1 mg tablets of
folic acid
1. What Folacin is and what it is used for
Folacin tablets contain folic acid, a B vitamin required for normal blood formation. In most cases, you get a sufficient amount of folic acid through food, but in some conditions, an extra supplement is needed. A prolonged deficiency of folic acid can manifest itself as a special kind of anemia.
Folacin is given to cure or prevent folic acid deficiency. Folic acid deficiency can occur, for example, during treatment with certain drugs and in certain intestinal diseases or other conditions when it is not possible to assimilate folic acid into the diet. Extra folic acid supplements may be needed during pregnancy and lactation.
Folic acid contained in Folacin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you use Folacin
Do not use Folacin
- if you are allergic to folic acid or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
- Do not use Folacin without a doctor’s prescription, as folic acid may mask vitamin B12 deficiency
- Folacin should be used with caution in certain tumor diseases. Consult your doctor if you are being treated for any tumor disease before you start using Folacin.
Other medicines and Folacin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The treatment effect may be affected if this medicine is taken at the same time as certain other medicines. This is especially true if you are taking certain medicines for epilepsy, depression, or diabetes, as well as cholestyramine (for high blood fats), birth control pills, levodopa (for Parkinson’s disease ), and certain antibiotics.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
No adverse effects on the fetus have been demonstrated.
Folacin passes into breast milk but is unlikely to affect breastfed infants.
Driving and using machines
Folacin does not affect the ability to drive or use machines.
Folacin contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
3. How to use Folacin
Always use this medicine exactly as your doctor has told you and only with your doctor’s prescription, as folic acid may mask vitamin B12 deficiency. Ask your doctor or pharmacist if you are unsure.
Dosage one of Folacin is different depending on what you are being treated for. The dose and duration of treatment are determined by your doctor.
The recommended dose for the prevention of folic acid deficiency in adults: 1 tablet daily.
The recommended dose in case of established folic acid deficiency in adults: 2 tablets 2-3 times a day for about 2 weeks. Thereafter, the dose can usually be reduced to 1 tablet daily.
For preventive treatment before and during pregnancy and during breast-feeding, Folacin should be taken as prescribed by a doctor.
Use for children and adolescents
The recommended dose for folic acid deficiency in children and adolescents 10-18 years: 1 tablet daily.
If you use more Folacin than you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for risk assessment and advice.
If you forget to use Folacin
If you forget to take a dose, just take the next dose at the correct time. Do not take a double dose to make up for a forgotten tablet.
If you stop using Folacin
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare side effects ( may affect up to 1 in 1,000 people):
Itching, rash, hives.
Has been reported (occurs in an unknown number of users):
Hypersensitivity reaction with fever, rash, swelling, and sometimes a drop in blood pressure.
5. How to store Folacin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
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. Contents of the packaging and other information
Content declaration
- The active substance is folic acid. One tablet contains 1 mg of folic acid.
- The other ingredients are microcrystalline cellulose, povidone, sodium starch glycolate, calcium hydrogen phosphate dihydrate, magnesium stearate.
What the medicine looks like and the contents of the pack
Folacin 1 mg is a yellow tablet. It has a breaking notch and is embossed with FA on one side and Pfizer on the other side. The tablet can be divided into two equal parts.
Pack sizes:
Plastic jar containing 98, 100, and 1000 (for dose dispensing) tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Pfizer AB
191 90 Sollentuna
Tel: 08 – 550 520 00
Email: eumedinfo@pfizer.com
Manufacturer
Farmasierra Manufacturing SL
Madrid, Spain