FOSFOCINA 250 MG/5 ML POWDER FOR ORAL SUSPENSION

Introduction

Patient Information Leaflet

Fosfocina 250 mg/5 ml powder for oral suspension

Fosfomycin calcium

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

Contents of the leaflet:

1. What Fosfocina is and what it is used for
2. What you need to know before taking Fosfocina
3. How to take Fosfocina
4. Possible side effects
5. Storage of Fosfocina
6. Package contents and additional information

1. What Fosfocina is and what it is used for

Fosfocina contains the active ingredient fosfomycin (as fosfomycin calcium). It is an antibiotic that works by eliminating the bacteria that can cause infections.

Fosfocina is used to treat uncomplicated bladder infections in women.

2. What you need to know before taking Fosfocina

Do not take Fosfocina

If you are allergic to fosfomycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Fosfocina if you are in any of the following situations:

• you have persistent bladder infections,
• you have ever had diarrhea after taking any other antibiotic.

Symptoms to pay attention to

Fosfocina may cause serious side effects. For example, allergic reactions and inflammation of the large intestine. You should pay attention to certain symptoms while being treated with this medicine to reduce the risk of problems. See "serious side effects" in section 4.

Children and adolescents

This medicine should not be given to children under 12 years of age, as its safety and efficacy have not been established in this age group.

Other medicines and Fosfocina

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

This is especially important if you are taking:

• metoclopramideor other medicines that increase the movement of food through the stomach and intestines, as they may reduce the absorption of fosfomycin in your body,
• anticoagulants, as fosfomycin and other antibiotics may alter your ability to prevent blood clotting.

Taking Fosfocina with food and drinks

Food may delay the absorption of fosfomycin. Therefore, this medicine should be taken on an empty stomach (2-3 hours before or 2-3 hours after a meal).

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, your doctor will only prescribe this medicine when it is strictly necessary.

Driving and using machines

You may experience side effects such as dizziness that could affect your ability to drive or use machines.

Fosfocina contains fructose and sucrose

This medicine contains 2,000 mg of fructose per 5 ml. If your doctor has told you that you have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.

It also contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Fosfocina

Follow the administration instructions for this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

For the treatment of uncomplicated bladder infections in women, the recommended dose is 2 tablespoons of 5 ml (500 mg of fosfomycin) or 4 tablespoons of 5 ml (1 g of fosfomycin) every 8 hours.

The Fosfocina suspension is suitable for people with swallowing problems (difficulty swallowing food or medicine) who cannot take Fosfocina 500 mg hard capsules.

Use in patients with renal insufficiency

This medicine should not be used in patients with severe renal insufficiency (creatinine clearance <10 ml min).< p>

Use in children and adolescents

This medicine should not be used in children under 12 years of age.

Method of administration

For oral use.

This medicine should be taken orally, on an empty stomach (approximately 2-3 hours before or 2-3 hours after a meal), with the last dose preferably before bedtime and after urination.

To prepare the extemporaneous suspension, invert the bottle to loosen the powder stuck to the bottom. Add a little water and shake. Fill with water up to the line marked by the arrow on the label.

Record the preparation date in the corresponding box. Keep in mind the validity days of the suspension once reconstituted (15 days). Shake well before use.

For accurate dosing, use the measuring spoon included in the package.

If you take more Fosfocina than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Fosfocina

Do not take a double dose to make up for forgotten doses.

If you forget to take a dose, take the next one as soon as possible and continue as before.

If you interrupt treatment with Fosfocina

Remember to take your medicine. Your doctor will indicate the duration of your treatment with Fosfocina.

Do not interrupt treatment, even if you feel better, unless your doctor tells you to.

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

4. Possible side effects

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

Serious side effects

If you experience any of the following symptoms during treatment with Fosfocina, stop taking the medicine and contact your doctor immediately:

• anaphylactic shock, a potentially life-threatening allergic reaction (frequency not known). Symptoms are sudden onset of a rash, itching, or hives, and/or shortness of breath, wheezing, or difficulty breathing,
• swelling of the face, lips, tongue, or throat with difficulty breathing (angioedema) (frequency not known),
• moderate to severe diarrhea, abdominal cramps, bloody stools, and/or fever, which may indicate that you have an infection of the large intestine (antibiotic-associated colitis) (frequency not known). Do not take medicines that stop intestinal movement (antiperistaltics).

Other side effects

Frequent (may affect up to 1 in 10 people):

• headache
• dizziness
• diarrhea
• nausea
• indigestion
• abdominal pain
• infection of the female genital organs with symptoms such as inflammation, irritation, itching (vulvovaginitis).

Uncommon (may affect up to 1 in 100 people):

• vomiting
• rash
• hives
• itching

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

• anemia
• overinfections with antibiotic-resistant bacteria

Frequency not known (cannot be estimated from available data):

• allergic reactions
• visual disturbances
• loss of appetite
• inflammation of the veins
• increase in white blood cell and platelet count
• appearance of petechiae (small hemorrhages in the skin)
• alteration of liver enzymes

If you experience any of these reactions or other discomforts that you think are related to the treatment, inform your doctor as soon as possible.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosfocina

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

This medicine does not require special storage conditions. Once reconstituted, the suspension can be used for 15 days, keeping it below 25°C.

Do not use this medicine after the expiration date stated on the package, after EXP. The expiration 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 pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Fosfocina composition

• The active ingredient is fosfomycin calcium. Each 5 ml of reconstituted suspension contains 250 mg of fosfomycin in the form of calcium salt.
• The other ingredients are: sucrose palmitate (E-473), guar gum (E-412), banana flavor, colloidal silica, and fructose.

Product appearance and package contents

Fosfocina is presented as a white powder for extemporaneous oral suspension, in amber glass bottles to prepare 60 ml or 120 ml of suspension, with an aluminum cap, along with a graduated measuring spoon.

Marketing authorization holder

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain.

Manufacturer

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188 – 08210 Barberá del Vallés, Barcelona, Spain.

Date of last revision of this leaflet: February 2022.

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