Ferro sanol duodenal 100mg, 50 capsules

Ferro sanol duodendal 100 mg hard capsules. With isolated iron deficiency

Against iron deficiency with and without anemia.

1 capsule contains 100 mg iron.

active ingredients

• 567.7 mg iron (II) glycine sulfate complex

excipients

• hyprolose
• hypromellose
• Iron(II,III) oxide
• Iron(III) oxide hydrate, black
• Methacrylic acid ethyl acrylate copolymer (1:1)
• Triethyl 2-acetoxypropane-1,2,3-tricarboxylate
• cellulose, microcrystalline
• ferric oxide
• gelatin
• ascorbic acid
• Sodium Lauryl Sulfate
• Polysorbate 80
• titanium dioxide
• talc

- Iron deficiency
- Iron deficiency anemia (anemia due to iron deficiency)
There are various causes of anemia. Only the doctor can decide whether the drug is effective against the present form of anemia.

indication

• The drug is an oral iron supplement for iron deficiency.

• The drug is used for iron deficiency, especially iron deficiency anemia, during pregnancy and lactation; in childhood; with an iron-poor diet, after chronic and acute blood loss.

dosage

• Always take the medicine exactly as instructed in this leaflet. Please check with your doctor or pharmacist if you are not sure.

• Unless otherwise prescribed by the doctor, is the usual dose

  • in adults and children over 6 years: 1 hard capsule daily.

  • In the early phase of severe iron deficiency in adults and adolescents over the age of 15 or weighing 50 kg: 2 to 3 hard capsules daily, to be taken throughout the day.

  • A daily intake of 5 mg Fe ²⁺ /kg body weight should not be exceeded.

• duration of use

  • The doctor determines the duration of the application.

  • Depending on the severity of the anemia and the individual circumstances, the replenishment of the body's iron stores can take between 3 and 6 months.

  • Please talk to your doctor or pharmacist if you have the impression that the effect of the medicine is too strong or too weak.

• If you take more of the medicine than you should

  • If you have taken too much medicine, you should inform a doctor immediately. To delay or prevent the absorption of iron into the body, you should drink milk or take chicken protein.

  • In the event of an intentional or accidental overdose, the side effects come more to the fore. In the event of an overdose with clinical signs of poisoning, contact a doctor immediately.

  • Overdose can cause poisoning, especially in children.

• If you forget to take the medicine

  • Do not take a double dose to make up for a forgotten dose.

  • If you have accidentally forgotten to take the medicine one or more times, this will prolong the total duration of therapy.

• If you stop taking the medicine

  • If you stop taking the medicine, the success of the therapy is at risk.

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

way

• Swallow the medicine whole with enough water (preferably 1 glass).

• It should be taken either in the morning on an empty stomach (about 1 hour before breakfast) or at a sufficient interval of about 2 hours before or after a meal.

• If there are problems with swallowing or swallowing the capsule is not desired, the contents of the capsule can also be taken without the capsule shell. To do this, use both hands to carefully pull the capsule shells apart over a spoon and collect the capsule contents in the spoon. After taking the contents of the capsule, you should drink enough water.

side effects

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

• The frequency of side effects is based on the following categories:

  • Very common: affects more than 1 in 10 people

  • Common: affects 1 to 10 users in 100

  • Uncommon: affects 1 to 10 users in 1000

  • Rare: affects 1 to 10 users in 10,000

  • Very rare: affects less than 1 in 10,000 people

  • Not known: frequency cannot be estimated from the available data

• Diseases of the gastrointestinal tract

  • frequently

    • Gastrointestinal complaints

    • Diarrhea

    • constipation

    • heartburn

    • nausea

    • Vomit

    • The frequency increases with increasing dose.

    • A dark discoloration of the stool that occurs during the course of treatment can be attributed to the iron content and is harmless.

  • Rarely:

    • Reversible discoloration of the tooth area

• Skin and subcutaneous tissue disorders

  • Rarely:

    • Hypersensitivity reactions (eg, skin lesions, exanthema, rash, and hives)

• Please tell your doctor or pharmacist if any of the side effects gets serious, or if you notice any side effects not listed in this leaflet.

interactions

• Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.

• Enhancement of the effect and possible enhancement of side effects

  • Painkillers and rheumatism drugs (e.g. salicylate and phenylbutazone): can intensify an irritating effect on the mucous membranes in the gastrointestinal tract of the drug.

  • Intravenous formulations of iron: Concomitant administration of intravenous formulations of iron with oral forms of iron may cause a drop in blood pressure (hypotension) or collapse due to excessive iron release and transferrin saturation. The combination is not recommended.

• weakening of the effect

  • Tetracyclines (certain antibiotics, e.g. doxycycline) or bisphosphonates (medicines for the treatment of osteoporosis): the absorption of both iron and tetracyclines or bisphosphonates is reduced.

  • Colestyramine or drugs containing Ca ²⁺ -, Mg ²⁺ -, Al ^{3+ -} (e.g. antacids, calcium and magnesium salts for substitution): inhibit iron absorption.

