Package Insert: Information for the User

Losferron 695 mg Effervescent Tablets

Iron (II) Gluconate

Read this package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Losferron belongs to a group of medications known as antianemic agents.

Losferron is indicated for the prevention and treatment of iron deficiency anemia resulting from inadequate diet, malabsorption, pregnancy, and/or blood loss.

Do not take Losferron

•If you are allergic to iron gluconate (II) or any of the other components of this medication (listed in section 6).

•If you have diseases that cause excessive iron accumulation in the body, such as hemochromatosis.

•In case of hemolysis (destruction of red blood cells).

•If you have iron metabolism disorders (sideroblastic anemia, thalassemia, lead anemia).

Warnings and precautions

•Your doctor should diagnose you with iron deficiency anemia before prescribing this medication, as iron administration can be toxic, especially in children.

•If you are taking a diet rich in iron and/or iron supplements, as this increases the risk of excessive iron accumulation in your body.

•The liquid preparation resulting from dissolving the effervescent tablets can discolor teeth, which can be prevented by sipping the preparation with a straw and brushing your teeth.

•During treatment with Losferron, your stools may become dark. This effect is harmless and is caused by the iron that has not been absorbed.

Consult your doctor or pharmacist before starting to take Losferron.

Taking Losferron with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medications.

Certain medications may interact with Losferron, in which case it may be necessary to change the dose or discontinue treatment with one of the medications.

It is essential to inform your doctor if you are taking any of the following medications:

•Tetracyclines (a type of medication used to treat infections) such as doxycycline, minocycline, oxytetracycline, tetracycline, as they can cause a decrease in the effect of both these medications and Losferron. You should separate the intake of both medications by 2 or 3 hours.

•Quinolones (a type of medication used to treat infections) such as ciprofloxacin, levofloxacin, norfloxacin, ofloxacin, as they can cause a decrease in the effect of this medication. It is not recommended to use quinolones with Losferron, but if necessary, you should take the quinolone 2 hours before or 4-6 hours after taking Losferron.

•Penicillamine (a medication used to treat rheumatoid arthritis) as it can cause a decrease in the effect of this medication.

•Levodopa (a medication for the treatment of Parkinson's disease), as it can cause a decrease in the effect of this medication.

•Metildopa (a medication for the treatment of high blood pressure), as it can cause a decrease in the effect of this medication.

•Bisphosphonates (medications for the treatment of osteoporosis) and levotiroxine (a medication for the treatment of hypothyroidism), as they can cause a decrease in the effect of these medications. You should separate the intake of these medications and Losferron by 2 or 3 hours.

•Colestiramine (a medication that reduces elevated cholesterol levels), as it can cause a decrease in the effect of Losferron. You should separate the intake of both medications by at least 4 hours.

•Antacids (medications used to treat stomach acid), phosphates, calcium and magnesium salts, as they can cause a decrease in the effect of Losferron. You should separate the intake of these medications and Losferron by 2 or 3 hours.

•Treatment with certain medications for pain relief belonging to the group of non-steroidal anti-inflammatory drugs (such as aspirin, diclofenac, ibuprofen, naproxen, and piroxicam), as they can intensify the gastrointestinal disturbances caused by iron.

•Caffeine (present in coffee and tea) as it can cause a decrease in the effect of Losferron.

Taking Losferron with food and beverages

The ingredients of some vegetarian foods (such as bread and whole grain cereals) and the ingredients of milk, coffee, and tea can cause a decrease in the effect of Losferron.

Take Losferron one hour before or 3 hours after any of the meals or foods and beverages mentioned.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

You may need additional iron supplementation during pregnancy and breastfeeding.

During pregnancy, do not take more than 1 tablet per day of Losferron.

Driving and operating machinery

No information available.

Losferron contains Yellow No. 5 (E-110)

This medication may cause allergic reactions because it contains Yellow No. 5 (E-110). It can cause asthma, especially in patients allergic to aspirin.

Losferron contains Sodium

This medication contains 229 mg of sodium (main component of table salt/for cooking) in each tablet. This is equivalent to 12% of the recommended daily maximum sodium intake for an adult. Consult your doctor or pharmacist if you need 2 or more tablets per day for a prolonged period, especially if you have been recommended a low-sodium diet.

Losferron contains Benzyl Alcohol

This medication contains 0.152 mg of benzyl alcohol in each tablet.

Benzyl alcohol can cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been linked to the risk of severe adverse effects, including respiratory problems ("breathing difficulty") in children.

Do not administer this medication to your newborn (up to 4 weeks old) unless your doctor recommends it.

