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.
Folic acid Colonis 1mg/ml oral solution
⚠ 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.
What it is and what it is used for
for This medicine is called Folic acid Colonis 1 mg/ml Oral Solution (referred to in this leaflet as Folic acid oral solution). It contains folic acid (vitamin B9), which belongs to a group of vitamins called 'B vitamins'. Each 1 ml contains 1 mg of folic acid. Folic acid oral solution is used for the prevention and treatment of conditions caused by deficiency of folic acid: 1. Prevention of neural tube defects (abnormalities of the spine, eg. spina bifida) in babies, including if you have previously had a baby with this disorder. 2. Prevention and treatment of anaemia caused by folic acid deficiency. This may occur in the following situations: • • • • •
pregnancy excessive alcohol intake or poor nutrition effects of other drugs (eg. anticonvulsants, used to prevent fits) sickle cell anaemia (or other types of anaemia caused by abnormal red blood cells) problems with absorption of folic acid from the gut (e.g. tropical sprue or coeliac disease).
What you need to know before you take it
e Folic acid oral solution Do not take Folic acid oral solution: • •
if you are allergic (hypersensitive) to folic acid or any of the other ingredients in this liquid (see section 6) if you display signs of an allergic reaction such as a rash, itching or breathing problems Page 1 of 6
•
if you have a tumour or cancer.
If any of the above apply to you, do not take this medicine and talk to your doctor. Warnings and precautions Talk to your doctor or pharmacist before taking this medicine if:
- you have been told that you have something called 'pernicious anaemia' or 'vitamin B12 deficiency'
- you are having haemodialysis. Children and adolescents Folic acid oral solution is not suitable for use in infants under the age of 1 years old. Other medicines and Folic acid oral solution Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This includes medicines you have bought without a prescription, including herbal medicines. This is because either Folic acid oral solution affects the way some other medicines work, or some medicines can affect the way Folic acid oral solution works. In particular, tell your doctor if you are taking any of the following:
- antiepileptics (used to treat epilepsy and fits) such as phenytoin, phenobarbital and primidone
- antibiotics (used to treat infections) such as chloramphenicol and co-trimoxazole. This is because antibiotics may affect the way Folic acid oral solution works.
- sulfasalazine, a medicine known as an immunosuppressant (used to treat ulcerative colitis, Crohn's disease or rheumatoid arthritis)
- methotrexate (used to treat Crohn's disease, rheumatoid arthritis or cancer). Pregnancy, breast-feeding and fertility Talk to your doctor before taking this medicine if you are pregnant, planning to become pregnant or are breast-feeding. Pregnancy •
Folic acid supplements are often necessary in pregnancy. There are no known risks in using them unless the points listed above in section 2 apply to you. If these apply to you talk to your doctor before you take this medicine.
Breast-feeding •
Folic acid is passed into breast milk. However, no adverse effects have been observed in breast fed infants whose mothers were receiving folic acid.
Fertility •
There are no known risks to fertility from the use of folic acid.
Driving and using machines Folic acid oral solution is not likely to affect your ability to drive or use any tools or machines. Page 2 of 6
Other precautions you should take If you see another doctor or go into hospital, let them know what medicines you are taking. Folic acid oral solution contains sodium methyl parahydroxybenzoate (E219) and sodium
- Sodium methyl parahydroxybenzoate (E219) may cause allergic reactions (possibly delayed).
- This medicine contains less than 1 mmol sodium (23 mg) per 1 ml that is to say essentially 'sodium-free'.
