Totylem

PACKAGE LEAFLET

Package leaflet: information for the user

TOTYLEM 60 mg/0,4 mg, film-coated tablet

iron/folic acid
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

1. What TOTYLEM is and what it is used for
2. What you need to know before taking TOTYLEM
3. How to take TOTYLEM
4. Possible side effects
5. How to store TOTYLEM
6. Contents of the pack and other information

1. What TOTYLEM is and what it is used for

TOTYLEM contains iron and folic acid as active substances.
This medicinal product belongs to a group of medicines used to treat disorders related to iron deficiency.
TOTYLEM is used for the prophylaxis and treatment of iron deficiency with increased need for folic acid during pregnancy, the postpartum period, and breastfeeding.
Medicinal product intended exclusively for pregnant women, women in the postpartum period, and those who are breastfeeding.

2. What you need to know before taking TOTYLEM

Do not take TOTYLEM

• If you are allergic to iron, folic acid, or any of the other ingredients of this medicine (listed in section 6),
• If you suffer from iron overload,
• If you have anaemia not caused by iron deficiency (e.g. due to Vitamin B12 deficiency),
• If you receive frequent blood transfusions.

Warnings and precautions
Talk to your doctor or pharmacist before taking TOTYLEM

• If you have difficulty swallowing. You may be at risk of developing ulcers in the throat or oesophagus (the tube connecting the mouth to the stomach) or in the bronchi (the main airways to the lungs) if the tablet enters the respiratory tract (see next warning).
• If you accidentally choke on a tablet, contact your doctor as soon as possible. There is a risk of ulcers or narrowing of the bronchi if the tablet enters the respiratory tract. This may cause persistent cough, coughing up blood and/or difficulty breathing, even if the incident occurred days or months before these symptoms appear. Therefore, you must undergo an urgent check-up to ensure that the tablet has not damaged the respiratory tract.
• If you have a gastrointestinal disorder such as chronic inflammatory bowel disease, intestinal stenosis, diverticula, gastritis, gastric or intestinal ulcer.
• If you have liver dysfunction. Your doctor will treat you with appropriate caution.
• If you have renal insufficiency, your iron requirements may increase. In case of severe kidney disease, iron should be administered intravenously.
• If you are taking other iron supplements, since high doses of iron may cause poisoning, especially in children.
• If you are taking TOTYLEM for the treatment of iron deficiency, the underlying cause of the deficiency should also be investigated so that it can be properly treated.
• If iron deficiency is associated with an inflammatory condition, treatment with TOTYLEM may not be effective.
• If you have a clinically significant folic acid deficiency, a preparation containing higher amounts of folic acid may be required.
• If you know you have vitamin B12 deficiency.
• Iron intake may cause your stools to turn black.
• According to published data from patients treated with iron, the lining of your stomach and gastrointestinal tract may become discoloured, which could interfere with gastrointestinal surgery.
• Due to the risk of mouth ulcers and tooth staining, the tablets must not be sucked, chewed, or held in the mouth, but swallowed whole with a full glass of water. If you are unable to follow these instructions or have difficulty swallowing, contact your doctor.

Children and adolescents
This medicine is not intended for use in children and adolescents. It is intended exclusively for pregnant women, postpartum women, and those who are breastfeeding.
Other medicines and TOTYLEM
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines cannot be used at the same time as TOTYLEM, while others require certain precautions (specific dose adjustments or changes in timing of administration), for example:

• injectable medicines containing iron,
• a medicine used to treat infected urinary stones (acetohydroxamic acid),
• certain antibiotics (tetracycline antibiotics, fluoroquinolones, chloramphenicol),
• medicines used to treat bone fragility (bisphosphonates, strontium),
• medicines used to treat joint disorders (penicillamine),
• a medicine used to treat thyroid diseases (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 high blood pressure),
• zinc and calcium,
• medicines used to treat excessive stomach acidity: acid neutralisers, proton pump inhibitors, activated charcoal, or antacids (aluminium, calcium, and magnesium salts),
• medicines used to reduce or prevent epileptic seizures, such as carbamazepine, phenobarbital, primidone, phenytoin, fosphenytoin, pheneturide,
• folic acid antagonists such as methotrexate or sulfasalazine,
• 5-fluorouracil or other fluoropyrimidines used to treat tumours,
• medicines used to treat high cholesterol (cholestyramine).

