SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Novasil Plus Antacid Suspension Lloyds Antacid Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Dried aluminium hydroxide gel BP 200mg/5ml Magnesium hydroxide BP 200mg/5ml Simethicone USP 25mg/5ml

3 PHARMACEUTICAL FORM

Oral suspension.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Antacid-deflatulent for the treatment of indigestion, heartburn, wind and dyspepsia.

4.2 Posology and method of administration

Oral

Adults, the elderly and children over 12 years: 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.

4.3 Contraindications

Novasil Plus Antacid Suspension should not be taken by patients who are severely debilitated or suffering from kidney failure.

4.4 Special warnings and precautions for use

If you are taking any other medicine, consult your doctor or pharmacist before taking this product.

If symptoms persist, consult your doctor.

Keep out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

If taken simultaneously with cimetidine, it can reduce the absorption of this drug. It can also reduce or delay the absorption of the following drugs: mexilitine, diflunisal, chlorpromazine, ketoconazole, pivampicillin and tetracycline.

4.6 Pregnancy and lactation

Novasil Plus Antacid Suspension can be used in pregnancy. (General literature indicates no adverse effects for the active ingredients of Novasil Plus Antacid Suspension on pregnancy or on the health of the foetus/newborn child).

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

None stated.

4.9 Overdose

Serious symptoms are unlikely to follow overdose.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Antacid, deflatulent

5.2 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

None stated

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

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

6.2 Incompatibilities

None stated.

6.3 Shelf life

24 months unopened. 28 days after opening.

6.4 Special precautions for storage

Store below 25°C. Do not freeze. Discard four weeks after opening.

6.5 Nature and contents of container

100ml, 140ml, 150ml, 200ml, 300ml: amber glass bottles with polypropylene caps in cartons.

6.6 Special precautions for disposal

None.

MARKETING AUTHORISATION HOLDER

Ayrton Saunders Ltd

9 Arkwright Road

Astmoor Industrial Estate

Runcorn

Cheshire

WA7 1NU

8 MARKETING AUTHORISATION NUMBER(S)

PL 16431/0095

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

30 January 1990 / 19 June 1996

10 DATE OF REVISION OF THE TEXT

25/01/2011