LOSFERRON 695 mg EFFERVESCENT TABLETS

2. What you need to know before you take Losferron

Do not take Losferron

• If you are allergic to iron (II) gluconate or any of the other ingredients of this medicine (listed in section 6).
• If you have diseases that involve excessive iron accumulation in the body, such as hemochromatosis.
• In case of hemolysis (destruction of red blood cells).
• If you have disorders of iron metabolism (sideroblastic anemia, thalassemia, lead anemia).

Warnings and precautions

• Your doctor should diagnose you with iron deficiency anemia before prescribing this medicine, as iron administration can be toxic, especially in children.
• If you are on a diet rich in iron and/or taking iron supplements, as this increases the risk of excessive iron accumulation in your body.
• The liquid preparation resulting from the dissolution of the effervescent tablets can darken teeth; this can be avoided by sipping the preparation with a straw and brushing your teeth.
• During treatment with Losferron, stools may turn 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 medicines

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

Certain medicines may interact with Losferron; in these cases, it may be necessary to change the dose or interrupt treatment with one of the medicines.

It is important that you inform your doctor if you are taking any of the following medicines:

• Tetracyclines (a type of medicine used to treat infections) such as doxycycline, minocycline, oxytetracycline, tetracycline, as a decrease in the effect of these medicines and the effect of Losferron may occur. You should take both medicines 2 or 3 hours apart.
• Quinolones (a type of medicine used to treat infections) such as ciprofloxacin, levofloxacin, norfloxacin, ofloxacin, as a decrease in the effect of this medicine may occur. The use of quinolones with Losferron is not recommended, but if necessary, you should take the quinolone 2 hours before or 4-6 hours after taking Losferron.
• Penicillamine (a medicine used to treat rheumatoid arthritis) as a decrease in the effect of this medicine may occur.
• Levodopa (a medicine for the treatment of Parkinson's disease) as a decrease in the effect of this medicine may occur.
• Methyldopa (a medicine for the treatment of high blood pressure) as a decrease in the effect of this medicine may occur.
• Bisphosphonates (medicines for the treatment of osteoporosis) and levothyroxine (a medicine for the treatment of hypothyroidism) as a decrease in the effect of these medicines may occur. You should take these medicines and Losferron 2 or 3 hours apart.
• Colestyramine (a medicine that reduces high cholesterol levels) as a decrease in the effect of Losferron may occur. You should take both medicines at least 4 hours apart.
• Antacids (medicines used for stomach acidity), phosphates, calcium and magnesium salts, as a decrease in the effect of Losferron may occur. You should take these medicines and Losferron 2 or 3 hours apart.
• Treatment with certain pain-relieving medicines belonging to the group of non-steroidal anti-inflammatory drugs (such as acetylsalicylic acid, diclofenac, ibuprofen, naproxen, and piroxicam), as they may intensify the gastrointestinal disorders caused by iron.
• Caffeine (present in coffee and tea) as a decrease in the effect of Losferron may occur.

Taking Losferron with food and drinks

The ingredients of some vegetarian foods (such as wholemeal bread and cereals) and the ingredients of milk, coffee, and tea may decrease the effect of Losferron.

Take Losferron 1 hour before or 3 hours after any of the meals or the foods and drinks mentioned.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It may be necessary to take iron supplements during pregnancy and breastfeeding.

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

Driving and using machines

Not applicable.

Losferron contains Orange Yellow S (E-110)

This medicine may cause allergic reactions because it contains Orange Yellow S (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

Losferron contains Sodium

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

Losferron contains Benzyl Alcohol

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

Benzyl alcohol may 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 serious side effects, including respiratory problems ("gasping syndrome") in children.

Do not give this medicine to your newborn (up to 4 weeks of age) unless your doctor has recommended it.

This medicine should not be used for more than one week in children under 3 years of age unless advised by your doctor or pharmacist.

Losferron contains Sorbitol

This medicine contains 1.087 mg of sorbitol in each tablet.

3. How to take Losferron

Follow exactly the administration instructions of this medicine indicated by your doctor. If in 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 of the meals (see section "Taking Losferron with food and drinks"). In case of gastrointestinal disorders (nausea, stomach upset, diarrhea, heartburn, or constipation), Losferron can be taken with meals.

Adults

The recommended dose is 1 effervescent tablet of Losferron once a day. In case of severe anemia, the dose can be increased to 2 or 3 tablets per 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 with a weight of 14 kg or more, 3 mg/kg of body weight of iron (II) should be administered (each effervescent tablet contains 80 mg of iron (II)). The daily dose should not exceed 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 stop treatment before, as the desired effects will not be achieved.

Usually, the duration of treatment is 4-6 weeks, and maintenance therapy is prolonged based on blood count results. Treatment is generally continued until normal blood values are reached, which can take several weeks (4 to 6), and then for an additional minimum of 3 months to replenish iron stores.

This medicine 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 be with or without blood, abdominal pain, diarrhea with blood), fever, lethargy, low blood pressure, and increased white blood cell count.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 (indicating the medicine and the amount ingested). Bring this leaflet with you.

If you forget to take Losferron

Do not take a double dose to make up for forgotten doses. Take a new dose as soon as possible. Then continue treatment as indicated by your doctor.

If you stop taking Losferron

Do not stop treatment before your doctor indicates, even if you feel better, as the desired effects will not be achieved.

If you have any further questions on 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 side effects that may occur most frequently are abdominal discomfort, nausea, metallic taste, heartburn, constipation, and diarrhea.

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

• Nervous system disorders: alteration of taste (metallic taste).
• Vascular disorders: flushing*, dizziness*.
• Gastrointestinal disorders: rarely tooth discoloration, generally darkening of stools, abdominal discomfort, epigastric pain*, nausea*, vomiting, constipation, diarrhea, sensation of heartburn in the esophagus.
• Skin and subcutaneous tissue disorders: allergic reactions (rash).

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Losferron

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Losferron

• The active substance is iron (II) gluconate. Each effervescent tablet contains 695 mg of iron (II) gluconate (equivalent to 80 mg of elemental iron).
• The other ingredients 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), Orange Yellow S (E-110), and orange flavor (natural orange essential oil, 5 times concentrated natural orange essential oil, natural mandarin essential oil, natural blackcurrant liquid flavor, vanilla, mannitol (E-421), maltodextrin, gluconolactone (E-575), sorbitol (E-420), benzyl alcohol, propylene glycol (E-1520), glucose syrup, sodium).

Appearance of the product and pack contents

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

CASEN RECORDATI, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza)

Spain

Manufacturer:

HERMES Pharma Ges.m.b.H

Schwimmschulweg 1a

9400 Wolfsberg,

Austria

Date of last revision of this leaflet: December 2020

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/