Tardisol

Leaflet attached to the packaging: patient information

Tardysol, 20 mg/ml, oral solution

Ferrum asFerrosi sulfas heptahydricus

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tardysol and what is it used for
• 2. Important information before taking Tardysol
• 3. How to take Tardysol
• 4. Possible side effects
• 5. How to store Tardysol
• 6. Contents of the packaging and other information

1. What is Tardysol and what is it used for

Tardysol contains iron.
The medicine is used in children over 2 years of age and in adults:

• to treat iron deficiency anemia (a lack of red blood cells due to insufficient iron in the body);
• to prevent iron deficiency anemia in pregnant women, when the diet cannot provide enough iron.

2. Important information before taking Tardysol

When not to take Tardysol

• if the patient is allergic to iron or any of the other ingredients of this medicine (listed in section 6);
• if the patient has more iron in their body than they need;
• if the patient has a type of anemia (a lack of red blood cells) that is not caused by iron deficiency or that causes iron overload (e.g. thalassemia, anemia resistant to treatment, anemia caused by bone marrow deficiency).

IN CASE OF ANY DOUBTS ABOUT THIS MEDICINE, YOU SHOULD CONSULT A DOCTOR OR PHARMACIST.

Warnings and precautions

Before starting treatment with Tardysol, you should discuss it with your doctor or pharmacist.

• If the patient is taking Tardysol for iron deficiency anemia, the doctor will also investigate the cause of the anemia, so that it can be treated.
• If the patient's iron deficiency anemia is related to an inflammatory disease, treatment with Tardysol will not be effective.
• As indicated by literary data, in elderly patients with renal failure, diabetes (abnormally high blood sugar levels) and (or) high blood pressure (hypertension), who are taking medications for these conditions and iron supplements for anemia, discoloration of the gastrointestinal tract has been reported. Such a change in color may make surgical procedures in the gastrointestinal tract more difficult. Due to the risk, if surgery is planned, the surgeon should be informed about the use of iron (see section 4).
• In case of accidental inhalation of the medicine (aspiration "in the wrong direction"), it may enter the airways. Contact of the medicine with the airways may cause injuries, such as necrosis (tissue death) or bronchitis (places where air passes through the lungs) or esophagitis (the section connecting the mouth to the stomach). These injuries may cause bronchial narrowing. Symptoms associated with such injuries may include: persistent cough, coughing up blood and (or) feeling short of breath, even if the inhalation occurred several days or months before the onset of these symptoms.
• If the medicine enters the airways and the patient has at least one of the mentioned symptoms, they should contact a doctor or the nearest emergency department as soon as possible to undergo a specialist assessment and ensure that no damage to the airways has occurred.

Children and adolescents

This does not apply.

Tardysol and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Some medicines should not be taken at the same time as Tardysol, while the use of other medicines requires certain changes (e.g. time of administration).
If the patient is receiving iron injections, they should not take Tardysol.
If the patient is taking the following medicines, they should maintain a 2-hour interval between their administration and the administration of Tardysol:
antibiotics (tetracyclines, fluoroquinolones)
medicine used to treat chronic urinary tract infections (acetohydroxamic acid)
medicines used to treat HIV infection (integrase inhibitors, including bictegravir)

• medicines used to treat bone fragility (bisphosphonates)
• medicines used to treat joint diseases, Wilson's disease, or to prevent kidney stone formation (penicillamine, trientine) medicines used to treat excessive stomach acid production: preparations containing mineral compounds, charcoal, or antacids (aluminum, calcium, and magnesium salts) medicines used to treat thyroid diseases (levothyroxine, liotyronine) medicines used to treat Parkinson's disease (levodopa, carbidopa, entacapone) supplements and (or) medicines containing zinc, calcium, or strontium.

If the patient is taking cholestyramine, Tardysol should be administered 1-2 hours before or 4 to 6 hours after its administration.

Using Tardysol with food and drink

Foods rich in calcium may reduce iron absorption and make the treatment less effective. Therefore, Tardysol should be administered some time before a meal or after a meal, and before or after the administration of dairy products.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
There is limited data on the use of iron in the first trimester of pregnancy, but there is a large amount of literary data on women in the second and third trimesters of pregnancy. They do not indicate toxicity to the fetus and (or) newborn.
Therefore, Tardysol may be used in pregnant women in case of clinical indications.
Tardysol may be used during breastfeeding.

Driving and using machines

It is unlikely that Tardysol will affect the ability to drive and use machines.

Tardysol contains sorbitol, sodium, and propylene glycol

• This medicine contains 360 mg of sorbitol in each 1 ml. Sorbitol (E420) is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or hereditary fructose intolerance (HFI), a rare genetic disease in which the patient's body does not break down fructose, they should consult their doctor before taking this medicine.
• This medicine contains less than 1 mmol (23 mg) of sodium per ml, which means the medicine is considered "sodium-free".
• This medicine contains 12 mg of propylene glycol (E1520) in each 1 ml.

3. How to take Tardysol

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Treatment in pregnant women can only be started after consulting a doctor.
Recommended dose
If the patient is taking Tardysol to treat iron deficiency anemia:

• Children with a body weight of 15 to 20 kg: the usual dose is 30 to 40 mg once a day.
• Children with a body weight of 20 to 35 kg: the usual dose is 40 to 50 mg once a day.
• Children with a body weight over 35 kg, adolescents, and adults: the usual dose is 50 to 100 mg once a day.

