Panadol Sinus is a white capsule-shaped tablet which
contains Paracetamol which is Analgesic and Antipyretic and
Pseudoephedrine which is a nasal decongestant. For the short
time relief of sinusitis symptoms including sinus headache, sinus
pain, and nasal congestion.
Also it used for relief of fever and body aches.

a. Do not use Panadol Sinus Caplet if:
- You have previous history of hypersensitivity to paracetamol,
pseudoephedrine, or any of the other ingredients of Panadol Sinus.
- You have severe hypertension or severe coronary artery disease.
- You are taking other sympathomimetics (such as decongestants,
appetite suppressants, and amphetamine-like psychostimulants).
- You are taking or have taken in the past 2 weeks drug named
Monoamine Oxidase Inhibitors (MAOIs) as it may lead to
hypertensive crisis.
- You have severe renal impairment.
- There have been reports of acute systemic vasoconstrictive
events with pseudoephedrine. Significant examples include:
• Acute Coronary Syndrome (ACS): Symptoms include sudden
chest pain, tightness, heavy sweating and dyspnoea at rest.
• lschaemic colitis: Symptoms include sudden abdominal pain and
rectal bleeding.
• Posterior reversible encephalopathy (PRES)/reversible cerebral
vasoconstriction syndrome (RCVS): Symptoms included
sudden onset of severe headache, nausea, vomiting, and visual
disturbances. Most cases improved or resolved within a few days
following appropriate treatment.
- Pseudoephedrine should be discontinued immediately and
medical advice sought if any signs/symptoms vasoconstrictive
events develop

b. Take special care with Panadol Sinus if:
You should consult your doctor before taking this product if:
- You have liver impairment ormild to moderate kidney impairment.
- You have cardiovascular disease, arrhythmias, hypertension,
hyperthyroidism, prostatic enlargement, diabetes, glaucoma or
phaeochromocytoma.
- You are taking beta-blockers or other antihypertensives.
- You have glutathione depleted states such as sepsis or you have
a severe infection as the use of Paracetamol may increase the risk
of metabolic acidosis. Signs of metabolic acidosis include:
- deep, rapid, difficult breathing
- Feeling sick (nausea), being sick (vomiting)
- Loss of appetite
Contact a doctor immediately if you get a combination of these
symptoms.
- There have been reports of ischaemic colitis with
Pseudoephedrine. Pseudoephedrine should be discontinued
immediately and medical advice sought if sudden abdominal pain,
rectal bleeding or other symptoms of ischaemic colitis develop.
- There have been rare cases of posterior reversible
encephalopathy (PRES)/reversible cerebral vasoconstriction
syndrome (RCVS) reported with sympathomimetic drugs,
including pseudoephedrine. Symptoms reported included
sudden onset of severe headache, nausea, vomiting, and visual
disturbances. Most cases improved or resolved within a few
days following appropriate treatment. Pseudoephedrine should
be discontinued, and medical advice sought immediately, if
signs/symptoms of PRES/RCVS
develop.
- If you experience sudden severe headache.
* This product contains 0.6 mg Sodium benzoate per tablet to be
taken into consideration by patients on controlled Sodium diet.
*Do not exceed the stated dose.
* This product contains Paracetamol and Pseudoephedrine. Do not
use with other products containing paracetamol or decongestants
products.
* Keep medication out of sight and reach of children.
* Please see your doctor if your symptoms persist, do not improve,
worsen or new symptoms occur.

C. Taking other medications:
- The liver toxic effects of Paracetamol may be increased by the
use of alcohol. Avoid drinking alcohol with this medicine.
- The anticoagulant effect of warfarin and other coumarins
may be enhanced by prolonged regular daily use of
paracetamol-containing products with increased risk of bleeding;
occasional doses have no significant effect.
- Concomitant administration of pseudoephedrine
hydrochloride-containing products and MAOIs (or within two
weeks of stopping of MAOI) may lead to hypertensive crisis.
- Concomitant use of this medication with sympathomimetic
agents (such as decongestants, appetite suppressants and
amphetamine-like psychostimulants) which interfere with the
catabolism of sympathomimetic amines, may occasionally cause a
rise in blood pressure.
- Pseudoephedrine-containing products may antagonise the
effect of certain classes of antihypertensives.
d. Pregnancy and lactation:
This product should not be used during pregnancy or while
breastfeeding without consulting your doctor.
Safe use of Pseudoephedrine in pregnancy has not been
established despite widespread use over many years.
Caution should be exercised by balancing the potential benefit
of treatment to the mother against any possible hazards to the
developing foetus.
Pseudoephedrine is excreted in breast milk in small amounts but
the effect of this on breast fed infants is unknown.

