Pseudoephedrine 60mg Film-coated Tablets – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Pseudoephedrine 60mg Film-coated Tablets

Sedrindo Decongestant 60mg Film-coated Tablets

Almus Nasal and Sinus Decongestion 60mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 60mg of 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 tablets (tablets).

Orange, round, film-coated tablets.

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

Posology

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

For oral use.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Concomitant use of other sympathomimetic decongestants, beta-blockers (see section 4.5) or monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOI treatment (see section 4.5). The concomitant use of MAOIs may cause a rise in blood pressure or hypertensive crisis.

Diabetes mellitus.

Phaeochromocytoma.

Hyperthyroidism.

Closed angle glaucoma.

Severe hypertension or uncontrolled hypertension.

Severe acute or chronic kidney disease/renal failure.

4.4 Special warnings and precautions for use

Patients experiencing difficulty in urination due to enlargement of the prostate, or patients with thyroid disease who are receiving thyroid hormones should not take pseudoephedrine unless directed by a physician.

Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment and in occlusive vascular disease.

If any of the following occur, this product should be stopped:

• Hallucinations
• Restlessness
• Sleep disturbances

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.

Posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

Cases of PRES and RCVS have been reported with the use of pseudoephedrine-containing products (see section 4.8). The risk is increased in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease/renal failure (see section 4.3).

Pseudoephedrine should be discontinued and immediate medical assistance sough if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances. Most reported cases of PRES and RCVS resolved following discontinuation and appropriate treatment.

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

This medicine contains sunset yellow which may cause allergic reactions.

This medicine contains ponceau 4R which may cause allergic reactions.

4.5 Interaction with other medicinal products and other forms of interaction

• MAOIs and/or RIMAs: Pseudoephedrine exerts its vasoconstricting properties by stimulating α-adrenergic receptors and displacing noradrenaline from neuronal storage sites. Since monoamine oxidase inhibitors (MAOIs) impede the metabolism of sympathomimetic amines and increase the store of releasable noradrenaline in adrenergic nerve endings, MAOIs may potentiate the pressor effect of pseudoephedrine. This product should not be used in patients taking monoamine inhibitors or within 14 days of stopping treatment as there is an increased risk of hypertensive crisis.
• Moclobemide: risk of hypertensive crisis.
• Antihypertensives; Because of its pseudoephedrine content, this product may partially reverse the hypotensive action of antihypertensive drugs which interfere with sympathetic activity including bretylium, betanidine, guanethidine, debrisoquine, methyldopa, adrenergic neurone blockers and beta-blockers.
• Cardiac glycosides: increased risk of dysrhythmias.
• Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism.
• Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension.
• Oxytocin: risk of hypertension.
• Anticholinergic drugs: Enhances effects of anticholinergic drugs (such as tricyclic antidepressants).
• Anaesthetic agents: Concurrent use with halogenated anaesthetic agents such as chloroform, cyclopropane, halothane, enflurane or isoflurane may provoke or worsen ventricular arrhythmias.

4.6 Fertility, Pregnancy and lactation

This product should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs the possible risks to the developing foetus or nursing infant.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. 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.

Breast-feeding

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 0.4-0.7% of a single dose of pseudoephedrine ingested by the mother will be excreted in the breast milk over 24 hours. Data from a study of lactating mothers taking 60 mg pseudoephedrine every 6 hours suggests that from 2.2 to 6.7% of the maximum daily dose (240 mg) may be available to the infant from a breast-feeding mother.

4.7 Effects on ability to drive and use machines

No known effects

4.8 Undesirable effects

Clinical Trial Data

The safety of pseudoephedrine from clinical trial data is based on data from 6 randomised, placebo-controlled single dose clinical trials and 6 randomised, placebo-controlled multiple dose clinical trials for the treatment of nasal congestion with allergic rhinitis or common cold or prevention of sinus symptoms/infection after a natural cold.

Table 1 includes adverse events from clinical trial and post-marketing experience. Adverse events included from clinical trials are those that occurred where greater than one event was reported, and the incidence was greater than placebo and in 1% of patients or more.

Post-marketing Data:

Adverse drug reactions (ADRs) identified during post-marketing experience with pseudoephedrine are included in Table 1 below.

The adverse drug reactions are ranked by frequency, using the following convention:

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

Table 1: Adverse Reactions Reported in Clinical Trials and Post-marketing Experience

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

Overdose may result in:

Hyperglycaemia, hypokalaemia CNS stimulation, insomnia; irritability, restlessness, anxiety, agitation; confusion, delirium, hallucinations, psychoses, seizures, tremor, intracranial haemorrhage including intracerebral haemorrhage, drowsiness in children, mydriasis, palpitations, tachycardia, reflex bradycardia, supraventricular and ventricular arrhythmias, dysrhythmias, myocardial infarction, hypertension, vomiting, ischaemic bowel infarction, acute renal failure, difficulty in micturition.

Management

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 IP Ltd,

Unit G4,

Riverside Industrial

Estate, Riverside Way,

Dartford,

DA1 5BS

UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 55612/0015

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

10/03/2025

10 DATE OF REVISION OF THE TEXT

10/03/2025