Gloros

GLOROS
“80 mg Effervescent Granules”
Ferrous Gluconate
Generic medicinal product
THERAPEUTIC CATEGORY
Antianaemic agents based on bivalent iron.
THERAPEUTIC INDICATIONS
Treatment of iron-deficiency anaemias.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients listed in the Composition section.
Haemosiderosis, haemochromatosis, all non-iron-deficiency anaemias, particularly haemolytic anaemias, chronic pancreatitis, hepatic cirrhosis.
Iron-containing preparations are contraindicated in cases of active peptic ulcer, Crohn’s disease, and ulcerative colitis.
Ferrous gluconate is contraindicated in patients receiving repeated blood transfusions or in patients receiving iron therapy via parenteral route.
PRECAUTIONS FOR USE
Ferrous gluconate should be used with caution in patients with intestinal stenosis or diverticula.
Treatment should be preceded by a precise diagnosis of iron-deficiency anaemia.
Iron administration may be toxic, especially in children, at doses exceeding 400 mg (more than 5 sachets).
To avoid a potential risk of iron overdose, particular attention must be paid when using dietary supplements or other iron salt supplements.
In patients with pre-existing gastrointestinal mucosal inflammation or ulceration, the benefits of treatment must be carefully weighed against the risk of worsening gastrointestinal disease.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
Iron salts reduce the absorption of tetracyclines, penicillamine, levodopa, and methyldopa.
There may be a risk of toxicity with penicillamine when iron therapy is discontinued.
Iron-containing medicines interfere with the absorption of quinolone antibiotics (e.g., ciprofloxacin, levofloxacin, norfloxacin, ofloxacin).
Iron salts reduce the absorption of thyroxine in patients on thyroxine replacement therapy.
Iron absorption is reduced by concomitant use of colestyramine, as well as calcium and magnesium supplements.
Iron salts may reduce the absorption of mycophenolate.
Concomitant intake of iron salts and salicylates or non-steroidal anti-inflammatory drugs (NSAIDs) may enhance the irritating effect of iron on the gastrointestinal mucosa.
Antacid preparations (magnesium or aluminium salts) reduce iron absorption. A 2–3 hour interval should be maintained between the administration of GLOROS and antacid preparations.
SPECIAL WARNINGS
Consult your doctor or pharmacist before taking any medicine.
PREGNANCY AND LACTATION
Pregnancy
This product may be administered during pregnancy.
The iron requirement in the second half of pregnancy is approximately 6 mg/day.
In case of iron deficiency, dosage should be adjusted according to the response to therapy and gastrointestinal tolerance.
High doses are better tolerated when divided into 3 or 4 administrations.
Lactation
It is not known whether GLOROS is excreted in breast milk.
The risk to neonates/infants cannot be excluded.
Effects on the ability to drive and use machines
No effects on the ability to drive or use machinery have been observed.
Important information on some excipients
This medicine contains a source of phenylalanine. It may be harmful if you have phenylketonuria. Each effervescent granule sachet of GLOROS contains 8.01 mEq of sodium; this should be taken into consideration in patients with impaired renal function or those on a low-sodium diet.
This medicine contains sucrose; therefore, if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The daily requirement in adult males is generally 13 μg/kg or 1 mg/day.
The daily requirement in females (with normal menstruation) is generally 21 μg/kg or 1.4 mg/day.
During the last 6 months of pregnancy, the requirement increases: 80 μg/kg/day or, generally, 5–6 mg/day.
Children: 22 μg/kg.
In case of iron deficiency, the dose should range between 50 and 250 mg/day, depending on the severity of anaemia.
DOSAGE
Adults
One effervescent granule sachet per day, dissolved in water, taken ½ hour before a meal.
In cases of severe anaemia, the dose may be adjusted at the physician’s discretion based on haematological tests performed 2 or 3 times per week after initiation of treatment.
Children
½ to 1 sachet according to body weight.
If anaemia persists after 3 weeks of treatment, another underlying cause should be investigated.
OVERDOSE
In case of iron salt overdose, the patient may experience epigastric pain, nausea, vomiting, diarrhoea, and haematemesis, often associated with drowsiness, pallor, cyanosis, shock, and even coma.
Treatment must be initiated as soon as possible and consists of administration of an emetic, followed, if necessary, by gastric lavage, and appropriate supportive therapy.
The use of an iron chelating agent such as deferoxamine should also be considered.
Accidental ingestion of a large dose of iron salts is fatal in children.
Therefore, it is essential to keep the medicine out of reach of children.
In case of accidental ingestion/overdose of an excessive amount of GLOROS, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of GLOROS, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, GLOROS can cause adverse effects, although not everybody experiences them.
The adverse effects associated with GLOROS are listed below according to system organ class.
Gastrointestinal disorders
Vomiting, nausea, diarrhoea (which, in case of overdose, may be severe and complicated by gastrointestinal haemorrhage; see “Overdose”).
During administration of iron-containing preparations, harmless black discolouration of the stools, dark urine, or temporary tooth staining may occur.
Immune system disorders
Allergic reactions may occur rarely.
EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
The expiry date refers to the product stored in its original, unopened packaging under recommended conditions.
Warning: do not use the medicine after the expiry date stated on the packaging.
Store at a temperature not exceeding 25°C.
Keep the medicine out of the reach and sight of children.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
COMPOSITION
One effervescent granule sachet contains:
Active substance: Ferrous Gluconate 695 mg (equivalent to 80 mg of Fe++)
Excipients: Ascorbic acid, citric acid, tartaric acid, sodium bicarbonate, monohydrate sodium carbonate, sodium saccharin, aspartame, sucrose, orange flavouring, Orange Yellow (E 110)
PHARMACEUTICAL FORM AND CONTENT
Effervescent granules in packs of 30 or 40 sachets
MARKETING AUTHORISATION HOLDER
ELLEVA PHARMA S.r.l.
Via San Francesco n. 5/7
80034 Marigliano (NA)
MANUFACTURER
LA.FA.RE. srl – Pharmaceutical Laboratory
Via Sac. Benedetto Cozzolino 77
80056 Ercolano-Napoli
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY: