Fosfomycin Tarbis 3 g granules for oral solution in sachets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fosfomicina Tarbis 3 g granules for oral solution in sachets EFG

Fosfomicin

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 may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Fosfomicina Tarbis is and what it is used for

Fosfomicina Tarbis contains the active substance fosfomicin (as fosfomycin trometamol). It is an antibiotic that works by eliminating bacteria that can cause infections.

Fosfomicina Tarbis is used to treat uncomplicated urinary bladder infections in adult and adolescent women.

Fosfomicina Tarbis is used as antibiotic prophylaxis for transrectal prostate biopsies in adult men.

2. What you need to know before taking Fosfomicina Tarbis.

Do not take Fosfomicina Tarbis

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

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine if you are in any of the following situations:

• you suffer from persistent bladder infections,
• you have ever had diarrhoea after taking any other antibiotic.

Symptoms to be aware of

Fosfomicina Tarbis may cause serious adverse effects. For example, allergic reactions and inflammation of the large intestine. You should pay attention to certain symptoms while taking this medicine in order to reduce the risk of complications. See “serious adverse reactions” in section 4.

Children and adolescents

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

Other medicines and Fosfomicina Tarbis

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

This is especially important if you are taking:

• metoclopramide or 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, since fosfomycin and other antibiotics could alter their ability to prevent blood clotting.

Taking Fosfomicina Tarbis with food

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 are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

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

Breastfeeding mothers may take a single oral dose of this medicine.

Driving and using machines

You may experience adverse effects such as dizziness, which could affect your ability to drive or operate machinery.

Fosfomicina Tarbis contains sucrose, glucose, and sodium

This medicine contains sucrose and glucose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per sachet; this means it is essentially ‘sodium-free’.

3. How to take Fosfomicina Tarbis

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

In the treatment of uncomplicated bladder infection in women and adolescent females, the recommended dose is 1 sachet of Fosfomicina Tarbis (3 g of fosfomycin).

When used as antibiotic prophylaxis for transrectal prostate biopsy, the recommended dose is 1 sachet of Fosfomicina Tarbis (3 grams of fosfomycin) 3 hours before the procedure and 1 sachet of Fosfomicina Tarbis (3 g of fosfomycin) 24 hours after the procedure.

Use in patients with renal impairment

This medicine must not be used in patients with severe renal impairment (creatinine clearance <10 ml/min).

Use in children and adolescents

This medicine must 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), preferably before going to bed and after having passed urine.

The contents of one sachet should be dissolved in a glass of water and taken immediately.

If you take more Fosfomicina Tarbis than you should

If you accidentally take more than the prescribed dose, contact your doctor or pharmacist.

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 experiences them.

Serious adverse effects

If you experience any of the following symptoms while taking Fosfomicina Tarbis, you must stop taking the medicine and contact your doctor immediately:

• Anaphylactic shock, a type of potentially life-threatening allergic reaction (frequency not known). Symptoms include sudden onset of rash, itching, or hives, and/or shortness of breath, wheezing (whistling sound when breathing), or difficulty breathing,
• Swelling of the face, lips, tongue, or throat with difficulty breathing (angioedema) (frequency not known),
• Moderate to severe diarrhoea, abdominal cramps, bloody stools and/or fever, which may indicate an infection of the large intestine (antibiotic-associated colitis) (frequency not known). Do not take anti-diarrhoeal medicines that inhibit intestinal movements (antiperistaltics).

Other adverse effects

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

• Headache
• Dizziness
• Diarrhoea
• Nausea
• Indigestion
• Abdominal pain
• Genital infection in women with symptoms such as inflammation, irritation, itching (vulvovaginitis).

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

• Vomiting
• Rash
• Urticaria
• Itching (pruritus)

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

• Allergic reactions.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosfomicina Tarbis

Keep this medicine out of sight and reach of children.

No special storage conditions are required. Store in the original packaging.

Do not use this medicine after the expiry date stated on the container 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 empty containers and unused medicines at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Fosfomicina Tarbis

-The active substance is fosfomicin (as fosfomycin trometamol). Each sachet contains 3 grams of fosfomycin (as fosfomycin trometamol).

-The other components (excipients) are: sucrose, sodium saccharin, mandarin flavour (contains glucose derived from corn maltodextrin and sodium), and orange flavour (contains glucose derived from corn maltodextrin and sodium).

Appearance of the medicinal product and contents of the pack

Granules for oral solution in sachets. White or almost white granules.

Single-dose sachets made of surlyn/aluminum/low-density polyethylene/paper, packed in cardboard boxes containing 1 or 2 sachets.

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Manufacturer

Labiana Pharmaceuticals, S.L.U.

C/ Casanova 27-31

08757 Corbera de Llobregat

(Barcelona)

Date of the most recent revision of this leaflet: January 2021

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