Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Sodium bicarbonate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for 2. What you need to know before you take Sodium Bicarbonate Capsules 3. How to take Sodium Bicarbonate Capsules 4. Possible side effects 5. How to store Sodium Bicarbonate Capsules 6. Contents of the pack and other information
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Sodium Bicarbonate Capsules
Sodium Bicarbonate 500 mg Capsules, Hard
PACKAGE LEAFLET: INFORMATION FOR THE USER
160 mm
, not listed in this leaflet. See section 4.
If your doctor has prescribed this medicine, always take Sodium Bicarbonate Capsules exactly as your doctor or pharmacist has told you. If you are not sure how to take this medicine, talk to your doctor or pharmacist.
provide more information on the safety of this medicine.
The product name Sodium Bicarbonate 500 mg Capsules Hard is referred to as Sodium Bicarbonate Capsules in this leaflet.
Sodium Bicarbonate Capsules
If you forget to take your medicine If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4. Possible side effects
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.
What Sodium Bicarbonate Capsules contain The active substance is sodium bicarbonate. Each capsule contains 500 mg 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 Sodium laurilsulfate and the printing ink contains shellac (E904), black iron oxide (E172) and Propylene Glycol (E1520). What Sodium Bicarbonate Capsules look like and contents of the pack Empty Hard Gelatin Capsule shell, size"1", Clear Transparent Cap and body, imprinted with SB on Cap and 500 on body, containing white to off-white granular powder or powder plug. These capsules are available in pack sizes of 56.
Marketing Authorization Holder Like all medicines, this medicine can cause side Flamingo Pharma (UK) Ltd. effects, although not everybody gets them. 1st floor, Kirkland House, Contact your doctor immediately if you experience: 11-15 Peterborough Road, Harrow, Middlesex,
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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Sodium Bicarbonate 500 mg Capsules comes as capsule containing 500mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Sodium Bicarbonate 500 mg Capsules is sodium bicarbonate.
This leaflet reproduces the patient information leaflet approved for Sodium Bicarbonate 500 mg Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Sodium Bicarbonate is intended for the treatment of dyspepsia. It may also be used to treat metabolic acidosis arising from a variety of disorders as well as severe respiratory acidosis. The dosage must be calculated on an individual basis and is dependent on the acid-base balance and electrolyte status of the patient.
Adults
Dyspepsia: 1g – 5g when required
Metabolic Acidosis: The dosage is dependent upon the acid-base balance and electrolyte status of the patient and must be calculated on an individual basis.
Paediatric population
Not recommended.
Method of administration
For oral administration. To be swallowed whole with a drink of water.
Patients with hypersensitivity to sodium bicarbonate or any ingredient of the formulation.
Contraindicated in patients with metabolic alkalosis or respiratory alkalosis, hypokalaemia, hypernatraemia, low sodium diet, hypocalcaemia, or hypochlorhydria.
Not to be taken by children under 12 years old.
Overtreatment with bicarbonate must be avoided. Frequent monitoring of serum electrolytes and acid-base status is essential. In patients with moderate and advanced chronic renal disease, the association between serum bicarbonate concentration and all-cause mortality is U-shaped. The lowest mortality rate is seen in patients with serum bicarbonate concentration in the range of 26–29 mmol/l. The highest mortality rate is observed among patients with serum bicarbonate levels of < 22 mmol/l but an increase in mortality is also seen in patients with serum bicarbonate levels of > 29 mmol/l.
Sodium bicarbonate should be given extremely cautiously to patients with heart failure, oedema, renal impairment, hypertension, eclampsia, aldosteronism, or other conditions associated with sodium retention.
Do not take if you are hypersensitive to sodium bicarbonate.
Consult your doctor or pharmacist if symptoms persist after 7 days.
This medicine can mask the symptoms of stomach cancer or ulcer.
The effects of a number of drugs may be reduced or increased by the alkalinisation of the urine (e.g. aspirin or diflunisal) and changes in gastric pH brought about by sodium bicarbonate.
