Maxtra P Tablet

Paracetamol, Phenylephrine Hydrochloride & Chlorpheniramine Maleate Tablets

Each uncoated tablet contains :

Paracetamol IP 500 mg

Phenylephrine Hydrochloride IP 10 mg

Chlorpheniramine Maleate IP 4 mg

Excipient q.s.

Tablets, Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg and Chlorpheniramine Maleate 4 mg

4.1 Therapeutic indication

For symptomatic treatment of common cold and flu-like syndrome.

4.2 Posology and method of administration

Adults and children 12 years of age and older : Take 1 tablet every 4 to 6 hours.

4.3 Contraindications

• Hypersensitivity to any of the ingredients of the formulation.

• Avoid in patients with cardiovascular disease, high blood pressure, diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement and phaeochromocytoma.

• Taking a monoamine oxidase inhibitor (MAOI), (certain drugs for depression, psychiatric or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug.

• Patients with peripheral or mesenteric vascular thrombosis, because ischemia may be increased and the area of infarction extended with the use of Phenylephrine.

• Premature or full-term neonates.

• Patients with hepatocellular insufficiency and in patients with hepatic failure or active liver disease as the formulation contains Paracetamol.

4.4 Special warnings and precautions for use

Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions and death. Antihistamines may diminish mental alertness. In young children, they may produce excitation.

• General : This product should be used with caution in patients with a history of narrow-angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction (enlarged prostate), a breathing problem such as emphysema or chronic bronchitis.

• Because of its sympathomimetic component, this product should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.

• Care is advised in the administration of Paracetamol to patients with alcohol dependency and severe renal or severe hepatic impairment. The hazards of overdose are greater in those with noncirrhotic alcoholic liver disease. Do not exceed the recommended dose.

• If symptoms persist consult your doctor.

• Keep out of the reach and sight of children.

• Do not take with any other Paracetamol-containing products.

• 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.

4.5 Drugs interactions

• Avoid using with any other drug containing Acetaminophen.

• Avoid use if you are now taking monoamine oxidase inhibitor (MAOI) (drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.

• Anticoagulants : the effect of Warfarin and other coumarins may be enhanced by prolonged regular use of Paracetamol with increased risk of bleeding. Occasional doses have no significant effect.

• Metoclopramide, Domperidone : may increase speed of absorption of Paracetamol.

• Colestyramine : May reduce absorption if given within one hour of Paracetamol.

• Imatinib : restriction or avoidance of concomitant regular Paracetamol use should be taken with Imatinib.

4.6 Use in special populations

Pregnancy

Pregnancy category C. It is not known whether this product can cause fetal harm when administered to a pregnant woman. This product should be given to pregnant woman only if clearly needed.

Labor and delivery

Use of sympathomimetic amines during late pregnancy or during labor may cause fetal anoxia and bradycardia by increasing contractibility of the uterus and decreasing uterine blood flow

Nursing mothers

Because of the higher risk of intolerance of antihistamines in infants in general, and in new-borns in particular, this product is contraindicated in nursing mothers

Pediatrics

The use of antihistamines is not recommended in new-borns and infants. This age group may be at a higher risk than others because of an increased susceptibility to anticholinergic effects such as CNS excitation, and an increased tendency toward convulsion. In older children, antihistamines may cause a paradoxical reaction characterized by hyperexcitability. Very young children may be more sensitive to the effects of sympathomimetics.

Geriatrics

The elderly (60 years or older) may be more susceptible to the vasopressor effects of sympathomimetics. Confusion, hallucinations, seizures and CNS depression may be more likely to occur in geriatric patients taking sympathomimetics. Antihistamines may cause confusion, dizziness, sedation, hypotension, hyperexcitability, and anticholinergic side effects such as dryness of the mouth and urinary retention in geriatric patients. If these symptoms occur and continue, or are severe, medication should probably be discontinued.

4.7 Effects on the ability to drive and use machines

Maxtra P Tablet may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur.

