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1. Fomicyt 40 Mg/Ml Powder For Solution For Infusion
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PACKAGE LEAFLET: INFORMATION FOR THE USER

TM

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.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, or 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, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Fomicyt is and what it is used for

2.    What you need to know before you are given Fomicyt

3.    How Fomicyt is given

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 belongs to a group of medicines called antibiotics. It works by killing certain types of germs (bacteria) that cause serious infectious diseases. If left untreated, an infectious disease can spread through your body and may be fatal. It is important that you receive effective treatment for this condition.

This medicine is given as an infusion into a vein (a drip) by a doctor or a nurse.

Fomicyt is used in adults and children to treat the following infections caused by bacteria.

•    Infections of the lung

•    Infections of the bones

•    Infections of the kidney and bladder

•    Infections of the brain (meningitis)

This medicine is used when other antibiotics cannot be used or have not worked.

This medicine can be given alone or in combination with other antibiotics.

2.    What you need to know before you are given Fomicyt

In certain circumstances your doctor may decide not to give you this medicine.

Do not have Fomicyt and tell your doctor if:

•    You are allergic (hypersensitive) to fosfomycin or any of the other ingredients of this medicine (see section 6: Content of the pack and other information).

If you are not sure, talk to your doctor, pharmacist or nurse before having Fomicyt.

Warnings and precautions:

Talk to your doctor, pharmacist or nurse before taking this medicine if you suffer from one of the following disorders:

-    heart problems (cardiac insufficiency)

-    high blood pressure (hypertension)

-    a certain disorder of the hormone system (hyperaldosteronism)

-    high levels of blood sodium (hypernatraemia)

-    fluid accumulation in the lungs (pulmonary oedema)

-    kidney problems. Your doctor may need to change the dose of your

medicine (see section 3 of this leaflet).

Conditions you need to look out for

Fomicyt can cause serious side effects. These include allergic reactions and inflammation of the large intestine. You must look out for certain symptoms while you are taking this medicine, to reduce the risk of any problems. See “Conditions to look out for” in Section 4.

Other medicines and Fomicyt

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

So far, no harmful interference has been noted when this medicine is given together with other medicines.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before you are given Fomicyt if you are pregnant, planning to become pregnant, or if you are breast-feeding. 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 dizziness, confusion or problems with the vision (see also section 4 “Possible Side Effects”). If these occur, you should not drive or operate machinery.

Important information about some of the ingredients of Fomicyt

This medicine contains sodium (14 mmol (320 mg) sodium per 1 g fosfomycin). 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 Fomicyt is given

Administration

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.

Dosage

The dose you will be given, and the frequency of the dose will depend on:

•    The type and severity of infection you have

•    Your kidney function.

In children, it also depends on

•    The child's weight

•    The child's age

If you have kidney problems or if you are receiving dialysis your doctor may prescribe a lower dose of this medicine.

The general dosage guidelines for patients with normal kidney function are as follows:

Individual doses must not exceed 8 g.

If you have problems with your kidneys or require dialysis, your doctor may need to reduce your dose of this medicine.

The following information is intended for medical or healthcare professionals only:

Fomicyt 40 mg/ml powder for solution for infusion is for single use only and any unused solution should be discarded.

The powder must be reconstituted prior to use.

Preparation of the solution for infusion In order to prepare the solution for infusion:

Fomicyt 2 g should be dissolved in 50 ml of Water for Injections,

5 % Glucose Infusion or 10 % Glucose Infusion.

Fomicyt 4 g should be dissolved in 100 ml of Water for Injections,

5 % Glucose Infusion or 10 % Glucose Infusion.

Fomicyt 8 g should be dissolved in 200 ml of Water for Injections,

5 % Glucose Infusion or 10 % Glucose Infusion.

A slight degree of warming occurs when the powder is dissolved.

Displacement value

The displacement values for the reconstituted solutions are 1 ml for the 2 g pack size, 2 ml for the 4 g pack size and 4 ml for the 8 g pack size.

These volumes are equivalent to an increase of volume of 2 %. This has to be considered when preparing the final solution in case of not using the entire content of the vial.

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 product, please ask your doctor or pharmacist.

4. Possible side effects

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

Conditions to look out for

Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:

•    Signs of a serious allergic reaction (very rare, affecting less than

1 person in 10 000). These may include: breathing or swallowing problems, sudden wheezing, dizziness, swelling of eyelids, face, lips or tongue, rash or itching.