How to take it
Folic acid oral solution Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. This medicine is for oral use only. Dose: Adults and Elderly people To treat folate deficiency anaemia: The recommended dose is 5 ml a day for 4 months, which may be increased up to a maximum of 15 ml a day. To prevent folate deficiency caused by some medicines: The recommended dose is 5 ml a day for 4 months, which may be increased up to a maximum of 15 ml a day. To prevent folate deficiency caused by long-term red blood cell damage or kidney dialysis: The recommended dose can vary from a minimum of 5 ml every week to a maximum of 5 ml every day. Your doctor will tell you what dose you should take. To prevent neural tube defects in babies, in women who have previously had an affected child: The recommended dose is 5 ml a day started before conception and continued throughout the first three months of pregnancy. To prevent neural tube defects in babies, in women who are at a lower risk of having an affected child: The recommended dose is 0.4 ml a day started before conception and continued throughout the first three months of pregnancy. Dose: Pregnancy The recommended dose during pregnancy is 5 ml a day, continued until birth in women who have previously had an affected child and 0.4 ml per day in women who are at lower risk of having an affected child. Dose: Children The usual dose is 5 to 10 ml a day. Your doctor will decide the correct dose for you, and will advise you how long to take your medicine for.
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Directions for use This medicine should be taken by mouth using the graduated oral syringe and Press-In Bottle Adaptor (PIBA) provided with the product. 1. Open the bottle by pressing down on the child resistant cap very firmly and turning it anticlockwise. 2. Insert the syringe adaptor (PIBA) into the bottle neck and press it down very firmly into the bottle neck to make sure that it fits well enough to avoid any spillages (figure A). 3. Take the syringe and push it firmly into the adaptor opening (figure B). 4. Turn the bottle upside down and fill the syringe with a small amount of solution by pulling the plunger down (figure C). 5. Then push the plunger fully back up to remove any possible bubbles (figure C).
6. Finally, pull the plunger down until the thumb guard is lined up with the graduation mark for the required ml dose/measure (figure D). 7. Turn the bottle the right way up and remove the syringe from the adaptor (figure E). 8. Put the end of the syringe into your mouth and push the plunger slowly back in to take the medicine (figure F). 9. Repeat steps 3 to 6 if necessary to take the full dose prescribed by your doctor. 10. Wash the syringe with water and let it dry before you use it again (figure G).
11. Leaving the adaptor in the bottle neck, screw the plastic cap back onto the bottle. If you take more Folic acid oral solution than you should
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There have been no cases of people taking an overdose with this medicine, even extremely high doses are unlikely to cause harm to patients. However, if you think you have taken more than you should, talk to your doctor or go to a hospital straight away. If you forget to take Folic acid oral solution
- If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.
- Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
- If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Folic acid oral solution can cause side effects although not everybody gets them. Tell your doctor if you get any of these rare side effects (may affect up to 1 in 1,000 people): • •
Loss of appetite, feeling sick (nausea), being sick (vomiting) or an upset stomach Allergic reactions such as erythema (red skin rash), rash, itching, urticaria (itchy skin rash), difficulty in breathing and 'anaphylactic shock' (swelling of the face, lips, tongue, throat, severe wheezing).
If you have an allergic reaction to Folic acid oral solution see a doctor straight away. Reporting of suspected 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 to the relevant medicines authority (see details below). By reporting side effects you can help provide more information on the safety of this medicine. The Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
How to store it
Folic acid oral solution • • • • • • • •
Keep this medicine out of the sight and reach of children. Do not store above 25°C. Keep the bottle in the outer carton. After first opening do not store above 25°C. Once this bottle has been opened use within 3 months. Do not use this medicine after the expiry date which is stated on the label after Exp: The expiry date refers to the last day of that month. Do not use Folic acid oral solution if you notice a change in the appearance or smell of the medicine. Talk to your pharmacist. 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 to protect the environment.
Contents of the pack and other information
What Folic acid oral solution contains
- The active ingredient is folic acid. Each 1 ml oral solution contains 1 mg folic acid.
- The other ingredients are: o Sodium Methyl Parahydroxybenzoate (E219), see section 2 Page 5 of 6
o o o o
Disodium Edetate (E385) Mannitol (E421) Hydrochloric Acid, Concentrated (E507) Water, Purified.
