TARDYFERON

TARDYFERON depot iron (II) sulfate 80 mg prolonged-release tab.

Important notes (mandatory information)

Tardyferon Depot-Iron(II)-sulfate 80 mg Retard tablets. Active ingredient: Dried iron(II)-sulfate. Areas of application: for the treatment of iron deficiency.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR USERS

Tardyferon Depot-Iron(II)-sulfate 80 mg Retard tablets for use in adults and children aged 10 years and over
Active ingredient: Dried iron(II)-sulfate

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 4 weeks, contact your doctor.

What this package leaflet contains

1. WHAT IS TARDYFERON AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING TARDYFERON?
3. HOW TO TAKE TARDYFERON?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE TARDYFERON?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS TARDYFERON AND WHAT IS IT USED FOR?

Tardyferon is an iron preparation with blood-forming effect (antianemic) and is used for the treatment of iron deficiency. If you do not feel better or if you feel worse after 4 weeks, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING TARDYFERON?

Tardyferon must not be taken:

• if you are allergic to dried iron(II)-sulfate or any of the other ingredients of this medicine listed in section 6.
• if you have iron overload such as hemochromatosis, genetic anemia (thalassemia) or other forms of anemia (refractory anemia or medullary insufficiency).
• by children under 10 years of age.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Tardyferon. If dietary or other iron salt supplements are used, to avoid the risk of possible iron overdose. In case of pre-existing inflammation or ulcers of the gastrointestinal mucosa, the benefit of treatment should be carefully weighed against the risk of worsening the gastrointestinal disease.

If you have difficulty swallowing

If you have accidentally swallowed a tablet, please contact your doctor as soon as possible. If the tablet enters the respiratory tract, there is a risk of ulcers and narrowing of the bronchi. This can lead to persistent coughing, coughing up blood and/or shortness of breath, even if the swallowing occurred days to months before these symptoms. Therefore, you must be examined urgently to ensure that the tablet has not damaged your airways.

Due to the risk of mouth ulcers (mouth ulcers) and tooth discoloration, the tablets must not be sucked, chewed or left in the mouth for a long time, but should be swallowed whole with water. If you are unable to follow these instructions or have difficulty swallowing, talk to your doctor. Cases of open stomach ulcers and stomach bleeding have been reported in the literature in patients treated with iron tablets. In this case, it is recommended to switch to a liquid iron formulation (see section 4).

Children

Tardyferon must not be used in children under 10 years of age.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, i.e. it is virtually "sodium-free".

Taking Tardyferon with other medicines

If you are already taking any of the following medicines, do not take Tardyferon unless your doctor has prescribed it. Some medicines must not be taken at the same time; other medicines require certain changes in use (e.g. in the time of taking).

If you are taking any of the following medicines, you should allow an interval of at least 2 hours before taking Tardyferon:

• Antibiotics (tetracyclines or related antibiotics, cefdinir).
• Medicines for the treatment of osteoporosis (bisphosphonates).
• Medicines for the treatment of joint diseases, copper storage disease (Wilson's disease) or for the prevention of kidney stones (penicillamine, trientine).
• Medicines for the treatment of excess stomach acid: Mineral preparations for the gastrointestinal tract, 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, carbidopa, entacapone).
• Medicines for the treatment of HIV (bictegravir, integrase inhibitors).
• Medicines for the treatment of urinary tract infections (acetohydroxamic acid).
• Dietary supplements and/or medications containing zinc, magnesium or calcium.
• Gold compounds.

The simultaneous intake of iron salts with salicylic acid salts (salicylates, e.g. acetylsalicylic acid) or non-steroidal anti-inflammatory drugs (medicines for pain or inflammation) can increase the irritant effect of iron on the mucous membrane of the gastrointestinal tract. With simultaneous intake of iron salts and cefdinir, reddish stools may occur. Iron salts influence the absorption of quinolone antibiotics (e.g. ciprofloxacin, levofloxacin, norfloxacin, ofloxacin). Quinolones should be taken 4 hours before or 4 - 6 hours after an iron salt dose.

If you are taking cholestyramine

Tardyferon should be given 1 to 2 hours before or 4 to 6 hours after cholestyramine.

If you are receiving injectable iron-containing medicines, you should avoid taking Tardyferon.

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines.

Taking Tardyferon with food, drink and alcohol

You should not drink large amounts of tea (e.g. black tea, green tea, other tea containing tea), coffee or red wine, as this inhibits the absorption of iron in your body. You should not take Tardyferon at the same time as dairy products, whole grains (bran, legumes, oilseeds), some proteins (eggs) or calcium-containing foods (cheese, milk, etc.), as these inhibit iron absorption. Allow an interval of at least 2 hours between taking iron and consuming these foods.

Pregnancy and breast-feeding

A large amount of data in pregnant women indicate no congenital malformations when iron(II) salts are used therapeutically. Animal studies showed no reproductive toxicity. If clinically necessary, Tardyferon can be taken during pregnancy. Iron(II) salts pass into breast milk. At therapeutic doses of Tardyferon, no effects are expected for the newborn/infant. If clinically necessary, Tardyferon can be taken during breast-feeding. Animal studies showed no effects on female and male fertility. At therapeutic doses, no effects on fertility are expected in humans. If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Treatment with the high dosage of 2 retard tablets per day should not be taken over a longer period of time.

