Paracetamol + Tramadol (Remop) 325/37.50 Tablet

Product Description:

Paracetamol + Tramadol (Remop) 325mg/37.5mg Tablet is a combination medication used for the relief of moderate to severe pain. It combines two active ingredients: Paracetamol (Acetaminophen), a widely used analgesic and antipyretic, and Tramadol, a centrally acting opioid analgesic.

• Paracetamol helps reduce pain and fever by inhibiting the synthesis of prostaglandins (chemicals that promote inflammation and pain) in the brain.

• Tramadol works by binding to opioid receptors in the brain and spinal cord, altering the way the body perceives pain.

This combination provides effective relief from various types of pain, including musculoskeletal pain, post-operative pain, and pain associated with conditions like osteoarthritis.

Each Remop tablet contains 325 mg of Paracetamol and 37.5 mg of Tramadol.

Indications:

Paracetamol + Tramadol (Remop) is indicated for the relief of moderate to severe pain that requires an opioid analgesic. These may include:

• Post-operative pain.

• Chronic pain (e.g., due to osteoarthritis).

• Musculoskeletal pain.

• Pain associated with conditions such as back pain or fibromyalgia.

• Headaches or migraines when combined with other therapies.

• Dental pain.

It is usually prescribed when other pain relievers, such as nonsteroidal anti-inflammatory drugs (NSAIDs), are not effective or appropriate for the patient's condition.

Dosage:

The dosage of Paracetamol + Tramadol (Remop) will depend on the severity of the pain and the individual patient's medical condition. Always follow the healthcare provider's recommendations. A general dosage regimen is:

Adults and Children over 12 years:

• Initial Dose: Typically, 1 tablet every 4 to 6 hours as needed for pain relief.

• Maximum Dose: 8 tablets per day (not exceeding 400 mg of Paracetamol and 300 mg of Tramadol in a 24-hour period).

• It is important not to exceed the recommended dose to avoid liver damage from excessive Paracetamol and the risk of Tramadol-related side effects.

Children under 12 years:

• Not recommended for children under 12 years unless directed by a healthcare provider.

Administration:

• Take orally, with or without food.

• Swallow the tablet whole with a glass of water.

• Do not chew or crush the tablet to avoid altering the intended release of the medication.

Side Effects:

Common side effects of Paracetamol + Tramadol (Remop) include:

• Drowsiness or sedation (due to Tramadol).

• Nausea or vomiting.

• Constipation.

• Dizziness.

• Headache.

• Dry mouth.

• Sweating.

• Loss of appetite.

More serious side effects, although rare, include:

• Severe allergic reactions: Symptoms may include rash, itching, swelling of the face, lips, or throat, and difficulty breathing.

• Respiratory depression (slowed or difficult breathing), especially with high doses of Tramadol or in sensitive individuals.

• Seizures: Tramadol can lower the seizure threshold, and seizures may occur, particularly with higher doses.

• Liver damage: Prolonged or excessive use of Paracetamol can cause liver toxicity.

• Addiction or dependency: Tramadol, being an opioid-like drug, has the potential for abuse and dependency, particularly with prolonged use.

• Serotonin syndrome: Rare but potentially serious condition that can occur when Tramadol is used with other medications that affect serotonin levels (e.g., antidepressants).

Contraindications:

Paracetamol + Tramadol (Remop) should not be used in the following situations:

• Hypersensitivity to Paracetamol, Tramadol, or any of the inactive ingredients in the tablet.

• Severe liver dysfunction: Paracetamol can cause significant liver damage in patients with liver disease or those who consume excessive amounts of alcohol.

• Severe respiratory insufficiency or acute asthma: Tramadol may worsen breathing problems.

• Acute intoxication with alcohol, hypnotics, analgesics, or psychotropic drugs: Tramadol can exacerbate the depressant effects of these substances.

• Severe renal impairment (creatinine clearance less than 30 mL/min): Use with caution, and adjust the dose if necessary.

• History of epilepsy or seizures: Tramadol may lower the seizure threshold and increase the risk of seizures.

• Pregnancy: Tramadol should not be used during pregnancy unless the benefit outweighs the risk. It can cause withdrawal symptoms in the newborn.

• Breastfeeding: Tramadol passes into breast milk and should be avoided, as it can lead to infant sedation or respiratory depression.

Precautions:

• Liver and kidney function: Patients with impaired liver or kidney function should use this medication with caution. The dose may need to be adjusted.

• Drug interactions: Tramadol can interact with other central nervous system depressants (such as benzodiazepines, sedatives, alcohol), increasing the risk of respiratory depression and sedation. It can also interact with serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) and increase the risk of serotonin syndrome.

• Alcohol consumption: Avoid alcohol while taking this medication, as it can increase the risk of severe liver damage and CNS depression.

• Driving and operating machinery: Tramadol can cause drowsiness and impair coordination. Avoid engaging in activities that require alertness until you know how the medication affects you.

• Use in elderly: Elderly patients may be more sensitive to the effects of Tramadol (such as drowsiness and dizziness) and should be monitored carefully.

Important Note: Paracetamol + Tramadol (Remop) is typically used for short-term management of moderate to severe pain. Prolonged use or misuse of this medication can lead to tolerance, dependence, and addiction due to the Tramadol component. Always follow the prescribed dosage and consult a healthcare provider if you have concerns about long-term use.

Never exceed the prescribed dose, and seek medical help immediately if you suspect an overdose, as this can be life-threatening, especially in the case of Paracetamol overdose, which can cause liver damage.