Acidex Advance Heartburn and Indigestion Relief Aniseed Flavour 1000 mg / 200 mg / 10 ml oral suspension – patient leaflet, side effects, dosage

1. WHAT ACIDEX ADVANCE IS AND WHAT IT IS USED FOR

Acidex Advance Heartburn and Indigestion Relief Aniseed flavour Oral Suspension (referred to as ‘Acidex Advance’ throughout this leaflet) belongs to a group of medicines called “reflux suppressants”. Reflux is when the acid stomach contents flow back up the gullet (oesophagus) and this can cause pain and discomfort known as heartburn or acid indigestion. This medicine contains the active ingredients sodium alginate and potassium hydrogen carbonate which together form a protective layer at the top of your stomach to stop reflux from happening by keeping the stomach contents away from the lining of the food pipe to relieve the symptoms of heartburn and acid indigestion. It can therefore be taken to prevent and relieve the symptoms of acid reflux, including during pregnancy and 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 (PPIs) or H2 Antagonists.

2. BEFORE YOU ACIDEX ADVANCE

Do not take Acidex Advance if you:

• are allergic (hypersensitive) to any of the ingredients in this medicine, including the esters of hydroxybenzoates (parabens) (see Section 6 and end of Section 2)

Warnings and precautions:This medicine contains sodium (5.1 mmol per 10 ml), potassium (2.0 mmol per 10 ml) and calcium.

• If you have been advised to follow a diet restricted in any of these please consult you doctor before taking this product.
• The maximum recommended daily dose of this medicinal product contains 424 mg sodium (found in table salt). This is equivalent to 21 % of the adult recommended maximum daily intake for sodium.
• 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.

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 lease 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 medicication used to treat osteoporosis) and estramustine (a medication to treat prostate cancer).

Pregnancy and breast-feeding

This medicine can be used during pregnancy and breast-feeding, however it is recommended to limit the treatment duration as much as possible.

Driving and using machines

There are no known effects of this medicine on ability to drive or operate machinery.

Important information about some of the ingredients of Acidex Advance

This medicine also contains:

• Parahydroxybenzoates: may cause allergic reactions, possibly delayed
• Sodium: Each 10 ml dose of this medicine contains about 5.1 mmol of sodium and therefore care should be exercised in patients on a sodium restricted diet.
• Potassium: Each 10 ml dose of this medicine contains about 2 mmol of potassium and therefore care should be taken when taking drugs which can increase potassium levels.

3. HOW TO TAKE ACIDEX ADVANCE

To be taken by mouth, after meals and at bedtime. Shake bottle well before use. If you are unsure how to use this medicine, check with your doctor or pharmacist.

WARNING: DO NOT EXCEED THE STATED DOSE

If you take more of this medicine than you should

If you take too much of this product you may feel bloated and experience some abdominal discomfort. It is unlike to cause you any harm, but please consult your doctor or pharmcist if this doesn’t go away.

If symptoms persist after 7 days consult your doctor.

If you forget to take this medicine

If you forget to take your medicine, take it as soon as you remember, Do not take a double dose to make up for the forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this product can cause side effects, although not everybody gets them.

• 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 difficulty breathing, hives and swelling of the face. Uncommonly reported side-effects are diarrhoea, nausea and vomiting. If you experience these or any other side effects stop taking the product and consult your doctor immediately.

Reporting of side effects:

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 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.

5. HOW TO STORE ACIDEX ADVANCE

Keep out of the sight and reach of children.

Do not store above 25^oC. Do not refrigerate or freeze.

Do not use this product after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

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. FURTHER INFORMATION

What Acidex Advance contains:

• The active ingredients are: Sodium alginate 1000 mg/10 ml, Potassium hydrogen carbonate 200 mg/10 ml
• The other ingredients are: Calcium Carbonate, Carbomer, Sodium Hydroxide, Saccharin Sodium, Ethyl Parahydroxybenzoate (E214), Propyl Parahydroxybenzoate (E216), Butyl Parahydroxybenzoate, Isopropyl Alcohol, Star Anise Oil and Purified Water (see end of Section 2 for further information)

What Acidex Advance looks like and contents of the pack

This medicine is an aniseed flavoured white or cream coloured suspension.

It comes in amber glass bottles of 150 ml, 200 ml, 250 ml, 300 ml and 500 ml with white polypropylene caps. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

UK.

Manufacturer

Pinewood Laboratories Limited,

Ballymacarbry,

Clonmel,

Co. Tipperary, Ireland.

PL 29831/0682

This leaflet was last updated in March 2021

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