Composition

Each caplet contains: 

Paracetamol D.C. ....................................................................... 500 mg

Caffeine anhydrous .................................................................... 65 mg

Inactive ingredients: 

Microcrystalline cellulose PH 102, plasidone XL, magnesium stearate, colloidal silicon dioxide, opadry II white.

Therapeutic Indications     

CETAL EXTRA is a mild analgesic and antipyretic formulated to give extra pain relief. The caplets are recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, backache, toothache, rheumatic pain and dysmenorrhoea, and relief of the symptoms of colds, influenza and sore throat.

Dosage and Administration         

Adults and Elderly:

2 caplets up to four times daily.

Do not exceed 8 caplets in 24 hours.

Children:

CETAL EXTRA Caplets are not recommended for children under 12 years.

Administration:

CETAL EXTRA Caplets are for oral administration only.

Contraindications       

Hypersensitivity to paracetamol, caffeine or to any of the the other constituents.

Warnings and Precautions          

Care is advised in the administration of paracetamol to patients with severe renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.

Do not exceed the stated dose.

Patients should be advised to consult their doctor if their headaches become persistent.

Patients should be advised not to take other paracetamol-containing products concurrently.

If symptoms persist, consult your doctor.

Keep out of the reach and sight of children. 

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Drug Interactions            

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. 

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.

Pregnancy and Lactation             

Pregnancy:

CETAL EXTRA is not recommended for use during pregnancy, due to the possible increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption.

Caffeine in breast milk may potentially have a stimulating effect on breastfed infants.

Due to the caffeine content of CETAL EXTRA, it should not be used if you are pregnant or breastfeeding.

Effects on ability to drive and to use machines         

None known.

Undesirable Effects             

Due to limited clinical trial data, the frequency of the adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Post-marketing data:

Blood and Lymphatic system disorders: Thrombocytopenia, agranulocytosis.

Immune system disorders: Anaphylaxis, cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis.

Respiratory, Thoracic and Mediastinal disorders: Bronchospasm^*.

Hepatobiliary disorders: Hepatic dysfunction.

^* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Caffeine:

Central Nervous system: Nervousness, dizziness.

When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as: insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.

Overdose       

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Gastric lavage or the administration of activated charcoal may be beneficial when performed within one hour of the overdose but can be considered for up to four hours after the overdose. Antidotes such as N-acetylcysteine (NAC) and methionine protect the liver if administered within 12 hours of overdose. NAC is effective up to and possibly beyond 24 hours. General supportive measures must be available.

Symptoms of paracetamol overdose 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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10 g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue.

Overdose of caffeine may result in epigastric pain, vomiting, diuresis, tachycardia or cardia arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).

It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related toxicity.

Pharmacological Properties     

Pharmacodynamic properties:

Pharmacotherapeutic group: Other Analgesics and Antipyretics – Anilides.

Pharmacodynamic properties:

The combination of paracetamol and caffeine is a well established analgesic combination.

Pharmacokinetic properties:

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. It is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost exclusively renal, in the form of conjugated metabolites.

Caffeine is absorbed readily after oral administration, maximal plasma concentrations are achieved within 1 hour and the plasma half-life is about 3.5 hours. 65 - 80% of administered caffeine is excreted in the urine as 1-methyluric acid and 1-methylxanthine.

Storage                  

Store at a temperature not exceeding 30^°C.

Packaging            

CETAL EXTRA Caplets: Box containing 2 strips of 10 caplets each.