TOTYLEM 60 MG/0.4 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Totylem 60 mg/0.4 mg film-coated tablets

iron/folic acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve.

Contents of the package leaflet

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

1. What is Totylem and what is it used for

Totylem contains iron and folic acid as active ingredients.

This medicine belongs to a group of medicines used to treat iron deficiency disorders.

Totylem is used for the prophylaxis and treatment of iron deficiency with increased folic acid needs during pregnancy, postpartum, and lactation.

Medicine indicated only in women during pregnancy, postpartum, and lactation.

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 components of this medicine (listed in section 6),
• if you have iron overload,
• if you have anemia that is not due to iron deficiency (e.g., due to vitamin B12 deficiency),
• if you receive frequent blood transfusions.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine

• If you have difficulty swallowing. It may present a risk of ulceration of the throat or esophagus (the duct that connects the mouth to the stomach) or bronchi (the main respiratory airways of the lungs) if the tablet penetrates the respiratory tract (see warning below).
• If you accidentally choke on a tablet, contact your doctor as soon as possible. This is because there is a risk of ulcers and narrowing of the bronchi if the tablet penetrates the respiratory tract. This can cause persistent cough, bloody sputum, and/or feeling of shortness of breath, even if the choking occurred days or months before these symptoms appear. Therefore, you should be urgently evaluated to ensure that the tablet does not damage your respiratory tract.
• If you have a gastrointestinal disease such as chronic inflammatory bowel disease, intestinal stenosis, diverticula, gastritis, gastric and intestinal ulcers.
• If you have liver failure. Your doctor should be cautious.
• If you have kidney failure, because your iron needs may increase. In case of severe kidney disease, iron should be administered intravenously.
• If you are taking other iron supplements, as high doses of iron can cause poisoning, especially in children.
• If you are taking this medicine for the treatment of iron deficiency, the cause of the deficiency should also be investigated in order to treat it.
• If your iron deficiency is associated with an inflammatory disease, treatment with this medicine will not be effective.
• If you have a clinically relevant folic acid deficiency, you will need a formulation with a higher dose of folic acid.
• If you know you have a vitamin B12 deficiency.
• Taking iron can change the color of the stool to black.
• According to published data obtained from patients receiving iron-based treatments, the lining of your stomach and gastrointestinal tract may be pigmented, which can interfere with gastrointestinal surgery.
• Due to the risk of mouth ulcers and tooth discoloration, the tablets should not be sucked, chewed, or kept in the mouth, but swallowed whole with a large glass of water. If you cannot follow these instructions or have difficulty swallowing, contact your doctor.

Children and adolescents

This medicine should not be administered to children or adolescents. It is indicated exclusively in women during pregnancy, postpartum, and lactation.

Other medicines and Totylem

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.

Some medicines cannot be used at the same time as Totylem, while others require some precautions (specific dose adjustments or changes in the time of intake), for example:

• injectable medicines containing iron,
• a medicine for the treatment of urinary tract infection stones (acetohydroxamic acid),
• certain antibiotics (tetracycline antibiotics, fluoroquinolones, chloramphenicol),
• medicines for the treatment of bone fragility (bisphosphonates, strontium),
• medicine for the treatment of joint diseases (penicillamine),
• medicines for the treatment of thyroid disease (e.g., levothyroxine),
• medicines for the treatment of Parkinson's disease (entacapone, carbidopa, levodopa),
• medicines for the treatment of HIV (integrase inhibitors),
• trientine (a medicine used for Wilson's disease),
• methyldopa (a medicine used for arterial hypertension),
• zinc and calcium,
• medicines for the treatment of stomach acidity: acid neutralizers, proton pump inhibitors, activated carbon, or antacids (aluminum, calcium, and magnesium salts),
• medicines to eliminate or reduce the frequency of epileptic seizures, such as carbamazepine, phenobarbital, primidone, phenytoin, fosphenytoin, pheneturide,
• an antifolate antagonist such as methotrexate or sulfasalazine,
• 5-fluorouracil or other fluoropyrimidines used for cancer treatment,
• a medicine for the treatment of high cholesterol (cholestyramine).

Totylem with food and drinks

Concomitant consumption of vegetables, dairy products, tea, coffee, red wine, eggs, or whole grains limits iron absorption. The administration of iron salts should be spaced from these foods by more than 2 hours (if possible).

