FERRO SANOL

FERRO SANOL überzogene Tabletten

Important notes (mandatory information)

ferro sanol® 40 mg coated tablets. Active ingredient: Iron(II) glycine sulfate complex. Areas of application: Iron deficiency, iron deficiency anemia in adults and children aged 6 and over (with a body weight of at least 20 kg).

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


Patient information: Information for users
ferro sanol® 40 mg coated tablets
For use in adults and children aged 6 and over
Active ingredient: Iron(II) glycine sulfate complex

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. 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 is in this package leaflet
1. WHAT ARE FERRO SANOL COATED TABLETS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING FERRO SANOL COATED TABLETS?
3. HOW TO TAKE FERRO SANOL COATED TABLETS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE FERRO SANOL COATED TABLETS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE FERRO SANOL COATED TABLETS AND WHAT ARE THEY USED FOR?

ferro sanol coated tablets are an oral iron preparation for iron deficiency. ferro sanol coated tablets are used to treat iron deficiency and iron deficiency anemia.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING FERRO SANOL COATED TABLETS?

ferro sanol coated tablets 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 have an esophageal stricture.
. if you suffer from a hereditary iron storage disease (hemochromatosis).
. if you suffer from iron overload (chronic hemolysis, thalassemia, other hemoglobinopathies).
. if you suffer from iron utilization disorders (e.g. sideroachrestic anemia, lead anemia).
. if you receive repeated or chronic blood transfusions.
. by children under 6 years of age (with a body weight below 20 kg).

Warnings and precautions
Please talk to your doctor or pharmacist before taking ferro sanol coated tablets.

Special care should be taken when taking ferro sanol coated tablets,
. if you have existing diseases of the digestive tract such as chronic inflammatory bowel diseases, intestinal strictures, diverticula of the intestine, gastritis, stomach and intestinal ulcers.
. in elderly patients and patients with severe renal impairment, as no reliable clinical data are available.
. in patients with hepatic impairment and in patients who suffer from alcoholism.
. if you suffer from chronic kidney disease and require erythropoietin, iron should be administered intravenously, as orally administered iron is poorly absorbed in uremic individuals.
. in elderly people with initially unexplained iron deficiency or anemia. Here, the cause of the iron deficiency or the source of bleeding must be carefully investigated.
. in children, as an overdose can lead to poisoning.

Note
Tooth discoloration may occur during treatment with ferro sanol coated tablets. According to the scientific literature, this tooth discoloration can regress spontaneously after discontinuation of the drug or must be removed by using an abrasive toothpaste or by professional teeth cleaning.

Taking ferro sanol coated tablets with other medicines
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan to take/use any other medicines. Iron inhibits the absorption of many medicines. The time interval between taking ferro sanol coated tablets and the following medicines should be as long as possible. Keep a time interval of at least 2 hours.

Increased effect and possible increased side effects
Pain and rheumatism medicines (e.g. salicylates and phenylbutazone) can increase the gastrointestinal mucosal irritation of ferro sanol coated tablets.

The simultaneous administration of intravenous iron-containing medicines together with oral dosage forms of iron can cause a drop in blood pressure (hypotension) or even collapse due to the too rapid release of iron and saturation of transferrin. The combination is not recommended. Reduced effect With simultaneous administration of iron with bisphosphonates (medicines for the treatment of osteoporosis), both the absorption of iron and the absorption of bisphosphonates are reduced.
Colestyramine or Ca2+, Mg2+, Al3+-containing medicines (e.g. antacids, calcium and magnesium salts for substitution) inhibit the absorption of iron.
Penicillamine, oral gold compounds, L-methyldopa, levodopa and L-thyroxine are less well absorbed when taken together with iron.
Proton pump inhibitors (medicines that reduce the production of stomach acid) such as omeprazole can reduce the absorption of oral iron. Therefore, a dose adjustment or a change to an intravenously administered iron-containing medicine may be necessary. No data from clinical studies are available. The absorption of fluoroquinolones (certain antibiotics, e.g. ciprofloxacin, levofloxacin, norfloxacin, gatifloxacin and ofloxacin) is greatly reduced when taken together with iron. Fluoroquinolones should be taken at least 2 hours before or at least 4 hours after ferro sanol coated tablets.
With simultaneous administration of iron with tetracyclines (certain antibiotics, e.g. doxycycline), both the absorption of iron and the absorption of tetracyclines are reduced. The administration of doxycycline together with ferro sanol coated tablets should be avoided. A time interval of at least 3 hours should be kept between taking ferro sanol coated tablets and tetracyclines other than doxycycline.

Note
The stool may become dark in color, which is not due to gastrointestinal bleeding. The stool blood tests commonly used today may give false positive results.

Taking ferro sanol coated tablets with food and drink
Substances contained in plant-based foods (e.g. cereal products and vegetables) that form complexes with iron (e.g. phytates, oxalates and phosphates), as well as components of coffee, tea, milk and cola drinks, inhibit the absorption of iron into the blood. Calcium-containing foods and drinks should be taken independently of ferro sanol coated tablets, as simultaneous intake reduces the absorption of iron. The time interval between taking ferro sanol coated tablets and the aforementioned foods and drinks should be as long as possible. Keep a time interval of at least 2 hours.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy and breastfeeding
In the recommended dosage, there are no restrictions on the use of ferro sanol coated tablets. Fertility There are no data on impaired fertility in connection with the use of ferro sanol coated tablets in humans.

