100 mg hard capsules 
isavuconazole

– Save this information, you may need to read it again.

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information.

In this leaflet: 
1. What Cresemba is and what it is used for 
2. What you need to know before you use Cresemba 
3. How to use Cresemba 
4. Possible side effects 
5. How to store Cresemba 
6. Contents of the packaging and other information 

1. What Cresemba is and what it is used for

What Cresemba is

Cresemba is a fungicide that contains the active substance isavuconazole.

How Cresemba works

Isavuconazole works by killing or preventing the growth of the fungus that causes infection.

What Cresemba is used for

Cresemba is used in adults to treat the following fungal infections:

  • invasive aspergillosis, caused by a fungus in the Aspergillus group
  • mucormycosis, caused by a fungus in the Mucorales group in patients for whom treatment with amphotericin is not appropriate.

2. What you need to know before using Cresemba

Do not use Cresemba

– if you are allergic to isavuconazole or any of the other ingredients of this medicine (listed in section 6)

– if you have a heart problem called “hereditary QT syndrome”

– if you are taking any of the following medicines:

  • ketoconazole used to treat fungal infections
  • high dose ritonavir (more than 200 mg every 12 hours), is used to treat HIV
  • rifampicin, rifabutin, is used to treat tuberculosis
  • carbamazepine, used for epilepsy
  • barbiturate is like e.g. phenobarbital, used for epilepsy and sleep disorders
  • phenytoin, used for epilepsy
  • St. John’s wort, a (traditional) herbal medicine used to treat depression
  • efavirenz, etravirine, is used to treat HIV
  • nafcillin, used against bacterial infection.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Cresemba:

– if you have had an allergic reaction to other azole-type fungicides, e.g. ketoconazole, fluconazole, itraconazole, voriconazole, or posaconazole

– if you have liver disease. Your doctor should check you for possible side effect s

Be aware of the side effect s

Stop taking Cresemba and tell your doctor immediately if you notice any of the following side effects:

  • skin rash, swelling of the lips, mouth, tongue, or pharynx along with difficulty breathing. These may be signs of an allergic reaction (hypersensitivity).

Changes in liver function

Cresemba can sometimes affect liver function. Your doctor may take blood samples while you are taking this medicine.

Skin problems

Tell your doctor immediately if you develop severe blistering on your skin, mouth, eyes, or genitals.

Children and young people

Cresemba should not be used in children and adolescents under 18 years of age as there is no information on its use in this age group.

Other medicines and Cresemba

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines can affect or be affected by Cresemba if taken at the same time.

It is especially important that you do not take this medicine and tell your doctor or pharmacist if you are taking any of the following medicines:

  • ketoconazole used to treat fungal infections
  • high dose ritonavir (more than 200 mg every 12 hours), is used to treat HIV
  • rifampicin, rifabutin, is used to treat tuberculosis
  • carbamazepine, used for epilepsy
  • barbiturate is like e.g. phenobarbital, used for epilepsy and sleep disorders
  • phenytoin, used for epilepsy
  • St. John’s wort, a (traditional) herbal medicine used to treat depression
  • efavirenz, etravirine, is used to treat HIV
  • nafcillin, used against bacterial infection.

Only take this medicine on a doctor’s prescription and tell your doctor or pharmacist if you are taking any of the following medicines:

  • rufinamide or other drugs that reduce the QT interval on the ECG
  • aprepitant is used to prevent nausea and vomiting during cancer treatment
  • prednisone, used against rheumatoid arthritis
  • pioglitazone, used in diabetes.

Tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines as dose adjustment or control may need to be done to ensure that the medicine still has the desired effect:

  • ciclosporin, tacrolimus, and sirolimus used to prevent transplant rejection
  • cyclophosphamide, used against cancer
  • digoxin used to treat heart failure or irregular heartbeat
  • colchicine, used in gout attacks
  • dabigatran etexilate is used to prevent blood clots after hip or knee surgery
  • clarithromycin, used against bacterial infection s
  • saquinavir, indinavir, nevirapine, a combination of lopinavir and ritonavir, used against HIV
  • alfentanil, fentanyl, is used for severe pain
  • vincristine, vinblastine, is used against cancer
  • mycophenolate mofetil (MMF), is used in transplant patients
  • midazolam is used to treat severe sleep problems and stress
  • bupropion, used for depression
  • metformin used to treat diabetes
  • daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrone, and topotecan, are used against different types of cancer.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Do not take Cresemba if you are pregnant unless your doctor tells you to. The reason is that it is not known whether the drug can affect or harm the unborn child.

You should not breast-feed if you are taking Cresemba.

Driving and using machines

Cresemba may make you feel confused, tired, or sleepy. It can also make you faint. You should therefore be very careful when driving or using machines.

3. How to use Cresemba

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Starting dose for the first two days (48 hours)

The recommended dose is two capsules every 8 hours.

Usual dose after the first two days

This is started 12 to 24 hours after the last starting dose. The recommended dose is two capsules once daily.