e. Driving and usingmachines:
• This product can cause drowsiness, dizziness, or blurred vision.
You should not drive or operate machinery until you are sure
you are not affected.

Adults (including the elderly) and children aged 12 years and over:
- 1 to 2 caplets to be taken orally every 4 to 6 hours but do not
take more than
8 caplets in 24hours.
- Consult your doctor if symptoms persist for more than 7 days.
- Do not take more frequently than every 4 hours.

- Do not use in children under the age of 12 years.
- Do not exceed the stated dose.
Overdose
Seek medical advice immediately in the event of overdose even if
symptoms of overdose are not present.
Paracetamol:
Paracetamol overdose may cause liver failure. Immediate medical
management is required in the event of overdose, even if
symptoms of overdose are not present.
- In massive over dosage exceeding 10g of paracetamol may
cause liver damage. Early symptoms may include pallor, nausea,
vomiting, excessive sweating and general malaise.
- Clinical and laboratory evidence of liver damage may not be
apparent until 48 to 72 hours past ingestion.
Overdose should be promptly treated by gastric lavage followed
by intravenous N- acetylcysteine or methionine without waiting
for the results of plasma paracetamol levels.
- Additional antidote therapy is normally considered in light of
further plasma paracetamol levels and the time elapsed since
ingestion. In all cases of suspected overdose, prompt medical
attention is critical for adults as well as for children, even if you do
not notice any signs or symptoms.
Pseudoephedrine:
Pseudoephedrine overdose may result in symptoms due to central
nervous system and cardiovascular stimulation e.g. excitement,
restlessness, hallucinations, hypertension and arrhythmias. In
severe cases, psychosis convulsions, coma and hypertensive
crisis may occur. Serum Potassium levels may be low due to
extracellular shifts in Potassium.
Treatment should consist of standard supportive measures. Beta
blockers should reverse the cardiovascular complications and the
hypokalemia.

Stop using this product and consult your doctor immediately if:
Paracetamol:
- You experience allergic reactions such as skin rash or itching,
sometimes with breathing problems or swelling of the lips,
tongue, throat or face.
- You experience a skin rash or peeling, or mouth ulcers.
- You experience angioedema or Stevens Johnson syndrome.
- You have previously experienced breathing problems or
bronchospasm with aspirin or non steroidal anti-inflammatories,
and experience a similar reaction with this product.
- You experienced liver dysfunction related symptoms or signs.
- You experience unexplained bruising or bleeding.
Pseudoephedrine HCl:
- Nervousness, difficulty sleeping, dizziness, dry mouth, nausea
and vomiting, may occasionally occur.
- Rare reactions may include hallucinations, tachycardia,
palpitations, increased blood pressure (increase in systolic
blood pressure has been observed, at the therapeutic doses the
effects of Pseudoephedrine on blood pressure are not clinically
significant), rash, allergic dermatitis (such as bronchospapsm and
angioedema).
- Uncommon reactions such as agitation, restlessness, dysuria,
urinary retention(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 not listed in this leaflet, please contact your doctor or
pharmacist.

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
-Haleon Saudi Arabia - Head Office, Jeddah
• Tel: +966-12-601-5444
• Mobile: +966-53-553-3647
• Email: mystory.sa@haleon.com
• P.O. Box 48034, Jeddah 21572, Saudi Arabia

5. How to store Panadol Sinus
• Keep out of the reach and sight of children.
• Store Panadol Sinus at below 30°C.
• Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
• Protect from light and heat.