Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Folic Acid Injection 5mg in 1mL. It does not contain all the available information. It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given Folic Acid Injection 5mg in mL against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor.

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

What Folic Acid Injection 5mg in 1mL is used for

Folic Acid Injection 5mg in 1mL is used to treat megaloblastic anaemia, when it has been caused by folic acid deficiency. It is also used to prevent folic acid deficiency during pregnancy and breast-feeding.

Folic acid belongs to a group of medicines called vitamins.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor’s prescription.

There is not enough information to recommend the use of this medicine for children.

Before you are given Folic Acid Injection 5mg in 1mL

When you must not be given it

You should not be given Folic Acid Injection 5mg in 1mL if you have an allergy to:

• any medicine containing folic acid
• any of the ingredients listed at the end of the leaflet
• any other similar medicines

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash itching or hives on the skin.

Do not give this medicine to children. The safety and effectiveness of Folic Acid Injection 5mg in 1mL in children have not been established.

You should not be given this medicine if your anaemia is caused by a vitamin B₁₂ deficiency.

You should not be given Folic acid Injection 5mg in 1mL if the solution is discoloured, cloudy, turbid, or a precipitate is present. The solution is normally a clear, light yellow solution.

The doctor or nurse will check to ensure the medicine is not past its expiry date and has not been tampered with.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• a cancer, which causes tumours.
• megaloblastic anaemia due to vitamin B₁₂ deficiency.
• hypersensitivity to folic acid.

Tell your doctor if you have any other medical conditions.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you are given Folic Acid Injection 5mg in 1mL.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket, health food shop, naturopath or herbalist.

Some medicines and Folic Acid Injection 5mg in 1mL may interfere with each other. These include:

• medicines used to treat epilepsy, such as anti convulsant drugs.
• multivitamin preparations
• large amounts of alcohol
• medicines used to treat cancer, such as methotrexate
• medicines used to treat infections, such as trimethoprim
• medicines used to prevent malaria, such as pyrimethamine
• medicines used to treat bowel disease, such as sulfasalazine.
• medicines used to treat high blood pressure.

These medicines may be affected by Folic Acid Injection 5mg in 1mL, or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor has more information on medicines to be careful with or avoid while being given Folic Acid Injection 5mg in 1mL.

How Folic Acid Injection 5mg in 1mL is given

Folic Acid Injection 5mg in 1mL must only be given by a doctor or nurse.

How it is given

Folic Acid Injection 5mg in 1mL is diluted in sterile water for injection.

It is usually given as an injection into a muscle but may also be injected into a vein or under the skin.

How much is given

Your doctor will decide what dose of Folic Acid Injection 5mg in 1mL you will receive and for how long you will receive it. This depends on your medical condition and other factors, such as your weight or age. Sometimes only a single dose is required.

If you are given too much (overdose)

As Folic Acid Injection 5mg in 1mL is always given to you in a hospital under the supervision of a doctor, it is unlikely that you will receive an overdose. Symptoms of an overdose are the same as the side effects but may be more severe. The symptoms of a side effect are listed under Side effects below.

If you notice any symptoms of an overdose immediately contact your doctor or go to the Emergency department at the nearest hospital.

Contact the Poisons Information Centre on 13 11 26 for further advice on overdose management.

While you are being given Folic Acid Injection 5mg in 1mL

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given Folic Acid Injection 5mg in 1mL.

Tell any other doctors, dentists, and pharmacists who treat you that you have been given this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you have been given this medicine. It may affect other medicines used during surgery.

If you become pregnant while being given this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are being given this medicine. It may interfere with the results of some tests.

Keep all your doctor’s appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things to be careful of

Be careful driving or operating machinery until you know how Folic Acid Injection 5mg in 1mL affects you.

Be careful when drinking alcohol while you are being given this medicine. This medicine may not work as well if you drink alcohol.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Folic Acid Injection 5mg in 1mL. This medicine helps most people with megaloblastic anaemia caused by folic acid deficiency, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by the following list of side effects, you may not experience any of them.

Ask your doctor to answer any questions you may have.

Tell your doctor or nurse if you notice any of the following and they worry you:

• nausea
• diarrhoea or wind
• rash
• irritability
• sleep disturbances.

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

If any of the following happen, tell your doctor or nurse immediately or go to the Emergency Department at your nearest hospital:

• difficulty breathing, wheezing or coughing
• change in heart rate or chest pain
• fits or seizures
• allergic reaction.

The above list includes some very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or nurse if you notice anything that is making you feel unwell. Other side effects not listed above may occur in some people.

After being given Folic Acid Injection 5mg in 1mL

Storage

Folic Acid Injection 5mg in 1mL will be stored in the surgery, pharmacy or ward of a hospital. The solution is kept below 25°C, protected from light.

Folic Acid Injection 5mg in 1mL will only be opened when it is time for you to have the injection.

Product description

What it looks like

Folic Acid Injection 5mg in 1mL is a clear, light yellow solution in an amber glass vial with a rubber stopper and aluminium seal with a plastic flip off cap.

Folic Acid Injection 5mg in 1mL is available in a 2mL vial.

Ingredients

Folic Acid Injection 5mg in 1mL contains 5mg in 1mL folic acid in water for injections. Sodium hydroxide and hydrochloric acid are added for pH adjustment when required.

This medicine does not contain lactose, sucrose, gluten, tartrazine, dyes or any preservatives.

Manufacturer

Folic Acid Injection 5mg in 1mL is made in Australia by:

Phebra Pty Ltd
19 Orion Road
Lane Cove West, NSW 2066
Australia

AUST R 22852

Phebra Product Code: INJ085

This leaflet was last amended in August 2013.

