Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Sodium bicarbonate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Thamicarb contains the active substance sodium bicarbonate which belongs to a group of medicines called antacids. Thamicarb is used to treat hyperacidity, dyspepsia (indigestion) and to provide symptomatic relief from heartburn and peptic ulceration. Thamicarb is also used to treat metabolic acidosis in patients with chronic kidney disease.
e Thamicarb Do not take Thamicarb: if you are allergic to sodium
bicarbonate or any of the other ingredients of this medicine (listed in section 6) if you have reduced stomach acid if you have low levels of potassium in the blood if you have low levels of chloride in the blood if you have low levels of calcium in the blood if you have a liver problem if you have toxaemia of pregnancy if you have problems with urination if you have excess sodium in the blood if you are under 12 years old
PIL/UK/MFG011/02/SMD/v1
Warnings and precautions: Talk to your doctor or pharmacist before taking Thamicarb: if you are on a salt-restricted diet if you have heart disease if you have high blood pressure or high blood pressure due to pregnancy if you suffer from kidney disease or kidney stones if you are taking steroids
Thamicarb with food and drink You can take Thamicarb before or after food as directed by your doctor or pharmacist. Do not take this medicine with large amounts of milk or milk products or calcium containing products. This may result in milk-alkali syndrome. Pregnancy and breast-feeding
Other medicines and Thamicarb Tell your doctor or pharmacist if you are taking or have recently taken any other medicine. This includes medicines obtained without a prescription, also herbal medicines. This is because Thamicarb can affect the way some other medicines work. Also, some other medicines can affect the way Thamicarb works: lithium
If you are pregnant or breast-feeding,
think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not use this medicine
during the first three months of pregnancy unless your doctor feels it is absolutely necessary.
aspirin and other salicylates
Driving and using machines
ACE inhibitors such as captopril, enalapril and fosinapril
Thamicarb does not affect the ability to drive or operate machinery.
antibacterials and anti fungals such
as azithromycin, cefaclor, cephadoxime, isoniazid, itraconazole, rifampicin, tetracyclines, ketoconazole and the quinoline group of antibacterials
antivirals such as atazanivir,
fosamprenavir and tipranavir
antihistamines such as fexofenadine bisphosphonates digoxin quinidine (used to treat e.g. heart
rhythm disorders)
dipyridamole antiepileptics such as gabapentin
and phenytoin
barbiturates such as phenobarbital ulcer healing drugs such as
lansoprazole
levothyroxine mycophenolate lipid regulating drugs such as
rosuvastatin
antipsychotics such as sulpiride,
phenothiazines
Thamicarb Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Doses Your doctor or pharmacist will determine what dose is appropriate for you. 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. For metabolic acidosis in chronic kidney failure Adults (including elderly) In the treatment of metabolic acidosis in patients with chronic renal failure, the dose will be determined by your doctor. Not recommended for use in children.
corticosteroids such as deflazacort
Like other antacid preparations, taking Thamicarb may mask the symptoms of other more serious underlying medical conditions like stomach cancer. If there has been no response for more than 7 days then consult with your doctor or pharmacist.
tricyclic antidepressants
Route and method of administration
sympathomimetics (used to treat
This medicinal product must be taken orally. Use the measuring syringe provided in the pack to deliver the required dose.
chloroquine hydrochloroquine penicillamine nilotinib
e.g. asthma, severe allergic reactions, sinusitis or attention deficit hyperactivity disorder)
anticholinergics (used to treat e.g.
asthma, Parkinson, motion sickness, abdominal cramps and urinary tract disorders)
TURN OVER
Instructions for the use of the oral syringe: a) Open the bottle: press the cap and turn it anticlockwise (figure 1). b) Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).
If you forget to take Thamicarb If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
d) Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).
For 500ml bottle: Discard your medicine 7 days after first opening.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Do not use this medicine if you notice that the solution has become discoloured or shows any signs of deterioration. Seek the advice of your pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor immediately if you experience:
e) Empty the contents of the syringe into the patient's mouth by pushing the piston to the bottom of the syringe (figure 7). The contents of the syringe should be emptied into the side cheek of the patient's mouth to avoid a choking hazard. Close the bottle with the plastic screw cap. Wash the syringe with water (figure 8).
7
If you take more Thamicarb than you should Call your doctor or go to your
nearest hospital casualty department straight away. Take the medicine pack with you. Overdose may make you feel ill.
belching or flatulence increased blood pressure fluid retention or fluid in the lungs frequent urge to urinate headache loss of appetite mood or mental changes nausea or vomiting nervousness or restlessness slow breathing swelling of feet or lower legs unpleasant taste unusual tiredness or weakness extreme irritability muscle spasms increased potassium in the blood increased thirst stomach cramps stomach discomfort bloating formation of kidney stones with prolonged use
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
c) Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upwards in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).
Do not use if crystals are observed in the product.
SyriMed, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK. If this leaflet is hard to see or read, please call +44(0) 208 515 3700 for help. This leaflet was last revised in 05/2020. Thamicarb is a registered trademark of Thame Laboratories.
Thamicarb Keep this medicine out of the sight and reach of children. Do not use after the expiry date which is stated on the carton or bottle after 'Exp'. The expiry date refers to the last day of that month. Do not store above 25°C. Do not refrigerate or freeze.
PIL/UK/MFG011/02/SMD/v1
For 100ml bottle: Discard your medicine 3 days after first opening.
Do not take a double dose to make up for a forgotten dose.
What Thamicarb contains The active substance is sodium bicarbonate. Each 1ml contains 84mg sodium bicarbonate (equivalent to 1mmol/ml sodium and bicarbonate). The other ingredient is purified water. What Thamicarb looks like and contents of the pack Thamicarb is a clear, colourless oral solution supplied in an amber glass bottle, with a tamper-evident, child-resistant white plastic cap with a 20ml oral syringe having 1ml graduation mark and an adaptor for the syringe. Thamicarb is supplied in a bottle containing 100ml or 500ml oral solution. Not all pack sizes may be marketed.
increased bicarbonate in the blood
POM
Reporting of side effects If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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. By reporting side effects you can help provide more information on the safety of this medicine.
Marketing Authorisation Holder and Manufacturer:
(metabolic alkalosis).
Thamicarb 84mg/ml Oral Solution comes as oral solution containing 84mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Thamicarb 84mg/ml Oral Solution is sodium bicarbonate.
Medicines with the same active substance, strength and form include: Sodium Bicarbonate 84 mg/ml Oral Solution. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Thamicarb 84mg/ml Oral Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Thamicarb is used to treat hyperacidity, dyspepsia and symptomatic relief of heartburn and peptic ulceration.
Thamicarb is also indicated for the treatment of metabolic acidosis in adults with chronic kidney disease.
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.
For metabolic acidosis in chronic kidney disease
Adults (including elderly)
Metabolic Acidosis : Dosage is calculated on an individual basis and administered according to the acid-base balance and electrolyte status.
Children
There is no experience using Thamicarb in the management of metabolic acidosis in children.
Method of administration
The required dose should be drawn from the container into the graduated syringe using the syringe adaptor (see section 6.6).
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.
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.
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 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.
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.
Ask anything about Thamicarb 84mg/ml Oral Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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