PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Bicarbonate 1.26% solution for infusion

Sodium Bicarbonate 1.4% solution for infusion

Sodium Bicarbonate 2.74% solution for infusion

Sodium Bicarbonate 4.2% solution for infusion

Sodium Bicarbonate 8.4% solution for infusion

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    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.

What is in this leaflet:

1.    What Sodium Bicarbonate infusion is and what it is used for

2.    What you need to know before you are given Sodium Bicarbonate infusion

3.    How you are given Sodium Bicarbonate infusion

4.    Possible side effects

5.    How Sodium Bicarbonate infusion is stored

6.    Contents of the pack and other information

1. What Sodium Bicarbonate Infusion is and what is it used for

Sodium Bicarbonate Infusion is an intravenous infusion (into a vein). Sodium Bicarbonate Infusion is used when your blood and urine contain too much acid.

The full names of the medicines covered by this leaflet are:

Sodium Bicarbonate 1.26% solution for infusion Sodium Bicarbonate 1.4% solution for infusion Sodium Bicarbonate 2.74% solution for infusion Sodium Bicarbonate 4.2% solution for infusion Sodium Bicarbonate 8.4% solution for infusion

In this leaflet they are jointly referred to as Sodium Bicarbonate Infusion.

2. What you need to know before you are given Sodium Bicarbonate Infusion

You should not receive Sodium Bicarbonate Infusion if you:

•    suffer from high blood pressure (hypertension)

•    suffer from kidney disease

•    suffer from heart disease

•    have fluid in the lungs (pulmonary oedema)

•    have above normal pH levels in your body (respiratory or metabolic alkalosis)

•    are overbreathing (hyperventilating)

•    have high levels of sodium in your blood (hypernatraemia)

•    have complications in your pregnancy called eclampsia (symptoms include: convulsions, increased blood pressure, circulatory problems, severe headaches, vision problems, pain in the upper abdomen, vomiting, sudden swelling of your feet, ankles, face and hands and excessive weight gain).

Warnings and precautions

Sodium Bicarbonate Infusion must be given directly into a vein and not into body tissue.

Patients receiving resuscitation may risk the possibility of fluid in their lungs if they are given Sodium Bicarbonate Infusion.

Prolonged use of sodium bicarbonate should be avoided because it may cause hypokalaemia (condition in which the body fails to retain sufficient potassium levels)

The doctor or nurse will check that the solution is free from particles before use.

Other Medicines and Sodium Bicarbonate Infusion

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

The following drugs should not be mixed with Sodium Bicarbonate Infusion:

•    Vitamin c (ascorbic acid)

•    benzylpenicillin, oxytetracycline, tetracycline, streptomycin, vancomycin (antibiotics)

•    calcium chloride

•    calcium gluconate (used in effervescent calcium tablets)

•    calcium salts of drugs

•    carmustine, cisplatin (used in chemotherapy)

•    codeine phosphate (painkiller, anti-diarrhoeal

•    adrenaline, corticotrophin, noradrenaline (hormone)

•    dobutamine (used for heart disease)

•    insulin (used in treatment of diabetes)

•    labetalol (high blood pressure)

•    levorphanol, pethidine, morphine sulphate (used to treat severe pain)

•    magnesium salts

•    methadone (used in the treatment of drug addiction)

•    pentobarbitone (tranquilizer and anticonvulsive medicine)

•    procaine (a local anesthetic drug)

•    suxamethonium (muscle relaxant)

•    vitamin B complex with c

•    lithium (used in the treatment of mania, antidepressant)

•    hexamine based drugs (urinary antiseptics)

•    amphetamine (prescription stimulant used to treat attention-deficit hyperactivity disorder (ADHDD

•    quinidine (antiarrhythmic agent)

•    quinine (fever-reducing, painkiller and anti-inflammatory medicine)

If you are unsure whether you are taking one of the above drugs, ask your doctor or pharmacist. These medicines may be affected by sodium bicarbonate or may affect how well it works.

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.

Sodium Bicarbonate Infusion is considered safe to use during pregnancy and breastfeeding.

Driving and using machines

Sodium Bicarbonate Infusion should not affect your ability to drive or operate machinery.

3.    How you are given Sodium Bicarbonate Infusion

Sodium Bicarbonate Infusion will be given to you in hospital by a healthcare professional via intravenous infusion (into a vein).

The amount and rate at which the infusion is given depends on your requirements.

Your doctor will decide on the correct dose for you

If you receive more Sodium Bicarbonate Infusion than you should It is very unlikely that you will receive more infusion than you should.

If you suspect that you received too much sodium bicarbonate you should immediately inform your doctor describing the symptoms. Excessive amounts of infused Sodium Bicarbonate Infusion may result in:

•    abnormally fast breathing (hyperpnoea)

•    nausea (feeling sick)

•    convulsions (fits)

If Sodium Bicarbonate Infusion is administered too quickly it may result in chemical imbalance in the body (hyperosmolarity).

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Sodium Bicarbonate Infusion can cause side effects, although not everybody gets them.

Thrombosis (the formation of a clot) may occur in the vein where the infusion is given. The symptoms of thrombosis include:

•pain, swelling and redness at the blood clot site.

•an itchy rash at the clot site •warm skin around the clot •a mild fever

•major veins that stand out from your skin.

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 at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How Sodium Bicarbonate Infusion is stored

Keep out of the sight and reach of children.

Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Sodium Bicarbonate Infusion.

Sodium Bicarbonate Infusion should be stored between 2°C and 25°C. The solutions must not be used after the expiry date shown on the label. The expiry date refers to the last day of that month.

Any solution remaining after treatment should be disposed of via approved hospital procedures.

6.    Contents of the pack and other information

What Sodium Bicarbonate Infusion contains

Sodium Bicarbonate Infusions contain:

Sodium Bicarbonate

The concentration of sodium bicarbonate in the infusion can be seen

in the name of the product. The following concentrations are available:

Sodium Bicarbonate 1.26% solution for infusion

Sodium Bicarbonate 1.4% solution for infusion

Sodium Bicarbonate 2.74% solution for infusion

Sodium Bicarbonate 4.2% solution for infusion

Sodium Bicarbonate 8.4% solution for infusion

The infusions also contain water for injections, disodium edetate, carbon dioxide.

What Sodium Bicarbonate Infusions look like and contents of the pack

Sodium Bicarbonate Infusions come in a sealed semi-rigid, cylindrical plastic container with a 'Twist-off' seal at one end and a ring tab at the opposite end. The solutions are available in 500ml size. Sodium Bicarbonate Intravenous Infusion BP 8.4% is available in 200 ml size.

Marketing authorisation holder

Fresenius Kabi Limited Cestrian Court Eastgate Way Manor Park Runcorn Cheshire WA71NT UK

Manufacturer:

Terumo BCT Limited,

Old Belfast Road, Millbrook,

Larne, Co. Antrim, BT40 2SH. UK.

This leaflet was last revised in September 2014.