Preconceive 400 micrograms Folic Acid Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FOLIC ACID

Available from:

G. R. Lane Health Products Limited Sisson Road, Gloucester, GL2 0GR, United Kingdom

ATC code:

B03BB01

INN (International Name):

FOLIC ACID 0.4 mg

Pharmaceutical form:

TABLET

Composition:

FOLIC ACID 0.4 mg

Prescription type:

OTC

Therapeutic area:

ANTIANEMIC PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2005-12-23

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you 
still need to use Preconceive Tablets carefully to get the best 
results from them.
s
s
advice. 
s
pharmacist.
In this leaflet:
1. What Preconceive Tablets are and what they are used for


4. Possible side effects
5. How to store Preconceive Tablets
6. Further information
5. HOW TO STORE PRECONCEIVE TABLETS
+EEP
$O
IS
Do not store above 25ºC.
Do not use if foil strip is damaged.
6. FURTHER INFORMATION
What Preconceive Tablets contain
4HE
micrograms.
The other ingredients are:
Core: Calcium Hydrogen Phosphate, Magnesium Stearate, 
-AIZE
What Preconceive Tablets look like and contents of the 
pack
Preconceive Tablets are creamy-yellow, circular tablets.  They 
ARE
Marketing Authorisation Holder and Manufacturer
G. R. Lane Health Products Limited
Sisson Road
Gloucester
',
5NITED
4EL
Email: [e-mail]
4HIS

Current leaflet - approved 
following User testing 
30/04/2008
1.  WHAT PRECONCEIVE TABLETS ARE AND WHAT THEY ARE  
USED FOR 
Preconceive Tablets are for the prevention of neural tube 
defects, such as spina bifida that can occur during pregnancy. 
The neural tube forms in the baby during the first few 
WEEKS
baby’s brain, spinal cord and their coverings. Spina bifida 
occurs when the neural tube does not develop properly 
in the baby and results in an incorrectly developed spine. 
-EDICAL
folic acid daily during the first three months of pregnancy, 
it prevents these neural tube defects, without harming the 
mother or the baby. Folic acid, one of the B vitamins, is the 
ACTIVE
fresh and processed foods.
2. BEFORE YOU TAKE PRECONCEIVE TABLETS
Do not take Preconceive Tablets: 
s
FOR
s
BY
s
your doctor 
s
BLOOD
"
Taking other medicines
0LEASE
0RECONCEIVE
any other medicines, including:
s
PHENOBARBITAL
THESE
dosage of anti-epileptic medication should be adjusted at 
r

Summary of Product characteristics

Page 1 of 4 
SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Preconceive 400 micrograms Folic Acid Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Ingredient 
mg/tablet 
Folic Acid 
0.4 

For a full list of excipients, see section 6.1. 

3 
PHARMACEUTICAL FORM 

Tablet. 
Cream/yellow circular biconvex tablet. 

4 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

For the prevention of first occurrence of neural tube defect in all women who are planning a 
pregnancy. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

For oral use. 
Women  who  are  planning  a  pregnancy  or  who  are  in  the  first  three  months  of  pregnancy: 
Swallow  1  tablet  with  water  and  food  once  a  day,  at  about  the  same  time  each  day.  
Continue until the end of the third month of pregnancy (first trimester). 

4.3 
CONTRAINDICATIONS 

Hypersensitivity to the active substance or to any of the excipients. 
Should not be taken by people with folate dependant tumours. 

Page 2 of 4 
4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

Interactions  with  anti-epileptics:  Folic  acid  should  not  be  given  alone  in  the  treatment  of 
Addisonian  pernicious  anaemia  and  other  B
12 
deficiency  states,  as  it  may  precipitate  the 
onset of sub-acute combined degeneration of the spinal cord. 

4.5 
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 

Interactions  with  anti-epileptics:  Folic  acid  reduces  plasma  phenytoin  concentrations. 
Consequently,  patients  on  anti-epileptic  therapy  should  have  their  dose  adjusted  at  regular 
intervals and be supervised by the physician. 

4.6 
PREGNANCY AND LACTATION