PL 16431/0095

PATIENT INFORMATION LEAFLET NOVASIL PLUS ANTACID SUSPENSION

Please read this leaflet before taking this medicine as it contains important information. If you are unsure about anything, ask your doctor or pharmacist.

Each 5ml of Novasil Plus Antacid Suspension contains the following active ingredients:

Simethicone USP    25mg

Dried aluminium hydroxide gel BP    200mg

Magnesium hydroxide BP    200mg

It also contains:

Sodium carboxymethylcellulose 7 MF, avicel RC 501, peppermint oil, methyl hydroxybenzoate, propyl hydroxybenzoate, alcohol 96%, chloroform, sodium cyclamate 1968, sodium saccharin, sorbitol solution, water.

The Contents

A white, viscous opaque suspension contained in an amber glass bottle containing either 100, 140, 150, 200 or 300ml of suspension.

Your Medicine

Novasil Plus Antacid Suspension possesses both antacid (to reduct acid indigestion) and antiflatulent (to relieve trapped wind) properties.

Magnesium hydroxide and aluminium hydroxide are antacids. Simethicone acts on gas bubbles, thus providing the antiflatulent properties.

Product Licence Holder Ayrton Saunders Ltd.,

9 Arkwright Road,

Astmoor Industrial Estate,

Runcorn,

Cheshire,

WA7 1NU

Manufacturer Cupal Ltd,

King Street,

Blackburn,

BB2 2DX

Uses

Novasil Plus Antacid Suspension is an antacid and antiflatulent used for the relief of

dyspepsia (indigestion) and flatulence (wind) associated with heartburn.

Before Using Novasil Plus Antacid Suspension

The following information should be read before using this medicine:

1.    Do not take Novasil Plus Antacid Suspension if you are sensitive to any of the ingredients listed at the beginning of this leaflet.

2.    Can be used during pregnancy, however if in doubt consult your doctor.

3.    Consult you doctor if you are taking any of the following medicines before taking this product: mexilitine, diflunisal, chlorpromazine, ketoconazole, pivampicillin, tetracycline or cimetidine.

4.    Make sure Novasil Plus Antacid Suspension is suitable for you to use - ask your doctor or pharmacist.

5.    Contains sodium, which may be harmful for those on a low sodium diet.

6.    Contains methyl and propyl hydroxybenzoates, which may cause allergic type reactions, including rashes and itching and wheezing.

7.    Contains 1% v/v alcohol per 100ml bottle and up to 0.04g of alcohol per 5ml spoonful. Harmful for those suffering from liver problems, alcoholism, epilepsy, brain injury or disease. May modify or increase the effects of other medicines.

8.    Contains sorbitol, which is unsuitable for those with hereditary fructose intolerance and may cause stomach upset and diarrhoea. Each 100ml of product contains 7ml of sorbitol and up to 0.35ml of sorbitol per 5ml dose.

Directions for Using Novasil Plus Antacid Suspension

Adults, the elderly and children over 12 years: take one to two 5ml spoonfuls twenty

minutes to one hour after meals and at bedtime if required.

Not to be given to children under 12 years of age except on the advice of a doctor. If

symptoms persist, consult your doctor.

In the event of deliberate or accidental overdose, seek medical attention immediately.

Side Effects

There have been no side effects reported following use of this product.

If you experience any reactions following use of this product, then discontinue its use immediately, and report this to your doctor or pharmacist, who will advise you on the necessary action to take.

Storage

This unopened bottle has a two year shelf-life, which is given on the bottle and the carton. Do not use the product after the expiry date shown. Discard the contents 28 days after first opening this bottle.

Novasil Plus Antacid Suspension should be stored below 25^oC out of the reach of children.

Do not freeze.

Date of revision: January 2011