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OTC - Tydol - Analgesics - Tydol Rhenac

COMPOSITION:

Acetaminophen 500 mg

Diclofenac sodium 50 mg

Per each film coated tablet.


INDICATIONS:

Bone pain, headache, body ache, myalgias, neuralgias, toothache, earache, low back pain, pain due to non-articular rheumatoid conditions, rheumatoid or osteo-arthritis, cervical spondylosis, infective inflammation, primary dysmenorrhoea.

Fever as associated with inflammation.


ADMINISTRATION AND DOSAGE:

Adults and children over the age of 12 years: take 1 caplet twice or three times a day.


CONTRAINDICATIONS:

Allergic to components of this product, aspirin or non-steroidal anti-inflammatory.

Severe liver failure and/or renal failure.

Gastro-duodenal ulcers in evolution.

Patients with anemia, cardiovascular, respiratory, lacking G6PD, asthma or bronchial spasm.

During the last trimester of pregnancy.


WARNINGS AND PRECAUTIONS:

Should not be used with other products containing Acetaminophen.

Prolonged use and high dose of Acetaminophen may cause hepatocellular impairment.

Patients have heart failure, elderly, and taking non-steroidal anti-inflammatory drug.

Patients with a history of peptic ulcers, phenylketonuria, anemia and heavy drinking.

Pregnancy and lactation.


SIDE EFFECTS:

There are rarely some cases of hypersensitivity such as: skin rash, erythema or urticaria. May cause hepatocellular insufficiency, particularly after over dosage. Other side effects are nausea, vomiting, diarrhea, headache, tiredness.


INTERACTIONS:

Antacids can delay and decrease the oral absorption of Acetaminophen.

Phenytoin, barbiturate, carbamazepin, isoniazid may increase the hepatotoxicity of acetaminophen.

Do not concurrent with potassium sparing diuretics.

Diclofenac decreases salicylats concentration.

Diclofenac increases serum digoxin, lithium, methotrexate concentration.

Warfarin: increase a risk of serious GI bleeding.


PRESENTATION:

Box of 10 blisters x 10 coated caplets.