Panadol Cold & Flu Vapour Release + Decongestant is recommended for relief of symptoms of influenza, feverishness, chills
and feverish colds including headache, sore throat pain, aches and pains, nasal congestion, sinusitis and its associated
pain, and acute nasal catarrh.

A. Do not take Panadol Cold & Flu Vapour Release + Decongestant in case of:
- Known or previous history of hypersensitivity to paracetamol, phenylephrine, ascorbic acid or any of the other
ingredients in the product.
- Concomitant use of other sympathomimetic decongestants.
- Phaeochromocytoma.
- Closed angle glaucoma.
- Hepatic or renal impairment, diabetes, hyperthyroidism and cardiovascular disease.
- You are taking, or have taken,within the last two weeks,monoamine oxidase inhibitors (MAOIs), usually used to treat
depression.
B. Take special care with Panadol Cold & Flu Vapour Release + Decongestant:
- Do not exceed the recommended dose.
- This product contains Paracetamol, Phenylephrine. Do not take with any other product containing Paracetamol,
or other medicines for the relief of cough and colds, congestion or blocked nose.
- May be harmful to teeth.
- Keep this and all medication out of sight and reach of children.
Please see your doctor if your symptoms do not improve or persist or get worsen or new symptoms occur
because these could be signs of a serious condition.
Medical advice should be sought before taking Panadol Cold & Flu Vapour Release + Decongestant if you:
- Have been diagnosed with severe renal or severe hepatic impairment. (Because Paracetamol is metabolised in the
liver and excreted by the kidney in urine).
- An enlargement of the prostate gland, Occlusive Vascular disease (e.g. Raynaud’s Phenomenon) which may appear as pain
in the fingers or toes in response to cold or stress.
- You are pregnant, trying to become pregnant or breastfeeding.
Use with caution if you are:
- Taking beta-blockers and other antihypertensive drugs.
- Taking tricyclic antidepressants.
- Diabetic or have any intolerance to some sugars as this product contains sucrose 3.755gm/sachet and saccharine sodium
10mg/sachet.
- Phenylketonuria patient as it contains aspartame 50mg/sachet (a source of phenylalanine)
Panadol Cold & Flu Vapour Release + Decongestant should not be used by:
- Patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like
psychostimulants).
- Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or
sucrase-isomaltase insufficiency. This product contains sucrose.
C. Taking other medicines:
Paracetamol
The liver toxic effects of Panadol Cold & Flu Vapour Release + Decongestant may be increased by the use of alcohol.
The 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.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced
by colestyramine.
Phenylephrine
Medical consultation should be sought before taking Panadol Cold & Flu Vapour Release + Decongestant if you are:
- Taking beta-adrenergic blocking agents and other antihypertensive. Phenylephrine may reduce the efficacy of beta
blocking drugs and antihypertensive drugs. The risk of hypertension and other cardiovascular side effects may be
increased.
- Taking tricyclic antidepressants (used to treat depression), whichmay increase the risk of cardiovascular side effects
with phenylephrine.
- Taking other sympathomimetics (such as decongestants, appetite suppressants, and amphetamine_like
psychostimulants). Concomitant use of phenylephrine with sypathomimetic amines can increase the risk of
cardiovascular side effects.
- Taking Digoxin and cardiac glycosides. Concomitant use of phenylephrine with digoxin or cardiac glycosides may
increase the risk of irregular heartbeat or heart attack.
- Taking ergot alkaloids. use with (ergotamine and methylsergide) increased risk of ergotism.
- Taking Monoamine oxidase inhibitors. Concomitant use of phenylephrine with other sympathomimetic amines can
increase the risk of cardiovascular and hypertensive side effects.
D. Pregnancy and breast feeding:
Panadol Cold & Flu Vapour Release + Decongestant should not be used during pregnancy or breast feeding without
medical advice. Phenylephrine may be excreted in breast milk.

E. Ability to perform tasks that require judgment, motor or cognitive skills:
should not drive or operate machinery if affected by dizziness.

Powder For oral solution.
If symptoms persist, consult a doctor.
Do not take more frequently than every 4 hours.
Adults (including elderly) and children aged 16 years and over:
- One sachet to be taken every 4 hours if necessary, up to a maximum of six sachets in any 24 hours.
- Empty the contents of the sachet into a cup and half fill with very hot water. Stir well.
Add cold water as necessary.
- Do not use for more than 7 days without medical advice.
Not to be given to children under 16 years of age except on medical advice.

Paracetamol
If you are in doubt of any symptoms or sign, please consult your physician.
Stop using Panadol Cold & Flu Vapour Release +Decongestant and consult your doctor immediately if:
You experience: Thrombocytopenia Agranulocytosis These are not necessarily causally related to paracetamol
You experience: anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens
Johnson syndrome/ toxic epidermal necrolysis you experience: bronchospasm (more likely in asthmatics sensitive to
aspirin or other NSAIDs)
Hepatic dysfunction
These reactions are rare
Phenylephrine
Adverse events have been observed in clinical trials with phenylephrine: nervousness, irritability, restlessness, and
excitability, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting. The reactions frequency of
adverse events reported is unknown but likely to be rare as mydriasis, acute angle closure glaucoma (most likely
to occur in those with closed angle glaucoma), tachycardia, palpitations, allergic reactions (e.g. rash, urticaria, and
allergic dermatitis), dysuria, and urinary retention (This is most likely to occur in those with bladder outlet obstruction,
such as prostatic hypertrophy).
* If any of the side effects gets serious or if you notice any side effects listed or not listed in this leaflet stop taking
Panadol Cold & Flu Vapour Release +Decongestant and tell your doctor.
Overdosage:
Paracetamol

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol
may lead to liver damage if the patient has risk factors (patients on long term treatment with carbamazepine,
phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes, Regularly
consumes ethanol in excess of recommended amounts , Is likely to be glutathione deplete e.g. eating disorders, cystic
fibrosis, HIV infection, starvation, cachexia.
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain.
Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic
acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia,
cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria
and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have
been reported.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma
paracetamol concentration should be measured at 4 hours or later after ingestion. Treatment with N-acetylcysteine
may be used up to 24 hours after ingestion of paracetamol, If required the patient should be given intravenous
N-acetylcysteine. If vomiting is not a problem, oral methionine may be a suitable alternative. Management of patients
who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with Physician.
In all cases of suspected overdose, immediate medical attention is critical for adults as well as for children, even if you
do not notice any signs or symptoms
Phenylephrine
Overdose of Phenylephrine is likely to result in effects similar to those listed under adverse reactions. Additional
symptoms may include hypertension, and possibly reflux bradycardia. In severe cases confusion, hallucination, seizures
and arrhythmias may occur. Treatment should be as clinically appropriate. Severe hypertension may need to be treated
with alpha blocking drug such as Phentolamine.

To report any side effect(s):
Kingdom of Saudi Arabia
-National Pharmacovigilance centre (NPC)
Fax: +966-11-205-7662
Reporting Hotline: 19999
E-mail: npc.drug@sfda.gov.sa
Website: https://ade.sfda.gov.sa
-GlaxoSmithKline Consumer Healthcare - Head Office, Jeddah
Tel: +966-12-601-5444
Mobile: +966-53-553-3647
Email: contactus-me@gsk.com
P.O. Box 48034, Jeddah 21572, Saudi Arabia

For any information about this medicinal product, please contact:
GlaxoSmithKline Consumer Healthcare - Head Office, Jeddah
Tel: +966-12-601-5444
Email: contactus-me@gsk.com
P.O. Box 48034, Jeddah 21572, Saudi Arabia

Store below 30°C
Store in original container. Protect from Light and Heat.