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INSIG

Indapamide hemihydrate

Consumer Medicine Information

What is INSIG?

INSIG TABLETS contain 2.5mg of Indapamide hemihydrate.

INSIG TABLETS also contain: lactose, microcrystalline cellulose, maize starch, magnesium stearate, hypromellose, sodium lauryl sulphate, opadry pink OY6925 and purified water.

INSIG TABLETS are available in blisters strips, pack size 90 tablets.

INSIG TABLETS are supplied by: Sigma Pharmaceuticals (Australia) Pty Ltd
96 Merrindale Drive, Croydon
Victoria 3136
Phone: 03 9839 2800
Aust. R 62057

What is INSIG used for?

INSIG is a diuretic (fluid tablet) that is used to treat mild to moderate hypertension (high blood pressure).

How does INSIG work and what does it do?

INSIG allows the heart muscle and surrounding bloods vessels to relax more fully and hence carry the same volume of blood more easily.

When should INSIG TABLETS not be taken?

INSIG TABLETS should not be taken if you have an allergy to medicine containing indapamide hemihydrate, other sulphonamide-derived agents or any of the other ingredients listed above. INSIG should not be taken if you have very poor kidney or liver function.

What precautions should be taken?

INSIG can cause an imbalance of the electrolyte levels in the blood. This is more likely if you are vomiting a lot, are on a drip, have heart failure, poor kidney or liver function, or are on a salt restricted diet. If you suffer from a dry mouth, thirst, weakness, fatigue, lethargy, drowsiness, restlessness, muscle pains or cramps, low blood pressure, low urine output, stomach upsets or irregular heart beat, see your doctor.

Take care if you are also taking medicine containing digoxin.

If you are on long term therapy with INSIG TABLETS, ensure the electrolytes in your blood are monitored regularly by your doctor.

INSIG should not be used in pregnant or breastfeeding women unless the benefits of treatment outweigh the potential risk to the child. Your doctor or pharmacist can advise you if you are concerned.

INSIG should not be used if you are taking lithium as INSIG can increase the side effects caused by Lithium.

Advise your doctor if you have Systemic Lupus Erythematosus (SLE) or gout.

Advise your doctor if you are taking any other medicines including strong pain killers and medicine to treat high blood pressure.

INSIG may cause dizziness or drowsiness, do not drive or operate machinery until you are aware how this medicine may affect you.

How should I take INSIG TABLETS?

The recommended dose of INSIG is one 2.5 mg tablet, taken in the morning.

INSIG tablets may be taken either before or after food.

What if one or more doses have not been taken?

Do not take an extra dose. Take the next INSIG dose at the next regular time.

INSIG tablets may be taken either before or after food.

What unwanted side effects might INSIG TABLETS cause?

Side effects caused by INSIG are usually mild and do not last for periods of time.

INSIG can cause weakness, headache and stomach upsets. Changes to electrolyte levels can occur but the changes are usually too mild to cause actual symptoms. Contact you doctor immediately, if you experience a fast or irregular heart beat, a skin rash or itching.

INSIG may cause other side effects other than those listed above. If you experience any further side effects that you are concerned about, please contact your doctor.

In case of overdose

Symptoms of overdose are nausea, vomiting, weakness, stomach upsets, electrolyte imbalance, reduced breathing, fainting or dizziness.

If the person is unconscious, ensure he/she is still breathing and has a pulse, place in recovery position and call an ambulance. If the person has stopped breathing or does not have a pulse, immediately start artificial respiration or heart massage.

For the conscious person who has only just swallowed the tablets, attempt to assist the person to vomit.

Lie the person in the recovery position and call an ambulance. Give the ambulance officer the INSIG box.

How should I store INSIG TABLETS?

Protect your INSIG TABLETS from light and moisture. Store them at a temperature below 25°C. Keep out of reach of children.

Do not use INSIG TABLETS after the expiry date. This date can be found on the blister foil and on the carton.

For further information about INSIG TABLETS consult your local health care professional or Douglas Pharmaceuticals Australia Ltd, phone (02) 894-6455 or fax (02) 894-6498.

INSIG TABLETS are only available on a doctor's prescription.

This leaflet was prepared on 22 September, 1997 and updated on 18 November 1997

Issue 1: Approved by TGA 13/10/94
Issue 2: New formulation including SLS date 1 March 1995
Issue 3: New ARTG number 22 May 1996
Issue 4: New storage condition 25 June 2010

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