUN PHARMA LABORATORIES LTD.

PRAMIPEX 0.125 MG TABLET is a prescription medication used to manage neurological conditions in adults. It is produced by SUN PHARMA LABORATORIES LTD..

Name

• Brand Name: Pramipex 0.125 Tablet
• Common Name: Pramipexole

Composition

Each PRAMIPEX 0.125 MG TABLET contains 0.125 mg of Pramipexole as its active ingredient. Pramipexole is a non-ergot dopamine agonist that functions by stimulating dopamine receptors in the brain, thereby mimicking the action of dopamine—a natural substance crucial for controlling body movements.

Uses

PRAMIPEX 0.125 MG TABLET is prescribed for:

• Parkinson's Disease: It helps alleviate symptoms such as tremors, stiffness, slowed movement, and poor muscle control, thereby improving mobility and daily functioning. It can be used as a monotherapy or in conjunction with levodopa.
• Restless Legs Syndrome (RLS): It is used to treat moderate to severe Willis-Ekbom disease (restless legs syndrome), reducing the uncomfortable urge to move the legs, especially at night, and enhancing sleep quality.
• Other Uses: In some instances, it may be used for fibromyalgia, though this is considered an off-label use.

Dosage and Administration

PRAMIPEX 0.125 MG TABLET is intended for oral administration and can be taken with or without food; taking it with food may help reduce nausea. For restless legs syndrome, the recommended starting dose is typically 0.125 mg taken once daily, 2 to 3 hours before bedtime. For Parkinson's disease, the initial treatment usually starts with 0.125 mg taken three times per day, with gradual dose adjustments made by a healthcare professional at weekly intervals. Do not crush, break, or chew the tablet. It is crucial not to discontinue the medication abruptly without consulting your doctor, as this can lead to worsening symptoms or withdrawal effects.

Side Effects

Common Side Effects:

• Drowsiness, sleepiness, or sudden onset of sleep
• Nausea, vomiting, constipation
• Dizziness, lightheadedness, fatigue
• Headache
• Hallucinations (seeing or hearing things that are not real)
• Dry mouth
• Muscle spasms or weakness
• Peripheral oedema (swelling of legs or ankles due to fluid retention)
• Trouble sleeping or unusual dreams

Serious Side Effects (should be reported to a healthcare professional immediately):

• Fainting or orthostatic hypotension (a sudden drop in blood pressure upon standing)
• Mental or mood changes, including confusion, agitation, aggressive behavior, abnormal thoughts, or psychosis
• Unusual strong urges such as increased gambling, increased sexual urges, or compulsive overeating
• Increased difficulty moving or walking, abnormal body movements, or dyskinesia (uncontrollable, involuntary movements)
• Muscle injury, indicated by unusual weakness, fatigue, muscle pain, or dark-colored urine
• Unusual posture changes, such as the neck bending forward

Precautions

• Allergies: Patients should inform their doctor if they have any known allergies to pramipexole or other ingredients in the tablet.
• Pregnancy and Breastfeeding: Consult a doctor if pregnant or breastfeeding. The medication's safety during pregnancy is advised with caution, and it is unknown if it passes into breast milk.
• Alcohol Consumption: Alcohol should be avoided while taking Pramipex 0.125 MG TABLET as it can increase drowsiness and dizziness.
• Driving and Operating Machinery: Due to potential drowsiness and dizziness, patients should avoid driving or operating heavy machinery until they understand how the medication affects them.
• Pre-existing Medical Conditions: Inform your doctor about any history of kidney problems, heart conditions (e.g., irregular heartbeat, low blood pressure), liver impairment, mental/mood disorders (e.g., confusion, hallucinations, psychosis), or sleep disorders (e.g., sleep apnea). Dose adjustments may be necessary for individuals with kidney impairment.
• Drug Interactions: Patients should disclose all current medications, including over-the-counter drugs and herbal supplements, as some substances may interact with pramipexole (e.g., antipsychotics, cimetidine, metoclopramide, other sedating medications).
• Orthostatic Hypotension: To mitigate the risk of dizziness or fainting from a sudden drop in blood pressure, patients are advised to rise slowly when changing from a sitting or lying position.

Storage

PRAMIPEX 0.125 MG TABLET should be stored at room temperature, ideally between 68°F and 77°F (20°C and 25°C), away from direct light and moisture. It should not be stored in the bathroom. Keep this medication and all other medicines out of the reach and sight of children and pets.

Here are frequently asked questions about PRAMIPEX 0.125 MG TABLET:

What is Pramipex 0.125 MG Tablet used for?

