Sodium Bicarbonate Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Bicarbonate BP Numark Sodium Bicarbonate BP Boots Sodium Bicarbonate BP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Bicarbonate 100%
3. PHARMACEUTICAL FORM
Oral Powder
4.1 Therapeutic indications
1. For use as an antacid for the symptomatic relief of dyspepsia.
2. As an external lotion for the relief of the symptoms of insect bites and sunburn.
4.2 Posology and method of administration
1. Oral: For the relief of the symptoms of dyspepsia, heartburn and indigestion: Adults, the elderly and children aged 12 years and over: Take 1 to 5 g in water 4 to 6 hourly as required. Not recommended for children under 12 years of age.
2. Cutaneous: As an external lotion: Dissolve one 5 ml spoonful in a pint of warn water. Apply with lint or cotton wool.
4.3 Contraindications
Contraindicated in patients with metabolic or respiratory alkalosis, hypocalcaemia, or hypochlorhydria.
Not to be taken by children under 12 years old.
It should be used with extreme caution in patients with congestive heart failure, renal impairment, cirrhosis of the liver, or hypertension, or to patients receiving corticosteroids.
Hypersensitivity to sodium bicarbonate.
4.4 Special warnings and precautions for use
Caution should be exercised in patients who are on Sodium restricted diets and those with cardiac disease, hypertension, renal or hepatic impairment.
A physician should be consulted if the patient is receiving other medications before taking this product. If symptoms persist consult your doctor.
4.5 Interaction with other medicinal products and other forms of interaction
The effects of a number of drugs may be reduced or increased by the alkalinisation of the urine (e.g. aspirin or diflunisal) and reduction in gastric pH brought about by sodium bicarbonate.
The following drugs are reported to be susceptible to inactivation on mixing with sodium bicarbonate solution: adrenaline hydrochloride, benzyl penicillin potassium, carmustine,
glycopyrronium bromide, isoprenaline hydrochloride, and suxamethonium chloride.
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.
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 avoidedwith nilotinib.
Antacids possibly reduce absorption of bile acids
4.6 Pregnancy and Lactation
Data on a large number of exposed pregnancies indicate no adverse effects of Bicarbonate of Soda (Sodium Bicarbonate BP) on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available.
Caution should be exercised, when prescribing to pregnant women.
4.7 Effects on Ability to Drive and Use Machines
None known
4.8 Undesirable effects
This medicine may cause abdominal cramps and flatulence. Excessive administration may lead to metabolic alkalosis, especially in patients with impaired renal function.
Additional undesirable effects associated with oral use of sodium bicarbonate include possible increase in blood pressure, exacerbation of hyperkalaemia, and fluid retention and pulmonary oedema may be caused in those at risk.
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 at: www.yellowcard.mhra.gov.uk.
4.9 Overdose
Excessive amounts of this medicine may cause metabolic alkalosis. Dyspepsia and muscle weakness may occur owing to potassium depletion. Twitching tetany may occur in hypercalcaemic patients. Severe overdosages may lead to convulsions and coma. Treatment consists of appropriate correction of fluid and electrolyte balance and is otherwise supportive and symptomatic. Anti-convulsant therapy may be needed in severe overdosage.
5
PHARMACOLOGICAL PROPERTIES
Not applicable
5.2 Pharmacokinetic Properties
Not applicable
5.3 Preclinical Safety Data
Never undertaken by Abdine Limited. This product was granted a 'Licence as of Right' some 25 years ago.
6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
None
6.2 Incompatibilities
None
6.3 Shelf life
As packaged for sale: Three years As reconstituted for use: Thirty minutes After first opening the container: One month
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
A spirally wound, varnished, cardboard tub with a press-fit lid or polypropylene jar and cap containing 100g, 150g, 200g, 250g, 300g or 500g of sodium bicarbonate.
6.6 Instruction for use and handling Take 1 to 5g in water.
7. MARKETING AUTHORISATION HOLDER
Bell Sons & Co (Druggists) Ltd
Gifford House
Slaidburn Crescent
Southport
Merseyside
PR9 9AL
UK
8. MARKETING AUTHORISATION NUMBER
PL 03105/0067
9. DATE OF FIRST AUTHORISATION
AUTHORISATION/RENEWAL
OF
THE
12th February 1999
10
DATE OF REVISION OF THE TEXT
10/02/2016