ACIDO 0.4 MG Coated tablet

Зміст інструкції

1. Acido Folico Teva 0,4 mg compresse
   1. What is Acido Folico Teva and what is it used for
   2. What you need to know before taking Acido Folico Teva
   3. How to take Acido Folico Teva
   4. Possible side effects
   5. How to store Acido Folico Teva
   6. 6. Package contents and other information
2. Acido Folico Teva 5 mg tablets
   1. What is Acido Folico Teva and what is it used for
   2. What you need to know before taking Acido Folico Teva
   3. How to take Acido Folico Teva
   4. Possible side effects
   5. How to store Acido Folico Teva
   6. Contents of the pack and other information

Acido Folico Teva 0,4 mg compresse

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Acido Folico Teva is and what it is used for
• 2. What you need to know before you take Acido Folico Teva
• 3. How to take Acido Folico Teva
• 4. Possible side effects
• 5. How to store Acido Folico Teva
• 6. Contents of the pack and other information

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

Acido Folico Teva contains the active ingredient 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 need an adequate
intake of folic acid for the development of the baby.
Acido Folico Teva 0.4 mg tablets should be used by women who are planning a pregnancy from
at least four weeks before pregnancy until twelve weeks after the start of pregnancy. This
reduces the possibility of having a child with a neural tube defect (e.g. spina bifida, a deformation
of the spinal cord). This applies to women who do not have risk factors that can 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 can 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 or megaloblastic anemia of unknown origin.

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

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

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

• if you have a malignant tumor, as folic acid should generally not be taken by patients with tumors;
• if you suffer from a vitamin B deficiency associated with some forms of anemia (megaloblastic anemia, pernicious anemia), as this medicine, if administered alone, could worsen or cause the appearance of symptoms of your illness that can lead to serious neurological damage;
• if you are taking anti-epileptic drugs (see section “Other medicines and Acido Folico Teva”).

Antibiotics can alter the result of some laboratory tests relating to folic acid concentrations.

Other medicines and Acido Folico Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.
This particularly concerns the following medicines:

• medicines to treat seizures such as phenytoin, phenobarbital and primidone, as this medicine may reduce their effect;
• methotrexate (used to treat some tumors), sulfasalazine (used as an anti-inflammatory for ulcerative colitis, Crohn's disease or rheumatoid arthritis) and pyrimethamine (used to treat infections caused by parasites such as toxoplasmosis and isosporiasis), as they may decrease the activity of this medicine;
• paracetamol, aspirin, ibuprofen and other anti-inflammatory drugs, if taken at very high doses, as they may decrease the effectiveness of this medicine;
• trimethoprim or sulfonamides, alone or in combination such as, for example, cotrimoxazole (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 hyperacidity), but also cholestyramine and colestipol (used in the treatment of hypercholesterolemia in the blood), as they may decrease the activity of this medicine;
• antitubercular 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 some tumors), as toxicity phenomena 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 used safely during pregnancy and is often helpful.
Folic acid is excreted in breast milk.

Driving and operating machinery
Acido Folico Teva does not or negligibly alters the ability to drive vehicles 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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Oral use:

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

The recommended dose is 1 tablet a day, 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 adequate if you have one or more risk factors that may lead to neural tube defects
development, for example one or more previous pregnancies in which such defects have been observed
(see paragraph 2).
Acido Folico Teva is not effective in preventing the onset of neural tube defects if
treatment is started after the fourth week of pregnancy.

Use in children and adolescents
Acido Folico Teva should not be used in girls before menarche. In cases of folic acid deficiency in
children 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
(over 15 mg of folic acid per day for more than 4 weeks), with the manifestation of the following symptoms:
bitter taste, loss of appetite, nausea, flatulence, nightmares, agitation and depression.
If you inadvertently take an overdose of Acido Folico Teva, no specific actions are necessary.

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 a day, take the remaining tablets
at the correct time.
If you have any doubts about the use of this medicine, ask 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. Rarely, gastrointestinal disorders and hypersensitivity reactions have been reported.
The following side effects have also been reported:

Not known: frequency cannot be estimated from available data:

• Fever, hypersensitivity and severe allergic reaction (anaphylactic reaction).
• Sleep disturbances, agitation 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 higher doses than those contained in this medicine.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 Acido Folico Teva

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 pack after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. 6. Package contents and other information

What Acido Folico Teva contains

• The active ingredient is folic acid as folic acid hydrate. Each tablet contains 0.4 mg of folic acid.
• The other ingredients are hydroxypropylcellulose, 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 package contents
The tablets are off-white to yellowish in colour, round, convex and with a bevelled edge, with a diameter of 7 mm.
Acido Folico Teva is available in PVC-PVDC/Al blisters in packs of 28 and 120 tablets.
Not all pack sizes may be marketed.

