FOLSAN

FOLSAN 0.4 mg tablets

Important notes (mandatory information)

Folsan 0.4 mg Tablets. Active ingredient: Folic acid. Areas of application: for the prevention of folic acid deficiency when an adequate intake of folic acid with food is not possible and for the prevention of neural tube defects in newborns through preventive treatment of women before and during pregnancy. Taking folic acid is also indicated for a balanced diet.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Folsan 0.4 mg Tablets
Active ingredient: Folic acid

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Folsan 0.4 mg must be used as directed in order to achieve the best possible treatment results.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you must see a doctor in any case.
• If any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet includes

1. WHAT IS FOLSAN 0.4 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING FOLSAN 0.4 MG?
3. HOW SHOULD FOLSAN 0.4 MG BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD FOLSAN 0.4 MG BE STORED?
6. FURTHER INFORMATION

1. WHAT IS FOLSAN 0.4 MG AND WHAT IS IT USED FOR?

Folsan 0.4 mg is a remedy for the prevention of anemia and for the prevention of neural tube defects in newborns
Folsan 0.4 mg is used for:

• Prevention of folic acid deficiency when an adequate intake of folic acid with food is not possible.
• Prevention of neural tube defects in newborns through preventive treatment of women before and during pregnancy. Taking folic acid is also indicated for a balanced diet.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING FOLSAN 0.4 MG?

Folsan 0.4 mg must not be taken:

• if you are hypersensitive (allergic) to folic acid or any of the other ingredients of Folsan 0.4 mg.
• if you suffer from megaloblastic anemia due to a vitamin B12 deficiency without simultaneous vitamin B12 treatment.
• if you suffer from megaloblastic anemia of unclear cause, as long as a vitamin B12 deficiency has not been ruled out.

Special care should be taken when taking Folsan 0.4 mg,
if there is a risk of megaloblastic anemia due to a vitamin B12 deficiency. Folic acid can mask a vitamin B12 deficiency. In the case of untreated progressive megaloblastic anemia, there is a risk of permanent damage to the nervous system.

When taking Folsan 0.4 mg with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines. Treatment with anticonvulsants can increase the risk of seizures. When high doses are administered, it cannot be ruled out that folic acid and folic acid antagonists administered at the same time, such as certain drugs for bacterial infections or malaria (trimethoprim, proguanil, pyrimethamine) and methotrexate (active ingredient, among others, for the treatment of tumors), mutually inhibit their effects. The simultaneous administration of high doses of folic acid with 5-fluorouracil (a drug for the treatment of tumors) increases the efficacy and also the toxicity of 5-fluorouracil. Chloramphenicol (active ingredient for the treatment of infections) can prevent the response to treatment with folic acid.

Pregnancy and breastfeeding

No risks are known.

Driving and operating machinery

No effects on the ability to drive and operate machinery are to be expected.

Important information about certain other ingredients of Folsan 0.4 mg

This medicine contains lactose and sucrose. Therefore, please only take Folsan 0.4 mg after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW SHOULD FOLSAN 0.4 MG BE TAKEN?

Always take Folsan 0.4 mg exactly as your doctor has instructed you. Please ask your doctor or pharmacist if you are not sure.

Method of administration

The tablets are taken whole with sufficient liquid during meals. Unless otherwise prescribed by your doctor, the usual dose is

• Prevention of folic acid deficiency: One tablet daily (equivalent to 0.4 mg folic acid). On medical advice, the dose can be increased to two tablets daily (equivalent to 0.8 mg folic acid).
• Prevention of neural tube defects in newborns: It is recommended that pregnant women and women wishing to have children take one tablet daily (equivalent to 0.4 mg folic acid). On medical advice, this dose can be increased to two tablets daily (equivalent to 0.4 mg folic acid).

Duration of use:

• Prevention of folic acid deficiency: The duration of use is determined by the attending physician.
• Prevention of neural tube defects in newborns: It is important that you start taking the tablets before becoming pregnant (preferably four weeks before). The treatment should then be continued for the first 12 weeks of pregnancy.

Please talk to your doctor or pharmacist if you have the impression that the effect of Folsan 0.4 mg is too strong or too weak.

If you have taken more Folsan 0.4 mg than you should

No overdose symptoms are to be expected with occasional higher doses. However, in patients with epilepsy, there may be an increased risk of seizures. At high doses (over 15 mg per day and for more than four weeks), gastrointestinal disorders, sleep disorders, agitation and depression may occur. In these cases, you should contact your doctor.

If you forget to take Folsan 0.4 mg

Do not take a double dose if you have forgotten to take the previous dose, but continue taking the tablets as normal.

If you stop taking Folsan 0.4 mg

Before you decide to stop taking the tablets on your own, talk to your doctor about it. Continuous use is necessary to prevent neural tube defects in newborns. 1

If you have any further questions about the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Folsan 0.4 mg can have side effects, although not everybody gets them. The following categories are used as a basis for the frequency of side effects

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

Significant side effects or signs to watch out for, and measures to take if you are affected

Side effects:

• In individual cases, hypersensitivity reactions may occur, e.g. in the form of skin redness (erythema), itching, shortness of breath (bronchospasm), nausea or circulatory collapse (anaphylactic shock).
• Very high doses can lead to gastrointestinal disorders, sleep disorders, agitation and depression.
• If 5-fluorouracil is administered at the same time, high doses of folic acid can lead to damage to the mucous membranes (e.g. in the form of severe diarrhea).

Countermeasures

Please inform your doctor about any side effects that occur so that he/she can treat them specifically if necessary. Please inform your doctor or pharmacist if any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package leaflet.

Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD FOLSAN 0.4 MG BE STORED?

Keep medicines out of the reach of children. Do not use the medicine after the expiry date which is stated on the carton/container after "Use by". The expiry date refers to the last day of the month.

Storage conditions

Do not store above 30°C. Store the blisters in the folding box.

6. FURTHER INFORMATION

What Folsan 0.4 mg contains

The active ingredient is: Folic acid. One tablet contains 0.4 mg folic acid. The other ingredients are: Lactose monohydrate, macrogol 4000, magnesium stearate (Ph. Eur.), corn starch, sucrose, stearic acid (Ph. Eur.).

What Folsan 0.4 mg looks like and contents of the pack

Folsan 0.4 mg are light yellow, round, curved tablets with a break notch. They are available in pack sizes of 20, 50 or 100 tablets.

Pharmaceutical entrepreneur

Teofarma S.r.1.
Via F.1Ii Cervi, 8
27010 Valle Salimbene (PV)
Italy
Fax 0039.0382.525845
e-mail: servizioclienti@teofarma.it

Manufacturer

Recipharm Parets, S.L.
Ramón y Cajal, 2
08150 Parets del Vallés (Barcelona)
Spain

This package leaflet was last revised in June 2015.

Source: Information from the package leaflet
Status: 02/2016
Active ingredient: Folic acid. Areas of application: for the prevention of folic acid deficiency when an adequate intake of folic acid with food is not possible and for the prevention of neural tube defects in newborns through preventive treatment of women before and during pregnancy. Taking folic acid is also indicated for a balanced diet.