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Sodium Bicarbonate 500mg Capsules

Document: label-leaflet CO-PHARMA_PL 17496-0018 change

Label-leaflet text (Co-pharma)

Outer face:

Sodium Bicarbonate 500 mg Capsules

56 Capsules For oral use.

Swallow whole with a drink of water. Adults: For indigestion take 2 to 10 capsules as required, or as directed by your doctor.

Each capsule contains: sodium bicarbonate 500 mg, which provides 137 mg of sodium. Not recommended for use in children under 12 years, unless prescribed by a doctor. Read all the leaflet before use.

Warning. Do not exceed the stated dose. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 25°C.

Store in the original container. Keep the container tightly closed.

PL Holder: Dalkeith Laboratories Ltd., Woburn, MK17 9PG, UK.

Distributed by: Co-pharma Ltd., Herts., WD1 8SS, UK.

PL 17496/0018

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BN:    Exp:


Co-pharma logo


Inner leaflet:

Patient Information Leaflet

Sodium Bicarbonate 500 mg Capsules

Read the leaflet carefully and keep it in case you want to read it again.

Do not share medicines with other people.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1.    What these capsules are and what they are used for

These capsules contain the active ingredient, sodium bicarbonate. Sodium Bicarbonate can be used as an antacid and works by neutralising acid in your stomach.

Sodium Bicarbonate Capsules are used to treat dyspepsia (heartburn or indigestion). They may also be used to treat acidosis (metabolic or respiratory), a condition where the blood is more acidic than it should be.

2.    Before you take these capsules

Some people must not take these capsules. Do not take these capsules if:

You know you are allergic to sodium bicarbonate or to any of the other ingredients (these are listed in section 6).

You must be especially careful if:

•    You have previously suffered from heart failure

•    You suffer from liver or kidney problems

•    You have high blood pressure

•    You are on a low salt diet (each capsule contains 137 mg of sodium)

•    You are elderly

•    You are pregnant or breastfeeding.

Discuss your treatment with your doctor before taking this medicine if any of the above applies to you.

Taking other medicines

These capsules can affect some other medicines you may be taking. Make sure your doctor knows if you are taking any of the following:

•    Drugs containing lithium (for depression)

•    Phenothiazines (to treat anxiety)

•    Anti-bacterials (e.g. rifampicin or tetracycline)

•    Anti-fungals (e.g. ketoconazole, itraconazole)

•    Drugs to treat high blood pressure (eg. captopril, enalapril)

•    Dipyridamole (to prevent blood clotting)

•    Quinidine (for heart rhythm disturbances)

•    Phenytoin and gabapentin (for epilepsy)

•    Chloroquine and hydroxychloroquine (to prevent or treat malaria or for arthritis)

•    Penicillamine (for rheumatism)

•    Bisphosphonates (to treat Pagets disease, in which bones form too quickly or to treat established osteoporosis to slow down bone loss)

•    Methotrexate (used in cancer treatment)

•    Ephedrine (used in cold remedies/nasal decongestants)

•    Aspirin.

Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as those you have on prescription from your doctor.

Driving and using machinery

Sodium Bicarbonate Capsules should not affect your ability to drive or operate machinery.

3. How to take these capsules

The capsules should be swallowed whole (do not chew) with a drink of water.

If this medicine has been given to you by your doctor, he/she will decide what dose you need to take. Always take the capsules exactly as the doctor has told you. The dose will be on the pharmacist’s label. If you are not sure, ask your doctor or pharmacist. Carry on taking them for as long as you have been told unless you have any problems. In that case, check with your doctor.

The usual doses are as follows:

Adults:

Indigestion: Take 1 to 5 g (2 to 10 capsules) when required.

Do not take more than the stated dose.

Acidosis: To be taken as instructed by your doctor. The dose will depend on each individual patient’s acid-base balance and electrolyte status.

If you have bought the capsules yourself, take the dose described above. Do not continue to take these capsules for a long period of time without consulting the doctor.

Children under 12 years of age should not take this medicine unless prescribed by a doctor.

If you take more capsules than you should:

Speak to your doctor or pharmacist straightaway.

If you forget to take these capsules:

Do not take a double dose to make up for a forgotten dose, just carry on with the normal routine.

4. Possible side effects

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

The following have been reported:

•    Stomach pains

•    Flatulence (wind)

•    Alkalosis (an increase in pH of the blood), symptoms may include tiredness/weariness, vomiting, thirst and restlessness. (Possibly due to prolonged use, which is not advised).

Sodium supplements such as Sodium Bicarbonate Capsules may also cause:

•    High blood pressure

•    Fluid retention

•    Hypokalaemia (low potassium levels in the blood), symptoms may include an abnormal heartbeat, muscle weakness and numbness.

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. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store these capsules

Keep out of the sight and reach of children.

Do not store above 25°C. Store in the original container. Keep the container tightly closed.

Do not use the capsules after the expiry date shown on the label.

Take any unused medicine back to your pharmacist to be destroyed.

6.    Further information Ingredients

Each white capsule printed with “NaB 500” contains 500 mg of the active ingredient, sodium bicarbonate. The other ingredients are microcrystalline cellulose, and magnesium stearate. The capsule shell contains gelatin, water and titanium dioxide (E171), and the printing ink contains shellac, black iron oxide (E172), soya lecithin and antifoam DC 1510.

They are supplied in containers of 56 or 100 capsules.

Both of the pack sizes may not be available.

Product licence holder: Dalkeith Laboratories Ltd., 2 Park Street, Woburn, Bedfordshire, MK17 9PG, UK.

Manufacturer: Aspar Pharmaceuticals Ltd, 29-30 Capitol Way, Capitol Way Industrial Park, Colindale, London, NW9 0EQ, UK.

Date of revision: May 2015.

If you would like the leaflet in a different format, please contact the licence holder above.