FOLSAN

FOLSAN 5 mg tablets

Important notes (mandatory information)

Folsan 5 mg Tablets Active ingredient: Folic acid. Areas of application: used for: treatment of folic acid deficiency states that cannot be remedied through diet; for the prevention of neural tube defects in newborns through preventive treatment of women with an increased risk (e.g. if a child with a neural tube defect was born previously or in women who suffer from seizures and are treated with antiepileptics). Taking folic acid is also indicated for a balanced diet; for the treatment of increased concentrations of homocysteine in the blood that are caused by folic acid deficiency.

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


PACKAGE INSERT: INFORMATION FOR THE USER

Folsan 5mg Tablets
Active ingredient: Folic acid

Read the entire package insert carefully, as it contains important information for you. This medicine is available without a prescription. However, Folsan 5 mg must be used as prescribed in order to achieve the best possible treatment results.

• Keep the package insert. 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 insert, please inform your doctor or pharmacist.

This package insert contains

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

1. WHAT IS FOLSAN 5 MG AND WHAT IS IT USED FOR?

This medicine is a vitamin.
Folsan 5 mg is used for:

• Treatment of folic acid deficiency states that cannot be remedied through diet.
• Prevention of neural tube defects in newborns through preventive treatment of women with an increased risk (e.g. if a child with a neural tube defect was born previously or in women who suffer from seizures and are treated with antiepileptics beh
• Treatment of increased concentrations of homocysteine in the blood that are caused by folic acid deficiency.

The treatment of homocystinuria exclusively with folic acid may only be carried out if a vitamin B12 deficiency has been ruled out.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING FOLSAN 5 MG?

Folsan 5 mg must not be taken:

• if you are hypersensitive (allergic) to folic acid or any of the other ingredients of Folsan 5 mg.
• if there is anemia due to impaired development of red blood cells (megaloblastic anemia), as the increase in young red blood cells (reticulocytes) caused by folic acid administration can mask a vitamin B12 deficiency. Because

Special care should be taken when taking Folsan 5 mg,
if there is a risk of megaloblastic anemia due to a vitamin B12 deficiency. Even in the case of life-threatening megaloblastic anemia, a possible vitamin B12 deficiency must be ruled out before the start of treatment due to the risk of permanent damage to the nervous system (ensuring serum and erythrocyte samples and determining the vitamin B12 content).

When taking Folsan 5 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 (anticonvulsants) can increase the risk of seizures. When high doses are administered, it cannot be ruled out that folic acid and folic acid inhibitors 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 (an agent for the treatment of tumors) increases the efficacy and also the toxicity of 5-fluorouracil. Severe diarrhea may occur. Chloramphenicol (active ingredient for the treatment of infections) can prevent the response to treatment with folic acid and should therefore not be administered to patients with severe folic acid deficiency symptoms.

Pregnancy and breastfeeding

No risks are known for dosages of up to 5 mg folic acid per day. Folic acid must not be used in doses higher than 5 mg per day during pregnancy and breastfeeding.

Driving ability and operating machinery

No effects are to be expected with regard to impaired driving ability and the operation of machinery.

Important information about certain other ingredients of Folsan 5 mg

This medicine contains lactose and sucrose. Therefore, please only take Folsan 5 mg after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW SHOULD FOLSAN 5 MG BE TAKEN?

Always take Folsan 5 mg exactly as your doctor has instructed you. Please ask your doctor or pharmacist if you are not quite sure. Unless otherwise prescribed by your doctor, the usual dose is

• Treatment of folic acid deficiency and increased homocysteine concentration in the blood: Depending on the need, 1 to 3 tablets (corresponding to 5 to 15 mg folic acid) per day.
• Prevention of neural tube defects in newborns: It is recommended that pregnant women and women who want to have children take one tablet daily (corresponding to 5 mg folic acid).

Method of administration

The tablets are taken whole with meals with sufficient liquid.

Duration of use:

• Treatment of folic acid deficiency and increased homocysteine concentration in the blood: the duration of treatment depends on the extent of the folic acid deficiency and is based on the clinical picture and, if applicable, on the corresponding laboratory diagnostic parameters and is determined by the doctor for each patient.
• 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

In women with seizure disorders (epilepsy) who are treated with antiepileptics, the concentration of this medicine in the blood must be carefully monitored.
Please talk to your doctor or pharmacist if you have the impression that the effect of Folsan 5 mg is too strong or too weak.

If you have taken a larger amount of Folsan 5 mg than you should

No overdose symptoms are to be expected with occasional higher doses. However, in patients with seizure disorders, there may be an increased risk of seizures. At high doses (over 15 mg per day and longer than four weeks), a bitter taste, loss of appetite, nausea, flatulence, nightmares, agitation and depression may occur. In these cases, you should contact your doctor.

If you forget to take Folsan 5 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 5 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.

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 5 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

If you are affected by any of the following side effects, stop taking Folsan 5 mg and see your doctor as soon as possible.

Gastrointestinal disorders

Rare: Gastrointestinal disorders at very high doses. When 5-fluorouracil is administered at the same time, high doses of folic acid can lead to mucosal intoxications (e.g. in the form of severe diarrhea) (see section "When taking Folsan 5 mg with other medicines").

Immune system disorders

In individual cases: Hypersensitivity reactions, e.g. in the form of skin redness (erythema), itching, shortness of breath (bronchospasm), nausea or circulatory collapse (anaphylactic shock).

Psychiatric disorders

Rare: Sleep disorders, agitation and depression at very high doses.

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 insert.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not listed in this package insert. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, 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 5 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/blister 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 5 mg contains

The active ingredient is: Folic acid. One tablet contains 5 mg folic acid. The other ingredients are: Lactose monohydrate, macrogol 4000, magnesium stearate (Ph. Eur.), corn starch, sucrose, stearic acid (Ph. Eur.).

What Folsan 5 mg looks like and contents of the pack

Falsan 5 mg are light orange, 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 insert was last revised in June 2015.

Source: Information from the package insert
Status: 02/2016
Active ingredient: Folic acid. Areas of application: used for: treatment of folic acid deficiency states that cannot be remedied through diet; for the prevention of neural tube defects in newborns through preventive treatment of women with an increased risk (e.g. if a child with a neural tube defect was born previously or in women who suffer from seizures and are treated with antiepileptics). The intake of folic acid is also indicated for a balanced diet; for the treatment of increased concentrations of homocysteine in the blood that are caused by folic acid deficiency.