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GAVISCON ADVANCE ANISEED FLAVOUR ORAL SUSPENSION – patient leaflet, side effects, dosage

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Patient leaflet - Gaviscon Advance Aniseed Flavour oral suspension

1. What is this medicine and what is it used for?

Gaviscon Advance Aniseed flavour Oral Suspension belongs to a group of medicines called "reflux suppressants". This product forms a protective layer that floats on top of the stomach contents. This layer prevents reflux and keeps the stomach contents away from the lining of the food pipe to relieve the symptoms of heartburn and acid indigestion. It can also be used to relieve the symptoms of conditions such as

hiatus hernia (protrusion of muscle through a muscle wall), reflux oesophagitis (inflamed foodpipe) and symptoms of hoarseness and other voice disorders, sore throat and cough associated with reflux. It

can also be taken to control heartburn symptoms which may occur when taking, or following withdrawal of, medication to reduce stomach acid such as Proton Pump Inhibitors (PPI's) or H2 Antagonists.

2. What you need to know before taking this medicine

Do not take Gaviscon Advance Aniseed flavour Oral Suspension:

  • If you know you are allergic (hypersensitive) to any of the ingredients of in this product

(listed in section 6 for a full list on ingredients).

Warnings and precautions:

This medicine contains 57.85 mg sodium (main component of cooking/table salt) in each 5 ml. This is equivalent to 2.9 % of the recommended maximum daily dietary intake of sodium for an adult.

The maximum recommended daily dose of this medicinal product contains 462.8 mg sodium (found in table salt). This is equivalent to 23.14 % of the adult recommended maximum daily dietary intake for sodium. This medicine contains 0.525 mg benzyl alcohol in each 5 ml.

Benzyl alcohol may cause allergic reactions.

Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”). Ask your doctor or pharmacist for advice if you have liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”). This medicine contains 1.0 mmol (39.06 mg) of potassium per 5 ml. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

  • Please also talk to your doctor or pharmacist if you need this product on a daily basis for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet or if you suffer or have suffered from significant kidney or heart disease, as certain salts could interfere with these diseases.

3. How to take this medicine

Check that the cap seal is unbroken before first using this product. Shake well before use.

Adults including the elderly and children 12 years and over: 5-10 ml (one to two 5ml spoonfuls) after meals and at bedtime. Children under 12 years: Should only be taken on medical advice.

If you forget a dose it is not necessary to double the dose next time, just carry on taking as before. If you take too much of this product you may feel bloated and experience some abdominal discomfort. It is unlikely to cause you any harm, but please consult your doctor or pharmacist if this doesn’t go away. If symptoms persist after 7 days consult your doctor.

4. Possible side effects

Very rarely (less than 1 in 10,000 patients) 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. If you experience these or any other side effects stop taking the product and consult your doctor immediately.

If you get any side effects, talk to your doctor, pharmacist or nurse. 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" or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

150ml

Read the package leaflet before use.

Dosage: For oral use. Adults, including the elderly and children 12 years and over: Take 5-10 ml (one to two 5 ml spoonfuls) after meals and at bedtime. Shake well before use. Children under 12 years: Should only be taken on medical advice. If symptoms persist after 7 days consult your doctor. Contains sodium, potassium, benzyl alcohol (present in fennel flavour), methyl (E218) and propyl (E216) para-hydroxybenzoates. High in sodium - see leaflet for further information. Manufacturer and Product Licence holder in the UK: Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS. PL 00063/0749

What is this product? Each 10 ml contains

sodium alginate 1000 mg and potassium

hydrogen carbonate 200 mg.

Checkthatthecapsealisunbrokenbefore

firstusingthisproduct.

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ADVANCE

ANISEED FLAVOUR

Oral suspension

Peel here. Donot remove.

Potassium hydrogen carbonate

Sodium alginate

  • Acid reflux symptoms
  • Heartburn

& Indigestion

Extra Strength Formula

Do not refrigerate.

Keepoutofthesight andreachofchildren.

Donotusethis productafterthe expirydate(EXP:

month/yearshown).

Glassbottle,handle withcare.Donot drinkdirectlyfrom

thebottle

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N/A

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N/A

155mm

1.5mm

2mm1.5mm

2mm

2mm

1.5mm

1.5mm

7.5mm

2mm

2mm

2mm

2mm

56.5mm

50mm

48.5mm

FOP

PRINTING READS This Way

2.5 mm

Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout

Guides 2 (if applicable) MultiPackaging Solutions(Bourne, UK) G-Lbl-D8346142-60x155mmPPTD1740 TR1979545

PERMISSION FROM TRIDENT. CUSTOMER INFO:

Leaflet Copy = 9pt

7.00pt

GAVISCON ADVANCE ANISEED FLAVOUR ORAL SUSPENSION

TBR2687-D8346142 – English

Gaviscon Advance Aniseed flavour Oral Suspension.

Sodium alginate and potassium hydrogen carbonate.

Read all of this leaflet carefully before you start using this medicine because it contains important information for 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  • You must talk to your doctor if you do not feel better or if you feel worse after 7 days.

In this leaflet:

  1. 1. What is this medicine and what is it used for?
  2. 2. What you need to know before you take this medicine.
  3. 3. How to take this medicine.
  4. 4. Possible side effects.
  5. 5. How to store this medicine
  6. 6.

    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. Wait at least 2 hours between taking this medicine and other medicines such as tetracyclines, fluoroquinolones (types of antibiotics), iron salts, thyroid hormones, chloroquine (a medication used to prevent malaria), bisphosphonates (a medication used to treat osteoporosis) and estramustine (a medication to treat prostate cancer).

    Pregnancy and breast-feeding:

    You can take this product if you are pregnant or breast-feeding. As with all medicines, the treatment duration should be limited as much as possible.

    Important information about some of the ingredients of Gaviscon Advance Aniseed flavour Oral Suspension:

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

    Driving and using machines:

    This medicine has no influence on the ability to drive and use machines.

5. How to store this medicine

Do not use this product after the expiry date (EXP: month/year) shown. Keep out of the sight and reach of children. Do not refrigerate.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

Each 10 ml of oral suspension contains 1000 mg sodium alginate and 200 mg potassium hydrogen carbonate as the active ingredients. The other ingredients are calcium carbonate, carbomer, methyl (E218) and propyl (E216) parahydroxybenzoates, benzyl alcohol (present in fennel flavour), sodium saccharin, sodium hydroxide, aniseed flavour derived from fennel and purified water. This product does not contain sugar or gluten. This medicine is available in bottles of 80ml, 100ml, 125ml, 140ml, 150ml, 180ml, 200ml, 250ml and 300ml. Not all pack sizes may be marketed.

Manufacturer and Product Licence Holder:

Reckitt Benckiser Healthcare (UK) Limited, Hull, HU8 7DS.

Date of preparation: September 2020.

About this document

Source: MHRA - Medicines and Healthcare products Regulatory Agency (products.mhra.gov.uk)

Last revision stated in the text: September 2020

What the sections and the side effect frequencies mean: How to read a patient leaflet

Found a mistake? Tell us on the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Facts about Gaviscon Advance Aniseed Flavour oral suspension

What these facts mean

Active substance? Sodium alginate
Marketing authorisation? PL 00063/0749

Sources: the MHRA product information (products.mhra.gov.uk). Contains public sector information licensed under the Open Government Licence v3.0.