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine can be taken during and after pregnancy under normal use conditions.

Women during lactation can take this medicine.

Driving and using machines

It is unlikely that the use of this medicine will cause effects on the ability to drive or operate machines.

Totylem contains lactose and sodium.

This medicine contains lactose. Patients with hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Totylem

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist. Consult your doctor or pharmacist if you are not sure.

Women during pregnancy, postpartum, and lactation

The recommended dose for prophylaxis and treatment of iron deficiency with increased folic acid needs is 1 tablet per day, i.e., 60 mg of iron and 0.4 mg of folic acid. The recommended treatment duration is as follows:

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

Swallow the tablet whole with a glass of water. Do not suck, chew, or keep the tablet in your mouth.

Take the tablet preferably before a meal; some foods may limit iron absorption (see above the section "Totylem with food and drinks"). The intake time can be modified if necessary. The tablet can be taken with food in case of gastrointestinal intolerance.

If you take more Totylem than you should

Taking large amounts of iron can cause poisoning, especially in small children (where it can be fatal).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you take large amounts of iron, you may experience the following effects:

Severe gastrointestinal irritation, abdominal pain, vomiting (with or without blood), diarrhea often with blood, decreased blood pressure, increased respiratory and heart rate, convulsions, and kidney and liver failure.

In very high doses, folic acid can cause the following side effects: gastrointestinal disorders, mental disorders, and sleep disorders.

Consult your doctor or the nearest emergency service immediately to receive appropriate treatment.

In case of ingestion by small children, the risk of poisoning is higher and emergency treatment should be started immediately.

If you forget to take Totylem

Do not take a double dose to make up for a forgotten dose.

If you stop taking Totylem

This is not applicable.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following effects may occur, classified in decreasing order of frequency:

Frequent (may affect up to 1 in 10 patients):

• constipation,
• diarrhea,
• abdominal distension,
• abdominal pain,
• nausea,
• heartburn,
• vomiting,
• black stools (usual color).

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

• allergic reaction (hypersensitivity),
• severe allergic reaction, which can be life-threatening, including respiratory difficulties, swelling of lips, throat, and tongue, and hypotension that requires emergency treatment (anaphylactic reaction),
• skin rash, itching (pruritus), urticaria, allergic skin reaction with skin irritation and red spots on the skin (allergic dermatitis),
• sudden swelling of lips, cheeks, eyelids, tongue, palate, pharynx, or larynx (angioedema),
• gastrointestinal irritation,
• acute stomach inflammation (gastritis),
• ulceration of the mouth and throat* (pharyngeal ulceration),
• injury to the duct that connects the mouth to the stomach (esophageal injury),
• narrowing of the airways (bronchial stenosis),
• pulmonary necrosis (death of cells in the lungs),
• ulceration of the mouth (in case of incorrect use, when tablets are chewed, sucked, or kept in the mouth),
• brown or black spots on the teeth, reversible when treatment is discontinued (in case of incorrect use, when tablets are chewed, sucked, or kept in the mouth),
• staining of the lining of the stomach and gastrointestinal tract (pseudomelanosis gastrointestinal).

• Patients with difficulty swallowing also may be at risk of ulceration of the throat or esophagus (the duct that connects the mouth to the stomach) or bronchi (the main respiratory airways of the lungs), if the tablet penetrates the respiratory tract.

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Totylem

Keep this medicine out of the sight and reach of children.

Store in the original package to protect it from light. This medicine does not require any special storage temperature.

Do not use this medicine after the expiration date stated on the carton. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Totylem

• The active ingredients are:

Iron (as ferrous gluconate hydrate) 60,000 mg

Folic acid (as folic acid hydrate) 0.400 mg

In each film-coated tablet.

• The other ingredients are:

Ascorbic acid, hypromellose, sodium croscarmellose, magnesium stearate, lactose monohydrate, cornstarch.

Coating: hypromellose, stearic acid, microcrystalline cellulose, titanium dioxide (E171), carmine lake (E120), aluminum potassium silicate.

Appearance of the product and contents of the pack

This medicine is presented in the form of round, pinkish-beige film-coated tablets, 12 mm in diameter and 7 mm in thickness.

Each pack contains 30 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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

This medicine is authorized 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

Date of the last revision of this leaflet:07/2023.

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)