1 mg tablets of
folic acid

1. What Folic Acid Orifarm is and what it is used for

Folic acid Orifarm 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.

Folic acid Orifarm 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 Folic Acid Orifarm may also be approved for the treatment of other diseases 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 using Folic Acid Orifarm

Do not use Folic Acid Orifarm

  • if you are allergic to folic acid or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Folic Acid Orifarm:

  • Do not use Folic Acid Orifarm without a doctor’s prescription, as folic acid may mask vitamin B 12 deficiency; a condition that can cause damage to the nervous system.
  • Folic acid Orifarm should be used with caution in certain tumor diseases. Talk to your doctor if you are being treated for any tumor disease before you start using Folic Acid Orifarm.

Other medicines and Folic acid Orifarm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of the treatment can 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) and certain antibiotics.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.


No adverse effects on the fetus have been demonstrated.

Folic acid passes into breast milk but is not expected to affect the baby.

Driving and using machines

Folic acid Orifarm does not affect the ability to drive or use machines.


You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Folic Acid Orifarm

Always use this medicine exactly as your doctor or pharmacist has told you, and only on a doctor’s prescription, as folic acid may mask vitamin B12 deficiency. Ask your doctor or pharmacist if you are unsure.

Dosage one of Folic Acid Orifarm is different depending on what you are being treated for. The dose and duration of treatment are determined by your doctor.

  • The usual dose for the prevention of folic acid deficiency in adults: 1 tablet daily.
  • The usual dose in case of established folic acid deficiency in adults: 2 tablets 2-3 times a day for two weeks or until blood levels are normal. Thereafter, the dose can usually be reduced to 1 tablet daily.
  • The usual dose for folic acid deficiency in children: 1 tablet daily.
  • For preventive treatment before and during pregnancy and during breast-feeding, Folic Acid Orifarm should be taken according to a doctor’s prescription.


Folic acid Orifarm is also available as a 5 mg tablet.

If you use more Folic Acid Orifarm then 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 for risk assessment and advice.

If you forget to use Folic Acid Orifarm

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 have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.


Contact a doctor immediately if the following serious side effects occur:


Severe allergic reaction ( anaphylactic reaction ) with rash, swelling, and sometimes a drop in blood pressure ( has been reported in an unknown number of users).


Other side effects may occur:


Itching, rash, hives ( has been reported in an unknown number of users ).

5. How to store Folic Acid Orifarm

Keep this medicine out of the sight and reach of children.


No special storage instructions.


Do not use this medicine after the expiry date which is stated on the can 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. 1 tablet contains 1 mg of folic acid.
  • The other ingredients are hydroxypropylcellulose (E 463); croscarmellose sodium; cellulose, microcrystalline (E 460); silica, colloidal, anhydrous; stearic acid.

What the medicine looks like and the contents of the pack

Appearance

Yellowish to orange round convex tablets, 7 mm in diameter, marked with “1” on one side and scored on the other side. The tablet can be divided into two equal parts.


Pack sizes

Blister: 90 and 100 tablets

Plastic jar: 100 tablets and 1000 tablets (for dose dispensing).


Not all pack sizes may be marketed.


This medicine is available as tablets with strengths of 5 mg and 1 mg.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Orifarm Generics A / S

Energizer 15

5260 Odense S

Denmark


Local representative:

Orifarm Generics AB,

Box 56048

102 17 Stockholm 

info@orifarm.com


Manufacturer:

Orifarm Generics A / S

Energizer 15

5260 Odense S

Denmark 


or


SC Santa SA

Page Carpatilor no. 60

Objective no. 47, 48, 58, 133

500269 Brasov, Jud. Brasov

Romania

Muhammad Nadeem

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