GALPSEUD

For oral administration.

Adults and children over 12 years:

One tablet four times daily.

Elderly:

Adult dose is appropriate.

The following side effects may be associated with the use of pseudoephedrine: (frequencies not known: cannot be estimated from the available data).

Immune system disorders:

Hypersensitivity reactions – cross-sensitivity may occur with other sympathomimetics.

Psychiatric disorders:

Hallucinations (particularly in children), insomnia, sleep disturbances, anxiety, restlessness, irritability, excitability, psychotic disorder has occurred rarely following misuse of pseudoephedrine.

Nervous system disorders:

Headache, tremor, dry mouth.

Eye disorders:

Angle-closure glaucoma.

Cardiac disorders:

Tachycardia, palpitations, arrhythmia.

Vascular disorders:

Hypertension, impaired circulation to the extremities.

Gastrointestinal disorders:

Nausea, vomiting, ischaemic colitis.

Skin and subcutaneous tissue disorders:

Fixed drug eruption in the form of erythematous nodular patches, rash. Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP).

Renal and urinary disorders:

Urinary retention. 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.

Caution should be used when prescribing pseudoephedrine for patients with prostatic enlargement or bladder dysfunction. Also use with caution in patients with severe hepatic impairment, or with mild to moderate renal impairment. If any of the following occur, the product should be stopped • Hallucinations • Restlessness • Sleep disturbances.

Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption should not take this medicine. Do not exceed the stated dose. Keep out of the sight and reach of children.

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 Galpseud 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. 8). 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.

This product should not be used in patients hypersensitive to pseudoephedrine or any of the other ingredients. Patients receiving monoamine oxidase inhibitors or who have received these agents in the last two weeks. Patients using other sympathomimetic decongestants or beta-blockers.

5). Patients with cardiovascular disease including ischaemic heart disease, occlusive vascular disease and hypertension. Children under 12 years of age. Patients with: • Severe renal impairment • Phaeochromocytoma • Diabetes • Hyperthyroidism • Closed angle glaucoma • Severe hypertension or uncontrolled hypertension • Severe acute or chronic kidney disease/renal failure.