Tardysol

Package leaflet: Information for the patient

Tardysol, 20 mg/ml, oral solution
Ferrum as Ferrosi sulfas heptahydricus
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Tardysol is and what it is 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 pack and other information

1. What Tardysol is and what it is used for

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

• for the treatment of iron deficiency anaemia (a reduced number of red blood cells due to insufficient iron in the body);
• for the prevention of iron deficiency anaemia in pregnant women, when diet alone cannot provide sufficient iron.

2. Important information before using 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 excess iron in the body;
• if the patient has a type of anaemia (insufficient number of red blood cells) which is not caused by iron deficiency or which leads to iron overload (e.g. thalassaemia, anaemia refractory to treatment, anaemia due to bone marrow failure).

IF YOU HAVE ANY DOUBTS ABOUT THIS MEDICINE,
PLEASE CONSULT YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Before taking Tardysol, discuss it with your doctor or pharmacist.

• If the patient is taking Tardysol due to iron-deficiency anaemia, the doctor will also investigate the underlying cause of this anaemia so that it can be appropriately treated.
• If the patient's iron-deficiency anaemia is associated with inflammatory disease, treatment with Tardysol will not be effective.
• According to published data, gastrointestinal wall discolouration has been reported in elderly patients with renal insufficiency, diabetes (abnormally high blood sugar levels), and/or hypertension (high blood pressure), who are receiving medications for these conditions along with iron supplementation for anaemia. Such discolouration may complicate gastrointestinal surgical procedures. Due to this risk, if surgery is planned, the surgeon should be informed about iron intake (see section 4).
• In case of accidental aspiration of the medicine (going "the wrong way"), it may enter the respiratory tract. Contact of the medicine with the respiratory tract may cause injuries such as necrosis (tissue death) or bronchitis (inflammation of the airways through which air passes in the lungs) or oesophagitis (inflammation of the oesophagus, the tube connecting the mouth to the stomach). These injuries may lead to bronchial stenosis. Symptoms related to such injuries may include: persistent cough, haemoptysis (coughing up blood), and/or shortness of breath, even if aspiration occurred several days or months earlier.
• If the medicine enters the respiratory tract and the patient experiences at least one of the symptoms listed above, contact a doctor or the nearest emergency department immediately for specialist evaluation and to ensure that no respiratory tract damage has occurred.

Children and adolescents
Not applicable.
Tardysol and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking,
has recently taken, or plans to take.
Some medicines must not be taken at the same time as Tardysol, while
others require specific adjustments (e.g. timing of administration).
If the patient is receiving iron by injection, Tardysol must not be taken.
If the patient is taking any of the following medicines, at least a 2-hour interval should be maintained between their administration and administration of Tardysol:
antibiotics (tetracyclines, fluoroquinolones)
a medicine used to treat chronic urinary tract infection (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 gastric acid secretion: mineral-containing preparations, charcoal, or medicines that neutralize gastric juice (aluminium, calcium, and magnesium salts)
• medicines used to treat thyroid disorders (levothyroxine, liothyronine)
• medicines used to treat Parkinson's disease (levodopa, carbidopa, entacapone)
• supplements and/or medicines containing zinc, calcium, or strontium.

If the patient is taking colestyramine, Tardysol should be administered 1–2 hours before or 4 to 6 hours after colestyramine.
Taking Tardysol with food and drink
Calcium-rich foods may reduce iron absorption and make treatment less effective. Therefore, Tardysol should be administered some time before or after meals and before or after consuming dairy products.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
There is limited data on the use of iron during the first trimester of pregnancy, but extensive literature data are available for women during the second and third trimesters. These data do not indicate fetal and/or neonatal toxicity.
Therefore, Tardysol may be used in pregnant women when clinically indicated.
Tardysol may be used during breastfeeding.
Effects on ability to drive and use machines
It is unlikely that Tardysol affects the ability to drive or operate machinery.
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 certain sugars or hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient's body cannot metabolize fructose, consult a doctor before administering this medicine.
• This medicine contains less than 1 mmol (23 mg) of sodium per ml, meaning it is considered "sodium-free".
• This medicine contains 12 mg of propylene glycol (E1520) in each ml.

3. How to use Tardysol

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Treatment in pregnant women should only be initiated after consultation with the attending physician.

Recommended dose
If the patient is taking Tardysol to treat iron deficiency anaemia:

• Children weighing 15 to 20 kg: the usual dose is 30 to 40 mg once daily.
• Children weighing 20 to 35 kg: the usual dose is 40 to 50 mg once daily.
• Children weighing over 35 kg, adolescents and adults: the usual dose is 50 to 100 mg once daily.

