Nitrofurantoin 50 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Furantoína 50 mg tablets

Nitrofurantoin

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

Leaflet contents

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

1. What Furantoin is and what it is used for

The active substance in Furantoin is nitrofurantoin.

Nitrofurantoin is an antibiotic belonging to the group known as nitrofurans.

It is used to treat urinary tract infections caused by bacteria in girls over 6 years of age, adolescents, and adult women.

2. What you need to know before taking Furantoin

Do not take Furantoin:

• If you are allergic to nitrofurantoin or to any of the other ingredients of this medicine (listed in section 6).
• For more than 7 consecutive days or in treatments that are repeated frequently; see further in the Warnings and precautions section.
• If you have severe kidney problems.
• If you have a blood disorder called porphyria.
• 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 properly.
• If you are pregnant and are in the last two weeks of pregnancy.

Warnings and precautions

The use of nitrofurantoin in prolonged treatments (continuously or frequently repeated) has been associated with serious adverse pulmonary, hepatic, and hypersensitivity reactions.

Consult your doctor or pharmacist before starting to take Furantoin if:

• You have any kidney disease.
• You have been diagnosed with any neurological disorder.
• You are prone to allergic reactions.
• You have liver or lung problems.
• You are diabetic.
• You have anemia.
• You have a deficiency in vitamin B, especially a vitamin called folic acid.
• You experience fatigue, yellowing of the skin or eyes, itching, skin rashes, joint pain, abdominal discomfort, nausea, vomiting, loss of appetite, dark urine, or pale or grey stools. These may be symptoms of a liver disorder.

Please note that when taking Furantoin, your urine may become dark yellow or brownish. This is a normal effect and you should not discontinue the medication because of it.

Furantoin may interfere with urine glucose tests, potentially leading to false positive results.

Children and adolescents

The tablets are not recommended for girls under 6 years of age (see section 3). Another formulation of this medicine is available: Furantoin oral suspension, which is suitable for this population group.

Use of Furantoin with other medicines

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

• Antacids used to reduce stomach acidity, such as magnesium trisilicate. Take Furantoin at least 1 hour before or 2 hours after taking an antacid.
• Medicines for the treatment of gout, such as probenecid and sulfinpyrazone, as they may reduce the effect of Furantoin.
• Medicines for the treatment of ocular hypertension (glaucoma), such as carbonic anhydrase inhibitors, as they may reduce the effect of Furantoin.
• Medicines that reduce urine acidity, as they may reduce the effect of Furantoin.
• Other antibiotics, for example those belonging to the quinolone group, as they may reduce the effect of both antibiotics.

Use of Furantoin with food and drinks

It is advisable to take Furantoin during meals or with a glass of milk, and never on an empty stomach, to enhance tolerance and improve absorption of the medicine.

Pregnancy, breastfeeding, and fertility

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

• You must not take this medicine if you are in the last two weeks of pregnancy.
• You should avoid taking Furantoin while breastfeeding if the infant is less than three months old or if the child has a blood disorder called: glucose-6-phosphate dehydrogenase deficiency (G6PD).

Driving and using machines

This medicine may cause dizziness; therefore, you should not take Furantoin if you need to drive or operate machinery.

3. How to take Furantoin

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is: In women over 18 years of age: 50–100 mg (1–2 tablets) every 8 hours for 5–7 days.

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

Use in children and adolescents

In girls over 6 years of age and adolescents, the recommended dose is 5–7 mg/kg body weight per day, without exceeding the adult dose, divided into four doses for 5–7 days.

If you take more Furantoin than you should

If you (or someone else) swallow many tablets at once, or if you think a child has swallowed any tablets, contact your doctor or pharmacist immediately. Overdose may cause gastric irritation, nausea, and vomiting.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Take this leaflet, any remaining tablets, and the packaging with you to the hospital or doctor so they know which tablets have been taken.

If you forget to take Furantoin

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 forgotten doses.

