TARDYFER 80 mg Extended-Release Tablet

Зміст інструкції

1. TARDYFER 80 mg prolonged-release tablets
   1. What is Tardyfer and what is it used for?
   2. What you need to know before you take Tardyfer
   3. How to take Tardyfer
   4. Possible side effects
   5. HOW TO STORE TARDYFER
   6. Contents of the pack and other information

TARDYFER 80 mg prolonged-release tablets

Iron as ferrous sulfate

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What Tardyfer is and what it is used for
• 2. What you need to know before you take Tardyfer
• 3. How to use Tardyfer
• 4. Possible side effects
• 5. How to store Tardyfer
• 6. Contents of the pack and other information

1. What is Tardyfer and what is it used for?

Tardyfer is used for the treatment of iron deficiency.
This medicine is reserved for use in adults and children over 10 years of age.

2. What you need to know before you take Tardyfer

Do not take Tardyfer

• If you are allergic to ferrous sulfate or any of the other ingredients of this medicine (listed in section 6).
• If you have a disease that causes an excess of iron in your body (e.g. hemochromatosis).
• In case of concomitant parenteral therapy with iron.
• If you have an intestinal obstruction.
• If you are a patient receiving frequent blood transfusions.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tardyfer.

• If you are taking food supplements and/or iron supplements, as high doses of iron (10-20 times the usual dosage) can cause poisoning, especially in children.
• If you have a disease that affects the accumulation and absorption of iron (e.g. hemolytic anemia, hemoglobinopathy, myelodysplasia).
• If iron deficiency is associated with an inflammatory disease, treatment with Tardyfer will not be effective.
• Iron therapy should be combined, as far as possible, with treatment for the cause of the deficiency.
• Patients, especially the elderly and those with difficulty swallowing, if the tablet enters the airways, may be at risk of ulceration of the throat, esophagus (the tube connecting your mouth to your stomach) or bronchi (the major airways to the lungs). Necrosis (tissue death) of the bronchus or granuloma (inflammation) can cause bronchostenosis

(narrowing of the airways). If the tablet takes the wrong path, contact
your doctor or the nearest emergency room immediately to receive appropriate treatment.

• Based on data from the literature, in elderly patients with chronic kidney disease, diabetes (high blood sugar levels), and/or hypertension (high blood pressure), who have taken many medications to treat these diseases and who have treated associated anemia with iron supplements, gastrointestinal melanosis (discoloration of the gastrointestinal tract) has been found.
• Due to the risk of mouth ulceration and tooth discoloration, the tablets should 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.

Children and adolescents
Tardyfer cannot be used in children under 10 years of age.

Other medicines and Tardyfer
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
If you are already taking the medicines described below, do not take Tardyfer unless your
doctor has decided so. In fact, some medicines must not be used at the same time, while for others it is
necessary to make changes (for example, the time of taking).
If you are taking medicines for injection containing iron or chloramphenicol, you should avoid taking
Tardyfer.
If you are taking the medicines listed below, you should take Tardyfer at least 2 hours apart:

• certain antibiotics (tetracyclines or fluoroquinolones).
• medicines for the treatment of fragile bones (bisphosphonates)
• medicines for the treatment of joint diseases (penicillamines).
• medicines for the treatment of excess stomach acid: mineral gastrointestinal preparations, charcoal or antacids (aluminum, calcium and magnesium salts)
• medicines for the treatment of thyroid disease (thyroxine)
• medicines for the treatment of Parkinson's disease (methyldopa, levodopa and carbidopa).
• Supplements and/or medicines containing calcium, zinc.

If you are taking anti-inflammatory drugs belonging to the group of non-steroidal anti-inflammatory drugs,
they should be taken with food to reduce gastrointestinal irritation and bleeding caused
by these types of medicines.
If you are taking cholestyramine (used in patients with high cholesterol levels), Tardyfer should be
taken 1 or 2 hours before or 4 to 6 hours after taking cholestyramine.

Tardyfer with food, drinks and alcohol
You should not drink large amounts of tea, coffee, red wine, as this can reduce the absorption of iron
in your body.
It is not advisable to take this medicine at the same time as whole grains (bran,
legumes, oilseeds) with some proteins (eggs) or foods or drinks containing calcium (such as cheese,
milk, etc.).
Allow an interval of time (at least 2 hours) between taking iron salts and these foods.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine. Tardyfer can be
used during pregnancy and breastfeeding.

Driving and operating machinery
It is unlikely that the use of Tardyfer will affect your ability to drive vehicles and operate machinery.

