FERRO SANOL 100 mg GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Ferro Sanol 100mg Gastro-Resistant Capsules

Iron (Fe2+)

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ferro Sanol and what is it used for
2. What you need to know before you take Ferro Sanol
3. How to take Ferro Sanol
4. Possible side effects
5. Storage of Ferro Sanol
6. Contents of the pack and other information

1. What is Ferro Sanol and what is it used for

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 gastro-resistant because they do not release their contents in the stomach. They release the iron in your intestine where it is absorbed.

Ferro Sanol is used for the treatment of iron deficiency.

2. What you need to know before you take Ferro Sanol

Do not take Ferro Sanol

• if you are allergic to the iron complex or to any of the other ingredients of this medicine (listed in section 6),
• if you have a narrowing in your oesophagus,
• if you suffer from a hereditary disease of iron storage (haemochromatosis),
• if you suffer from a disease with iron accumulation (chronic haemolysis, thalassemia, other haemoglobinopathies)
• if you suffer from any disorder in the use of iron (e.g., sideroblastic anaemia (defective red blood cells may be produced), lead poisoning),
• if you receive periodic blood transfusions.

Children

• Children under 6 years of age should not take Ferro Sanol.
• Children from 6 years of age onwards whose body weight is 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 suffer from a disease of the digestive system such as chronic inflammatory disease of the intestine, narrowing of the oesophagus and intestine, protrusions in the intestine (diverticula), gastritis, gastric and intestinal ulcers.
• If you suffer from chronic kidney disease that requires erythropoietin, iron should be administered intravenously since oral iron is poorly absorbed in uraemic individuals.
• If you suffer from liver failure and/or you suffer from alcoholism.
• If you are an elderly person with blood or iron loss of unknown origin. In this case, the cause of the anaemia/source of the bleeding must be carefully studied.
• Your teeth may become discoloured during treatment with Ferro Sanol. This discolouration may disappear when you stop taking Ferro Sanol. If it does not, it can be removed with an abrasive toothpaste or a professional dental cleaning.

Children

Be careful when administering Ferro Sanol to children, as an overdose can lead to poisoning in children.

Other medicines and Ferro Sanol

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Increased efficacy and possible side effects

• Pain relievers (analgesics) and anti-rheumatics (e.g., salicylates and phenylbutazone): may worsen any stomach irritation that Ferro Sanol may cause.
• The administration of intravenous iron concomitantly with oral iron administration may induce a decrease in blood pressure (hypotension) or even collapse due to the very rapid release of iron and possible overload. This combination is not recommended.

Decreased efficacy and possible increased side effects

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

The time interval between the administration of Ferro Sanol and any of the above-mentioned medicines should be at least 2 hours.

The 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 positives may frequently occur in blood tests for traces of blood in stools.

Taking Ferro Sanol with food and drinks

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

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There are no known risks associated with the use of Ferro Sanol during pregnancy and breastfeeding.

Driving and using machines

Ferro Sanol does not affect your ability to drive or use machines.

Ferro Sanol contains sodium lauryl sulfate

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

3. How to take Ferro Sanol

Follow the instructions for administration of this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

You should 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 of age (with a minimum body weight of 20 kg), adolescents and adults

Adolescents over 15 years of age (with a body weight over 50 kg) and adults

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

Children and adolescents

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

Children over 6 years of age (minimum body weight of 20 kg) (see section 2) may be given one capsule per day. For other doses, see table.

Method of administration

Take the Ferro Sanol capsules with sufficient 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), as 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. When doing this, carefully separate the two parts of the capsule over a bowl. Gently shake the contents, collect with a spoon and ingest. You should drink some water after ingesting the contents of the capsule.

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 if the underlying condition persists.

The duration of treatment to prevent iron deficiency varies depending on the situation (pregnancy, blood donation, chronic haemodialysis 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 side effects" are those that occur most frequently and will be more severe.

If you have taken too much Ferro Sanol, you should inform your doctor immediately.

Overdose can cause poisoning, especially in children.

Iron poisoning can present with symptoms such as agitation, stomach pain, nausea, vomiting and diarrhoea. The stools show a tar-like colour, 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 (abnormal breathing pattern, characterized by alternating periods of shallow and deep breathing), coma and pulmonary oedema.

If you forget to take Ferro Sanol

Do not take a double dose to make up for forgotten doses. If you have forgotten to take one or more doses of Ferro Sanol, continue taking it for a little longer.

If you stop taking Ferro Sanol

You do not need to take special precautions before stopping treatment with Ferro Sanol.

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91 5620420.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Common side effects (may affect up to 1 in 10 people):

• stomach or intestinal disorders (abdominal)
• heartburn
• vomiting
• liquid stools (diarrhoea)
• nausea
• constipation
• dark stools (faeces)

Rare side effects (may affect up to 1 in 1000 people):

• tooth discolouration (see also "Special care with Ferro Sanol" in section 2)
• hypersensitivity (e.g., skin manifestations, exanthema, rash, urticaria)

Unknown frequency (cannot be estimated from the available data):

• abdominal pain and pain in the upper abdomen
• gastrointestinal bleeding
• discolouration of the tongue
• discolouration of the inside of the mouth

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ferro Sanol

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ferro Sanol

• The active substance is ferroglycine sulfate complex. One capsule contains: 567.7 mg of ferroglycine sulfate complex (equivalent to 100 mg of Fe2+).
• The other ingredients are:

Pellets with ferroglycine sulfate complex:

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

Capsule:

• body: gelatine, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172)
• cap: gelatine, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172)

Appearance of the product and contents of the pack

Ferro Sanol is a hard gastro-resistant gelatine capsule, approximately 21.7 mm x 7.5 mm in size, with a brown chocolate-coloured cap, without imprint, and an orange-coloured body, without imprint. It contains coated, enteric, grey-brown pellets.

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder

UCB Pharma, S.A.

Plaza de Manuel Gómez Moreno, s/n

Edificio Bronce, planta 5

28020 Madrid

Spain

Manufacturer

Aesica Pharmaceuticals GmbH

Alfred-Nobel-Strabe 10

40789 Monheim

Germany

This medicine is authorised in the Member States of the European Economic Area under the following names:

Denmark: Niferex

Spain: Ferro Sanol

Greece: Ferro Sanol Duodenal

Italy: Niferex

Poland: Obsidan

Portugal: Ferbisol

Norway: Niferex

Sweden: Niferex

Date of last revision of this leaflet: April 2023

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