PATIENT INFORMATION LEAFLET:INFORMATION FOR THE USER

FOLIFERRON 100 mg / 0.150 mg coated tablets

Iron fumarate / Folic acid

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult your doctor if you get worse or do not improve.

1. What is Foliferron and what it is used for.

2. What you need to know before starting to take Foliferron.

3. How to take Foliferron.

4. Possible side effects.

5. Storage of Foliferron.

6. Contents of the pack andadditional information

Foliferron tablets constitute an additional iron and folic acid (a vitamin) supplement and is used for the prevention of iron and folic acid deficiencies in pregnant women as well as to prevent certain alterations in the fetus.

Do not take Foliferron

• If you are allergic to iron, folic acid, or any of the other components of this medication (listed in section 6).
• If you have an excess of iron in your body (e.g. hemochromatosis, hemosiderosis).
• If you have a deficiency of vitamin B12 (megaloblastic anemia).
• If you have been subjected to repeated blood transfusions.
• If you are receiving simultaneous intravenous therapy with iron.

Warnings and precautions

• It is possible, although rare, that you may develop a hypersensitivity reaction to folic acid.
• If you have an acute condition in your digestive system (such as a gastric or duodenal ulcer or colitis).
• Do not use this medication in case of certain types of anemia, such as megaloblastic anemia or pernicious anemia.
• When taking Foliferron, your stools may become dark green or black. This effect is harmless.

Use of Foliferron with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

Be aware that these instructions may also apply to medications that have been used before or may be used afterwards.

Inform your doctor if:

• You are taking barbiturates, as concurrent administration may reduce folic acid levels and the effectiveness of the barbiturate.
• You are taking medications with cholestyramine or cholestipol (medications to reduce blood cholesterol levels), as this may decrease the absorption of folic acid.
• You are taking medications with sulfasalazine (used to treat inflammatory bowel diseases, such as ulcerative colitis), as the folic acid needs of these patients may increase.
• You are epileptic and being treated with anticonvulsants such as phenytoin and primidone, as Foliferron may increase the frequency of seizures.
• You are taking medications with pyrimethamine (used to treat malaria), as concurrent administration with folic acid may reduce the effectiveness of pyrimethamine.
• You are taking medications with vitamin C (ascorbic acid), as this may alter iron absorption.
• You are being treated with proton pump inhibitors, such as pantoprazole, esomeprazole, omeprazole, or lansoprazole, as these may reduce the effect of iron salts.
• You are being treated with medications with alpha-hydroxyacetic acid (used to treat urinary tract infections), as concurrent use with iron supplements may reduce the absorption of these medications.
• You are receiving treatment with dimercaprol (a medication used as an antidote for certain substance intoxications), as concurrent administration with iron produces a toxic complex, so iron treatment should be postponed for at least 24 hours after discontinuation of dimercaprol treatment.
• You are taking some antibiotics, such as tetracyclines or quinolones, take Foliferron 2-3 hours before or after the antibiotic.
• You are taking medications with thyroxine (for thyroid disorders) or penicillamine (antirheumatic), Foliferron may decrease the effect of these medications, so avoid taking Foliferron within 2 hours before and after administration of these medications.
• You are taking antacids, calcium supplements, or medications containing bicarbonate, carbonate, oxalates, or phosphates, these compounds may reduce the absorption of Foliferron. Take these medications at least 2 hours after Foliferron administration.
• You are taking medications with chloramphenicol (an antibiotic), as these may reduce folic acid absorption and decrease the effect of iron.
• You are taking medications with methyldopa, Foliferron may reduce its hypotensive effect.
• You are being treated with non-steroidal anti-inflammatory drugs, such as salicylates or methylbutazone, as concurrent oral administration with Foliferron may produce a reciprocal potentiation of effects by irritating the gastrointestinal mucosa.
• You are being treated with oral bisphosphonates, used for the treatment and prevention of osteoporosis, administration of Foliferron should be avoided within 2 hours before and after administration of these medications.

Use of Foliferron with food and beverages

Some foods, such as tea, coffee, milk, cereals, may reduce iron absorption.

Pregnancy, lactation, and fertility

Consult your doctor or pharmacist before taking any medication.

The use of Foliferron during pregnancy is safe, as pregnancy may cause iron and folic acid deficiency, and therefore it is recommended as a preventive measure.

The use of iron and folic acid, the two active principles of Foliferron, during lactation is safe, although folic acid is excreted in breast milk. This is a physiological situation in which deficiency in the two nutrients may occur, and therefore it is recommended as a preventive measure.

Driving and operating machinery

The influence of Foliferron on the ability to drive and operate machinery is negligible or insignificant.

Foliferron contains saccharose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for Foliferron tablets as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is 1 tablet 3 times a day.Take the entire tablet with a little water or fruit juice (avoid milk), preferably after meals.

If you take more Foliferron than you should

Foliferron overdose is rare in adults, but may occur in children. Toxicity due to excessive intake is related to iron overdose. If you have taken a large amount of Foliferron at one time, you may experience stomach discomfort or other symptoms that require urgent attention and treatment.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service. Phone 915 620 420, indicating the medication and the amount used.

If you forget to takeFoliferron

Remember to take your medication.If you forget to take a dose, take it as soon as possible unless it is almost time to take the next dose. Do not take a double dose to make up for the missed doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, Foliferron tablets may produce adverse effects, although not everyone will experience them.

The most frequent adverse effects (which may affect up to 1 in 100 patients) are especially, abdominal pain, stomach acid, nausea, vomiting, constipation, or diarrhea. It is common for dark green or black stools to appear due to iron excretion. This effect is harmless.

Rare adverse effects (which may affect up to 1 in 1,000 patients): in rare cases, a severe allergic reaction may occur. Consult your doctor immediately if you experience any of the following symptoms: flushing, itching/swelling (especially on the face, tongue, or throat), dizziness, and/or breathing difficulties.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Store at room temperature.

Do not use Foliferron after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Foliferron tablets

• The active principles are: Iron (in the form of iron fumarate) and folic acid. Each tablet contains 100 mg of iron fumarate (equivalent to 32.8 mg of iron) and 0.150 mg of folic acid.
• The other components are: Sucrose, cornstarch, sodium caramel, magnesium stearate, microcrystalline cellulose, povidone K90, cetyl alcohol, ethyl alcohol, colloidal silica, polyethylene glycol 3350, gum arabic, polyethylene glycol 6000, calcium phosphate, gelatin, polyvinyl acetate, Eudragit E; talc, ferric oxide brownish red, ferric oxide yellow (E-172), beeswax, and water.

Appearance of the product and contents of the packaging

Foliferron are brown-coated tablets in packs of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Teofarma S.R.L.

Via F.lli Cervi 8

27010 VALLE SALIMBENE (Pavia)

ITALY

Last review date of this leaflet: January 2018

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es