FORMULA:
Each TYLOL HOT sachet contains;
Paracetamol (micronised) 500 mg
Chlorpheniramine maleate 4 mg
Pseudoephedrine hydrochloride 60 mg
Sugar and lemon flavors as a sweetener.

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.
Chlorpheniramine maleate has an antagonistic property against histamine H1-receptor, thus relieves following symptoms; rhinorrhea, nasal congestion, redness and/or hypersensitivity of eyes.
Pseudoephedrine hydrochloride is a sympathomimetic amine which has a strong decongestant property on upper respiratory tract.

INDICATIONS:
TYLOL HOT is indicated for the relief of common cold, influenza and other upper respiratory tract infections showing symptoms listed below:

• Malaise
• Fever and headache
• Rhinorrhea
• Nasal congestion
• Sneeze
• Simple painful conditions

CONTRAINDICATIONS:
TYLOL HOT should not be used in patients hypersensitive to any of the ingredients of it.
Also, patients presenting severe hepatic and renal illness, should not use this medication. Prior to TYLOL HOT administration, patients should be informed about not to take Monoamine oxidase inhibitors together and it had to be dropped out 2 weeks before the onset of TYLOL HOT administration.

DRUG INTERACTIONS and OTHER INTERACTIONS:
It potentiates the effects of anticoagulants with prolonged therapy at higher doses. Paracetamol taken at higher doses for prolonged periods of time, may interact with coumarine, indandion-derivatives and phenothiazines. Blood pressure elevation may occur occasionally in case of pseudoephedrine hydrochloride co-administration with decongestants, tricyclic antidepressants, anti-appetizers, amphetamine like psychostimulants and MAO inhibitors.

WARNINGS / PRECAUTIONS:
In patients with hepatic, renal, cardiac and pulmonary disorders and preexisting anemia, it should be used under the supervision of a physician.
TYLOL HOT 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°C unless advised by the physician.
Although lack of pressor property related with pseudoephedrine on normotensives; in patients with hypertension it should be used under the supervision of a physician. Fatigue may occur during TYLOL HOT therapy; due caution should therefore be exercised when driving a car or operating potentially dangerous machinery.
Concurrent use of TYLOL HOT with alcohol should be avoided because additional reductions in alertness may occur.
Patients, using antihypertensive and/or antidepressant drugs, should seek proper medical advice.
Children below 12 years of age, should use Tylol Hot only under the supervision of a physician.
Physician supervision is advisable for use in pregnant and nursing women.
Physician supervision is advisable for use in diabetic patients.

DOSAGE and ADMINISTRATION:
TYLOL HOT is taken orally as directed below:
Ingredient of each packet should be dissolved in a hot water of 160 ml (=a standard size cup) and immediately be drunk without waiting. A period of 6 hours should be considered in case of adjacent administration. Recommended maximum daily dose is 4 sachets.

OVERDOSE:
If overdose is suspected, the patient should be immediately taken to a health care center.
Paracetamol may cause hepatotoxicity in case of overdosage in some patients. It is due to the amount of drug ingested.
It is recommended that acetylcysteine administration should be instituted as soon as possible after ingestion of an overdose has been reported, without waiting for the results of plasma paracetamol determinations.
Removing by gastric lavage and inducing emezis by administrating ipecac syrup may be advisable.
Chlorpheniramine toxicity becomes overt in few hours after ingestion; treatment should be applied as written in antihistaminic/anticholinergic overdose treatment schema.
Pseudoephedrine overdose related symptoms are mild anxiety, tachycardia and/or mild hypertension. Symptoms become overt following 4 to 8 hours after ingestion. All symptoms are temporary and no specific treatment is required.

HOW SUPPLIED:
TYLOL HOT Sachets: In packages of 12 sachets.

OTHER PHARMACEUTICAL DOSAGE FORMS:
TYLOL HOT Pediatric Sachets: In packages of 12 sachets.
TYLOL HOT D Sachets: In packages of 12 sachets.