Sodium Bicarbonate 8.4% w/v Solution for Injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• you are allergic to sodium bicarbonate or any of the other ingredients of this medicine (listed in section 6)
• your breathing is slower or more shallow than usual (hypoventilation)
• you have any blood abnormalities such as high levels of sodium, low levels of calcium, potassium or chloride, or your blood is less acidic than usual (your doctor will need to check this)
• you have high blood pressure
• you have kidney failure
• you have heart failure
• you suffer from fluid retention

If any of the above apply to you please tell your doctor or nurse before you are given Sodium Bicarbonate Injection.

Talk to your doctor, pharmacist or nurse before you are given Sodium Bicarbonate Injection.

Your doctor or nurse may want to regularly check your blood acid levels during the course of treatment with this medicine.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Talk to your doctor if you are taking:

• corticosteroids or corticotropin (medicines used to reduce swelling or to treat hormone problems)
• medicines of an acidic nature (e.g. tetracycline, doxycycline or methenamine)
• quinidine, flecainide (medicines used to treat heart problems)
• amphetamines (medicines used to treat certain mental disorders and drowsiness)
• ephedrine and pseudoephedrine (medicines used to treat colds and asthma)
• potassium supplements
• medicines used to treat water retention and problems with passing urine such as ethacrynic acid, bumetanide, thiazides or frusemide
• medicines used to treat high blood pressure (e.g mecamylamine)
• medicines used to treat Alzheimers disease (e.g. memantine)
• medicines used to treat diabetes mellitus (e.g. chlorpropamide)
• medicines used to treat mood disorders (e.g. lithium)
• aspirin (acetylsalicylic acid)

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.

Sodium Bicarbonate Injection will only be given to you if your doctor considers the treatment necessary.

This medicine is unlikely to affect your ability to drive or use machines.

This medicine contains 23 mg sodium (main component of cooking/table salt) in each mL. This is equivalent to 1.15% of the recommended maximum daily dietary intake of sodium for an adult.

• The usual starting dose is 1 mmol for every kg you weigh
• Followed by 0.5 mmol/kg given at 10-minute intervals

• The usual dose is 1 mmol for every kg you weigh given by slow intravenous injection
• The medicine should be diluted 1:1 with 5% dextrose for premature infants and new-borns.

As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much. However, if you think you have been given too much of this medicine, please tell your doctor.

Signs of too much sodium bicarbonate include hyperventilation (over-breathing), sensitivity to slight stimuli, twitching and high potassium levels in your blood which may cause you to feel dizzy or tired.

• Low levels of potassium causing twitching, muscle weakness, ‘pins and needles’ in the hands or feet, irritability or abnormal heart rhythm
• Low levels of blood sugar and high concentration of sodium in the blood causing feeling hungry, thirsty, nervous, confused, extreme irritation, increased urination, shakiness or sweating
• Too much acid in the blood, which many cause an increased rate of breathing (intracellular acidosis)
• A blood disorder consisting of an increase in the volume of circulating blood
• Low levels of calcium causing involuntary contraction of your muscles
• Swelling due to a build-up of fluid under the skin
• New born babies may have bleeding inside the skull
• Sodium bicarbonate may leak out of the veins into the surrounding tissue. This may cause pain, redness or irritation to the skin
• If the medicine is not correctly injected it could cause the skin to die around the injection site.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme 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 1 mL solution for injection contains 84 mg sodium bicarbonate.
• The other ingredients are disodium edetate and Water for Injections.

Sodium Bicarbonate Injection is a clear and colourless aqueous solution supplied in 10 mL glass ampoules. Each pack contains 10 ampoules.