FURANTOIN 10 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Furantoína 10 mg/ml Oral Suspension

Nitrofurantoin

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Furantoína and what is it used for

The active substance of Furantoína is nitrofurantoin.

Nitrofurantoin is an antibiotic belonging to the group of nitrofurans.

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

2. What you need to know before you take Furantoína

Do not take Furantoína:

• If you are allergic to nitrofurantoin 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 the section on Warnings and Precautionsbelow.
• If you have severe kidney problems.
• If you have a blood disease called porphyria.
• If you have been diagnosed with a blood disease called glucose-6-phosphate dehydrogenase deficiency, which is a substance that red blood cells need to function properly.
• If you are pregnant and are in the last two weeks of gestation.

Warnings and Precautions

The use of nitrofurantoin in prolonged treatments (either continuous or frequent repeat treatments) has been associated with the occurrence 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.
• Are prone to allergic reactions.
• Have liver or lung problems.
• Are diabetic.
• Have anemia.
• If you have a lack of vitamin B, especially a vitamin called folic acid.
• Experience fatigue, yellowing of the skin or eyes, itching, skin rash, joint pain, abdominal discomfort, nausea, vomiting, loss of appetite, dark urine, and pale or gray stools. These may be symptoms of a liver disorder.

Note that when taking Furantoína, the urine may turn dark yellow or brown. This is a normal effect and does not mean you should 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 Medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, 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.
• Medicines for the treatment of gout, such as probenecid and sulfinpyrazone, as the effect of Furantoína may be reduced.
• Medicines for the treatment of ocular hypertension (glaucoma), such as carbonic anhydrase inhibitors, as they reduce the effect of Furantoína.
• Medicines that reduce the acidity of the urine because they reduce the effect of Furantoína.
• Other antibiotics, for example, those belonging to the quinolone group, as it may reduce the effect of both antibiotics.

Use of Furantoína with Food and Drinks

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

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.

• You must not take this medicine if you are in the last two weeks of pregnancy.
• You should avoid taking Furantoína during breastfeeding if your baby is under three months or if the child has a blood disease called glucose-6-phosphate dehydrogenase deficiency (G6PD).

Driving and Using Machines

The use of this medicine 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 some sugars, consult them before taking this medicine.

It may have 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).

3. How to Take Furantoína

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Provided you do not have significant renal impairment, 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 to 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 else) swallow a lot of it at once or if you think a child has swallowed some, contact your doctor or pharmacist immediately. Overdose could cause stomach irritation, nausea, and vomiting.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. Bring this leaflet and the packaging 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 nearly time for your next dose. Do not take a double dose to make up for forgotten doses.

If You Stop Taking Furantoína

Do not stop taking your medicine without talking to your doctor first, even if you feel better. It is very important that you keep taking Furantoína for the duration indicated by your doctor, or the infection may come back.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

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

If you experience any of the following, stop taking Furantoína and contact your doctor immediately or go to the emergency department of your nearest hospital:

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

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

When you take Furantoína, you may experience one or more of the following side effects:

Common

(may affect up to 1 in 100 people)

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

Uncommon

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

• Leukopenia, thrombocytopenia, and aplastic anemia, affecting blood cells (reduction in the number of white blood cells or platelets). Due to this, you may experience bruising and delayed coagulation. These blood cells usually return to normal levels after stopping treatment.
• Collapse and cyanosis, which is a lack of oxygen in the blood manifested externally by a bluish discoloration of the skin and mucous membranes.
• Skin diseases: Skin rashes and exfoliative dermatitis (inflammation of the skin with or without scaling), erythema multiforme, and Stevens-Johnson Syndrome (appearance of blisters or bubbles on the skin).

Rare

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

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

Frequency Not Known

• Agranulocytosis, granulocytopenia, hemolytic anemia, megaloblastic anemia, glucose-6-phosphate dehydrogenase deficiency anemia, which are blood diseases characterized by the decrease and/or absence of one or more blood cells.
• Eosinophilia, which is 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 walls of small blood vessels, causing skin lesions with an unknown frequency.
• Fever and arthralgia (joint pain).
• Depression, euphoria, and psychotic reactions.
• Nystagmus (involuntary eye movements), vertigo (apparent sensation of spinning or movement), asthenia (feeling of fatigue, weakness, and physical and mental exhaustion), headache, and somnolence.
• Anorexia (severe alteration of eating behavior).
• Inflammation of the liver tissue due to activation of the immune system against liver cells with an unknown frequency.
• Inflammation of the kidney tissue surrounding the tubules, causing renal failure with an unknown frequency.

In very long treatments (more than 6 months) or in very frequent repeat treatments, very serious side effects such as:

• Pulmonary fibrosis, which is a hardening of lung tissue with progressive loss of lung function.
• Chronic active hepatitis (chronic liver inflammation), liver necrosis (death of liver cells), and fulminant hepatitis (the liver suddenly stops working).

Other Adverse Reactions

• Transient alopecia (temporary hair loss), benign intracranial hypertension (increase in pressure within the skull, characterized by symptoms such as headache).
• As with other antibiotics, superinfections by fungi or other microorganisms resistant to nitrofurantoin, such as Pseudomonasspp., may occur. These superinfections are limited to the genitourinary tract.

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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Furantoína

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

Do not store above 30°C.

Do not use Furantoína after the expiry date stated on the packaging, after EXP. The expiry 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 medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Furantoína

Each ml contains 10 mg of the active substance nitrofurantoin.

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

Appearance of the Product and Packaging Contents

Topaz-colored polyethylene terephthalate (PET) bottle with a white polypropylene screw cap and a dosing cup, 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

Manufacturers

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona, Spain

Date of Last Revision of this Leaflet: May 2022

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