Package Insert: Information for the Patient

Ferbisol 100 mg Hard Gastrorresistant Capsules

Iron (Fe2+)

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

• Keep this package insert, as you may need to refer to it again.

- If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed only for you, and you should not give it to others

who may have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed

in this package insert. See section 4.

1. What is Ferbisol and how is it used

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

3. How to take Ferbisol

4. Possible adverse effects

5. Storage of Ferbisol

6. Contents of the package and additional information

Ferbisol is a form of iron that can be taken orally to treat or prevent iron deficiency. Iron is essential for oxygen transport and energy transfer in the body. The capsules are called gastro-resistant because they do not release their content in the stomach. They release iron in the intestine where it is absorbed.

Ferbisol is used for the treatment of iron deficiency.

Do not take Ferbisol

• If you are allergic to the iron complex or to any of the other components of this medication (listed in section 6),
• If you have a narrowing of your throat (esophagus),
• If you have a genetic disorder called iron storage disease (hemochromatosis),
• If you have a disease with iron accumulation (chronic hemolysis, thalassemia, other hemoglobinopathies),
• If you have any disorder in the use of iron (e.g., sideroblastic anemia (defective red blood cells may be produced), lead anemia),
• If you receive periodic blood transfusions.

Children

• Children under 6 years old should not take Ferbisol.
• Children 6 years old and above, with a body weight of less than 20 kg, should not take Ferbisol.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ferbisol.

Special care should be taken with Ferbisol.

• If you already have a digestive system disease such as chronic inflammatory bowel disease, esophageal and intestinal narrowing, intestinal protrusions (diverticula), gastritis, gastric and intestinal ulcers.
• If you have chronic kidney disease that requires erythropoietin, iron should be administered intravenously as oral iron is poorly absorbed in uraemic individuals.
• If you have liver insufficiency and/or suffer from alcoholism.
• If you are an elderly person, with unexplained blood or iron loss. In this case, the cause of anemia/source of bleeding should be studied carefully.
• Your teeth may become discolored during treatment with Ferbisol (this discoloration may disappear when you stop taking Ferbisol. If not, it can be removed with a abrasive toothpaste or a professional dental cleaning).

Children

• Be especially careful when administering Ferbisol to children, as an overdose may lead to poisoning in children.

Other medications and Ferbisol

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Increased efficacy and possible adverse effects

• Pain relievers (analgesics) and anti-inflammatory medications (e.g., salicylates and phenylbutazone): may worsen any stomach mucosa irritation caused by Ferbisol.
• The administration of intravenous iron concomitantly with oral iron administration may induce hypotension or even collapse due to the rapid release of iron and possible overload. This combination is not recommended.

Decreased efficacy and possible increased adverse effects

• Certain antibiotics (tetracyclines) or medications (bisphosphonates) used to treat weakened bones (osteoporosis): if you are taking Ferbisol, both iron and tetracyclines or bisphosphonates absorption will be reduced. This means that the effects of all these medications will be reduced. Ask your doctor if you need to increase the dose of these medications.
• Medications containing calcium, magnesium, or aluminum, e.g., antacids, calcium and magnesium salts for substitution: these medications reduce or prevent the absorption of iron from Ferbisol. You may need to increase the amount of Ferbisol you take.
• Medications for arthritis, such as penicillamine and gold compounds administered orally, medications for Parkinson's disease, such as L-methyldopa and levodopa, and L-thyroxine, used in the treatment of thyroid deficiency: these medications are poorly absorbed when taken with Ferbisol containing iron. You should consult your doctor if you need to increase your dose of these medications.
• Treatments for infections (antibiotics) belonging to the group known as fluoroquinolones, such as ciprofloxacin, levofloxacin, norfloxacin, and ofloxacin: iron reduces the amount of these medications absorbed. You should consult your doctor if you are taking Ferbisol before starting treatment with these medications.

The time interval between the administration of Ferbisol and any of the medications mentioned above should be at least 2 hours.

The interval between the administration of Ferbisol and tetracyclines and other doxycyclines (see below) should be at least 3 hours.

• You should not take doxycycline and Ferbisol together, as doxycycline may inhibit the absorption and circulation of Ferbisol.

Other possible side effects

• False positives may occur in stool blood tests in some cases.

Taking Ferbisol with food and drinks

Ferbisol should not be taken with food. Some substances contained in plant foods (e.g., cereals and vegetables) may form complexes with iron (e.g., phytates, oxalates, and phosphates). These complexes interrupt iron absorption. Ingredients in coffee, tea, milk, and cola drinks may also reduce iron absorption in the blood.

The time interval between the administration of these compounds and Ferbisol should be at least 2 hours.

Pregnancy, breastfeeding, and fertility

No known risks are associated with the use of Ferbisol during pregnancy and breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Ferbisol does not affect your ability to drive or operate machinery.

Ferbisol contains sodium lauryl sulfate

This medication contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Do not take more than 5 mg of Ferbisol per kilogram of body weight. For example, if you weigh 60 kg, the maximum daily dose should be 5 x 60 = 300 mg (3 capsules).

