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FERRO SANOL, iron(ii) sulfate, folic acid, vitamin B12, iron deficiency anemia

UCB Pharma GmbH

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Iron(ii) sulfate, folic acid, vitamin B12, iron deficiency anemia, FERRO SANOL comp. Hard caps.m.msr.coated.pellets

Dosage form:Hard capsules containing enteric coated pellets

ferro sanol® comp capsules
Active ingredients: iron(II) glycine sulfate complex, folic acid, vitamin B12.


Areas of FERRO SANOL, iron(ii) sulfate, folic acid, vitamin B12, iron deficiency anemia application:


Iron deficiency states, especially iron deficiency anemia, with simultaneous deficiency of vitamin B12 and folic acid

active FERRO SANOL, iron(ii) sulfate, folic acid, vitamin B12, iron deficiency anemia ingredients

  • 0.5 mg folic acid
  • cyanocobalamin
  • 170 mg ferrous glycine sulfate complex (enteric-coated)

excipients FERRO SANOL, iron(ii) sulfate, folic acid, vitamin B12, iron deficiency anemia

  • magnesium stearate
  • hyprolose
  • hypromellose
  • Iron(III) oxide hydrate, black
  • Methacrylic acid ethyl acrylate copolymer (1:1)
  • Triethyl 2-acetoxypropane-1,2,3-tricarboxylate
  • Silica, colloidal
  • cellulose, microcrystalline
  • ferric oxide
  • Carboxymethyl Starch, Sodium
  • gelatin
  • ascorbic acid
  • Sodium citrate-2 water
  • Sodium Lauryl Sulfate
  • citric acid
  • dextrin
  • 28.65 mg lactose-1 water
  • Polysorbate 80
  • titanium dioxide
  • talc

 

indication FERRO SANOL, iron(ii) sulfate, folic acid, vitamin B12, iron deficiency anemia

 

  • The drug is an oral iron/folic acid/vitamin B12 supplement .
  • application areas
    • Iron deficiency states, iron deficiency anemia and for the simultaneous prevention of a deficiency in vitamin B 12 and folic acid.

dosage FERRO SANOL, iron(ii) sulfate, folic acid, vitamin B12, iron deficiency anemia

  • 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 your doctor, the usual dose for adults and children over 6 years of age (weighing at least 20 kg) is:
    • 1 hard capsule 3 times a day
  • Elderly patients
    • There are no clinical data showing that dose adjustments are required in elderly patients.
  • Patients with renal or hepatic impairment
    • There are no clinical data that necessitate dose adjustments in patients with renal or hepatic impairment.
  • children and young people
    • The medicine must not be used in children under the age of 6 years (weighing less than 20 kg).

 

  • 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 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.
    • In the event of an intentional or accidental overdose, the symptoms described under side effects become more prominent. 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 one or more doses, this will extend the total duration of therapy.

 

  • If you stop taking the medicine
    • If you stop taking it, 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 FERRO SANOL, iron(ii) sulfate, folic acid, vitamin B12, iron deficiency anemia

  • Take ferro sanol comp hard capsules 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.
  • Notice
    • 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, carefully pull the capsule shells apart over a spoon and collect the capsule contents (pellets and one mini-tablet) in the spoon. You should drink enough water after taking the pellets and the mini-tablet.

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
    • Not known:
      • stomach pain
      • epigastric pain
  • Skin and subcutaneous tissue disorders
    • Rarely:
      • Hypersensitivity reactions (eg, skin lesions, exanthema, rash, and hives)
  • Diseases of the nervous system
    • Rarely:
      • Central nervous disorders at high doses
  • Please tell your doctor or pharmacist if any of the listed side effects gets serious, or if you notice any side effects that are not listed.

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 increase the irritating effect of the drug on the mucous membranes in the gastrointestinal tract.
    • 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 substances or any of the other ingredients of the medicine.
    • If you have a 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, chronic transfusion requirements).
    • If you suffer from iron utilization disorders (e.g. sideroachrestic anemia, lead anemia).
    • If you have megaloblastic anemia due to isolated vitamin B 12 deficiency.

pregnancy and breast feeding period

  • If you are pregnant or breastfeeding, you should only take this medicine if your doctor tells you to.

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
      • Discolouration of the teeth can occur during treatment with ferro sanol comp. 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.