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FOLIC ACID TABLETS BP 5 MG - patient leaflet, side effects, dosage

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Patient leaflet - FOLIC ACID TABLETS BP 5 MG

LABORATORIES


Title: Folic Acid Tablets 5 mg PIL

Colours

Colours

Ref: D-FA

rne

Black

Guides

Date: 30/06/20

Process

SPECIAL

Size (mm): 297(H) x 148(W)

Modified: 30/06/20

Folded to 37 × 148


Package leaflet: Information for the user

=Folic Acid Tablets BP 5 mg

This medicine will be called Folic Acid Tablets in this leaflet.


Read all of this leaflet carefully before you start taking 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, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • 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.

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 belongs to the Vitamin B group. It is necessary for the normal production of blood cells. Folic Acid Tablets may be used:

To treat:

  • Folate deficiency anaemia caused by poor diet, poor absorption of food (such as in coeliac disease or a digestive disorder called sprue) or increased use of folate in the body (as in pregnancy)

To prevent:

  • Folate deficiency caused by some medicines (e.g. those used to treat epilepsy such as phenytoin, phenobarbital and primidone)
  • Folate deficiency caused by long-term red blood cell damage or kidney dialysis
  • Neural tube defects in babies (e.g. spina bifida), where women are at risk of having an affected child.

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 to any of the other ingredients of this medicine (listed in section 6)
  • You have an untreated vitamin B12 deficiency such as in certain anaemias and lifelong vegetarians
  • You are suffering from pernicious anaemia or another condition caused by vitamin B12 deficiency
  • You have cancer.

Warnings and precautions

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

  • You have a folate dependent tumour
  • You are pregnant
  • You 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, including medicines obtained without a prescription or other vitamin supplements. Especially:

  • Medicines for epilepsy e.g. carbamazepine, phenytoin, primidone, sodium valproate or phenobarbital (the dose of these drugs may need to be adjusted)
  • Sulfasalazine, used to treat some inflammatory conditions including rheumatoid arthritis, Crohn’s disease or _____

ulcerative colitis

  • Triamterene, a diuretic used to treat raised blood pressure and oedema
  • Methotrexate, a cancer drug which can also be used to treat psoriasis and rheumatoid arthritis
  • Antibacterials (to treat infections) such as trimethoprim, chloramphenicol and co-trimoxazole
  • Aspirin
  • Drugs containing lithium, used to treat depression
  • A general anaesthetic (a gas and air mixture to put you to sleep for an operation or to relieve pain while you are awake)
  • Alcohol.

Pregnancy and breastfeeding

If you are pregnant or breast feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machinery

Folic Acid Tablets should not affect your ability to drive or operate machinery.

Folic Acid Tablets contain lactose and sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Folic Acid Tablets

Always take Folic Acid Tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed with a drink of water.

The recommended doses are:

Adults (including the elderly):

  • To treat folate deficiency anaemia:

5 mg (1 tablet) a day for 4 months, which may be increased up to a maximum of 15mg (3 tablets) a day.

  • To prevent folate deficiency caused by some medicines:

5 mg (1 tablet) a day for 4 months, which may be increased up to a maximum of 15mg (3 tablets) a day.

  • To prevent folate deficiency caused by long-term red blood cell damage or kidney dialysis:

5mg (1 tablet) every 1 –7 days.

  • To prevent neural tube defects in babies, where women are at risk of having an affected child:

5 mg (1 tablet) a day started before conception and continued throughout the first three months.

  • To treat folate deficiency during pregnancy:

5mg (1 tablet) a day continued to birth.

Continued, please turn over.

Use in children and adolescents:

For young children a more suitable form of the medicine should be used.

  • To treat folate deficiency anaemia:

Children 1–18 years old: 5mg (1 tablet) a day for 4 months. The maintenance dose is 5mg (1 tablet) every 1 –7 days.

  • To treat haemolytic anaemia and metabolic disorders:

Children 1–12 years old: 2.5mg-5mg (half to 1 tablet) once a day.

Children 12–18 years old: 5–1 Omg (1 to 2 tablets) once a day.

  • To prevent folate deficiency in kidney dialysis:

Children 1–12 years old: 250 micrograms per kg of body weight (up to a maximum of 10mg) once a day.

Children 12–18 years old: 5–1 Omg (1 to 2 tablets) once a day.

If you take more Folic Acid Tablets than you should

If you have taken more tablets than you should, speak to your doctor or pharmacist straightaway or contact your nearest hospital casualty department. Take your tablets or the pack with you so they know what you have taken.

If you forget to take a dose of Folic Acid Tablets

If you miss a dose don’t worry. Miss this dose and carry on with the normal routine.

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.

Stop taking the tablets and tell your doctor if you experience the following effects:

Rare: may affect up to 1 in 1,000 people

  • Allergic reactions which can include itchy red skin, rash, hives, breathlessness.

Not known: frequency cannot be estimated from the available data

  • Severe allergic reaction (anaphylactic reaction) symptoms may include swelling of the face, lips, tongue or throat, difficulty breathing, dizziness, shock.

Other rare effects which have been reported are:

  • Nausea (feeling sick), loss of appetite
  • Bloated or swollen stomach or abdomen, wind.

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

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 shown on the carton or label which is stated after EXR The expiry date refers to the last day of that month.

Blisters: Do not store above 25°C. Store in the original package.

Containers: Do not store above 25°C. Keep the container tightly closed.

If you stop taking the tablets, please take any left over back to your pharmacist to be destroyed. 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 contain

The active substance is folic acid. Each tablet contains 5mg of the active substance. The other ingredients are lactose, pregelatinised maize starch, sucrose and stearic acid.

What Folic Acid Tablets look like and contents of the pack

The tablets are round and yellow with no markings. They are supplied to your pharmacist in packs of 28, 50, 56, 100, 500 or 1000 tablets. Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer:

The Marketing Authorisation Holder is Dalkeith Laboratories Ltd., 2 Park Street, Woburn, Bedfordshire, MK17 9PG, UK. Manufactured by Surepharm Services Ltd., Bretby, Burton upon Trent, Staffs, DE15 0YZ, UK.

Product Licence Number: PL 17496/0017

This leaflet was last revised in July 2020.

If you would like the leaflet in a different format, please contact the marketing authorisation holder above.