Active ingredient
- fosfomycin
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL 15011/0017, PA 1972/001/001 .
Fomicyt 40 mg/ml powder for solution for infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
FOMICYT® 40 mg/ml
Powder for solution for infusion
Fosfomycin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Fomicyt is and what it is used for
2. What you need to know before you use Fomicyt
3. How to use Fomicyt
4. Possible side effects
5. How to store Fomicyt
6. Contents of the pack and other information
1. What Fomicyt is and what it is used for
Fomicyt contains the active substance fosfomycin. It belongs to a group of medicines called antibiotics. It works by killing certain types of germs (bacteria) that cause serious infectious diseases.
Your doctor has decided to treat you with Fomicyt to help your body fight an infection. It is important that you receive effective treatment for this condition.
Fomicyt is used in adults, adolescents and children to treat bacterial infections of:
2. What you need to know before you use Fomicyt
Do not use Fomicyt:
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before using Fomicyt if you suffer from one of the following disorders:
Conditions you need to look out for
Fomicyt can cause serious side effects.
These include allergic reactions, inflammation of the large intestine and a decreasing number of white blood cells.
You must look out for certain symptoms while you are taking this medicine, to reduce the risk of any problems. See “Serious side effects” in Section 4.
Other medicines and Fomicyt
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
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 you are given this medicine.
Fosfomycin may pass to the baby in the womb or through breast milk. If you are pregnant or breast-feeding your doctor will only give you this medicine when it is clearly needed.
Driving and using machines
When Fomicyt is given, there may be side effects such as confusion and weakness.
If these occur, you should not drive or operate machinery.
Important information about some of the ingredients of Fomicyt
This medicine contains 14 mmol (320 mg) sodium per 1 g fosfomycin. This is equivalent to 16 % of the recommended maximum daily dietary intake of sodium for an adult. One bottle with 2 g fosfomycin contains 28 mmol (640 mg) sodium, one bottle with 4 g fosfomycin contains 56 mmol (1280 mg) sodium and one bottle with 8 g fosfomycin contains 111 mmol (2560 mg) sodium.
This should be taken in consideration if you are on a controlled sodium diet.
While on treatment with this medicine, you should follow a low-salt diet to reduce your sodium intake.
3. How to use Fomicyt
Fomicyt is given to you into a vein (a drip) by a doctor or a nurse.
Dosage
The dose you will be given and the frequency of the dose will depend on:
In children, it also depends on
If you have problems with your kidneys or require dialysis, your doctor may need to reduce your dose of this medicine
Route and method of administration
For intravenous use.
Fomicyt is given to you into a vein (a drip) by a doctor or a nurse. The infusion will normally take 15 to 60 minutes, depending on your dose. Usually this medicine is given 2, 3 or 4 times a day.
Duration of treatment
Your doctor will decide how long your treatment should last depending on how fast your condition will improve. When treating bacterial infections it is important to complete the full course of treatment.
Even after the fever has passed and the symptoms have abated, treatment should be continued for a few days more.
Certain infections, such as infections of the bones, may require an even longer treatment period after the symptoms have subsided.
If you are given more Fomicyt than you should
It is unlikely that your doctor or nurse will give you too much medicine. Ask them immediately if you think that you have been given too much of this medicine.
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
Tell your doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
Tell your doctor or nurse as soon as possible if you notice any of the following side effects:
Other side effects can include:
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Side effects with not known frequency (frequency cannot be estimated from the available data)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
via the Yellow Card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Ireland
5. How to store Fomicyt
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Content of the pack and other information
What Fomicyt contains
The active substance is fosfomycin. Each ml of the solution for infusion contains 40 mg of fosfomycin.
The other ingredient is succinic acid.
What Fomicyt looks like and contents of the pack
This medicine is a white to cream-coloured powder for solution for infusion.
The solution for infusion is clear and colourless to slightly yellowish.
It is packed in clear glass bottles (type I) with a rubber stopper (bromobutyl rubber) and pull-off cap.
Three sizes of vials are available:
Marketing Authorisation Holder and Manufacturer
Distributor in the UK
Distributor in Ireland
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom
(Northern Ireland): Fomicyt 40 mg/ml
Powder for solution for infusion
Italy: InfectoFos
Poland: InfectoFos, 40 mg/ml, proszek do sporządzania roztworu do infuzji
Ireland: Fomicyt 40 mg/ml
Powder for solution for infusion
The Netherlands: Fomicyt 40 mg/ml
Poeder voor oplossing voor infusie
Greece: Fomicyt 40 mg/ml
Κόνις για διάλυμα προς έγχυση
Sweden, Finland,
Denmark,
Norway: Fosfomycin
Infectopharm
Croatia: Fomicyt 40 mg/ml
prašak za otopinu za infuziju
Austria: Fomicyt 40 mg/ml
Pulver zur Herstellung einer Infusionslösung
Belgium: Fomicyt 40 mg/ml
poeder voor oplossing voor infusie/
Fomicyt 40 mg/ml
Poudre pour solution pour perfusion/
Fomicyt 40 mg/ml
Pulver zur Herstellung einer Infusionslösung
Czech Republik: Fomicyt
Hungary: Fomicyt 40 mg/ml por oldatos infúzióhoz
Romania: Fomicyt 40 mg/ml
pulbere pentru soluție perfuzabilă
Slovakia: Fomicyt
This leaflet was last revised in: 01/2021.
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