Ferracin 100 Mg Gastro-Resistant Capsule Hard
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ferracin 100 mg gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg elemental iron as dried ferrous sulfate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Transparent red body and an opaque white cap, imprinted with ‘FER 100’.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Ferracin 100 mg gastro-resistant capsules are indicated in adults and children > 12 years for the treatment of iron deficiency with or without development of anaemia.
4.2 Posology and method of administration
Posology
Adults:
The usual dose is one capsule per day.
Paediatric population (> 12 years and > 44 kg):
The usual dose is one capsule per day.
The safety of Ferracin 100 mg gastro-resistant capsules in children younger than 12 years or weighing less than 44 kg has not been established. This medicine is therefore not recommended in this population.
Depending on the severity of iron deficiency, the initial daily dose can be increased up to two or three capsules in adults and adolescents > 15 years of age or with a body weight of at least 50 kg. A daily dose of 5 mg iron per kg body weight should not be exceeded.
Following achievement of normal haemoglobin values, treatment should be continued for at least a further 3 months to replenish body iron stores. During treatment, serum ferritin concentrations should be monitored.
Special populations
Elderly patients (> 65 years): The usual adult dose can be administered.
Patients with renal or hepatic impairment: The usual adult dose can be administered. However, patients with chronic renal failure may require intravenous iron therapy.
Method of administration
For oral administration. The capsules should be swallowed whole with 100 - 200 ml of water, either in the morning on an empty stomach (approximately 1 hour before breakfast) or with a time interval of 2 hours before or after a meal. The capsules should not be crushed or chewed.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Repeated blood transfusions.
Concomitant parenteral iron therapy.
Haemochromatosis and other iron overload syndromes.
4.4 Special warnings and precautions for use
Caution should be exercised in patients with chronic haemolysis, iron-absorption diseases and haemoglobinopathies as well as in patients with existing gastrointestinal disease such as inflammatory bowel disease, intestinal stricture, diverticulae, gastritis, stomach and intestinal ulcers.
To avoid the risk of iron overload, special care should be taken if dietary or other iron salt supplements are used.
Before treatment initiation, any specific underlying cause of iron deficiency (e.g. gastric erosions or colonic carcinoma) should be excluded.
Paediatric population
Children younger than 12 years or weighing less than 44 kg should not take Ferracin 100 mg gastro-resistant capsules. Especially in children, iron preparations may cause poisoning.
4.5 Interaction with other medicinal products and other forms of interaction
Dimercaprol forms a toxic complex with iron and should not be given concomitantly.
The absorption of iron is enhanced by ascorbic acid and meat.
The absorption of iron/iron response is impaired by proton pump inhibitors, antacids, cholestyramine, chloramphenicol, zinc, magnesium, aluminium, calcium, phosphorus, tea, coffee, coke, milk, eggs, vegetable food and whole grain food.
Iron chelates with tetracyclines and the absorption of both agents may be decreased.
Iron salts (may) reduce the bioavailability offluoroquinolone antibiotics (e.g. ciprofloxacin, norfloxacin, levofloxacin or ofloxacin), bisphosphonates , methyldopa, levodopa, entacapone, penicillamine and levothyroxine.
The potential interactions mentioned above can be reduced by separating the administration of each product by at least 2 hours, for tetracyclines at least 3 hours.
Oral administration of ferrous sulfate preparations may lead to false positive blood stool tests.
4.6 Fertility, pregnancy and lactation
Pregnancy
A large amount of data on pregnant women indicate no malformative nor feto/neonatal toxicity of ferrous salts in therapeutic doses. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Ferracin 100 mg gastro-resistant capsules can be used during pregnancy if clinically needed.
Breast-feeding
No effects of ferrous salts in therapeutic doses have been shown in breastfed newborns/infants of treated mothers. Ferracin 100 mg gastro-resistant capsules can be used during breast-feeding if clinically needed.
Fertility
There are no data from controlled studies on the effect of ferrous salts on human fertility.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
The most frequently reported adverse reactions to oral ferrous sulfate treatment are gastrointestinal in nature. Blackening of stool may occur during iron supplementation and is harmless.
For specifying undesirable effect frequencies, the following definitions are used: very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1,000 to < 1/100), rare (> 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Gastrointestinal disorders
Very common: nausea, epigastric or abdominal pain, constipation Common: diarrhoea, discoloured faeces, vomiting Immune system disorders Not known: hypersensitivity reaction
Skin and subcutaneous tissue disorders Common: rash
Nausea and epigastric pain are dose-related whereas the relationship between altered bowel habits (e.g. constipation) and dose is less clear. Particular in older patients, continued administration of oral iron preparations may cause constipation, occasionally resulting in faecal impaction. Following parenteral iron administration hypersensitivity reactions have been reported, with a pattern ranging from rash, sometimes severe, to anaphylactic reaction. The frequency of occurrence is not known for oral administration of ferrous sulfate but isolated cases have been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Symptoms
Symptoms of intoxication may appear after ingestion of > 20 mg elemental iron per kg body weight and 200-250 mg/kg are potentially fatal. Clinical symptoms and laboratory investigations should be taken into account for its assessment. Acute iron overdose can be divided into four stages. In the first phase (up to 6 hours after ingestion), symptoms may include abdominal pain, vomiting, diarrhoea and haematemesis, with in more severe cases, coma, convulsions and shock. The second phase (6-24 hours after ingestion) is characterised by abatement of symptoms, with either recovery or recurrence of gastrointestinal toxicity. In the third phase, symptoms can include severe lethargy or coma, gastrointestinal haemorrhage, severe shock, metabolic acidosis, convulsions, jaundice, coagulation disorders, hypoglycaemia, renal failure and pulmonary oedema. In the fourth phase, 2 to 5 weeks after ingestion, gastrointestinal obstruction, encephalopathy and late hepatic damage may occur.
