FLUCONAZOLO 2 mg /Ml Infusion Solution

Зміст інструкції

1. Fluconazole Noridem 2 mg/mL solution for infusion
   1. What is Fluconazolo Noridem and what is it used for
   2. What you need to know before you receive Fluconazolo Noridem
   3. How Fluconazolo Noridem is administered
   4. Possible side effects
   5. How to store Fluconazolo Noridem
   6. Contents of the pack and other information

Fluconazole Noridem 2 mg/mL solution for infusion

Fluconazole

Equivalent medicine

Read this leaflet carefully before you receive this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

The name of the medicine is Fluconazole Noridem solution for infusion
Fluconazole Noridem.

Contents of this leaflet

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

1. What is Fluconazolo Noridem and what is it used for

Fluconazolo Noridem belongs to a group of medicines called “antifungals”. The active ingredient is
fluconazole.
Fluconazolo Noridem is used for the treatment of fungal infections and can also be used to prevent
Candidainfections. The most common cause of fungal infections is a yeast
called Candida.

Adults
Your doctor may prescribe this medicine for the treatment of the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain
• Coccidioidomycosis - a disease of the bronchopulmonary system
• Infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• Thrush - infection of the oral mucosa, throat and inflammation of the mouth from dentures.

Fluconazolo Noridem may also be prescribed for:

• preventing cryptococcal meningitis from recurring
• preventing thrush from recurring
• preventing Candidainfections (if your immune system is weak or not functioning properly).

Children and adolescents (from 0 to 17 years)
Your doctor may prescribe this medicine for the treatment of the following fungal infections:

• Thrush - infection of the oral mucosa, throat
• Infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• Cryptococcal meningitis - a fungal infection of the brain

Fluconazolo Noridem may also be prescribed for:

• preventing Candidainfections (if the immune system is weak or not functioning properly).
• preventing cryptococcal meningitis from recurring

2. What you need to know before you receive Fluconazolo Noridem

Do not receive Fluconazolo Noridem:

• if you are allergic to fluconazole, to other medicines you have taken for the treatment of fungal infections or to any of the other components of this medicine (listed in section 6). The symptoms may include itching, redness of the skin or difficulty in breathing
• if you are taking astemizole or terfenadine (antihistamines used to treat allergies)
• if you are taking cisapride (used to treat stomach disorders)
• if you are taking pimozide (used to treat mental disorders)
• if you are taking quinidine (used to treat heart arrhythmias)
• if you are taking erythromycin (antibiotic used to treat infections).

Warnings and precautions
Consult your doctor or nurse before taking Fluconazolo Noridem

• if you have liver or kidney problems
• if you suffer from heart disease, including heart rhythm problems
• if you have abnormal levels of potassium, calcium or magnesium in your blood
• if you develop severe skin reactions (itching, redness of the skin or difficulty in breathing)
• if you develop symptoms of “adrenal insufficiency” in which the adrenal glands do not produce an adequate amount of certain steroid hormones such as cortisol (chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
• if you have ever developed a severe skin rash or peeling of the skin, blistering and/or skin ulcers after taking fluconazole.

Severe skin reactions, including the reaction
caused by a drug with eosinophilia and systemic symptoms (DRESS), have been reported in association with fluconazole treatment. Stop using Fluconazolo Noridem and consult
your doctor immediately if you notice any of the symptoms related to these severe skin reactions described
in section 4.
Consult your doctor or pharmacist if the fungal infection does not improve as an alternative therapy may be
needed.

