Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Folic Acid 5mg Tablets

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Folic acid may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Folic acid

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

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

Folic acid Tablets can also be given to some women before and during pregnancy to prevent spina bifida (an abnormality of the spine) in babies, which can be caused by deficiency of this vitamin.

What you need to know before you take it

E FOLIC ACID TABLETS

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

  • if you are undergoing haemodialysis due to kidney failure
  • if you are receiving a coronary stent (a tube that is inserted in the artery that leads to the heart, in order to stop blockages)
  • if you suffer from pernicious anaemia (a disorder preventing the absorption of vitamin B12) or could be suffering from a lack of vitamin B12
  • if you have a tumour. Care needs to be taken in patients with certain tumours.

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).
  • if you have cancer (unless you have anaemia due to a deficiency of folic acid)

Driving and using machinery This medicine should not affect your ability to drive a car or operate machinery. Folic Acid Tablets contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take it

FOLIC ACID TABLETS Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Your doctor will decide the right dose for you; this will be on the pharmacist's label. Check this carefully, it will tell you how much of this medicine to take and how often to take it. This medicine should be swallowed. Unless told otherwise, take your tablet with water.

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Process Black

PRODUCT : CUSTOMER : FP CODE: PLANT LOCATION : DIMENSIONS : PHARMACODE No. : ITEM CODE No. : TEXT FONT SIZE : FILE NAME : SOFTWARE : TYPEFACES : ARTWORK (DETAILS) RECEIVED ON : PROOF REVISION :

Folic Acid 5mg – 28 Tabs Wockhardt UK FP2033 For alternative UK supply (w)148 x (h)210mm 625 11001908 8pt. Folic Acid 5mg_Lit_UK_107289-4.ai Adobe Illustrator CS5 Myriad Pro Regular / Bold 24th May & 7th June, 2018 R 1st PDF sent on – 7TH JUNE 2018

CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Changes in detail: • Regulatory text amends

Non-Regulatory

Possible 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.

How to store it

FOLIC ACID TABLETS Keep out the sight and reach of children.

Folic Acid Tablets are available in:

  • polypropylene or polyethylene tablet containers containing 100, 500 or 1,000 tablets
  • glass bottles containing 100, 500 or 1,000 tablets
  • blister packs containing 28 tablets.

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As can happen with any medicine, a few people may develop an allergic reaction (hypersensitivity) or a severe allergic reaction (anaphylactic reaction). If you experience any of the following, seek medical help immediately:

  • itchy/red skin, rash, swelling of the face, lips, tongue or throat or difficulty breathing or swallowing, shock (cold sweaty skin, weak pulse, dry mouth, dilated pupils; dizziness; weakness and/or fainting).

What Folic Acid Tablets look like and contents of the pack Folic Acid Tablets are plain yellow, biconvex tablets with a breakline on one face and CP on the reverse.

Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK. Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK. Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only). Please be ready to give the following information: Product name

Reference number

Folic Acid 5mg Tablets

29831/0097

This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in 05/2018.

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Like all medicines, this medicine can cause side effects, although not everybody gets them.

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If you take more Folic Acid Tablets than you should If you (or anybody else, including a child), takes more Folic Acid Tablets than you should, it is unlikely that this medicine will cause any harm. If you are at all concerned contact your doctor. Always take the carton and this leaflet with you.

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.

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Prevention of spina bifida: One tablet a day, starting before conception and continuing for the first three months of pregnancy.

Do not take after the expiry date on the container (bottle label or carton) or if the tablets show signs of 'going off' such as discolouration. The expiry date refers to the last day of the month.

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Children less than 1 year of age: 500 micrograms per kilogram of body weight daily.

Do not store above 25°C. Store in the original container in order to protect from light.

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The recommended doses are as follows: Anaemia Adults and children over 1 year: One tablet a day for the treatment of anaemia or one tablet everyone to seven days for the prevention of anaemia (depending on diet and underlying disease).

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Contents of the pack and other information

If you forget to take Folic Acid Tablets If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. Do not take a double dose to make up for a forgotten dose.

What Folic Acid Tablets contain The active substance is folic acid. The tablet comes in one strength, 5mg.

4. POSSIBLE SIDE EFFECTS

The other ingredients are: lactose, maize starch, acacia spray-dried, magnesium stearate and stearic acid.

The side effects that some patients have had with Folic Acid Tablets are:

  • loss of appetite (anorexia)
  • feeling sick
  • bloating of the stomach
  • flatulence (wind)
  • worsening of the symptoms of vitamin B12 deficiency. Folic acid should never be used to treat anaemia without a full investigation of the cause. 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

Frequently asked questions about Folic Acid 5mg Tablets

How do I take Folic Acid 5mg Tablets?