Phebra and the Phi symbol are trademarks of Phebra Pty Ltd

Version 06

Published by MIMS March 2016

1 Name of Medicine

Folic acid.

2 Qualitative and Quantitative Composition

Folic Acid Injection contains 5 mg of folic acid in water for injections to 1 mL.
Folic acid is a complex organic compound present in liver, yeast and natural sources. It also may be prepared synthetically. The pH range is 8.0-11.0.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Folic Acid Injection is a sterile solution. It is presented as 1 mL of solution in a 2 mL glass vial.

4 Clinical Particulars

4.1 Therapeutic Indications

Folic Acid Injection is indicated for the treatment of megaloblastic anaemia, where this has been shown to be due to folic acid deficiency either due to inadequate dietary intake, malabsorption or increased utilisation, including pregnancy and lactation, haemolytic anaemia, hyperthyroidism, exfoliative dermatitis and chronic infection. It is also indicated for prophylaxis during pregnancy and lactation.

4.2 Dose and Method of Administration

Folic Acid Injection is used for parenteral folic acid therapy, and may be administered, usually by intramuscular, or less commonly by intravenous or subcutaneous injection.
A dilute solution of folic acid containing 100 microgram/mL may be prepared by adding 1 mL (5 mg of folic acid) of the injection to 49 mL of sterile water for injection.
For treatment of megaloblastic anaemia in adults, 1 to 5 mg/day is recommended. Adjust the dosage according to the severity of the anaemia and to the presence or absence of malabsorption syndromes. For the treatment of megaloblastic anaemia in preterm infants less than 2 kg bodyweight, 100 to 200 microgram daily, orally or intramuscularly, should be used. Treating megaloblastic anaemia in infants 5-12 months of age, a satisfactory response has been obtained using 50 microgram daily, orally or intramuscularly.
The usual therapeutic dose in paediatric practice for the treatment of megaloblastic anaemia due to folic acid deficiency is 1 to 5 mg daily. This supraphysiological dosage can produce a partial haematological response in primary B₁₂ deficiency and therefore must not be used until B₁₂ deficiency has been excluded.
For prophylaxis in pregnancy and lactation, 500 microgram folic acid/day prevented signs of folic acid deficiency in well nourished pregnant women.
Folic Acid Injection should be used in one patient on one occasion only. It contains no antimicrobial preservative. Unused solution should be discarded.

4.3 Contraindications

Folic Acid Injection is contraindicated in patients who may be hypersensitive to it. Although rare, an anaphylactic reaction has been reported. Folic Acid Injection should not be prescribed for megaloblastic anaemia due to vitamin B₁₂ deficiency.

4.4 Special Warnings and Precautions for Use

Folic acid should not be added to multivitamin preparations as it may lower the concentration of vitamin B₁₂ in the blood.
Folic acid treatment may correct the haematological features of vitamin B₁₂ deficiency without correcting the progressive neurological damage due to vitamin B₁₂ deficiency. Therefore vitamin B₁₂ deficiency needs to be excluded before treatment with folic acid alone.
Patients receiving diphenylhydantoin treatment should be monitored for possible loss of seizure control following large doses of folic acid. Folic acid does not correct folate deficiency due to dihydrofolate reductase inhibitors, such as methotrexate. Folinic acid should be used for this purpose.
Caution is advised in patients who may have folate dependent tumours.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Folic acid affects the disposition of anticonvulsants. 15 mg of folic acid given intramuscularly decreased total serum diphenylhydantoin concentration by 15% without altering its unbound concentration, by increasing the urinary excretion of metahydroxy-diphenylhydantoin and diphenylhydantoin. A decrease in the steady-state plasma concentration and a decrease in the half-life for phenobarbitone have been reported following 30 mg of folic acid daily for 3 months in folate deficient epileptics.
Dihydrofolate reductase inhibitors such as methotrexate, trimethoprim and pyrimethamine prevent the reduction of folic acid to tetrahydrofolate.
Sulphasalazine has been reported to depress folic acid absorption.
Absorption of folic acid is decreased in chronic alcoholics. This effect can be partially reversed by abstinence from alcohol.
See Section 6.2 Incompatibilities.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Folic Acid Injection appears to be well tolerated, however nausea, flatulence, diarrhoea, irritability and sleep disturbances have been reported uncommonly (with 5 mg/day) along with isolated reports of rash and bronchospasm. EEG changes and convulsion have been reported with intravenous therapy. Although rare, an anaphylactic reaction has been reported.

Reporting suspected adverse effects.

4.9 Overdose

In a double blind randomised trial, 15 mg of folic acid per day for one month produced no signs of toxicity in healthy volunteers.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Folic Acid Injection contains 5 mg of folic acid, sodium hydroxide and hydrochloric acid for pH adjustment in water for injections to 1 mL.
The sodium content is approximately 34.5 mg/mL.

6.2 Incompatibilities

Folic acid is incompatible with oxidising and reducing agents and with ions of heavy metals.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG)¹. The expiry date can be found on the packaging.
¹ AUST R 22852.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

It is presented as 1 mL of solution in a 2 mL glass vial.
It is supplied in a carton containing 10 vials.
Phebra product code: INJ085.
The vial stopper is not made with natural rubber latex.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical name: (2S)-2-[[4-[[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino]benzoyl]amino]pentanedioic acid.
The molecular weight of the compound is 441.4. The molecular formula is C₁₉H₁₉N₇O₆.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes