Each caplet contains for CETAL :
- Paracetamol 500 mg
- Pseudoephedrine hydrochloride 30 mg
- Chlorpheniramine maleate 2 mg
Inactive ingredients for CETAL :
- Microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate.
Therapeutic Indications for CETAL
- Cetal Cold & Flu Caplets are indicated for the relief of symptoms of common cold & influenza such as: fever, nasal congestion, sinus congestion, headache, and sinus pain, sneezing, itchy and watery eye.
Dosage and Administration for CETAL
- CETAL Cold & Flu Caplets are suitable for adults and children of 12 years of age and over.
- Adults and Children ≥ 12 years old: 2 caplets up to 4 times a day.
- If necessary the dose may be repeated every 4-6 hours, up to a maximum of four doses (8 caplets) in 24 hours.
Contraindications for CETAL
- In patients with known hypersensitivity to paracetamol, pseudoephedrine hydrochloride, chlorpheniramine maleate or related compounds.
- In patients taking monoamine oxidase inhibitor antidepressants or within 2 weeks of stopping such treatment.
- In children under the age of 12 years.
Warnings and Precautions
- CETAL Cold & Flu Caplets contain paracetamol. The stated dose should not be exceeded.
- Other paracetamol-containing medications, nasal decongestants or antihistamines should not be administered at the same time with CETAL Cold & Flu.
- CETAL Cold & Flu should be administered with caution in patients with hepatic or renal dysfunction, sever hypertension, cardiac or peripheral disease, hyperthyroidism, or 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 be precipitated in angina pectoris.
Antihistamines should be used with caution in conditions such as epilepsy, prostatic enlargement, urinary retention, glaucoma, severe cardiovascular disorders or pyloroduodenal obstruction.
- CETAL Cold & Flu should not be used for pain for more than 10 days, or for fever for more than 3 days, unless directed by a doctor. If pain persists or gets worse, or new symptom occur, or if redness and swelling is present, consult a doctor because these could be signs of a serious condition. If nervousness, dizziness or insomnia occur, or if a sore throat is severe and persists for more than 2 days and is accompanied by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
- Use in children: Do not give to children below 12 years of age.
- Keep out of reach of children.
- CETAL Cold & Flu may interact with anticoagulant agents on prothrombin time.
- The liver effects of CETAL Cold & Flu may be increased by the use of alcohol and the concomitant use of certain drugs which enhance the metabolism of paracetamol in the liver (i.e. barbiturates, tricyclic antidepressants).
- Co-administration of pseudoephedrine and MAO inhibitors my lead to hypertensive crisis. This effect may persist for up to 2 weeks after discontinuation of MAOI’s.
- Enhanced sedative effect of chlorpheniramine can occur with simultaneous administration of alcohol, anxiolytics and hypnotics.
- Tricyclic antidepressants and antimuscarinics can increase side effects.
Pregnancy and Lactation
- Although there are no known risks associated with the use of these active ingredients during pregnancy, as with all medicines, medical advice should be sought before using this product.
- CETAL Cold & Flu should not be used during breastfeeding as there may be risks associated with the use of antihistamines in infants.
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