This information is intended for use by health professionals

1. Name of the medicinal product

Sodium bicarbonate 84mg/ml oral solution

Bidex 84mg/ml oral solution

2. Qualitative and quantitative composition

Each 1ml of oral solution contains 84mg of sodium bicarbonate (equivalent to 1 mmol/ml sodium bicarbonate). For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Oral solution.

Clear colourless solution, free of visible particles.

4. Clinical particulars
4.1 Therapeutic indications

Sodium bicarbonate is indicated in adults (including elderly) for:

• the treatment of metabolic acidosis arising from a variety of disorders. The dosage must be calculated on an individual basis and is dependent on the acid-base balance and electrolyte status of the patient.

• the short-term symptomatic treatment of mild or transient dyspepsia.

4.2 Posology and method of administration

Posology

Adults (including elderly):

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

Dyspepsia: Doses of 12 – 60ml (approximately 1 – 5g) every 4 – 6 hours as required.

Paediatric population:

The efficacy of sodium bicarbonate in children under 18 years of age has not been established. No data are available.

Method of administration

For oral use.

Measuring oral syringe

The required dose should be drawn from the container into the graduated oral syringe using the oral syringe adaptor (see section 6.6).

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

• Metabolic or respiratory alkalosis

• Hypocalcaemia

• Hypochlorhydria

4.4 Special warnings and precautions for use

Sodium bicarbonate should be used with caution in patients with cirrhosis of the liver and patients on low sodium diets.

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

This medicine can mask the symptoms of stomach cancer or ulcer

Sodium bicarbonate should be given extremely cautiously to patients with eclampsia, aldosteronism or other conditions associated with sodium retention.

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

If symptoms persist consult your doctor.

Caution is recommended in elderly patients (aged from 65 years).

Keep all medicines out of the sight and reach of children.

Since the efficacy of sodium bicarbonate in children under 18 years of age has not been established Sodium bicarbonate 84mg/ml oral solution is not recommended in 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 (e.g. ketoconazole), dipyridamole, phenothiazines, chloroquine, phenytoin and penicillamine.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of sodium bicarbonate in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Sodium bicarbonate is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breast-feeding

There is insufficient information on the excretion of sodium bicarbonate/metabolites in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from sodium bicarbonate therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

No information is available on the effect of this product on fertility.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

MedDRA System Organ Class

Adverse reaction

Metabolism and nutrition disorders

Frequency not known

Alkalosis on prolonged use, Fluid retention, Hypokalaemia may be exacerbated, Loss of appetite (continuing)

Psychiatric disorders

Frequency not known

Mood or mental changes, Nervousness or restlessness

Nervous system disorders

Frequency not known

Headache (continuing)

Vascular disorders

Frequency not known

Hypertension, Slow breathing, Breathing difficulties, Fluid on the lungs

Respiratory, thoracic and mediastinal disorders

Frequency not know

Pulmonary oedema

Gastrointestinal disorders

Frequency not known

Pain in the stomach

Flatulence

Spontaneous stomach rupture

Nausea

Vomiting

Unpleasant taste

Skin and subcutaneous tissue disorders

Frequency not known

Swelling of feet or lower legs

Renal and urinary disorders

Frequency not known

Frequent urge to urinate

General disorders and administration site conditions

Frequency 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Excessive amounts of this medicine may cause metabolic alkalosis, especially if renal function is impaired. Shortness of breath, muscle weakness, convulsions and coma has been reported in severe cases. Sodium overload and hyperosmolarity may also occur.

Treatment is supportive with appropriate correction of fluid and electrolyte imbalance using sodium free fluids.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Alimentary tract and metabolism; Drugs for acid related disorders; Antacids; Antacids with sodium bicarbonate, ATC code: A02AH

Sodium bicarbonate is used for a variety of therapeutic purposes including the correction of metabolic acidosis and as an antacid for the treatment of dyspepsia. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide.

Sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses clinical manifestations of metabolic acidosis.

5.2 Pharmacokinetic properties

Absorption

Sodium bicarbonate is readily absorbed from the gastro-intestinal tract.

Distribution

Sodium bicarbonate is present in all body fluids. Sodium bicarbonate causes neutralization of gastric acid with the production of carbon dioxide.

Biotransformation

Sodium bicarbonate is not significantly metabolized.

Elimination

Any bicarbonate not involved in the gastric acid neutralisation reaction is absorbed and in the absence of a deficit of bicarbonate in the plasma, bicarbonate ions are excreted in the urine. The urine is rendered alkaline and there is an accompanying dieresis.

5.3 Preclinical safety data

No relevant information additional to that contained elsewhere in the SPC.

6. Pharmaceutical particulars
6.1 List of excipients

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Unopened: 12 months.

After first opening: 7 days

6.4 Special precautions for storage

Store below 25°C. Do not refrigerate or freeze. Do not use if crystals are observed in the product.

6.5 Nature and contents of container

Bottle: 100ml Amber PET bottle

Closure: White PP tamper evident child resistant closure with EPE liner

Dosing device: 20ml CE marked measuring oral syringe.

6.6 Special precautions for disposal and other handling

The product may be administered using an oral syringe. The instructions for using the oral syringe are as follows:

The required dose should be drawn from the container into the graduated oral syringe provided using the oral syringe adaptor (see detailed instructions below). The oral syringe should be held into the mouth of the patient, and the contents of the oral syringe should then be ejected into the mouth and swallowed.

a) Open the bottle: press the cap and turn it anticlockwise (figure a)

b) Separate the adaptor from the oral syringe. Insert the adaptor into the bottle neck.

Ensure it fits well (figure b). Take the oral syringe and put it in the adaptor opening. Turn the bottle upside down (figure c).

c) Fill the oral syringe with a small amount of solution by pulling the piston down, then push the piston up in order to remove any possible bubble. Pull the piston down to the graduation mark corresponding to the required dosage in millilitres (ml) (figure d).

d) Turn the bottle the right way up. Remove the oral syringe from the adaptor.

Empty the contents of the oral syringe into the patient's mouth by pushing the piston to the bottom of the oral syringe (figure e). Close the bottle with the plastic screw cap.

Drain any remaining solution in the oral syringe and wash it with water after use. Store the oral syringe in a clean and dry place.

7. Marketing authorisation holder

Ennogen Healthcare Ltd,

Unit G4, Riverside Industrial Estate,

Riverside Way,

Dartford, DA1 5BS.

United Kingdom

8. Marketing authorisation number(s)

PL 40739/0091

9. Date of first authorisation/renewal of the authorisation

14/01/2019

10. Date of revision of the text

14/01/2019