Package leaflet: Information for the patient

Ferlatum 40 mg/15 ml oral solution

ferriprotinate
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 they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Ferlatum is and what it is used for
What you need to know before taking Ferlatum
How to take Ferlatum
Possible side effects
How to store Ferlatum
Contents of the pack and other information

1. What Ferlatum is and what it is used for

Ferlatum contains the active substance ferrous protoporphyrin, used to treat iron deficiency in the blood.
Ferlatum is used for the treatment of absolute or relative iron deficiency states such as: latent or manifest iron-deficiency anemias (caused by inadequate iron intake or absorption), anemias of childhood and adulthood, anemias due to chronic hemorrhages, and anemias during pregnancy and lactation.

2. What you need to know before taking Ferlatum

Do not take Ferlatum

if you are allergic to ferric protein succinylate or to any of the other ingredients of this medicine (listed in section 6);
if you have chronic pancreatitis (chronic inflammation of the pancreas) or liver cirrhosis (chronic liver inflammation) secondary to haemochromatosis (excessive accumulation of iron in the body);
if you have haemosiderosis or haemochromatosis (conditions characterized by excessive iron accumulation in the body);
if you have aplastic anaemia (insufficient production of blood cells in the bone marrow), haemolytic anaemia (excessive destruction of red blood cells), or iron-utilization anaemia (sideroblastic anaemia).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ferlatum.
The cause of iron deficiency or anaemia should be identified, and in addition to iron therapy, your doctor will prescribe treatment for these conditions, if available.
This medicine does not pose any risk of habituation or dependence. However, its administration should not exceed 6 months, unless you have ongoing bleeding, menorrhagia (excessive blood loss during menstruation), or are pregnant.
Exercise particular caution with Ferlatum if you have milk protein intolerance, as you may experience allergic reactions.

Other medicines and Ferlatum
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Iron absorption may be increased by concomitant administration of more than 200 mg of ascorbic acid, or reduced by concomitant administration of antacids.
Chloramphenicol (an antibiotic) may delay the response to treatment with iron-containing medicines.
Iron may reduce the absorption or bioavailability (the amount of medicine that enters the body after administration) of the following medicines:
tetracyclines and quinolones (antibiotics);
bisphosphonates (used for osteoporosis and certain tumours);
penicillamine (used for rheumatoid arthritis and certain liver and kidney disorders);
thyroxine (a hormone);
levodopa and carbidopa (used for Parkinson's disease);
methyldopa (used for high blood pressure).
Take Ferlatum at least 2 hours apart from these medicines.

Ferlatum with food and drink
Substances that bind to iron (such as phosphates, phytates, and oxalates) present in vegetables, milk, coffee, or tea inhibit iron absorption. Take Ferlatum at least 2 hours apart from consuming these foods.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
FERLATUM is indicated for iron deficiency states that may occur during pregnancy and breastfeeding.

Driving and using machines
No effects on the ability to drive or operate machinery are known.

Ferlatum contains parabens and sorbitol E420
This medicine contains parabens (preservatives) such as sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause allergic reactions, including delayed reactions.
This medicine contains sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Ferlatum

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults: 1 to 2 containers per day (equivalent to 40–80 mg of Fe/day), according to medical judgment,
divided into two doses, preferably before meals.
Use in children
Take 1.5 ml/kg/day (equal to 4 mg/kg/day of Fe), or as directed by the physician,
divided into two doses, preferably before meals.
Drink the contents of the single-dose container as is, or diluted in still water.
The medicine should be taken until the body has restored its normal iron stores (usually,
2–3 months).
There are no indications regarding the use of the medicine at doses higher than those
recommended.
If you take more Ferlatum than you should
In case of ingestion/overdose of this medicine, consult your doctor immediately or go to the nearest
hospital.
In such cases, symptoms such as epigastralgia (stomach, abdominal, or chest pain),
nausea, vomiting, diarrhoea, and haematemesis (vomiting of blood) may occur, often associated with drowsiness, pallor, cyanosis
(blue discoloration of the skin), shock, and even coma.
Treatment must be initiated as soon as possible and consists of administering an emetic
(medicine that induces vomiting), followed, if necessary, by gastric lavage, and providing appropriate supportive therapy. The possible administration of an iron chelator
(a medicine able to bind and remove iron from the body), such as desferrioxamine, should also be evaluated.
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 following side effects have been reported with the use of Ferlatum:

diarrhoea,
constipation,
nausea,
epigastric pain (stomach, abdominal, chest pain). These side effects occur particularly at higher doses and resolve upon discontinuation of treatment or dose reduction.

Iron-containing preparations may turn stools black or dark grey.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist.
You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ferlatum

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The indicated expiry date applies to the product stored in its original, unopened packaging and correctly stored.
Store this medicine at a temperature not exceeding 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ferlatum contains

The active substance is iron protoporphyrin (ferriprotinate). One single-dose container contains 800 mg of ferriprotinate (equivalent to 40 mg of Fe).
The other components are: sorbitol E420, propylene glycol, methyl parahydroxybenzoate sodium salt, propyl parahydroxybenzoate sodium salt, blackcurrant flavour, sodium saccharin, purified water.

Description of the appearance of Ferlatum and contents of the pack
Ferlatum is a solution for oral use.
Pack contents: 10 or 20 single-dose containers of 15 ml each.
Marketing Authorization Holder
LIFEPHARMA S.p.A. – Via dei Lavoratori, 54 - 20092 Cinisello Balsamo (MI)
Selling Authorization Holder
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. - ROMA
Manufacturer
Italfarmaco S.A. - Calle S. Rafael, 3 Polígono Industrial – 28108 Alcobendas – Madrid - SPAIN