Other medicines and Fluconazolo Noridem
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine. Tell your doctor immediatelyif you are taking astemizole, terfenadine
(antihistamine used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat mental
disorders), quinidine (used to treat heart arrhythmias) or erythromycin (antibiotic used to treat infections), as they
cannot be taken together with Fluconazolo Noridem (see section: “Do not receive Fluconazolo Noridem”).
There are some medicines that can interact with Fluconazolo Noridem. Make sure your doctor knows
that you are taking any of the following medicines as a dose adjustment or monitoring may be necessary to
ensure that the medicines still have the desired effect:

• rifampicin or rifabutin (antibiotics for the treatment of infections)
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
• alfentanil, fentanyl (used as anesthetics)
• amitriptyline, nortriptyline (used as antidepressants)
• amphotericin B, voriconazole (antifungals)
• medicines that thin the blood to prevent blood clots (warfarin or similar medicines)
• benzodiazepines (midazolam, triazolam or similar medicines) used to help sleep or for anxiety
• carbamazepine, phenytoin (used to treat seizures)
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (used to treat hypertension - high blood pressure)
• olaparib (used to treat ovarian cancer)
• cyclosporine, everolimus, sirolimus or tacrolimus (used to prevent transplant rejection)
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used to treat cancer
• halofantrine (used to treat malaria)
• statins (atorvastatin, simvastatin, fluvastatin and similar medicines) used to reduce high cholesterol levels
• methadone (used to treat pain)
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs - NSAIDs)
• oral contraceptives
• prednisone (steroid)
• zidovudine, also known as AZT; saquinavir (used in patients with HIV)
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• theophylline (used to control asthma)
• tofacitinib (used to treat rheumatoid arthritis)
• tolvaptan, used to treat hyponatremia (low sodium levels in the blood) or to slow the decline of kidney function
• vitamin A (dietary supplement)
• ivacaftor (alone or in combination with other drugs, used to treat cystic fibrosis)
• amiodarone (used to treat irregular heartbeats, or arrhythmias)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used to treat blood cancers)
• lurasidone (used to treat schizophrenia)

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are trying to become pregnant or are breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine.
If you are planning a pregnancy, it is advisable to wait one week after a single dose of
fluconazole before starting pregnancy.
For longer cycles of treatment with fluconazole, consult your doctor regarding the need for
adequate contraception during treatment and for one week after the last dose.
You should not receive Fluconazolo Noridem if you are pregnant, suspect you are pregnant, are trying to
become pregnant or are breastfeeding, unless your doctor has told you to do so. If you become pregnant
while taking this medicine or within 1 week of the most recent dose, consult your doctor.
Fluconazolo Noridem administered during the first or second trimester of pregnancy may increase the
risk of miscarriage.
Fluconazolo Noridem administered during the first trimester may increase the risk that the baby
will be born with congenital defects affecting the heart, bones and/or muscles.
Cases of babies born with congenital defects affecting the skull, ears and thigh and elbow bones have been
reported in women treated for three months or more with high doses (400-800 mg per day) of fluconazole for
coccidioidomycosis. The link between fluconazole and these cases is unclear.
You can continue to breastfeed if you have received a single dose of 150 mg of fluconazole. You should not
breastfeed if you are receiving repeated doses of Fluconazolo Noridem.

Driving and using machines
When driving vehicles or using machines, you should keep in mind that dizziness or seizures may occasionally
occur.

Fluconazolo Noridem contains sodium (salt)
Fluconazolo Noridem contains salt (3.54 mg of sodium chloride per mL).
This medicine contains 708 mg of sodium (the main component of table salt) per 200 mL bottle. This is equivalent
to 35.4% of the recommended maximum daily intake of salt with the diet for an
adult.
Consult your doctor or pharmacist if you need 400 mg or more bottles/bags per day for a
prolonged period, especially if you have been advised to follow a low-salt diet.

3. How Fluconazolo Noridem is administered

This medicine will be given to you by a doctor or nurse as a slow injection
(infusion) into a vein. Fluconazolo Noridem is available as a solution, which will not be further diluted.
Further instructions for healthcare professionals are included in a paragraph at the end of this leaflet.
The recommended doses of this medicine to be taken depending on the infection are listed below.
If you have doubts about why you are receiving Fluconazolo Noridem, consult your doctor or pharmacist.