  • Penicillamine, oral gold compounds, L-methyldopa, levodopa and L-thyroxine: are poorly absorbed when iron is administered at the same time.

  • Certain antibiotics (fluoroquinolones such as ciprofloxacin, levofloxacin, norfloxacin, gatifloxacin and ofloxacin): Iron greatly reduces the absorption of these drugs.

  • There should be a gap of at least 2 hours between taking the drug and the above drugs.

• Other possible interactions

  • The stool may become darker in colour, and this is not due to gastrointestinal bleeding.

  • Today's tests for traces of blood in the stool can be falsely positive.

• When taken with food and drink

  • Substances that form complexes with iron (e.g. phytates, oxalates and phosphates) contained in plant foods (e.g. grain products and vegetables) as well as components of coffee, tea, milk and cola drinks inhibit the absorption of iron into the blood.

Contraindications

• The medicine must not be taken

  • if you are allergic (hypersensitive) to the active substance or any of the other ingredients of the medicine.

  • if you have narrowing of the esophagus.

  • if you suffer from an inherited iron storage disease (haemochromatosis).

  • if you suffer from iron overload (chronic haemolysis, thalassemia, other haemoglobinopathies).

  • if you suffer from iron utilization disorders (e.g. sideroachrestic anaemia, lead anaemia).

  • if you receive repeated or chronic blood transfusions.

  • by children under 6 years of age.

pregnancy and breast feeding period

• pregnancy and breast feeding period

  • Since the body has an increased need for iron during pregnancy and breastfeeding, it is particularly important to ensure that the drug is taken regularly in the dosage specified by the doctor during this period.

patient notes

• Special care is required when taking the drug

  • if you suffer from existing diseases of the digestive tract such as chronic inflammatory bowel disease, narrowing of the intestines, protrusions of the intestine (diverticula), inflammation of the stomach lining (gastritis), stomach and intestinal ulcers.

  • if you have chronic kidney disease and need erythropoietin, then you should be given iron intravenously since iron given orally is poorly absorbed in uremic individuals.

  • in older people with initially unexplainable iron deficiency or anemia. Here, the cause of the iron deficiency or the source of the bleeding must be carefully sought.

  • in children, as an overdose can lead to poisoning.

  • Notice

    • Discoloration of the teeth can occur during treatment with the drug. According to the scientific literature, this tooth discoloration may resolve spontaneously after drug discontinuation or may need to be removed by using an abrasive toothpaste or by professional teeth cleaning.

• Driving and using machines

  • There are no special precautions required.

The total dose should not be exceeded without consulting a doctor or pharmacist.

Type of application?
Take the medicine with liquid (e.g. 1 glass of water). For ease of ingestion, you can open the capsule and swallow only the contents. Drink plenty of liquid afterwards.

Duration of use?
The duration of use depends on the type of symptoms and/or the course of the disease. It should therefore be determined in consultation with your doctor.

overdose?
A variety of overdose symptoms can occur, including nausea, vomiting blood, upset stomach, diarrhea, drowsiness, and circulatory collapse. Small children in particular are very vulnerable. If you suspect an overdose, contact a doctor immediately.

Forgot to take?
Continue taking it as normal (i.e. not double the amount) at the next prescribed time.

In general, pay attention to a conscientious dosage, especially for babies, small children and the elderly. If in doubt, ask your doctor or pharmacist about any effects or precautions.

A dosage prescribed by the doctor may deviate from the information on the package leaflet. Therefore, since the doctor adjusts them individually, you should use the medicine according to his instructions.

What speaks against an application?

Always:
- hypersensitivity to the ingredients
- anemia with iron utilization disorder, such as:
  - sideroachrestic anemia
  - thalassemia
  - lead anemia
- hemochromatosis (iron overload)
- hemolytic anemia (anaemia due to shortened lifespan of red blood cells)

Under certain circumstances - talk to your doctor or pharmacist about this :
- Inflammation of the gastric mucosa
- Ulcers in the digestive tract
- Inflammatory bowel diseases such as:
  - Ulcerative colitis
  - Crohn's disease

Which age group should be considered?
- Children under 6 years: The medicine must not be used.

What about pregnancy and lactation?
- Pregnancy: According to current knowledge, the medicine has no harmful effects on the development of your child or the birth.
- Breast-feeding: According to current knowledge, there are no indications that the drug should not be used during breast-feeding.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use entails in the event of a contraindication.

What adverse effects may occur?

- Gastrointestinal complaints, such as:
  - abdominal pain
  - nausea
  - vomiting
  - loss of appetite
  - diarrhea
  - constipation
- black discoloration of the stool, which is harmless

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Storage

The medicinal product must be stored away from heat.

What should you consider?
- Be careful if you are allergic to iron hydroxide sucrose!
- Be careful if you are allergic to ascorbic acid (vitamin C)!
- There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or have been using for some time.

How does the ingredient of the medicine work?

Iron is one of the vital trace elements and is involved in many metabolic processes in the body. Iron is important, for example, for the formation of red blood cells.

What is included in medicines?