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1. Pseudoephedrine 60mg Tablets
2. Pseudoephedrine 60mg Tablets

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Pseudoephedrine 60mg Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Tablet contains 60mg Pseudoephedrine Hydrochloride For excipients, see 6.1.

3    PHARMACEUTICAL FORM

Film-coated tablet.

Orange, round, film-coated tablets scored on on side.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Pseudoephedrine 60mg Tablets are indicated for symptomatic relief of congestion of the mucous membranes in the upper respiratory tract. Pseudoephedrine is particularly useful as a decongestant in the nasal mucosa and sinuses, and as such is indicated in allergic rhinitis, vasomotor rhinitis, the common cold and influenza.

4.2 Posology and method of administration

Adults and Children over 12 years 1 tablet every 4 - 6 hours up to 4 times a day.

Children under 12 years

Not recommended as a smaller dosage is required.

Elderly As for adults.

Hepatic dysfunction

Patients with severe liver impairment should be treated with caution.

Renal Dysfunction

Patients with moderate to severe renal impairment should be treated with caution.

Method of Administration Oral

4.3 Contraindications

•    Pseudoephedrine 60mg Tablets are contraindicated in the following circumstances

•    individuals sensitive to Pseudoephedrine or any of the excipients of the tablet.

•    coronary artery disease or severe hypertension.

•    concurrent use or treatment within the past two weeks of Monoamine Oxidase Inhibitors, as this may lead to an increase in blood pressure.

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

•    Concomitant use with other pseudoephedrine containing products may occasionally cause a rise in blood pressure.

4.4 Special warnings and precautions for use

Caution should be taken when treating patients with hyperthyroidism, diabetes mellitus, heart disease, mild to moderate hypertension and elevated intraocular pressure.

Care is advised when using Pseudoephedrine with patients with prostatic enlargement as this may lead to problems with micturition.

Patients with severe hepatic or moderate to severe renal difficulties, especially with concurrent cardiovascular disease, should be treated with caution, as there is an increase risk of drug accumulation and adverse effects.

Pseudoephedrine Tablets contain azo colouring agents, sunset yellow (E110) and ponceau 4R (E124), which can cause allergic reactions. Care is advised when treating patients who may be hypersensitive to these excipients.

4.5 Interaction with other medicinal products and other forms of interaction

Hypertension has been reported when Pseudoephedrine is used concurrently with tricyclic antidepressants or sympathomimetic agents e.g. decongestants, appetite suppressors and amphetamine type psychostimulants. There is potential for a hypertensive crisis when Pseudoephedrine is used concomitantly with Monoamine Oxidase Inhibitors (MAOIs)

Pseudoephedrine may oppose the hypotensive effect of drugs that interfere with sympathomimetic activity. Such drugs include adrenic neurone blocking agents (e.g. bethanidine, guanethidine, debrisoquine), methyldopa and a- and P- adrenergic antagonists.

4.6 Fertility, Pregnancy and lactation

No specific studies have been performed during pregnancy. However Pseudoephedrine has been widely used for many years with few visible adverse consequences documented in pregnant women. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus.

Systemic administration of pseudoephedrine, up to 50 times the human daily dosage in rats and up to 35 times the human daily dosage in rabbits, did not produce teratogenic effects.

Small amounts of pseudoephedrine are excreted in the breast milk. But the effect on breast-fed infants is not known. It has been estimated that 0.5-0.7% of a single dose of pseudoephedrine ingested by the mother will be excreted in the breast milk over 24 hours.

4.7 Effects on ability to drive and use machines

No known effects

4.8 Undesirable effects

There have been very few serious undesirable reactions to Pseudoephedrine.

The most frequently reported adverse effects are anxiety, restlessness, insomnia, headaches, dizziness and psychosis (which are thought to be due to central nervous system excitation), tachycardia and angina. Elderly patients appear to be more sensitive to central nervous system stimulant effects.

Occasionally tremor, dry mouth, gastrointestinal disturbances (nausea, vomiting, anorexia and ischaemic colitis), hypertension, cardiac arrhythmias, urinary retention (in men) and skin rashes (with or without irritation) have been reported.

Rarely reports of hallucinations have been documented.

4.9 Overdose

Due to the nature of this sympathomimetic agent, overdosage tends to lead to central nervous system stimulation, the symptoms of which are irritability, restlessness, excitement, tremor, convulsions, palpitations, hypertension and difficulty in micturition.

Action should be taken to control convulsions; diazepam can be used as an anticonvulsant and sedative. Measures should be taken to sustain respiration. P- blockers can be used to constrain the possible side effects of tachycardia, arrhythmia and hypokalaemia.

If necessary the removal of the drug can be attempted by performing gastric lavage.

To hasten the elimination of Pseudoephedrine, dialysis or acid diuresis can be utilised. It may be necessary to catheterise the bladder.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Sympathomimetics

ATC code: R01B A02

Pseudoephedrine is a direct and indirect sympathomimetic agonist. As a stereoisomer of ephedrine, its mode of action is similar to that of ephedrine. However Pseudoephedrine has fewer CNS excitatory side effects than

Ephedrine, although it is also less potent as a result of decreased pressor activity.

Pseudoephedrine is a direct agonist of cardiac P-adrenoreceptors and peripheral a1-adrenoreceptors. This action leads to an increased cardiac output and relaxation of the bronchial smooth muscle. The effect on the -adrenoreceptor in the mucosa of the respiratory tract leads to vasoconstriction which in turn reduces mucosal oedema. Pseudoephedrine therefore produces symptomatic relief of infections and inflammation in the upper respiratory tract.

5.2 Pharmacokinetic properties

Pseudoephedrine is absorbed readily and completely from the gastro-intestinal tract. Peak plasma concentrations are seen between 1 and 3 hours after oral administration. Within 24 hours Pseudoephedrine is excreted practically unchanged in the urine and less than 1% is excreted due to N-demethylation in the liver. The half life is about 5 to 8 hours, however this is dependent on the acidic nature of the urine. Urinary elimination is increased, and therefore the half-life decreased, when the urine is more acidic, while tubular reabsorption increases in alkaline urine.

5.3 Preclinical safety data

None known.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Cellactose, magnesium stearate, colloidal anhydrous silica, lactose, hypromellose, macrogol 4000, Ponceau 4R aluminium lake (E124), titanium dioxide (E171), sunset yellow aluminium lake (E110), macrogol 6000.

6.2 Incompatibilities

None known

10 DATE OF REVISION OF THE TEXT

29/08/2012