Adults

Adolescents from 12 to 17 years
Follow the dose prescribed by the doctor (adult or children's dosage)

Children up to 11 years
The maximum dose for children is 400 mg per day.
The dose will be based on the child's weight in kilograms.

Use in infants from 0 to 4 weeks of age
Use in infants of 3 or 4 weeks:

• The same dosage as described above but administered once every 2 days. The maximum dose is 12 mg per kg of body weight every 48 hours. Use in infants less than 2 weeks of age:
• The same dosage as described above but administered once every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.

Elderly
The same dose as intended for adults should be used unless there are kidney problems.

Patients with kidney problems
The doctor may adjust the dosage based on kidney function.

If you receive more Fluconazolo Noridem than you should
If you are concerned that you may have been given a dose of Fluconazolo Noridem higher than
necessary, inform your doctor or nurse immediately. Symptoms of a possible overdose may
include seeing, hearing, perceiving and thinking things that are not real (hallucinations and paranoid behavior).

If you forget to take Fluconazolo Noridem
Since this medicine will be administered under close medical supervision, it is unlikely that a
dose may be forgotten. However, inform your doctor or pharmacist if you think a dose has been forgotten.
If you have any doubts about the use of this medicine, consult 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 Fluconazolo Noridem and contact a doctor immediatelyif you notice any of the
following symptoms:

• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)

Some people develop allergic reactions, although severe allergic reactions are rare. If you experience
any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. If you experience any of the following symptoms, inform your doctor immediately:

• sudden shortness of breath, difficulty breathing or feeling of tightness in the chest
• swelling of the eyelids, face or lips
• itching all over the body, redness of the skin or itchy red spots
• rash
• severe skin reactions such as rash with blistering (may affect the mouth and tongue).

Fluconazolo Noridem can have effects on the liver. Signs of liver problems include:

• fatigue
• loss of appetite
• vomiting
• yellowing of the skin and the white of the eyes (jaundice)

If you experience any of these symptoms, stop taking Fluconazolo Noridem and inform your doctor
immediately.
Other side effects:
Also, if any of the following side effects becomes severe or if you notice side effects not listed in
Common side effects (which may affect up to 1 in 10 people) are:

• headache
• stomach pain, diarrhea, nausea, vomiting
• increased liver function values in blood tests
• rash

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

• reduction in red blood cells which can cause paleness or weakness or shortness of breath
• loss of appetite
• insomnia, drowsiness
• convulsions, dizziness, feeling of spinning, tingling, prickling or numbness, changes in sense of taste
• constipation, difficulty digesting, flatulence, dry mouth
• muscle pain
• liver damage and yellowing of skin and eyes (jaundice)
• swellings, blisters (urticaria), itching, increased sweating
• fatigue, general feeling of discomfort, fever

Rare side effects (which may affect up to 1 in 1,000 people) are:

• lower than normal number of white blood cells that help fight infections and blood cells that help stop bleeding
• red or purple discoloration of the skin, which may be caused by a low platelet count, other changes in blood cells
• changes in the chemical composition of the blood (high levels of cholesterol, fats)
• low levels of potassium in the blood
• tremor
• altered electrocardiogram (ECG), changes in heart rate and rhythm
• liver failure
• allergic reactions (sometimes severe), including widespread rash with blisters and skin peeling, severe skin reactions, swelling of lips or face
• hair loss.

