Panadol CF CAPLETS

PHARMACEUTICAL DOSAGE FORM AND FORMULA

Pharmaceutical dosage form: Caplets

Formula

Each Panadol CF Caplet Contains:

Paracetamol ВР

500 mg

Pseudoephedrine Hydrochloride BP

60 mg

And Chlorpheniramine Maleate BP

4 mg

PANADOL CF CONTAINS:

Panadol CF contains a combination of an antipyretic/ analgesic, a decongestant and an antihistamine.

INDICATIONS:

For the relief of symptoms of common cold and influenza such as: fever, muscle ache, nasal congestion, sinus congestion, headache and sinus pain, sneezing, itchy and watery eyes.

Panadol USUAL DOSAGE AND ADMINISTRATION:

Adults and children over 12 years: One caplet every 4-6 hours as needed.

Children under 12 years: Do not give to children under 12 years of age.

Maximum dosage: 4 caplets in 24 hours.

Minimum dosing interval: 4 hours.

Do not exceed the stated dose or frequency of dosing.

Should not be used with other products containing paracetamol, decongestants or antihistamines, including cough and cold preparation.

Use only under medical advice if symptoms persist for more than 7 days.

CONTRAINDICATIONS:

with known or previous history of hypersensitivity to paracetamol, pseudoephedrine, chlorpheniramine, other antihistamines or excipients
with severe hypertension or severe coronary artery disease
who are receiving other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants)
who are receiving MAOIs, or for two weeks after stopping a MAOI drug
with severe renal impairment

WARNINGS AND PRECAUTIONS

If you have been diagnosed with liver or kidney impairment seek medical advice

before taking this medication

Stop using this product and seek immediate medical advice if you experience:

Sudden abdominal pain, blood in your stool or other symptoms of ischaemic colitis develop.

Sudden severe headache, nausea, vomiting and usual disturbances or any signs of posterior reversible encephalopathy (PRES)/ reversible cerebral

vasoconstriction syndrome (RCVS).

Check with doctor before use:

Caution should be exercised in patients with cardiovascular disease, arrhythmias, hypertension, hyperthyroidism, prostatic enlargement, diabetes, glaucoma, phaechromocytoma, epilepsy, bronchitis, bronchiectasis and bronchial asthma





پیناڈول سی ایف کیپٹ

Signs of metabolic acidosis include: Deep rapid difficult breathing Feeling sick (nausea), being sick (vomiting)

– Loss of appetite

(contact your doctor immediately if you get a combination of these symptoms)

Avoid drinking alcohol with this medicine.
Children and the elderly are more likely to experience neurological anticholinergic effects and paradoxical excitations (e.g. increased energy, restlessness, nervousness).
If symptoms persist, get worsen or new symptoms arise immediate medicaladvice must be sought.
Keep out of sight and reach of children.

DRUG INTERACTION:

Also anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Cocomitant administration of pseudoephedrine hydrochloride-containing procust and Monoamine oxidase inhibitors – MAOIS (or within two weeks of stopping MAOI) may lead to hypertensive crisis. The anticholinergic effects of chlorphenamine are intensified by MAOIs.

Pseudoephedrine-containing products may antagonise the effect of certain classes of antihypertensives.

Concurrent use of chlorphenamine and hypnotics or anxiolytics may potentiate drowsiness. Concurrent use of alcohol may have similar effect.

Chlorphenamine inhibits phenytoin metabolism and can lead to phenytoin toxicity.

PREGNANCY AND LACTATION:

Do not use during pregnancy and breast feeding unless considered essential by physician. Safe use of pseudoephedrine in pregnancy has not been established despite widespread use over many years. Caution should by balancing the potential benefit of treatment to the mother against any possible hazards to the developing fetus.

Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast fed infants is unknown.

There are no adequate data from the use of chlorphenamine maleate in pregnant women. The potential risk for humans is unknown. Use during the third trimester may result in reactions in the newborn or premature neonates.

Chlorphenamine maleate and other antihistamines may inhibit lactation and may be secreted in breast milk.

ABILITY TO PERFORM TASKS THAT REQUIRE JUDGEMENT, MOTOR OR COGNITIVE SKILLS

blurred vision and psychomotor impairment in some patients which might seriously affect ability to drive and use machinery.

Paracetamol:

* Symptoms and Signs – Paracetamol overdose may cause liver failure.
Administration of N-acetylcysteineor methionine may be required. ethioninter Pseudoephedrine Hydrochloride:
In severe cases, psychosis, convulsions, coma and hypertensive crisis may occur. Serum potassium
levels may be low due to extracellular to intracellular shifts in potassium. Treatment Treatment should consist of standard supportive measures. Beta blockers should reverse the cardiovascular complications and the hypokalemia.
Chlorpheniramine: Symptoms and Signs – Overdose is likely to result in effects similar to those listed
under adverse reactions. Additional symptoms may include paradoxical excitation,
toxic psychosis, convulsions, apnoea, dystonic reactions and cardiovascularcollapse including arrhythmias. Treatment Treatment should be supportive and directed towards specific symptoms.
HOW SUPPLIED:

Carton of 100 caplets.

LIST OF EXCIPIENTS:

Silicone dioxide, stearic acid, sodium benzoate, povidone, pregelatinized starch, maize starch, talc.

Store below 30°C in a dry place.

Protect from light.

Keep out of reach of children.

For Oral Use only.

MDS/5.0/2001/09

GSK Specifications

خوراک اور طریقہ استعمال :

ڈاکٹر کی ہدایت کے مطابق صرف کھانے کے لئے استعمال کریں مقررہ خوراک سے تجاوز نہ کریں

ہر خوراک کے درمیان ۴ سے ۶ گھنٹے کا وقفہ ضروری ہے۔ کسی ایسی دوسری دوائی کے ساتھ نہ لیں جس میں Paracetamol شامل ہو

خشک جگہ پر رکھیں

روشنی سے محفوظ ۳۰ سینٹی گریڈ سے کم درجہ حرارت پر رکھیں

تمام ادویات بچوں کی پہنچ سے دور رکھیں

gsk GlaxoSmithKline

Manufactured By:

GlaxoSmithKline Pakistan Limited F-268, S.I.T.E., Karachi

RDCP 19/4 11/2014

relating to our products and we encourage healthcare professionals to report adverse events

to us on +92 (21) 111 475 725 or pk_pharmasafety@gsk.com

-Updated on GDS v5

-Revision Date: November 2014