This information is intended for use by health professionals

1. Name of the medicinal product

Decongestant Tablets

2. Qualitative and quantitative composition

Active ingredient

Pseudoephedrine hydrochloride

60mg/tablet

3. Pharmaceutical form

Tablets

4. Clinical particulars
4.1 Therapeutic indications

For the relief of nasal and sinus congestion without causing drowsiness.

For oral administration.

4.2 Posology and method of administration

Adults and children over 12 years: One tablet if necessary, up to four times daily at intervals of not less than 4 hours.

Children under 12 years: Not recommended.

Elderly: There is no need for dosage reduction in the elderly.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Avoid in patients with cardiovascular disease, hypertension, severe renal impairment, diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement and phaeochromocytoma.

4.4 Special warnings and precautions for use

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 localized 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 Decongestant 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.

If symptoms are not controlled by Boots Decongestant Tablets, medical advice should be sought.

Keep all medicines out of the reach of children.

Warning: Do not exceed the stated dose.

4.5 Interaction with other medicinal products and other forms of interaction

Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment. May enhance the effects of anticholinergic drugs such as tricyclic antidepressants. May increase the possibility of arrhythmias in digitalised patients. May increase the vasoconstrictor effects of ergot alkaloids.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are limited amount of data on the use of pseudoephedrine in pregnant women. The use of pseudoephedrine during the first trimester of pregnancy has been associated with an increased frequency of gastroschisis (a developmental defect in the abdominal wall with intestinal herniation) and of small intestinal atresia (congenital obstruction of small intestine). Due to the vasoconstrictive properties of pseudoephedrine, it may induce a reduction in uteroplacental circulation.

Pseudoephedrine is not recommended in pregnancy.

Breast-feeding

Pseudoephedrine has been detected in human milk with a small percentage of the maternal dose potentially administered to the breastfed infant. Irritability and disturbed sleep have been reported in breastfed infants. Pseudoephedrine may suppress lactation.

4.7 Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

Adverse effects may include dry mouth, anxiety, restlessness, tremor, insomnia, tachycardia, cardiac arrhythmias, palpitations, hypertension, nausea, vomiting, headache and occasionally urinary retention in males and skin rashes. Hallucinations have been reported rarely, particularly in children.

Skin and subcutaneous tissue disorders:

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

Gastrointestinal Disorders

Frequency unknown: Ischaemic colitis

Eye disorders

Frequency unknown: Ischaemic optic neuropathy

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 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

Symptoms of overdosage include irritability, restlessness, palpitations, hypertension, difficulty in micturition, nausea, vomiting, thirst and convulsions. In severe overdosage gastric lavage and aspiration should be performed. Symptomatic and supportive measures should be undertaken, particularly with regard to cardiovascular and respiratory systems. Convulsions should be controlled with intravenous diazepam. Chlorpromazine may be used to control marked excitement and hallucinations. Severe hypertension may need to be treated with an alpha-adrenoreceptor blocking drug, such as phentolamine. A beta blocker may be required to control cardiac arrhythmias.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta adrenergic activity and some stimulant effect on the central nervous system. The sympathomimetic effect of pseudoephedrine produces vasoconstriction which in turn relieves nasal congestion.

5.2 Pharmacokinetic properties

Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted in the urine unchanged. It has an elimination half-life of 5 to 8 hours but its urinary elimination and hence half-life is pH dependent. Pseudoephedrine is rapidly distributed throughout the body, its volume of distribution being 2 to 3L/KG bodyweight.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6. Pharmaceutical particulars
6.1 List of excipients

Sodium Starch Glycolate

Maize Starch prd

Microcrystalline Cellulose

Pregelled Maize Starch

Purified Water

Stearic Acid

6.2 Incompatibilities

None are known.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

None.

6.5 Nature and contents of container

Blister pack of white or clear 250 microns PVC coated with 40gsm PVdC and 20 micron aluminium foil.

Pack sizes: 6, 7, 10, 12 tablets.

6.6 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

The Boots Company PLC

1 Thane Road West

Nottingham

NG2 3AA

8. Marketing authorisation number(s)

PL 00014/0375

9. Date of first authorisation/renewal of the authorisation

28 January 1988 / 17 December 1997 / 17 December 2002

10. Date of revision of the text

22nd June 2020