COMPOSITION :

Each 5 ml (teaspoonful) contains : Chlorpheniramine maleate 1 mg

Pseudoephedrine HCl 15 mg

Paracetamol 160 mg

Dextromethorphan HBr 7.5 mg.

DESCRIPTION :

FLU OFF PLUS syrup is an effective formula that contains four active ingredients including Paracetamol that is an effective

pain reliever and fever reducer which acts by inhibiting 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 provide a

drying effect on the nasal mucosa, Dextromethorphan HBr is an antitussive.

INDICATIONS :

- Treatment of minor and moderate pain , fever reducer.

- Relief cold , flu and allergy symptoms such as nasal and sinus congestion, headache, sneezing, runny nose, itching of the nose

or throat.

- For the symptomatic relief of dry, non productive cough.

DOSAGE & ADMINISTRATION :

The dose can be taken 2 - 4 times per day as the following :

Children 2-5 years : 2.5 - 5 ml.

Children 6-12 years: 5 - 10 ml.

RESTRICTIONS ON USE :

Contraindication

- 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 occular pressure or alcohol dependence.

- Patients with asthma or productive cough as it may impair the expectoration of secretion.

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

Effects on the ability to drive vehicles or use machines.

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

Use in pregnancy and lactation.

There are no studies that show the effect of the drug administration during pregnancy and lactation, so FLU OFF PLUS should

not be used during pregnancy or lactation unless prescribed by physician.

DRUG INTERACTIONS :

- Co-administration of FLU OFF PLUS with Metoclopramide may accelerate the absorption of paracetamol while when given

with cholestyramine the absorption of paracetamol is reduced.

- Alcohol, anxiolytics, MAOI, tricyclic antidepressants or hypnotics may enhance the sedative effect of FLU OFF PLUS.

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

- Co-administration of FLU OFF PLUS 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 or 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 to that gastric lavage or induction of emesis should be done.

STORAGE INSTRUCTIONS :

Store below 30oC, do not refrigerate.

Protect from light.

PRESENTATIONS :

FLU OFF PLUS syrup : Bottle of 60 ml.