Folic Acid 5mg Tablets comes as tablet containing 5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Folic Acid 5mg Tablets?

The active substance in Folic Acid 5mg Tablets is folic acid.

Are there equivalent medicines to Folic Acid 5mg Tablets?

Medicines with the same active substance, strength and form include: Folic Acid Tablets 5mg. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Folic Acid 5mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Folic Acid 5mg Tablets without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Folic acid (9 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Folic acid is indicated for the treatment of megaloblastic anaemia due to folic acid deficiency. It is also used for prophylaxis in chronic haemolytic states, in renal dialysis, and in drug induced folate deficiency.

Folic acid is used for the prevention of recurrence of neural tube defects.

4.2. Posology and method of administration

Posology

Adults

In folate deficient megaloblastic anaemia:

5mg daily for 4 months

Up to 15mg daily may be necessary for malabsorption states

For prophylaxis in chronic haemolytic states or in renal dialysis:

5mg every 1-7 days depending on diet and underlying disease.

In drug induced folate deficiency:

5mg daily

Prevention of recurrence of neural tube defects

5mg daily starting before conception and continuing throughout the first trimester of pregnancy is recommended.

Paediatric population

Over 1 year : As adult dose

Up to 1 year: 500µg/kg daily

Method of administration

The tablets are for oral use.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Patients with malignant disease, unless megaloblastic anaemia due to folic acid deficiency.

4.4. Special warnings and precautions for use

Folic acid should not be administered for treatment of pernicious anaemia or undiagnosed megaloblastic anaemia without sufficient amounts of cyanocobalamin (vitamin B12) as folic acid alone will not prevent and may precipitate development of subacute combined degeneration of the spinal cord. Therefore a full clinical diagnosis should be made before initiating treatment.

Folate should not be routinely used in patients receiving coronary stents.

Caution should be exercised when administering folic acid to patients who may have folate dependent tumours.

Folic acid is removed by haemodialysis.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5. Interaction with other medicinal products and other forms of interaction

Absorption of folic acid may be reduced by sulfasalazine.

Concurrent administration with cholestyramine may interfere with folic acid absorption. Patients on prolonged cholestyramine therapy should take folic acid 1 hour before or 4 to 6 hours after receiving cholestyramine.

Antibiotics may interfere with the microbiological assay for serum and erythrocyte folic acid concentrations and may cause falsely low results.

Trimethoprim or sulfonamides, alone or in combination as co-trimoxazole, may reduce the effect of folic acid and this may be serious in patients with megaloblastic anaemia.

Serum levels of anticonvulsant drugs (phenytoin, phenobarbital, primidone) may be reduced by administration of folate and therefore patients should be carefully monitored by the physician and the anticonvulsant drug dose adjusted as necessary.

Fluorouracil toxicity may occur in patients taking folic acid and this combination should be avoided.

Edible clay or antacids containing aluminium or magnesium may reduce folic acid absorption. Patients should be advised to take antacids at least two hours after administration of folic acid.

Folic acid may reduce intestinal absorption of zinc (of particular importance in pregnancy).

4.6. Fertility, pregnancy and lactation

Pregnancy

Folic acid deficiency during pregnancy may lead to the appearance of foetal malformations. Imbalance in folate requiring trophoblast cells may also lead to detachment of the placenta.

Very high doses of folic acid have been shown to cause foetal abnormalities in rats; however, harmful effects in the human foetus, mother or the pregnancy have not been reported following ingestion of folic acid.

Breastfeeding

Folic acid is excreted in breast milk.

No adverse effects have been observed in breast-fed infants whose mothers were receiving folic acid.

4.7. Effects on ability to drive and use machines

None known

4.8. Undesirable effects

Folic acid is generally well tolerated although the following side effects have been reported:

Blood and lymphatic system disorders:

Folic acid may worsen the symptoms of co-existing vitamin B12 deficiency and should never be used to treat anaemia without a full investigation of the cause.

Immune system disorders:

Rare: Allergic reactions, comprising erythema, rash, pruritus, urticarial, dyspnoea, and anaphylactic reactions (including shock).

Gastrointestinal disorder:

Abdominal distension, flatulence, anorexia and nausea.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.

4.9. Overdose

No cases of acute overdosage appear to have been reported, but even extremely high doses are unlikely to cause harm to patients. No special procedures or antidote are likely to be needed.

💬 Ask about this leaflet

Ask anything about Folic Acid 5mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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