•    Severe and persistent diarrhoea (which may be associated with abdominal pain or fever). This may be a sign of a serious bowel inflammation. Do not take medicines against diarrhoea that inhibit the bowel movements (antiperistaltics)!

•    Yellowing of the skin or the whites of your eyes (jaundice). This can be an early sign of liver problems.

•    Confusion, muscle twitching or abnormal heart rhythm. This could be caused by high levels of blood sodium or low levels of blood potassium (uncommon, affecting less than 1 person in 100).

Tell your doctor or nurse as soon as possible if you notice any of the following side effects:

•    Pain, burning, redness or swelling along the vein which is used during infusion of this medicine (common, affecting less than 1 person in 10).

•    You bleed or bruise more easily and get more infections as usual. This could be because you have a low number of white blood cells or blood platelets.

Other side effects can include:

Common side effects (affecting less than 1 person in 10)

•    Retching, stomach ache

Uncommon side effects (affecting less than 1 person in 100)

•    Feeling sick, vomiting, or mild diarrhoea

•    Taste disturbances

•    Shortness of breath

•    Rash

•    Decreased appetite

•    Headache

•    Feeling of dizziness or “spinning”

•    Tiredness

•    High levels of blood liver enzymes, possibly associated with liver problems.

•    Swelling due to fluid retention (oedema)

Rare side effects (affecting less than 1 person in 1 000)

•    Pale skin, weakness or breathlessness (possibly due to a reduction in blood cells)

•    High levels of certain white blood cells (eosinophilia), usually associated with allergic diseases.

Very rare side effects (affecting less than 1 person in 10 000)

•    Fatty liver

•    Visual impairment

Side effects with unknown frequency

•    Liver problems (hepatitis)

•    Shortness of breath, wheezing or a tight feeling in the chest. These may

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Information for healthcare professionals (continued)

Method of administration

Disodium fosfomycin is intended for intravenous administration. Each infusion should last at least 15 minutes for the 2 g pack size, at least 30 minutes for the 4 g pack size and at least 60 minutes for the 8 g pack size.

As damaging effects can result from inadvertent intra-arterial administration of products not specifically recommended for intra-arterial therapy, it is essential to ensure that fosfomycin is only administered into veins.

be signs of an asthma attack.

•    Faster heart beat

•    Low number of certain white blood cells (neutropenia)

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.

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie

5.    How to store Fomicyt

•    Keep out of the reach and sight of children.

•    This medicine does not require any special storage conditions.

•    Do not use this medicine after the expiry date which is stated on the carton and label after “EXP”. The expiry date refers to the last day of that month.

•    After being mixed with solvent this medicine should be used immediately or stored in a refrigerator (at 2-8°C) protected from light for up to 24 hours.

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 reconstituted solution contains 40 mg of fosfomycin.

•    Each bottle of Fomicyt 2 g with 2.69 g of powder for reconstitution in 50 ml solvent contains 2.64 g disodium fosfomycin, corresponding to

2 g fosfomycin and 0.64 g sodium.

•    Each bottle of Fomicyt 4 g with 5.38 g of powder for reconstitution in 100 ml solvent contains 5.28 g disodium fosfomycin, corresponding to 4 g fosfomycin and 1.28 g sodium.

•    Each bottle of Fomicyt 8 g with 10.76 g of powder for reconstitution in 200 ml solvent contains 10.56 g disodium fosfomycin, corresponding to 8 g fosfomycin and 2.56 g sodium.

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 reconstituted solution is clear and colourless to slightly yellowish.

It is packed in clear glass bottles (type II) with a rubber stopper (bromobutyl rubber) and pull-off cap.

Three sizes of vials are available:

•    bottles with 2 g fosfomycin

•    bottles with 4 g fosfomycin

•    bottles with 8 g fosfomycin Each pack contains 10 bottles.

Distributor

Nordic Pharma UK Ltd Abbey House

1650 Arlington Business Park

Theale

Berkshire

RG7 4SA

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom:    Fomicyt    40 mg/ml    Powder for    solution    for infusion

Italy:    InfectoFos

Poland:    InfectoFos, 40 mg/ml, proszek do sporzqdzania 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 Kovic; Yia SiaAupa npoc £YX^UCTfl

This leaflet was last revised in: 12/2015

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Before administration, the reconstituted solution should be inspected visually. Only clear solutions should be used.

Shelf life of the reconstituted solution

Chemical and physical in-use stability of the reconstituted solution that has been produced under aseptic conditions has been demonstrated for 24 hours at 25°C if protected from light. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.