FOLIFERRON 100 MG / 0.150 MG FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET:INFORMATION FOR THE USER

FOLIFERRON 100 mg / 0.150 mg coated tablets

Iron fumarate / Folic acid

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor.

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

Contents of the package leaflet

1. What is Foliferron and what is it used for.
2. What you need to know before taking Foliferron.
3. How to take Foliferron.
4. Possible side effects.
5. Storage of Foliferron.
6. Package contents and additional information

1. What is Foliferron and what is it used for

Foliferron tablets are an additional supplement of iron and folic acid (a vitamin) and are used to prevent iron and folic acid deficiencies in pregnant women, as well as to prevent certain fetal alterations.

2. What you need to know before taking Foliferron

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 vitamin B12 deficiency (megaloblastic anemia)
• If you have undergone 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 gastroduodenal ulcer or colitis).
• This medication should not be used in cases of certain types of anemia, such as megaloblastic or pernicious anemia.
• When taking Foliferron, the stools may turn dark green or black. This effect is harmless.

Using Foliferron with other medications

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

Note that these instructions may also apply to medications that have been used before or may be used after.

Tell 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 colestipol (medications to reduce blood cholesterol levels), as they may decrease folic acid absorption.
• you are taking medications with sulfasalazine (used to treat inflammatory bowel diseases, such as ulcerative colitis), as the need for folic acid in these patients may increase.
• you are epileptic and are 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 ascorbic acid (vitamin C), as iron absorption may be altered.
• you are being treated with proton pump inhibitors, such as pantoprazole, esomeprazole, omeprazole, or lansoprazole, as they may reduce the effect of iron salts.
• you are being treated with medications containing acetohydroxamic acid (used to treat infectious kidney stones), as simultaneous use with iron supplements reduces 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 until at least 24 hours after discontinuation of dimercaprol treatment.
• you are taking certain antibiotics, such as tetracyclines or quinolones, you should take Foliferron 2 or 3 hours before or after the antibiotic.
• you are taking medications with thyroxine (for thyroid disorders) or penicillamine (an antirheumatic), Foliferron may decrease the effect of these medications, so you should avoid taking Foliferron 2 hours before and after administration of these medications.
• you are taking antacids, calcium supplements, or medications containing bicarbonate, carbonate, oxalates, or phosphates, as these compounds may reduce Foliferron absorption. You should take these medications at least 2 hours after Foliferron administration.
• you are taking medications with chloramphenicol (an antibiotic), as they 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 due to irritation of the gastrointestinal mucosa.
• you are being treated with oral bisphosphonates, used to treat and prevent osteoporosis, Foliferron administration should be avoided 2 hours before and after administration of these medications.

Using Foliferron with food and beverages

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

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before taking any medication.

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

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

Driving and using machines

The influence of Foliferron on the ability to drive and use machines is nil or insignificant.

Foliferron contains sucrose

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

3. How to take Foliferron

Follow the administration instructions for Foliferron tablets exactly 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 tablet whole, with a little water or fruit juice (avoid milk), preferably after meals.

If you take more Foliferron than you should

Overdose with Foliferron is rare in adults, but it can occur in children. Toxicity due to excessive intake is related to iron overdose. If you have taken a large amount of Foliferron at once, 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 Toxicology Information Service. Phone 915 620 420, indicating the medication and the amount used.

If you forget to take Foliferron

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

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

4. Possible side effects

Like all medications, Foliferron tablets can cause side effects, although not everyone experiences them.

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

Rare side effects (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 of the face, tongue, or throat), dizziness, and/or breathing difficulties.

Reporting side effects

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

5. Storage of Foliferron

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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Foliferron tablets

• The active ingredients 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 ingredients are: sucrose, cornstarch, sodium carmellose, magnesium stearate, microcrystalline cellulose, povidone K90, cetyl alcohol, ethanol, colloidal silica, polyethylene glycol 3350, arabic gum, polyethylene glycol 6000, basic calcium phosphate, gelatin, polyvinyl acetate, Eudragit E; talc, reddish-brown iron oxide, yellow iron oxide (E-172), wax, and water.

Appearance of the product and package contents

Foliferron is brown coated tablets in packages of 30 tablets.

Marketing authorization holder and manufacturer

Teofarma S.R.L.

Via F.lli Cervi 8

27010 VALLE SALIMBENE (Pavia)

ITALY

Date of the last revision of this package leaflet: January 2018

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es