4.8 Undesirable effects

Phenylephrine may cause restlessness, anxiety, nervousness, weakness, dizziness, precordial pain or discomfort, tremor, respiratory distress, pallor or blanching of the skin, or a pilomotor response. Over dosage of Phenylephrine may cause hypertension, headache, seizures, cerebral hemorrhage, palpitation, paresthesia, or vomiting. Phenylephrine can cause severe peripheral and visceral vasoconstriction, reduced blood flow to vital organs, decreased renal perfusion, and probably reduced urine output and metabolic acidosis. Severe vasoconstrictive effects may be most likely to occur in hypovolemic patients. Phenylephrine can cause severe bradycardia and decreased cardiac output

The adverse effects of Paracetamol include allergic dermatitis, angioedema, drug-induced hepatitis, hepatitis, leukopenia, maculopapular rash, fixed drug eruption, neutropenic disorder, thrombocytopenic disorder, urticaria, vomiting, diarrhea, constipation, nausea, dyspepsia, and fatigue and chest pain.

Most common adverse effects of Chlorpheniramine are drowsiness and thick bronchial secretions. Other side effects include abdominal pain with cramps, allergic reactions, anorexia, blurred vision, dizziness, dry nose, dry throat, excitement, headache disorder, hyperhidrosis, impaired cognition, nervousness, nightmares, skin photosensitivity, skin rash etc.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to : medico@zuventus.com

By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

Initiate general symptomatic and supportive measures in all cases of over dosages where necessary.

5.1 Mechanism of action / pharmacodynamic properties

Phenylephrine is sympathomimetic post-synaptic α1–adrenergic receptor agonist with low cardioselective beta receptor affinity and minimal central nervous stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.

Chlorpheniramine is a potent antihistamine (H1-antagonist).

Antihistamines diminish or abolish the actions of histamine in the body by competitive reversible blockade of histamine H1-receptor sites on tissues. Chlorpheniramine also has anticholinergic activity. Antihistamines act to prevent the release of histamine, prostaglandins and leukotrienes and have been shown to prevent the migration of inflammatory mediators. The actions of Chlorpheniramine include inhibition of histamine on smooth muscle, capillary permeability and hence reduction of oedema and wheal in hypersensitivity reactions such as allergy and anaphylaxis. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and to a lesser extent, through a peripheral action by blocking pain-impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.

Antipyretic : Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat-regulation centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged Paracetamol. The elimination half-life varies from about 1 to 4 hours. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.

A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following Paracetamol over dosage and cause liver damage.

Phenylephrine is absorbed from the gastrointestinal tract, but has reduced bioavailability by the oral route due to first-pass metabolism. It retains activity as a nasal decongestant when given orally, the drug distributing through the systemic circulation to the vascular bed of the nasal mucosa. When taken by mouth as a nasal decongestant Phenylephrine is usually given at intervals of 4 - 6 hours. Chlorpheniramine is well absorbed from the gastro-intestinal tract, following oral administration. The effects develop within 30 minutes, are maximal within 1 to 2 hours and last 4 to 6 hours. The plasma half-life has been estimated to be 12 to 15 hours. Chlorpheniramine is metabolised to the monodesmethyl and didesmethyl derivatives. About 22% of an oral dose is excreted unchanged in the urine.

6.1 Animal toxicology or pharmacology

No studies have been performed to evaluate the carcinogenic or mutagenic potential of this product.

Maxtra P tablet is a combination of anti-allergic Chlorpheniramine Maleate, analgesic/antipyretic Paracetamol and decongestant Phenylephrine Hydrochloride.

8.1 Incompatibilities

Not applicable

8.2 Shelf-life

Refer on the pack.

8.3 Packaging information

PVC/PVDC-Alu blister strip of 10 tablets.

8.4 Storage and handling instructions

Store below 30°C. Protect from moisture.

Keep out of reach of children.

• It may cause dizziness and sleepiness. Don't drive or do anything that requires mental focus until you know how it affects you.

• Avoid consuming alcohol when taking this medicine as it may cause excessive drowsiness.

• Do not take it with any other medicine containing Paracetamol (drugs for pain / fever or cough-and-cold) without asking your doctor first.

• Inform your doctor if you are pregnant, planning to conceive or breastfeeding.