Fosfomycin 3g Granules For Oral Solution
Package leaflet: Information for the user
Fosfomycin 3g granules for oral solution, 3g, granules for oral solution
Fosfomycine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What in in this leaflet:
1. What Fosfomycin 3g granules for oral solution is and what it is used for
2. What you need to know before before you take Fosfomycin 3g granules for oral solution
3. How to take Fosfomycin 3g granules for oral solution
4. Possible side effects
5. How to store Fosfomycin 3g granules for oral solution
6. Contents of the pack and other information
1. What Fosfomycin 3g granules for oral solution is and what it is used for
Fosfomycin 3g granules for oral solution belongs to a group of medicines known as antibiotics. It works by killing bacteria, which can cause infections.
Fosfomycin is used to treat or prevent infections of the bladder.
Fosfomycin is not suitable for the treatment of children less than 12 years of age.
2. What you need to know before you take Fosfomycin 3g granules for oral solution
Do not use Fosfomycin 3g granules for oral solution:
• if you are allergic to fosfomycin or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from severe kidney problems
• if you are on heamodialysis
• if you are a child
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Fosfomycin 3g granules for oral solution:
- if you have an intolerance to some sugars (see below)
- if you have previously experienced diarrhoea upon administration of any other antibiotics. Children and adolescents
Do not give this medicine to children less than 12 years of age, as its safety has not been established.
Other medicines and Fosfomycin 3g granules for oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially a medicine called metoclopramide (a medicine to stop you from feeling sick) as this may have an affect on Fosfomycin 3g granules for oral solution.
Fosfomycin 3g granules for oral solution with food and drink
Fosfomycin 3g granules for oral solution should be taken on an empty stomach preferably before bedtime after emptying the bladder. The contents of a sachet should be dissolved in a glass of water and taken immediately.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is preferable to avoid the use of Fosfomycin 3g granules for oral solution during pregnancy. Your doctor will decide whether you should use Fosfomycin 3g granules for oral solution.
Small amounts of this medicine may pass into the breast milk and it may affect the baby. Therefore, your doctor will decide whether you should use Fosfomycin 3g granules for oral solution while breast-feeding.
Driving and using machines
No studies on the effect on the ability to drive and use machines have been performed.
You may experience side effects such as dizziness or fatigue which may affect your ability to drive or use machines. Do not drive or use machines if your are affected.
Fosfomycin 3g granules for oral solution contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Fosfomycin 3g granules for oral solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults including the elderly
The usual dose is one sachet (3 g) of Fosfomycin 3g granules for oral solution as a single dose.
Use in Children
Fosfomycin 3g granules for oral solution should not be used in children less than 12 years of age.
Methods of administration
Fosfomycin 3g granules for oral solution should be taken orally and should be taken on an empty stomach, preferably before bedtime after emptying the bladder. The contents of the sachet should be dissolved in a glass of water and taken immediately after its preparation.
If you take more Fosfomycin 3g granules for oral solution than you should
If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital.
If you forget to take Fosfomycin 3g granules for oral solution
If you forget to take a dose, take one as soon as you remember.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Fosfomycin 3g granules for oral solution
Do not stop taking Fosfomycin 3g granules for oral solution because you feel better. It is important to take this medicine for as long as the doctor has told you to, otherwise the problem might come back.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects
Whilst taking Fosfomycin 3g granules for oral solution, if you develop any of the following symptoms you should contact your doctor immediately:
• Anaphylactic shock; a life threatening type of allergic reaction (not known: frequency cannot be estimated from the available data). The signs may include a sudden onset of rash, itching or hives on the skin and or shortness of breath, wheezing or trouble breathing
• Swelling of the face, lips, tongue or throat with breathing difficulties (angiooedema)
• Faster heart beat (tachycardia) (rare, may affect up to 1 in 1,000 people)
• Mild to severe abdominal crumps, bloody stools and /or fever may mean that you have an infection of the large intestine (pseudomembranous colitis) (not known: frequency cannot be estimated from the available data)
These are very serious side effects. You may need immediate medical attention.
Other side effects
If any of the following side effects occur, contact your doctor as soon as possible:
Common (may affect up to 1 in 10 people):
• Headache
• Dizziness
• Indigestion
• Infection of the female genital organs with symptoms like inflamation, irritation, itching (vulvovaginitis)
Uncommon (may affect up to 1 in 100 people):
• Tingling or numbness
• Diarrhoea
• Nausea
• Vomiting
• Stomachache
• Rash
• Itching
• Tiredness
Rare (may affect up to 1 in 1,000 people):
• Itching
Not known (frequency cannot be estimated from the available data):
• Allergic reactions
• Low blood pressure
• Asthma; with symptoms such as wheezing, shortness of breath, coughing
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.* By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Fosfomycin 3g granules for oral solution
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after <EXP>. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Fosfomycin 3g granules for oral solution contains
The active substance is Fosfomycin trometamol. Each sachet contains 5631 mg Fosfomycin trometamol, equivalent to 3.000 g fosfomycin.
The other ingredients are:
Orange flavour consisting of maltodextrin, dextrose monohydrate, acacia (E414), anhydrous citric acid (E330), butylhydroxyanisole (E 320); Saccharin sodium, Sucrose, Calcium hydroxide.
What Fosfomycin 3g granules for oral solution looks like and contents of the pack
White, off-white granules in a single-dose sachet.
Fosfomycin 3g granules for oral solution is available in packs of:
Paper/LDPE/Alu/LDPE sachet
1 sachet of 8 g (3g of fosfomycin)
2 sachets of 8 g (3g of fosfomycin)
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o. ul. gen. Jozefa Zaj^czka 9 01-518 Warszawa
Manufacturer
SPECIAL PRODUCT’S LINE S.p.A. Strada Paduni, 240 03012 Angani (FR) - Italia
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Fosfomycin 3g granules for oral solution CZ: Urifos 3g
EE: Fosfomycin LadeePharma 3g
HU: Fosfomycine Exeltis 3g granulatum belsoleges oldhatoz
LT: Fosfomycin LadeePharma 3g granules geriamajam tirpalui
LV: Fosfomycin LadeePharma 3g granulas iekskigi lietojama skiduma pagatavosanai
PL: Afastural
SK: Afastural 3g