FERRO KOMPLEX 126 mg/10 ml Roztwór doustny
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Treść ulotki
FERRO COMPLEX 695 mg (80 mg Fe ) effervescent granules, 126 mg /10 ml (15.7 mg Fe ) powder and solvent for oral solution
Ferrous gluconate
Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What FERRO COMPLEX is and what it is used for
- 2. What you need to know before you take FERRO COMPLEX
- 3. How to take FERRO COMPLEX
- 4. Possible side effects
- 5. How to store FERRO COMPLEX
- 6. Contents of the pack and other information
1. What is FERRO COMPLEX and what it is used for
FERRO COMPLEX contains the active ingredient iron gluconate which belongs to a group of
medicines called anti-anemic agents that work by increasing the number of red blood cells and helping to
counteract anemia, a condition caused by a decrease in the level of hemoglobin (a protein
present in red blood cells capable of transporting oxygen).
This medicine is indicated for the treatment of anemia due to iron deficiency.
2. What you need to know before taking FERRO COMPLEX
Do not take FERRO COMPLEX
- if you are allergic to ferrous gluconate, to similar medicines (chemically related substances) or to any of the other ingredients of this medicine (listed in section 6);
- if you have a condition characterised by iron accumulation in certain parts of the body (haemosiderosis, haemochromatosis);
- if you suffer from other forms of anaemia not due to a lack of iron in the body (non-sideropenic haemolytic anaemias);
- if you suffer from chronic inflammation of the pancreas (chronic pancreatitis);
- if you suffer from a severe liver problem (liver cirrhosis);
- if you have lesions in the stomach or intestines (active peptic ulcer);
- if you suffer from inflammatory bowel diseases (Crohn's disease, ulcerative colitis);
- if you are undergoing frequent blood transfusions;
- if you receive iron via intravenous infusion (parenterally).
Warnings and precautions
Talk to your doctor or pharmacist before taking FERRO COMPLEX.
Take this medicine with caution and inform your doctor if:
- you suffer from intestinal problems (intestinal stenosis, diverticula);
- you are taking dietary supplements or other products containing iron;
- you have inflammation or lesions of the stomach or intestines (gastrointestinal mucosa);
You must only take this medicine after your doctor has diagnosed a form of anaemia
due to iron deficiency in the body (sideropenic anaemia).
Children
In children, this medicine must be taken under strict medical supervision. Doses
higher than 400 mg can cause serious toxicity problems (See section “Use in
children”).
Other medicines and FERRO COMPLEX
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Take this medicine with caution and inform your doctor if you are taking the following medicines:
- tetracyclines, penicillamines, quinolone antibiotics (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin) used for the treatment of infections;
- levodopa for the treatment of Parkinson's disease;
- methyldopa for the treatment of high blood pressure;
- thyroxine used in case of thyroid problems;
- cholestyramine used to lower cholesterol levels in the blood;
- calcium and magnesium supplements;
- mycophenolate used following an organ transplant;
- non-steroidal anti-inflammatory drugs, such as salicylates, used to relieve pain and inflammation;
- antacids (magnesium and aluminium salts) used for stomach disorders. If it is necessary to take antacids during treatment with FERRO COMPLEX, it is recommended to take these medicines 2-3 hours apart.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
FERRO COMPLEX can be used if you are pregnant. The doctor will determine the dose of FERRO
COMPLEX to be taken based on your health condition (response to therapy, gastrointestinal
tolerance), considering that, in the second part of pregnancy, it is necessary to take 6 mg
of iron per day. If you need to take high doses of the medicine, it is recommended to divide them into 3-4
administrations per day.
Breastfeeding
This medicine is not recommended during breastfeeding.
Driving and using machines
This medicine does not impair the ability to drive vehicles and operate machinery.
FERRO COMPLEX effervescent granules
This medicine contains:
- 80 mg of aspartameper sachet. Aspartame is a source of phenylalanine which may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to build up because the body cannot break it down properly.
- 205.5 mg of sodium(the main component of table salt) per sachet. This is equivalent to approximately 10.3% of the recommended maximum daily intake with the diet of an adult. Talk to your doctor or pharmacist if you need more sachets per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.
- sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine. It may be harmful to your teeth.
- the colourant yellow orange (E110), which may cause allergic reactions.
FERRO COMPLEX powder and solvent for oral solution
This medicine contains:
- sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine. It may be harmful to your teeth.
- Parabens (methyl hydroxy benzoate, propyl hydroxy benzoate)which may cause allergic reactions (including delayed reactions).
3. How to take FERRO COMPLEX
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
FERRO COMPLEX should be taken half an hour before meals.
Effervescent granules
The recommended dose is 1 sachet per day dissolved in water. Unless otherwise prescribed by your doctor.