Important information about some of the excipients of Tardyfer
Not applicable

3. How to take Tardyfer

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Tardyfer is indicated for children over ten years of age and in adults. It must be administered orally.
The recommended dose for adults and children over 10 years of age is: 1 tablet per day (80 mg per day).
In case of more pronounced iron deficiency, the dose may be increased to 2 tablets per day, 1 in the morning and 1 in the evening (160 mg per day).
Method of administration
Oral use.
Swallow the tablet whole with water. Do not suck, chew or hold the tablet in your mouth. The tablets must be taken with 1 glass of water before meals or during meals depending on gastric tolerability (except with the foods specified in the paragraph “ Tardyfer with food, beverages and alcohol”).
Duration of treatment
The duration of treatment must be sufficient to correct iron deficiency (anemia) and to restore iron stores; generally from 3 to 6 months. Your doctor will inform you about the duration of treatment.
If you have any doubts, consult your doctor or pharmacist.

If you take more Tardyfer than you should
Cases of overdose with iron salts have been reported, particularly from ingestion of large amounts of iron in children.
The symptoms of overdose include signs of gastrointestinal irritation accompanied by abdominal pain, nausea, vomiting, diarrhea, cardiovascular shock symptoms or metabolic acidosis (fast or short breathing, increased heart rate, headache, confusion, drowsiness, fatigue, loss of appetite, stomach upset, vomiting) followed by liver or kidney failure.
If you have taken too many Tardyfer tablets, contact a doctor or the nearest emergency room immediately so that you can receive appropriate treatment.

If you forget to take Tardyfer
If you forget to take a tablet at the usual time, take it as soon as you remember, but if it is close to the time of taking the next tablet, do not take the forgotten dose, but take the next dose normally. Do not take a double dose to make up for the forgotten dose.
If you stop taking Tardyfer
Tardyfer must be taken for the time prescribed by your doctor. After premature discontinuation of therapy, the disorders may recur.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur, listed from most frequent to least frequent:

Common(may affect up to 1 in 10 people)
Constipation, diarrhoea, abdominal bloating, abdominal pain, discolored stools, nausea.

Uncommon(may affect up to 1 in 100 people)
Swelling of the throat (laryngeal edema), abnormal stools, general feeling of discomfort or pain in the upper
abdomen (dyspepsia), vomiting, acute inflammation of the stomach (gastritis), tingling (pruritus), skin rash with
redness (erythematous rash).

Frequency not known(cannot be estimated from the available data)
Allergic reaction (hypersensitivity reaction), rash accompanied by itching (urticaria), pulmonary necrosis
(tissue death)*, pulmonary granuloma (inflammation)*, bronchostenosis (narrowing of the airways)*, alteration
of tooth color**, mouth ulceration**, esophageal lesions**, discoloration of the
gastrointestinal tract (gastrointestinal melanosis).
* Patients, especially elderly patients and patients with difficulty swallowing, if the tablet enters
the airways, may be at risk of ulceration of the throat, esophagus (the tube connecting the
mouth to the stomach) or bronchi (the major airways to the lungs). Necrosis (death
of tissue) of the bronchus or granuloma (inflammation) can cause bronchostenosis (narrowing of the
airways). If the tablet takes the wrong path, contact your
doctor or the nearest emergency room immediately to receive appropriate treatment.
**in case of incorrect use, when the tablets are chewed, sucked or held in the mouth.
Based on literature data, in elderly patients with kidney disease, diabetes (high blood sugar
levels), and/or hypertension, who have taken many medicines to treat these diseases and who have
treated anemia associated with iron-based supplements, gastrointestinal melanosis has been found
(discoloration of the gastrointestinal tract).
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system, at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa By reporting side effects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE TARDYFER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the packaging. The expiry date refers to the last day of the month.
No special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tardyfer contains

• The active ingredient is: iron (80 mg), as ferrous sulfate.
• The other components are: Maltodextrin, Microcrystalline cellulose, Triethyl citrate, Talc, Ammonium methacrylate copolymer dispersion Type B (EUDRAGIT RS 30D), Ammonium methacrylate copolymer dispersion Type A (EUDRAGIT RL 30D), Glycerol dibehenate, Titanium dioxide, Sepifilm LP010*, Yellow iron oxide, Red iron oxide. * composition of Sepifilm LP010: Hypromellose, Microcrystalline cellulose, Stearic acid.

Description of the appearance of Tardyfer and contents of the pack
Tardyfer is available in packs containing 20, 30 or 60 prolonged-release tablets, round, of
orange - pink color.
Not all pack sizes may be marketed.
Pierre Fabre Pharma S.r.l.
Via G. Washington, 70
20146 MILANO
ITALIA

Manufacturer responsible for batch release
Pierre Fabre Médicament Production
Etablissement Progipharm
Rue du Lycée
45500 Gien – France