Tardyferon 50 mg 30 tablets

Indications Tardyferon 50 mg 30 tablets

TARDYFERON 50mg contains iron.

It is used to prevent iron deficiency in pregnant women when the diet does not provide a sufficient amount of this element.

This medicine is reserved for adult women.

Dosage Tardyferon 50 mg 30 tablets

The usual dose is 50 mg per day (1 tablet) from the 4th month of pregnancy.

Method and route of administration Tardyferon 50 mg 30 tablets

This medicine is used orally. As a rule, you should take this medicine with a glass of water before or during meals. You should choose the time of day when your stomach will best tolerate this medication.

Swallow the tablets whole with water. Do not suck, chew or hold the tablet in your mouth.

DURATION OF TREATMENT

Your doctor will tell you how long you should take this medication.

Always take this medicine exactly as directed in this leaflet or as instructed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Precautions for use Tardyferon 50 mg 30 tablets

SPECIAL WARNINGS

Because of the risk of mouth ulcers and discoloration of the teeth, the tablets should not be sucked, chewed or held in the mouth but swallowed whole with water. If you are unable to follow this instruction or have difficulty swallowing, please contact your physician.

Patients, especially elderly patients and patients with swallowing difficulties, may also be at risk of damage to the throat, esophagus (the tube connecting your mouth to your stomach) or bronchial tubes (where air passes through the lungs) if the tablet enters the airways. Bronchial necrosis (tissue death) or granuloma (inflammation) can lead to bronchostenosis (narrowing of the airways). In the event of a false airway, you should immediately contact your doctor or the nearest emergency room for appropriate treatment.

Patients who have aspirated a tablet should contact a physician immediately, and pulmonary consultation should be considered. Patients may be at risk of unnoticed inhalation of a tablet and should be advised to seek medical attention if they experience inhalation symptoms such as coughing and/or other airway symptoms after ingestion of a tablet.

Based on data published in the literature, staining of the gastrointestinal tract wall has been observed in elderly patients with renal failure, diabetes and/or increased blood pressure who were receiving medication for these conditions and iron supplementation to treat their anemia.

PRECAUTIONS FOR USE

If you are taking TARDYFERON for iron deficiency, the cause of the deficiency should also be investigated and treated.

If your iron deficiency is associated with an inflammatory disease, treatment with TARDYFERON will not be effective.

This medication contains :

- a sugar (sucrose). It is not recommended for use in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).

- castor oil which can cause digestive disorders (mild laxative effect, diarrhea).

PREGNANCY AND LACTATION

This medicine can be used in pregnant and breastfeeding women.

Ask your doctor or pharmacist for advice before taking any medication

CONTRAINDICATIONS

Never take TARDYFERON 50 mg, coated tablet:

- If you are allergic (hypersensitive) to the active substance (iron) or to any of the other components contained in this medicine

- If you have more iron in your body than you need.

- If you have anaemia (insufficient number of red blood cells in the blood) not related to iron deficiency, or causing iron overload (e.g. thalassaemia, refractory anaemia, bone marrow failure anaemia).

- If you have an intestinal obstruction (stopped intestinal transit), because of the presence of castor oil.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

UNDESIRABLE EFFECTS

Like all medicines, this medicine can cause side effects, but they do not occur systematically in everyone.

Like all medicines, TARDYFERON 50 mg, coated tablet is likely to have side effects, although not everyone is susceptible:

The following effects, listed in descending order of frequency, may occur:

Common (1 to 10 in 100 patients)

- constipation,

- diarrhea,

- abdominal distension,

- abdominal pain,

- abnormal stool color,

- nausea.

Uncommon (1 to 10 in 1000 patients)

- throat swelling (laryngeal edema),

- abnormal stools

- discomfort and pain in the upper abdomen (dyspepsia)

- vomiting,

- acute inflammation of the stomach (gastritis)

- itching (pruritus)

- red rash on the skin (erythematous rash).

Unknown (frequency cannot be estimated based on available data) (the following adverse events have been reported since marketing):

- allergic reaction (hypersensitivity reaction),

- itchy skin rash (urticaria)

- tooth discolouration (if used incorrectly when chewed, sucked or held in the mouth)

- mouth ulceration (if used incorrectly when chewed, sucked or held in the mouth)

- Esophageal injury

- Lung tissue death (pulmonary necrosis)

- Lung inflammation (pulmonary granuloma)

- Airway narrowing (Bronchial stenosis)

- Staining of the gastrointestinal tract wall.

Elderly patients and patients with swallowing problems may also be prone to ulcerations of the throat, esophagus (the tube connecting your mouth to your stomach) or bronchi (the main airways of the lungs) if the tablet enters the airway.

In the event of a false route, you should contact a doctor or the nearest emergency room immediately to receive appropriate treatment.

Based on data published in the literature, staining of the gastrointestinal tract wall has been observed in elderly patients with renal failure, diabetes and/or increased blood pressure who were receiving medication for these conditions and iron supplementation to treat their anemia

COMPOSITION

ACTIVE INGREDIENTS

Iron as dried ferrous sulfate ...................................................................... 50 mg

EXCIPIENTS

ascorbic acid, avian mucoproteosis, potato starch, copolymer of methacrylic acid and methyl methacrylate (1:2) (Eudragit S), triethyl citrate, povidone K30, talc, magnesium stearate, hydrogenated castor oil, magnesium trisilicate

Coating : talc, titanium dioxide (E171), rice starch, erythrosine aluminium lake (E127), carnauba wax, copolymer of 2(dimethyl amino) ethyl methacrylate, butyl methacrylate and methyl methacrylate 2 :1 :1 (Eudragit E100), saccharose.

PACKAGING

Tardyferon 50 mg is presented in the form of 30 coated tablets.

If your symptoms persist, consult your doctor.

See the leaflet of this medicine