Ferrlecit 2 plated tablets, 100 pcs

Instructions for use for Ferrlecit 2 plated tablets, 100 pcs

Important notes (compulsory information):

Ferrlecit 2 280 mg, plated tablet. Active substance: Iron (II) succinate, anhydrous. Applications: For the therapy of iron deficiency states in child and adulthood.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


LEAFLET: INFORMATION FOR THE USER

Ferrlecit 2 280 mg, plated tablet
Active substance: iron (II) succinate, anhydrous

Read the entire leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine as described in this leaflet or just as your doctor or pharmacist is directed.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
• If you do not feel better or even worse, contact your doctor.

What is in this leaflet

1. What is Ferrlecit 2 and what is it used for?
2. What should you consider before taking Ferrlecit 2?
3. How to take Ferrlecit 2?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep Ferrlecit 2?
6. Content of the pack and more information

1. What is Ferrlecit 2 and what is it used for?

Ferrlecit 2 is a means of iron deficiency in the blood. Ferrlecit 2 Is used for the therapy of iron deficiency states in child and adulthood.

2. What should you consider before taking Ferrlecit 2?

Ferrlecit 2 must not be taken,

• if they are allergic to iron (II) succinate, yellow orange S-aluminum salt (E 110) or one of the section 6. other ingredients of this medicine are,
• if they suffer from diseases in which an enrichment of iron occurs (hemochromatoses, chronic hemolyses),
• if you suffer from iron recovery disorders (sideroblastic anemias, lead anemias, thalassaemias.
• if you receive repeatedly blood transfusions.

Warnings and Precautions:
Special care when taking Ferrlecit 2 is required,

• if you use dietary or other iron salt supplements to avoid the risk of possible overdose.
• if you suffer from inflammation or ulcers of the gastrointestinal mucosa. In these cases, the benefit of treatment should be carefully weighed against the risk of aggravating the gastrointestinal disease.
• if you suffer from chronic kidney disease and need erythropoietin. Then iron should be in a vein (intravenous) are administered, as in this case taken (orally administered) iron is poorly absorbed.
• in the case of older people with initially non-explanatory iron deficiency or anemia. Here you must carefully search for the cause of the iron deficiency or the bleeding source.
• for children, because above all, an overdose can lead to a poisoning.

The intake of Ferrlecit 2 tablets must be exposed to blood in the chair for a few days before a study, otherwise the test result is falsified. In these cases, it is essential to inform the attending physician about iron intake.

Taking Ferrlecit 2 together with other medicines:
Inform your doctor or pharmacist if you take / use other medicines, recently taken / applied or intend other medicines to take / use. Ferrlecit 2 should not be taken within the following 2-3 hours after administration of one of the following substances:

Reinforcement of the effect and possibly enhancement of side effects:

• Salicylates or non-steroidal anti-rheumatics (pain and rheumatics): With simultaneous use, the irritation of the iron can be reinforced on the mucosal of the gastrointestinal tract.
• Iron preparations for intravenous administration: The simultaneous administration of iron preparations for intravenous administration together with oral dosage forms of iron can cause a drop in blood pressure or a collapse due to rapid iron release by saturation of iron transport protein. The combination is not recommended.

Attachment of the effect:

• Tetracycline (certain antibiotics), methyldopa (medicines for hypertension), Levodopa (ParkinsonGuhrmittel), penicillamine and gold compounds (rheumatics): reducing the receptacle by iron salts.
• Chinolon antibiotics (eg ciprofloxacin, Levofloxacin, Norfloxazine, Ofloxacin): influence of absorption by iron salts.
• Thyroxine (thyroid hormones): iron salts reduce the intake of thyroxine in patients receiving a thyroxine thyroxine hormone replacement therapy.
• Cholestyramine (medicines for reducing blood fats), Antacida (CA2 +, MG2 +, AI3 + salts) (gastric acid-binding medicines) As well as calcium and magnesium supplementary preparations: reducing iron intake.
• Bisphosphonates (medicines for the treatment of osteoporosis): With simultaneous application, the uptake of bisphosphonates can be impaired.

Taking Ferrlecit 2 together with food and beverages:
Iron-binding foods (phosphates containing in them, phytate or oxalate) and drinks such as milk, coffee and tea inhibit iron uptake and should be taken from them only with a large temporal distance (2-3 hours) for ferrlecit 2 intake.

Pregnancy and breast feeding period:
If you are pregnant or breastfeeding or if you suspect to be pregnant, or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Reports on unwanted effects after taking oral iron preparations in therapeutic doses for the treatment of a bloodlessness in pregnancy are not yet known. If you are pregnant or breastfeed, you can take Ferrlecit 2 for the treatment of iron deficiency states in the intended dosage.

Driving and ability to operate machines:
There are no special precautions required.

Ferrlecit 2 contains sucrose:
This medicine contains sucrose. Please take Ferrlecit 2 Only after consultation with your doctor, if you know that you suffer from an intolerance to certain sugars.