Driving and using machines

Taking Tardyferon is unlikely to affect your ability to drive or operate machines.

3. HOW TO TAKE TARDYFERON?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Tardyferon is used in children aged 10 years and over and in adults. It is taken orally.

The recommended dose is:

• For mild iron deficiency 1 retard tablet Tardyferon.
• For severe iron deficiency and a body weight >32 kg 1 retard tablet each in the morning and evening.

A daily dose of 5 mg iron/kg body weight should not be exceeded. After 3 weeks, the dose can be reduced to 1 retard tablet once daily.

Method of administration

Swallow the tablet whole with water. Do not suck or chew the tablet, and do not leave the tablet in your mouth for a long time. The retard tablets should be swallowed with a large glass of water, depending on gastrointestinal tolerance, before or during meals (except for certain foods, which are listed in the section "Taking Tardyferon with food and drink"). The duration of use depends on the type and severity of the iron deficiency. To replenish iron stores, the intake of 1 retard tablet daily should be continued for another 1-3 months after the values have returned to normal.

If you have taken more Tardyferon than you should

There have been reports of cases, especially in children, where massive ingestion of iron salts has resulted in overdose. Symptoms of overdose include signs such as: gastrointestinal irritation, accompanied by abdominal pain, nausea, vomiting, diarrhea, symptoms of cardiovascular shock or metabolic acidosis (rapid or shallow breathing, increased heart rate, headache, confusion, drowsiness, fatigue, loss of appetite, nausea, vomiting), followed by liver or kidney failure. If Tardyferon has been taken in too large quantities, a doctor should be informed immediately or the emergency department of a hospital should be visited to initiate the necessary treatment.

If you forget to take Tardyferon

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects, listed in descending frequency, may occur

Common side effects (1 to 10 in 100 treated)

Diarrhea, constipation, bloating, abdominal pain, discoloration of stools, nausea.

Uncommon side effects (1 to 10 in 1000 treated)

Swelling of the throat (laryngeal edema), abnormal stools, malaise and upper abdominal discomfort (indigestion), vomiting, acute gastritis (gastritis), itching (pruritus), rash with reddening of the skin (erythematous rash).

Not known (frequency cannot be estimated from the available data)

Hypersensitivity reactions (allergic reactions), itchy rash (urticaria), death of lung tissue (lung necrosis)*, inflammatory, nodular tissue proliferation of lung tissue (lung granuloma)*, narrowing of the airways (bronchostenosis)*, tooth discoloration**, mouth ulcer**, throat ulcer**, esophageal injuries (esophageal lesions)*, open stomach ulcer, stomach bleeding, darkening in the gastrointestinal tract (gastrointestinal melanosis).

* In all patients, but especially in elderly patients or patients with difficulty swallowing, there is also a risk of ulcers in the throat or esophagus (the connection between the mouth and stomach). If the tablets enter the respiratory tract, there is a risk of ulcers in the main airways of the lungs (bronchi), leading to narrowing of these airways.
** In case of incorrect use, if the tablets are chewed, sucked or left in the mouth for a long time.

Based on literature data, darkening in the gastrointestinal tract (gastrointestinal melanosis) has been observed in elderly patients with chronic kidney disease, diabetes (high blood sugar) and/or high blood pressure who were treated with various medications for these diseases and at the same time received iron preparations for the treatment of anemia. This discoloration of the gastrointestinal wall can interfere with gastrointestinal surgery. In view of this risk, it is advisable to inform the surgeon of any ongoing iron supplementation prior to planned surgery.

Investigations

Certain tests for the detection of blood in the stool may be falsified. Tardyferon must be discontinued before such a test.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TARDYFERON?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the container (blister pack). The expiry date refers to the last day of the month.

Storage conditions

No special requirements.

Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. This helps to protect the environment. For more information, see www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Tardyferon contains

The active ingredient is: Dried iron(II)-sulfate. 1 retard tablet contains 247.25 mg iron(II)-sulfate (equivalent to 80 mg iron). The other ingredients are: Tablet core: Maltodextrin, microcrystalline cellulose, ammonium methacrylate copolymer type B (Eudragit RS 30D) ammonium methacrylate copolymer type A (Eudragit RL 30D), talc, triethyl citrate, glyceryl dibehenate (Ph.Eur.) Tablet coating: Sepifilm LP010 (hypromellose, microcrystalline cellulose, stearic acid), iron(III) oxide yellow (E 172), iron(III) oxide red (E 172), titanium dioxide, triethyl citrate

What Tardyferon looks like and contents of the pack

The orange-pink retard tablets are sealed in blisters (PVC/PVDC) with PET-coated aluminum foil. Tardyferon is available in packs of 20, 50 or 100 retard tablets.

Pharmaceutical entrepreneur

Pierre Fabre Pharma GmbH
Neuer Messplatz 5
D-79108 Freiburg

Manufacturer

Pierre Fabre Médicament Production
Progipharm Rue du Lycée
F-45500 Gien

This leaflet was last revised in May 2023.

Source: Information from the package leaflet
Status: 07/2024
Active ingredient: Dried iron(II)-sulfate. Areas of application: for the treatment of iron deficiency.