For pregnant women taking Tardysol to prevent iron deficiency anemia: the usual dose is 50 mg once a day.
The dose is measured directly with a graduated pipette (see explanatory drawings).
How to prepare and take the dose
This medicine should be taken orally. If it is diluted in ½ glass of water, it should be administered immediately after dilution. The medicine should be administered some time before a meal or after a meal, and before or after the administration of dairy products (see "Using Tardysol with food and drink").
The medicine should be administered to the child under adult supervision.
The time of administration should be chosen according to the time when the child's stomach will best tolerate the medicine.
Preparing the dose
Only the measuring pipette provided with the Tardysol packaging should be used.
Before use, you should check if the pipette is clean.
The pipette allows you to draw the oral solution from the bottle and indicates the dose (mg) to be administered.

• 1) To open the bottle, you should first press the cap and then unscrew it.

• 2) Insert the measuring pipette into the bottle, making sure the plunger is fully pressed.

• 3) To draw the medicine, you should pull the pipette plunger until the solution reaches the mark on the scale

closest to the prescribed dose (scale every 10 mg). If there is an air bubble in the drawn solution, you should repeat the drawing stage.

• 4) The dose indicated by the scale will be visible above the pipette collar.

Administering the dose
If necessary, the contents of the measuring pipette can be diluted in ½ glass of water.
The contents of the glass should be drunk immediately.

Cleaning the pipette

• 1. After use, the bottle should be closed with the cap.
• 2. The pipette should be rinsed several times with water, as shown in the following drawings:

• 3. The pipette should be left to dry on a kitchen towel, and then placed with the bottle in the cardboard box and stored in a place invisible and inaccessible to children. The pipette should never be left in any other place than the packaging or leaflet.

Duration of treatment
If the patient is taking the medicine to treat iron deficiency, the duration of treatment must be long enough to correct the deficiency and replenish the body's iron stores. The treatment may last from 3 to 6 months, or even longer, if the cause of the anemia is not effectively treated.
If a pregnant woman is taking the medicine to prevent iron deficiency anemia, the treatment will start in the last two trimesters of pregnancy (or from the fourth month of pregnancy).

Taking more than the recommended dose of Tardysol

If the patient has taken a very large dose of Tardysol, they should contact a doctor or the nearest emergency department immediately, especially if the overdose occurred in a child.
Symptoms of iron overdose include:
severe irritation of the gastrointestinal tract, which can lead to tissue necrosis (necrosis of the mucous membranes of the gastrointestinal tract). The main symptoms are: abdominal pain, nausea, vomiting (sometimes with blood) and diarrhea (sometimes with black stools).
This may be accompanied by metabolic acidosis and shock with the following main symptoms: rapid breathing or shortness of breath, rapid heart rate, headache, confusion, drowsiness, fatigue, loss of appetite, stomach pain, vomiting, and sudden decrease in blood pressure, which can lead to loss of consciousness with seizures (coma).
symptoms of abnormal kidney function (significant decrease in the amount of urine excreted) and liver function (pain in the right upper abdomen, yellowing of the skin or eyes, dark urine).
Long-term consequences of overdose are possible, including narrowing of the gastrointestinal tract (stenosis), characterized by nausea, bloating, constipation, and abdominal distension.

Missing a dose of Tardysol

If the patient misses a dose, they should take it as soon as possible. However, if it is almost time for the next dose, they should wait for the time of its administration and then continue treatment as usual.
A double dose should not be taken to make up for the missed dose.

Stopping treatment with Tardysol

Tardysol should be taken according to the doctor's recommendations. After stopping treatment, problems may occur.
If you have any further questions about taking this medicine, you should consult a 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 common to rarest:

• constipation
• diarrhea
• abdominal distension
• abdominal pain
• change in stool color
• nausea

Uncommon (may occur in less than 1 in 100 people)

• throat swelling (laryngeal edema)
• abnormal stools
• indigestion
• vomiting
• gastritis
• itching
• red skin rash (erythematous rash)

Frequency not known (frequency cannot be estimated from the available data):

• allergic reaction (hypersensitivity reaction)
• itchy rash (urticaria)
• tooth discoloration
• discoloration of the gastrointestinal tract (gastrointestinal melanosis) (see section 2)

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Tardysol

The medicine should be stored in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the outer packaging.
The expiry date refers to the last day of the stated month.
After opening the bottle, the solution can be stored for 2 months. The medicine should be stored away from light, in its cardboard packaging.
Between administrations, the bottle and measuring pipette should always be stored together in the box.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tardysol contains

• Each 1 ml of oral solution contains 20 mg of elemental iron in the form of iron sulfate heptahydrate.
• Other ingredients are: liquid sorbitol (non-crystallizing) (E420), orange flavor*, sulfuric acid, sodium propionate, sodium saccharin, purified water. * Orange flavor ingredients: acetic aldehyde, octanal, nonanal, decanal, ethyl acetate, citronellal, water, citral, linalool, orange essential oil, propylene glycol (E1520).

What Tardysol looks like and what the packaging contains

• The medicine is a yellow to orange solution.
• 90 ml of oral solution in a brown glass bottle, closed with a child-resistant cap.
• The outer packaging contains a 5 ml measuring pipette with a scale from 10 to 100 mg (marked every 10 mg), allowing for oral administration.

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium
Tardysol
Croatia
Tardyferon
Estonia
Tardysol
France
Tardyferon
Greece
Tardy-Fer
Netherlands
Tardysol
Lithuania
Tardyliq
Latvia
Tardysol
Luxembourg
Tardysol
Slovenia
Tardyferon

Marketing authorization holder

Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur, France

Manufacturer

Pierre Fabre Medicament Production
Site Progipharm
Rue du Lycée
45500 Gien, France
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
Pierre Fabre Medicament Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw
tel. 22 559 63 60

Date of last revision of the leaflet: December 2024