Document: spc-doc_PL 13931-0021 change

• spc-doc_PL 00289-1423
• spc-doc_PL 13931-0021
• spc-doc_PL 17496-0018

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1. NAME OF THE MEDICINAL PRODUCT

Sodium Bicarbonate 500mg Capsules

2.    * QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains sodium bicarbonate 500 mg.

For the full list of excipients, see section 6.1.

3. Pharmaceutical Form

Capsules, hard.

Capsules for oral administration.

White to off white capsules containing a white crystalline powder.

4.    CLINICAL PARTICULARS

4.1 _Therapeutic Indications

Sodium bicarbonate is used to treat dyspepsia in doses of 1-5 g.

It may also be used for the treatment of 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.

4.2 _Posology and method    of administration

Posology

Adults

Dyspepsia: 1 g to 5 g in water as required.

Metabolic acidosis: dosage is calculated on an individual basis and is dependent on acid-base balance and electrolyte status.

_Children

_No recommendation.

4.3_Contraindications

None

4.4 Special warnings and precautions for use

Should be administered with caution to patients suffering from congestive heart failure, hepatic and renal impairment or hypertension.

Sodium bicarbonate should be used with caution by patients on low sodium diets.

Sodium bicarbonate should be used with caution by patients with cirrhosis of the liver.

If symptoms persist consult your doctor.

Do not exceed the recommended dose as excess or prolonged use may lead to alkalosis.

Caution in the elderly.

Keep this medicine out of the sight and reach of children.

4.5_Interaction with other medicinal products and other forms of interaction

Avoid in patients on salt restricted diets and in patients taking corticosteroids. Sodium bicarbonate increases the excretion of lithium. The excretion of aspirin and methotrexate is increased and quinidine and ephedrine reduced in alkaline urine. Antacids reduce the absorption of antibacterials (for example tetracyclines and rifampicin), antifungals (eg. ketoconazole), dipyridamole, phenothiazines, chloroquine, phenvtoin and penicillamine.

4.6 Pregnancy and lactation

_The safety of Sodium Bicarbonate during pregnancy and lactation has not been

established. May be used during this period if the usual precautions are followed and the anticipated benefits outweigh any risks.

4.7 Effects on ability to drive and use machines

None known.

4.8_Undesirable effects

Stomach pains and flatulence has been reported. Alkalosis on prolonged use.

Sodium supplements may increase blood pressure or cause fluid retention and pulmonary oedema in those at risk.

Hypokalaemia may be exacerbated.

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 Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.

4.9_Overdose

Metabolic alkalosis may occur especially if renal function is impaired. In severe cases shortness of breath, muscle weakness, convulsions and coma have been reported. Sodium overload and hyperosmolarity may also occur. Treatment is supportive with appropriate correction of fluid and electrolyte imbalance using sodium-free fluids.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

_Pharmacotherapeutic group: Alimentary tract and metabolism - Antacids.

ATC Code: A02AH

The normal concentration range of bicarbonate in plasma is 22 to 32mmol per litre. The average intake of bicarbonate in the diet is negligible and very little is excreted in the urine under normal conditions; bicarbonate ions formed in the body are excreted in biliary, intestinal, pancreatic, and salivary fluids. If bicarbonate is administered therapeutically thus increasing the plasma-bicarbonate is concentration above the normal range then compensatory renal mechanisms come into play and bicarbonate is excreted in the urine.

5.2_Pharmacokinetic properties

Administration of sodium bicarbonate by mouth causes neutralisation of gastric acid with the production of carbon dioxide. sodium bicarbonate not involved in that reaction is absorbed and in the absence of a deficit of bicarbonate in the plasma, bicarbonate ions are excreted in the urine along with sodium ions; the urine is rendered alkaline and there is an accompanying diuresis.

5.3_Preclinical safety data

Not applicable.

PHARMACEUTICAL PARTICULARS

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

_18 July 2002 / 07 November 2007

10 DATE OF REVISION OF THE TEXT

02/02/2016