EISENTABLETTEN-

Iron tablets-ratiopharm 100 mg film-coated tablets

Important notes (mandatory information)

Iron tablets-ratiopharm 100 mg film-coated tablets. Active ingredient: Iron. Areas of application: for the treatment of iron deficiency.

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Iron tablets-ratiopharm 100 mg film-coated tablets for use in adults
Active ingredient: Iron

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse, talk to your doctor.

What this package leaflet contains

1. WHAT IS IRON TABLETS-RATIOPHARM 100 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING IRON TABLETS-RATIOPHARM 100 MG?
3. HOW TO TAKE IRON TABLETS-RATIOPHARM 100 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE IRON TABLETS-RATIOPHARM 100 MG?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS IRON TABLETS-RATIOPHARM 100 MG AND WHAT IS IT USED FOR?

Iron tablets-ratiopharm 100 mg is a medicine for the treatment of iron deficiency. Iron tablets-ratiopharm 100 mg is used to treat iron deficiency.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING IRON TABLETS-RATIOPHARM 100 MG?

Iron tablets-ratiopharm 100 mg must not be taken:

• if you are allergic to iron or any of the other ingredients of this medicine listed in section 6.
• if you suffer from anemia caused by infections or cancer, unless there is also an iron deficiency.
• if you have an accumulation of iron in the blood (elevated iron levels) and iron utilization disorders.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Iron tablets-ratiopharm 100 mg:

• if you suffer from inflammation or ulcers of the gastrointestinal mucosa. Talk to your doctor before taking Iron tablets-ratiopharm 100 mg. He will carefully weigh the benefits of treatment against the risk of worsening gastrointestinal disease.
• if you are also using dietary or other iron salt supplements. To avoid the risk of a possible iron overdose, talk to your doctor before taking Iron tablets-ratiopharm 100 mg.
• if you have difficulty swallowing.

Due to the risk of mouth ulcers (mouth ulcers) and tooth discoloration, the tablets must not be sucked, chewed or left in the mouth for a long time, but should be swallowed whole with water. If you are unable to follow these instructions or have difficulty swallowing, talk to your doctor. If you accidentally swallow a film-coated tablet, please inform your doctor as soon as possible. The reason for this is that there is a risk of ulcers forming and the bronchi narrowing after the film-coated tablet has entered the respiratory tract. This can lead to persistent coughing, coughing up blood and/or shortness of breath, even if the swallowing occurred days or months before the symptoms appear. Therefore, you must be examined immediately to ensure that the tablet does not damage your airways.

Taking Iron tablets-ratiopharm 100 mg with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Iron salts such as Iron tablets-ratiopharm 100 mg:

• reduce the absorption of:
  • certain antibiotics (tetracyclines).
  • Penicillamine (a medicine for rheumatic diseases).
  • Levodopa (a Parkinson's medicine).
  • Methyldopa (a medicine for high blood pressure).
  • Thyroxine (thyroid hormone) in patients who are being treated with thyroxine.
  • Zinc.
• affect the absorption of quinolone antibiotics (e.g. ciprofloxacin, levofloxacin, norfloxacin, ofloxacin).
• may increase the irritant effect on the mucous membrane of the gastrointestinal tract if taken at the same time as non-steroidal anti-inflammatory drugs (these include, for example, some common medicines for pain, fever and inflammation, such as acetylsalicylic acid, ibuprofen, diclofenac).

The absorption of iron is reduced by the simultaneous intake of the following medicines:

• Cholestyramine (a medicine to lower elevated blood fat levels).
• Antacids (calcium, magnesium, aluminum salts that bind stomach acid).
• Calcium, magnesium and zinc supplements.

You should not take Iron tablets-ratiopharm 100 mg within 2 - 3 hours of taking any of the above substances.

Taking Iron tablets-ratiopharm 100 mg with food and drink

You should take Iron tablets-ratiopharm 100 mg 1 hour before or possibly between meals, as food can interfere with iron absorption. Iron-binding substances such as phytates (e.g. from cereals), phosphoric acid salts (e.g. from milk), oxalic acid salts (e.g. from spinach or rhubarb), tannins (tea) or coffee inhibit the absorption of iron by the body.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking/using any medicine. Iron tablets-ratiopharm 100 mg should only be taken after careful consideration of the benefits and risks and consultation with your doctor and the high dosage of 2 film-coated tablets of Iron tablets-ratiopharm 100 mg per day should not be prescribed for a prolonged period of time. Iron tablets-ratiopharm 100 mg should only be prescribed during breast-feeding after careful consideration of the benefits and risks and after consultation with a doctor.

Driving and using machines

No effects are known.

Iron tablets-ratiopharm 100 mg contains lactose and sucrose (sugar)

Therefore, please only take Iron tablets-ratiopharm 100 mg after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE IRON TABLETS-RATIOPHARM 100 MG?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

Adults take 1 film-coated tablet of Iron tablets-ratiopharm 100 mg 1 to 2 times a day, corresponding to 100 - 200 mg of iron(II) ions.

Use in children and adolescents

Use in children and adolescents under 18 years of age is not intended.

Patients with kidney or liver disease

There are insufficient data for specific dosage recommendations in the case of impaired renal/hepatic function.

The film-coated tablets should be taken on an empty stomach in the morning or 1 hour before meals, without chewing, with sufficient liquid to prevent possible damage to the mucous membrane caused by stuck tablets. Do not suck or chew the tablet and do not leave the tablet in the mouth for a long time. The amount of iron to be supplied to the body depends on the stage of iron deficiency. Please ask your doctor about this.

Duration of use

The duration of treatment depends on the type and severity of the disease. In principle, iron therapy is necessary for a period of at least 8 weeks in order to achieve therapeutic success. After normalization of the blood values (hemoglobin), treatment should be continued for another 6 - 8 weeks to replenish the iron stores.

Please talk to your doctor or pharmacist if you have the impression that the effect of Iron tablets-ratiopharm 100 mg is too strong or too weak.

If you have taken more Iron tablets-ratiopharm 100 mg than you should

or if there is a suspicion of an overdose due to uncontrolled or unintentional intake, especially by children, a doctor must be consulted immediately!

If you forget to take Iron tablets-ratiopharm 100 mg

In principle, medicines should be taken as prescribed by the doctor. Do not take double the amount if you have forgotten to take the previous dose, but continue taking it as originally intended.

If you stop taking Iron tablets-ratiopharm 100 mg

Please contact your doctor or pharmacist beforehand, who can best assess any possible effects on your well-being.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated
Common	1 to 10 in 100 treated
Uncommon	1 to 10 in 1,000 treated
Rare	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known	Frequency cannot be estimated from the available data.

Common

Darkening of the stool. However, this is a completely harmless event after taking oral iron preparations.

Uncommon

Gastrointestinal disorders and constipation. Constipation can be relieved by a balanced diet.

Rare

Hypersensitivity reactions (e.g. skin reactions)

Not known

Mouth ulcers (if used incorrectly, if the tablets are chewed, sucked or left in the mouth for a long time). In all patients, but especially in elderly patients or patients with difficulty swallowing, there is also a risk of ulcers in the throat, esophagus (the connection between the mouth and stomach) or bronchi (the main airways of the lungs) if the tablets enter the respiratory tract, leading to narrowing of the bronchi.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE IRON TABLETS-RATIOPHARM 100 MG?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister packs after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Iron tablets-ratiopharm 100 mg contains

The active ingredient is: dried iron(II) sulfate. Each film-coated tablet contains 302.237 - 309.106 mg of dried iron(II) sulfate, corresponding to 100 mg of elemental iron. The other ingredients are: maltodextrin, calcium stearate (Ph.Eur.), lactose monohydrate, copovidone, macrogol 4000, talc, calcium carbonate (E 170), cocoa butter, magnesium stearate (Ph.Eur.) (vegetable), shellac, titanium dioxide (E 171), cellulose powder, corn starch, sodium carboxymethyl starch (type A) (Ph.Eur.), sodium dodecyl sulfate, sucrose, povidone K25, iron oxides and hydroxides (E 172).

What Iron tablets-ratiopharm 100 mg looks like and contents of the pack

Round, convex and brown film-coated tablet. Iron tablets-ratiopharm 100 mg is available in packs of 20, 50 and 100 film-coated tablets.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren

This leaflet was last revised in November 2019.

Source: Information from the package leaflet
Status: 07/2020
Active ingredient: Iron. Areas of application: for the treatment of iron deficiency.