WOCKHARDT COLD RELIEF

Posology ADULTS AND CHILDREN OVER 12 YEARS:

One to two capsules every four hours as required up to a maximum of eight capsules in any 24 hour period. Maximum daily dose: eight capsules in divided doses in any 24 hour period. Do not take continuously for more than 3 days without medical advice.

CHILDREN UNDER 12 YEARS:

Do not give to children under twelve years unless your doctor tells you to. Method of administration For oral administration. The capsules are to be taken with water.

). Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with intravenous busulfan. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.

If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

Caffeine Care is advised in the administration of caffeine to patients with cardiac disease. g. coffee, tea and some canned drinks) should be avoided while taking this product. Phenylephrine Care is advised in the administration of phenylephrine in patients with cardiovascular conditions such as hypertension, Prinzmetal’s angina, thromboembolic disorders, following myocardial infarction or a history of ischaemic heart disease.

Phenylephrine should be used with caution in elderly patients. This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) (see interactions).

The following warnings appear in the leaflet and on the label:

Label- Contains paracetamol. Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well.

Leaflet- Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. Generally: • Do not exceed the recommended dose. • If symptoms persist consult your doctor.

• Do not give to children under twelve years except on advice from a doctor. • Keep out of the reach and sight of children. Patients should be advised not to take other paracetamol-containing products concurrently. 4). Analgesics Diflunisal increases blood concentrations of paracetamol.

Anion–exchange resins:

Absorption reduced by colestyramine; administration should be separated by at least 1 hour. Antibacterials Isoniazid may increase the risk of hepatotoxicity with therapeutic doses of paracetamol. 4). Anticoagulants 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.

Antiepileptics Carbamazepine, phenobarbital, phenytoin and primidone can reduce the effects of paracetamol and increase the risk of hepatotoxicity. Paracetamol may increase lamotrigine metabolism. Motility stimulants The speed of absorption of paracetamol may be increased by metoclopramide or domperidone.

Oral Contraceptives Paracetamol is cleared from the body more quickly in women taking oral contraceptives and the analgesic effects may be reduced. Uricosurics Probenecid can reduce the loss of paracetamol from the body.

Caffeine Antibacterials:

Some quinolone antibiotics, including enoxacin, pipemidic acid and ciprofloxacin can reduce the clearance of caffeine and prolong its plasma half-life. Antidepressants Fluvoxamine can reduce the clearance of caffeine and increase its stimulant and side effects.

Antiepileptics Phenytoin may increase the clearance of caffeine. Benzodiazepines Caffeine can reduce the sedative effects of diazepam. Disulfiram May reduce the clearance of caffeine. Lithium Caffeine may increase the clearance of lithium.

Mexiletine May reduce the clearance of caffeine. Oestrogens and progestogens Oral contraceptives or oestrogen replacement therapy may reduce the clearance of caffeine. Phenylpropanolamine Concomitant administration may increase blood pressure, resulting in hypertensive crises in a few susceptible individuals.

Manic psychosis has occurred. Phenylpropanolamine can increase serum caffeine levels. Theophylline Concomitant administration can increase plasma theophylline and plasma caffeine levels. Phenylephrine Hydrochloride Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported.

Adrenergic neurone blockers May enhance the hypertensive effect of phenylephrine. Atropine There is an increased risk of hypertension when used with atropine. Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa) Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs.

The risk of hypertension and other cardiovascular side effects may be increased. g. (ergotamine and methylsergide) increased risk of ergotism. Monoamine oxidase inhibitors (including moclobemide) Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see contraindications).

Oxytocin Potential increased risk of hypertension with oxytocin. Sympathomimetic amines Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side […]

Paracetamol Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with alcoholic liver disease. Paracetamol should be given with care to patients with alcoholic dependence.

Paracetamol is well tolerated by the majority of people with asthma. However, a small percentage of aspirin sensitive asthmatics are also sensitive to paracetamol. 8 Undesirable Effects). Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with intravenous busulfan.

g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended.

The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors. Caffeine Care is advised in the administration of caffeine to patients with cardiac disease.

g. coffee, tea and some canned drinks) should be avoided while taking this product. Phenylephrine Care is advised in the administration of phenylephrine in patients with cardiovascular conditions such as hypertension, Prinzmetal’s angina, thromboembolic disorders, following myocardial infarction or a history of ischaemic heart disease.

Phenylephrine should be used with caution in elderly patients. This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) (see interactions).

The following warnings appear in the leaflet and on the label:

Label- Contains paracetamol. Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well.

Leaflet- Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. Generally: • Do not exceed the recommended dose. • If symptoms persist consult your doctor.

• Do not give to children under twelve years except on advice from a doctor. • Keep out of the reach and sight of children. Patients should be advised not to take other paracetamol-containing products concurrently.

1.

Caffeine:

Hypersensitivity to caffeine. Do not give to patients with a history of peptic ulceration. Phenylephrine hydrochloride • Hyper susceptible patients • Hyperthyroidism • Closed angle glaucoma • Aneurysm • Arteriosclerosis • Phaeochromocytoma • Hypertension • Prostatic enlargement • Cardiovascular disease • Diabetes • Concomitant use with other sympathomimetic decongestants • Monoamine oxidase inhibitors, including moclobemide or within the last two weeks • Tricyclic antidepressants • Beta blockers