Package Insert: Information for the User

Furantoína 50 mg Tablets

Nitrofurantoína

Read this package insert carefully before starting to take this medication because 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, pharmacist, or nurse.
• This medication 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, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

The active ingredient of Furantoína is nitrofurantoína.

Nitrofurantoína is an antibiotic belonging to the group of nitrofuranos.

It is used to treat urinary tract infections caused by bacteria in girls over 6 years old, 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.
• Are prone to 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 be discontinued for this reason.

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

Children and adolescents

The tablets are not recommended for girls under 6 years of age (see section 3). There is another presentation of this medication: Furantoína oral suspension, which is suitable for this age group.

Use of Furantoína with other medications

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

• 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 reduce the effect of Furantoína.
• Medications that reduce urine acidity, as they reduce 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 drinks

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 absorption of the medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be 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 old or in cases where the baby has a blood disorder called: glucose-6-phosphate dehydrogenase deficiency (G6PD).

Driving and operating machinery

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

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 old: 50-100 mg (1-2 tablets) every 8 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 old.

Use in children and adolescents

For girls over 6 years old and adolescents, the recommended dose is 5-7 mg/kg of body weight per day, not exceeding the adult dose, divided into four doses for 5-7 days.

If you take more Furantoína than you should

If you (or someone) ingest many tablets at once or if you think a child has swallowed some tablets, 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, some of the remaining tablets, and the packaging to the hospital or to your doctor so they know which tablets you have taken.

If you forget to take Furantoína

If you forget to take a tablet, 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 taking 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 leukocytes 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 hepatitis 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 frequently repeated treatments, very severe 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 Medicinal Products 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.

Store the blister pack in the outer packaging to protect it from light.

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 packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Furantoína

Each tablet contains 50 mg of the active ingredient nitrofurantoína.

• The other components are: Povidone, sodium carboxymethylcellulose (type A) derived from potato, calcium dihydrogen phosphate, talc, magnesium stearate.

Appearance of the product and content of the packaging

Round tablets, yellow in color, and scored. The tablet can be divided into equal doses.

It is presented in PVC blister packs sealed with a thermosoldered aluminum foil in containers of 21, 42 tablets and 500 tablets (clinical container).

Holder of the marketing authorization

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturing responsible parties

Laboratorios ERN, S.A.

Gorcs i Lladó, 188 – 08210 Barberá del Vallés. Barcelona. Spain.

Date of the last review of this leaflet: February 2019

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