FORMULA:
Each TYLOL PLUS Tablet, contains 500 mg paracetamol and 30 mg caffeine.

PHARMACOLOGICAL PROPERTIES:
Paracetamol is a clinically proven analgesic and antipyretic. It produces analgesia by elevating the pain threshold and antipyresis by acting on the thermo-regulatory center in the hypothalamus.
Caffeine enhances the amount of cyclic AMP by blocking phosphodiesterase.
Caffeine demonstrates its own efficacy by elevating intracellular cyclic AMP.
Caffeine is a central nervous system (CNS) stimulant. It dilates peripheral blood vessels when constricting cerebral blood vessels concomitantly.
Caffeine administration with paracetamol enhances analgesic efficacy.

INDICATIONS:
TYLOL PLUS Tablet is indicated for the symptomatic treatment of conditions characterized by mild to moderate pain and fever.

CONTRAINDICATIONS:
TYLOL PLUS Tablet should not be used in patients hypersensitive to paracetamol and caffeine also in patients with severe hepatic and renal illness.

DRUG INTERACTIONS and OTHER INTERACTIONS:
It potentates the effects of anticoagulants with prolonged therapy at higher doses.

WARNINGS / PRECAUTIONS:
In patients with hepatic, renal, cardiac, and pulmonary disorders and preexisting anemia, it should be used under the supervision of a physician. Physician supervision is advisable for use in pregnant and nursing women.
Paracetamol should not be used more than 5 days in children and more than 10 days in adults for the management of pain and should not be administered for treating recurrent febrile conditions continuing for more than 3 days above 39.5 0C unless advised by the physician.

DOSAGE and ADMINISTRATION:
TYLOL PLUS Tablet is taken orally.
The recommended dosage of TYLOL PLUS Tablet:
In children 12 to under 15 years: 1 to 3 times 1 tablet per 24 hours.
Daily dose of 50 mg/kg should not be exceeded.
Dose interval between adjacent drug intake, shouldn’t be shorter than 4 hours.
Maximum 4 doses should be administered per 24 hours. The use of TYLOL PLUS Tablet in children under 6 years of age is not suitable.
Adult: 1 to 3 times 1 to 2 tablets. Maximum 8 tablets (4 gr paracetamol) should be administered per 24 hours.
In patients presenting severe renal insufficiency (creatinine clearance is below 10ml/min.), at least 8 hours should be, among adjacent drug intake.

HOW SUPPLIED:
TYLOL PLUS Tablets: In blister packages of 20 tablets.

OTHER PHARMACEUTICAL DOSAGE FORMS:
TYLOL Suspension: In bottles of 100 ml with original 5 ml capable spoon in its carton.
TYLOL 6 PLUS Suspension: In bottles of 100 ml with original 5 ml capable spoon in its carton.