Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Syri Limited, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK Trading as: Thame Laboratories, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK. OR Trading as: SyriMed, Unit 4, Bradfield ...
Patients with hypersensitivity to sodium bicarbonate or any ingredient of the formulation.
Contraindicated in patients with metabolic alkalosis or respiratory alkalosis, hypokalaemia, hypernatraemia, low sodium diet, hypocalcaemia, or hypochlorhydria.
Not to be taken by children under 12 years old.
Overtreatment with bicarbonate must be avoided. Frequent monitoring of serum electrolytes and acid-base status is essential. In patients with moderate and advanced chronic renal disease, the association between serum bicarbonate concentration and all-cause mortality is U-shaped. The lowest mortality rate is seen in patients with serum bicarbonate concentration in the range of 26–29 mmol/l. The highest mortality rate is observed among patients with serum bicarbonate levels of <22 mmol/l but an increase in mortality is also seen in patients with serum bicarbonate levels of >29 mmol/l.
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.
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.
The effects of a number of drugs may be reduced or increased by the alkalinisation of the urine (e.g. aspirin or diflunisal) and changes in gastric pH brought about by sodium bicarbonate.
In particular cases elimination of weak acids and bases may be affected by sodium hydrogen carbonate treatment via an increase of the pH in urine. This might for example apply to sympathomimetics, anticholinergics, tricyclic antidepressants, barbiturates, H2-blockers, captopril, and quinidine.
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.
Large amounts of milk or calcium containing products should not be taken whilst taking Thamicarb. Such administration may result in milk-alkali syndrome.
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.
Functional interactions with gluco- and mineralocorticoids, androgens and diuretics associated with increased potassium excretion may occur.
Antacids possibly reduce absorption of bile acids.
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.
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.
The potential risks of sodium on fertility are not known.
None known.
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, Abdominal Discomfort, Abdominal distension, Flatulence, Unpleasant taste |
| Metabolism and nutrition disorders | |
| Frequency not known | Metabolic alkalosis, 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), Dizziness |
| 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, Promotion of renal urolithiasis (formation of calcium or magnesium phosphate calculi) upon prolonged use. |
| General disorders and administration site conditions | |
| Frequency not known | Extreme irritability, unusual tiredness or weakness, muscle spasms or cramps |
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.
Not Applicable.
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