CETAL COLD & FLU ( PARACETAMOL 500 MG + PSEUDOEPHEDRINE 30 MG + CHLORPHENIRAMINE MALEATE 2 MG ) 20 CAPLETS

Composition

Each caplet contains: 
Paracetamol ............................................................................ 500 mg
Pseudoephedrine hydrochloride ........................................... 30 mg
Chlorpheniramine maleate ...................................................... 2 mg
Inactive ingredients: 

Microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate.                                                        

Therapeutic Indications                       

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                

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               

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.                                                             

Drug Interactions                     

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.                                                         

Effects on ability to drive and to use machines         

Since CETAL Cold & Flu Caplets contain an antihistamine, sedation may occur impairing the ability to drive or to operate machinery.                                                           

Undesirable Effects               

Paracetamol: When taken in recommended dose, 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.
Chlorpheniramine: The antihistamine may cause sedation, gastrointestinal disturbances and antimuscarinic effects.                                                              

Overdose        

In massive paracetamol overdosage, CETAL Cold & Flu may cause liver damage.
Early symptoms may include pallor, nausea, vomiting, (diaphoresis) and general malaise.
Clinical and laboratory evidence of liver damage may not be apparent for 48 to 72 hours post-ingestion.
Overdose should be promptly treated by gastric lavage followed by intravenous N-acetylcysteine or methionine without waiting for 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 overdose is likely to result in effects similar to those listed as adverse effects, and may also produce excess sympathetic stimulation.
7-8 caplets has been shown to cause hypertension in normotensive patients.
Treatment of pseudoephedrine overdose is mainly symptomatic. Elimination of pseudoephedrine can be accelerated by acidification of the urine. Measures should be taken to support respiration and control hypertension.
Convulsions should be supported with an anticonvulsant if required.
Antihistamine overdosage may cause sedation and central nervous system depression.                                                        

Pharmacological Properties                      

CETAL Cold & Flu Caplets contain: Paracetamol, pseudoephedrine and chlorpheniramine maleate.
Paracetamol a clinically proven analgesic and antipyretic.
Pseudoephedrine is a sympathomimetic agent for symptomatic relief from nasal congestion.
Chlorpheniramine maleate is an antihistamine.                                                             

Storage    

Store in a dry place at a temperature not exceeding 30°C.                                                    

Packaging             

CETAL Cold & Flu Caplets:  Box containing 2 strips of 10 caplets each.

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