If you stop taking Furantoin

Do not stop taking your medicine without first consulting your doctor, even if you feel better. It is very important that you continue taking Furantoin for the length of time prescribed by your doctor; otherwise, the infection may recur.

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 can cause adverse effects, although not everyone will experience them.

If you experience any of the following, stop taking Furantoin immediately and see your doctor or go to the nearest hospital emergency department straight away:

• Chest pain, cough, difficulty breathing.
• Abdominal pain and jaundice (caused by liver inflammation), characterized by yellowing of the skin or the whites of the eyes.
• Appearance of hives, rashes, blisters, or vesicles 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 adverse effects that may be serious. You may require urgent medical attention or hospitalization.

When taking Furantoin, you may experience one or more of the following adverse effects:

Common

(may affect up to 1 in 100 people)

• Allergic skin reactions (itching, urticaria).
• Lupus-like 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. Taking nitrofurantoin with food reduces these effects.

Rare

(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). This may result in bruising and delayed blood clotting. These blood cells usually return to normal levels after stopping treatment.
• Collapse and cyanosis, which is a lack of oxygen in the blood, externally manifested by a bluish discoloration of the skin and mucous membranes.
• Skin disorders: Skin rashes and exfoliative dermatitis (inflammation of the skin with or without peeling), erythema multiforme, and Stevens-Johnson syndrome (appearance of blisters and vesicles on the skin).

Very rare

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

• Acute pulmonary disease, a type of lung disease characterized by fever, chills, cough, chest pain, and difficulty breathing. These symptoms disappear upon discontinuation of the antibiotic.
• Cytolytic hepatitis and cholestatic hepatitis, liver inflammation with abdominal pain and onset of jaundice (yellowing of the skin or the whites of the eyes).

Frequency not known

• Agranulocytosis, granulocytopenia, hemolytic anemia, megaloblastic anemia, glucose-6-phosphate dehydrogenase deficiency anemia—these are blood disorders characterized by decreased and/or absence of one or more types of blood cells.
• Eosinophilia, which is an abnormally high number of blood cells called eosinophils.
• Anaphylaxis (generalized allergic reaction that may 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 unknown frequency.
• Fever and arthralgia (joint pain).
• Depression, euphoria, and psychotic reactions.
• Nystagmus (involuntary eye movements), vertigo (sensation of spinning or movement), asthenia (feeling of tiredness, fatigue, and physical and mental weakness), headache, and somnolence.
• Anorexia (severe eating disorder).
• Liver inflammation due to immune system activation against liver cells, with unknown frequency.
• Inflammation of the kidney tissue surrounding the tubules, leading to renal failure, with unknown frequency.

In very long-term treatments (more than 6 months) or in very frequently repeated treatments, the following very serious adverse effects are increasingly being observed:

• Pulmonary fibrosis, which is hardening of lung tissue with progressive loss of lung function.
• Chronic active hepatitis (chronic liver inflammation), hepatic necrosis (death of liver cells), and fulminant hepatitis (liver suddenly and rapidly ceases to function).

Other adverse reactions

• Transient alopecia (temporary hair loss), benign intracranial hypertension (increased pressure within the skull, characterized among other symptoms by headache).
• As with other antibiotics, superinfections by fungi or other microorganisms resistant to nitrofurantoin such as Pseudomonas spp. may occur. These superinfections 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Furantoin

Keep this medicine out of sight and reach of children.

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

Do not use Furantoin after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Furantoin

Each tablet contains 50 mg of the active substance nitrofurantoin.

• The other components are: Povidone, sodium carboxymethyl starch (type A) derived from potato, calcium hydrogen phosphate dihydrate, talc, magnesium stearate.

Appearance of the product and contents of the pack

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

Supplied in blisters of polyvinyl chloride (PVC) sealed with a heat-sealable aluminum foil, in packs of 21, 42 tablets, and 500 tablets (hospital pack).

Marketing Authorization Holder

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturers

Laboratorios ERN, S.A.

Gorcs i Lladó, 188 – 08210 Barberà del Vallès. Barcelona. Spain.

Date of the most recent review of this leaflet: February 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/