Package Insert: Information for the User

Ferro sanol 100mg gastro-resistant capsules

Iron (Fe2+)

Read this 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 to you alone, and you should not give it to others even if they 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 Ferro sanol and how is it used

2. What you need to know before starting to take Ferro sanol

3. How to take Ferro sanol

4. Possible adverse effects

5. Storage of Ferro sanol

6. Contents of the package and additional information

Ferro sanol 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 gastroresistant because they do not release their content in the stomach. They release iron in the intestine where it is absorbed.

Ferro sanol is used for the treatment of iron deficiency.

Do not take Ferro sanol

• if you are allergic to the iron complex or any of the other components of this medication (listed in section 6),
• if you have a narrowing of your esophagus,
• if you have a hereditary 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 Ferro sanol.
• Children 6 years old and above with a body weight of less than 20 kg should not take Ferro sanol.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ferro sanol.

Special care should be taken with Ferro sanol:

• 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 alcoholism.
• If you are an elderly person with unknown iron loss or bleeding. In this case, the cause of anemia/bleeding source should be studied carefully.
• Your teeth may become discolored during treatment with Ferro sanol. This discoloration may disappear when you stop taking Ferro sanol. If not, it can be removed with a abrasive toothpaste or a professional dental cleaning.

Children

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

Other medications and Ferro sanol

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 Ferro sanol.
• 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 Ferro sanol, both iron and tetracyclines or bisphosphonates absorption are 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 Ferro sanol. You may need to increase the amount of Ferro sanol 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 Ferro sanol 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 Ferro sanol before starting treatment with these medications.

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

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

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

Other possible side effects

• False positive results in blood tests may occur in stool.

Taking Ferro sanol with food and beverages

Ferro sanol 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 beverages may also reduce iron absorption in the blood.

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

Pregnancy, lactation, and fertility

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

No known risks are associated with the use of Ferro sanol during pregnancy and lactation.

Driving and operating machinery

Ferro sanol does not affect your ability to drive or operate machinery.

Ferro sanol 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 contained in this leaflet or indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Do not take more than 5 mg of Ferro sanol 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.

Children and adolescents

Ferro sanol 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 Ferro sanol 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 in a bowl. Gently shake the contents, scoop up with a spoon and ingest. You should drink something after ingesting the capsule contents.

Treatment duration

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, and planned autologous transfusion).

If you take more Ferro sanol 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 Ferro sanol, inform your doctor immediately.

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, 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 breathing (an abnormal breathing pattern characterized by alternating periods of shallow breathing and deep breathing), coma, and pulmonary edema.

If you forget to take Ferro sanol

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

If you interrupt treatment with Ferro sanol

No special precautions are needed before interrupting treatment with Ferro sanol.

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 5620420.

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

Ferro sanol 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 (may affect up to 1 in 10 patients):

• Abdominal or intestinal discomfort
• Pain
• Vomiting
• Loose stools (diarrhea)
• Nausea
• Constipation
• Dark stools

Rare Adverse Effects (may affect up to 1 in 1000 patients):

• Dental discoloration (see also “Be especially careful with Ferro sanol” in section 2)
• 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
• Discoloration of the inside of the mouth

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: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not use this medication after 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 above 25°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Ferro Sanol Composition

• 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:

Ferrous glycinate (II) sulfate pellets:

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)
• lid: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172)

Appearance of the product and contents of the package

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

Ferro Sanol is available in packages containing 30, 50, 90, 100, and 500 x 1 gastro-resistant capsules. Not all package sizes may be marketed.

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

Responsible Manufacturer

Aesica Pharmaceuticals GmbH

Alfred-Nobel-Strabe 10

40789 Monheim

Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Dinamarca:Niferex

Spain: Ferro Sanol

Grecia:Ferro Sanol Duodenal

Italia:Niferex

Poland: Obsidan

Portugal: Ferbisol

Norway:Niferex

Sweden: Niferex

Last review date of this leaflet: April 2023

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