Active ingredients: Iron (Ferrous Sulphate)
FERRO-GRAD® 40 prolonged-release tablets
Why is Ferro-Grad used? What is it for?
FERRO-GRAD® is a drug based on ferrous sulphate, belonging to the category of anti-anemic drugs.
FERRO-GRAD is indicated:
- for the martial therapy of iron deficiency anemia.
- In anemias due to
- acute or chronic blood loss,
- deficient intake or absorption of iron,
- increased need for iron (growth, pregnancy),
- infectious diseases.
COMPOSITION:
Each Gradumet tablet contains:
- Active principle: Dried ferrous sulphate 329.7 mg (equal to 105 mg of Fe + 2).
- Excipients: Methylacrylate-methylmethacrylate, Magnesium Stearate, Povidone, Polyethylene glycol 6000. Covering solution: Cellulose acetophthalate, Polyethylene glycol 6000, E-172, Ethylvanillin, Egg albumin, Propylene glycol, Polysorbate 80, Castor oil, Saccharin.
PHARMACEUTICAL FORM:
Blister packs of 40 prolonged-release tablets (Gradumet).
PHARMACO-THERAPEUTIC CATEGORY:
Anti-anemic drug
Contraindications When Ferro-Grad should not be used
Hypersensitivity already known to the components. Hemochromatosis. Hemosiderosis. Hemolytic anemia.
Ferro-Grad is contraindicated in the presence of intestinal diverticula or in the presence of any other intestinal obstruction.
Iron is contraindicated in patients who repeatedly receive blood transfusions.
Oral iron preparations are contraindicated in conjunction with parenteral iron therapy.
Precautions for use What you need to know before taking Ferro-Grad
As with other oral iron preparations, Ferro-Grad should be kept out of the reach of children to avoid accidental iron poisoning.
Black discolouration of stool can interfere with laboratory tests used to detect blood in stool.
Occasionally, the guaiac resin test gave false positives for the blood.
Avoid taking oral iron-based preparations 1 hour before or 2 hours after taking antacids.
Avoid oral intake of iron-based preparations concurrently with or in the 2 hours following the intake of quinolones.
Interactions Which drugs or foods can modify the effect of Ferro-Grad
Like all iron-based preparations, Ferro-Grad also inhibits the absorption of tetracyclines from the gastrointestinal tract and tetracyclines inhibit the absorption of iron.
If both therapies are to be taken, the tetracyclines must be administered 2 hours before or 3 hours after taking the iron-based preparation. Iron can reduce the gastrointestinal absorption of penicillamines.
If both therapies are to be taken, penicillamines must be administered at least 2 hours before or 2 hours after taking the iron-based preparation. Chloramphenicol can delay the response of iron therapy.
The concomitant administration of antacids and iron-based oral preparations can reduce iron absorption.
The concomitant administration of oral iron-based preparations can interfere with the absorption of some oral quinolones such as ciprofloxacin, norfloxacin and ofloxacin as results from the decreased concentration of quinolones in serum and urine.
It can also decrease the absorption of methyldopa and, in subjects with primary hypothyroidism, that of thyroxine.
Warnings It is important to know that:
The use in case of pregnancy and lactation is recommended by the international literature. No effect is reported in the literature on attention and the ability to drive or use machines.
Dosage and method of use How to use Ferro-Grad: Dosage
Adults and children over 10 years: 1 tablet per day to be swallowed without chewing.
Overdose What to do if you have taken an overdose of Ferro-Grad
Signs of severe toxicity may be delayed as the iron is in a controlled release form. In acute iron intoxication, increased capillary permeability, plasma hypovolemia, increased cardiac output and sudden cardiovascular collapse may occur.
In the case of overdosing, it is necessary to try to hasten the elimination of ingested Gradumet tablets. An emetic should be given as soon as possible, followed, if appropriate, by gastric lavage. Immediately after vomiting, a strong dose of saline purgative should be administered in order to accelerate the passage of the drug into the intestinal system. Then you can think of performing a radiological examination to ascertain the position and number of comps
Side Effects What are the side effects of Ferro-Grad
The likelihood of gastric intolerance to iron in the controlled-release Gradumet vehicle is low. If this occurs, the tablet can be taken after a meal. In addition, the following adverse events were observed with low incidence: diarrhea, constipation, nausea, vomiting, abdominal pain or discomfort, black discolouration of the stool and, in some isolated cases, allergic reactions ranging from rash to anaphylaxis.
Expiry and Retention
Keep this medicine out of the reach and sight of children. No special storage precautions.
WARNING: Do not use the medicine after the expiry date indicated on the package.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
IRON-GRAD
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active principle
Dried ferrous sulphate 329.7 mg
(equal to 105 mg of Fe + 2)
03.0 PHARMACEUTICAL FORM
Prolonged-release tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
For the martial therapy of iron deficiency anemia. In anemia due to acute or chronic blood loss, deficient iron intake or absorption, increased iron requirements (growth, pregnancy). In anemia due to infectious diseases.
04.2 Posology and method of administration
Adults and children over 10 years: 1 tablet per day to be swallowed without chewing.
04.3 Contraindications
Hypersensitivity already known to the components. Hemochromatosis. Hemosiderosis. Hemolytic anemia.
Ferro-Grad is contraindicated in the presence of intestinal diverticula or in the presence of any other intestinal obstruction.
Iron is contraindicated in patients who repeatedly receive blood transfusions.
