CAREWAY DECONGESTANT 60 MG FILM-COATED TABLETS, LLOYDS PHARMACY DECONGESTANT 60 MG FILM-COATED TABLETS, SEDRINDO DECONGESTANT 60 MG FILM-COATED TABLETS, PSEUDOEPHEDRINE 60 MG TABLETS - Summary of medicine characteristics

Pseudoephedrine 60mg Film-coated Tablets

Sedrindo Decongestant 60mg Film-coated Tablets

Lloyds Pharmacy Decongestant 60mg Film-coated Tablets

Careway Decongestant 60mg Film-coated Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Tablet contains 60mg Pseudoephedrine

Hydrochloride

Excipients with known effect:      Lactose

Sunset Yellow (E110)

Ponceau 4R (E124)

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablet (tablets).

Orange, round, film-coated tablets scored on one 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 individuals with known hypersensitivity to the product or any of its excipients.

Pseudoephedrine 60mg Tablets are contraindicated in individuals with severe hypertension or coronary artery disease.

Pseudoephedrine 60mg Tablets are contraindicated in individuals who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks. The concomitant use of pseudoephedrine and this type of product may occasionally cause a rise in blood pressure.

4.4 Special warnings and precautions for use

Although pseudoephedrine has virtually no pressor effects in normotensive patients, Pseudoephedrine 60mg Tablets should be used with caution in patients suffering mild to moderate hypertension. As with other sympathomimetic agents, Pseudoephedrine 60mg Tablets should be used with caution in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement.

Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment (particularly if accompanied by cardiovascular disease).

This product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Severe Skin reactions

Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localised on the skin folds, trunk and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of Pseudoephedrine 60mg Tablets should be discontinued and appropriate measures taken if needed.

Ischaemic colitis

Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.

Ischaemic optic neuropathy

Cases of ischaemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use of Pseudoephedrine 60mg Tablets with tricyclic antidepressants, sympathomimetic agents (such as decongestants, appetite suppressors and amphetamine type psychostimulants) or with Monoamine Oxidase Inhibitors which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure.

Because of its pseudoephedrine content, Pseudoephedrine 60mg Tablets may partially reverse the hypotensive effect of drugs that interfere with sympathomimetic activity-including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, alpha- and beta- adrenergic blocking agents.

4.6 Fertility, Pregnancy and lactation

Although pseudoephedrine has been in widespread use for many years without apparent ill consequence, there are no specific data on its use during pregnancy. 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.

Pseudoephedrine is excreted in breast milk in small amounts, but the effect of this on breast-fed infants is not known. It has been estimated that 0.50.7% 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

The most frequently reported adverse effects are anxiety, restlessness, 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 and cardiac arrhythmias have been reported.

Serious adverse effects associated with the use of pseudoephedrine are rare. Symptoms of central nervous system excitation may occur, including sleep disturbances and rarely hallucinations have been reported.

Skin rashes with or without irritation have occasionally been reported. Urinary retention has been reported occasionally in men receiving pseudoephedrine, prostatic enlargement could have been an important predisposing factor.

Skin and subcutaneous tissue disorders

Frequency unknown: Severe skin reactions, including acute generalised exanthematous pustulosis (AGEP)

Gastrointestinal disorders

Frequency unknown: Ischaemic colitis

Eye disorders

Frequency not known (cannot be estimated from the available data):

Ischaemic optic neuropathy

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 the Yellow Card Scheme at:

www.mhra.gov.uk/y­ellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

As with other sympathomimetic agents, symptoms of overdose include irritability, restlessness, tremor, convulsions, palpitations, hypertension and difficulty in micturition.

Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage should be performed if indicated.

Catheterisation of the bladder may be necessary. If desired, the elimination of pseudoephedrine can be accelerated by, acid diuresis or dialysis

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic                 ­group:

Sympathomimetics

ATC code: R01B

A02

Pseudoephedrine has direct and indirect sympathomimetic activity and is an orally effective upper respiratory tract decongestant.

Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation in systolic blood pressure and considerably less potent in causing stimulation of the central nervous system.

5.2 Pharmacokinetic properties

Pseudoephedrine is rapidly and completely absorbed after oral administration. After a dose of 180 mg to man, peak plasma concentrations of 500–900 ng/ml were obtained about 2 hours post dose. The plasma half life was about 5.5 hours and was increased in subjects with alkaline urine and decreased in subjects with acid urine. The only metabolism was N-demethylation which occurred to a small extent. Excretion was mainly via the urine.

5.3 Preclinical safety data

The active ingredient of Pseudoephedrine 60mg Tablets is a well-known constituent of medicinal products and its safety is well documented. The results of pre-clinical studies do not add anything of relevance for therapeutic purposes.

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 and indigo carmine (E132).

6.2 Incompatibilities

None known

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C. Store in original package.

6.5 Nature and contents of container

PVC/Aluminium Blister pack, in pack size of 12 tablets

6.6 Special precautions for disposal Not applicable.

7 MARKETING AUTHORISATION HOLDER

Ennogen Pharma Limited

Unit G4,

Riverside Industrial Estate,

Riverside Way,

Dartford

DA1 5BS

UK