Description
Each caplet contains:
- Paracetamol 500 mg
- Pseudoephedrine Hydrochloride 30 mg
Pharmacology
Paracetamol: A clinically proven analgesic and antipyretic.
Pseudoephedrine: A sympathomimetic agent for symptomatic relief from nasal congestion.
Indications
Relief of sinus pain, nasal congestion, and fever.
Dosage and Administration
Panadol Sinus is suitable for adults and children aged 12 years and over.
Adults and Children (12 years and over):
- Two caplets up to four times a day.
- If necessary, the dose may be repeated every four to six hours.
- Do not take more than four doses (8 caplets) in 24 hours.
Contraindications
Panadol Sinus caplets are contraindicated in patients with:
- Known hypersensitivity to paracetamol, pseudoephedrine hydrochloride, or related compounds.
- Patients taking monoamine oxidase inhibitor (MAOI) antidepressants or within 2 weeks of stopping such treatment.
Precautions
- Keep out of reach of children.
- This preparation contains paracetamol. Do not exceed the stated dose.
- Do not take other paracetamol-containing medications or nasal decongestants at the same time as Panadol Sinus caplets.
- Use with caution in patients with hepatic or renal dysfunction, severe hypertension, cardiac or peripheral vascular disease, hyperthyroidism, or those on antihypertensive or antidepressant therapy.
- Pseudoephedrine should be given with care to patients with diabetes mellitus, closed-angle glaucoma, or prostate enlargement. Anginal pain may occur in patients with angina pectoris.
- Do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. If pain persists or worsens, if new symptoms occur, or if redness and swelling are present, consult a doctor.
- If nervousness, dizziness, or insomnia occurs, or if a sore throat is severe and persists for more than 2 days accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Use in Pregnancy & Lactation
Although there are no known risks associated with the use of these active ingredients during pregnancy and breastfeeding, medical advice should be sought before using this product.
Use in Children
Do not give to children below 12 years of age.
Side Effects
Paracetamol:
When taken in recommended doses, paracetamol is usually free from side effects. However, skin reactions such as urticaria have been reported rarely.
Pseudoephedrine:
May occasionally cause anxiety, tremor, dizziness, cardiovascular effects (including tachycardia and hypertension), insomnia, and urinary retention. A fixed erythematous drug eruption has been reported rarely.
Drug Interactions
Paracetamol:
- Panadol Sinus caplets may interact with anticoagulant agents on prothrombin time.
- The liver effects of Panadol Sinus caplets may be increased by alcohol and certain drugs that enhance the metabolism of paracetamol in the liver (e.g., barbiturates, tricyclic antidepressants).
Pseudoephedrine:
- Co-administration of pseudoephedrine and MAOIs may lead to hypertensive crisis. This effect may persist for up to 2 weeks after discontinuation of MAOIs.
Overdosage
Paracetamol:
In massive overdosage, Panadol Sinus caplets may cause severe liver damage. Early symptoms may include pallor, nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of liver damage may not be apparent until 48 to 72 hours post-ingestion. Overdosage should be promptly treated by gastric lavage followed by intravenous N-acetylcysteine or methionine without waiting for plasma paracetamol levels. Additional antidote therapy is considered based on further plasma paracetamol levels and the time elapsed since ingestion. In all cases of suspected overdose, prompt medical attention is critical for adults and children, even if no signs or symptoms are noticed.
Pseudoephedrine:
Overdose is likely to result in effects similar to those listed as adverse effects and may also produce excess sympathetic stimulation. Hypertension has been observed in normotensive subjects after taking 7-8 caplets. Treatment of pseudoephedrine overdose is mainly symptomatic. Measures should be taken to support respiration and control hypertension. Convulsions can be managed with an anticonvulsant if required. Elimination of pseudoephedrine can be accelerated by acidification of the urine.
Pharmaceutical Precautions
- Store below 25°C.
- Store in a well-sealed container.
Important Information
Medicines are products that affect your health, and failure to follow the instructions may be dangerous for you.
- Follow your doctor’s advice carefully, including the method of use, and the instructions of the pharmacist who sold you the medicine.
- Your doctor and pharmacist are experts in the use of medicines, including their benefits and risks.
- Do not stop your course of treatment early unless advised to do so by your doctor or pharmacist.
- Do not repeat your prescription without consulting your doctor.
KEEP MEDICINES OUT OF REACH OF CHILDREN
Manufacturer Information
Manufactured by GlaxoSmithKline Australia Pty Limited,
82 Hughes Avenue, Ermington NSW 2115, Australia.
PANADOL and the roundels device are trademarks of the GlaxoSmithKline group of companies.
Product Information Prepared April 2004. Version 4.0.
Council of Arab Health Ministers
Union of Arab Pharmacists
Frequently Asked Questions
When does Panadol Sinus Caplets take effect? Panadol Sinus Caplets starts working within 30 minutes of taking the dose. The effect of the dose lasts for 8 to 12 hours.
What is the duration of treatment with Panadol Sinus Caplets? Due to the presence of pseudoephedrine in Panadol Sinus Caplets, the duration of treatment with Panadol Sinus Caplets should not exceed 7 days for a dosage of one caplet twice daily (one caplet every 12 hours).
Can Panadol Sinus Caplets be chewed? Do not crush, chew, or break Panadol Sinus Caplets, as they are manufactured as coated caplets. Breaking or chewing the caplet may lead to the release of too much of the medicine at once.
What to do if symptoms do not improve? If symptoms do not improve within 7 days, a doctor should be consulted. Persistent cold, flu, and congestion symptoms for an extended period may indicate a complex medical condition such as chronic sinusitis or allergies, and a doctor should be consulted for proper diagnosis and treatment.
Does Panadol Sinus Caplets reduce fever? Yes, Panadol Sinus Caplets is used as a fever reducer. This medication contains paracetamol, which reduces temperature or treats fever.
When should I stop taking Panadol Sinus Caplets? Treatment with Panadol Sinus Caplets can be stopped as soon as symptoms disappear, and there is no need to complete a 5-day period.
Does Panadol Sinus Caplets cause drowsiness? Panadol Sinus Caplets does not cause drowsiness because it does not contain antihistamines, which affect alertness and attention and cause drowsiness.
Does Panadol Sinus Caplets treat cough? Panadol Sinus Caplets may help relieve cough caused by respiratory allergies or that accompanies colds and flu. It is important to note that if the cough persists for more than 3 days, or if other symptoms such as fever appear, a doctor should be consulted.
Is Panadol Sinus Caplets used to treat colds and flu? This medication relieves the symptoms caused by colds, flu, and sinusitis, including: nasal congestion, increased nasal secretions, watery eyes, cough, headache in cases of sinusitis, and fever.
What should I do if I take an overdose of Panadol Sinus Caplets? In case of an overdose, the patient should vomit and then take charcoal tablets to absorb the excess medication. If vomiting is not possible, gastric lavage with a saline solution is recommended.
Panadol Sinus Caplets Package Insert
Dr. Ahmad Baker, PharmD
Senior Pharmacist & Health Educator
With over 23 years of clinical experience in hospital and community pharmacy across Egypt and Saudi Arabia, Dr. Ahmad specializes in reproductive health and pharmaceutical safety. He is dedicated to providing evidence-based guidance to empower patients in the MENA region.
Medical Disclaimer: This content is for educational purposes and reflects the latest pharmaceutical protocols. It is not a substitute for personal medical advice. Always consult Dr. Ahmad Baker or your healthcare provider before starting any treatment.