What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL39307/0005.

Thamicarb 84mg/ml Oral Solution

Package leaflet: Information for the user

Thamicarb™ 84mg/ml Oral Solution

(sodium bicarbonate)

(1mmol/ml sodium)

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Thamicarb 84mg/ml Oral Solution but it will be referred to as Thamicarb throughout this leaflet.

In this leaflet:

1. What Thamicarb is and what it is used for
2. What you need to know before you take Thamicarb
3. How to take Thamicarb
4. Possible side effects
5. How to store Thamicarb
6. Contents of the pack and other information

1. What Thamicarb is and what it is used for

Thamicarb contains 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.

2. What you need to know before you take Thamicarb

Do not take Thamicarb:

  • if you are hypersensitive to sodium bicarbonate
  • 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 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

Warnings and precautions:

Talk to your doctor or pharmacist before taking Thamicarb:

  • if you are on salt-restricted diet
  • if you have heart disease
  • if you have high blood pressure and high blood pressure due to pregnancy
  • if you suffer from kidney disease or kidney stones
  • if you are taking steroids

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
  • aspirin and other salicylates
  • ACE inhibitors such as captopril, enalapril and fosinapril
  • antibacterials and anti fungals such as azithromycin, cefaclor, cephadoxime, isoniazide, itraconazole, rifampicin, tetracyclines, ketoconazole and the quinoline group of antibacterial
  • antiviral as such as atazanivir, fosamprenavir and tipranavir
  • antihistamines such as fexofenadine
  • bisphosphonates
  • digoxin
  • 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
  • chloroquine
  • hydrochloroquine
  • penicillamine
  • nilotinib
  • corticosteroids such as deflazacort

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. This may result in milk-alkali syndrome.

Pregnancy and breast-feeding

  • 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.

Driving and using machines

Thamicarb does not affect the ability to drive or operate machinery.

Important information about some of the ingredients of Thamicarb

Thamicarb contains 23mg sodium per ml.

To be taken into consideration by patients on a controlled sodium diet.

3. How to take 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.

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.

Taking your medicine

Use the measuring syringe provided in the pack to deliver the required dose.

1. Open the bottle: press the cap and turn it anticlockwise.

2. Separate the adaptor from the syringe. Insert the adaptor into the bottle neck. Ensure it fits well.

3. Take the syringe and put it in the adaptor opening. Turn the bottle upside down.

4. 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 quantity in millilitres (ml) prescribed by your healthcare provider. Turn the bottle the right way up. Remove the syringe from the adaptor.

5. Empty the contents of the syringe into the mouth by pushing the piston to the bottom of the syringe. Close the bottle with the plastic screw cap.

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

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.

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.

  • Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience:

  • 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

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.

5. How to store 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. Do not use if crystals are observed in the product.

For 100ml bottle:

Discard your medicine 3 days after first opening.

For 500ml bottle:

Discard your medicine 7 days after first opening.

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.

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.

6. Contents of the pack and other information

What Thamicarb contains

The active substance is sodium bicarbonate.

Each 1ml contains 84mg sodium bicarbonate (equivalent to 1mmol/ml sodium).

The other ingredient is purified water.

What Thamicarb looks like and contents of the pack

Thamicarb is a clear, colourless oral solution. It comes in an amber glass bottle with a white tamper-evident child-resistant plastic cap.

Pack size: 100ml or 500ml

The pack also contains 20ml white oral syringe with 1ml graduation marks and a syringe adaptor.

P

Marketing Authorisation Holder and Manufacturer:

Thame Laboratories
Unit 4
Bradfield Road
Ruislip
Middlesex
HA4 0NU
UK

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom: Thamicarb 84mg/ml Oral Solution

Ireland: Thamicarb 84mg/ml Oral Solution

If this leaflet is hard to see or read, please call +44(0) 208 515 3700 for help.

This leaflet was last revised in 02/2018.

Thamicarb is a registered trademark of Thame Laboratories.

PIL/UK/MFG011/02/V8