Saturday, September 14, 2013

NOFLU

NOFLU 
NOFLU TABLETS & SYRUP
Company Name: 
Kahira Pharmaceutical and Chemical md. Co.
Product Name: NOFLU Generic Name: Paracetamol, Pseudoephedrine Hydrochloride,
Chlorpheniramine Maleate
Pharmaceutical Form: Tablets & Syrup
Pharmaceutical Group : Analgesic, Antihistamine, Decongestant
Composition:
Active Ingredient 
Paracetamol (micronized) Pseudoephedrine hydrochloride
Chiorpheniramine malee
Inactive Ingredients (tablets)
Magnesium Stearate, Sodium Benzoate, Sorbitol Powder, Starch
Maize,Talc, Propylene Glycol.
Inactive Ingredients (syrup) Propylene Glycol, Polyethylene Glycol 400, Glycerin, Sorbitol Powder,
Citric Acid hydrous, Sodium Citrate, Sodium Benzoate, Sugar, Saccharin
Sodium, Essence fraise, Purified water.
CLINICAL PHARMACOLOGY NOFLU is a well formulated preparation which contains specially selected components that act together to provide rapid relief from symptoms of upper respiratory tract congestion ,common cold and influenza.
Paracetamol is a pain reliever and fever reducer. It produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat regulating Center.
Pseudoephedrine hydrochloride is a decongestant that shrinks blood vessels in the nasal passages. It acts predominantly on alpha receptors in the mucosa of respiratory tract and has little action on beta receptors. It therefore functions as an oral nasal decongestant with minimal central nervous system (CNS) stimulation.
Chlorpheniramine maleate is potent, rapidly acting antihistamine which helps in alleviating rhinorrhoea, nasal stuffiness and sneezing. It is well tolerated and generally causes minimal dtnwsincss than other antihistamines.
THERAPEUTIC INDICATIONS
For the relief of symptoms associated with colds and flu; including relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract, sneezing, runny nose, coughing fever, headache, muscular aches and pains.
POSOLOGY AND METHOD OF ADMINISTRATION Adults, the elderly and children aged 12 years and over: One tablet up to four times daily, as required. Do not take more frequently than every four hours.
Children 6 to 12 years:
One (5 ml) teaspoonful to be given every 6 hours daily
Children under 6 years:
NOFLU Tablets are contraindicated in children under the age of 6 years. Do not exceed the stated dose.
CONTRAINDICATIONS Hypersensitivity to any of the ingredients.
p. ii
Paracetamol should not be used in patients with severe liver disease.
Do not use this product if you are being treated with monoamine oxidase inhibitors, or within two weeks, of stopping treatment with these medications.
Pseudoephedrine hydrochloride should not be used in patients suffering from any of the Ibllowing: heart disease (especially coronary insufficiency or arrhythntias), high blood pressure (hypertension), an overactive thyroid gland (hyperthyroidism), tumour of the adrenal gland (phaeochromocytoma), raised intraocular pressure (closed-angle glaucoma) and diabetes inellitus. Pseudoephedrine hydrochloride should be avoided in patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics. NOFLU is contraindicated in pregnancy and lactation.
UNDESIRABLE EFFECTS Paracetamol may cause pancreatitis, allergic reactions in the form of a rash or blood disorders (including neutropenia, pancytopenia, leucopenia, agranulocytosis and thrombocytopenia). These should disappear on stopping the treatment. The rash usually appears as red areas or allergic wheals, and may be accompanied by fever and involvement of the mucous membranes.
The most common side effect due to chlorpheniramine is sedation varying from slight drowsiness to deep sleep, including lassitude, dizziness, and inco-ordination. Paradoxical central nervous system stimulation may occur especially in children, with ‘insomnia, nervousness, euphoria, irritability, tremors, and less frequently, nightmares, hallucinations, and convulsions.
Other side el’I’ects may include di’ mouth, thickened respiratory tract secretions and tightness of the chest, blurred vision, urinary difficulty and retention, constipatioti and lreased gastric reflux. In addition, gastro-intestinal disturbances may occur such as nausea, vomiting, diarrhea or epigastric pain.
Hypersensitivity reactions may occur. Blood disorders including agranulocytosis, leucopenia, haetitolytic anaemia and thrombocytopenia, have been reported. Other less frequently reported side effects include hypotension, tinnitus, headache and paraesthesias
WARN INGS Taking more than the recommended dose may cause severe liver damage. Patients suffering from liver or kney disease should take paracetamol only if instructed to do so by a doctor.
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other agents which slow down the nervous system activity. Patients should be warned against taking charge of vehicles or machinery or performing potentially dangerous tasks where loss of concentration may lead to accidents.
Consult your doctor if no relief is obtained with the recommended dosage. Do not use continuously for Iger than 10 days without consulting a doctor.
PRECAUTIONS Chlorpheniramine should be giveg’with care to patients with glaucoma, urinary retention, prostatic hypertrophy or pyloroduodenal obstruction. Caution is advised in patients with epilepsy and severe cardiovascular disorders.
Chlorpheniramine may enliancIhe sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotic, analgesics,
\1O\ sedatives anà tranquillisers. Care should be taken when taking medicines containing tricycic antidepressants or atropine together. Elderly patients are more susceptible to the central nervous system depressant and lowering of blood pressure effects even at dose quantities effective for treatment.
The warning signs of damage caused by ototoxic medicines may be masked by chlorpheniramine.
Other central nervous system depressants, such as alcohol, barbiturates, hyponotics, narcotic analgesics, sedatives and tranquillisers, if taken together will increase the chance of sedation. Be careful when taking medicines containing tricyclic antidepressants or atropine together. Pseudoephedrine hydrochloride may cause giddiness, headache, nausea, vomiting, sweating, thirst, rapid or irregular heart beat (tachycardia, ventricular arrhythmia), pain in front of the heart (precordial pain,) palpitations, raised blood pressure (hypertension), micturition, difficulty in urination, muscular weakness, tremors, anxiety, restlessness and inability to sleep, fear, confusion, psychotic states, reduced appetite, dyspnoea, sweating, hypersalivation, altered metabolism including disturbance in glucose metabolism. Tolerance with dependence may occur after continued use.
The effects of pseudoephedrine hydrochloride are lessened by medicines containing guanethidine, reserpine, methyldopa and may be diminished or enhanced by tricyclic antidepressants. It may increase the possibility of irregular heart beat in patients taking digitalis. Pseudoephedrmne may increase blood pressure and therefore special care is advisable in patients receiving antihypertensive therapy. Not to be used in children under the age of 6 years.
PACKAGE:
NOFLU Tablets: Carton box containing 2 strips (PVC/AL) each of tablets with leaflet.
NOFLU Syrup: Carton box containing amber glass bottle of 100 ml with leaflet.
STORAGE: Store at temperature not exceeding 30°C, in dry place away from light.
Produced By
Kahira Pharm. & Chem. md. Co. Cairo Egypt.
Each tablet contains 400 mg
60 mg
3 mg
Each 5n1 contains 160 tog
15 mg
1 mg
This is Medicament Medicament is a product which affects your health and its consumption contrary to instructions, is dangerous for you.
Follow strictly the doctor’s prescription the method of use and the instructions of the pharmacist who sold the medicament.
The doctor and pharmacist are esperts in medicine, its benefits and risks.
Do not by yourself interrupt the period of the treatment prescribed for you.
Do not repeat the same prescription without consulting your doctor Reep Medicament Out Of The Reach of Children.
Council of Arab Health Ministers
Union Of Arab Pharmacists.