Oral iron preparations are contraindicated in conjunction with parenteral iron therapy.
04.4 Special warnings and appropriate precautions for use
As with other oral iron preparations, Ferro-Gradumet should be kept out of the reach of children to avoid accidental iron poisoning.
Avoid taking oral iron-based preparations 1 hour before or 2 hours after taking antacids.
Avoid oral intake of iron-based preparations concurrently with or in the 2 hours following the intake of quinolones.
Black discolouration of stool can interfere with laboratory tests used to detect blood in stool.
04.5 Interactions with other medicinal products and other forms of interaction
Like all iron preparations, Ferro-Grad also inhibits the absorption of tetracyclines by the gastrointestinal tract and tetracyclines inhibit the absorption of iron. If both therapies are to be taken, the tetracyclines must be administered 2 hours before or 3 hours after taking the iron-based preparation.
Iron can reduce the gastrointestinal absorption of penicylamines. If both therapies are to be taken, penicylamines must be administered at least 2 hours before or 2 hours after taking the iron-based preparation.
Chloramphenicol can delay the response of iron therapy.
The concomitant administration of antacids and iron-based oral preparations can reduce iron absorption.
The concomitant administration of iron-based preparations can interfere with the absorption of some oral quinolones such as ciprofloxacin, norfloxacin and ofloxacin as results from the decreased concentration of quinolones in serum and urine.
It can also decrease the absorption of methyldopa and, in subjects with primary hypothyroidism, that of thyroxine.
04.6 Pregnancy and lactation
The use in case of pregnancy and lactation is recommended by the international literature.
04.7 Effects on ability to drive and use machines
No effect is reported in the literature on attention and the ability to drive or use machines.
04.8 Undesirable effects
The likelihood of gastric intolerance to iron in the controlled-release Gradumet vehicle is low. If this occurs, the tablet can be taken after a meal. In addition, the following adverse events were observed with low incidence: diarrhea, constipation, nausea, vomiting, abdominal pain or discomfort, black discoloration of the stool and in some isolated cases allergic reactions ranging from rash to anaphylaxis have been reported.
04.9 Overdose
Signs of severe toxicity may be delayed as the iron is in a controlled release form. In acute iron intoxication, increased capillary permeability, plasma hypovolemia, increased cardiac output and sudden cardiovascular collapse may occur. In the case of overdosing, it is necessary to try to hasten the elimination of ingested Gradumet tablets. An emetic should be given as soon as possible, followed, if appropriate, by gastric lavage. Immediately after vomiting, a strong dose of saline purgative should be administered in order to accelerate the passage of the drug into the intestinal system.
Subsequently, a radiological examination can be considered to ascertain the position and number of Gradumet tablets that have remained in the gastrointestinal tract.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Iron absorption occurs in the stomach and in the first duodenal portion, and it is inversely proportional to the degree of saturation of the body's martial supplies.
Essential for the purpose of absorption is that iron is present as divalent iron.
Today we tend to explain the regulation of the absorption of elemental iron in relation to the saturation of plasma transferrin and therefore in direct relationship with the saturation of iron deposits.
The excess iron needed by hemoglobin, myoglobin and other cellular functions is stored as ferritin and hemosiderin, especially in the parenchymal cells of the liver and spleen.
The average daily excretion of iron in normal physiological conditions is 0.5-1 mg.
In women, the menstrual cycle involves a further excretion of about 0.3-1.0 mg per day.
The oral dose of 1 g of elemental iron is considered toxic and requires appropriate treatment.
Ferro-Grad is a Teofarma preparation that allows effective martial therapy by mouth, sparing the patient the problems that sometimes characterize the oral administration of iron.
Each Gradumet tablet contains 329.7 mg of dried ferrous sulphate (corresponding to 105 mg of elemental iron) and consists of a porous and inert resin matrix impregnated with the iron salt. The release time of the ferrous sulphate is controlled so as to release most of the mineral during the passage of the tablet in the duodenum and in the upper tract of the small intestine. The resinous matrix, emptied of its content, is not absorbed and is eliminated with the faeces.
Acute toxicity: rat Wistar strain per os LD50 mg 1119 (981-1275).
Prolonged administration toxicity.
Rat: Os 326 mg for 20 days.
Ferrous sulphate is contained in the interstitial spaces of the matrix, and is released after about an hour from the ingestion of the tablet, by means of a simple osmolar mechanism. The ferrous ion then follows the metabolic fate common to dietary iron.
05.2 Pharmacokinetic properties
05.3 Preclinical safety data
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Methylacrylate-methylmethacrylate, magnesium stearate, povidone, polyethylene glycol 6000.
Coating solution: cellulose acetophthalate, polyethylene glycol 6000, E-172, ethylvanillin, egg albumin, propylene glycol, polysorbate 80, castor oil, saccharin.
06.2 Incompatibility
Like all iron-based products, IRON-GRAD is also incompatible with penicylamines due to the risk of increased toxicity of the latter.
06.3 Period of validity
The product is stable in unopened packaging for 36 months.
06.4 Special precautions for storage
No special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
Blister of 40 tablets.
06.6 Instructions for use and handling
07.0 MARKETING AUTHORIZATION HOLDER
Teofarma S.r.l. - Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
08.0 MARKETING AUTHORIZATION NUMBER
"105 mg prolonged release tablets" 40 tablets - A.I.C. n. 021922024
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Ferro-Grad 40 tablets 09/06/1971
10.0 DATE OF REVISION OF THE TEXT
June 2010
