Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
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.
E FOLIC ACID TABLETS
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Warnings and precautions Talk to your doctor or pharmacist before taking Folic Acid Tablets:
Do not take Folic Acid Tablets:
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.
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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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
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.
FOLIC ACID TABLETS Keep out the sight and reach of children.
Folic Acid Tablets are available in:
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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:
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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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:
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.
The active substance in Folic Acid 5mg Tablets is folic acid.
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.
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.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
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.
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.
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.
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).
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.
None known
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.
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 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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