Powder and solvent for oral solution
The recommended dose is 1 vial, 1-2 times a day. Unless otherwise prescribed by your doctor
Using the tear-open tab, remove the closure cap of the vial and press on the plunger at the top, in
order to let the contents of the cap fall into the solution below.
Shake for 30 seconds, until the contents are completely dissolved.
You can ingest the resulting solution directly or you can dilute it first in a glass of water and other
drinks, such as milk or fruit juices.
In more severe cases, the doctor may decide to increase the dose based on the results of blood tests
that must be performed 2-3 times a week, after the start of treatment.
Use in children
The recommended dose is 1 vial of powder and solvent for oral solution, 1-2 times a day
depending on the child's weight. The medicine must be taken by mouth (orally), half an hour before
meals.
If after 3 weeks of treatment you do not experience any improvement, inform your doctor.
If you take more FERRO COMPLEX than you should
In case of accidental ingestion/intake of an excessive dose of FERRO COMPLEX, immediately
notify your doctor or go to the nearest hospital.
In case of taking an excessive dose of this medicine, the following symptoms may occur:
- stomach pain (epigastralgia);
- nausea;
- vomiting, even with blood (hematemesis);
- diarrhea;
- drowsiness;
- paleness;
- bluish discoloration of the skin (cyanosis);
- severe circulatory problem (shock);
- deep state of unconsciousness (coma);
- death, especially in children. The doctor will establish the most appropriate therapy based on the severity of the symptoms.
If you forget to take FERRO COMPLEX
Do not take a double dose to make up for a missed dose.
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.
The following side effects may occur:
Frequency not known(frequency cannot be estimated from available data):
- vomiting;
- nausea;
- diarrhoea;
- stomach or intestinal bleeding (gastrointestinal haemorrhage);
- black stools;
- dark urine;
- temporary discolouration of the teeth;
- allergic reactions. Reporting of side effects If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 FERRO COMPLEX
Keep this medicine out of the sight and reach of children.
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, for the product in intact packaging
and correctly stored.
Effervescent granules: store at a temperature below 25° C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What FERRO COMPLEX contains
FERRO COMPLEX 695 mg (80 mg Fe) effervescent granules
- The active ingredient is iron gluconate. Each sachet contains 695 mg (equivalent to 80 mg of Fe).
- The other ingredients are: ascorbic acid, citric acid, tartaric acid, sodium bicarbonate, sodium carbonate monohydrate, sodium saccharin, aspartame, sucrose, orange flavour, yellow orange (E110).
FERRO COMPLEX 126 mg /10 ml (15.7 mg Fe) powder and solvent for oral solution
- The active ingredient is iron gluconate. Each vial contains 126 mg (equivalent to 15.7 mg of Fe++).
- The other ingredients are: sucrose, caramel, methyl hydroxybenzoate, propyl hydroxybenzoate, caramel flavour, purified water.
Description of the appearance of FERRO COMPLEX and contents of the pack
FERRO COMPLEX 695 mg (80 mg Fe) effervescent granules
Box of 30 sachets.
FERRO COMPLEX 126 mg /10 ml (15.7 mg Fe) powder and solvent for oral solution
Box of 10 single-dose vials with reservoir cap and closing capsule.
Marketing Authorisation Holder
PHARMAFAR S.r.l. - Corso Vittorio Emanuele II, 82 - 10121 - Turin – Italy
Manufacturers
Effervescent granules
LA.FA.RE. S.r.l. - Pharmaceutical Laboratory - Via Sac. Benedetto Cozzolino 77 - Ercolano (NA) – Italy
Powder and solvent for oral solution
ABC FARMACEUTICI S.p.A. - Strada Vicinale dei Moretti – Ivrea (TO) – Italy
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- Kraj rejestracji
- Postać farmaceutycznaOral solution, 126 MG/10 ML
- Kod ATCB03AA03
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki FERRO KOMPLEXPostać farmaceutyczna: Effervescent tablet, 80 MGSubstancja czynna: ferrous gluconateBez receptyPostać farmaceutyczna: Effervescent tablet, 80 MGSubstancja czynna: ferrous gluconateProducent: EG S.P.A.Bez receptyPostać farmaceutyczna: Effervescent tablet, 80 MGSubstancja czynna: ferrous gluconateBez recepty
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FERRO KOMPLEX 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 FERRO KOMPLEX jest ferrous gluconate. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
FERRO KOMPLEX jest produkowany przez PHARMAFAR S.R.L.. 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 FERRO KOMPLEX 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 FERRO KOMPLEX 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 (ferrous gluconate) to m.in. KROMATONFERRO, FERRO LUKONATO EG, FERROGYN. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
