Leaflet: information for the user

Furantoin 10 mg/ml oral suspension

Nitrofurantoin

Read this leaflet carefully before you start taking this medicine because 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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

The active ingredient of Furantoína is nitrofurantoína.

Nitrofurantoína is an antibiotic belonging to the group of compounds known as nitrofuranos.

It is used to treat urinary tract infections caused by bacteria in girls, adolescents, and adult women.

Do not take Furantoína:

• If you are allergic to nitrofurantoína or any of the other components of this medication (listed in section 6).
• For more than 7 consecutive days or in frequent repeat treatments, see more in the section onWarnings and precautions.
• If you have severe kidney problems.
• If you have a blood disorder called porfiria.
• If you have been diagnosed with a blood disorder called: glucose-6-phosphate dehydrogenase deficiency, which is a substance that red blood cells need to function correctly.
• If you are pregnant and in the last two weeks of gestation.

Warnings and precautions

The use of nitrofurantoína in prolonged treatments (continuous or frequent repeat treatments) has been associated with the appearance of severe pulmonary, hepatic, and hypersensitivity reactions.

Consult your doctor or pharmacist before starting to take Furantoína if you:

• Have any kidney disease.
• Have been diagnosed with any neurological disease.
• Have a predisposition to suffer allergic reactions.
• Have liver or lung problems.
• Are diabetic.
• Have anemia.
• Have a lack of vitamin B, especially a vitamin called folic acid.
• Experience fatigue, yellowish discoloration of the skin or eyes, pruritus, skin eruptions, joint pain, abdominal discomfort, nausea, vomiting, loss of appetite, dark urine, and pale or grayish stools. These may be symptoms of a liver disorder.

Be aware that taking Furantoína may cause urine to turn dark yellow or brown. This is a normal effect and should not cause you to stop taking the medication.

Furantoína may interfere with urine glucose tests, potentially giving false positive results.

Children and adolescents

Do not administer to children under three months.

Use of Furantoína with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, such as:

• Antacids used to reduce stomach acidity, such as magnesium trisilicate. Take Furantoína at least 1 hour before or 2 hours after taking an antacid.
• Medications for gout treatment, such as probenecid and sulfinpirazona, as the effect of Furantoína may be reduced.
• Medications for glaucoma treatment, such as carbonic anhydrase inhibitors, as they decrease the effect of Furantoína.
• Medications that reduce urine acidity, as they decrease the effect of Furantoína.
• Other antibiotics, such as those in the quinolone group, as it may reduce the effect of both antibiotics.

Use of Furantoína with food and beverages

It is recommended to take Furantoína with meals or with a glass of milk and never on an empty stomach to increase tolerance and improve medication absorption.

Pregnancy, breastfeeding, and fertility

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

• You cannot take this medication if you are in the last two weeks of gestation.
• You should avoid taking Furantoína during breastfeeding with babies under three months or in cases where the child has a blood disorder called: glucose-6-phosphate dehydrogenase deficiency (G6PD).

Driving and operating machinery

The use of this medication may cause dizziness, so you should not take Furantoína if you need to drive or operate machinery.

Furantoína oral suspension contains sorbitol

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

It may cause a mild laxative effect because it contains 3.5 g of sorbitol per 10 ml dose.

Caloric value: 2.6 kcal/g of sorbitol.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218).

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is: For women over 18 years: 5 to 10 ml of oral suspension every 6 hours for 5-7 days.

Unless you have a severe kidney disease (significant renal insufficiency), the recommended dose is the same as for women over 18 years.

Use in children and adolescents

Do not administer to children under three months.

The recommended dose is 0.1 - 0.2 ml of oral suspension per kg of body weight every 6 hours, not exceeding the adult dose, for 5-7 days.

If you take more Furantoína than you should

If you (or someone) ingest a large amount at once or if you think a child has swallowed some, contact your doctor or pharmacist immediately. Overdose may cause stomach irritation, nausea, and vomiting.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested. Bring this leaflet and the packaging with you to the hospital or to your doctor so they know how much you have taken.

If you forget to take Furantoína

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Furantoína

Do not stop taking your medication without consulting your doctor first, even if you feel better. It is very important that you continue to take Furantoína for the time your doctor has indicated, or the infection may recur.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking Furantoína and seek immediate medical attention or visit the nearest hospital emergency room:

• Chest pain, cough, difficulty breathing.
• Abdominal pain and jaundice (caused by liver inflammation) characterized by a yellowish discoloration of the skin or the white part of the eyes.
• Rashes, eruptions, vesicles, or blisters on the skin.
• Swelling of the lips, face, or tongue.
• Loss of sensation in the hands or loss of muscle strength, confusion, weakness, blurred vision.