This medication should not be used for more than a week in children under 3 years old unless your doctor or pharmacist advises it.

Losferron contains Sorbitol

This medication contains 1.087 mg of sorbitol in each tablet.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dissolve the effervescent tablet in a glass of water (approximately 200 ml) and drink.

Take Losferron 1 hour before or 3 hours after any meal (see section “Taking Losferron with food and drinks”). In case of digestive disorders (nausea, stomach discomfort, diarrhea, stomach burning or constipation), Losferron can be taken with meals.

Adults

The recommended dose is 1 Losferron effervescent tablet once a day. In case of severe anemia, the dose can be increased to 2 or 3 tablets a day, divided into 2 or 3 doses. The maximum daily dose in adults should not exceed 3 tablets (240 mg of iron (II)).

Use in children and adolescents

Losferron is not recommended for children weighing less than 14 kg.

In the case of children weighing 14 kg or more, administer 3 mg/kg of body weight of iron (II) (each effervescent tablet contains 80 mg of iron (II)). Do not exceed a daily dose of more than 5 mg/kg of body weight and the maximum daily dose should not exceed 100 mg of iron (II).

Your doctor will indicate the duration of your treatment with Losferron. Do not discontinue treatment before, as desired effects will not be achieved.

Often, the treatment duration is 4-6 weeks and maintenance therapy is prolonged according to blood test results. Treatment is generally continued until normal blood values are reached, which may take several weeks (4 to 6) and, subsequently, an additional minimum of 3 months to replenish iron reserves.

This medication can be used by diabetics.

If you take more Losferron than you should

If you have taken more Losferron than you should, consult your doctor or pharmacist immediately.

Acute iron poisoning requires immediate medical treatment, which is especially important in children.

The initial symptoms of acute poisoning are gastrointestinal (nausea, vomiting that may or may not be bloody, abdominal pain, diarrhea with blood), fever, lethargy, low blood pressure, and increased white blood cells.

After ingesting high doses of iron for prolonged periods exceeding individual needs, chronic poisoning may occur with typical symptoms of iron overload (weakness, fatigue, weight loss, skin discoloration to a grayish metallic color, abdominal pain, and loss of libido).

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 medication and the amount ingested). Bring this leaflet with you.

If you forget to take Losferron

Do not take a double dose to compensate for the missed doses. Take a new dose as soon as possible. Then continue treatment as indicated by your doctor.

If you interrupt treatment with Losferron

Do not discontinue treatment before the indicated time by your doctor, even if you feel better, as desired effects will not be achieved.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The adverse effects that may appear more frequently are abdominal discomfort, nausea, metallic taste, burning sensation, constipation, and diarrhea.

Commonly with other iron preparations, the adverse effects that may occur with the use of Losferron are of unknown frequency (cannot be estimated from available data):

-Nervous System Disorders:alteration of the sense of taste (appearance of metallic taste).

-Vascular Disorders:shortness of breath*, dizziness*.

-Gastrointestinal Disorders:rarely, darkening of teeth, generally darkening of stools, abdominal discomfort, epigastric pain*, nausea*, vomiting, constipation, diarrhea, sensation of burning in the esophagus.

-Skin and Subcutaneous Tissue Disorders:allergic reactions (rash).

*These adverse effects may occur at the beginning of treatment in patients with severe iron deficiency.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Losferron

- The active principle is gluconate iron (II). Each effervescent tablet contains 695 mg of gluconate iron (II) (equivalent to 80 mg of elemental iron).

- The other components are sodium cyclamate (E-952), sodium saccharin (E-954), ascorbic acid (E-300), citric acid (E-330), tartaric acid (E-334), sodium hydrogen carbonate (E-500), sodium carbonate (E-500), yellow-orange S (E-110), and orange aroma (natural orange essential oil, natural concentrated orange essential oil 5 times, natural mandarin essential oil, natural cassis liquid flavor, vanilla, mannitol (E-421), maltodextrin, gluconolactone (E-575), sorbitol (E-420), benzyl alcohol, propylene glycol (E-1520), glucose syrup, and sodium).

Appearance of the product and content of the packaging

Losferron 695 mg effervescent tablets are presented in the form of effervescent tablets of gray-brown color in a polypropylene tube with a polyethylene cap containing silica gel, in containers with 30 effervescent tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

CASEN RECORDATI, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza)

Spain

Responsible for manufacturing:

HERMES Pharma Ges.m.b.H

Schwimmschulweg 1a

9400 Wolfsberg,

Austria

Last review date of this leaflet: December 2020

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/