COMPOSITION :

Each 5 ml (teaspoonful)contains : Chlorpheniramine maleate 2 mg

Pseudoephedrine HCl 15 mg

Paracetamol 120 mg.

DESCRIPTION :

FLU OFF syrup is an effective formula that contains three active ingredients including Paracetamol that is an effective pain reliever and

fever reducer acts by inhibition of prostaglandins biosynthesis. Pseudoephedrine is a decongestant that helps to produce

vasoconstriction, which temporarily reduces the swelling associated with inflammation of the mucous membranes lining the nasal

passages. Chlorpheniramine is an antihistaminic agent and has anticholinergic action provides a drying effect on the nasal mucosa.

FLU OFF syrup is well absorbed after oral administration, highly metabolized by the liver and almost completely excreted by kidneys.

INDICATIONS :

FLU OFF is effective in treating the symptoms of common cold and flu including sinus and nasal congestion, fever, headache, aches,

sneezing, runny nose , itching of the nose or throat.

DOSAGE & ADMINISTRATION :

* The dose can be repeated every 4 - 6 hours but do not exceed 2 doses for infants and 4 doses for children and adults per day.

RESTRICTIONS ON USE :

Contraindications

- Hypersensitivity to the ingredients.

- Severe liver or kidney disease .

- In patients who are taking or have taken monoamine oxidase inhibitors (MAOIs) for the last two weeks.

Precautions

- Caution should be taken in elderly and patients with epilepsy, glaucoma, pyloroduodenal obstruction, diabetes, hypertension, ischemic

heart disease, hyperthyroidism, hepatic impairment, renal dysfunction, prostatic hypertrophy , urinary retention, increase intraoccular

pressure or alcohol dependence.

- Concomitant administration of FLU OFF syrup with any product containing Paracetamol should be avoided.

- The treatment should be ceased before taking allergy skin tests due to possible false positive results .

Effects on the ability to drive vehicles or use machines.

FLU OFF may cause drowsiness, patients should take care during driving or use machines.

Use in pregnancy and lactation.

There are no adequate studies on FLU OFF use during pregnancy ,so it should be used only when the potential benefit of treatment to

the mother outweighs any possible risks to the fetus. FLU OFF passes through breast milk in an amount that is too small to be

harmful.However,it should be used with caution during lactation.

DRUG INTERACTIONS :

- Concomitant use of FLU OFF with metoclopramide may accelerate the absorption of paracetamol while when given with

cholestyramine the absorption of paracetamol is reduced .

- Concomitant use of FLU OFF with alcohol, anxiolytics, MAOI, tricyclic antidepressants or hypnotics may enhance the sedative effect of

FLU OFF. Tricyclic antidepressants , MAOI and the other anticholinergic agents may enhance the anticholinergic side effects .

- Concomitant use of FLU OFF with oxytocin, Beta antagonist, Guinithidine, Methyldopa and MAOI may increase the risk of hypertension,

while concurrent use with ergotamine may increase the risk of ergotism.

SIDE EFFECTS :

The most common effect is drowsiness .There are some minor effects such as headache , dry mouth, blurred vision ,gastrointestinal

disturbances , skin rash. Very rarely tinnitus , dizziness, blood disorders have been reported .

OVER DOSAGE :

Symptoms of over dosage : Sedation, stimulation of CNS, convulsions, anticholinergic effects, fast and short breath, high blood pressure,

arrhythmia.

Treatment : the patient should be given symptomatic and supportive treatment with monitoring cardiac , respiratory , renal and hepatic

functions and fluid and electrolyte balance. In addition, gastric lavage or induction of emesis should be done.

STORAGE INSTRUCTIONS :

Store below 30oC,do not refrigerate.

Protect from light.

PRESENTATIONS :

FLU OFF syrup : Bottle of 60 ml.

Infants 6- 12 months

Children 1 - 6 years

Children 6 - 12 years

Adults and children 12 years and above

2.5 ml

2.5 ml

5 ml

10 ml

Age Dosage