FERPLEX 60 mg /22,5 Ml Roztwór Doustny
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Jak stosować FERPLEX 60
Treść ulotki
Ferplex 60 mg/22.5 ml oral solution, mg granules for oral solution, mg tablets
Ferriprotinato
Read this leaflet carefully before taking this medicine as 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 they have the same symptoms as you, as it could be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Ferplex 60 is and what it is used for
- 2. What you need to know before you take Ferplex 60
- 3. How to take Ferplex 60
- 4. Possible side effects
- 5. How to store Ferplex 60
- 6. Contents of the pack and other information
1. What is Ferplex 60 and what is it used for
Ferplex contains the active ingredient ferriprotinate, which belongs to the therapeutic category
of anti-anemic drugs based on trivalent iron active by oral route.
This medicine is used for the treatment of absolute or
relative iron deficiency states: latent or manifest sideropenic anemias (anemia caused by a lack of iron in the body)
in childhood and adulthood, due to insufficient intake or insufficient
absorption of iron, or resulting from chronic bleeding, or infectious diseases,
pregnancy, breastfeeding.
2. What you need to know before taking Ferplex 60
Do not take Ferplex 60
- if you are allergic to iron(II) protein succinate or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from hemosiderosis (excess iron that deposits in the tissues);
- if you suffer from hemochromatosis (a disorder of iron metabolism that leads to iron accumulation in the tissues);
- if you have aplastic anemia (characterized by a decrease in the three components of the blood: red blood cells, white blood cells and platelets);
- if you have hemolytic anemia (excessive destruction of red blood cells);
- if you have sideroacrestic anemia (due to defective iron utilization);
- if you suffer from chronic pancreatitis (chronic inflammation of the pancreas) secondary to hemochromatosis;
- if you suffer from hepatic cirrhosis (chronic inflammation of the liver) secondary to hemochromatosis.
Warnings and precautions
Consult your doctor or pharmacist before taking Ferplex 60.
Once the cause of iron deficiency or anemia has been identified, in addition to iron therapy, your doctor will advise treatment for these conditions, if
available.
Pay particular attention when using Ferplex if you suffer from hepatic insufficiency (reduced
liver function). The liver is one of the major sites of iron storage; in case of
hepatic insufficiency (reduced liver function) a greater accumulation of
iron may occur.
The medicine does not pose a risk of habituation or dependence. Its administration
should not exceed 6 months, unless in the presence of continuous bleeding, menorrhagia
(excessive or prolonged menstruation) or pregnancy.
Use caution if you suffer from milk protein intolerance, as
allergic reactions may occur.
Other medicines and Ferplex 60
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Iron can reduce the absorption or bioavailability (the amount of medicine that enters
the body after administration) of:
tetracyclines(medicines belonging to the class of antibiotics),
bisphosphonates(medicines used to inhibit bone resorption),
quinolones(medicines belonging to the class of antibiotics),
penicillamine(medicine used in rheumatoid arthritis),
thyroxine(a hormone),
levodopaand carbidopa(medicines used in the treatment of Parkinson's disease),
alpha-methyldopa(medicine used to lower blood pressure).
Take Ferplex 60 at least 2 hours after taking these medicines.
The absorption of iron may be increased by the simultaneous administration of
more than 200 mg of ascorbic acid, or reduced by the simultaneous intake of antacids.
Chloramphenicol(a bacteriostatic antibiotic) may delay the response to therapy with
iron-based preparations
Substances that bind to iron (such as phosphates, phytates and oxalates) contained in vegetables and in
milk, coffee or tea inhibit iron absorption. Take Ferplex 60 at least 2 hours after
taking these foods.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
There are no particular precautions for use in pregnancy or breastfeeding, as
Ferplex 60 is particularly indicated in conditions of iron deficiency, which may occur
in these conditions.
Driving and using machines
Ferplex 60 does not impair the ability to drive vehicles or operate machinery.
Ferplex 60 mg/22,5 ml oral solution (single-dose container) contains sorbitol,
sodium, methylparaben and propylparaben
Ferplex 60 contains sorbitol. If your doctor has diagnosed you with an intolerance to some
sugars, contact him before taking this medicine.
Ferplex 60 contains 2.85 mmol of sodium per dose. This should be taken into account in people with
impaired renal function or who are following a low-sodium diet.
Ferplex 60 contains E218 sodium methylparaben and E216 sodium propylparaben which may cause allergic reactions (including delayed reactions).
Ferplex 60 mg granules for oral solution (sachet) contains sorbitol, lactose,
methylparaben and propylparaben
Ferplex 60 contains sorbitol and lactose. If your doctor has diagnosed you with an intolerance to
some sugars, contact him before taking this medicine.
Ferplex 60 contains E218 methylparaben and E216 propylparaben which may
cause allergic reactions (including delayed reactions).
Ferplex 60 mg tablets contains methylparaben and propylparaben
Ferplex 60 contains E218 methylparaben and E216 propylparaben which may
cause allergic reactions (including delayed reactions).
3. How to take Ferplex 60
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Ferplex 60 mg/22,5 ml oral solution (single-dose containers)
Adults: 2 containers per day (equivalent to 120 mg of Fe 3+), divided into two administrations, before meals.
