Ferro Sanol Duodenal for iron deficiency, 100 capsules

ferro sanol duodenal 100 mg hard capsules. Active ingredient: Iron(II) glycine sulfate complex. Indications: for iron deficiency, especially iron deficiency anemia, during pregnancy and breastfeeding, in childhood with an iron-deficient diet, after chronic and acute blood loss.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

ferro sanol duodenal 100 mg hard capsules, for use in children from 6 years of age and adults.
Active ingredient: Iron(II) glycine sulfate complex.

Read the entire package leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

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

What this package leaflet contains

1. WHAT IS FERRO SANOL DUODENAL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING FERRO SANOL DUODENAL?
3. HOW SHOULD FERRO SANOL DUODENAL BE TAKED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD FERRO SANOL DUODENAL BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT IS FERRO SANOL DUODENAL AND WHAT IS IT USED FOR?

Ferro Sanol Duodenal is an oral iron supplement for iron deficiency. Ferro Sanol Duodenal is used for iron deficiency, especially iron deficiency anemia, during pregnancy and breastfeeding, in childhood with a low-iron diet, and after chronic and acute blood loss.

2. WHAT SHOULD YOU KNOW BEFORE TAKING FERRO SANOL DUODENAL?

Ferro Sanol Duodenal 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 a narrowing of the esophagus.
• if you suffer from an inherited 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.
• of children under 6 years of age (with a body weight under 20 kg).

Warnings and precautions:
Please talk to your doctor or pharmacist before taking Ferro Sanol Duodenal. Special care is required when taking Ferro Sanol Duodenal:

• if you suffer from existing diseases of the digestive tract such as chronic inflammatory bowel diseases, intestinal strictures, diverticula, gastritis
• (Gastritis), stomach and intestinal ulcers. The occurrence and severity of damage to the gastrointestinal mucosa depend on the local concentration of free iron ions. Due to the special dosage form of Ferro Sanol Duodenal, high local drug concentrations are avoided and potential mucosal damage is minimized.
• In older people with initially unexplained iron deficiency or anemia, the cause of the iron deficiency or the source of bleeding must be carefully investigated.
• If you suffer from a severe and chronic kidney disease and require erythropoietin, then iron should be administered intravenously, as orally administered iron is poorly absorbed in uremic individuals.
• in patients with liver dysfunction and in patients suffering from alcoholism.
• especially in children, as an overdose can lead to poisoning.

Note:
Tooth discoloration may occur during treatment with Ferro Sanol Duodenal. According to scientific literature, this discoloration may disappear spontaneously after discontinuing the medication or may need to be removed by using an abrasive toothpaste or by professional dental cleaning.

Taking Ferro Sanol Duodenal with other medications:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. Iron inhibits the absorption of many medications. The time interval between taking Ferro Sanol Duodenal and the following medications should be as long as possible. Maintain an interval of at least 2 hours.

Increased effect and possible increase in side effects:
Pain relievers and anti-inflammatory drugs (e.g., salicylates and phenylbutazone) may increase the irritating effect of Ferro Sanol Duodenal on the gastrointestinal mucosa. When taking Ferro Sanol Duodenal and tetracyclines (except doxycycline), an interval of at least 3 hours should be observed.

Reduced effectiveness:
When iron is administered concurrently with bisphosphonates (medicines for the treatment of osteoporosis), the absorption of both iron and bisphosphonates is reduced. Cholestyramine or drugs containing Ca2+, Mg2+, or Al3+ (e.g., antacids, calcium and magnesium supplements) inhibit iron absorption. Penicillamine, oral gold compounds, L-methyldopa, levodopa, and L-thyroxine are absorbed less effectively when administered concurrently 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 substitution with an intravenously administered iron-containing medicine may be necessary. No data from clinical trials are available. The absorption of fluoroquinolones (certain antibiotics, e.g., ciprofloxacin, levofloxacin, norfloxacin, gatifloxacin, and ofloxacin) is significantly reduced when iron is taken at the same time. Fluoroquinolones should be taken at least 2 hours before or at least 4 hours after Ferro Sanol Duodenal. When iron is administered concurrently with tetracyclines (certain antibiotics, e.g., doxycycline), both iron and tetracycline absorption are reduced. Doxycycline should not be taken with Ferro Sanol Duodenal. An interval of at least 3 hours should be observed between taking Ferro Sanol Duodenal and tetracyclines other than doxycycline.

Note:
Darkening of the stool may occur, but this is not due to gastrointestinal bleeding. Current tests for blood in the stool can produce false positive results.

