Asthmatics should consult a medical practitioner before using this product.
Caution should be exercised in patients with renal impairment, urinary retention, diabetes, hyperthyroidism, glaucoma, hepatic impairment or cardiovascular disease and those taking other sympathomimetic agents, such as decongestants, amphetamine-like psychostimulants and appetite suppressants.
The effects of single dose of Galpseud Plus on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment. As with other sympathomimetic agents, caution should be exercised in patients with prostatic enlargement or bladder dysfunction.
In severe hepatic or renal dysfunction, a single dose of Galpseud Plus should be given, and the patient's response used as a guide to the dosage requirement for further administration.
If symptoms persist consult your doctor.
Do not exceed the stated dose.
Do not take with other cough and cold medicines.
Consult a pharmacist or other healthcare professional before use in children under 6 years.
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 this product 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 encephalography 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 sought 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.
Excipient warnings:
This medicine contains sodium parahydroxybenzoates (E215,E217,E219) and amaranth (E123). May cause allergic reactions (possibly delayed).
This medicine contains 154mg of alcohol (ethanol) in each 10ml dose which is equivalent to 1.9%v/v. The amount in 10ml of this medicine is equivalent to less than 4ml of beer or 2ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects.
This medicine contains less than 1mmol sodium (23mg) per 2.5ml dose, that is to say essentially “ sodium-free''.