Folic acid Teva: detailed information

Package leaflet: Information for the user

Folic Acid Teva 0.4 mg tablets

Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Folic Acid Teva is and what it is used for
What you need to know before taking Folic Acid Teva
How to take Folic Acid Teva
Possible side effects
How to store Folic Acid Teva
Contents of the pack and other information

1. What Acido Folico Teva is and what it is used for

Acido Folico Teva contains the active substance folic acid.
Folic acid is a medicine belonging to the vitamin B group.
You need a regular intake of folic acid to stay healthy.
In particular, women who are planning a pregnancy and pregnant women require an adequate intake of folic acid for the baby's development.
Acido Folico Teva 0.4 mg tablets should be taken by women who are planning a pregnancy, starting at least four weeks before conception and continuing until twelve weeks after the beginning of pregnancy. This reduces the risk of having a child with a neural tube defect (e.g. spina bifida, a malformation of the spinal cord). This applies to women who do not have risk factors that could lead to such defects (see section 2. What you need to know before taking Acido Folico Teva).

2. What you need to know before taking Acido Folico Teva

Do not take Acido Folico Teva

if you are allergic to folic acid or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue;
if you have been diagnosed with untreated or inadequately treated pernicious anemia with vitamin B(_{12}) or megaloblastic anemia of unknown origin.

Warnings and precautions
Consult your doctor in all of the following situations, as your doctor may prescribe a higher dose of folic acid than that contained in one tablet of Acido Folico Teva 0.4 mg:

if you have a known folic acid deficiency;
if you have previously had a pregnancy (completed or not) in which neural tube defects were diagnosed in the baby;
if you are taking antiepileptic medicines (e.g. carbamazepine or valproic acid);
if someone in your family has had neural tube defects;
if you are taking folic acid antagonists (e.g. sulfasalazine, methotrexate);
if you have type I or II diabetes mellitus.

Your doctor may also prescribe a higher dose of folic acid than that contained in one tablet of Acido Folico Teva 0.4 mg in other circumstances.
Consult your doctor or pharmacist before taking Acido Folico Teva

if you have a malignant tumour, since folic acid is generally not recommended for patients with tumours;
if you suffer from vitamin B(_{12}) deficiency associated with certain types of anaemia (megaloblastic anaemia, pernicious anaemia), as this medicine, if administered alone, could worsen or trigger the onset of symptoms of your disease, potentially leading to severe neurological damage;
if you are taking antiepileptic drugs (see section “Other medicines and Acido Folico Teva”).

Antibiotics may alter the results of certain laboratory tests regarding folic acid levels.
Other medicines and Acido Folico Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
This particularly concerns the following medicines:

medicines used to treat epileptic seizures such as phenytoin, phenobarbital, and primidone, as this medicine may reduce their effectiveness;
methotrexate (used to treat certain tumours), sulfasalazine (used as an anti-inflammatory for ulcerative colitis, Crohn’s disease, or rheumatoid arthritis), and pyrimethamine (used to treat parasitic infections such as toxoplasmosis and isosporiasis), as they may reduce the activity of this medicine;
paracetamol, aspirin, ibuprofen, and other anti-inflammatory medicines, when taken at very high doses, as they may reduce the effectiveness of this medicine;
trimethoprim or sulfonamides, alone or in combination such as cotrimoxazole (an antibacterial medicine), as they may reduce the effect of this medicine;
chloramphenicol, as its use may reduce the effectiveness of folic acid supplementation;
cimetidine and other antacids (used to treat heartburn and gastric hyperacidity), as well as colestyramine and colestipol (used in the treatment of hypercholesterolemia), as they may reduce the activity of this medicine;
antituberculosis medicines, alcohol, and oral contraceptives, as they may reduce the effectiveness of this medicine;
green tea and black tea, which should be avoided during treatment with folic acid;
fluorouracil (used to treat certain tumours), as toxicity may occur.

Acido Folico Teva with food and drink
Do not take this medicine with alcohol. Alcohol may reduce the effectiveness of this medicine.
Pregnancy, breast-feeding and fertility
This medicine can be safely used during pregnancy and is often beneficial.
Folic acid is excreted in breast milk.
Driving and using machines
Acido Folico Teva does not affect or has a negligible effect on the ability to drive and operate machinery.
Acido Folico Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Acido Folico Teva

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Oral use:

swallow the tablet whole with water, at the same time each day, on an empty stomach;
take this medicine for the length of time indicated by your doctor.

The recommended dose is 1 tablet daily, continuously from 1 month before conception and up to
3 months after conception.
The daily dose may be doubled in case of inadequate intake of folic acid.
This dosage is not sufficient if you have one or more risk factors that may lead to neural tube development defects, for example one or more previous pregnancies in which such defects were observed
(see section 2).
Acido Folico Teva is not effective in preventing the occurrence of neural tube development defects if
treatment is started after the fourth week of pregnancy.
Use in children and adolescents
Acido Folico Teva must not be used in girls before menarche. In cases of folic acid deficiency in girls and adolescents, other formulations with a higher dose are more appropriate.
If you take more Acido Folico Teva than you should
The amount of folic acid contained in Acido Folico Teva is very low.
Folic acid overdose has been observed after chronic administration of very high doses
(more than 15 mg of folic acid daily for more than 4 weeks), resulting in the following symptoms:
bitter taste, loss of appetite, nausea, flatulence, nightmares, restlessness, and depression.
If you accidentally take an overdose of Acido Folico Teva, no specific actions are required.
If you forget to take Acido Folico Teva
If you forget to take a tablet, take it as soon as you remember, unless it is almost time to take the next tablet. Do not take a double dose to make up for the forgotten tablet.
If your doctor has prescribed more than one tablet per day, take the remaining tablets at the correct time.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Folic acid is generally well tolerated. Gastrointestinal disturbances and hypersensitivity reactions have rarely been reported.
The following adverse reactions have also been reported:
Not known: frequency cannot be estimated from the available data:

Fever, hypersensitivity and severe allergic reaction (anaphylactic reaction).
Sleep disorders, restlessness and depression.*
Bitter taste, flatulence, loss of appetite, nausea.*
Skin rash, itching, skin redness, urticaria, sudden swelling of the face.* Adverse effects observed in patients treated with doses higher than those contained in this medicine.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Folic Acid Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6.6. Contents of the pack and other information

What Acido Folico Teva contains

The active substance is folic acid as hydrated folic acid. Each tablet contains 0.4 mg of folic acid.
The other components are hydroxypropyl cellulose, sodium croscarmellose (see section 2 “Acido Folico Teva contains sodium”), microcrystalline cellulose, anhydrous colloidal silica, stearic acid 50.

Description of the appearance of Acido Folico Teva and contents of the pack
The tablets are white to slightly yellowish, round, convex, with bevelled edges, 7 mm in diameter.
Acido Folico Teva is available in PVC-PVDC/Al blisters in pack sizes of 28 and 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
SANTA SA
Str. Panselelor nr. 25, 27, 29
Brasov, jud. Brasov, cod 500419
Romania

Package leaflet: information for the user

Folic Acid Teva 5 mg tablets

Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Folic Acid Teva is and what it is used for
What you need to know before taking Folic Acid Teva
How to take Folic Acid Teva
Possible side effects
How to store Folic Acid Teva
Contents of the pack and other information

1. What Acido Folico Teva is and what it is used for

Acido Folico Teva contains the active substance folic acid.
Folic acid is a medicine belonging to the vitamin B group.
Acido Folico Teva is used for:

Treatment of folic acid deficiency, including a condition called megaloblastic anaemia caused by folic acid deficiency. This may be caused by a poor diet, malabsorption of food, as in coeliac disease or sprue, during pregnancy, or due to breakdown of red blood cells.
Prevention of folic acid deficiency caused by certain medicines, for example phenytoin, phenobarbital and primidone, used to treat epilepsy.
Prevention of neural tube defects in the foetus (such as spina bifida) in women who are planning pregnancy and are at risk of having a child with this defect.

2. What you need to know before taking Acido Folico Teva

Do not take Acido Folico Teva

if you are allergic to folic acid or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include skin rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue;
if you have been diagnosed with untreated or inadequately treated pernicious anemia with vitamin B12 or megaloblastic anemia of unknown origin.

Warnings and precautions
This medicine is intended for use in pregnant women if any of the following situations apply:

if you have a known folic acid deficiency;
if you have previously had a pregnancy (resulting in live birth or not) in which neural tube defects were diagnosed in the baby;
if you are taking antiepileptic medicines (e.g. carbamazepine or valproic acid);
if someone in your family has had neural tube defects;
if you are taking folic acid antagonists (e.g. sulfasalazine, methotrexate);
if you have type I or II diabetes mellitus.

This medicine may also be prescribed to pregnant women in other circumstances.
Talk to your doctor or pharmacist before taking Acido Folico Teva

if you have a malignant tumour, since folic acid generally should not be taken by patients with tumours;
if you have vitamin B12 deficiency associated with certain types of anaemia (megaloblastic anaemia, pernicious anaemia), as this medicine, if administered alone, could worsen or trigger the onset of symptoms of your condition, possibly leading to severe neurological damage;
if you are taking anti-epileptic drugs (see section “Other medicines and Acido Folico Teva”).

