CONIRAMOL Tablet

For the relief of symptoms associated with the common cold and flu, including relief of aches and pains, sore throat, headaches, fatigue and drowsiness, nasal congestion and lowering of temperature, control of all allergic conditions responsive to antihistamines, including by fever, vasomotor rhinitis, urticaria, angioneurotic oedema, food allergy.

Dosage and directions for use

Dosage

Adults and Children 12 years or over:

2 tablets every 4 hours as required to a maximum of 4 doses in any 24 hours.

Do not exceed 8 tablets in any 24 hours.

Do not take continuously for more than 7 days without medical advice.

This product is contraindicated in children under the age of 12 years.

Direction for use

For oral use.

The tablets should be swallowed whole with glass of water. The tablets should not be chewed or crushed.

Paracetamol: Hypersensitivity to paracetamol or any of the other constituents.

Chlorpheniramine maleate: Hypersensitive to antihistamines or any of the tablet ingredients. The anticholinergic properties of chlorpheniramine are intensified by monoamine oxidase inhibitors (MAOIs). Coniramol tablets are therefore contra-indicated in patients who have been treated with MAOIs within the last 14 days.

Phenylephrine Hydrochloride: Severe coronary heart disease and cardiovascular disorders, hypertension, hyperthyroidism. Contraindicated in patients currently receiving or within 2 weeks of stopping therapy with monoamine oxidase inhibitors.

Caffeine: Should be given with are to patients with a history of peptic ulcer.

Enzyme-including drugs may increase hepatic damage, as does excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

These interactions are considered to be of unlikely clinical significance in acute usage at the dosage regimen proposed.

Paracetamol

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 use of paracetamol with increased risk of bleeding, occasional doses have no significant effect.

Drugs which induce hepatic microsomal enzymes, such as alcohol, barbiturate, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage.

Contraindicated in patients currently receiving or within 2 weeks of stopping therapy with monoamine oxidase inhibitors because of a risk of hypertensive crisis.

Phenylephrine Hydrochloride

Phenylephrine may adversely interact with other sympathomimetics, vasodilator s and beta blockers.

Chlorpheniramine maleate

Concurrent use of chlorpheniramine and hypnotics or anxiolytics may cause an increase in sedative effects, therefore medical advice should be sought before taking chlorpheniramine concurrently with these medicines. Chlorpheniramine inhibits phenytoin metabolism and can lead to phenytoin toxicity.

The anticholinergic effects of chlorpheniramine are intensified by MAOIs.

Caffeine

Caffeine has no significant drug interaction except ephedrine.

Coniramol should not be used in pregnancy or in nursing mothers unless considered essential by the physician.

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

Use with caution in patients with Raynaud’s Phenomenon and diabetes mellitus.

Chlorpheniramine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intra-ocular pressure including glaucoma; prostatic hypertrophy; severe hypertension or cardiovascular disease; bronchitis, bronchiectasis or asthma; hepatic impairment; renal impairment. Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness, nervousness).

The anticholinergic properties of chlorpheniramine may cause drowsiness, dizziness, blurred vision and psychomotor impairment in some patients with may seriously affect ability to drive and use machinery.

The effects of alcohol may be increased and therefore concurrent use should be avoided.

Should not be used with other antihistamine containing products, including antihistamine containing cough and cold medicines.

Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

The following warnings should consider:

- If symptoms persist consult your doctor.

- Do not exceed the stated dose.

- Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Paracetamol

Analgesic: The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting a prostaglandin synthesis in the central nervous system 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 action of other substance that sensities pain receptors to mechanical or chemical stimulation.

Antipyretic: Paracetamol probably produces antipyresis by acting on the hypothalamic heat-regulating 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.

Chlorpheniramine maleate

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 mediation. The action 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.

Phenylephrine Hydrochloride

Sympathomimetic amines, such as phenylephrine, act on alpha-adrenergic receptors of the respiratory tract to produce vasoconstriction, which temporally reduces the swelling associated with inflammation of the mucous membranes lining the nasal and sinus passages. This allows the free drainage of the sinusoidal fluid from the sinuses.

In addition to reducing mucosal lining swelling, decongestants also suppress the production of mucus, therefore preventing a build up of fluid within the cavities which could otherwise lead to pressure and pain.

Caffeine

Central nervous system stimulant-Caffeine stimulates all levels of the CNS, although its cortical effects are milder and of shorter duration than those of amfetamines.

Analgesia Adjunct: Caffeine constricts cerebral vasculature with an accompanying decrease in cerebral blood flow and in the oxygen tension of the brain. It is believed that caffeine helps to relieve headaches by providing a more rapid onset of action and/or enhanced pain relief with lower doses of analgesic. Recent studies with ergotamine indicate that the enhancement of effect by the addition of caffeine may also be due to improved gastrointestinal absorption of ergotamine when administered with caffeine.