You will take this dose until your doctor tells you otherwise. If your doctor considers it necessary, treatment with Cresemba may last longer than 6 months.

The capsules can be taken with or without food. Swallow the capsules whole. The capsules should not be chewed, dissolved, or opened.

If you use more Cresemba than you should  

If you take more Cresemba than you should, talk to a doctor immediately or go to the nearest hospital. Take the medicine pack with you so that the doctor knows what you have taken.

You can get more side effects such as:

  • headache, dizziness, restlessness, or drowsiness
  • tingling, decreased sensitivity to touch or sensations in the mouth
  • difficulty concentrating, hot flashes, anxiety, joint pain
  • altered sense of taste, dry mouth, diarrhea, vomiting
  • palpitations, increased heart rate, increased photosensitivity.

If you forget to use Cresemba

Take the capsules as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten dose.

If you stop using Cresemba

Do not stop taking Cresemba unless your doctor tells you to. It is important to continue taking the medicine for as long as your doctor prescribes it. This is to make sure that the fungal infection has disappeared.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Stop taking Cresemba and tell your doctor immediately if you notice any of the following side effects:

  • skin rash, swelling of the lips, mouth, tongue, or pharynx along with difficulty breathing. These may be signs of an allergic reaction (hypersensitivity).

Tell your doctor immediately if you notice any of the following side effects:

  • severe blistering of the skin, mouth, eyes, or genitals.

Other side effects ar

Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:

Common: may affect up to 1 in 10 users

  • low potassium in the blood
  • decreased appetite
  • hallucinations ( delirium )
  • headache
  • somnolence
  • inflamed veins that can cause blood clots
  • shortness of breath or sudden great difficulty in breathing
  • nausea (nausea), vomiting (vomiting), diarrhea, abdominal pain
  • altered liver function values ​​(seen with blood tests)
  • rash, itching
  • renal failure (symptoms may include swollen bones)
  • chest pain, fatigue, or drowsiness

Uncommon: may affect up to 1 in 100 people

  • decreased white blood cell count – may increase the risk of infection and fever
  • decreased platelet count – may increase the risk of bleeding or bruising
  • decreased red blood cell count – may make you feel weak or short of breath or may make your skin pale
  • severely reduced number of blood cell s – can make you feel weak, causing bruising and increase the risk of infection s
  • skin rash, swelling of the lips, mouth, tongue, or throat together with difficulty breathing (hypersensitivity)
  • low blood sugar
  • low level of magnesium in the blood
  • low levels of protein and albumin in the blood
  • insufficient intake of nutrients via the diet (malnutrition)
  • depression, difficulty sleeping
  • seizures, fainting or feeling of fainting, dizziness
  • the feeling of tingling and numbness in the skin ( paresthesia )
  • altered mental state ( encephalopathy )
  • altered sense of taste ( dysgeusia )
  • feeling unsteady or dizzy ( vertigo )
  • heart problems – may be too fast or irregular heart rate or extra heartbeat – this can be seen in an ECG
  • problems with blood circulation
  • low blood pressure
  • wheezing, very rapid breathing, bloody or blood-stained cough, nosebleeds
  • indigestion
  • constipation
  • swelling (swollen abdomen)
  • enlarged liver
  • hepatitis
  • skin problems, red or purple spots on the skin ( petechiae ), inflamed skin ( dermatitis ), hair loss
  • back hurts
  • feeling weak, very tired or drowsy, or general malaise (feeling sick).

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Cresemba

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 after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Store in the original package. Moisture sensitive.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is isavuconazole. Each capsule contains 186.3 mg of isavuconazonium sulfate, equivalent to 100 mg of isavuconazole.
  • Other ingredients are:
    • Capsule content: magnesium citrate (anhydrous), microcrystalline cellulose, talc, anhydrous colloidal silica, stearic acid.
    • Capsule shell: hypromellose, water, red iron oxide (E172) (lower part of the capsule only), titanium dioxide (E171), gellan gum, potassium acetate, disodium edetate, sodium lauryl sulfate.
    • Printing inks: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).

What the medicine looks like and the contents of the pack

Cresemba 100 mg hard capsules are capsules with a reddish-brown base marked with “100” in black ink and a white top marked with “C” in black ink.

Cresemba is available in cartons containing 14 capsules. Each carton contains 2 aluminum blisters, with 7 capsules each.

Each capsule pocket is connected to a pocket that contains desiccant to protect the capsule from moisture.

Do not puncture the blister containing the desiccant.

The desiccant should not be swallowed or used.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Basilea Pharmaceutica Deutschland GmbH

Marie-Curie-Strasse 8

79539 Lörrach

Germany

Manufacturer:

Almac Pharma Services (Ireland) Limited

Finnabair Industrial Estate

Dundalk

Co. Louth

Ireland

Contact the representative of the marketing authorization holder to find out more about this medicine:

Unimedic Pharma AB

Tel: +46 (0) 10-130 99 50

Muhammad Nadeem

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