Folic Acid 0.4 mg Tablets – patient leaflet, side effects, dosage

1. What Folic Acid Tablets are and what they are used for

Folic acid is a member of the Vitamin B group it is the active ingredient of Folic Acid Tablets. It is essential for good health and is present in fresh and processed foods.

You should also use this medicine if you are trying to become pregnant or think you are pregnant and also for the first three months of your pregnancy.

Folic acid is necessary for the development and growth of healthy cells and tissues. It is vital for the development and proper function of the central nervous system.

Folic acid is used to help prevent babies being born with neural tube defects such as Spina Bifida. The neural tube is part of the nervous system and is located in the spine. The baby’s neural tube develops during the early stages of pregnancy and it is at this particular critical stage that neural tube defects such as Spina Bifida can occur.

2. What you need to know before you take Folic Acid Tablets

Do not take Folic Acid Tablets and tell your doctor if you have:

• an allergy (hypersensitivity) to folic acid or any of the other ingredients of this medicine (listed in section 6)
• an untreated vitamin B12 deficiency such as in certain anaemias and lifelong vegetarians • pernicious anaemia (a form of anaemia caused by lack of vitamin B12) or another condition caused by vitamin B12 deficiency • a malignant (cancerous) disease.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Folic Acid tablets if you:

• have a folate dependent tumour
• are pregnant
• have any disease that reduces the amount of vitamin B12 in the body.

Other medicines and Folic Acid Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines obtained without a prescription. Especially

• antiepileptics (to treat epilepsy) such as phenytoin, phenobarbital, primidone, sodium valproate and carbamazepine.

• lithium for mental health problems. • aspirin for pain relief or to thin your blood. • antibacterials (to treat infections) such as trimethoprim, chloramphenicol or

  co-trimoxazole.

• methotrexate (to treat Crohn's disease, psoriasis or rheumatoid arthritis).

  • sulphasalazine (to treat ulcerative colitis, Crohn's disease or rheumatoid arthritis). • triamterene, a diuretic (or 'water tablet'). • alcohol.

  • a gas and air mixture to put you to sleep for an operation or to relieve pain while you are awake.

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.

3. How to take Folic Acid Tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Women planning a pregnancy or who are in the first three months of pregnancy:

The recommended dose is one tablet (400 micrograms) daily. The tablet should be swallowed with water.

You should begin taking this medicine before you become pregnant or if you think you are pregnant and continue taking it for at least the first 12 weeks of pregnancy.

If you take more Folic Acid Tablets than you should

If you take too many tablets you should contact your doctor, however large doses of folic acid are unlikely to cause harm.

If you forget to take Folic Acid Tablets

If you forget to take a dose, take it as soon as you remember. If it is nearly 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, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following serious side effects, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department:

• severe allergic reaction (anaphylactic reaction); signs of which may include itchy/red skin, rash, sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse. The frequency of such reactions is not known (frequency cannot be estimated from the available data).

Other possible side effects include

Rare (may affect up to 1 in 1,000 people): • loss of appetite

• feeling and/or being sick
• bloating of the stomach
• flatulence (wind).

Reporting of side effects

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.

5. How to store Folic Acid Tablets

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiry date that is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.

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 Folic Acid Tablets contains

• The active substance is Folic acid hydrate. Each 0.4 mg tablet contains 0.4 mg Folic Acid (as Folic acid hydrate).

• The other ingredients are

  Hydroxypropylcellulose, Croscarmellose sodium, Cellulose, microcrystalline, Silica, colloidal anhydrous and Stearic acid. What Folic Acid Tablets looks like and contents of the pack

• Folic Acid 0.4 mg Tablets are off-white to yellowish, round, bevelled-edged, convex tablet with a diameter of 7 mm.

• The product is available in pack sizes of;

  • PVC/PVdC/Aluminium foil blister packs, Blister packs contained in a carton together with the patient information leaflet. Blister packs are sold in pack of 20, 28, 30, 50, 56, 60, 90 and 100 tablets. - HDPE bottles with caps in packs of 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Orbit Pharma Limited

128 City Road, London

United Kingdom, EC1V 2NX

Manufacturer

SANTA S.A.

Str. Panselelor, nr. 25, nr. 27 si nr. 29, Municipiul Brasov, Judet Brasov,

cod postal 500419, Romania

Distributor

Novumgen Limited

G-34, Suite F, Breakspear Park,

Breakspear Way, Hemel Hempstead, HP2 4TZ, United Kingdom

This leaflet was last revised in January 2026.