INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
FLUTEX COLD AND FLU CAPSULES WITH VITAMIN “C”

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

FLUTEX COLD AND FLU CAPSULES WITH VITAMIN “C”

COMPOSITION:
Each capsule contains:

Paracetamol	100 mg
Caffeine anhydrous	30 mg
Salicylamide	75 mg
Ascorbic acid	50 mg
Chlorpheniramine Maleate	2 mg
Phenylephrine Hydrochloride	2 mg

Preservative:

Sodium Benzoate

0,011% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 5.8 Preparations for the common cold, including nasal decongestants and antihistaminics.

PHARMACOLOGICAL ACTION:
Flutex capsules have analgesic, antipyretic, antihistaminic and decongestant properties.

INDICATIONS:
Flutex capsules are indicated for the relief of symptoms associated with colds and influenza such as nasal congestion, headache, minor aches and pains.

CONTRA-INDICATIONS:
Flutex capsules are contra-indicated in persons with hypertension, cardiovascular disease, hyperthyroidism and hypersensitivity to any of the ingredients.
It is also contra-indicated in pregnancy and in persons being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment.
Severe liver function impairment.

WARNINGS:
Dosage in excess of those recommended may cause severe liver damage. Do not use continuously for more than 10 days without consulting your doctor.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned not to drive a motor vehicle, operate dangerous machinery or climb dangerous heights, as impaired decision making could lead to accidents.
Aspirin has been implicated in Reye’s Syndrome, a rare but serious illness, in children and teenagers with chickenpox and influenza. Since salicylamide is a compound related to aspirin, a doctor should be consulted before this product is used in such patients.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
1 - 2 capsules 3 times a day after meals.
Children (6 - 12 years]:
1 capsule 3 times a day after meals
Not recommended for children under the age of 6 years.
Do not exceed the stated dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
PARACETAMOL
Side-effects of paracetamol include skin rashes and other hypersensitivity reactions, and blood disorders such as thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis may occur.
Paracetamol should be given with care to patients taking other medicines that affect the liver.
CAFFEINE ANHYDROUS
Gastro-intestinal irritation and stimulation of the central nervous system, nausea, vomiting, abdominal pain, diarrhoea, gastro-intestinal bleeding, insomnia, headache, anxiety, restlessness, dizziness, hypotension, tremor and palpitations.
Caffeine should be given with care to patients with a history of peptic ulceration.
SALICYLAMIDE
Gastro-intestinal disturbances such as nausea, dyspepsia and vomiting. Irritation of the gastric mucosa with erosion, ulceration, haematemesis and melaena may occur. Sensitivity to salicylamide may produce skin rashes, angioedema, rhinitis, severe paroxysmal bronchospasm and dyspnoea. Salicylamide may cause hepato-toxicity, especially in patients with juvenile arthritis or other connective tissue disorders.
Salicylamide should not be administered to patients with haemophilia or other haemorrhagic disorders.
ASCORBIC ACID
Large doses causes diarrhoea and other gastro-intestinal disturbances. Use with care in patients with hyperoxaluria.
CHLORPHENIRAMINE MALEATE
Sedation, lassitude, dizziness, inco-ordination, gastro-intestinal disturbances, headache, blurred vision, tinnitus, tremors, irritability, nightmares, anorexia, difficulty in micturition, dryness of mouth and tightness of chest.
Because chlorpheniramine may produce sedation, persons should not operate machinery, drive cars, climb dangerous heights or perform potentially dangerous tasks where impaired decision making could lead to accidents. Other central nervous system depressants, such as barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers, if taken concomitantly, will enhance sedation. Care should be observed when tricyclic depressants, guanethidine, reserpine, methyldopa or atropine are taken concomitantly.
PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine may cause giddiness, headache, nausea, vomiting, reduced appetite, sweating, hypersalivation, tachycardia, palpitations, difficulty in micturition, urinary retention, and tremors, anxiety, fear, confusion, psycotic states, restlessness and insomnia. Hypertension and ventricular arrhythmias may occur.
Use with caution in patients with hyperthyroidism, cardiovascular disease, diabetes mellitus or closed-angle glaucoma.
An increased risk of arrhythmias may also occur if phenylephrine is given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 24 to 48 hours after ingestion.
Abnormalities of glucose metabolism and metabolic acidosis may occur. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported. Symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may become manifest on the second day (or later) initially by elevation of serum transaminase and lactic dehydrogenase activity increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death. Cerebral oedema and nonspecific, myocardial depression have also occurred.
In the event of overdosage, consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible.
Any patient who has ingested about 7,5 g of paracetamol in the preceding 4 hours should undergo gastric lavage.
Specific therapy with an antidote such as acetylcysteine or methionine may be necessary.
If decided upon, acetylcysteine should be administered IV as soon as possible preferably within 8 hours of overdosage.

IV:	An initial dose of 150 mg/kg in 200 mL glucose injection given intravenously over 15 minutes followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours and then 100 mg/kg in 1000 mL over the next 16 hours. The volume of intravenous fluid should be modified for children.
Orally:	140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses Acetylcysteine is effective if administered within 8 hours of overdosage.

Symptoms of caffeine overdosage include tremor, delirium, tachycardia, cardiac arrthymias, convulsions, and death may occur.
Symptoms of salicylamide overdosage include hyperventilation, fever, restlessness, ketosis, and respiratory alkalosis and metabolic acidosis. Depression of the central nervous system may lead to coma; cardiovascular collapse and respiratory failure can occur.
In children drowsiness and metabolic acidosis commonly occur; hypoglycaemia may be severe.
In acute salicylamide overdosage the stomach should be emptied by lavage. Fluid and electrolyte management is the mainstay of treatment with the immediate aim being correction of acidosis, hyperpyrexia, hypokalaemia and dehydration.
Symptoms of chlorpheniramine overdosage include ataxia, excitement, tremors, psychoses, hallucinations, and convulsions; hyperpyrexia may also occur. Deepening coma and cardiorespiratory collapse may follow.

IDENTIFICATION:
A No. 1 hard gelatin capsule with an opaque orange cap and an opaque white body, imprinted in black ink with "FLUTEX" on cap and body.

PRESENTATION:
"Securitainers" containing 20 capsules and tins containing 1000 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C, in airtight containers and protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBER:
G1221 [Act 101/1965]

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
PHARMACARE LIMITED
7 Fairclough Road
Korsten
Port Elizabeth
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 1988

                D110
        A & S PRINTERS

Updated on this site: February 2001
Current: September 2004
Source: Community Pharmacy
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