200

S

£

BARCODE NUMBER MUST FACE OUTWARDS

LEAFLET POSITION GUIDE

Heartburn and indigestion suspension

163

500 ml

PEPPERMINT

FLAVOUR

Acidex Max Strength Heartburn Relief Oral Suspension

sodium alginate, sodium bicarbonate, calcium carbonate

Each 10 ml of the oral suspension contains 1000 mg of sodium alginate, 200 mg of sodium bicarbonate and 200 mg of calcium carbonate. Also contains parahydroxybenzoates (Parabens, E214 and E216) which may cause allergic reactions (possibly delayed). This medicinal product contains about 7.5 mmol of sodium per 10 ml dose. To be taken into consideration by patients on a controlled sodium diet. Care should also be taken if on calcium controlled diet. Read the attached leaflet carefully before use. To be taken by mouth after meals and at bedtime. Shake bottle well before use. Leave 1-2 hours between taking this medicine and other medicines. Keep out of the reach and sight of children. Take special care if you are allergic to any of the ingredients of this medicine.

Side effects are occasional. See leaflet for further information.

Store below 25°C. Do not use after the expiry date shown on the label. Do not refrigerate or freeze.

Marketing Authorisation Holder:

Pinewood Laboratories Limited, Ballymacarbry,

Clonmel, Co. Tipperary, Ireland PL 04917/0114    23LL04324PW

LABEL SIZE: 200 x 75mm

Leaflet size: 643 x 75mm (163 161 160 159)

GSL

ORAL    SUSPENSION

159mm

160mm

161mm

163nTop visible panel

PACKAGE LEAFLET: INFORMATION FOR THE USER Acidex Max Strength Heartburn Relief Oral Suspension

sodium alginate 1000 mg/10 ml, sodium bicarbonate 200 mg/10 ml and calcium carbonate 200 mg/10 ml

Read all of this leaflet carefully before you start taking this medicine.

This medicine is available without prescription. However, you still need to use the product carefully to get the best results from it. You must contact a doctor if your symptoms worsen or do not improve after seven days.

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

-    If you have any further questions, ask your doctor or pharmacist.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further information

1.    WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR

Max Strength Heartburn Relief 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, sodium bicarbonate and calcium carbonate which together form a protective layer at the top of your stomach to stop reflux from happening. It can therefore be taken to prevent and relieve the symptoms of acid reflux, including during pregnancy.

2.    BEFORE YOU TAKE THIS MEDICINE Do not take Max Strength Heartburn Relief 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)

Take special care with Max Strength Heartburn Relief

You must tell your doctor or pharmacist and take special care if you are:

•    on a sodium restricted diet or suffer from too much calcium in the blood (see end of section 2)

•    Treatment of children younger than 12 years of age is not generally recommended, except on medical advice

Max Strength Heartburn Relief should not be taken within 1 to 2 hours of taking other medicines by mouth, or for more than 7 days if symptoms persist.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, including medicines obtained without a prescription and especially if you are taking any of the following, as interactions can occur:

ACE inhibitors Analgesics Antibacterials Antiepileptics Antifungals Antimalarials Antipsychotics Bisphosphonates Lithium Penicillamine

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AcicexMax Sttength Heartburn Relief Oral Suspension

sodium alginate, sodium bicarbonate, calcium carbonate

500 ml

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flavour

Heartburn and indigestion suspension

Each 10 ml of the oral suspension contains 1000 mg of sodium alginate, 200 mg of sodium bicarbonate and 200 mg of calcium carbonate. Also contains parahydroxybenzoates (Parabens, E214 and E216) which may cause allergic reactions (possibly delayed). This medicinal product contains about 7.5 mmol of sodium per 10 ml dose. To be taken into consideration by patients on a controlled sodium ^iet* Care should    be taken if on calcium controlled diet.

FteadtbRttclLdteaflC carefully before use. To be taken by mouth after meals and at bedtime. Shake bottle well before use. Leave 1-2 hours betwe3n taking this medicine and other medicines. feepCtofthe^eqpfl <N sight of children. Take special care if you are allergic to any of the ingredients of this medicine.

Side effects are occasional. See leaflet for further information.

Store below 25°C. Do not use after the expiry date shown on the label. Do not refrigerate or freeze.

Marketing Authorisation Holder:

Pinewood Laboratories Limited, Ballymacarbry,

Clonmel, Co. Tipperary, Ireland

PL 04917/0114    23LL04324PW    GSL

163mm

161mm

160mm

159mm

Taking this medicine with food and drink

This medicine should be taken after meals and at bedtime.

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 Max Strength Heartburn Relief

This medicine also contains:

•    Parahydroxybenzoates: may cause allergic reactions, possibly delayed

•    Sodium: Each 10 ml dose of this medicine contains about 7.5 mmol of sodium and therefore care should be exercised in patients on a sodium restricted diet.

3. HOW TO TAKE THIS MEDICINE

To be taken by mouth, after meals and at bedtime. Shake bottle well before use. Leave 1-2 hours between taking this medicine and other medicines. 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

Overdose is very unlikely but if it occurs it may cause bloating.

If you forget to take Max Strength Heartburn Relief

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:

• Patients who are sensitive to the ingredients can develop allergic reactions such as difficulty breathing, hives and swelling of the face.

If this occurs you should stop taking the medicine and seek immediate medical attention.

Occasional:

Constipation Flatulence Stomach cramp Belching

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE THIS MEDICINE

Keep out of the reach and sight of children. Do not store above 25°C. 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 Max Strength Heartburn Relief contains:

-    The active ingredients are: Sodium alginate 1000 mg/10 ml, Sodium bicarbonate 200 mg/10 ml and Calcium carbonate 200 mg/10 ml

-    The other ingredients are: Carbomer, Sodium Hydroxide, Saccharin Sodium, Ethyl Parahydroxybenzoate (E214), Propyl Parahydroxybenzoate (E216), Butyl Parahydroxybenzoate, Isopropyl Alcohol, Peppermint Oil, and Purified Water (see end of Section 2 for further information)

What Max Strength Heartburn Relief 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 and 500 ml with white polypropylene caps.

Not all pack sizes may be marketed.

Manufacturer/Marketing Authorisation Holder

Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland.

PL 04917/0114

This leaflet was last updated in 12/2011