Temporary relief of symptoms of sinus headache, pain and nasal congestion (including fever) and hay fever.

Direction:

 

Do not give to children under 12 years of age.

 

Adults and Children over 12 years: Two Taplets every 4 to 6 hours when necessary. No more than 4 doses should be taken in 24 hours.

 

Use in adults: Paracetamol should not be taken for more than a few days at a time except on medical advice.

 

Use in Children: Paracetamol should not be taken for more than 48 hours except on medical advice.

Paracetamol Paracetamol is contraindicated for use in patients with known hypersensitivity or idiosyncratic reaction to paracetamol (or any of the other ingredients in the product). Refer to Section 4.5 Interactions with Other Medicines and Other Forms of Interaction for additional information. Pseudoephedrine hydrochloride Pseudoephedrine is contraindicated for use in patients: • with known hypersensitivity or idiosyncratic reaction to pseudoephedrine (or any of the other ingredients in the product); • with severe hypertension or coronary artery disease; • taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the previous 14 days. Refer to Section 4.5 Interactions with Other Medicines and Other Forms of Interaction for additional information. Chlorpheniramine maleate Chlorpheniramine is contraindicated for use in patients with: • a history of hypersensitivity to the substance or substances of similar chemical structure (or any of the other ingredients in the product); • narrow-angle glaucoma; • stenosing peptic ulcer; • symptomatic prostatic hypertrophy; • bladder neck obstruction; • pyloroduodenal obstruction. Chlorpheniramine is contraindicated for use in: • newborns or premature infants; • lactating women; • patients taking monoamine oxidase inhibitors (MAOIs). Refer to Section 4.5 Interactions with Other Medicines and Other Forms of Interaction for additional information

Paracetamol

Paracetamol should be used with caution in patients with:

 

·        impaired hepatic function;

 

·        impaired renal function.

 

Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5- oxoproline, is recommended.

 

Pseudoephedrine hydrochloride

 

Risks of abuse

 

As with other CNS stimulants, pseudoephedrine carries the risk of abuse. Increased doses may ultimately produce toxicity. Continuous use can lead to tolerance resulting in an increased risk of overdosing.

 

Pseudoephedrine should be used with caution in patients with:

 

·       hypertension;

·       hyperthyroidism;

·       diabetes mellitus;

·       coronary heart disease;

·       ischaemic heart disease;

·       glaucoma;

·       prostatic hypertrophy;

·       severe hepatic or renal dysfunction

 

Chlorpheniramine maleate

 

Chlorpheniramine may cause drowsiness and may increase the effects of alcohol. Drowsiness may continue the following day. Those affected should not drive or operate machinery; alcohol should be avoided.

 

Use with caution in patients with renal or hepatic impairment and in patients with epilepsy.

 

Refer to Section 4.5 Interactions with Other Medicines and Other Forms of Interaction for additional information.

 

Use in the Elderly

 

The elderly may experience paradoxical excitation with chlorpheniramine. The elderly are more likely to have central nervous system (CNS) depressive side effects, including confusion (see Section 4.3 Contraindications).

 

Paediatric Use

 

Children may experience paradoxical excitation with chlorpheniramine.

 

Effects on Laboratory Tests

 

No data available.

Paracetamol

The following interactions with paracetamol have been noted:

·       Anticoagulant drugs (warfarin) - dosage may require reduction if paracetamol and anticoagulants are taken for a prolonged period of time.

·       Paracetamol absorption is increased by substances that increase gastric emptying, eg. metoclopramide.

·       Paracetamol absorption is decreased by substances that decrease gastric emptying, eg. propantheline, antidepressants with anticholinergic properties, and narcotic analgesics.

·       Paracetamol may increase chloramphenicol concentrations.

·       The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes such as alcohol and anticonvulsant agents.

·       Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.

·       Cholestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.

·       Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risks factors (see section 4.4)

·       Phenytoin may reduce the analgesic and antipyretic effects of paracetamol and may increase the formation of the toxic N-acetyl-p-benzoquinone imine (NAPQI) metabolite of paracetamol leading to increased risk of hepatotoxicity.

 

Pseudoephedrine hydrochloride

The following interactions with pseudoephedrine have been noted:

 

·       Anti-depressant medication eg. tricyclic anti-depressants and monoamine oxidase inhibitors (MAOIs) may cause a serious increase in blood pressure or hypertensive crisis.

·       Other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants may cause an increase in blood pressure and additive effects.

·       Methyldopa and β-blockers – may cause an increase in blood pressure.

·       Urinary acidifiers enhance elimination of pseudoephedrine.

·       Urinary alkalinisers decrease elimination of pseudoephedrine.

 

Chlorpheniramine maleate

 

The following interactions with chlorpheniramine have been noted:

 

·       Central nervous system (CNS) depressants (alcohol, sedatives, opioid analgesics, hypnotics) – may cause an increase in sedation effects.

·       Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants (TCAs) – may prolong and intensify the anticholinergic and CNS depressive effects.

·       Chlorpheniramine when taken concomitantly with phenytoin may cause a decrease in phenytoin elimination.

 

Effects on Fertility

No data available.

 

Use in Pregnancy

 

Paracetamol

 

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

 

Pseudoephedrine

 

Pseudoephedrine has been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals are inadequate or may be lacking, but available data shows no evidence of an increased occurrence of foetal damage.

 

Pseudoephedrine should be used in pregnancy only if the potential benefits to the patient are weighed against the possible risk to the foetus.

 

Chlorphenamine

 

There are no adequate data from the use of chlorphenamine maleate in pregnant women. The potential risk for humans is unknown. Use during the third trimester may result in reactions in the newborn or premature neonates. Not to be used during pregnancy unless considered essentially by a physician.

 

Use in Lactation

 

 

Paracetamol is excreted in small amounts (< 0.2%) in breast milk.

 

Pseudoephedrine is also secreted in breast milk in small amounts. It has been estimated that 0.5% to 0.7% of a single dose of pseudoephedrine ingested by the mother will be excreted in the breast milk over 24 hours.

 

Chlorpheniramine is also excreted in breast milk. Therefore this product it is not recommended for breastfeeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant.

Chlorpheniramine may cause drowsiness and may increase the effects of alcohol. Drowsiness may continue the following day. Those affected should not drive or operate machinery; alcohol should be avoided.

Paracetamol

 

Side effects of paracetamol are rare and usually mild, although haematological reactions have been reported. Skin rashes and hypersensitivity reactions occur occasionally. Overdosage with paracetamol if left untreated can result in severe, sometimes fatal liver damage and rarely, acute renal tubular necrosis.

Pseudoephedrine hydrochloride

Adverse effects include:

·        cardiovascular stimulation – elevated blood pressure, tachycardia or arrhythmias;

·        central nervous system (CNS) stimulation – restlessness, insomnia, anxiety, tremors and (rarely) hallucinations;

·        skin rashes and urinary retention.

Children and the elderly are more likely to experience adverse effects than other age groups.

Chlorpheniramine maleate

·        Central Nervous System (CNS) effects

CNS depressive effects of chlorpheniramine include sedation and impaired performance (impaired driving performance, poor work performance, incoordination, reduced motor skills, and impaired information processing). Performance may be impaired in the absence of sedation and may persist the morning after a night-time dose.

CNS stimulatory effects of chlorpheniramine may include anxiety, hallucinations, appetite stimulation, muscle dyskinesias and activation of epileptogenic foci.

High doses of chlorpheniramine may cause nervousness, tremor, insomnia, agitation, and irritability.

·        Anticholinergic effects

Side effects of chlorpheniramine associated with cholinergic blockage include dryness of the eyes, mouth and nose, blurred vision, urinary hesitancy and retention, constipation and tachycardia.

To report any side effects:   For Saudi Arabia: The National Pharmacovigilance and Drug Safety Centre (NPC) Reporting hotline: 19999. E-mail: npc.drug@sfda.gov.sa Website: https://ade.sfda.gov.sa   For UAE Pharmacovigilance & Medical Device section P.O.Box: 1853 Tel: 80011111 Email: pv@moh.gov.ae Drug Department, Ministry of Health & Prevention, Dubai, UAE.   For Oman Department of Pharmacovigilance & Drug Information Directorate General of Pharmaceutical Affairs & Drug Control Ministry of Health, Sultanate of Oman Phone Nos. 22357687 / 22357686 Fax: 22358489 Email: dg-padc@moh.gov.om Website: www.moh.gov.om

 

 

If an overdose is taken or suspected, immediately go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage.

Mechanism of Action

 

Paracetamol

 

Paracetamol is a p-aminophenol derivative that exhibits analgesic and antipyretic activity. It does not possess anti-inflammatory activity. Paracetamol is thought to produce analgesia through a central inhibition of prostaglandin synthesis.

 

Pseudoephedrine hydrochloride

 

Pseudoephedrine has direct- and indirect- sympathomimetic activity and is an effective decongestant in the upper respiratory tract. It is a stereoisomer of ephedrine and has a similar action, but has been found to have less pressor activity and fewer central nervous system (CNS) effects.

 

Sympathomimetic agents are used as nasal decongestants to provide symptomatic relief. They act by causing vasoconstriction resulting in redistribution of local blood flow to reduce oedema of the nasal mucosa, thus improving ventilation, drainage and nasal stuffiness.

 

Chlorpheniramine maleate

 

Chlorpheniramine competes with histamine at central and peripheral histamine1-receptor sites, preventing the histamine-receptor interaction and subsequent mediator release.

 

Chlorpheniramine is a highly lipophilic molecule that readily crosses the blood-brain barrier.

 

Chlorpheniramine is highly selective for histamine1-receptors but has little effect on histamine2 or histamine3 receptors. Chlorpheniramine also activates 5-hydroxytryptamine (serotonin) and α-adrenergic receptors and blocks cholinergic receptors.

 

Clinical Trials

 

No data available.

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is 1 - 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 30% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 - 100% of the drug may be recovered in the urine within the first day. However, practically no paracetamol is excreted unchanged and the bulk is excreted after hepatic conjugation.

 

 

Pseudoephedrine hydrochloride is readily and completely absorbed from the gastro-intestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted unchanged in the urine.

 

 

Chlorphenamine maleate is readily absorbed from the gastro-intestinal tract. It is extensively metabolised in the liver and excreted in the urine.

 

Genotoxicity

 

No data available.

 

Carcinogenicity

 

No data available.

 

- Maize starch

- Maize starch pre-gelatinized

- Kollidon CL BASF

- Hydroxypropyl Cellulose Low-S

- Colloidal Silicon Dioxide

- Sodium CMC 600 cps

- Sodium Stearyl Fumerate

Not applicable

24 months/2 years

Store below 25 °c

Pack size:

30 tablets per unit carton.

10 tablets per blister.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.