Totilem

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

TOTYLEM, 60 mg + 0,4 mg, coated tablets

Iron + Folic acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 TOTYLEM and what is it used for
• 2. Important information 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 is TOTYLEM and what is it used for

The active substances of TOTYLEM are iron and folic acid.
This medicine belongs to a group of medicines used to treat iron deficiency disorders.
TOTYLEM is used for the prevention and treatment of iron deficiency in conditions of increased demand for folic acid during pregnancy, after childbirth, and during breastfeeding.
The 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 an excess of iron,
• if the patient has anemia 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, the patient should discuss it with their doctor or pharmacist

• In case of difficulty swallowing. If the tablet gets into the airways, the patient may be at risk of throat, esophagus (the tube connecting the mouth to the stomach), or bronchial ulcers (see the next warning).
• In case of accidental choking on a tablet, the patient should contact their doctor as soon as possible. This is related to the risk of ulcers and bronchial narrowing if the tablet gets into the airways. It can cause persistent cough, coughing up blood, and/or shortness of breath, even if the choking occurred several days or months before the onset of these symptoms. Therefore, the patient should urgently consult a doctor to ensure that the tablet has not damaged the airways.
• If the patient has a gastrointestinal disease, such as: chronic inflammatory bowel disease, intestinal narrowing, diverticula, gastritis, stomach and intestinal ulcers.
• If the patient has liver dysfunction. The doctor will exercise caution during treatment.
• If the patient has kidney dysfunction, as this may increase the need for iron. In case of severe kidney disease, iron should be administered intravenously.
• If the patient is taking other iron supplements, as high doses of iron can cause poisoning, especially in children.
• If the patient is taking TOTYLEM to treat iron deficiency, the cause of the deficiency should also be determined so that it can be treated.
• If the iron deficiency is related to an 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 needed.
• If the patient has been diagnosed with vitamin B12 deficiency.
• Taking iron may change the color of the stool to black.
• According to published data from patients taking iron-containing medicines, the mucous membrane of the stomach and gastrointestinal tract may become discolored, which can interfere with the course of gastrointestinal surgery.
• Due to the risk of oral ulcers and tooth discoloration, the tablets should not be sucked, chewed, or kept in the mouth, but swallowed whole, washed down with a large glass of water. If the patient is unable to follow these instructions or has difficulty swallowing, they should consult their doctor.

Children and adolescents

This medicine is not intended for use in children and adolescents. It is intended exclusively for women during pregnancy, after childbirth, and during breastfeeding.

TOTYLEM and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Certain medicines cannot be taken at the same time as TOTYLEM, while others require certain precautions (special dose adjustment or change in administration time), for example:

• iron injections,
• a medicine used to treat kidney stones associated with urinary tract infections (acetohydroxamic acid),
• certain antibiotics (tetracyclines, fluoroquinolones, chloramphenicol),
• medicines used to treat brittle bones (bisphosphonates, strontium),
• a medicine used to treat joint diseases (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 excess stomach acid: antacids, proton pump inhibitors, activated charcoal, or medicines that neutralize stomach acid (aluminum, calcium, and magnesium salts),
• medicines that eliminate or reduce the frequency of seizures, such as carbamazepine, phenobarbital, primidone, phenytoin, fosphenytoin, pheneturide,
• a folic acid antagonist, such as methotrexate or sulfasalazine,
• 5-fluorouracil or other fluoropyrimidines used to treat cancer,
• a medicine used to treat high cholesterol (cholestyramine).

Taking TOTYLEM with food and drink

Eating vegetables, dairy products, tea, coffee, red wine, eggs, or whole grain products at the same time as taking iron can reduce iron absorption. The patient should leave a gap of at least 2 hours between taking iron salts and these foods (if possible).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
This medicine can be taken during pregnancy and after childbirth, under normal conditions of use.
Women who are breastfeeding can take this medicine.

Driving and using machines

It is unlikely that taking TOTYLEM will affect the patient's ability to drive or use machines.

TOTYLEM contains lactose and sodium.

