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FOLIC ACID COLONIS 1MG/ML ORAL SOLUTION

Active substance(s): FOLIC ACID / FOLIC ACID / FOLIC ACID

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Package leaflet: Information for the user

Folic acid Colonis 1mg/ml oral solution
Folic Acid
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 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.

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).

What is in this leaflet
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

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.

1. What Folic acid oral solution is
and what it is used for
This medicine is called Folic acid Colonis
1mg/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
1ml contains 1mg 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).

2. What you need to know before
you take 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
■ 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.

Driving and using machines
Folic acid oral solution is not likely to
affect your ability to drive or use any tools
or machines.
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)
This medicine contains sodium methyl
parahydroxybenzoate (E219) which may
cause allergic reactions (possibly delayed).

3. How to take 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 5ml a day for
4 months, which may be increased up to a
maximum of 15ml a day.
To prevent folate deficiency caused by
some medicines:
The recommended dose is 5ml a day for
4 months, which may be increased up to a
maximum of 15ml 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 5ml every week to a maximum
of 5ml 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 5ml 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 0.4ml a day
started before conception and
continued throughout the first three
months of pregnancy.
Dose: Pregnancy
The recommended dose during pregnancy is
5ml a day, continued until birth in women
who have previously had an affected child
and 0.4ml per day in women who are at
lower risk of having an affected child.

Dose: Children
The usual dose is 5 to 10ml a day.
Your doctor will decide the correct dose for
you, and will advise you how long to take
your medicine for.
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.
PIBA
A
1. Open the bottle by
pressing down on the
child resistant cap very
firmly and turning it
anticlockwise.
2.  Insert the syringe
adaptor 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.

B

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
Medicines and Healthcare Products
Regulatory Agency
151 Buckingham Palace Road,
Victoria, London, SW1W 9SZ
Website: www.yellowcard.mhra.gov.uk

5. How to store 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.

C

■ 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

D

-----

DOSE

Thumb
guard
on outer
part of
syringe

E

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.

6. Contents of the pack and other
information

F

G

If you take more Folic acid oral solution
than you should
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.

4. Possible side effects

lips, tongue, throat, severe wheezing)
If you have an allergic reaction to
Folic acid oral solution see a doctor
straight away.

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,

What Folic acid oral solution contains
■ The active ingredient is folic acid. Each
1ml oral solution contains 1mg folic acid.
■ The other ingredients are:
■ Sodium Methyl Parahydroxybenzoate,
(E219 see section 2)
■ 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 1mg/ml is a clear,
yellow and odourless solution supplied in a
150ml amber glass bottle with childresistant cap.
A 5ml 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
Hanover Place, 8 Church Road
Royal Tunbridge Wells,
Kent, TN1 1JP, United Kingdom
E-mail: medinfo@colonis.co.uk
Manufacturer
Vianex S.A.
PLANT A
12km National Road Athinon-Lamias,
Metamorfosi Attiki,
14451, Greece
Distributed by
Quantum Pharmaceutical
Hobson Industrial Estate
Burnopfield, County Durham
NE16 6EA, United Kingdom
This leaflet was last revised in
September 2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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