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Anidulafungin 100 mg powder for concentrate for solution for infusion

Active Ingredient:
anidulafungin
Company:  
Wockhardt UK Ltd See contact details
ATC code: 
J02AX06
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 29 Mar 2023
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 29831/0705.

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Anidulafungin 100 mg powder for concentrate for solution for infusion

Package leaflet: Information for the user

Anidulafungin 100 mg Powder for concentrate for solution for infusion

(Referred to as Anidulafungin in the remainder of the leaflet)

Read all of this leaflet carefully before you start using 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.
  • 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. See section 4.

What is in this leaflet:

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

1. What Anidulafungin is and what it is used for

Anidulafungin contains the active substance Anidulafungin and is prescribed in adults to treat a type of fungal infection of the blood or other internal organs called invasive candidiasis. The infection is caused by fungal cells (yeasts) called Candida.

Anidulafungin belongs to a group of medicines called echinocandins. These medicines are used to treat serious fungal infections.

Anidulafungin prevents normal development of fungal cell walls. In the presence of Anidulafungin, fungal cells have incomplete or defective cell walls, making them fragile or unable to grow.

2. What you need to know before you use Anidulafungin
Do not use Anidulafungin
  • if you are allergic to Anidulafungin, other echinocandins (e.g. caspofungin acetate), or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using Anidulafungin. Your doctor may decide to monitor you.

  • for liver function more closely if you develop liver problems during your treatment.
  • if you are given anaesthetics during your treatment with Anidulafungin.
  • for signs of an allergic reaction such as itching, wheezing, blotchy skin
  • for signs of an infusion–related reaction which could include a rash, hives, itching, redness
  • for shortness of breath/breathing difficulties, dizziness or lightheadedness.

Children and adolescents

Anidulafungin should not be given to patients under 18 years of age.

Other medicines and Anidulafungin

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

Pregnancy and breast-feeding

The effect of Anidulafungin in pregnant women is not known. Therefore Anidulafungin is not recommended during pregnancy. Effective contraception should be used in women of childbearing age. Contact your doctor immediately if you become pregnant while taking Anidulafungin.

The effect of Anidulafungin in breast-feeding women is not known. Ask your doctor or pharmacist for advice before taking Anidulafungin while 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.

Ask your doctor or pharmacist for advice before taking any medicines.

Anidulafungin contains fructose and sodium

This medicine contains 100mg fructose (a type of sugar) in each vial. If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine. Patients with HFI cannot break down fructose in this medicine, which may cause serious side effects. You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.

This medicine also contains less than 1mmol sodium (23mg) per vial, that is to say “essentially sodium free”.

3. How to use Anidulafungin

Anidulafungin will always be prepared and given to you by a doctor or a healthcare professional (there is more information about the method of preparation at the end of the leaflet in the section for medical and healthcare professionals only).

The treatment starts with 200 mg on the first day (loading dose). This will be followed by a daily dose of 100 mg (maintenance dose).

Anidulafungin should be given to you once a day, by slow infusion (a drip) into your vein. This will take at least 1.5 hours for the maintenance dose and 3 hours for the loading dose.

Your doctor will determine the duration of your treatment and how much Anidulafungin you will receive each day and will monitor your response and condition.

In general, your treatment should continue for at least 14 days after the last day Candida was found in your blood.

If you receive more Anidulafungin than you should

If you are concerned that you may have been given too much Anidulafungin, tell your doctor or another healthcare professional immediately.

If you forgot to use Anidulafungin

As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However tell your doctor or pharmacist if you think that a dose has been forgotten.

You should not be given a double dose by the doctor to make up for the forgotten dose.

If you stop using Anidulafungin

You should not experience any effects from Anidulafungin if your doctor stops Anidulafungin treatment.

Your doctor may prescribe another medicine following your treatment with Anidulafungin to continue treating your fungal infection or prevent it from returning.

If your original symptoms come back, tell your doctor or another healthcare professional immediately. If you have any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse.

4. Possible side effects

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

Some of these side effects will be noted by your doctor while monitoring your response and condition.

Life-threatening allergic reactions that might include difficulty breathing with wheezing or worsening of an existing rash have been rarely reported during administration of Anidulafungin.

Serious side effects – tell your doctor or another healthcare professional immediately should any of the following occur:
  • Convulsion (seizure)
  • Flushing
  • Rash, pruritis (itching)
  • Hot flush
  • Hives
  • Sudden contraction of the muscles around the airways resulting in wheezing or coughing
  • Difficulty of breathing.

Other side effects

Very common side effects (may affect more than 1 in 10 people) are:

  • Low blood potassium (hypokalaemia)
  • Diarrhoea
  • Nausea.

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

  • Convulsion (seizure)
  • Headache
  • Vomiting
  • Changes in blood tests of liver function
  • Rash, pruritis (itching)
  • Changes in blood tests of kidney function
  • Abnormal flow of bile from the gallbladder into the intestine (cholestasis)
  • High blood sugar
  • High blood pressure
  • Low blood pressure
  • Sudden contraction of the muscles around the airways resulting in wheezing or coughing
  • Difficulty of breathing.

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

  • Disorder of blood clotting system
  • Flushing
  • Hot flush
  • Stomach pain
  • Hives
  • Pain at injection site.

Not known (frequency cannot be estimated from the available data) are:

  • Life-threatening allergic reactions.

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 Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Anidulafungin

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 label. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

The reconstituted solution may be stored up to 25°C for up to 24 hours. The infusion solution may be stored at 25°C (room temperature) for 48 hours or stored frozen for at least 72 hours, and should be administered at 25°C (room temperature) within 48 hours.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Anidulafungin contains
  • The active substance is Anidulafungin. Each vial of powder contains 100 mg Anidulafungin.
  • The other ingredients are: fructose, mannitol, polysorbate 80, tartaric acid, sodium hydroxide (for pH-adjustment), hydrochloric acid (for pH-adjustment).

What Anidulafungin looks like and contents of the pack

Anidulafungin is supplied as a box containing 1 vial of 100 mg powder for concentrate for solution for infusion.

The powder is white to off-white.

Marketing Authorisation Holder:
Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK

Manufacturer:
Laboratori FUNDACIO DAU
C/ De la letra C
12-14
Polígono Industrial de la Zona Franca
08040 Barcelona
Spain

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information:

Product name Reference number

Anidulafungin 100 mg powder for concentrate for solution for infusion PL 29831/0705

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in 01/2023.

108400/2

13006184-A

Wockhardt UK Ltd
Company image
Address
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
WWW
www.wockhardt.co.uk
Telephone
+44 (0)1978 661 261
Fax
+44 (0)1978 661 702
Medical Information e-mail
[email protected]