GALPSEUD PLUS LINCTUS

For oral administration.

Adults:

Two 5ml spoonfuls three times daily.

Children:

Under 2 years: Not recommended. 5ml three times daily. 6 – 12 years: 5ml three times daily. Not more than 3 doses should be given in any 24 hours.

Pseudoephedrine may cause anxiety, tremor, cardiac arrhythmias, palpitations, tachycardia, hypertension, nausea, vomiting, headache and may occasionally cause insomnia and urinary retention in men. Rarely sleep disturbance and hallucinations have been reported.

There have been rare cases of psychosis following misuse of pseudoephedrine. Chlorphenamine may cause drowsiness, nausea, vomiting, headaches, blurred vision, anorexia and dryness of the mouth. The administration of antihistamines has also been associated with rash, angioedema, convulsions, parasthesias, dizziness and constipation.

4. 4. 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. uk/yellowcard or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.

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.

Contra-indicated in patients with a known hypersensitivity to pseudoephedrine hydrochloride or chlorphenamine maleate or any of the other ingredients. Contra-indicated in epileptics because of the antihistamine content and in patients currently taking or within 2 weeks of stopping monoamine oxidase inhibitors.

Contra-indicated in severe hypertension or uncontrolled hypertension, or in patients receiving antihypertensive therapy. Contra-indicated in severe acute or chronic kidney disease/renal failure. Not recommended for children under 2 years.