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VIAFOL 10 MG/ML ORAL SOLUTION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Viafol 10mg/ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine.
· Keep this leaflet. You may need to read it again.
· If you have further questions, ask your doctor or your pharmacist.
· This medicine has been prescribed only for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours
· If any of the side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Viafol is and what it is used for
2. Before you take Viafol
3. How to take Viafol
4. Possible side effects
5. How to store Viafol
6. Further information
1. What Viafol is and what it is used for
The name of your medicine is Viafol 10mg/ml oral solution (referred to as Viafol
in this leaflet). The active ingredient in your medicine is folic acid. Folic acid
belongs to a group of vitamins called ‘B vitamins’.
Viafol is used to prevent babies being born with Neural Tube Defects such
as Spina Bifida.
This product is not suitable where there is an increased risk of neural tube
defects in the baby, for example in women who have previously had an
affected child, or are diabetic, or are receiving medication for epilepsy. In
this case, an alternative product and a higher dose of folic acid should be
used.
2. Before you take Viafol
Do not take Viafol and tell your doctor if you:
· You are allergic (hypersensitive) to folic acid or any of the other ingredients in
this liquid (listed in Section 6). Signs of an allergic reaction include a rash, itching
or shortness of breath.
· You have Addison’s disease (a disease of the adrenal glands).
· This medicine is not recommended for use in children due to its content of
propylene glycol.
If any of the above applies to you, do not take this medicine and talk to your
doctor.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, planning
to become pregnant or are breast-feeding. If you are a woman and you are
pregnant, this medicine is unlikely to cause any harm to you or your unborn
child.
Driving and using machines
Viafol is not likely to affect you being able to drive or use any tools or machines.
Important information about some of the ingredients of Viafol
None.
3. How to take Viafol
Take this medicine as your doctor or pharmacist has told you. Look on the label
and ask the doctor or pharmacist if you are not sure.
Taking this medicine
• This medicine contains 10mg of folic acid in each ml (10mg/ml).
• Take this medicine by mouth.
Pregnancy
For the prevention of neural tube defects in the newborn whilst you are
trying to become pregnant and up to the 12 th week of pregnancy: 1 drop
daily.
The solution is equipped with an LDPE vertical dropper. A tamper-evident HDPE
screw cap closure is also provided.
Directions for using the dropper bottle:
• The bottle comes with an HDPE screw cap closure and should be opened as
follows:
- Push the plastic screw cap down while turning it counterclockwise (figure 1).
- Remove the unscrewed cap.
- Turn the bottle upside down vertically.
- Wait for a few instants, without shaking, until dropwise flow occurs(figure 2).
If flow is delayed, it may be necessary to gently tap the bottom of the bottle.

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After use:
- Close the bottle with precaution so as not to damage the drop dispenser.




Figure 1

Figure 2

If you take more Viafol than you should
There have been no cases of people taking an overdose with this medicine.
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 Viafol
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
Like all medicines, Viafol can cause side effects although not everybody gets
them.
If you have an allergic reaction to Viafol, see a doctor straight away.
An allergic reaction may include:
• Any kind of skin rash, flaking skin, boils or sore lips and mouth.
• Sudden wheezing, fluttering or tightness of the chest or collapse.
Tell your doctor if you get any of these side effects:
• Feeling sick (nausea), being sick (vomiting) or an upset stomach.
If any of the side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
5. How to store Viafol
• Keep out of the reach and sight of children.
• Do not store above 25°C.
Store in the original package in order to protect from light.
After first opening, use within 3 months.
• Do not use Viafol after the expiry date which is stated on the label and carton
(Exp: month, year).
• The expiry date refers to the last day of that month.
• Do not use Viafol if you notice a change in the appearance or smell of the
medicine. Talk to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
6. FURTHER INFORMATION
What Viafol contains
• The active substance is folic acid.
Each 1 ml (20 drops) of solution contains 10 mg of folic acid.
• The other ingredients are: Glycerol (E422), propylene glycol (E1520), sodium
hydroxide, Purified water.
What Viafol looks like and contents of the pack
A clear, yellow to orange, odourless solution.
It comes in a brown glass bottle holding 15ml of solution equipped with an
LDPE vertical dropper designed to deliver 20 drops per ml. A tamper-evident
HDPE screw cap closure is also provided.
Marketing Authorisation Holder
VIANEX S.A.,
Tatoiou str., 14671 Nea-Erythrea,
Greece
Manufacturer
VIANEX S.A.-Plant A,
12th Km Athens-Lamia National road, 14451 Metamorfosi Attiki,
Greece
This medicinal product is authorised in the Member States of the EEA
under the following names:
UK: Viafol
EL: Folioral
This leaflet was last approved in 05/2013.

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