CONTAC NON DROWSY

Adults:

One capsule to be taken in the morning and another at bedtime.

Children under 12 years:

Not recommended.

Elderly:

The healthy elderly may use an adult dose.

Route of administration:

Oral.

4) Eye disorders Frequency not known: Ischaemic optic neuropathy Cardiac disorders Rare (>1/10,000 to <1/1000): tachycardia, palpitations, Vascular disorders Rare (>1/10,000 to <1/1000): increased blood pressure* *Increases in systolic blood pressure have been observed.

At therapeutic doses, the effects of pseudoephedrine on blood pressure are not clinically significant. Gastrointestinal disorders Common (>1/100 to <1/10): dry mouth, nausea, vomiting Skin and subcutaneous tissue disorders Rare (>1/10,000 to <1/1000): rash, allergic dermatitis* *A variety of allergic skin reactions, with or without systemic features such as bronchospasm, angioedema have been reported following use of pseudoephedrine Renal and urinary disorders Uncommon (>1/1,000 to <1/100): dysuria, urinary retention** **Urinary retention is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.

CONTAC

Non Drowsy 12 Hour Relief should be used with caution in patients suffering from mild to moderate hypertension, heart disease, arrhythmias, diabetes, hyperthyroidism, phaeochromocytoma, glaucoma and prostatic enlargement. Caution should be exercised when using the product in the presence of moderate to severe renal impairment (particularly if accompanied by cardiovascular disease).

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. 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.

Risks of abuse Pseudoephedrine carries the risk of abuse. Increased doses may ultimately produce toxicity. Continuous use can lead to tolerance resulting in an increased risk of overdosing. 2). Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

The following pack warnings and advice are recommended:

Do not chew or crush the capsule contents as this will interfere with the 12 hour action of the capsules. If you are under the care of your doctor or receiving prescribed medicines or are pregnant or breast feeding, consult your doctor before taking this medicine.

Do not take with any other products for the relief of colds, congestion or hay fever. If symptoms persist for more than 7 days consult your doctor. Keep all medicines out of the reach and sight of children. Warning. Do not exceed the stated dose.

This product is contraindicated in patients with: • Severe hypertension or uncontrolled hypertension • Severe acute or chronic kidney disease/renal failure Known hypersensitivity to pseudoephedrine hydrochloride or excipients. Individuals with severe hypertension or severe heart disease.

Patients who are taking monoamine oxidase inhibitors (MAOI) or have taken them within the preceding two weeks. Patients receiving other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).