What Folic acid oral solution looks like and contents of the pack Folic acid oral solution 1 mg/ml is a clear, yellow and odourless solution supplied in a 150 ml amber glass bottle with child-resistant cap. A 5 ml graduated oral dosing syringe and a "press-in" syringe/bottle adaptor (PIBA) are also supplied in the carton. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Colonis Pharma Limited 25 Bedford Square Bloomsbury London WC1B 3HH United Kingdom Manufacturer Vianex S.A. PLANT A 12km National Road Athinon-Lamias, Metamorfosi Attiki, 14451, Greece This leaflet was last revised in March 2024.
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Frequently asked questions about Folic acid Colonis 1mg/ml oral solution
How do I take Folic acid Colonis 1mg/ml oral solution?
Folic acid Colonis 1mg/ml oral solution comes as oral solution containing 1mg/ml. 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 Colonis 1mg/ml oral solution?
The active substance in Folic acid Colonis 1mg/ml oral solution is folic acid.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Folic acid Colonis 1mg/ml oral solution, 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 Colonis 1mg/ml oral solution 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.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: folic acid
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
1. For the prophylaxis of neural tube defects in case of a positive history of previous neural tube defects (NTD).
2. For the prophylaxis of NTDs with no previous history of foetal neural tube defect and no other predisposing factors
3. For the treatment of folate deficiency:
a. Folate deficient megaloblastic anaemia (in pregnancy, associated with alcoholism, drug intake such as anticonvulsants). For the prevention of megaloblastic anaemia, the cobalamin status should be established before initiation of folic acid therapy.
b. Impaired utilization of folate i.e. use of concomitant drugs, in liver disease, inadequate intake (e.g. alcoholism, malnutrition etc.)
c. Increased excretion of folate (e.g. alcoholism, haemolytic states).
4. Folate deficiency / megaloblastic anaemia associated with haemolytic anaemia (e.g. sickle cell anaemia)
5. Treatment of folate deficiency in malabsorption syndromes (parenteral administration of folic acid may need to be considered if oral treatment is not effective)
(e.g.: tropical sprue. tropical sprue responds to folate supplements in the early stages of the disease but cobalamin status must also be checked, particularly later; coeliac disease in which case the necessity of supplementation with folate ceases once a gluten free diet is introduced; non-tropical sprue; in congenital folate malabsorption (oral treatment may not be effective and parental folate may therefore be required).
Cobalamin status needs to be established in all megaloblastic states (not only in pregnancy).
4.2. Posology and method of administration
For oral administration only.
Adults (including the elderly):
- In folate deficient megaloblastic anaemia: 5 mg daily for 4 months; up to 15 mg daily may be necessary for malabsorption states.
- In drug-induced folate deficiency: 5 mg daily for 4 months; up to 15 mg daily may be necessary for malabsorption states.
- For prophylaxis in chronic haemolytic states: 5 mg every 1-7 days depending on underlying disease.
- Prevention of neural tube defects for women planning a pregnancy and known to be at risk: 5 mg daily started before conception and continued throughout the first trimester.
- In established folate deficiency of pregnancy: 5 mg daily continued to term.
- In pregnancy with no previous history of foetal NTD and no other predisposing factors: 0.4 mg daily until 10 to 12 weeks after last menstrual period
Paediatric population:
- In folate deficient megaloblastic anaemia: Child 1-18 years, 5 mg daily for 4 months; maintenance, 5 mg every 1-7 days.
- In haemolytic anaemia; metabolic disorders: Child 1-12 years, 2.5 mg-5 mg once daily. Child 12-18 years, 5-10 mg once daily.
The duration of the folic acid regimen has not been determined precisely in all patient populations, but it is recommended to administer the vitamin until the formation of new colonies of red blood cells is observed.
Depending on the etiological factor, diet improvement, removal of etiological factor, treatment of an inflammation may lead to cessation of treatment. In cases of haemolytic anaemia or in cases of concomitant drug intake, a longer treatment may be necessary in order to prevent occurrence of haematological disorders.
Method of administration
A graduated oral syringe and a Press-In Bottle Adapter (PIBA) are provided with the product.
