Package leaflet: Information for the user

TOTYLEM, 60 mg + 0.4 mg, coated tablets
Ferrum + Acidum folicum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
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

What TOTYLEM is and what it is used for
Important information before taking TOTYLEM
How to take TOTYLEM
Possible side effects
How to store TOTYLEM
Contents of the pack and other information

1. What TOTYLEM is and what it is used for

The active substances in TOTYLEM are iron and folic acid.
TOTYLEM belongs to a group of medicines used in the treatment of disorders associated with iron deficiency.
TOTYLEM is used for the prevention and treatment of iron deficiency under conditions of increased demand for folic acid during pregnancy, after childbirth, and during breastfeeding.
This medicine is intended exclusively for women during pregnancy, after childbirth, and during breastfeeding.

2. Important information before taking Totylem

When not to take Totylem

if the patient is allergic to iron, folic acid, or any of the other ingredients of this medicine (listed in section 6),
if the patient has excess iron,
if the patient has anaemia due to causes other than iron deficiency (e.g. due to vitamin B12 deficiency),
in case of frequent blood transfusions.

Warnings and precautions
Before starting to take Totylem, discuss this with your doctor or pharmacist

In case of difficulty swallowing. If the tablet enters the airways, the patient may be at risk of developing ulcers in the throat, oesophagus (the tube connecting the mouth to the stomach), or bronchi (main airways in the lungs) (see next warning).
In case of accidental inhalation of the tablet, contact a doctor as soon as possible. This is due to the risk of developing ulcers and narrowing of the bronchi if the tablet enters the respiratory tract. This may cause persistent cough, coughing up blood and/or shortness of breath, even if the choking incident occurred several days or months before these symptoms appeared. Therefore, it is essential to seek medical advice promptly to ensure that the tablet has not damaged the respiratory tract.
If the patient has a gastrointestinal disorder such as: chronic inflammatory bowel disease, intestinal stricture, diverticula, gastric mucosal inflammation, gastric or intestinal ulcers.
If the patient has impaired liver function. The doctor will exercise caution during treatment.
If the patient has impaired kidney function, as this may increase iron requirements. In case of severe kidney disease, iron should be administered intravenously.
If the patient is taking other iron supplements, due to the risk of iron poisoning, especially in children, from high iron doses.
If the patient is taking Totylem to treat iron deficiency, the underlying cause of the deficiency should also be identified and addressed.
If iron deficiency is associated with inflammatory disease, treatment with Totylem will not be effective.
In case of clinically significant folic acid deficiency, a medicine containing a higher dose of folic acid is required.
If vitamin B12 deficiency has been diagnosed in the patient.
Iron intake may turn the stool black.
According to published data from patients receiving iron-containing medicines, the gastric and gastrointestinal mucosa may become discoloured, which could interfere with gastrointestinal surgery.
Due to the risk of oral mucosal ulcers and tooth discoloration, tablets should not be sucked, chewed, or held in the mouth, but swallowed whole with a full glass of water. If the patient is unable to follow this instruction or has difficulty swallowing, medical advice should be sought.

Children and adolescents
This medicine is not intended for use in children and adolescents. It is intended exclusively for
women during pregnancy, postpartum, and breastfeeding.
Totylem and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines must not be used together with Totylem, while others require certain precautions (special dose adjustment or change in timing of administration), for example:

injectable iron preparations,
a medicine used to treat urinary stones associated with urinary tract infection (acetohydroxamic acid),
certain antibiotics (tetracycline antibiotics, fluoroquinolones, chloramphenicol),
medicines used to treat bone fragility (bisphosphonates, strontium),
a medicine used to treat joint diseases (penicillamine),
a medicine used to treat thyroid disorders (e.g. levothyroxine),
medicines used to treat Parkinson's disease (entacapone, carbidopa, levodopa),
medicines used to treat HIV (integrase inhibitors),
trientine (a medicine used to treat Wilson's disease),
methyldopa (a medicine used to treat hypertension),
zinc and calcium,
medicines used to treat high stomach acidity: acid neutralizers, proton pump inhibitors, activated charcoal, or antacids (aluminium, calcium, and magnesium salts),
medicines reducing or preventing epileptic seizures, such as carbamazepine, phenobarbital, primidone, phenytoin, fosphenytoin, pheneturide,
folic acid antagonists, such as methotrexate or sulfasalazine,
5-fluorouracil or other fluoropyrimidines used in cancer treatment,
a medicine used to treat high cholesterol (cholestyramine).

