INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ENDCOL® COLD AND FLU CAPSULES

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ENDCOL® COLD AND FLU CAPSULES

COMPOSITION :
Each capsule contains:
  Paracetamol         300 mg
  Ascorbic acid         75 mg
  Phenylephrine hydrochloride         5 mg
  Chlorpheniramine maleate         2 mg
  Caffeine anhydrous         30 mg

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

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

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

CONTRA-INDICATIONS:
Endcol capsules are contra-indicated in persons with coronary disease, hypertension, cardiovascular disease, hyperthyroidism, epilepsy 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 10 days of stopping such treatment.

WARNING:
Dosages in excess of those recommended may cause severe liver damage. Do not use continuously for more than 10 days without consulting your doctor.
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by 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.

DOSAGE AND DIRECTIONS FOR USE:
Adults: 2 capsules 3 times daily.
Children (6 - 12 years): 1 capsule 3 times daily
Not recommended for children under the age of 6 years.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
PARACETAMOL:
Sensitivity reactions to paracetamol resulting in reversible skin rash or blood disorders may occur, but these are rare.
Dosages in excess of those recommended may cause severe liver damage.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
PHENYLEPHRINE:
Hypertension with headache, palpitations, vomiting and reflex bradycardia.
CHLORPHENIRAMINE:
Sedation, gastro-intestinal disturbances, headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of mouth, tightness of chest and tingling, heaviness and weakness of the hands. Cerebral stimulation, particularly in children, allergy and anaphylaxis may occasionally occur.
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.
CAFFEINE:
Nausea, headache, palpitations and insomnia. Caffeine should be given with care to patients with a history of peptic ulceration.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage with paracetamol include nausea and vomiting.
Liver damage which may be fatal may only appear after a few days. Kidney failure has been described following acute intoxication.
Chlorpheniramine overdosage may result in excitement, convulsions in susceptible persons and hypotension.
Overdosage of phenylephrine may cause tachycardia. Symptoms of overdosage of caffeine include restlessness, excitement, muscle tremor, tinnitus, scintillating scotoma, tachycardia and extrasystoles.
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.
The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.

IDENTIFICATION:
A No. 0 capsule with an opaque blue cap and opaque yellow body printed in black ink with a Lennon Logo and ‘LENNON’on the one part and ‘ENDCOL’on the other part.

PRESENTATION:
Blister packs of 24 capsules.
Plastic containers of 1 000 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light and moisture.
KEEP OUT OF THE REACH OF CHILDREN.

REGISTRATION NUMBER:
R/5.8/228.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8/83
                G777B
                KOHLER C&P P.E.

Updated on this site: April 2005
Source: Community Pharmacy

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