Ferro Sanol 100 mg gastro-resistant capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ferro sanol 100mg gastro-resistant capsules

Iron (Fe2+)

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ferro sanol is and what it is 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 referred to as gastro-resistant because they do not release their contents in the stomach. They release 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 taking 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 of your oesophagus,
• if you suffer from an inherited iron storage disorder (haemochromatosis),
• if you suffer from a condition involving iron accumulation (chronic haemolysis, thalassaemia, other haemoglobinopathies),
• if you have any disorders in iron utilization (e.g., sideroblastic anaemia (defective red blood cells may be produced), lead anaemia),
• if you receive periodic blood transfusions.

Children

• Children under 6 years of age must not take Ferro sanol.
• Children aged 6 years and older whose body weight is below 20 kg must not take Ferro sanol.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ferro sanol.

Special care is needed with Ferro sanol:

• If you already suffer from a gastrointestinal disorder such as chronic inflammatory bowel disease, narrowing of the oesophagus or intestines, intestinal pouches (diverticula), gastritis, gastric or intestinal ulcers.
• If you suffer from chronic kidney disease requiring erythropoietin, iron should be administered intravenously as oral iron is poorly absorbed in uraemic individuals.
• If you suffer from liver impairment and/or alcoholism.
• If you are elderly and have unexplained blood or iron loss. In this case, the cause of the anaemia/bleeding source must be carefully investigated.
• Your teeth may become discoloured during treatment with Ferro sanol. This discolouration may disappear when you stop taking Ferro sanol. If not, it can be removed with an abrasive toothpaste or professional dental cleaning.

Children

Take special care when administering Ferro sanol to children, as overdose may lead to poisoning in children.

Other medicines and Ferro sanol

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Increased efficacy and possible adverse effects

• Painkillers (analgesics) and anti-rheumatic drugs (e.g., salicylates and phenylbutazone): these may worsen any irritation of the stomach mucosa that Ferro sanol may cause.
• Concomitant administration of intravenous iron together with oral iron may induce a drop in blood pressure (hypotension) or even collapse due to rapid release of iron and possible overload. This combination is not recommended.

Reduced efficacy and possible increase in adverse effects

• Certain antibiotics (tetracyclines) or medicines (bis-phosphonates) used for treating weakened bones (osteoporosis): when taking Ferro sanol, the absorption of both iron and tetracyclines or bis-phosphonates is reduced. This means that the effects of all these medicines are diminished. Ask your doctor whether you need to increase the dose of these medicines.
• Medicines containing calcium, magnesium or aluminium, e.g., antacids, calcium and magnesium salts for replacement: these medicines reduce or prevent 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 orally administered gold compounds, 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 taken with Ferro sanol containing iron. You should consult your doctor whether you need to increase the dose of these medicines.
• Treatments for infections (antibiotics) in the group known as fluoroquinolones, such as ciprofloxacin, levofloxacin, norfloxacin and ofloxacin: iron substantially 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 administration of Ferro sanol and any of the above-mentioned medicines should be at least 2 hours.

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

• Do 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 faecal occult blood tests may frequently occur.

Taking Ferro sanol with food and drink

Ferro sanol must not be taken with food. Some substances present in plant-based foods (e.g., cereals and vegetables) may form complexes with iron (e.g., phytates, oxalates and phosphates). These complexes interfere with iron absorption. Ingredients in coffee, tea, milk and cola drinks may also reduce iron absorption into the blood.

The interval between intake of these substances and Ferro sanol should be at least two hours.

Pregnancy, breastfeeding and fertility

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

There are no known risks when Ferro sanol is used during pregnancy and breastfeeding.

Driving and using machines

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

Ferro sanol contains sodium lauryl sulphate

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

3. How to take Ferro sanol

Follow exactly the administration instructions for this medicine provided in this leaflet or as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You must 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 otherwise prescribed by your doctor, the usual dose is:

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

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

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

Children and adolescents

Ferro sanol must not be used in children under 6 years of age (with a body weight below 20 kg) (see section 2).

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

Method of administration

Take Ferro sanol capsules with sufficient water. DO NOT chew the capsule. The capsules should be taken at a sufficient time interval apart from meals (for example, on an empty stomach in the morning or between main meals), as absorption may be reduced by components of food.

Note

If you are unable to swallow the capsules or do not like them, you may empty the capsule and swallow the contents. To do this, carefully separate the two parts of the capsule over a bowl. Gently shake out the contents, collect them with a teaspoon, and swallow. You should drink some water after ingesting the capsule contents.

Duration of treatment

Your doctor will decide the duration of your treatment.

Treatment should continue until normal blood iron levels are achieved, which usually takes 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 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 side effects” are the most commonly occurring and may be more severe.

If you have taken a large amount of Ferro sanol, inform your doctor immediately.

Overdose may cause poisoning, especially in children.

Iron poisoning may cause symptoms such as agitation, stomach pain, nausea, vomiting, and diarrhea. Stools may appear tarry, and vomit may contain blood. Shock, metabolic changes such as increased acidity in the body, and coma may occur. Death may follow seizures, Cheyne-Stokes respiration (an abnormal breathing pattern characterized by alternating periods of shallow and deep breathing), coma, and pulmonary edema.

If you forget to take Ferro sanol

Do not take a double dose to make up for missed doses. If you have forgotten to take one or more doses of Ferro sanol, continue taking it for a slightly longer period of time.

If you stop taking Ferro sanol

No special precautions are required before stopping treatment with Ferro sanol.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Ferro sanol may in some cases (for which the frequency cannot be estimated) cause a serious allergic reaction (anaphylactic reaction). If you experience a severe rash, itching, or difficulty breathing, you must consult your doctor immediately.

Frequent adverse effects (may affect up to 1 in 10 patients):

• stomach or intestinal (abdominal) discomfort
• heartburn
• vomiting
• loose stools (diarrhea)
• nausea
• constipation
• dark stools (faeces)

Rare adverse effects (may affect up to 1 in 1,000 patients):

• tooth discoloration (see also “Take special care with Ferro sanol” in section 2)
• hypersensitivity (e.g., skin manifestations, exanthema, rash, urticaria)

Not known (cannot be estimated from available data):

• abdominal pain and upper abdominal pain
• gastrointestinal bleeding
• discoloration of the tongue
• discoloration inside the mouth

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse 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 stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ferro Sanol

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

Pellets with the ferrous glycinate (II) sulfate complex:

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

Capsule:

• Body: gelatin, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172)
• Cap: gelatin, titanium dioxide (E 171), red iron oxide (E 172), black iron oxide (E 172)

Appearance of the product and pack contents

Ferro Sanol is a hard gelatin gastro-resistant capsule of approximate size 21.7 mm x 7.5 mm, with a dark brown opaque cap, unprinted, and an opaque orange body, unprinted. It contains coated, enteric, greyish-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 Authorization Holder and Manufacturer

Marketing Authorization Holder

Teofarma S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene (PV) – Italy

Fax 0039.0382.525845

e-mail: [email protected]

Manufacturer

Aesica Pharmaceuticals GmbH

Alfred-Nobel-Strabe 10

40789 Monheim

Germany

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

Denmark: Niferex

Spain: Ferro Sanol

Greece: Ferro Sanol Duodenal

Italy: Niferex

Poland: Obsidan

Norway: Niferex

Sweden: Niferex

Date of the most recent review of this leaflet: April 2023

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