Patient leaflet - Sodium Bicarbonate 500 mg capsules
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.
2. What you need to know before you take Sodium Bicarbonate 500mg Capsules
Do not take Sodium Bicarbonate 500mg Capsules:
- if you are allergic to sodium bicarbonate or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Sodium Bicarbonate 500mg Capsules
if you have ever had any problems with your kidneys or liver;
- if you suffer from high blood pressure or heart problems;
Other medicines and Sodium Bicarbonate 500mg Capsules
Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines.
- 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, cefpodoxime, 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);
- diflunisal (used for pain relief);
- 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).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not known.
Sodium Bicarbonate 500mg Capsules contains Sodium
This medicine contains 135 mg sodium (main component of cooking/table salt) in each capsule. This is equivalent to 67.5% of the recommended maximum daily dietary intake of sodium for an adult.
3. How to take Sodium Bicarbonate 500mg Capsules
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. 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 and Elderly
- 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.
Use in children
Children over 12 years
- The usual dose is between 1 and 5g (2 to 10 capsules).
- The maximum daily dose is 5g (10 capsules).
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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Not known (cannot be estimated from the available data).
- 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 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 Sodium Bicarbonate 500mg Capsules
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month. Do not store above 25˚C.
Store in the original container and keep the container tightly closed.
Do not use this medicine if you notice any damage to or discoloration of the tablets. Return them to your pharmacist.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other 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 (E171) and black ink (containing shellac, dehydrated alcohol, isobutyl alcohol, butyl alcohol, propylene glycol, purified water, black iron oxide (E172) and strong ammonium 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 July 2019. Package leaflet: Information for the user Sodium Bicarbonate 500mg Capsules (Sodium Bicarbonate)
103489/LF/035/03
F1275
and technical approval needs to be taken, from the CMO, before Implementation.
Dimension: 148.5 x 210 mm Commodity No.: F1275
Version No.: 103489/LF/035/03 Revision No.: 1
Revision Date: 01-Aug-2019 Product Description: Sodium Bicarbonate
Capsules 500mg
Component: Leaflet
Product Code: 103489
Country: UK
Vendor Name: Dales
CRF(s): PR 33674 Revised by: PAT