Ferro-Grad

Package leaflet: Information for the user

FERRO-GRAD, 105 mg prolonged-release tablets

Ferrous sulfate
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What FERRO-GRAD is
2. What you need to know before taking FERRO-GRAD
3. How to take FERRO-GRAD
4. Possible side effects
5. How to store FERRO-GRAD
6. Contents of the pack and other information

1. What FERRO-GRAD is and what it is used for

This medicinal product is used to treat anaemia (a condition caused by a reduction in the number of red blood cells or in haemoglobin, a protein in the blood responsible for oxygen transport).
It is used to treat anaemia due to iron deficiency caused by:

• acute or chronic blood loss
• inadequate intake or absorption of iron
• increased iron requirement (growth, pregnancy)
• infectious disease

2. What you need to know before taking FERRO-GRAD

Do not take FERRO-GRAD:

• if you are allergic to ferrous sulfate or to any of the other ingredients of this medicine (listed in section 6)
• if you have haemochromatosis or haemosiderosis (iron overload in the body)
• if you have haemolytic anaemia (excessive destruction of red blood cells)
• if you have intestinal diverticula (a condition caused by protrusions of the colon) or intestinal obstruction
• if you are receiving repeated blood transfusions
• if you are already undergoing parenteral (injectable) iron therapy.

Warnings and precautions
Talk to your doctor or pharmacist before taking FERRO-GRAD.
Due to the risk of mouth ulceration and tooth discoloration, the tablets must not be sucked, chewed, or held in the mouth, but should be swallowed whole with water. If you are unable to follow these instructions or have difficulty swallowing, contact your doctor.
If you accidentally choke on a tablet, contact your doctor as soon as possible.
This is because if the tablet enters the respiratory tract, there is a risk of developing bronchial ulceration and narrowing. This may lead to persistent cough, haemoptysis (coughing up blood), and/or shortness of breath, even if the choking incident occurred days or months before the onset of symptoms. Therefore, your condition must be urgently evaluated to ensure that the tablet has not damaged the respiratory tract.
Black discoloration of the stools may interfere with laboratory tests used to detect blood in the faeces. Occasionally, the guaiac resin test (used to detect blood in the faeces) has produced false-positive results for blood.

Other medicines and FERRO-GRAD
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:

• tetracyclines (antibiotics): like all iron-containing preparations, Ferro-Grad slows the absorption of tetracyclines into the body, and tetracyclines slow the absorption of iron. If both treatments need to be taken, tetracyclines should be administered 2 hours before or 3 hours after taking Ferro-Grad.
• penicillamine (a medicine used for rheumatism): iron may reduce the absorption of penicillamine into the body. If both treatments need to be taken, penicillamine should be administered 2 hours before or 2 hours after taking the iron preparation.
• chloramphenicol (an antibiotic): may delay the response to iron therapy.
• antacids (used for certain digestive disorders): concomitant administration of antacids and oral iron preparations may reduce iron absorption. Avoid taking oral iron preparations 1 hour before or 2 hours after taking antacids.
• quinolones (antibiotics): concomitant administration of oral iron preparations may interfere with the absorption of certain oral quinolone antibiotics such as ciprofloxacin, norfloxacin, and ofloxacin, as shown by reduced quinolone concentrations in serum and urine. Avoid taking oral iron preparations simultaneously or within 2 hours after taking quinolones.
• methyldopa (used for arterial hypertension): concomitant administration of oral iron preparations may reduce the absorption of methyldopa.
• thyroxine (a drug used to treat certain thyroid diseases): in patients with primary hypothyroidism, concomitant administration of oral iron preparations may reduce the absorption of thyroxine.

Pregnancy and breastfeeding
The use of this medicine is recommended during pregnancy and breastfeeding.
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
No effects on attention or the ability to drive vehicles or operate machinery have been reported.

FERRO-GRAD contains castor oil
This medicine contains castor oil, which may cause gastrointestinal disturbances and diarrhoea.

3. How to take FERRO-GRAD

Dosage and method of administration
Adults and children over 10 years of age: 1 tablet per day, taken without chewing.
Swallow the tablet whole with water. Do not suck, chew, or hold the tablet in the mouth.
The likelihood of gastric intolerance (in the stomach) is low; however, if this should occur, you may take the tablet after a meal.

If you take more FERRO-GRAD than you should
If you think you have taken an excessive dose of FERRO-GRAD, inform your doctor immediately and go to the nearest hospital. Take the medicine package with you, including any remaining tablets.
Signs of severe toxicity may appear delayed because iron is in a controlled-release formulation. In case of acute iron poisoning, the following symptoms may occur: increased capillary permeability (blood vessels), plasma hypovolemia (reduced circulating blood volume), increased cardiac output (volume of blood expelled by a ventricle), and sudden cardiovascular collapse (reduced blood supply to organs, manifesting as weak and rapid heartbeat, sweating, cold sensation in hands and feet, pallor, and nausea).
In case of overdose, it is necessary to attempt accelerating the elimination of ingested Ferro-Grad tablets.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following have been observed with low frequency:

• diarrhoea,
• constipation,
• nausea,
• vomiting,
• abdominal pain or discomfort,
• blackening of the stools.

In isolated cases the following have been observed:

• allergic reactions ranging from rash (skin eruption) to anaphylaxis (a severe and potentially life-threatening allergic reaction).

The following have been observed with unknown frequency (frequency cannot be estimated from the available data):

• mouth ulceration (in case of incorrect use, when tablets are chewed, sucked or held in the mouth). All patients, but particularly elderly patients and patients with swallowing difficulties, may also be at risk of ulceration of the throat or oesophagus (the tube connecting the mouth to the stomach). If the tablet enters the airways, there may be a risk of bronchial ulceration (in the main air passages to the lungs), leading to bronchial narrowing.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FERRO-GRAD

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FERRO-GRAD contains
The active substance is: dried ferrous sulfate …………… 329.7 mg (equivalent to 105 mg of
Fe) per tablet.
The other components are:
Tablet core: methylacrylate-methylmethacrylate, magnesium stearate, povidone, polyethylene glycol
6000.
Tablet coating: cellulose acetate phthalate, polyethylene glycol 6000, E172,
ethyl vanillin, ovalbumin, propylene glycol, polysorbate 80, castor oil, saccharin.
Description of the appearance of FERRO-GRAD and pack contents
Blister pack containing 40 prolonged-release tablets
Marketing Authorization Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
Fax 0382.525845
e-mail: [email protected]
Manufacturer:
TEOFARMA S.r.l.
Viale Certosa, 8/A
27100 Pavia