1. Open the bottle and at first use insert the Press-In Bottle Adapter (PIBA).
2. Insert the syringe into the PIBA and draw out the required volume from the inverted bottle.
3. Remove the filled syringe from the bottle in the upright position
4. Discharge the syringe contents into the mouth. Repeat steps 2 to 4 as needed to achieve the required dose.
5. Rinse the syringe and replace the cap on the bottle (PIBA remains in place).
4.3. Contraindications
Known hypersensitivity to folic acid.
Known hypersensitivity to hydroxybenzoate esters.
Folic acid should not be given alone in the treatment of Addisonian pernicious anaemia and other vitamin B12 deficiency states because it may precipitate the onset of subacute combined degeneration of the spinal cord. In elderly people, a cobalamin absorption test should be done before long-term folate therapy.
Folic acid given to patients for 3 months or longer has precipitated cobalamin neuropathy. No harm results from short courses of folic acid.
Folic acid should not be used in folate-dependent tumours or malignant disease unless megaloblastic anaemia owing to folate deficiency is an important complication
4.4. Special warnings and precautions for use
If folic acid is used indiscriminately, there is a danger that patients with pernicious anaemia and other B12 deficiency states, despite a haematological remission, may develop irreparable neurological lesions. Therefore a full clinical diagnosis should be made before initiating treatment.
Folic acid is removed by haemodialysis.
The therapeutic effect should be monitored by laboratory analysis and the diagnosis should be reassessed (specialist workup) in case the expected response fails to appear. Serum Potassium levels and iron/ferritin status should be controlled.
Cobalamin status needs to be established in all megaloblastic states (not only in pregnancy).
Excipient warnings
Folic acid Colonis 1 mg/ml oral solution contains sodium methyl parahydroxybenzoate (E219) and sodium
• Sodium methyl parahydroxybenzoate (E219) may cause allergic reactions (possibly delayed).
• This medicine contains less than 1 mmol sodium (23 mg) per 1 ml that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Antiepileptics – if folic acid supplements are given to treat folate deficiency, which can be caused by the use of antiepileptics (phenytoin, phenobarbital and primidone), the serum antiepileptic levels may fall, leading to decreased seizure control in some patients.
Antibiotics – chloramphenicol and co-trimoxazole may interfere with folate metabolism.
Sulfasalazine - can reduce the absorption of folic acid.
Folic acid may interfere with the toxic and therapeutic effects of methotrexate.
4.6. Fertility, pregnancy and lactation
Pregnancy
The product is indicated for use during pregnancy.
There are no known hazards from the use of folic acid in pregnancy; indeed folic acid supplements are often beneficial in pregnancy. There is published evidence that folic acid is beneficial in the prevention of neural tube defects. Lack of the vitamin or its metabolites may also be responsible for some cases of spontaneous abortion and intrauterine growth retardation.
Breast-feeding
Folic acid is actively excreted in breast milk. Accumulation of folate in milk takes precedence over maternal folate needs. Levels of folic acid are relatively low in colostrum but as lactation proceeds, concentrations of the vitamin rise. No adverse effects have been observed in breast fed infants whose mothers were receiving folic acid.
Fertility
There are no known risks from the use of folic acid on fertility. See sub section “Pregnancy”.
4.7. Effects on ability to drive and use machines
Folic acid Colonis 1 mg/ml oral solution has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Rare
(≥ 1/10,000 to <1/1,000)
Gastrointestinal disorders:
Loss of appetite, nausea, abdominal distension and flatulence.
Immune system disorders:
Allergic reactions such as erythema, rash, itching, urticaria, difficulty in breathing and anaphylactic reactions (including shock)
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 Website: 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.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- ACIFOL 5 mg prescriptionACIDUM FOLICUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- Acidum folicum RichterAcidum folicum · taken by mouth
- FolikAcidum folicum · taken by mouth
- FolacidAcidum folicum hydricum · taken by mouth
- Folacid 0,4 mgAcidum folicum · taken by mouth
- Acidum folicum HascoAcidum folicum hydricum · taken by mouth
- Kwas foliowy OLIMPAcidum folicum · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Folic acid Colonis 1mg/ml oral solution. 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.