3. How to take Ferrlecit 2?

Always take this medicine exactly as described in this leaflet or just according to the consultation made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by the doctor, the usual dose is:

• Children (6-12 years): 1 tablet 1 tablet 1 times a day,
• Adults, adolescents and children from 12 years: 1 tablet 1-2 times a day.

A daily intake of 5 mg Fe2 + / kg body weight should not be exceeded (a tablet Ferrlecit 2 with 280 mg iron (II) succinate contains at least 95.2 mg Fe2 + ions).

Type of application:
To take. Please take the tablets so far with sufficient fluid during the meal (preferably a glass 200 ml drinking water).

Duration of application:
The duration of the application determines your attending physician. It depends on the hemoglobin value and is about 3-6 months. Please talk to your doctor or pharmacist if you have the impression that the effect of ferrlecit 2 too strong ODhe is too weak.

If you take a larger amount of ferrlecit 2 than you should:
If you take Ferrlecit 2 into large quantities, you should immediately inform a doctor. To treat iron poisoning, the administration of milk or raw eggs is recommended to bind the metal ions. As a specific antidote (antidote) Serves deferoxamine. In order to neutralize iron still in the gastrointestinal tract and to escape the recording, 5-10 g of deeroxamine (children up to 5 g) in 50-100 ml of fluid (Tap water) give and take. If the iron mirror in the blood exceeds 3 mg / l and the iron binding capacity of the iron transport protein is exceeded, the infusion in a vein of 1-2 g of deferoxamine (maximum 16 mg / kg bw / hour) becomes recommended. The infusion should be repeated the next day, if necessary and the serum iron values should be checked. Signs of overdose with ferrlecit 2 may be in a first phase nausea, bloody vomiting, bloody diarrhea and shock. After a phase of apparent recovery, there is a newly heavy shock; It can be a Cheyne-Stokes breathing (Periodically degrading and increasing respiratory depth) and finally can under cramps and any toxic hepatitis (Lebeneritis) death occurs. A lack of platelets (Thrombocytopenia) and at a certain coagulation factor (Hypophrothrombinemia) with hemorrhagic diathesis (Bleeding tendency) as well as central and peripheral paralysis are possible. If poisoning does not endanger, serious organ damage can develop such as pylorus, drugs (constriction of the gastric output), liver cirrhosis (chronic liver disease) and damage to the central nervous system.

If you forget to take Ferrlecit 2:
Do not take the double amount when you forget the previous taking. Take your next dose at the usual time.

If you cancel the intake of ferrlecit 2:
If the treatment with ferrlecit 2 is interrupted or terminated prematurely, a sufficient compensation of the iron deficiency is not guaranteed. Please contact your doctor immediately.

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other. As with all iron-containing preparations, occasional gastrointestinal disorders and constipation can occur. Yellow-orange S-aluminum salt (E 110) can cause allergic reactions.

Note:
After taking Ferrlecit 2, as with all iron-containing preparations, it can come to a harmless black staining of the chair.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also share effects directly

Federal Institute for Pharmaceuticals and Medical Products
Dept. Pharmacovigilance
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Website: www.bfarm.de

Show. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep Ferrlecit 2?

Keep this medicine inaccessible to children. You may not use this medicine after the expiry date specified on the carton and blister pack according to "until". The expiry date refers to the last day of the specified month. Storage conditions: Do not store more than 25 ° C.

6. Content of the pack and more information

What contains Ferrlecit 2:
The active ingredient is iron (II) succinate, anhydrous. 1 coated tablet contains 280 mg of iron (II) succinate (corresponding to at least 95.2 mg FE2 + ions).

The other ingredients are:
Amber acid, cellulose powder, sucrose, copovidone, magnesium stearate (ph. EUR.) Plant, glycerol 85%, talc, calcium carbonate, macrogol 35,000, starch hydrolyzate (Dry matter), Arab rubber, Povidon K 25, Sodium monohydrogen phosphate dihydrate (Ph. EUR.), Dinodium hydrogen phosphate 7 H2O, potassium dihydrogen phosphate, montanglycol wax, titanium dioxide (E 171), erythrosine aluminum salt (E 127), yellow orange S-aluminum salt (E 110), iron oxides and -hydroxides (E 172).

Like Ferrlecit 2 looks and content of the pack:
The coated tablets are round, bikonvex, shiny and earthbeerer (diameter approx. 11.5 mm, height approx. 5.4 mm).
Packs of 20, 40, 50, 100 and 500 (10 x 50 = clinic packing) Plated tablets.

Pharmaceutic entrepreneur:
Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main
Postal address:
Mailbox 80 08 60
65908 Frankfurt am Main
Telephone: (0180) 2 22 20 10*
Fax: (0180) 2 22 20 11*
*0.06 € / call (dt. Landline); Max. 0.42 € / min (mobile radio).

Manufacturer:
A. Nattermann & Cie. GmbH
Nattermannallee 1
50829 Cologne
Telephone: (0221) 5 09 01
Fax: (0221) 5 09 27 11

This leaflet was last revised in January 2014.

Source: Information of the leaflet
Status: 01/2015