Taking Ferro Sanol Duodenal with food and drinks:
Substances contained in plant-based foods (e.g., grains 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 bloodstream. Calcium-containing foods and drinks should be consumed separately from Ferro Sanol Duodenal, as simultaneous intake reduces iron absorption. The time interval between taking Ferro Sanol Duodenal and the aforementioned foods and drinks should be as long as possible. Maintain a minimum interval of 2 hours. Pregnancy, breastfeeding and fertility: Pregnancy and breastfeeding: Since there is an increased need for iron during pregnancy and breastfeeding, it is particularly important to ensure that Ferro Sanol Duodenal is taken regularly at the dosage prescribed by the doctor during this time.

Pregnancy, breastfeeding and fertility:
Pregnancy and breastfeeding:
Since there is an increased need for iron during pregnancy and breastfeeding, it is particularly important to ensure that Ferro Sanol Duodenal is taken regularly at the dosage prescribed by the doctor during this time.

Fertility:
There are no data on the impairment of fertility in connection with the use of Ferro Sanol Duodenal in humans.

Driving and using machines:
No special precautions are necessary.

3. HOW TO TAKE FERRO SANOL DUODENAL?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. For all age groups, weight classes, and dosage groups, the dosage should be adjusted according to the patient's needs, and the response of clinical variables (e.g., hemoglobin, ferritin, transferrin) should 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: For adults and children aged 6 years and over (weighing 20 kg or more)

Adults and adolescents aged 15 years and over (with a body weight of 50 kg or more): In cases of pronounced iron deficiency, the following dosage is recommended at the start of treatment for adults and adolescents aged 15 years and over or with a body weight of 50 kg or more:

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 duodenal should be used with caution in patients with hepatic impairment and in patients suffering from alcoholism. In patients with chronic kidney disease who require erythropoietin, iron should be administered intravenously.

Children and adolescents:
Ferro sanol duodenal must not be used in children under 6 years of age (weighing less than 20 kg) (see section 2).

Method of administration:
Swallow Ferro sanol duodenal whole with sufficient water (preferably a glass). It should be taken either in the morning on an empty stomach (approximately 1 hour before breakfast) or at a sufficient interval of about 2 hours before or after a meal.

Note:
If you have difficulty swallowing or do not wish to swallow the capsule, the contents can also be taken without the capsule shell. To do this, carefully pull the capsule shells apart over a spoon and collect the contents in the spoon. Drink plenty of water after taking the capsule contents.

Duration of use:
The duration of use is determined by your doctor. Replenishing the body's iron stores usually takes between 3 and 6 months, depending on the severity of the anemia and individual circumstances. Please talk to your doctor or pharmacist if you feel that the effect of Ferro Sanol Duodenal is too strong or too weak.

If you have taken more Ferro Sanol Duodenal than you should:
If you have taken too much Ferro Sanol Duodenal, you should inform a doctor immediately. In the event of an intentional or accidental overdose, the symptoms described in section 4, "Possible side effects," will be more pronounced. In case of an overdose with clinical signs of poisoning, contact a doctor immediately. An overdose can cause poisoning, especially in children.

If you forget to take Ferro Sanol Duodenal:
Do not take a double dose to make up for a missed dose. If you accidentally miss one or more doses of Ferro Sanol Duodenal, the total duration of treatment will be extended.

If you stop taking Ferro Sanol Duodenal:
If you stop taking Ferro Sanol Duodenal, the success of your treatment may be jeopardized.

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

4. POSSIBLE SIDE EFFECTS

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

Diseases of the gastrointestinal tract

• Common side effects include gastrointestinal discomfort, diarrhea, constipation, heartburn, nausea, and vomiting. The frequency increases with increasing dose. Dark stools that may occur during treatment are due to the iron content and are harmless.
• Rare: Reversible discoloration of the tooth area.
• Not known: Abdominal pain, upper abdominal pain, gastrointestinal bleeding.

Diseases of the skin and subcutaneous tissue

• Rare: Hypersensitivity reactions (e.g. skin reactions, exanthema, rash and hives)
• Not known: Anaphylactic reaction.

Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, Germany, website: 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 DUODENAL

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month. Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What ferro sanol duodenal contains:
The active ingredient is: iron(II) glycine sulfate complex. One hard capsule contains 567.7 mg iron(II) glycine sulfate complex (equivalent to 100 mg Fe2+). The other ingredients are: Iron(II) glycine sulfate pellets: Methacrylic acid-ethyl acrylate copolymer (1:1) (Ph. Eur.), microcrystalline cellulose, ascorbic acid, talc, triethyl (2-acetoxypropane-1,2,3-tricarboxylate), hyprolose, hypromellose, polysorbate 80, sodium dodecyl sulfate. Capsule shell: Gelatin, titanium dioxide (E 171), iron(III) oxide (E 172), hydrated iron oxide (E 172), iron(II,II) oxide (E 172), sodium dodecyl sulfate. What ferro sanol duodenal looks like and contents of the pack: ferro sanol duodenal consists of gastro-resistant coated pellets in hard capsules with a dark brown top and an orange bottom.

(Apo) Usually ship out within 3-5 business days