Ferro grad folic

FERRO GRAD FOLIC
Prolonged-release tablets
Ferrous sulfate / Ascorbic acid / Folic acid
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 they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

This medicine is an antianaemic agent (it acts against anaemia, which is a reduction in the number of red blood cells in the blood).
It is used for:

• treating iron deficiency and preventing concomitant folic acid deficiency
• treating and preventing hypochromic anaemia (reduced haemoglobin concentration in red blood cells) during pregnancy, especially when there is an associated deficiency of folic acid.

2. What you should know before taking FERRO GRAD FOLIC

Do not take FERRO GRAD FOLIC:

• if you are allergic to ferrous sulfate, ascorbic acid, folic acid or 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 suffer from certain types of anaemia (haemolytic anaemia, pernicious anaemia and megaloblastic anaemia due to vitamin B12 deficiency)
• if you have intestinal diverticula (an abnormality of the colon) or intestinal obstruction
• if you are receiving repeated blood transfusions
• if you are already receiving parenteral (injectable) iron therapy.

Warnings and precautions
Talk to your doctor or pharmacist before taking FERRO GRAD FOLIC.

• If you are an elderly patient and have diseases that tend to cause vitamin B12 depletion, because blood levels of vitamin B12 should be periodically monitored during treatment.
• If you have vitamin B12 deficiency, because concomitant parenteral (by injection) administration of vitamin B12 may be necessary.
• This medicine contains folic acid: Administration of folic acid at doses exceeding 0.1 mg per day may mask the signs of pernicious anaemia (anaemia due to vitamin B12 deficiency) by normalizing haematological parameters while neurological manifestations continue to progress.
• This medicine contains ascorbic acid (vitamin C):
• In humans, ascorbic acid is essentially non-toxic, although exceptionally high doses may cause side effects.
• Ascorbic acid is a strong reducing agent and, as such, may interfere with laboratory tests based on redox reactions.
• This medicine may turn stools black (see section 4), interfering with laboratory tests used to detect blood in the stool. If you need to undergo a guaiac resin test, taking Ferro Grad Folic may give false positive results for blood.
• Due to the risk of mouth ulcers 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 airways, there is a risk of developing bronchial ulceration and narrowing. This may lead to persistent cough, haemoptysis and/or shortness of breath, even if choking occurred days to months before these symptoms developed. Therefore, your condition must be urgently evaluated to ensure that the tablet has not damaged the airways.

Children
Keep FERRO GRAD FOLIC out of the reach of children to avoid accidental iron poisoning.
Other medicines and FERRO GRAD FOLIC
Tell 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, FerroGrad Folic slows down the absorption of tetracyclines into the body, and tetracyclines slow down 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 Folic.
• 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 at least 2 hours before or 2 hours after taking the iron preparation.
• ascorbic acid (vitamin C): may increase the body's absorption of iron.
• 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 decreased quinolone concentrations in serum and urine). Avoid taking oral iron preparations at the same time or within 2 hours after taking these antibiotics.
• methyldopa (used for arterial hypertension): concomitant administration of oral iron preparations may reduce the absorption of methyldopa.
• thyroxine (a medicine 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
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of iron-containing preparations is recommended during pregnancy and breastfeeding.
Driving and using machines
No effects on attention and the ability to drive vehicles or use machinery have been reported.

3. How to take FERRO GRAD FOLIC

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Dosage and method of administration
Adults: 1 tablet daily, taken without chewing, on an empty stomach or before the main meal.
Swallow the tablet whole with water. Do not suck, chew, or hold the tablet in the mouth.

If you take more FERRO GRAD FOLIC than you should
If you accidentally ingest an excessive amount of Ferro-Grad Folic, inform your doctor or go to the nearest hospital immediately.
Since the iron contained in FERRO GRAD FOLIC is in prolonged-release form, there is a lower likelihood of severe toxic effects occurring.
However, in cases of acute iron poisoning, increased capillary permeability (blood vessels), reduced plasma volume (decreased circulating blood volume), increased cardiac output (volume of blood pumped out by the ventricles), and sudden cardiovascular collapse (reduced blood supply to organs) may be observed.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• After administration of FERR GRAD FOLIC, gastrointestinal intolerance to iron may rarely occur; however, if this happens, the medicine can be taken after meals.
• The side effects reported with FERRO GRAD FOLIC are those observed with other iron-containing preparations:
• diarrhoea,
• constipation,
• nausea,
• vomiting,
• abdominal pain or discomfort,
• black discolouration of stools, and in isolated cases: allergic reactions ranging from rash (skin eruption) to anaphylaxis (a severe and potentially life-threatening allergic reaction).
• Ascorbic acid is generally well tolerated; however, in large quantities it may cause:
• diarrhoea,
• intestinal disturbances,
• kidney stones.

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

• Mouth ulcerations (in case of incorrect use, when tablets are chewed, sucked or held in the mouth). All patients, but especially elderly patients and patients with swallowing difficulties, may also be at risk of throat or oesophageal ulcerations (the tube connecting the mouth to the stomach). In case the tablet enters the airways, there may be a risk of bronchial ulcerations (the main air passages into 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, pharmacist or another healthcare professional (e.g. nurse).
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 FOLIC

Store this medicine at room temperature below 25 °C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the product in its original packaging, stored correctly.
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 FOLIC contains

• The active substances are: dried ferrous sulfate 329.7 mg (equivalent to 105 mg of Fe), granulated ascorbic acid 90% 555.56 mg (equivalent to 500 mg of ascorbic acid), folic acid 350 mcg

per tablet

• Other components are: Core: methacrylic acid-methyl methacrylate copolymer, magnesium stearate, polyvinylpyrrolidone, polyethylene glycol 8000, microcrystalline cellulose, talc, polyethylene glycol 400; Coating: hydroxypropylmethylcellulose, ethylcellulose, polyethylene glycol 400, polyethylene glycol 800, erythrosine red (E127), titanium dioxide.

Description of the appearance of FERRO GRAD FOLIC and package contents
FERRO GRAD FOLIC is supplied in a carton containing 20 prolonged-release tablets (Gradumet) in blisters.
Marketing Authorization Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
Fax: 0382/525 845
E-mail: [email protected]
Manufacturer:
TEOFARMA S.r.l.
Viale Certosa, 8/A
27100 Pavia