Thamicarb 84mg/ml Oral Solution

• 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 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

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

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, 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
• chloroquine
• hydrochloroquine
• penicillamine
• nilotinib
• corticosteroids such as deflazacort
• tricyclic antidepressants
• sympathomimetics (used to treat 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)

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.

• 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.

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

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.

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.

This medicinal product must be taken orally.

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

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).

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).

d) Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).

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).

• 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 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.

• 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
• increased bicarbonate in the blood (metabolic alkalosis).

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.

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.

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.

POM