Unless your doctor prescribes otherwise, the usual dose is::

Children over 6 years old (with a minimum body weight of 20 kg), adolescents, and adults

Adolescents over 15 years old (with a body weight over 50 kg) and adults.

In adolescents over 15 years old and adults, the following doses are recommended at the beginning of treatment in cases of pronounced iron deficiency.

Use in children and adolescents

Ferbisol should not be used in children under 6 years old (with a body weight of less than 20 kg) (see section 2).

To children over 6 years old (minimum body weight of 20 kg) (see section 2) may be administered one capsule per day. For other doses, see table.

Method of administration

Take Ferbisol capsules with enough water. DO NOT chew the capsule. The capsules are taken with a sufficient time interval from meals (e.g., on an empty stomach in the morning or between main meals), because absorption may be reduced by food ingredients.

Note

If you cannot swallow the capsules or do not like them, you can empty the capsule and swallow the contents. By doing this, carefully separate the two parts of the capsule on a plate. Gently shake the contents, scoop up with a spoon, and ingest. You should drink something after ingesting the capsule contents.

Duration of treatment

Your doctor will decide the duration of your treatment.

Treatment should continue until you reach normal iron levels in the blood, which requires between 10 to 20 weeks, or longer in the case of persistent underlying pathology.

The duration of treatment to prevent iron deficiency varies depending on the situation (pregnancy, blood donation, chronic hemodialysis, planned autologous transfusion).

If you take more Ferbisol than you should

After an intentional or accidental overdose, the symptoms described in section 4 "Possible adverse effects" are the most frequent and will be more severe.

If you have taken too much Ferbisol, inform your doctor immediately.

An overdose can cause poisoning, especially in children.

Iron poisoning may present symptoms such as agitation, stomach pain, nausea, vomiting, and diarrhea. Stools show a tar-like color, and vomiting may contain blood. Shock, metabolic changes such as an increase in the amount of acid in the body, and coma may occur. Death may occur after convulsions, Cheyne-Stokes respiration (an abnormal breathing model, characterized by alternating periods of shallow breathing and deep breathing), coma, and pulmonary edema.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Ferbisol

Do not take a double dose to compensate for the missed doses.s. If you have forgotten to take one or several doses of Ferbisol, continue taking it for a little longer.

If you interrupt treatment with Ferbisol

You do not need to take any special precautions before interrupting treatment with Ferbisol.

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

Like all medications, this medicationcan produce adverse effects, although not all people will experience them.

Ferbisol may in some cases (for which the frequency cannot be calculated) cause a severe allergy (anaphylactic reaction). If you experience a severe rash, itching, and difficulty breathing, you should consult your doctor immediately.

Frequent Adverse Effects(affect between 1 and 10 patients out of 100)

• stomach or intestinal discomfort (abdominal),
• burning sensations,
• vomiting,
• liquid stools (diarrhea),
• nausea,
• constipation,
• dark stools.

Rare Adverse Effects(affect between 1 and 10 patients out of 10,000)

• tooth discoloration (see also “Be especially careful with Ferbisol” in section 2),
• skin hypersensitivity (e.g. skin manifestations, exanthema, rash, urticaria).

Unknown(cannot be estimated from available data)

• abdominal pain and upper abdominal pain,
• gastrointestinal bleeding,
• lingual discoloration,
• buccal discoloration.

Other Effects in Children

In children under 6 years, iron capsules may cause poisoning (see sections 2 and 3).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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:http://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medicationafter the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGREpoint of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Ferbisol

• The active principle is the ferrous glycinate (II) sulfate complex. A capsule contains: 567.7 mg of ferrous glycinate (II) sulfate complex (which is equivalent to 100 mg of Fe2+).
• The other components are:

Pellets with the ferrous glycinate (II) sulfate complex:

Ascorbic acid, microcrystalline cellulose, hypromellose, hydroxypropyl cellulose, copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion 30% (Eudragit L30 D-55) (contains copolymer of methacrylic acid-ethyl acrylate, sodium lauryl sulfate, polysorbate 80), triethyl citrate and talc.

Capsule:

Body: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172).

Crown: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172).

Appearance of the product and content of the container

Ferbisol is a hard, gastro-resistant gelatin capsule of approximately 21.7 mm x 7.5 mm in size, with a brown chocolate opaque crown, unprinted, and an orange opaque body, unprinted. It contains enteric-coated, brown-gray pellets.

Ferbisol is available in containers containing 50 gastro-resistant capsules.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

UCB Pharma, S.A.

Plaza de Manuel Gómez Moreno, s/n

Edificio Bronce, 5th floor,

28020 Madrid

Spain

Local representative

Laboratorios BIAL, S.A.

C/Alcalá 265, Building 2, 2nd floor

28027 Madrid

Spain

Responsible manufacturer

Aesica Pharmaceuticals GmbH

Alfred-Nobel-Strasse 10

40789 Monheim

Germany

Last review date of this leaflet:01/2024

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