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GAVISCON FIZZOLVE ORAL POWDER FRUIT FLAVOUR

Active substance(s): CALCIUM CARBONATE / SODIUM ALGINATE / SODIUM BICARBONATE

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Package Leaflet: information for the user
GAVISCON FIZZOLVE ORAL POWDER FRUIT FLAVOUR
Sodium alginate
Sodium hydrogen carbonate
Calcium carbonate
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your pharmacist has
told you.
- 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. This includes any possible side effect
not listed in this leaflet.
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 Fizzolve Oral Powder is and what it is used for
2.
What you need to know before you take Gaviscon Fizzolve Oral Powder
3.
How to take Gaviscon Fizzolve Oral Powder
4.
Possible side effects
5.
How to store Gaviscon Fizzolve Oral Powder
6.
Contents of the pack and other information
1. What Gaviscon Fizzolve Oral Powder is and what is it used for.
Gaviscon Fizzolve Oral Powder forms a protective layer which floats above the
contents of the stomach. This layer prevents stomach acid escaping from the stomach
into the food pipe, thus relieving the burning feeling of heartburn and the feeling of
discomfort in the throat and mouth. Heartburn may occur following meals (e.g. when
eating fatty or spicy food) or during pregnancy or in patients with symptoms related to
an inflammation in the wall of the food pipe (e.g. difficult and / or painful
swallowing, mouth sores, vomiting).
Gaviscon Fizzolve Oral Powder is used for the treatment of symptoms of gastrooesophageal reflux such as acid regurgitation, heartburn and indigestion (related to
reflux), for example following meals or during pregnancy, and in patients with
symptoms related to oesophagitis.

2.

What you need to know before you take Gaviscon Fizzolve Oral Powder
Do not take Gaviscon Fizzolve Oral Powder:

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- if you know you are allergic to sodium alginate, calcium carbonate or sodium
hydrogen carbonate or any of the other ingredients of this medicine (listed in section
6) as very rarely difficulty in breathing and skin rashes have occurred.

Warnings and precautions
Talk to your pharmacist before taking Gaviscon Fizzolve Oral Powder
This medicine contains sodium (5.3mmol per dose (sachet)) and calcium (1.6mmol
per dose (sachet)).
- If you have been advised to follow a diet restricted in either of these salts please
consult your doctor before taking this product.
Please also talk to your doctor regarding these salt contents if you suffer or have
suffered from significant kidney or heart disease, as certain salts could interfere with
these diseases.

You should also consult your doctor if you are over 40 years and have never suffered
with heartburn and acid indigestion before.
If symptoms persist after 7 days consult your doctor.

Other medicines and Gaviscon Fizzolve Oral Powder:
Do not take this product within two hours of taking other medicines by mouth as it can
interfere with the action of some other medicines.
This is especially important if you are taking antibiotics (tetracyclines and quinolones
such as norfloxacin), iron preparation, antifungals such as ketoconazole, digoxin and
beta-blockers (for heart conditions), neuroleptics (for mental illness), thyroid
hormones, chloroquine (for malaria), estramustine (for prostate cancer) and
bisphosphonates (for osteoporosis).
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Pregnancy and breastfeeding.
You can take this product if you are pregnant or breast-feeding.
Gaviscon Fizzolve Oral Powder contains aspartame.
If you have phenylketonuria, note that this product is sweetened with aspartame, a
source of phenylalanine.

3.

How to take Gaviscon Fizzolve Oral Powder

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For oral administration without water.
Pour the contents of the sachet directly onto the tongue.

Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults, including the elderly and children 12 years and over: When symptoms
occur take one to two single dose containers (sachets) after meals and at bedtime, up
to four times a day.
Use in children under 12 years: Should only be taken on medical advice.
If you take more Gaviscon Fizzolve Oral Powder than you should
If you take too much of this product you may feel bloated. It is unlikely to cause you
any harm but please consult your doctor.
If you forget to take Gaviscon Fizzolve Oral Powder
If you forget a dose, it is not necessary to double the dose next time, just carry on
taking as before.
If you have any further questions on the use of this product, ask your doctor.

4.

Possible Side Effects
Like all medicines, Gaviscon Fizzolve Oral Powder can cause side effects, although
not everybody gets them.
If you experience any of the following side effects, stop taking the product and
consult your doctor immediately; Very rarely (less than 1 in 10,000 patients treated)
there is a 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 of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow
Card Scheme at: http://www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.

5.

How to store Gaviscon Fizzolve Oral Powder
Keep this medicine out of the sight and reach of children.
Do not store above 25oC
Do not use this medicine after the expiry date (EXP: month/year) shown. The expiry
date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help to protect the environment.

6.

Contents of the pack and other information
What Gaviscon Fizzolve Oral Powder contain:
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The active substances in each sachet are sodium alginate 500mg, sodium hydrogen
carbonate 267mg and calcium carbonate 160mg. The other ingredients are mint
flavour, passion fruit flavour, macrogol 20,000, macrogol 400, aspartame (E951),
citric acid anhydrous, acesulfame potassium (E950), xylitol and silicon dioxide.
What Gaviscon Fizzolve Oral Powder looks like:
Each sachet contains a cream coloured powder.
Available in packs containing 4, 6, 12, 20, 24, 32 sachets in either a carton or blister
pack composed of a cardboard backing card and plastic front.
Not all pack sizes /types may be marketed.
Marketing Authorisation Holder and Manufacturer:
Licence holder and Manufacturer: Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane, Hull HU8 7DS, United Kingdom.
Alternate Manufacturer: Reckitt Benckiser Healthcare International Limited,
Nottingham Site, Nottingham, NG902DB
This medicinal product is authorised in the member state of the EEA under the
following names:
United Kingdom
Belgium/Luxemburg
Ireland
France

The Netherlands

GAVISCON Fizzolve Oral Powder Fruit Flavour
GAVISCON Instants Poeder Voor Oraal gebruik passievrucht
GAVISCON Sachets Oral Powder Tropical Flavour
GAVISCONELL Sans Sucre Passion, poudre orale en sachet
dose édulcoré à l'aspartam, au xylitol et à l'acésulfame
postassique
GAVISCON Instants fresh tropical Poeder Voor Oraal gebruik

This leaflet was last revised in [02/2015]

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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