PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Bicarbonate 500mg Capsules

(Sodium Bicarbonate)

Read all of this leaflet carefully because it

contains important information for you.

This medicine is available without prescription.

However, you still need to take it carefully to get the

best results from it.

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

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

•    You must contact a doctor or pharmacist if your symptoms worsen or do not improve after seven days.

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

In this leaflet:

1.    What Sodium Bicarbonate 500mg Capsules are and what they are used for

2.    Before you take Sodium Bicarbonate 500mg Capsules

3. How to take Sodium Bicarbonate 500mg Capsules

4.    Possible side effects

5. How to store Sodium Bicarbonate 500mg Capsules

6.    Further information

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1.    What Sodium Bicarbonate 500mg Capsules are and what they are used for

What this medicine does

Sodium Bicarbonate 500mg Capsules are used to treat indigestion.

Sodium Bicarbonate is one of a group of medicines called antacids. It reduces the effect of excess acid produced in the stomach.

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2.    Before you take Sodium Bicarbonate 500mg Capsules

Do not take Sodium Bicarbonate 500mg Capsules if you:

• are allergic (hypersensitive) to sodium bicarbonate or any of the other ingredients of Sodium Bicarbonate 500mg Capsules (see section 6 - Further information).

Talk to your doctor or pharmacist if any of the following apply to you:

•    if you have ever had any problems with your kidneys or liver;

•    if you suffer from high blood pressure or heart problems;

•    if you are on a controlled low salt (sodium) diet, as each capsule contains 135 milligrams (mg) of sodium (see section 6 - Further information).

Using other medicines

Make sure your doctor knows if you are taking a medicine listed here because, taken with Sodium Bicarbonate 500mg Capsules, they may not be as effective:

•    aspirin or other salicylates (used as painkillers or to thin the blood);

•    lithium (used to treat mental illness);

•    ACE inhibitors e.g. captopril, enalapril and fosinopril (used to treat high blood pressure and heart problems);

•    antibiotics e.g. azithromycin, cefaclor, cefpo-doxime, ciprofloxacin, isoniazid, levofloxacin, moxifloxacin, norfloxacin, ofloxacin, rifampicin and tetracyclines (used to treat infection);

•    gabapentin or phenytoin (used to treat epilepsy);

•    itraconazole or ketoconazole (used to treat fungal infections);

•    fexofenadine (used to treat allergies);

•    chloroquine or hydroxychloroquine (used to prevent or treat malaria);

•    phenothiazines e.g. chlorpromazine (used to treat anxiety or depression);

•    sulpiride (used to treat schizophrenia);

•    digoxin (used to treat heart problems);

•    deflazacort (used to treat inflammation and allergic reactions);

•    penicillamine (used to treat rheumatism);

•    lansoprazole (used to help heal ulcers);

•    bile acids e.g. ursodeoxycholic acid (used to treat gall stones);

•    bisphosphonates e.g. alendronate (used to help prevent brittle bones);

•    levothyroxine (thyroxine) (used to treat an underactive thyroid gland);

•    antivirals e.g. amprenavir, atazanavir and tipranavir (used to treat viral infections);

•    dipyridamole (used to treat heart rhythm disorders or if you have had a stroke);

•    mycophenolate (used to prevent organ transplant rejection);

•    rosuvastatin (used to control cholesterol).

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant, thinking of getting pregnant or breast-feeding ask your doctor or pharmacist for advice before taking Sodium Bicarbonate 500mg Capsules.

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3.    How to take Sodium Bicarbonate 500mg Capsules

Unless your doctor or pharmacist has advised otherwise, always use Sodium Bicarbonate 500mg Capsules as described in this leaflet. Check with your doctor or pharmacist if you are not sure.

•    Swallow the capsules with a drink of water, or

•    Empty the contents of the capsules into a glass of water. Stir until the powder has dissolved and then drink the solution.

Adults (including elderly and children over 12 years)

•    The usual dose is between 1 and 5g (2 to 10 capsules).

•    The maximum daily dose is 5g (10 capsules).

If symptoms persist, consult your doctor.

Children under 12 years

•    Not recommended.

If you take more Sodium Bicarbonate 500mg Capsules than you should

•    If you take more Sodium Bicarbonate 500mg Capsules than the label states or than your doctor has prescribed, or if you think a child has accidentally swallowed any, contact the nearest hospital casualty department or a doctor for advice immediately.

•    Take this leaflet, and any capsules that you still have, to show the doctor.

If you forget to take Sodium Bicarbonate 500mg Capsules

•    If you miss a dose, take the next dose as soon as you remember. Do not take double the amount to make up for the forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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4.    Possible side effects

Like all medicines. Sodium Bicarbonate 500mg Capsules can cause side effects, although not everybody gets them.

Possible side effects are:

•    If you take this medicine for long periods of time you may experience muscle weakness and cramps;

•    stomach pain;

•    feeling bloated;

•    belching;

•    high blood pressure and water retention because the capsules contain a lot of sodium.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any 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. By reporting side effects, you can help provide more information on the safety of this medicine.

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5.    How to store Sodium Bicarbonate 500mg Capsules

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the label and the carton.

Do not store above 25°C.

Store in the original container and keep the container tightly closed.

Do not use if you notice any damage to or discoloration of the tablets. Return them to your pharmacist.

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.

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6.    Further information

What Sodium Bicarbonate 500mg Capsules contain

•    The active substance is sodium bicarbonate. There are 500 milligrams (mg) of sodium bicarbonate in each capsule, of which 135 milligrams (mg) is sodium.

•    The other ingredients are gelatin, titanium dioxide (El 71) and black ink (containing shellac, isopropyl alcohol, black iron oxide (El 72), n-butyl alcohol, propylene glycol and concentrated ammonia solution).

What Sodium Bicarbonate 500mg Capsules look like and contents of the pack

Sodium Bicarbonate 500mg Capsules are white, size 1, hard gelatin capsules marked ‘G SB500’. Each container of Sodium Bicarbonate 500mg Capsules holds either 56 or 100 capsules.

Marketing Authorisation Holder

Focus Pharmaceuticals Ltd, Capital House,

85 King William Street, London EC4N 7BL, UK.

Tel:    01283 495 280

Fax:    01283 495 290

Email:    medinfo@focuspharmaceuticals.co.uk

Manufacturer

Dales Pharmaceuticals Ltd, Keighley Road, Skipton, North Yorkshire, BD23 2RW, UK.

For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.

For information in large print, audio CD or Braille please telephone 01283 495 280 or email medinfo@focuspharmaceuticals.co.uk.

This leaflet was last revised in 04/2016. 103489/LF/035/02

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