TOTYLEM with food and drinks
Concurrent consumption of vegetables, dairy products, tea, coffee, red wine, eggs, or whole grains reduces the body's absorption of iron. Administration of iron salts should be spaced more than 2 hours apart from these foods (if possible).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine can be taken during and after pregnancy under normal conditions of use.
This medicine can be taken by women who are breastfeeding.
Driving and using machines
It is unlikely that the use of TOTYLEM will affect your ability to drive or operate machinery.
TOTYLEM contains lactose and sodium.
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially "sodium-free".

3. How to take TOTYLEM

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Pregnant, postpartum and breastfeeding women
The recommended dose for the prevention and treatment of iron deficiency with increased need for folic acid is 1 tablet daily, providing 60 mg of iron and 0.4 mg of folic acid. The expected duration of treatment is as follows:

• Pregnant women: throughout the entire duration of pregnancy,
• Women after childbirth: from 6 to 12 weeks after the baby's birth.

Swallow the tablet whole with a glass of water. Do not suck, chew, or hold the tablet in the mouth.
Take the tablet preferably before a meal; certain foods may reduce iron absorption (see above “TOTYLEM with food and drink”). The time of administration may be adjusted if necessary. The tablet may be taken with food in case of gastrointestinal intolerance.
If you take more TOTYLEM than you should
Ingestion of a large amount of iron may cause poisoning, especially in young children (where it can be fatal).
If you take significant amounts of iron, you may experience the following effects:
Acute gastrointestinal irritation, abdominal pain, vomiting (with or without blood), diarrhoea often with blood traces, decreased blood pressure, increased respiratory and heart rate, seizures, and kidney and liver failure.
At very high doses, folic acid may cause the following side effects: gastrointestinal disturbances, mental disorders, and sleep disturbances.
Contact your doctor or the nearest emergency department immediately to receive appropriate treatment.
In case of ingestion by young children, the risk of poisoning is extremely high and emergency treatment must be administered immediately.
If you forget to take TOTYLEM
Do not take a double dose to make up for the forgotten dose.
If you stop taking TOTYLEM
Not applicable.
If you have any questions about the use of this medicine, consult your 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 in order of decreasing frequency:
Common (may affect from 1 to 10 patients):

• constipation,
• diarrhoea,
• abdominal distension,
• abdominal pain,
• nausea,
• heartburn,
• vomiting,
• dark stools (normal colour).

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

• allergic reaction (hypersensitivity),
• acute allergic reaction, which may be life-threatening, including breathing difficulties, swelling of the lips, throat and tongue, and hypotension requiring emergency treatment (anaphylactic reaction),
• erythema, itching, urticaria, allergic skin reaction with skin irritation and red spots on the skin (allergic dermatitis),
• sudden swelling of the lips, cheeks, eyelids, tongue, palate, pharynx or larynx (angioedema),
• gastrointestinal irritation,
• acute inflammation of the stomach (gastritis),
• ulceration of the mouth and throat* (pharyngeal ulceration),
• injury to the tube connecting the mouth to the stomach (oesophageal injury),
• narrowing of the airways (bronchial stenosis),
• pulmonary necrosis (death of lung cells),
• ulceration of the mouth (in case of misuse, if tablets are chewed, sucked or held in the mouth),
• brown or black stains on teeth, which disappear after discontinuation of treatment (in case of misuse, if tablets are chewed, sucked or held in the mouth),
• pigmentation of the stomach lining and gastrointestinal tract (gastrointestinal pseudomelanosis).

* Patients with swallowing difficulties may also be at risk of ulceration of the throat or oesophagus (the tube connecting the mouth to the stomach) or bronchi (the main airways to the lungs), if the tablet enters the respiratory tract.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TOTYLEM

Keep this medicine out of the 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 that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TOTYLEM contains

• The active substances are: Iron (as ferrous gluconate hydrate) ............................................................................60.000 mg Folic acid (as folic acid hydrate) ............................................................................0.400 mg per film-coated tablet.
• The other components are: Ascorbic acid, hypromellose, sodium croscarmellose, magnesium stearate, monohydrate lactose, corn starch. Coating: hypromellose, stearic acid, microcrystalline cellulose, titanium dioxide (E171), carmine acid (E120), potassium aluminium silicate.

Description of the appearance of TOTYLEM and contents of the pack
This medicinal product is a 12 mm diameter, 7 mm thick, film-coated, round, pearly pink tablet.
Each pack contains 30 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
LABORATOIRE INNOTECH INTERNATIONAL
22 AVENUE ARISTIDE BRIAND
94110 ARCUEIL
FRANCE
Manufacturer
INNOTHERA CHOUZY
RUE RENE CHANTEREAU, CHOUZY-SUR-CISSE
41150 VALLOIRE-SUR-CISSE
FRANCE

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency https://www.aifa.gov.it/