Pramipex 0.125 MG Tablet, containing pramipexole, is primarily used to treat the symptoms of Parkinson's disease, including stiffness, tremors, muscle spasms, and poor muscle control. It is also used to treat moderate to severe restless legs syndrome (RLS), a condition causing an uncontrollable urge to move the legs, often accompanied by uncomfortable sensations, usually at night.

How does Pramipex 0.125 MG Tablet work?

Pramipex 0.125 MG Tablet belongs to a class of medicines called dopamine agonists. It works by mimicking the action of dopamine, a natural substance (neurotransmitter) in the brain that is essential for controlling body movement. In Parkinson's disease, there is a reduction in dopamine, and by stimulating dopamine receptors, pramipexole helps restore the balance and trigger nerve impulses that control body movements. For restless legs syndrome, its precise mechanism is not fully known, but it is believed to involve the dopaminergic system.

What is the usual dosage for Pramipex 0.125 MG Tablet?

For Parkinson's disease, the typical starting dose of immediate-release pramipexole (like Pramipex 0.125 MG Tablet) is 0.125 mg taken three times a day. The dose is gradually increased by your doctor over several weeks based on efficacy and tolerability, usually no more frequently than every 5 to 7 days, up to a maximum of 4.5 mg per day. For restless legs syndrome, the recommended starting dose is 0.125 mg once daily, taken 2 to 3 hours before bedtime. Your doctor may adjust the dose every 4 to 7 days if needed, with the dose usually not exceeding 0.5 mg per day. It's crucial to follow your doctor's specific instructions for dosage and titration.

What are the possible side effects of Pramipex 0.125 MG Tablet?

Common side effects can include sleepiness, nausea, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, headache, and leg swelling (peripheral edema). More serious side effects, though less common, can include sudden onset of sleep during daily activities, low blood pressure upon standing (orthostatic hypotension), mental/mood changes (such as confusion, agitation), unusual strong urges (e.g., increased gambling, sexual urges), and vision problems. You should contact your doctor if you experience any severe or persistent side effects.

Is Pramipex 0.125 MG Tablet safe during pregnancy or breastfeeding?

Pramipex 0.125 MG Tablet should be used during pregnancy only when clearly needed and after discussing the potential risks and benefits with your doctor. Animal studies have shown harmful effects on the developing baby at higher doses, but there is limited information in humans. During breastfeeding, it is generally considered unsafe. Pramipexole may reduce the production of breast milk and can pass into breast milk. Your doctor will advise whether to stop breastfeeding or stop the medication.

Can Pramipex 0.125 MG Tablet be taken with other medications?

Pramipex 0.125 MG Tablet can interact with other medications. It is especially important to inform your doctor about all medications you are taking, including over-the-counter drugs, vitamins, and herbal products. Combining it with other drugs that cause drowsiness (like antihistamines, sedatives, sleeping medicines, or pain medications) can worsen drowsiness. Certain medications like cimetidine, metoclopramide, and some antipsychotics can also interact with pramipexole. If you are taking levodopa for Parkinson's disease, your doctor may need to reduce its dosage when you start Pramipex.

What precautions should be taken while taking Pramipex 0.125 MG Tablet?

You should not stop taking Pramipex 0.125 MG Tablet suddenly, as this can lead to unpleasant withdrawal symptoms or worsening of your condition; your doctor will gradually decrease your dose. Avoid alcohol consumption, as it can increase drowsiness and dizziness. Be cautious when driving or operating machinery until you know how the medicine affects you, as it can cause dizziness, drowsiness, or even sudden sleep attacks. Rise slowly from sitting or lying down to prevent dizziness or fainting due to a sudden drop in blood pressure. Inform your doctor if you have kidney problems, heart problems, low blood pressure, or a history of mental/mood disorders, as dose adjustments or close monitoring may be necessary. Also, report any unusual strong urges or compulsive behaviors (like increased gambling or sexual urges) to your doctor.

What happens if a dose of Pramipex 0.125 MG Tablet is missed?

If you miss a dose of Pramipex 0.125 MG Tablet for Parkinson's disease, take it as soon as you remember. However, if it's almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double doses. If you miss a dose for restless legs syndrome, skip the missed dose and take your regular dose 2 to 3 hours before your next bedtime. Do not take two doses at one time.

How should Pramipex 0.125 MG Tablet be stored?

Pramipex 0.125 MG Tablet should be stored at room temperature, away from moisture, heat, and direct light. Keep it in a cool, dry place, protected from direct sunlight, moisture, and heat. Always keep this medicine out of the reach and sight of children and pets.