Tramadin Plus Tab

TRAMADIN PLUS TAB by MANKIND PHARMA LTD.

Name:

• Common Name: Tramadol HCl + Paracetamol (Tramadin Plus), Tramadin Plus Tablet
• Brand Name: TRAMADIN PLUS TAB by MANKIND PHARMA LTD. (PANACEA)

Composition: Each film-coated tablet typically contains Tramadol Hydrochloride 37.5 mg and Paracetamol (Acetaminophen) 325 mg.

Uses: Tramadin Plus is prescribed for the symptomatic treatment of moderate to severe pain. It is used for conditions such as headache, back pain, muscle pain, menstrual cramps, arthritis, toothache, and to reduce fever. It works by combining an opioid analgesic (tramadol) with a non-opioid analgesic (paracetamol) to block pain signals and reduce pain perception.

Dosage and Administration: For adults and adolescents (12 years and older), an initial dose of two tablets is recommended. Additional doses can be taken as needed, with a minimum dosing interval of six hours, not exceeding 8 tablets per day (equivalent to 2600 mg paracetamol and 300 mg tramadol). Tablets should be swallowed whole with liquid and not broken or chewed. It can be taken with or without food; taking it with food may help if stomach upset occurs. Do not use for longer than strictly necessary.

Side Effects:

• Common Side Effects: Nausea, vomiting, constipation, dizziness, dry mouth, sleepiness, headache, abdominal pain, dyspepsia, flatulence, trembling, anxiety, sleep disorder, and itching.
• Serious Side Effects: Slow or shallow breathing, severe drowsiness, confusion, seizures, yellowing of the skin (jaundice), allergic reactions (e.g., swelling, difficulty breathing), or unusual bleeding. Immediate medical attention is required if these occur.

Precautions: Tramadin Plus is not recommended for individuals with hypersensitivity to tramadol or paracetamol, severe hepatic impairment, severe renal insufficiency (creatinine clearance <10 ml/min), severe respiratory insufficiency, or uncontrolled epilepsy. It should not be administered to patients taking monoamine oxidase inhibitors (MAOIs) or within two weeks of their withdrawal. Caution is advised in patients with kidney or liver disease, and dose adjustments may be necessary. Avoid alcohol consumption, as it increases the risk of side effects like drowsiness and liver damage. The medicine may cause drowsiness or dizziness, impairing the ability to drive or operate machinery. Long-term use carries a risk of tolerance, dependence, or addiction. It is generally not recommended during pregnancy or breastfeeding, and should not be used in children below 12 years of age.

Storage: Store at temperatures not exceeding 30°C, in a cool and dry place, away from direct sunlight. Keep out of reach of children.

Tramadin Plus is a medication primarily used for pain relief. Below are frequently asked questions about this medicine.

What is Tramadin Plus used for?

Tramadin Plus is prescribed for the symptomatic treatment of moderate to severe pain. It is used when a single painkiller is not sufficient to control the pain. This can include conditions such as headache, back pain, muscle pain, menstrual cramps, and arthritis.

How does Tramadin Plus work?

Tramadin Plus is a combination medication containing Tramadol hydrochloride and Paracetamol (also known as Acetaminophen). Tramadol is an opioid analgesic that works centrally by binding to μ-opioid receptors and weakly inhibiting the reuptake of norepinephrine and serotonin, which helps to block pain signals to the brain. Paracetamol is an analgesic and antipyretic that works by inhibiting the production of certain chemical messengers in the brain called prostaglandins, which are responsible for pain and fever. This combination provides a synergistic effect for pain management.

What is the usual dosage of Tramadin Plus?

For adults and adolescents 12 years and older, an initial dose of two tablets of Tramadin Plus is recommended. Additional doses can be taken as needed, but the total should not exceed 8 tablets per day (equivalent to 2600 mg paracetamol and 300 mg tramadol). The dosing interval should not be less than six hours. It should be taken exactly as advised by your doctor, with or without food, but if stomach upset occurs, it can be taken with food. Tablets must be swallowed whole and not broken or chewed.

What are the possible side effects of Tramadin Plus?

Common side effects include nausea, vomiting, dizziness, headache, dry mouth, constipation, drowsiness, excessive sweating, shaking, confusion, mood changes, anxiety, sleep disorder, abdominal pain, dyspepsia, flatulence, and itching. More serious side effects, which require immediate medical attention, can include slow or shallow breathing, severe drowsiness, seizures, yellowing of the skin (jaundice), allergic reactions (like swelling or difficulty breathing), or unusual bleeding.

Is Tramadin Plus safe during pregnancy or breastfeeding?

Tramadin Plus should not be used during pregnancy as there is inadequate evidence to assess its safety, and long-term use may lead to withdrawal symptoms in the newborn. For breastfeeding, Tramadin Plus is generally not recommended because tramadol, one of its active ingredients, may pass into breast milk and cause adverse effects, such as respiratory depression, in the infant. If you are pregnant or breastfeeding, consult your doctor.

Can it be taken with other medications?

Tramadin Plus can interact with several medications. It should not be administered to patients receiving monoamine oxidase inhibitors (MAOIs) or within two weeks of their withdrawal, as this can lead to serious reactions like serotonin syndrome. Taking it with other pain medications like Pentazocine and Naltrexone should be done with caution. Caution is also advised with antidepressants like Carbamazepine. Co-administration with Leflunomide may increase the risk of liver problems. Always inform your doctor about all medications you are taking to avoid potential drug interactions.

What precautions should be taken?

Avoid alcohol consumption while taking Tramadin Plus, as it can increase drowsiness and the risk of liver damage. Since it can cause dizziness or drowsiness, avoid driving or operating heavy machinery until you know how the medication affects you. Patients with severe liver impairment, severe renal insufficiency, uncontrolled epilepsy, or severe respiratory insufficiency should not use Tramadin Plus. It is not recommended for children below 12 years of age. Long-term use may lead to dependence or addiction, and withdrawal symptoms can occur if discontinued abruptly; therefore, dose reduction should be gradual under medical supervision. Inform your doctor if you have a history of seizures, liver, kidney, or stomach/intestinal problems.

What happens if a dose is missed?

If you miss a dose of Tramadin Plus, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed one and continue with your regular dosing schedule. Do not double the dose to compensate for a missed one, and maintain a minimum of 6 hours between doses.

How should it be stored?

Tramadin Plus should be stored at temperatures not exceeding 30°C. Keep it in a cool and dry place, away from direct sunlight, and out of reach and sight of children.