Fero-Gradumet 105 mg prolonged-release tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
FEROGRADUMET 105 mg prolonged-release tablets
Iron (as ferrous sulphate)
Read the entire leaflet carefully before you start taking this medicine
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.
- If you think any of the side effects you experience is serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What FEROGRADUMET is and what it is used for
- Before you take FEROGRADUMET
- How to take FEROGRADUMET
- Possible side effects
- How to store FEROGRADUMET
- Further information
1. What FEROGRADUMET is and what it is used for
FEROGRADUMET belongs to a group of medicines called oral iron preparations.
FEROGRADUMET is used in adult patients for the treatment of iron deficiency anemia and iron deficiency states.
2. Before taking FEROGRADUMET
Do not take FEROGRADUMET
- If you are allergic (hypersensitive) to iron or any of the other ingredients of FEROGRADUMET.
- If you have iron overload (e.g. haemochromatosis, haemosiderosis).
- If you have anaemias not related to iron deficiency, such as aplastic, haemolytic, or sideroblastic anaemia.
- If you have undergone repeated blood transfusions.
- If you are receiving concomitant parenteral iron therapy.
- If you suffer from chronic inflammation of the pancreas or liver cirrhosis.
Take special care with FEROGRADUMET
- If you have an acute intestinal disorder or liver problems.
- When taking FEROGRADUMET, stools may become dark green or black. This effect is harmless.
- Due to the risk of mouth ulcers and tooth discoloration, tablets must not be sucked, chewed, or held in the mouth; they should be swallowed whole with water. If you are unable to follow this instruction or have difficulty swallowing, contact your doctor.
- If you accidentally inhale a tablet, contact your doctor as soon as possible. This is because there is a risk of ulcers and bronchial narrowing if the tablet enters the respiratory tract, which may result in persistent cough, bloody cough, and/or choking sensation, even if the inhalation occurred days or months before symptoms appear. Therefore, urgent evaluation is required to ensure the tablet has not damaged your respiratory tract.
Consult your doctor if any of the above conditions have ever applied to you.
Use of other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
FEROGRADUMET must not be administered together with:
- Iron (salts) (parenterally), due to the risk of collapse and shock attributed to the rapid release of iron complexes and transferrin saturation.
- Certain antibiotics such as tetracyclines or quinolones; FEROGRADUMET should be taken at least two to three hours before or after the antibiotic.
- Medicines containing thyroxine or penicillamine, as FEROGRADUMET may reduce their effectiveness.
- Antacids, calcium supplements, or medicines containing bicarbonate, carbonate, oxalates, or phosphates, as these may reduce iron absorption.
- Medicines containing ascorbic acid (vitamin C), as iron absorption may be altered.
- Medicines containing chloramphenicol, as the response to iron treatment may be delayed.
- Medicines containing methyldopa, as FEROGRADUMET may reduce its antihypertensive effect.
Taking FEROGRADUMET with food or drinks
FEROGRADUMET should not be taken together with milk or dairy products.
Some foods such as tea, coffee, milk, and cereals may reduce iron absorption.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
No problems have been reported in pregnant or breastfeeding mothers receiving oral iron.
Driving and using machines
The influence of FEROGRADUMET on the ability to drive and use machines is none or negligible.
Important information about some of the components of FEROGRADUMET
This medicine may cause stomach discomfort and diarrhoea because it contains castor oil.
It may cause allergic reactions because it contains cochineal red A (Ponceau 4R) (E-124). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take FEROGRADUMET
Follow exactly the administration instructions for FEROGRADUMET given by your doctor. Consult your doctor or pharmacist if you have any doubts.
The usual recommended dose for mild iron-deficiency anemias, iron deficiency states, and increased iron requirements is 1 tablet once daily.
For severe iron-deficiency anemias, with hemoglobin levels below 8–9 g/dl, the usual recommended dose is 1 tablet in the morning and another in the evening.
Swallow the tablets whole with water, preferably 1 hour before or 3 hours after meals. If gastric problems occur, the tablets may be taken after a meal (lunch or dinner). Do not suck, chew, or hold the tablet in the mouth.
If you think that the effect of FEROGRADUMET is too strong or too weak, inform your doctor or pharmacist.
If you take more FEROGRADUMET than you should
If you have taken more FEROGRADUMET than recommended, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20.
If you forget to take FEROGRADUMET
If you have missed a dose, take it as soon as possible and then continue with your regular schedule. Do not take a double dose to make up for missed doses.
Gastrointestinal irritation symptoms such as nausea and vomiting may occur.
If you stop taking FEROGRADUMET
Your doctor will determine the duration of treatment with FEROGRADUMET. To replenish the body's iron stores completely, treatment must continue for 3 months after hemoglobin levels have returned to normal in cases of iron-deficiency anemia. Do not discontinue treatment earlier, even if you feel better.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, FEROGRADUMET may have adverse effects, although not everyone will experience them.
The most common adverse effects are gastrointestinal in nature, especially abdominal pain, heartburn, nausea, vomiting, constipation or diarrhoea. It is common to observe dark green or black stools due to iron excretion. This effect is harmless.
Allergic reactions such as erythema, skin rash, pruritus, and breathing difficulties may rarely occur.
Frequency not known (cannot be estimated from available data):
Mouth ulcers (in case of incorrect use, when tablets are chewed, sucked or held in the mouth).
All patients, but especially elderly patients and those with swallowing difficulties, may also be at risk of throat or oesophageal ulceration (the tube connecting your mouth to your stomach). If the tablet enters the airways, there may be a risk of bronchial ulceration (the main air passage into the lungs), which could lead to bronchial narrowing.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. FEROGRADUMET Storage
Keep out of the reach and sight of children.
Do not store above 25°C. Keep in the original container.
Do not use FEROGRADUMET after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. INFORMATION FOR THE USER
Composition of FEROGRADUMET
- The active substance is iron in the form of ferrous sulfate. Each tablet contains 325 mg of ferrous sulfate, equivalent to 105 mg of elemental iron.
- The other components are: methylacrylate-methylmethacrylate copolymer, polyethylene glycol 8000 (Macrogol 8000), magnesium stearate, povidone, castor oil, hydroxypropylmethylcellulose 2910, ethylcellulose, polyethylene glycol 400 (Macrogol 400), lacquer, carmine red A (Ponceau 4R) (E124), and titanium dioxide (E171).
Appearance of the medicinal product and contents of the pack
Pack containing 30 red-coated tablets.
Marketing Authorization Holder and Manufacturer
Teofarma Srl
Via F.lli Cervi, 8
27010 Valle Salimbene
Pavia – Italy
This leaflet was last approved in October 2018.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/