Driving and operating machinery
No special precautions are required.

ferro sanol coated tablets contain lactose monohydrate, sucrose and glucose.
Therefore, please only take ferro sanol coated tablets after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW TO TAKE FERRO SANOL COATED TABLETS?

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.

For all age groups, weight classes and dosage groups, the dosage must be adjusted according to the patient's needs and the response of the clinical variables (e.g. hemoglobin, ferritin, transferrin) must be monitored by your doctor.

A daily dose of 5 mg Fe2+/kg body weight should not be exceeded.

Unless otherwise prescribed by your doctor, the usual dose is Adults
At the beginning of treatment
1 to 2 coated tablets 3 times a day, then 1 coated tablet 1 to 2 times a day.

Children and adolescents
ferro sanol coated tablets must not be used in children under 6 years of age (with a body weight of less than 20 kg) (see section 2).

Children aged 6 and over (with a body weight of at least 20 kg)
1 coated tablet 1 to 2 times a day

Elderly patients
There are no clinical data indicating that a dose adjustment is necessary in elderly patients.

Patients with renal or hepatic impairment
There are no clinical data indicating that a dose adjustment is necessary in patients with renal or hepatic impairment. Ferro sanol coated tablets should be used with caution in patients with hepatic impairment and in patients who suffer from alcoholism.

In patients with chronic kidney disease who require erythropoietin, iron should be administered intravenously.

Method of administration
Please take ferro sanol coated tablets unchewed with sufficient water (preferably a glass). They should be taken either on an empty stomach in the morning (approx. 1 hour before breakfast) or at a sufficient interval of approx. 2 hours before or after a meal.

Duration of use
The duration of use is determined by the doctor.
The replenishment of the body's iron stores usually takes between 3 and 6 months, depending on the severity of the anemia and the individual circumstances.

Please talk to your doctor or pharmacist if you have the impression that the effect of ferro sanol coated tablets is too strong or too weak.

If you have taken more ferro sanol coated tablets than you should
If you have taken too many ferro sanol coated tablets, you should inform a doctor immediately. In the event of an intentional or accidental overdose, the symptoms described in section 4. "What side effects are possible" will be more pronounced. Should an overdose occur with clinical signs of poisoning, consult a doctor immediately.

An overdose can cause poisoning, especially in children.

If you forget to take ferro sanol coated tablets
Do not take a double dose if you have forgotten to take the previous dose. If you have accidentally forgotten to take ferro sanol coated tablets one or more times, this will prolong the overall duration of therapy.

If you stop taking ferro sanol coated tablets
If you stop taking ferro sanol coated tablets, the success of the therapy is at risk.

If you have any further questions on 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 categories are used to classify the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known	frequency cannot be estimated from the available data.

Gastrointestinal disorders

Common

- Gastrointestinal complaints
- Diarrhea
- Constipation
- Heartburn
- Nausea
- Vomiting
The frequency increases with increasing dose.
A dark discoloration of the stool that occurs during treatment can be attributed to the iron content and is harmless.

Rare

- Reversible discoloration of the teeth

Not known

- Abdominal pain
- Upper abdominal pain

Skin and subcutaneous tissue disorders

Rare

- Hypersensitivity reactions (e.g. skin reactions, exanthema, rash and hives)

Not known

- Anaphylactic reaction

Reporting of side effects
If you notice 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: http://www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FERRO SANOL COATED TABLETS?

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the blister strips and the folding box. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What ferro sanol coated tablets contain
The active ingredient is: Iron(II) glycine sulfate complex.
1 coated tablet contains 225 mg iron(II) glycine sulfate complex (equivalent to 40 mg Fe2+).

The other ingredients are:
Sucrose, talc, calcium carbonate, corn starch, gum arabic, spray-dried; povidone K 25, magnesium stearate (Ph.Eur.) (vegetable), glucose syrup, gelatin, lactose monohydrate, glycerol 85%, stearic acid, macrogol 6000, montan glycol wax, highly dispersed silicon dioxide, titanium dioxide (E 171)

What ferro sanol coated tablets look like and contents of the pack
ferro sanol coated tablets are shiny, white, round and coated, biconvex tablets. ferro sanol coated tablets are available in packs of 20, 49, 58, 98 and 100 coated tablets.
Not all pack sizes may be marketed.

Pharmaceutical entrepreneur
SANOL GmbH
Alfred-Nobel-Straße 10
40789 Monheim
Phone: 02173/48-4848
Fax: 02173/48-4841

Manufacturer
Aesica Pharmaceuticals GmbH
Alfred-Nobel-Straße 10
40789 Monheim

This leaflet was last revised in December 2014.

Source: Information from the package leaflet
Status: 09/2015
Active ingredient: Iron(II) glycine sulfate complex. Areas of application: Iron deficiency, iron deficiency anemia in adults and children aged 6 and over (with a body weight of at least 20 kg).