Ferplex

Package leaflet: Information for the patient

Ferplex 40 mg/15 ml oral solution

Ferriprotinate
Read 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ferplex is and what it is used for

Ferplex contains the active ingredient ferriprotinate, used to treat iron deficiency in the blood.
Ferplex is used for the treatment of absolute or relative iron deficiency states such as: latent or manifest sideropenic anaemias (caused by inadequate iron intake or absorption), anaemias of childhood and adulthood, anaemias due to chronic haemorrhage, and anaemias occurring during pregnancy and lactation.

2. What you need to know before taking Ferplex

Do not take Ferplex

• if you are allergic to iron protoporphyrin 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 inflammation of the liver) secondary to hemochromatosis (excessive accumulation of iron in the body);
• if you have hemosiderosis or hemochromatosis (conditions characterized by excessive iron accumulation in the body);
• if you have aplastic anemia (inadequate production of blood cells in the bone marrow), hemolytic anemia (excessive destruction of red blood cells), or iron-utilization deficiency anemia (sideroblastic anemia).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ferplex.
The cause of iron deficiency or anemia should be identified, and in addition to iron therapy, your doctor will prescribe treatment for these conditions, if available.
This medicine does not pose risks of habituation or dependence. However, administration should not exceed 6 months unless there is continuous bleeding, menorrhagia (excessive blood loss during menstrual cycle), or pregnancy.
Pay particular attention if you have milk protein intolerance, as you may experience allergic reactions.

Other medicines and Ferplex
Tell 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 entering the body after administration) of the following medicines:
tetracyclines and quinolones (antibiotics),
bisphosphonates (used for osteoporosis and certain tumors),
penicillamine (used for rheumatoid arthritis and certain liver and kidney disorders),
thyroxine (a hormone),
levodopa and carbidopa (used for Parkinson's disease),
alpha-methyldopa (used for high blood pressure).
Take Ferplex at least 2 hours apart from these medicines.

Ferplex 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 Ferplex at least 2 hours apart from ingestion of these foods.

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.

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

FERPLEX contains sorbitol, sodium methyl para-hydroxybenzoate, sodium propyl para-hydroxybenzoate, propylene glycol, and sodium.
This medicine contains 1400 mg of sorbitol (E-420) per single-dose container, equivalent to 93.3 mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine. Sorbitol may cause gastrointestinal disturbances and has a mild laxative effect.
Ferplex contains sodium methyl para-hydroxybenzoate and sodium propyl para-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
This medicine contains 61.1 mg of propylene glycol per single-dose container, equivalent to 4.1 mg/ml. If the child is less than 4 weeks old, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
This medicine may contain up to 46.7 mg (2 mmol) of sodium (a main component of table salt) per single-dose container. This corresponds to 2.33% of the maximum recommended daily dietary intake for an adult.

3. How to take Ferplex

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 a 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 is no information available regarding the use of this medicine at doses higher than those recommended.
If you take more Ferplex than you should
If you ingest or take an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
In such cases, symptoms may include: epigastralgia (stomach, abdominal, or chest pain), nausea, vomiting, diarrhoea, and haematemesis (vomiting of blood), often associated with drowsiness, pallor, cyanosis (bluish discoloration of the skin), shock, and even coma.
Treatment must be initiated as soon as possible and consists of administering an emetic (a medicine that induces vomiting), possibly followed by gastric lavage, and providing appropriate supportive therapy. The administration of an iron chelating agent, such as desferrioxamine, should also be considered.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Very rare (may affect up to 1 in 10,000 people)

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

Iron-containing preparations may darken stools, turning them black or dark grey.
Following the instructions contained in this leaflet reduces the risk of side effects.
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 the following website: https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ferplex

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 stated expiry date applies to the product in its original, unopened packaging, 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Ferplex contains

• The active substance is iron proteinat. One single-dose container contains 800 mg of iron proteinat (equivalent to Fe 40 mg).
• The other components are sorbitol E420, propylene glycol (E-1520), sodium methyl para-hydroxybenzoate (E-219), sodium propyl para-hydroxybenzoate (E-217), blackberry flavour (containing propylene glycol), sodium saccharin, sodium hydroxide, purified water.

Description of the appearance of Ferplex and contents of the pack
Ferplex is an oral solution.
Pack contents: 10 or 20 single-dose containers of 15 ml each.
Marketing Authorization Holder
Italfarmaco S.p.A. - Viale F. Testi, 330 - 20126 Milan
Manufacturer
Italfarmaco S.A. - Alcobendas - Madrid - Calle S. Rafael, 3