Frequency not known (cannot be estimated from the available data):

• hypersensitivity reaction with rash, fever, swollen glands, increased type of white blood cells (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) (drug reaction with eosinophilia and systemic symptoms (DRESS))

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fluconazolo Noridem

Your doctor, nurse or pharmacist will generally store the medicine for you.
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 of the plastic container
after Exp. The expiry date refers to the last day of that month.
Do not use if the solution is cloudy, has changed colour or contains particles.
Do not store at a temperature above 25 °C. Do not freeze or refrigerate.
Keep the bag and the vial in the outer packaging to protect the medicine from light.
For single use only. Use immediately after first opening of the vial.
Chemical and physical stability during use after dilution has been demonstrated for 24 hours at 25 °C. From a
microbiological point of view, the product must be used immediately. If not used immediately, storage times under
utilisation conditions and conditions prior to use are the responsibility of the user
and should normally not exceed 24 hours at 2-8 °C, unless the dilution has been carried out
under controlled and validated aseptic conditions.
The medicine can be mixed with some other medicines that may also be administered
by infusion. If you would like more information about this, please ask your doctor, nurse or
pharmacist.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fluconazole Noridem contains

• The active substance is fluconazole. 1 mL of solution contains 2 mg of fluconazole. Each bag of 50 mL (milliliters) contains 100 mg (milligrams) of fluconazole .Each bag/vial of 100 mL (milliliters) contains 200 mg (milligrams) of fluconazole. Each vial of 200 mL (milliliters) contains 400 mg (milligrams) of fluconazole .
• The other ingredients are sodium chloride (see section 2), hydrochloric acid and water for injections.

Description of Fluconazole Noridem and contents of the pack
Fluconazole Noridem 2 mg/ml solution for infusion is a clear and colorless aqueous solution for infusion.
It is a ready-to-use plastic bag with rubber closures and aluminum caps.
It is a ready-to-use plastic vial with a rubber gasket, plastic caps and a tear-off ring or
with plastic caps and twin ports.
Pack sizes: Bags of 50 mL (100 mg of fluconazole) in packs of 10
Bags of 100 mL (200 mg of fluconazole) in packs of 10
Vials of 100 mL (200 mg of fluconazole) in packs of 10 or 20
Vials of 200 mL (400 mg of fluconazole) in packs of 10 or 20
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Noridem Enterprises Limited
Evagorou & Makariou
Mitsi Building 3, Office 115
1065 Nicosia, Cyprus

Manufacturer:
DEMO S.A. PHARMACEUTICAL INDUSTRY
21st Km National Road Athens–Lamia,
14568 Krioneri, Attiki, Greece
T: +30 210 8161802, F: +30 2108161587

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom
(Northern Ireland) with the following denominations:

The following information is only for doctors or healthcare professionals:
The infusion rate should not exceed 10 mL/minute. Fluconazole Noridem is formulated in
sodium chloride 9 mg/mL (0.9%) solution for infusion; 200 mg (100 mL vial) contains 15 mmol
each of Na and Cl. As Fluconazole Noridem is available diluted in sodium chloride solution, care should be
taken regarding the rate of fluid administration in patients requiring restriction of sodium or fluids.
Intravenous infusion of fluconazole is compatible with the administration of the following fluids:
Fluconazole Noridem can be administered using an existing line with one of the fluids listed above.
Although no specific incompatibilities have been noted, mixing other medicinal products is not recommended
before infusion.
The solution for infusion is for single use only.
From a microbiological point of view, dilutions should be used immediately. If not used
immediately, storage times and conditions prior to use are the responsibility of the user and should not normally
be longer than 24 hours at 2-8 °C, unless the dilution has been performed in controlled and validated aseptic
conditions.
Dilution should be carried out under aseptic conditions. The solution should be visually inspected
for the presence of particulate matter or changes in colour before administration. The
solution should only be used if it is clear and free from particles.
Unused medicinal product or waste material derived from such medicinal product should be disposed of in
accordance with local regulations.

DiluentResulting concentration of
fluconazole
Sodium chloride 0.9% injectable 1.0 mg/mL
20% Dextrose injectable 1.0 mg/mL
Ringer’s lactate injectable 1.0 mg/mL
Ringer’s injectable 1.0 mg/mL
Potassium chloride 0.3%-dextrose 5%
injectable
1.0 mg/mL
Sodium bicarbonate 4.2% injectable 1.0 mg/mL