For pregnant women taking Tardysol to prevent iron deficiency anaemia: the usual dose is 50 mg once daily.
The dose should be measured directly using the graduated pipette provided (see explanatory illustrations).

How to prepare and take the dose
This medicine is for oral use. If diluted in half a glass of water, it should be taken immediately after dilution.
The medicine should be taken some time before or after a meal, and also before or after consuming dairy products
(see "Taking Tardysol with food and drink").
The medicine should be administered to a child under the supervision of an adult.
The timing of administration should be chosen appropriately, depending on when the child's stomach will best tolerate the medicine.

Preparing the dose
Only use the measuring pipette supplied with the Tardysol packaging.
Before use, check that the pipette is clean.
The pipette allows oral solution to be drawn from the bottle and indicates the required dose (mg).
The dose is read directly from the scale on the pipette.

1. To open the bottle, press the cap down first, then unscrew it.

2. Insert the dosing pipette into the bottle, ensuring the plunger is fully depressed.

3. To draw up the medicine, slowly pull the pipette plunger until the solution reaches the graduation mark closest to the prescribed dose (graduations every 10 mg). If air bubbles are present in the drawn solution, repeat the drawing step.

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

Administering the dose
If necessary, the contents of the dosing pipette may be diluted in half a glass of water.
The contents of the glass should be drunk immediately.

Cleaning the pipette

1. After use, close the bottle with the cap.
2. Rinse the pipette thoroughly several times with water, as shown in the illustrations below:

3. Leave the pipette to dry on a kitchen towel, then return it together with the bottle to the cardboard box and store in a place out of sight and reach of children. The pipette must never be left outside the packaging or patient information leaflet.

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

Taking more Tardysol than recommended
If a patient has taken a very large dose of Tardysol, contact a doctor or the nearest emergency department immediately, especially if overdose occurs in a child.
Symptoms of iron overdose include:
severe irritation of the gastrointestinal tract, which may lead to tissue necrosis (necrosis of gastrointestinal mucosa). Main symptoms are: abdominal pain, nausea, vomiting (sometimes containing blood), and diarrhoea (sometimes with black stools).
This may be accompanied by metabolic acidosis and shock, with the following main symptoms: rapid breathing or breathlessness, increased heart rate, headache, confusion, drowsiness, fatigue, loss of appetite, stomach pain, vomiting, and sudden drop in blood pressure, which may lead to loss of consciousness with seizures (coma).
Signs of impaired kidney function (marked decrease in urine output) and liver function (pain in the upper right abdomen, yellowing of the skin or eyes, dark urine) may also occur.
Long-term consequences of overdose may include gastrointestinal strictures (stenosis), characterised by nausea, bloating, constipation and abdominal distension.

If a dose of Tardysol is missed
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, wait until the next scheduled dose and then continue treatment as usual.
Do not take a double dose to make up for a missed dose.

Stopping Tardysol treatment
Tardysol should be taken as directed by your doctor. Discontinuing treatment may lead to complications.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur, listed from most to least frequent:

Common (may occur in less than 1 in 10 people)

• constipation
• diarrhoea
• abdominal distension
• abdominal pain
• change in stool colour
• nausea

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

• throat swelling (laryngeal oedema)
• abnormal stools
• dyspepsia
• vomiting
• gastric mucosal inflammation
• itching
• red skin rash (erythematous rash)

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

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions, additional information on the safety of the medicine can be collected.
Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store Tardysol

Keep this medicine out of sight and reach of 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 first opening the bottle, the solution can be stored for 2 months. The medicine should be
stored away from light, in its cardboard packaging.
Between doses, the bottle and the dropper should always be stored together in the box.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Tardysol contains

• Each ml of oral solution contains 20 mg of elemental iron in the form of ferrous sulphate heptahydrate.
• Other ingredients are: liquid sorbitol (non-crystallising) (E420), orange flavour*, sulphuric acid, sodium propionate, sodium saccharin, purified water. * Components of the orange flavour: acetaldehyde, octanal, nonanal, decanal, ethyl butyrate, citronellal, water, citral, linalool, orange essential oil, propylene glycol (E1520).

What Tardysol looks like and contents of the pack

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

This medicinal product is authorised in the European Economic Area countries 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 Authorisation Holder
Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur, France

Manufacturer
Pierre Fabre Medicament Production
Site Progipharm
Rue du Lycée
45500 Gien, France

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Pierre Fabre Medicament Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw
tel. 22 559 63 60