FERROGRAD Prolonged release tablet (2019)

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

1. Name of the medicinal product

Ferrograd 325mg Prolonged release Tablets.

2. Qualitative and quantitative composition

Each tablet contains Dried Ferrous Sulphate 325mg (elemental iron 105mg). Excipients with known effect: Each tablet contains 19.4mg lactose monohydrate and sunset yellow FCF (E110). For the full ...

3. Pharmaceutical form

Prolonged release tablet. Circular, biconvex, red film-coated tablet.

4.1. Therapeutic indications

For the prevention and treatment of iron deficiency anaemias.

4.2. Posology and method of administration

Adults The recommended dosage is one tablet daily before food. Children Not recommended for children under 12 years. Above this age, as for adults. Elderly As for adults. The sustained release tablet and ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Use in patients with intestinal diverticular disease or any intestinal obstruction. Use in patients with haemochromatosis ...

4.4. Special warnings and precautions for use

The label will state Important warning: Contains iron. Keep out of reach and sight of children, as overdose may be fatal. This will appear on the front of the pack within a rectangle in which there is ...

4.5. Interaction with other medicinal products and other forms of interaction

Iron salts diminish the absorption of tetracyclines.Tetracycline antibiotics should be taken at least 2 hours before or 3 hours after taking Ferrograd. Concurrent administration of oral iron preparations ...

4.6. Pregnancy and lactation

Iron containing products if required, should be used during pregnancy after the first 13 weeks. Iron is excreted in breast milk so consult your doctor if you intend breast feeding.

4.7. Effects on ability to drive and use machines

Ferrograd has no influence on the ability to drive and use machines.

4.8. Undesirable effects

Those associated with conventional oral iron preparations, i.e. nausea, vomiting, abdominal pain or discomfort, diarrhoea and/or constipation, are less likely to occur because of the sustained release ...

4.9. Overdose

Initial symptoms of iron overdosage include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding. However, following a massive overdose, these initial symptoms may be absent due to ...

5.1. Pharmacodynamic properties

Iron provided by Ferrograd aids haemoglobin regeneration. Once haemoglobin returns to normal, continuing with iron supplementation for 3 months will help replenish the iron stores within the body.

5.2. Pharmacokinetic properties

The Gradumet device allows controlled release of ferrous sulphate over a number of hours, which increases iron utilisation and reduces gastro-intestinal intolerance. The device consists of an inert plastic ...

5.3. Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to information contained in other sections of the SPC.

6.1. List of excipients

Core: Methylacrylate methylmethacrylate copolymer Lactose monohydrate Povidone Magnesium stearate Film coating: Hypromellose Ethylcellulose Sodium saccharin Triethyl citrate Sorbitan oleate ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Do not store above 25°C. Store in the original package. Keep out of the reach and sight of children.

6.5. Nature and contents of container

Carton containing 30 (3 10) tablets in an AL/PVC blister.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Teofarma S.R.L, Valle Salimbene (PV), Via F. LLI Cervi, 8 CAP 27010, Italy

8. Marketing authorization number(s)

PA1235/001/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 01 April 1980 Date of last renewal: 01 April 2010

10. Date of revision of the text

January 2019

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

application/pdf