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

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

Acido Folico Teva 5 mg tablets

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Acido Folico Teva is and what it is used for
• 2. What you need to know before you take Acido Folico Teva
• 3. How to take Acido Folico Teva
• 4. Possible side effects
• 5. How to store Acido Folico Teva
• 6. Contents of the pack and other information

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

Acido Folico Teva contains the active ingredient 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 anemia caused by folic acid deficiency. This can be caused by a poor diet, poor absorption of food, as in the case of celiac disease or sprue, during pregnancy or due to the breakdown of red blood cells.
• Prevention of folic acid deficiency caused by certain medicines, such as phenytoin, phenobarbital and primidone, used to treat epilepsy.
• Prevention of neural tube defects in the fetus (such as spina bifida) in women who are planning a 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 or megaloblastic anemia of unknown origin.

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

• if you have a known folic acid deficiency;
• if you have previously had a pregnancy (brought to term 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 using folic acid antagonists (e.g. sulfasalazine, methotrexate);
• if you suffer from type I or II diabetes mellitus.

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

• if you have a malignant tumor, as folic acid should generally not be taken by patients with tumors;
• if you suffer from a vitamin B12 deficiency associated with certain forms of anemia (megaloblastic anemia, pernicious anemia), as this medicine, if administered alone, could worsen or cause the appearance of symptoms of your illness that can lead to serious neurological damage;
• if you are taking anti-epileptic drugs (see section “Other medicines and Acido Folico Teva”).

Antibiotics may alter the result of some laboratory tests relating to folic acid concentrations.

Other medicines and Acido Folico Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription.
This is particularly relevant for the following medicines:

• medicines to treat seizures such as phenytoin, phenobarbital and primidone, as this medicine may reduce their effect;
• methotrexate (used to treat some cancers), 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 decrease the activity of this medicine;
• paracetamol, aspirin, ibuprofen and other anti-inflammatory medicines, if taken at very high doses, as they may decrease the effectiveness of this medicine;
• trimethoprim or sulfonamides, alone or in combination such as, for example, with co-trimoxazole (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 hyperacidity), but also cholestyramine and colestipol (used in the treatment of hypercholesterolemia in the blood), as they may decrease 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 some cancers), 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 used safely during pregnancy and is often helpful.
Folic acid is excreted in breast milk.

Driving and using machines
Acido Folico Teva does not or negligibly alters the ability to drive vehicles and use 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 following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Oral use:

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

The score line is only to help you break 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 per day for 4 months. In some cases, your doctor may increase the dose up to 15
mg per day.
To treat folic acid deficiency during pregnancy, the recommended dose is: 5 mg per day continuously until the end of
pregnancy.
To treat a less severe folic acid deficiency, your doctor may prescribe a product with a
lower dosage.

Folic acid deficiency induced by drugs
The recommended dose is: 5 mg per day for 4 months. In some cases, your doctor may increase the dose up to 15
mg per day.

Prevention of fetal neural tube defects in women planning a pregnancy and

who have risk factors that may lead to these defects
The recommended dose is: 5 mg per day 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 developmental defects if
treatment is started after the fourth week of pregnancy.

Use in children and adolescents
Acido Folico Teva should not be used in children under 6 years of age because 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 between 6 and 18 years of age, the recommended dose is: 5 mg per day for 4
months.

Folic acid deficiency induced by drugs
In children and adolescents between 6 and 18 years of age, the recommended dose is: 5 mg per day for 4
months.

Prevention of fetal neural tube defects
Acido Folico Teva should not be used in girls before menarche.

If you take more Acido Folico Teva than you should
It is unlikely that Acido Folico Teva can harm your health in any way.
Folic acid overdose has been observed after chronic administration of very high doses
(over 15 mg of folic acid per day for more than 4 weeks), with the manifestation of the following symptoms:
bitter taste, loss of appetite, nausea, flatulence, nightmares, agitation and depression.
If you inadvertently take an overdose of Acido Folico Teva, no particular action is necessary.

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 missed tablet.
If your doctor has prescribed more than one tablet per day, take the remaining tablets
at the correct time.
If you have any questions about the use of this medicine, ask 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. Rarely, gastrointestinal disorders and hypersensitivity reactions have been reported.
The following side effects have also been reported:

Not known: frequency cannot be estimated from the available data:

• Fever, hypersensitivity and severe allergic reaction (anaphylactic reaction).
• Sleep disturbances, agitation 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 higher doses than those contained in this medicine.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 Acido Folico Teva

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 pack after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Acido Folico Teva contains

• The active ingredient 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,
with a diameter of 7 mm, imprinted with “5” on one side and with a fracture 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
Netherlands

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