Sodium Bicarbonate 500 Mg Capsules
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Bicarbonate 500 mg Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Bicarbonate 500 mg For excipients see 6.1
3. PHARMACEUTICAL FORM
Capsule, hard.
White, size1, hard gelatine capsules marked ‘G SB500’.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
For use in treatment of dyspepsia
4.2. Posology and Method of Administration
Adults and children over 12 years The usual dose is between 1 and 5 g.
Elderly As for adults.
Children under 12 years Not recommended.
Route of administration
Oral.
Contra-indications
4.3.
Patients with hypersensitivity to sodium bicarbonate or any ingredient of the formulation.
4.4. Special Warnings and Precautions for Use
Sodium bicarbonate should be used with caution by patients on low sodium diets or with congestive heart failure, hypertension, impaired renal function and cirrhosis of the liver.
Prolonged use should be avoided.
4.5 Interaction with other medicinal products and other forms of interaction
ACE Inhibitors: antacids possibly reduce absorption of ACE Inhibitors; antacids reduce absorption of captopril, enalapril and fosinopril.
Analgesics: alkaline urine due to some antacids increases excretion of aspirin.
Antibacterials: antacids reduce absorption of azithromycin, cefaclor, cefpodoxime, ciprofloxacin, isoniazid, levofloxacin, moxifloxacin, norfloxacin, ofloxacin, rifampicin and tetracyclines.
Antiepileptics: antacids reduce absorption of gabapentin and phenytoin.
Antifungals: antacids reduce absorption of itraconazole and ketaconazole.
Antihistamines: antacids reduce absorption of fexofenadine.
Antimalarials: antacids reduce absorption of chloroquine and hydroxychloroquine.
Antipsychotics: antacids reduce absorption of phenothiazines and sulpiride.
Antivirals: antacids possibly reduce absorption of amprenavir; antacids possibly reduce plasma concentration of atazanavir; antacids reduce absorption of tipranavir.
Bile Acids: antacids possibly reduce absorption of bile acids.
Bisphosphonates: antacids reduce absorption of bisphosphonates.
Cardiac Glycosides: antacids possibly reduce absorption of digoxin.
Corticosteroids: antacids reduce absorption of deflazacort.
Cytotoxics: antacids reduce absorption of mycophenolate.
Dipyridamole: antacids possibly reduce absorption of dipyridamole.
Lipid-regulating Drugs: antacids reduce absorption of rosuvastatin.
Lithium: sodium bicarbonate increases excretion of lithium (reduced plasma concentration).
Penicillamine: antacids reduce absorption of penicillamine.
Thyroid Hormones: antacids possibly reduce absorption of levothyroxine (thyroxine).
Ulcer-healing Drugs: antacids possibly reduce absorption of lansoprazole.
4.6. Pregnancy and Lactation
The safety of sodium bicarbonate during pregnancy and lactation has not been established, but its use during these periods is not considered to constitute a hazard.
4.7. Effects on Ability to Drive and Use Machines
None known.
Undesirable effects
4.8
Stomach cramps, belching and flatulence.
Metabolic alkalosis and/or hypokalaemia may ensue as a result of prolonged use or over-correction of the bicarbonate deficit, especially in patients with impaired renal function.
Reporting of suspected adverse reactions
Reporting of 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 at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Symptoms of overdosage include metabolic alkalosis.
Treatment should consist of hydration using sodium-free fluids. Treatment is supportive with appropriate correction of fluid and electrolyte imbalance.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Sodium bicarbonate has antacid properties and neutralises gastric acid with the production of carbon dioxide. Any bicarbonate ions not involved in that reaction are absorbed and in the absence of a deficit of bicarbonate in the plasma, are excreted in the urine, which is rendered alkaline and there is an accompanying diuresis.
5.2. Pharmacokinetic Properties
There is little pharmacokinetic information available. The volume of distribution depends on the acid-base status of the individual.
Once it has entered the body, the action and fate of sodium bicarbonate is identical to that of endogenous sodium and bicarbonate ions. The kinetics are therefore determined by the physiological state of the patient at the time. A sodium depleted patient or one with heart failure or renal failure will retain sodium. A replete patient with normal renal function will eliminate any excess in the urine.
5.3. Preclinical Safety Data
Not applicable since sodium bicarbonate has been used in clinical practice for many years and its effects are well known.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Gelatin
Titanium dioxide (E171)
Black Ink - Shellac, isopropyl alcohol, black iron oxide (E172), n-butyl alcohol, propylene glycol and concentrated ammonia solution.
6.2. Incompatibilities
Not applicable
6.3. Shelf Life
2 years.
6.4. Special Precautions for Storage
Do not store above 25°C. Keep the container tightly closed. Store in the original container.
6.5
Nature and contents of container
Polypropylene container with either a polyethylene, tamper-evident lid or a polyethylene, tamper-evident, child resistant cap.
Each bottle contains 56 or 100 capsules and is packed in a cardboard carton.
6.6. Instruction for Use/Handling
Not applicable.
7. MARKETING AUTHORISATION HOLDER
Focus Pharmaceuticals Limited
Capital House, 85 King William Street, London EC4N 7BL, UK.
8. MARKETING AUTHORISATION NUMBER
PL 20046/0004
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27 April 2004
10 DATE OF REVISION OF THE TEXT
29/06/2016