Losferron 695 mg effervescent tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Losferron 695 mg effervescent tablets
Iron (II) gluconate
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Losferron is and what it is used for
- What you need to know before taking Losferron
- How to take Losferron
- Possible adverse effects
- How to store Losferron
- Contents of the pack and other information
1. What Losferron is and what it is used for
Losferron belongs to a group of medicines called antianaemics.
Losferron is indicated for the prevention and treatment of iron deficiency anemia caused by inadequate diet, malabsorption, pregnancy and/or blood loss.
2. What you need to know before taking Losferron
Do not take Losferron
- If you are allergic to ferrous gluconate or to any of the other ingredients of this medicine (listed in section 6).
- If you have diseases associated with excessive accumulation of iron in the body, such as haemochromatosis.
- In case of haemolysis (destruction of red blood cells).
- If you have disorders of iron metabolism (sideroblastic anaemia, thalassaemia, lead anaemia).
Warnings and precautions
- Your doctor must diagnose you with iron-deficiency anaemia before prescribing this medicine, as iron administration can be toxic, especially in children.
- If you follow a diet rich in iron and/or take supplements containing iron salts, since this increases the risk of excessive iron accumulation in your body.
- The liquid preparation resulting from dissolving the effervescent tablets may stain teeth. This can be avoided by drinking the solution through a straw and brushing your teeth afterwards.
- During treatment with Losferron, stools may become dark. This effect is harmless and is caused by unabsorbed iron.
Consult your doctor or pharmacist before starting to take Losferron.
Taking Losferron with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines may interact with Losferron; in such cases, it may be necessary to adjust the dose or discontinue 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 they may reduce the effect of these medicines and of Losferron. You should separate the administration of both medicines by 2 or 3 hours.
- Quinolones (a type of medicine used to treat infections) such as ciprofloxacin, levofloxacin, norfloxacin, ofloxacin, as they may reduce the effect of these medicines. The use of quinolones with Losferron is not recommended, but if necessary, take the quinolone 2 hours before or 4–6 hours after taking Losferron.
- Penicillamine (a medicine used to treat rheumatoid arthritis), as it may reduce the effect of this medicine.
- Levodopa (a medicine for the treatment of Parkinson's disease), as it may reduce the effect of this medicine.
- Methyldopa (a medicine for the treatment of high blood pressure), as it may reduce the effect of this medicine.
- Bisphosphonates (medicines for the treatment of osteoporosis) and levothyroxine (a medicine for the treatment of hypothyroidism), as they may reduce the effect of these medicines. You should separate the administration of these medicines and Losferron by 2 or 3 hours.
- Cholestyramine (a medicine that reduces elevated cholesterol levels), as it may reduce the effect of Losferron. You should separate the administration of both medicines by at least 4 hours.
- Antacids (medicines used for stomach acidity), phosphates, calcium and magnesium salts, as they may reduce the effect of Losferron. You should separate the administration of these medicines and Losferron by 2 or 3 hours.
- Treatment with certain pain medicines belonging to the group of non-steroidal anti-inflammatory drugs (such as acetylsalicylic acid, diclofenac, ibuprofen, naproxen and piroxicam), as they may worsen gastrointestinal disturbances caused by iron.
- Caffeine (present in coffee and tea), as it may reduce the effect of Losferron.
Taking Losferron with food and drinks
Ingredients in certain vegetarian foods (such as wholemeal bread and cereals) and components of milk, coffee and tea may reduce the effect of Losferron.
Take Losferron one hour before or three hours after meals or consumption of the foods and drinks mentioned.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Additional iron supplementation may be necessary during pregnancy and breast-feeding.
During pregnancy, do not take more than 1 tablet of Losferron 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 may cause asthma, especially in patients allergic to acetylsalicylic acid.
Losferron contains Sodium
This medicine contains 229 mg of sodium (the main component of table/cooking salt) per tablet. This corresponds to 12% of the maximum daily sodium intake recommended 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 (sodium) diet.
Losferron contains Benzyl Alcohol
This medicine contains 0.152 mg of benzyl alcohol per tablet.
Benzyl alcohol may cause allergic reactions.
Consult your doctor or pharmacist if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol may 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 may accumulate in your body and cause adverse effects (metabolic acidosis).
Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome") in children.
Do not administer this medicine to your newborn (up to 4 weeks of age) unless your doctor has specifically recommended it.
This medicine should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist.
Losferron contains Sorbitol
This medicine contains 1.087 mg of sorbitol per tablet.
3. How to take Losferron
Follow exactly the instructions given by your doctor for taking this medicine. 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 meal (see section "Taking Losferron with food and drink"). In case of gastrointestinal disturbances (nausea, stomach discomfort, diarrhoea, heartburn or constipation), Losferron may be taken with meals.
Adults
The recommended dose is 1 effervescent tablet of Losferron once daily. In cases of severe anaemia, the dose may 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.
For children weighing 14 kg or more, administer 3 mg/kg body weight of iron (II) (each effervescent tablet contains 80 mg of iron (II)). A daily dose exceeding 5 mg/kg body weight should not be exceeded, and the maximum daily dose must not exceed 100 mg of iron (II).
Your doctor will advise you on the duration of your treatment with Losferron. Do not stop the treatment prematurely, as the desired effects will not be achieved.
Frequently, the treatment duration is 4–6 weeks, and maintenance therapy continues depending on blood count results. Treatment is generally continued until normal blood values are reached, which may take several weeks (4 to 6), followed by 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.
Initial symptoms of acute poisoning are gastrointestinal (nausea, vomiting which may or may not contain blood, abdominal pain, bloody diarrhoea), fever, lethargy, low blood pressure, and increased white blood cell count.
After prolonged intake of high doses of iron exceeding individual requirements, chronic poisoning may occur, with typical symptoms of iron overload (weakness, fatigue, weight loss, skin discolouration to a metallic grey, abdominal pain, and loss of libido).
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20 (indicating the medicine and amount ingested). Bring this leaflet with you.
If you forget to take Losferron
Do not take a double dose to make up for missed doses. Take a new dose as soon as possible. Then continue treatment as directed by your doctor.
If you stop treatment with Losferron
Do not stop treatment before the time indicated by your doctor, even if you feel better, as the desired effects will not be achieved.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The most frequently occurring adverse effects are abdominal discomfort, nausea, metallic taste, heartburn, constipation, and diarrhoea.
As with other iron preparations, the following adverse effects may occur with Losferron and are of unknown frequency (cannot be estimated from available data):
- Nervous system disorders: disturbance of taste sensation (metallic taste).
- Vascular disorders: hot flush*, dizziness*.
- Gastrointestinal disorders: rarely, darkening of teeth; generally, darkening of stools; abdominal discomfort; epigastric pain*; nausea*; vomiting; constipation; diarrhoea; sensation of oesophageal burning.
- 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 of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This 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 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), orange yellow S (E-110), and orange flavour (natural orange essential oil, 5-fold concentrated natural orange essential oil, natural mandarin essential oil, natural cassis flavouring liquid, 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 contents of the pack
Losferron 695 mg effervescent tablets are presented as grey-brown effervescent tablets in a polypropylene tube with a polyethylene cap containing silica gel, in packs containing 30 effervescent tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 the most recent revision of this summary: December 2020
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/