FOLIC ACID 400 MICROGRAMSTABLETS - Patient leaflet, side effects, dosage

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Patient leaflet - FOLIC ACID 400 MICROGRAMSTABLETS

Package leaflet: Information for the user

healthcare

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist told you.

– Keep this leaflet. You may need to read it again.
– Ask your pharmacist if you need more information or advice.
– 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.
– You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

1. What Folic Acid Tablets are and what they are used for
2. What you need to know before you take Folic Acid Tablets
3. How to take Folic Acid Tablets
4. Possible side effects
5. How to store Folic Acid Tablets
6. Contents of the pack and other information

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 use this medicines 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:

if you are allergic to folic acid or any of the other ingredients of this medicine (listed in section 6)
if you suffer from untreated ‘pernicious anaemia’ or Vitamin B12 (cobalamin) deficiency
if you have a folate dependant tumour (cancer affected by folic acid intake)
if you have cancer or a tumour (unless you have anaemia due to a deficiency of folic acid).

Warnings and precautions

Talk to your doctor or pharmacist before taking Folic Acid Tablets:

if you suffer from Vitamin B12 deficiency and have not been seen by your doctor, as your doctor will need to examine you and may wish to give you another medicine to take together with Folic Acid Tablets in order to treat this condition.
if you have pre-existing diabetes, are obese, have a family history of neural tube defects or have had a previous neural tube defect during pregnancy as your doctor may wish to prescribe a higher dose of folic acid for you.

Other medicines and Folic Acid Tablets

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

In particular tell your doctor if you are taking any of the following:

Antiepileptics (medicines used to treat epilepsy and fits) such as phenytoin, phenobarbital or primidone. Your doctor may need to change the amount of antieplieptic medicine you are taking because folic acid may reduce the effect these medicines.
Antibacterial (used to treat infections) e.g. chloramphenicol and co-trimoxazole.
Sulfasalazine, an anti-inflammatory drug used for the treatment of arthritis or inflammatory bowel disease, including ulcerative colitis or Crohn’s disease.
Methotrexate, a disease modifying anti rheumatic drug used to treat severe active rheumatoid arthritis, severe psoriasis and certain types of cancer.

Pregnancy and breast-feeding

Pregnancy

Folic Acid Tablets are intended for use before you become pregnant and during the first 12 weeks of pregnancy. If you think you are pregnant you should start taking Folic Acid Tablets. Folic acid is needed for the development of your baby’s spine and brain in the early weeks of pregnancy.

Breast-feeding

Folic Acid Tablets can be taken whilst 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 any medicine.

Driving and using machines

Folic Acid Tablets are not likely to affect your ability to drive or use machines.

3. HOW TO TAKE FOLIC ACID TABLETS

5. HOW TO STORE 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 or pharmacist.

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 or pharmacist.

This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme. Website at: 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.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton 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. Each tablet contains 400 micrograms (0.4 mg) of 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 Tablets are off-white to yellowish, round, bevelled-edged, convex tablets, 7 mm in diameter.

They are available in blister packs containing 30, 60 and 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Alissa Healthcare Research Limited, Unit 5, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, United Kingdom, PO15 7FE

Manufacturers

S.C. SANTA S.A.

Str. Carpatilor nr. 60, obiectiv nr. 47, 48, 58, 133

Brasov, jud. Brasov, cod 500269

Romania

This medicinal product is authorised in the Member States of the EEA under the following names:

Ireland Folic Acid 400 microgram Tablets

United Kingdom Folic Acid 400 microgram Tablets

This leaflet was last revised in 03/2021

2081 Folic Acid PIL.indd 2

05/03/2021 15:48

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is folic acid used for?

Folic acid is a B vitamin (B9) that is important for making DNA and other genetic material. It helps in cell division and is especially crucial during periods of rapid growth, such as during pregnancy.

Who should take folic acid supplements?

Folic acid supplements are recommended for women who are pregnant or planning to become pregnant, as well as individuals with certain medical conditions that can cause folate deficiency.

When should I start taking folic acid during pregnancy?

It is advisable to start taking folic acid at least one month before conception and continue through the first trimester of pregnancy.

Can I get enough folate from my diet alone?

While many people can get adequate folate from a balanced diet rich in fruits, vegetables, and whole grains, some may require supplements, especially during pregnancy.

Are there any side effects of taking folic acid 400 micrograms?

Folic acid is generally safe and well-tolerated. However, some may experience mild side effects like nausea or an upset stomach.

Is it safe to take folic acid if I'm not pregnant?

Yes, it is safe for non-pregnant individuals to take folic acid. It can help prevent folate deficiency and support overall health.

Can I take folic acid with other medications?

Folic acid can interact with certain medications. Always consult your healthcare provider before starting any new supplement if you are on medication.

What foods are rich in natural folate?

Natural sources of folate include leafy greens (like spinach), legumes (such as lentils), citrus fruits, nuts, and fortified cereals.

How does folic acid help prevent birth defects?

Folic acid helps prevent neural tube defects (NTDs) in developing babies by supporting healthy cell division during early fetal development.

Can I overdose on folic acid?

While high doses of folic acid are generally considered safe, excessive intake may mask vitamin B12 deficiency symptoms. Stick to the recommended dosage unless directed by a doctor.

What if I miss a dose of my folic acid tablet?

If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose and continue with your regular schedule.

Will taking folic acid improve my energy levels?

Folic acid supports overall health but is not specifically an energy booster. A balanced diet with adequate nutrients contributes more to energy levels.

What are the signs of folate deficiency?

Signs of folate deficiency include fatigue, weakness, irritability, headaches, and in severe cases, anemia.

Are there different forms of folate available?

Yes, there are different forms including natural food sources (folate) and synthetic supplements (folic acid). Folic acid is more stable and commonly used in supplements.

Can men benefit from taking folic acid?

Yes, men can benefit from taking folic acid as it supports overall health and may improve sperm quality.

Is it important to take the same brand of folic acid every time?

While it's not necessary to stick to the same brand, using one that you trust ensures consistent quality. Always check for quality certifications.

Does cooking affect the amount of natural folate in food?

Yes, cooking can reduce the amount of natural folate in foods. Steaming or microwaving vegetables can help preserve their nutrient content better than boiling.

How should I store my folic acid tablets?

Store your tablets in a cool, dry place away from direct sunlight. Keep them out of reach of children.

Can I take my folic acid tablet at any time of day?

Yes, you can take your folic acid tablet at any time of day; however, try to take it at the same time each day for better consistency.