This information is intended for use by health professionals

1. Name of the medicinal product

Thamicarb™ 84mg/ml Oral Solution

2. Qualitative and quantitative composition

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

3. Pharmaceutical form

Oral solution.

A clear, colourless solution.

4. Clinical particulars
4.1 Therapeutic indications

Thamicarb is used to treat hyperacidity, dyspepsia and symptomatic relief of heartburn and peptic ulceration.

4.2 Posology and method of administration

Posology

For acid indigestion

Adults and children over 12 years:

Take 12ml (1g) to 60ml (5g) every 4 to 6 hours.

Not recommended for use in children under 12 years of age.

Method of administration

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

4.3 Contraindications

Contraindicated in patients with metabolic or respiratory alkalosis, hypocalcaemia, or hypochlorhydria.

Not to be taken by children under 12 years old.

4.4 Special warnings and precautions for use

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.

Keep all medicines away from children.

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.

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.

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 avoided with nilotinib.

Antacids possibly reduce absorption of bile acids.

4.6 Fertility, pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

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).

MedDRA System Organ Class

Adverse Reaction

Gastrointestinal disorders:

Frequency not known

Wind, Nausea, Vomiting, Unpleasant taste

Metabolism and nutrition disorders:

Frequency not known

Fluid retention, Loss of appetite (continuing)

Psychiatric disorders:

Frequency not known

Mood or mental changes, Nervousness or restlessness

Vascular disorders:

Frequency not known

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

Nervous system disorders:

Frequency not known

Headache (continuing)

Skin and subcutaneous tissue disorders:

Frequency not known

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

4.9 Overdose

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 heart beat. 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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

ATC Code: A02A H, antacids with sodium bicarbonate.

Sodium bicarbonate is used as an antacid in relief of the symptoms of dyspepsia, heartburn and indigestion caused by excess gastrointestinal acid. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide.

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 neutralisation of gastric acid with the production of carbon dioxide.

Biotransformation

Sodium bicarbonate is not significantly metabolised.

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 that is rendered alkaline and there is an accompanying diuresis.

5.3 Preclinical safety data

No further relevant information.

6. Pharmaceutical particulars
6.1 List of excipients

Purified water

6.2 Incompatibilities

Not Applicable.

6.3 Shelf life

12 months.

For 100ml bottle: Discard your medicine 3 days after first opening.

For 500ml bottle: Discard your medicine 7 days after first opening.

6.4 Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze. Do not use if crystals are observed in the product. For storage conditions after first opening of the medicinal product, see section 6.3.

Keep out of the sight and reach of children.

6.5 Nature and contents of container

Bottle: Amber glass

Closure: White tamper-evident child-resistant polypropylene cap with HDPE-EPE wadding.

Pack size: 100ml or 500ml

Dosing Device: 20ml white polypropylene oral syringe with 1ml graduation marks and LDPE syringe adaptor

6.6 Special precautions for disposal and other handling

The required dose should be drawn from the container into the graduated syringe provided using the syringe adaptor (see detailed instructions below). The syringe should be held into the mouth of the patient, and the contents of the 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 syringe. Insert the adaptor into the bottle neck. Ensure it fits well (figure b). Take the syringe and put it in the adaptor opening. Turn the bottle upside down (figure c).

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

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

7. Marketing authorisation holder

Syri Limited, trading as Thame Laboratories

Unit 4, Bradfield Road,

Ruislip,

Middlesex,

HA4 0NU, UK.

8. Marketing authorisation number(s)

PL 39307/0005

9. Date of first authorisation/renewal of the authorisation

29/09/2014

10. Date of revision of the text

14/03/2018