Nitrofurantoin 10 mg/ml oral suspension

Package leaflet: Information for the user

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, 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 other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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 adverse effects
5. How to store Furantoína
6. Contents of the pack and other information

1. What Furantoína is and what it is used for

The active substance in Furantoína 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, 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 section Warnings and precautions.
• 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 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 (taken continuously or frequently repeated) has been associated with serious adverse pulmonary, hepatic, and hypersensitivity reactions.

Consult your doctor or pharmacist before taking Furantoin if you:

• Have any kidney disease.
• Have been diagnosed with a neurological disorder.
• Are prone to allergic reactions.
• Have liver or lung problems.
• Are diabetic.
• Have anemia.
• Are deficient in vitamin B, especially a vitamin called folic acid.
• 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 clay-colored stools. These may be symptoms of a liver disorder.

Note that when taking Furantoin, your urine may turn dark yellow or brownish. This is a normal effect and you should not stop taking the medication because of it.

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

Children and adolescents

Do not administer to children under three months of age.

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, for example 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 the effect of Furantoin may be reduced.
• 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 the effect of both antibiotics may be reduced.

Use of Furantoin with food and drinks

It is recommended to take Furantoin during meals or with a glass of milk, and never on an empty stomach, to improve tolerance and enhance the 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 your baby is under three months of age 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.

Oral Furantoin suspension contains sorbitol

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

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

Calorific value: 2.6 kcal/g of sorbitol.

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

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.

Recommended dose: In women over 18 years of age: 5 to 10 ml of oral suspension every 6 hours for 5–7 days.

Provided you do not 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

Do not administer to children under three months of age.

The recommended dose is 0.1–0.2 ml of oral suspension per kg of body weight every 6 hours, without exceeding the adult dose, for 5–7 days.

If you take more Furantoin than you should

If you (or someone) ingest a large amount at once, or if you think a child has swallowed any amount, 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. Bring this leaflet and the container with you to the hospital or to your doctor so they know how much has been taken.

If you forget to take Furantoin

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 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 full duration prescribed by your doctor; otherwise, the infection may return.

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 Furantoína and contact your doctor immediately or go to the nearest hospital emergency department:

• 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 Furantoína, you may experience one or more of the following adverse effects:

Frequent

(may affect up to 1 in 100 people)

• Allergic skin reactions (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. Taking nitrofurantoin with food reduces these effects.

Rare

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

• Leucopenia, 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 pneumonitis, a type of lung disease characterized by fever, chills, cough, chest pain, and difficulty breathing. These symptoms resolve 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 reduced and/or absent 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, frequency not known.
• 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 (a serious eating disorder).
• Liver inflammation due to immune system activation against liver cells, frequency not known.
• Inflammation of the kidney tissue surrounding the tubules, leading to renal failure, frequency not known.

In very long-term treatments (more than 6 months) or in 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 (the liver suddenly and rapidly stops functioning).

Other adverse reactions

• Transient alopecia (temporary hair loss), benign intracranial hypertension (increased pressure within the cranial cavity, 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 they are possible adverse effects 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 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 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 the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Furantoin

Each ml contains 10 mg of the active substance nitrofurantoin.

The other components are: anhydrous citric acid, sodium carmellose, microcrystalline cellulose, aluminium chloride, disodium phosphate, lemon flavouring, methyl 4-hydroxybenzoate (E-218), 70% sorbitol (E-420) and purified water.

Appearance of the product and contents of the pack

Topaz-coloured polyethylene terephthalate (PET) bottle with white polypropylene screw cap and a plastic dosing cup, containing either 80 ml or 250 ml of oral suspension, depending on the pack size.

The clinical pack 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 Barberà del Vallès, Barcelona, Spain

Date of the most recent revision of this leaflet: May 2022

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/