Management
When overdose occurs, measures of treatment depend on symptoms, dose and time of ingestion. Supportive and symptomatic measures include ensuring adequate pulmonary ventilation, monitoring of ECG, blood pressure and urine output, establishing intravenous access and ensuring adequate hydration. Whole bowel irrigation may be considered. If metabolic acidosis persists despite correction of hypoxia and adequate fluid resuscitation, for adults an initial dose of 50 mmol sodium bicarbonate may be administered and repeated as necessary, guided by arterial blood gas monitoring (aim: pH = 7.4). If the patient is symptomatic (other than nausea) and serum iron concentration is between 3-5 mg/L (55-90 micromol/L) and still rising, the administration of desferrioxamine should be considered. Haemodialysis does not remove iron effectively from the body but may be considered as supportive measure for acute renal failure as this will facilitate removal of the iron-desferrioxamine complex.
Paediatric population
Iron poising caused by iron preparations is most common in childhood and is usually accidental. Overdose of ferrous salts is particularly dangerous to young children. As little as 20 mg iron per kg body weight is sufficient to cause signs of toxicity.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: anti-anaemic preparations, iron preparations; ATC code: B03A A07
Mechanism of action
Iron is an essential constituent of the body. It is necessary for haemoglobin and myoglobin formation and thus for the transport and utilisation of oxygen. Moreover, iron is a component of a number of enzymes required for energy transfer. Administration of iron preparations rectifies erythropoietic abnormalities caused by iron deficiency.
5.2 Pharmacokinetic properties
Absorption
The mini-tablets which are contained in the Ferracin 100 mg gastro-resistant capsules are enteric-coated and remain intact until they are released into the duodenum. There, the active ingredient ferrous sulfate is rapidly released. The main site of iron absorption is the duodenum and proximal jejunum and is most efficient when iron is ingested in its ferrous (Fe2+) rather than its ferric (Fe3+) form, on an empty stomach.
In subjects with normal iron stores only a small fraction (up to 15%) of dietary iron is absorbed. Intestinal iron absorption increases in conditions of iron deficiency and decreases if the body stores are overloaded. After oral dosing of ferrous sulfate, 10 to 35% is absorbed usually but iron deficiency may up-regulate iron absorption from ferrous sulfate significantly. Concomitant food intake markedly reduces iron absorption from ferrous sulfate.
Distribution
Following oral intake, ferrous iron passes through the intestinal mucosa into the blood where it is bound to transferrin, the plasma transport protein for iron. Transferrin transports iron to the bone marrow where approximately two-thirds are incorporated into haemoglobin.
Elimination
No physiological system of elimination exists for iron. Most of the iron liberated by destruction of haemoglobin is reused by the body. Excretion of iron occurs principally through faeces and as desquamation of cells such as skin, gastrointestinal mucosa, nails and hair; only trace amounts of iron are excreted in bile and sweat. Substantial iron loss can occur through loss of blood. Iron from ferrous sulfate follows the same pattern of excretion as dietary iron.
5.3 Preclinical safety data
The preclinical data are incomplete. Based on the long standing clinical use, there is a sufficiently established safety of the usage of iron salts, including ferrous sulfate, in the given posology in humans. Studies on reproductive toxicity (including fertility, embryo-foetal and postnatal development), which correspond to the current standard, are not available. Studies on in vivo mutagenicity and carcinogenicity do not exist.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Capsule content:
Ascorbic acid Microcrystalline cellulose
Colloidal anhydrous silica
Copovidone
Calcium stearate
Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%
Triethyl citrate Talc
Titanium dioxide (E171)
Sodium hydroxide
Capsule shell:
Gelatin
Titanium dioxide (E171)
Iron oxide, red (E 172)
Edible black ink contains Iron oxide, black (E172)
Shellac
Propylene glycol Ammonia
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
24 months
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Polyvinylchloride (PVC), polyethylene (PE), and polyvinylidenchloride (PVDC) blister sealed with an aluminium foil.
Ferracin 100 mg gastro-resistant capsules are available in packs of 10, 20, 30, 50, 60, 90 and 100 capsules.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
ACINO AG Am Windfeld 35 83714 Miesbach Germany
8 MARKETING AUTHORISATION NUMBER(S)
PL 21806/0085
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19/01/2015
10 DATE OF REVISION OF THE TEXT
08/04/2015