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Gaviscon Advance Liquid Sachets

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Document: label-leaflet MAH BRAND_PL 00063-0112 change

1.


Name of the product

Gaviscon Advance Liquid Sachets

2.    Active substances

Each 5 m l dose of ora l suspe nsion contains 500 m g sodiu m alginate and 100 mg potassium hydrogen carbonate as the active ingredients.

3.    Excipients known to have a recognised action or effect

Conta ins methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

4.    Pharmaceutical form and contents

Each sachet contains <either> 5 or 10 ml of medicinal product.

4 sachets,

10 sachets,

12 sachets,

20 sachets,

24 sachets,

48 sachets.

5.    Method and route of administration

Tear across perforated line. Squeeze liquid from bottom of sachet either directly into mouth or onto a 5ml spoon.

6.    Special warnings

Keep out of the reach and sight of children.

7.    Other warnings

If symptoms persist after seven days consult your doctor.

Each 5ml dose of oral suspensio n contains 2.3 mmol of sodium, 1.0 mmol of potassium and 1.0 mmol of calcium. If you have been advised a diet restricted in any of these please consult your doctor before taking this pro duct. This product contains methyl parahydroxybenzoate (E218) and propyl parahy droxybenzoate (E216) which may cause allergic reactions (possibly delayed).

Do not use this medicine after the expiry date shown.

8.    Expiry date

M/YYYY.

M


9.    Special storage conditions

Do not refrigerate.

10.    Name and address of the marketing authorisation holder (U K):

Reckitt Benckiser Healthcare (UK) Ltd Danso    m Lane

Hull

East Yorkshire HU8    7DS.

UK.

11. Marketing authorisation numbers

(UK): PL 00063/0112

12. Batch number

BN

PATIENT INFORMATION LEAFLET

Gaviscon Advance Liquid Sachets

Sodium alginate Potassium bicarbonate

Please read this information leaflet carefully before you take this medicine.

If you are not sure about anything ask your pharmacist or doctor.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

-    You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

What is in this leaflet

1.    What Gaviscon Advance Liquid Sachets are and are they used for

2.    What you need to know before you take Gaviscon Advance Liquid Sachets

3.    How to take Gaviscon Advance Liquid Sachets

4.    Pos sible side effects

5.    How to store Gaviscon Advance Liquid Sachets

6.    Contents of the pack and other information

1.    What are Gaviscon Advance Liquid Sachets and what are they used for?

Gaviscon Advance Liquid Sachets are used for the relief of heartb urn and ac id indigestion (also known as dyspepsia).

2.    What you need to know before taking Gaviscon Advance Liquid Sachets

Do not take Gaviscon Advance: If you know you are allergic (hypersensitive) to any of the ingredients in this product (see section 6 for a full list of ingredients).

Take special care with Gaviscon Advance

Each 5 ml contains 2.3 mmol of sodium, 1.0 mmol of potassium and 1.0 mmol of calcium. If you have been advised to follow a diet restricted in any of th ese please consult your doctor before taking this product.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription

Pregnancy and beast-feeding:

You can take Gaviscon Advance Liquid Sachets if you are pregnant or breastfeeding.

Important information about some of the ingredients of Gaviscon Advance:

This product contains methyl (E218) and propyl (E216) parahydroxybenzoates which may cause allergic reactions (possibly delayed).

How to take Gaviscon Advance Liquid Sachets

3.


Adults including the elderly and chil dren 12 years and over: on e to two 5 ml spoonfuls after meals and at bedtime, or as directed. Children under 12 years: Should only be taken on medical advice.

Tear across perforated line. Squeeze liquid from bottom of sachet directly into mouth or onto a 5ml spoon.

If you forget a dose it is not necessary to double the dose next time. Just carry on taking the medicine at the recommended dose.

If symptoms persist after seven days consult your doctor.

If you take t oo much Gaviscon Advan ce Liquid Sachets you m ay fe el bloated. Consult your doctor or pharmacist if this feeling does not go away.

4. Possible side effects?

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience these side-effects stop taking the product and consult your doctor immediately. Very rare (less than 1 in 10,000) chance of an allergic reaction to the ingredients. Symptoms of this may include skin rash, itching, difficulty breathing, dizziness, or swelling of the face, lips, tongue or throat.

Reporting side effects

If you get any side effects tal k to your doctor or pharmacist. This in cludes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme www.mhra.gov.uk/yellowcard.

By reporting side effects

you can help provide more information on the safety of this medicine.

5.    Storing your medicine

Do not use after the expiry date (EXP: month/year) shown on this pack.

Keep all medicines safely away from children.

Do not refrigerate.

6.    Contents of the pack and other information What this product contains

Each 5 ml dose of oral suspension contains 500 mg sodium alginate and 100 mg potassium hydrogen carbonate as the active in gredients. It a lso contai ns calc ium carbonate, carbomer, m ethyl parahydroxybenzoate (E218) and prop    yl

parahydroxybenzoate ( E216), sodiu m saccharin, sodi um h ydroxide, pepp ermint flavour and purified water.

What this product looks like and the contents of the pack

Off-white viscous suspension in sachets. Available in cartons containing 2, 4, 10, 12, 20, 24 or 48 sachets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer: R eckitt Be nckiser Healthcare (UK) Limited, Hull, HU8 7DS

This leaflet was last revised in: 02/2014.

PRESENT SACHET

1.    Name of Medicinal Product

Gaviscon Advance Liquid Sachets

2.    Expiry Date MM /YY

3.    Batch Number

BN:    _

4.    Other

Dosage instructions.

See carton for further information.

Do not use this medicine after the expiry date