In particular cases elimination of weak acids and bases may be affected by sodium hydrogen carbonate treatment via an increase of the pH in urine. This might for example apply to sympathomimetics, anticholinergics, tricyclic antidepressants, barbiturates, H2-blockers, captopril, and quinidine.
Sodium-containing preparations should be avoided by patients on lithium because sodium is preferentially absorbed by the kidney resulting in increased lithium excretion and reduced plasma levels.
As a precaution for antacids, in order to minimise the risk of interactions affecting pharmacokinetics of concomitantly administered products, drug administrations should be separated by approximately 2 to 3 hours.
Large amounts of milk or calcium containing products should not be taken whilst taking Sodium bicarbonate capsules. Such administration may result in milk-alkali syndrome.
Sodium bicarbonate reduces the absorption of a number of other drugs taken concomitantly. These include ACE inhibitors (captopril, enalapril, and fosinapril), antibacterials and antifungals (azithromycin, cefaclor, cefpodoxime, isoniazid, itraconazole, rifampicin, tetracyclines, ketoconazole and the quinolone group of antibacterials); antivirals (atazanivir, fosamprenavir, tipranavir); antihistamines (fexofenadine); bisphosponates, corticosteroids (deflazacort); digoxin, dipyridamole, antiepileptics (gabapentin and phenytoin), ulcer healing drugs (lansoprazole); levothyroxine, mycophenolate, lipid regulating drugs (rosuvastatin); antipsychotics (sulpiride, phenothiazines), chloroquine, hydrochloroquine, and penicillamine. Antacids should be avoided with nilotinib.
Functional interactions with gluco- and mineralocorticoids, androgens and diuretics associated with increased potassium excretion may occur.
Antacids possibly reduce absorption of bile acids.
Pregnancy
Animal studies are insufficient with respect to effects on pregnancy, embryonal fetal development, parturition and postnatal development. The potential risk for humans is unknown. Sodium bicarbonate should not be taken during pregnancy unless advised by a doctor to do so.
Breast-feeding
The effects of sodium administration during breast-feeding are not known. Sodium bicarbonate should not be taken if breast-feeding unless advised by a doctor to do so.
Fertility
The potential risks of sodium on fertility are not known.
None known.
General adverse effects of sodium bicarbonate are as follows. The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: very common (≥ 10%), common (≥ 1% and < 10%); uncommon (≥ 0.1% and < 1%); rare (≥ 0.01% and < 0.1%), very rare (< 0.01%), not known (cannot be estimated from the available data).
System Organ Class
Frequency
Adverse reactions
Gastrointestinal disorders
Not known
Wind, Nausea, Vomiting, Abdominal Discomfort, Abdominal distension, Flatulence, Unpleasant taste
Metabolism & nutrition disorders
Not known
Metabolic alkalosis, Fluid retention, Loss of appetite (continuing)
Psychiatric disorders:
Not known
Mood or mental changes, Nervousness or restlessness
Vascular disorders:
Not known
Hypertension, Slow breathing, Breathing difficulties, Fluid on the lungs
Nervous system disorders:
Not known
Headache (continuing), Dizziness
Skin and subcutaneous tissue disorders:
Not known
Swelling of feet of lower legs
Renal and urinary disorders:
Not known
Frequent urge to urinate, Promotion of renal urolithiasis (formation of calcium or magnesium phosphate calculi) upon prolonged use.
General disorders and administration site conditions:
Not known
Extreme irritability, unusual tiredness or weakness, muscle spasms or cramps
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Excessive administration of bicarbonate may lead to hypokalaemia and metabolic alkalosis, especially in patients with impaired renal function. Symptoms include mood changes, tiredness, shortness of breath, muscle weakness and irregular heartbeat. Muscle hypertonicity, twitching and tetany may develop, especially in hypocalcaemic patients. Excessive doses of sodium salts may lead to sodium overloading and hyperosmolality.
Treatment of metabolic alkalosis and hypernatraemia is by correction of fluid and electrolyte balance. Replacement of calcium, chloride, and potassium ions may be of particular importance.
Ask anything about Sodium Bicarbonate 500 mg Capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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