If the patient has been told by their doctor that they have an intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take TOTYLEM

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Women during pregnancy, after childbirth, and during breastfeeding

The recommended dose for the prevention and treatment of iron deficiency in conditions of increased demand for folic acid is 1 tablet per day, which is 60 mg of iron and 0,4 mg of folic acid.
The recommended treatment duration is as follows:

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

The tablet should be swallowed whole, washed down with a glass of water. Do not suck, chew, or keep the tablet in the mouth.
The tablet is best taken before a meal; some foods may reduce iron absorption (see the section above "Taking TOTYLEM with food and drink"). If necessary, the administration time can be adjusted. In case of gastrointestinal intolerance, the tablet can be taken with a meal.

Taking a higher dose of TOTYLEM than recommended

Taking a large amount of iron can cause poisoning, especially in small children (which can be fatal).
In case of taking significant amounts of iron, the following symptoms may occur:
Severe gastrointestinal irritation, abdominal pain, vomiting (with or without blood), often bloody diarrhea, low blood pressure, rapid breathing and heart rate, seizures, kidney and liver failure.
In very high doses, folic acid can cause the following side effects:
gastrointestinal disorders, mental disorders, and sleep disorders.
The patient should immediately consult a doctor or emergency services to receive appropriate treatment.
In case of accidental ingestion by small children, the risk of poisoning is highest, and emergency treatment should be initiated immediately.

Missing a dose of TOTYLEM

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with TOTYLEM

This does not apply.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, TOTYLEM can cause side effects, although not everybody gets them.
The following effects may occur, listed in order of decreasing frequency:
common (may affect up to 1 in 10 people):

• constipation,
• diarrhea,
• bloating,
• abdominal pain,
• nausea,
• heartburn,
• vomiting,
• black stools (normal discoloration).

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

• allergic reaction (hypersensitivity),
• severe allergic reaction, which can be life-threatening, including difficulty breathing, swelling of the lips, throat, and tongue, and low blood pressure requiring immediate treatment (anaphylactic reaction),
• rash, itching (pruritus), hives, skin allergic reaction with skin irritation and red spots on the skin (allergic dermatitis),
• sudden swelling of the lips, cheeks, eyelids, tongue, palate, throat, or larynx (angioedema),
• gastrointestinal irritation,
• acute gastritis (gastric upset),
• mouth and throat ulcers* (throat ulcers),
• esophageal injury (esophageal injury),
• bronchial narrowing (bronchial narrowing),
• pulmonary necrosis (death of lung cells),
• mouth ulcers (in case of improper use, due to chewing, sucking, or keeping the tablets in the mouth),
• brown or black spots on the teeth, reversible after stopping treatment (in case of improper use, chewing, sucking, or keeping the tablets in the mouth),
• discoloration of the stomach and intestinal mucous membrane (pseudo-melanosis of the stomach and intestines).

* In relation to patients with swallowing difficulties, if the tablet gets into the airways, the patient may also be at risk of throat, esophagus (the tube connecting the mouth to the stomach), or bronchial ulcers.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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
PL 02-222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for more information to be collected on the safety of the medicine.

5. How to store TOTYLEM

The medicine should be stored out of sight and reach of children.
Store in the original packaging to protect from light. This medicine does not require special storage temperatures.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will 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 iron(II) gluconate hydrate) ...........................................................60,000 mg Folic acid (as folic acid hydrate) ........................................................0,400 mg
• Other ingredients are: Ascorbic acid, hypromellose, sodium croscarmellose, magnesium stearate, lactose monohydrate, corn starch. Coating: hypromellose, stearic acid, microcrystalline cellulose, titanium dioxide (E 171), carmine (E 120), potassium aluminum silicate.

What TOTYLEM looks like and contents of the pack

This medicine is in the form of round, pale pink, coated tablets with a diameter of 12 mm and a thickness of 7 mm.
Each carton pack contains 30 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

LABORATOIRE INNOTECH INTERNATIONAL

22 AVENUE ARISTIDE BRIAND
94110 ARCUEIL
FRANCE
Phone number: +33 (0)800 100 229
Email: information.vigilance@innothera.com
Manufacturer

INNOTHERA CHOUZY

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

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

NAMES:

Germany, France, Lithuania, Estonia, Portugal, Spain, Bulgaria, Malta, Croatia, Romania, Italy, Poland: TOTYLEM
Latvia: ARPELLA

Date of last revision of the leaflet:

Other sources of information

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