TYDOL^® 650

Acetaminophen

Keep out of the reach of children.

Read carefully the enclosed insert before use.

In case of any unexpected reaction consult your doctor or pharmacist.

PART I. INFORMATION LEAFLET FOR PATIENT

1. COMPOSITION: Each film coated tablet contains:

– Active ingredient: Acetaminophen………………………………650 mg.

– Excipients: Maize starch, povidone K30, pregelatinized starch, sodium starch glycolate, gelatin, colloidal anhydrous silica, talc, magnesium stearate, opadry II white.

2. DESCRIPTION OF PRODUCT:

White, oblong film coated tablet, printed with “Tydol 650” in black on both sides.

3. DESCRIPTION OF PACKAGING:

Box of 1 blister x 10 film coated tablets.

Box of 10 blisters x 10 film coated tablets.

4. WHAT IS THE MEDICINE USED FOR:

Relief fever.

Treatment of mild to moderate pain including: headache, pain in cold and flu, sore throat, dysmenorrhoea, pain after vaccination or tooth extraction, toothache, migraine, pain of osteoarthritis.

5. HOW MUCH AND HOW OFTEN SHOULD YOU USE THIS MEDICINE:

Administration: Oral route.

Dosage: Every 4-6 hours as necessary.

– Adults: 1 tablet. Do not exceed 6 tablets in 24 hours.

– Children 7 to 12 years: ½ tablet. Do not exceed 3 tablets in 24 hours.

Minimum dosing interval: 4 hours.

Note: Not to take TYDOL 650 for pain for more than 10 days in adults and more than 5 days in chidren, or for fever (39.5^oC) for more than 3 days unless directed by a doctor.

6. WHEN SHOULD YOU NOT TAKE THIS MEDICINE:

Hypersensitivity to acetaminophen or any component of this product.

Severe hepatic failure.

7. SIDE EFFECTS:

Uncommon:

Rash, nauseas, vomiting, blood dyscrasias (neutrophils, blood cells and leukocyte), anemia, renal impairment, prolonged use of acetaminophen may cause renal toxicity.

Rarely:

Such hypersensitivity reactions.

8. WHAT OTHER MEDICINE OR FOOD SHOULD BE AVOIDED WHILST TAKING THIS MEDICINE:

– Coumarin and indanedione-derivative anticoagulants.

– Phenothiazine.

– Alcohol.

– Anticonvulsants (including phenytoin, barbiturates, carbamazepine), isoniazid.

9. WHAT SHOULD YOU DO IF YOU MISS A DOSE:

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

10. HOW SHOULD YOU KEEP THIS MEDICINE:

Store at temperature below 30^oC, in a dry place, protect from light.

11. SIGNS AND SYMPTOMS OF OVERDOSE:

Symptoms:

Acetaminophen poisoning can be caused by using a single-dose, or by taking large doses of acetaminophen repeated (for example from 7.5 to 10 g per day for 1-2 days), or by taking a long day. Hepatic necrosis dose-dependent  is the most serious toxic acute effects of overdose and can be fatal.

Nausea, vomiting, and abdominal pain usually occur within 2-3 hours after ingestion of toxic doses of the drug. Methemoglobinemia resulting in cyanosis of the skin, mucosa, and fingernails is characteristic sign of acute p-aminophenol derivate toxicity; small amounts of sulfhemoglobin may also be produced. Children tend to form methemoglobin more readily than do adults after acetaminophen ingestion.

In severe poisoning, CNS stimulation, excitement, and delirium may occur initially. This may be followed by CNS depression: Stupor; hypothermia, marked prostration, rapid, shallow breathing; rapid, weak, irregular pulse; low blood pressure; and circulatory failure. Vascular collapse results from the relative hypoxia and from the central depressant action which occurs only with massive doses. Shock may develop if vasodilation is marked. Fatal asphyxial seizures may occur suddenly or may be deplayed for several days.

Clinical indications of hepatic damage become manifest within 2 to 4 days of ingestion of toxic doses. Plasma aminotransferases are elevated (sometimes markedly) and the concentration of bilirubin in plasma may be increased; in addition, the prothrombin time is prolonged. Perhaps 10% of poisoned patients who do not receive specific treatment develop severe liver damage; of these 10% to 20% eventually die of hepatic failure. Acute renal failure also occurs in some patients. Biopsy of the liver reveals centrilobular necrosis with sparing of the periportal area. In nonfatal cases, the hepatic lesions are reversible over a period of weeks of months.

12. WHAT TO DO WHEN YOU HAVE TAKEN MORE THAN THE RECOMMENDED DOSAGE:

Talk to your doctor or go to a hospital straight away.

Remember to take medicine that is left with you or medicine pack so the doctor knows what you have taken.

13. PRECAUTIONS THAT SHOULD BE TAKEN WHEN TAKING THIS MEDICINE:

Consult your doctor if symptoms persist or in case of severe liver or kidney impairment.

Patients with phenylketonuria, aneamia, alcoholic.

Should not be used with other products containing acetaminophen.

Sometimes, skin reactions including pruritic maculopapular rash and urticaria; other sensitivity reactions including laryngeal edema, angioedema and anaphylactid reactions may occur rarely. Thrombocytopenia, leukopenia and pancytopenia have been associated with the use of p-aminophenol derivatives, especially with prolonged administration of large doses. Neutropenia and thrombocytopenic purpura have been reported with acetaminophen use. Rarely, agranulocytosis has been reported in patients receiving acetaminophen.

Excessive intake of alcohol may increase the risk of acetaminophen induced hepatotoxicity, avoid or limit alcohol intake.

Pregnancy and lactation: Animal studies have not identified any risk to pregnancy or embryo-foetal development. Human studies have not identified any risk to lactation or the breast fed offspring. Acetaminophen should be used during pregnancy only if clearly needed.

Effects on ability to work: There is no known report of adverse effects or studies on medicine effects on the ability to operate machinery, drive vehicles, work at height and other activities.

14. WHEN SHOULD YOU CONSULT YOUR DOCTOR OR PHARMACIST:

In case of overdosage or adverse drug reactions.

When you are taking other drugs or foods.

For further information, consult your doctor or pharmacist.

15. SHELF-LIFE OF DRUG: 48 months from manufacturing date. Do not use after expiry date.