Document: leaflet MAH GENERIC_PL 20395-0124 change

• leaflet MAH GENERIC_PL 20046-0004
• leaflet MAH GENERIC_PL 20395-0124

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PATIENT INFORMATION LEAFLET

SODIUM BICARBONATE 500mg CAPSULES

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

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

•    If you have further questions, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    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.

•    Your doctor may have given you this medicine before from another company and it may have looked slightly different. Either brand will have the same effect.

Sodium Bicarbonate 500mg Capsules are part of a group of medicines called antacids which are used to reduce the effects of excess acid produced in the stomach.

Sodium Bicarbonate 500mg Capsules are used to treat indigestion and to treat acidosis (too much acid produced by the body, or acid not removed by the kidneys).

Do not take Sodium Bicarbonate 500mg Capsules if:

•    You are allergic to sodium bicarbonate or any of the other ingredients (see section 6 -Further information)

•    You have hypocalcaemia (low levels of calcium in the blood)

•    You have metabolic alkalosis (an increase in alkaline content of body fluids)

Take special care and talk to your doctor or pharmacist before taking Sodium Bicarbonate 500mg Capsules if:

•    You have had problems with your liver or kidneys

•    You suffer from high blood pressure or have suffered from heart problems

•    You are on a salt (sodium) restricted diet, since each capsule contains 137 milligrams (mg) of sodium (see section 6 - Further information)

You are elderly

Taking other medicines

Tell your doctor or pharmacist if you are taking any of the following medicines:

•    ACE inhibitors (e.g. captopril, used to treat heart problems)

•    Aspirin (anti-inflammatory)

•    Antibacterials (e.g. rifampicin, tetracyclines)

•    Medicines used to treat epilepsy (e.g. gabapentin and phenytoin)

•    Medicines used to treat fungal infections (e.g. itraconazole)

•    Fexofenadine, used to treat hayfever

•    Medicines used to prevent malaria (e.g. chloroquine)

•    Phenothiazines, used to treat anxiety

•    Sulpiride (an antipsychotic medicine)

•    Antivirals (e.g. amprenavir)

•    Bile acids (e.g. ursodeoxycholic acid, used to treat gallstones)

•    Bisphosphonates (e.g. alendronate, used to prevent brittle bones)

•    Digoxin, used to treat heart problems

•    Corticosteroids (e.g. deflazacort, used to treat inflammation)

•    Mycophenolate, used to prevent organ rejection after transplantation

•    Dipyridamole (used to prevent blood clots)

•    Rosuvastatin, used to lower cholesterol

•    Lithium (used to treat depression)

•    Penicillamine (used to treat arthritis)

•    Thyroid hormones

•    Lansoprazole, used to prevent excess stomach acid

•    Methotrexate (used in cancer treatment)

•    Quinidine (used to treat abnormal heart rhythms)

•    Ephedrine (used to treat asthma)

Please 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 currently are pregnant or breast-feeding or are planning to become pregnant or to start breast-feeding, speak to your doctor or pharmacist before taking this medicine. Always ask your doctor or pharmacist for advice before taking any medicine.

Important information about some of the ingredients in your medicine

Sodium Bicarbonate 500mg Capsules contain 137 milligrams (mg) sodium per capsule. If you are on a low salt diet, contact your doctor before taking this medicine.

Check with your doctor or pharmacist if you are not sure how to take this medicine. Unless specific advice is given to you about how to take your medicine, always follow the instructions given in this leaflet.

The capsules should be swallowed whole with a drink of water Adults

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

Metabolic Acidosis: as directed by your doctor.

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

If symptoms persist, contact your doctor or pharmacist for advice. Do not exceed your recommended dose.

Children under 12 years

Not recommended.

If you take more of your medicine than you should

If you take more capsules than you should or you think a child has accidentally swallowed some capsules, contact the nearest hospital casualty department or speak to your doctor for advice immediately. Take this leaflet and any capsules that you still have to show the doctor.

If you forget to take your medicine

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

The dose your doctor or pharmacist advises may be different to the doses given in this leaflet. Always follow your doctor or pharmacist’s instructions when taking any medicines.

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

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

Stop taking your medicine and tell your doctor immediately if:

•    You have an allergic reaction (symptoms may include difficulty in breathing; closing of the throat; swelling of the lips, tongue or face)

Possible side effects

•    Stomach pain

•    Flatulence

•    High blood pressure (symptoms include dizziness, headaches and nausea)

Fluid retention (symptoms include feelings of bloating and swelling of the skin)

•    Fluid on the lungs (symptoms include difficulty in breathing)

•    Low potassium (detected in a blood test)

•    Muscle weakness and cramps - caused by a disturbance in your body’s pH (alkalosis). This can happen if you take this medicine for long periods of time or if you exceed your recommended dose.

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.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the month.

Store in the original package.

Do not use if you notice any damage or discolouration to the capsules.

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.

What Sodium Bicarbonate 500mg Capsules contain

The active substance is sodium bicarbonate. Each capsule contains 500mg of sodium bicarbonate, of which 137 milligrams (mg) is sodium.

The other ingredients are microcrystalline cellulose and magnesium stearate. The capsule shell contains gelatin and titanium dioxide (E171) and the printing ink contains shellac (E904), black iron oxide (E172) and potassium hydroxide.

What Sodium Bicarbonate 500mg Capsules look like and contents of the pack Sodium Bicarbonate 500mg Capsules are white size “0”, hard gelatin capsules with axial print “KPL” on the body and axial print “01” on the cap.

These capsules are available in pack sizes of 56.

Marketing Authorisation Holder

Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP Manufacturer

Kent Pharmaceuticals Limited, Crowbridge Road, AshfordKentTN24 0GR, U.K.

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

Product licence number: PL 20395/0124.

This leaflet was last prepared in June 2015.