Clonfolic 0.4 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Folic acid

Available from:

Clonmel Healthcare Ltd

ATC code:

B03BB; B03BB01

INN (International Name):

Folic acid

Dosage:

0.4 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Folic acid and derivatives; folic acid

Authorization status:

Marketed

Authorization date:

1995-02-15

Patient Information leaflet

Package leaflet: Information for the user
Clonfolic 0.4mg Tablets
Folic Acid
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
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You must talk to a doctor if you do not feel better or if you feel
worse.
What is in this leaflet:
1. What Clonfolic 0.4 mg Tablets are and what they are used for
2. What you need to know before taking Clonfolic 0.4 mg Tablets
3. How to take Clonfolic 0.4 mg Tablets
4. Possible side effects
5. How to store Clonfolic 0.4 mg Tablets
6. Contents of the pack and other information
1. WHAT CLONFOLIC 0.4 mg TABLETS ARE AND WHAT THEY
ARE USED FOR
The name of your medicine is Clonfolic 0.4 mg Tablets. It
contains folic acid which belongs to a group of vitamins called ‘B
vitamins’. It is essential for good health. Folic acid is required
for the manufacture of nucleic acids-the genetic material of cells.
It is vital for the development and proper function of the central
nervous system.
Clonfolic is indicated for the prevention of first time neural tube
defects* (including Spina Bifida) in the foetus. The neural tube is
part of the nervous system and is located within the spine. Neural
tube defects cause stillbirth, neonatal death and severe disabilities
such as Spina Bifida. Clonfolic is indicated for use by all females
who are capable of conceiving, whether planning to do so or not.
For advice on dosing when planning a pregnancy and in the first
trimester of pregnancy see section 3.
* Studies have shown that over 70% of first time neural tube
defects such as Spina Bifida can be prevented by taking folic acid
(0.4mg) daily.
2. WHAT YOU NEED TO KNOW BEFORE

Summary of Product characteristics

Health Products Regulatory Authority
18 October 2019
CRN008SK4
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clonfolic 0.4 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.40 mg (400 micrograms) folic acid.
Excipient(s) with known effect
Contains 50 mg lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Pale yellow, circular, biconvex tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clonfolic is indicated for the prevention of first time neural tube
defects (including Spina Bifida) in the foetus. The neural tube
is part of the nervous system and is located within the spine. Neural
tube defects cause stillbirth, neonatal death and severe
disabilities such as Spina Bifida.
Clonfolic is indicated for use by all females who are capable of
conceiving, whether planning to do so or not. For advice on
dosing when planning a pregnancy and in the first trimester of
pregnancy see Section 4.2.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adult females
All females who are capable of conceiving should take ONE TABLET (0.4
MG) DAILY. If you are planning a pregnancy you should
begin taking Clonfolic at least 14 weeks before you become pregnant
and continue taking it for at least the first 12 weeks of
pregnancy.
Method of administration
Oral.
The tablets should be swallowed with water.
4.3 CONTRAINDICATIONS
1. Hypersensitivity to the active substance or to any of the
excipients listed in section 6.1.
2. Vitamin B
12
deficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is advised for patients under therapy for folate-dependent
tumours when taking folic acid.
Women with pre-existing diabetes, obesity, family history of neural
tube defects, or previous pregnancy affected by neural tube
defect have an increased risk of having a pregnancy affected by a
neural tube defect and higher doses should be considered.
Health Products Regulatory Authority
18 October 2019
CRN008SK4
Page 2 of 4
For women takin