Cromatonferro

Package leaflet: Information for the user

CROMATONFERRO 80 mg effervescent tablets

ferro gluconato
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CROMATONFERRO is and what it is used for

CROMATONFERRO is an anti-anaemic medicinal product (a medicine used to treat various forms of
anaemia, a condition characterised by a deficiency of blood cells, particularly red blood cells).
CROMATONFERRO is used in adults and children for the treatment of iron-deficiency anaemias.
Consult your doctor if you do not feel better or feel worse after 3 weeks of treatment.

2. What you need to know before taking CROMATONFERRO

Do not take CROMATONFERRO

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you have hemosiderosis (a condition characterized by the accumulation of high amounts of hemosiderin in tissues, a pigment containing iron derived from hemoglobin in red blood cells).
• If you have hemochromatosis (abnormal iron deposition in the liver, causing dysfunction of the liver, pancreas, heart, and pituitary gland, and bronze skin pigmentation).
• In all cases of non-iron-deficiency anemias (anemias not caused by iron deficiency), particularly in hemolytic anemias (caused by destruction of red blood cells), chronic pancreatitis (chronic inflammatory disease of the pancreas), or liver cirrhosis (chronic inflammatory disease of the liver).

Warnings and precautions
Talk to your doctor or pharmacist before taking CROMATONFERRO.
Before starting treatment with CROMATONFERRO, you must ensure that your anemia is due to iron deficiency by undergoing a precise diagnosis of iron-deficiency anemia.
Iron administration can be toxic, especially in children, at doses exceeding 400 mg (more than 5 effervescent tablets); therefore, it is essential to keep the medicine out of the reach of children (see sections “Children” and “If you take more CROMATONFERRO than you should”).

Children
In children, administration of iron in doses exceeding 400 mg (more than 5 effervescent tablets) can be toxic.
Accidental overdose with a high dose can be fatal in children (see “If you take more CROMATONFERRO than you should”).

Other medicines and CROMATONFERRO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concurrent use of CROMATONFERRO with:

• Tetracyclines (antibacterial agents) leads to inhibition of their absorption, rendering them ineffective; therefore, concomitant administration of these two drugs is not recommended.
• Antacids (medicines used to counteract stomach acidity) reduces iron absorption. An interval of 2–3 hours should be maintained between the intake of CROMATONFERRO and antacids (medicines used for hyperacidity or digestive disturbances).
• Penicillamine (a medicine used in heavy metal poisoning and in the treatment of joint inflammation) is not recommended. Penicillamine tends to form complexes with iron derivatives, reducing their absorption; consequently, when treatment with iron derivatives is discontinued, there may be an increased risk of penicillamine toxicity.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
CROMATONFERRO may be administered during pregnancy and breastfeeding.
Your doctor will determine the dosage based on your response to treatment and gastrointestinal tolerance (the medicine may cause stomach and intestinal problems; see section 4 “Possible side effects”).
High doses are better tolerated when divided into 3 or 4 administrations per day.

Driving and using machines
CROMATONFERRO does not affect the ability to drive or operate machinery.

This medicine contains 228.9 mg of sodium (the main component of kitchen salt) per tablet.
This corresponds to 11.4% of the maximum recommended daily dietary intake for an adult.

This medicine contains sunset yellow FCF (E110), which may cause allergic reactions.

This medicine contains orange flavour, containing 0.15 mg of benzyl alcohol and 1.1 mg of sorbitol per tablet.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing difficulties (gasping syndrome), in young children.
Do not use for more than one week in young children (under 3 years of age) unless otherwise directed by a doctor or pharmacist.
Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to take CROMATONFERRO

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
In cases of severe anaemia (reduced haemoglobin concentration in the blood), the dose may be adjusted at
the doctor's discretion based on haematological (blood) tests performed two or three times a week after
starting treatment.
If blood tests after three weeks of treatment still indicate that anaemia is present, it will then be necessary to
investigate for causes other than simple iron deficiency (e.g. presence of bleeding, use of medications or
toxic substances, infectious diseases, etc.).
Adults
Dosage
Take 1 effervescent tablet daily, dissolved in water, half an hour before a meal.
Children
Dosage
Take half to 1 tablet depending on body weight.
If you take more CROMATONFERRO than you should
If an excessive dose of the medicine is taken, this may cause diarrhoea, vomiting, abdominal pain,
leucocytosis (increased number of white blood cells in the blood), hyperglycaemia (high blood sugar levels),
and, in the most severe cases, haemochromatosis (abnormal deposition of iron in the liver, causing liver,
pancreas, heart and pituitary gland dysfunction, and bronze discoloration of the skin). In such cases, the
patient must be taken to hospital for appropriate emergency treatment (see section “Warnings and
precautions”).
Overdose due to accidental ingestion of a large dose is fatal in children; therefore, it is essential to keep the
medicine out of the reach of children.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The use of CROMATONFERRO may cause vomiting, nausea, and diarrhoea, which in case of overdose can become more severe and may be complicated by gastrointestinal haemorrhages (bleeding of the stomach and intestines).
During administration of iron-containing preparations, a harmless black discolouration of the faeces may occur.
These side effects may occur in both adults and children and adolescents.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CROMATONFERRO

Store at room temperature.
Keep this medicine out of the sight and reach of children. Accidental ingestion of an elevated dose leading to overdose can be fatal in children (see "If you take more CROMATONFERRO than you should").
Do not use this medicine after the expiry date stated on the packaging after 'Exp.'. The expiry date refers to the last day of that month and to the product kept in its original, undamaged packaging, correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CROMATONFERRO contains
Each tablet contains:
Active substance: ferro gluconato 695 mg (equivalent to 80 mg of Fe).
Other components: ascorbic acid, citric acid, tartaric acid, sodium bicarbonate, sodium carbonate
monohydrate, sodium cyclamate, sodium saccharinate, sunset yellow E110, orange flavour (containing
benzyl alcohol, propylene glycol, sorbitol, mannitol).
Description of the appearance of CROMATONFERRO and package contents
Light brown, shiny, round effervescent tablets with a break line, packed in a bottle of 30 tablets or in a blister pack of 60 tablets.
Marketing Authorisation Holder and manufacturer
A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi 3, Florence, Italy.
Under licence from Grünenthal S.A. - Belgium.
Manufacturer
Hermes Pharma Ges.m.b.H. - Schwimmschulweg 1a, 9400 Wolfsberg, Austria