Use in children:1 container per day (equivalent to 60 mg of Fe 3+), before meals, for a body weight less than 40 kg;
2 containers per day (equivalent to 120 mg of Fe 3+) for a body weight greater than 40 kg, in 2 administrations.
Ferplex 60 mg granules for oral solution (sachets)
Adults: 2 sachets per day (equivalent to 120 mg of Fe 3+), divided into 2 administrations, before meals.
Ferplex 60 mg tablets
Adults: 2 tablets per day (equivalent to 120 mg of Fe 3+), divided into 2 administrations, before meals.
Duration of treatment:The treatment must be continued until the body has restored its normal iron stores (usually two to three months).
Maximum daily dose:there are no indications regarding the use of the medicine at dosages higher than those recommended.
If you take more Ferplex 60 than you should
In case of an overdose of iron salts, epigastralgia (pain localized in the epigastrium, a region of the abdomen), nausea, vomiting, diarrhea and hematemesis (vomiting of blood) may occur, often associated with drowsiness, pallor, cyanosis (bluish discoloration of the skin caused by insufficient oxygenation of the blood), shock, up to coma.
In case of accidental ingestion/intake of an excessive dose of Ferplex 60 immediately notify your doctor or go to the nearest hospital.
Treatment should be as prompt as possible and consists of the administration of an emetic (a medicine that induces vomiting), possibly followed by gastric lavage, and in performing the necessary supportive therapies. It is also advisable to administer an iron chelator (a medicine used to remove metals deposited in the body in toxic concentrations), such as deferoxamine.
If you have any doubts 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 gets them.
Very rarely, gastrointestinal disorders such as may occur:
- diarrhea,
- constipation,
- nausea,
- epigastralgia (pain localized to the epigastrium). These adverse events occur particularly with higher dosages and regress with discontinuation of treatment or dose reduction.
Iron-based preparations may cause stools to become black or dark gray.
undesirable.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
please inform your doctor or pharmacist. You can also report side effects
directly through 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 Ferplex 60
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging after
Expiry. The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging,
correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What Ferplex 60 contains
Ferplex 60 mg/22.5 ml oral solution (single-dose containers)
- The active ingredient is iron proteinate. One single-dose container of 22.5 ml of oral solution contains 1200 mg of iron proteinate (equivalent to 60 mg of Fe).
- The other ingredients are: sorbitol, propylene glycol, E218 sodium methylhydroxybenzoate, E216 sodium propylhydroxybenzoate, Morella flavour, sodium saccharin, sodium hydroxide, purified water q.s. to 22.5 ml.
Ferplex 60 mg granules for oral solution (sachets)
- The active ingredient is iron proteinate. One sachet of 7.5 g contains 1200 mg of iron.
- The other ingredients are sorbitol, lactose, sodium lauryl sulfate, E218 methylhydroxybenzoate, E216 propylhydroxybenzoate, Caramel Mou flavour, Morella flavour, sodium saccharin.
Ferplex 60 mg tablets
- The active ingredient is iron proteinate. One tablet contains 1200 mg of iron proteinate (equivalent to 60 mg of Fe propionate (equivalent to 60 mg of Fe
).
- The other ingredients are: glyceryl palmitostearate, sodium carboxymethylcellulose, E218 methylhydroxybenzoate, E216 propylhydroxybenzoate.
Description of the appearance of Ferplex 60 and contents of the package
Ferplex 60 mg/22.5 ml oral solution
10 single-dose containers of oral solution of 1200 mg equivalent to 60 mg of Fe.
Ferplex 60 mg granules for oral solution
10 single-dose sachets for oral use of 1200 mg equivalent to 60 mg of Fe.
Ferplex 60 mg tablets
10 tablets for oral use of 1200 mg equivalent to 60 mg of Fe
.
Marketing Authorisation Holder
Italfarmaco s.p.a.Viale F. Testi, 330, 20126 Milano
Manufacturer
Ferplex 60 mg/22.5 ml oral solution
Italfarmaco s.a -Calle San Rafael, 3 - Alcobendas (Madrid)
Ferplex 60 mg granules for oral solution and tablets
Officina Farmaceutica Italfarmaco S.p.A.- v.le F.Testi, 330 - Milano
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- Kraj rejestracji
- Postać farmaceutycznaOral solution, 60 MG/22,5 ML
- Kod ATCB03AB09
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki FERPLEX 60Postać farmaceutyczna: Oral solution, 40 MG/15 MLSubstancja czynna: ferric proteinsuccinylateProducent: LIFEPHARMA S.P.A.Bez receptyPostać farmaceutyczna: Oral solution, 40 MG/15 MLSubstancja czynna: ferric proteinsuccinylateProducent: ITALFARMACO S.P.A.Bez receptyPostać farmaceutyczna: Hard capsule, 30 MGSubstancja czynna: ferric maltolProducent: NORGINE BVBez recepty
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FERPLEX 60 nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w FERPLEX 60 jest ferric proteinsuccinylate. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
FERPLEX 60 jest produkowany przez ITALFARMACO S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie FERPLEX 60 jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić FERPLEX 60 w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (ferric proteinsuccinylate) to m.in. FERLATUM, FERPLEX, FERAKKRU. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
