Folic acid Colonis 1mg/ml oral solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Folic acid oral solution is and what it is used for
2. What you need to know before you take Folic acid oral solution
3. How to take Folic acid oral solution
4. Possible side effects
5. How to store Folic acid oral solution
6. Contents of the pack and other information

• 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
• 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.

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.

Folic acid oral solution is not suitable for use in infants under the age of 1 years old.

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).

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.

Folic acid oral solution is not likely to affect your ability to drive or use any tools or machines.

If you see another doctor or go into hospital, let them know what medicines you are taking.

• 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’.

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.

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.

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.

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.

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 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.

• 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.

• The active ingredient is folic acid. Each 1 ml oral solution contains 1 mg folic acid.
• The other ingredients are:
  • Sodium Methyl Parahydroxybenzoate (E219), see section 2
  • Disodium Edetate (E385)
  • Mannitol (E421)
  • Hydrochloric Acid, Concentrated (E507)
  • Water, Purified.

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.

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