Taking Totylem with food and drink
Consuming vegetables, dairy products, tea, coffee, red wine, eggs, or wholegrain products at the same time inhibits iron absorption by the body. An interval of at least 2 hours should be maintained between taking iron salts and these foods (if possible).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine.
This medicine may be taken during pregnancy and after delivery, under normal conditions of use.
This medicine may be taken by breastfeeding women.
Driving and operating machinery
It is unlikely that taking Totylem will affect the ability to drive or operate machinery.
Totylem contains lactose and sodium.
If the patient has been told by a doctor that they have an intolerance to certain sugars, they should contact their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take TOTYLEM

This medicine should always be taken according to the instructions provided by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Women during pregnancy, postpartum, and breastfeeding
The recommended dose for prophylaxis and treatment of iron deficiency under conditions of increased
folic acid requirements is 1 tablet daily, providing 60 mg of iron and 0.4 mg of folic acid.
The recommended duration of treatment is as follows:

Pregnant women: throughout the entire pregnancy,
Women after childbirth: for 6 to 12 weeks postpartum.

The tablet should be swallowed whole with a glass of water. Do not suck, chew, or hold the tablet
in the mouth.
It is best to take the tablet before a meal; certain foods may impair iron absorption
(see section above: "Using TOTYLEM with food and drink"). If necessary, the timing of administration
can be adjusted. In case of gastrointestinal intolerance, the tablet may be taken with food.
Taking more than the recommended dose of TOTYLEM
Consuming large amounts of iron may cause poisoning, particularly in young children (which may be fatal).
In cases of excessive iron intake, the following symptoms may occur:
Severe irritation of the gastrointestinal tract, abdominal pain, vomiting (with or without blood), often bloody diarrhea,
decreased blood pressure, rapid breathing and heart rate, seizures, kidney and liver failure.
At very high doses, folic acid may cause the following adverse effects:
gastrointestinal disturbances, psychiatric disorders, and sleep disturbances.
You should immediately consult a doctor or emergency services to receive appropriate treatment.
If small children accidentally swallow the tablets, the risk of poisoning is highest, and immediate
emergency treatment must be initiated.
Missed dose of TOTYLEM
Do not take a double dose to make up for a missed dose.
Stopping treatment with TOTYLEM
Not applicable.
If you have any further doubts regarding 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 everybody will experience them.
The following effects may occur, listed in decreasing order of frequency:

Common (may affect up to 1 in 10 people):

constipation,
diarrhoea,
flatulence,
abdominal pain,
nausea,
heartburn,
vomiting,
black stools (normal discolouration).

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

allergic reaction (hypersensitivity),
severe, life-threatening allergic reaction, including breathing difficulties, swelling of the lips, throat and tongue, and hypotension requiring immediate treatment (anaphylactic reaction),
rash, itching (pruritus), urticaria, allergic skin reaction with skin irritation and red skin patches (allergic dermatitis),
sudden swelling of the lips, cheeks, eyelids, tongue, palate, throat or larynx (angioedema),
gastrointestinal irritation,
acute inflammation of the stomach (gastritis),
ulceration of the mouth and throat* (pharyngeal ulceration),
injury to the oesophagus (the tube connecting the mouth to the stomach),
narrowing of the airways (bronchoconstriction),
pulmonary necrosis (death of lung tissue cells),
ulceration of the oral cavity (due to improper use, such as chewing, sucking or holding tablets in the mouth),
brown or black stains on teeth, reversible after discontinuation of treatment (due to improper use, such as chewing, sucking or holding tablets in the mouth),
discolouration of the gastric and gastrointestinal mucosa (pseudomelanosis of the stomach and intestines).

* In patients with swallowing difficulties, if the tablet enters the respiratory tract, the patient may also be at risk of developing ulceration of the throat, oesophagus (the tube connecting the mouth to the stomach), or bronchi (main airways in the lungs).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine TOTYLEM

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from light. This medicine does not require any special storage temperature.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What TOTYLEM contains

One coated tablet contains the following active substances:
Iron (as ferrous gluconate dihydrate) ........................................................................ 60.000 mg
Folic acid (as folic acid dihydrate) .............................................................................. 0.400 mg
Other ingredients are: Ascorbic acid, hypromellose, sodium croscarmellose, magnesium stearate, lactose monohydrate, maize starch.
Coating: hypromellose, stearic acid, microcrystalline cellulose, titanium dioxide (E 171), cochineal (E 120), potassium aluminium silicate.

What TOTYLEM looks like and contents of the pack
This medicine is in the form of round, pearl-raspberry pink coated tablets with a diameter of 12 mm and thickness of 7 mm.
Each cardboard pack contains 30 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
LABORATOIRE INNOTECH INTERNATIONAL
22 AVENUE ARISTIDE BRIAND
94110 ARCUEIL
FRANCE
Telephone number: +33 (0)800 100 229
Email address: [email protected]

Manufacturer
INNOTHERA CHOUZY
RUE RENE CHANTEREAU, CHOUZY-SUR-CISSE
41150 VALLOIRE-SUR-CISSE
FRANCE

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany, France, Lithuania, Estonia, Portugal, Spain, Bulgaria, Malta, Croatia, Romania, Italy, Poland: TOTYLEM
Latvia: ARPELLA

Other sources of information
Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (www.urpl.gov.pl)