These are serious side effects that may require urgent medical attention or hospitalization.

You may experience one or more of the following side effects when taking Furantoína:

Frequent

(may affect up to 1 in 100 people)

• Allergic reactions on the skin (pruritus, urticaria).
• Pseudo-lupus manifestations (fever, chills, and joint pain).
• Angioedema (swelling of the lips, face, or tongue).
• Dizziness.
• Peripheral neuropathies (loss of sensation in the hands or loss of muscle strength).
• Nausea, vomiting, abdominal pain, diarrhea. The administration of nitrofurantoin with food reduces these effects.

Rare

(may affect up to 1 in 1,000 people)

• Leucopenia, thrombocytopenia, and aplastic anemia, affecting blood cells (decrease in the number of white blood cells or platelets). This may cause bruising and delayed coagulation. These blood cells usually return to normal levels after stopping treatment.
• Shock and cyanosis, a lack of oxygen in the blood that manifests externally as a bluish discoloration of the skin and mucous membranes.
• Skin diseases: skin eruptions and exfoliative dermatitis (inflammation of the skin with or without peeling), erythema multiforme, and Stevens-Johnson syndrome (appearance of vesicles and blisters on the skin).

Very rare

(may affect up to 1 in 10,000 people)

• Acute pneumonias, a type of lung disease characterized by fever, chills, cough, chest pain, and difficulty breathing. These symptoms disappear after stopping the antibiotic.
• Cytolytic and cholestatic hepatitis, liver inflammation with abdominal pain and appearance of jaundice (yellowish discoloration of the skin or the white part of the eyes).

Unknown frequency

• Agranulocytosis, granulocytopenia, hemolytic anemia, megaloblastic anemia, anemia due to glucose-6-phosphate dehydrogenase deficiency, which are blood disorders characterized by a decrease and/or absence of one or more blood cells.
• Eosinophilia, the presence of an abnormally high number of eosinophils, a type of blood cell.
• Anaphylaxis (generalized allergic reaction that can be potentially severe), sialadenitis (inflammation of the salivary glands), pancreatitis (inflammation of the pancreas).
• Inflammation of the small blood vessel walls, causing skin lesions with an unknown frequency.
• Fever and arthralgia (joint pain).
• Depression, euphoria, and psychotic reactions.
• Nystagmus (involuntary eye movements), vertigo (sensation of spinning or movement), asthenia (sensation of fatigue, weakness, and physical and mental debility), headache, and somnolence.
• Anorexia (severe alteration of eating behavior).
• Liver inflammation due to activation of the immune system against liver cells with an unknown frequency.
• Inflammation of the renal tissue surrounding the tubules, causing renal insufficiency with an unknown frequency.

In long-term treatments (over 6 months) or in very frequent repeated treatments, very serious side effects are appearing with increasing frequency, such as:

• Pulmonary fibrosis, a hardening of the lung tissue with progressive loss of lung function.
• Active chronic hepatitis (chronic liver inflammation), liver necrosis (death of liver cells), and fulminant hepatitis (sudden and rapid failure of the liver).

Other adverse reactions

• Transient alopecia (temporary hair loss), benign intracranial hypertension (increase in intracranial pressure, characterized by headache among other symptoms).
• Like other antibiotics, overinfections by fungi or other microorganisms resistant to nitrofurantoin, such as Pseudomonas spp., may occur. These overinfections are limited to the genitourinary tract.

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://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.

Do not store at a temperature above 86°F (30°C).

Do not use Furantoína after the expiration date that appears 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 medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Furantoína Composition

Each milliliter contains 10 mg of the active principle nitrofurantoína.

The other components are: Anhydrous citric acid, sodium carmelose, microcrystalline cellulose, aluminum chloride, disodium phosphate, lemon aroma, methyl parahydroxybenzoate (E-218), 70% sorbitol (E-420) and purified water.

Product appearance and packaging contents

PET (polyethylene terephthalate) bottle with a topaz color, a white polypropylene cap with a thread and a plastic dosing vial, containing 80 ml or 250 ml of oral suspension, depending on the format.

The clinical packaging format contains 10 bottles of 250 ml.

Marketing Authorization Holder

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturing Responsible Parties

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona. Spain

Last review date of this leaflet: May 2022

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