Antibiotics may alter the results of certain laboratory tests regarding folic acid concentrations.
Other medicines and Acido Folico Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
This particularly concerns the following medicines:

medicines used to treat epileptic seizures such as phenytoin, phenobarbital, and primidone, as this medicine may reduce their effectiveness;
methotrexate (used to treat certain tumours), sulfasalazine (used as an anti-inflammatory for ulcerative colitis, Crohn's disease, or rheumatoid arthritis), and pyrimethamine (used to treat parasitic infections such as toxoplasmosis and isosporiasis), as they may reduce the activity of this medicine;
paracetamol, aspirin, ibuprofen, and other anti-inflammatory medicines, when taken at very high doses, as they may reduce the effectiveness of this medicine;
trimethoprim or sulfonamides, alone or in combination (e.g. co-trimoxazole, an antibacterial medicine), as they may reduce the effect of this medicine;
chloramphenicol, as its use may reduce the effectiveness of folic acid supplementation;
cimetidine and other antacids (used to treat heartburn and gastric hyperacidity), as well as cholestyramine and colestipol (used in the treatment of hypercholesterolemia), as they may reduce the activity of this medicine;
antituberculosis medicines, alcohol, and oral contraceptives, as they may reduce the effectiveness of this medicine;
green tea and black tea, which should be avoided during treatment with folic acid;
fluorouracil (used to treat certain tumours), as toxicity may occur.

Acido Folico Teva with food and drink
Do not take this medicine with alcohol. Alcohol may reduce the effectiveness of this medicine.
Pregnancy, breastfeeding, and fertility
This medicine can be safely used during pregnancy and is often beneficial.
Folic acid is excreted in breast milk.
Driving and using machines
Acido Folico Teva does not impair or impairs negligibly the ability to drive and use machines.
Acido Folico Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Acido Folico Teva

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Oral use:

Swallow the tablet whole with water, at the same time each day, on an empty stomach.
Take this medicine for the length of time prescribed by your doctor.

The break line is only intended to help you split the tablet if you have difficulty swallowing it whole.
Adult patients (including elderly patients)
Folic acid deficiency
Folic acid deficiency must be confirmed by your doctor through a blood test.
The recommended dose is: 5 mg daily for 4 months. In some cases, your doctor may increase the dose up to 15
mg daily.
To treat folic acid deficiency during pregnancy, the recommended dose is: 5 mg daily continuously until the end
of pregnancy.
To treat milder folic acid deficiency, your doctor may prescribe a product with a lower dosage.
Drug-induced folic acid deficiency
The recommended dose is: 5 mg daily for 4 months. In some cases, your doctor may increase the dose up to 15
mg daily.
Prevention of neural tube defects in the fetus in women planning pregnancy and
who have risk factors that may lead to such defects
The recommended dose is: 5 mg daily, starting at least 3 months before conception and continuing throughout
the first trimester of pregnancy.
Acido Folico Teva is not effective in preventing the occurrence of neural tube development defects if treatment
is initiated after the fourth week of pregnancy.
Use in children and adolescents
Acido Folico Teva must not be used in children under 6 years of age, as the tablets do not contain a dose suitable
for children in this age group.
For children under 6 years of age, please refer to other folic acid formulations available on the market.
Folic acid deficiency
In children and adolescents aged between 6 and 18 years, the recommended dose is: 5 mg daily for 4 months.
Drug-induced folic acid deficiency
In children and adolescents aged between 6 and 18 years, the recommended dose is: 5 mg daily for 4 months.
Prevention of neural tube defects in the fetus
Acido Folico Teva must not be used in girls before menarche.
If you take more Acido Folico Teva than you should
It is unlikely that Acido Folico Teva will cause any harm to your health.
Folic acid overdose has been observed after chronic administration of very high doses (more than 15 mg of folic
acid daily for over 4 weeks), resulting in the following symptoms: bitter taste, loss of appetite, nausea, flatulence,
nightmares, restlessness, and depression.
If you accidentally take an overdose of Acido Folico Teva, no specific actions are required.
If you forget to take Acido Folico Teva
If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your next dose. Do not
take a double dose to make up for the forgotten tablet.
If your doctor has prescribed more than one tablet per day, take the remaining tablets at the correct time.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Folic acid is generally well tolerated. Rarely, gastrointestinal disturbances and hypersensitivity reactions have been reported.
The following adverse reactions have also been reported:
Not known: frequency cannot be estimated from the available data:

Fever, hypersensitivity and severe allergic reaction (anaphylactic reaction).
Sleep disorders, restlessness and depression.*
Bitter taste, flatulence, loss of appetite, nausea.*
Skin rash, itching, skin redness, urticaria, sudden swelling of the face.*
*Effects observed in patients treated with doses higher than those contained in this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Folic Acid Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Acido Folico Teva contains

The active substance is folic acid as folic acid hydrate. Each tablet contains 5 mg of folic acid.
The other ingredients are hydroxypropylcellulose, sodium croscarmellose (see section 2 “Acido Folico Teva contains sodium”), microcrystalline cellulose, anhydrous colloidal silica and stearic acid 50.

Description of the appearance of Acido Folico Teva and contents of the pack
Acido Folico Teva tablets are yellowish to orange in colour, round, convex, with bevelled edges, 7 mm in diameter, marked with the number “5” on one side and a break line on the other side.
Acido Folico Teva is available in PVC-PVDC/Al blisters in packs of 20, 28, 60 and 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
SANTA SA
Str. Panselelor nr. 25, 27, 29
Brasov, jud. Brasov, cod 500419
Romania