Fluconazol Krka

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Document: Fluconazol Krka capsule, hard ENG PL change

Package leaflet: Information for the patient user

Fluconazol Krka 50 mg, hard capsules

Fluconazol Krka 100 mg, hard capsules

Fluconazol Krka 150 mg, hard capsules

Fluconazol Krka 200 mg, hard capsules

Fluconazole

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

What is in this leaflet:

1. What Fluconazol Krka is and what it is used for

2. What you need to know before you take Fluconazol Krka

3. How to use Fluconazol Krka

4. Possible side effects

5. How to store Fluconazol Krka

6. Contents of the pack and other information

What Fluconazol Krka is and what it is used for

Fluconazol Krka is one of a group of medicines called “antifungals”. The active substance is fluconazole.

Fluconazol Krka is used to treat infections caused by fungi and may also be used to stop you from getting a candidal infection. The most common cause of fungal infections is a yeast called Candida.

Adults

You might be given this medicine by your doctor to treat the following types of fungal infections:

Cryptococcal meningitis – a fungal infection in the brain
Coccidioidomycosis – a disease of the bronchopulmonary system
Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract
Mucosal thrush - infection affecting the lining of the mouth, throat and denture sore mouth
Genital thrush – infection of the vagina or penis
Skin infections - e.g. athlete's foot, ringworm, jock itch, nail infection

You might also be given Fluconazol Krka to:

stop cryptococcal meningitis from coming back
stop mucosal trush from coming back
reduce recurrence of vaginal trush
stop you from getting an infection caused by Candida (if your immune system is weak and not working properly)

Children and adolescents (0 to 17 years old)

You might be given this medicine by your doctor to treat the following types of fungal infections:

Mucosal thrush - infection affecting the lining of the mouth, throat
Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract
Cryptococcal meningitis – a fungal infection in the brain

You might also be given Fluconazol Krka to:

stop you from getting an infection caused by Candida (if your immune system is weak and not working properly).
stop cryptococcal meningitis from coming back

What you need to know before you take Fluconazol Krka

Do not take Fluconazol Krka if you

are allergic to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of this medicine (listed in section 6). The symptoms may include itching, reddening of the skin or difficulty in breathing
are taking astemizole, terfenadine (antihistamine medicines for allergies)
are taking cisapride (used for stomach upsets)
are taking pimozide (used for treating mental illness)
are taking quinidine (used for treating uneven heartbeats "arrhythmias")
are taking erythromycin (an antibiotic for treating infections)

Warnings and precautions

Talk to your doctor or pharmacist or before taking Fluconazol Krka if you:

have liver or kidney problems
suffer from heart disease, including heart rhythm problems
have abnormal levels of potassium, calcium or magnesium in your blood

Tell your doctor if you:

develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)
develop signs of ‘adrenal insufficiency’ where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic, or long lasting fatigue , muscle weakness, loss of appetite, weight loss, abdominal pain).

Other medicines and Fluconazol Krka

Tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for treating allergies) or cisapride (used for stomach upsets) or pimozide (used for treating mental illness) or quinidine (used for treating uneven heartbeats "arrhythmias") or erythromycin (an antibiotic for treating infections) as these should not be taken with Fluconazol Krka (see section: “Do not take Fluconazol Krka if you”).

There are some medicines that may interact with Fluconazol Krka. Make sure your doctor knows if you are taking any of the following medicines:

rifampicin or rifabutin (antibiotics for infections)
alfentanil, fentanyl (used as anaesthetic)
amitriptyline, nortriptyline (used as anti-depressant)
amphotericin B, voriconazole (anti-fungal)
medicines that thin the blood to prevent blood clots (warfarin or similar medicines)
benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety
carbamazepine, phenytoin (used for treating fits)
nifedipine, isradipine, amlodipine felodipine and losartan (for hypertension- high blood pressure)
ciclosporin, everolimus , sirolimus or tacrolimus (to prevent transplant rejection)
cyclosphosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for treating cancer
halofantrine (used for treating malaria)
statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing high cholesterol levels
methadone (used for pain)
celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs (NSAID))
oral contraceptives
prednisone (steroid)
zidovudine, also known as AZT; saquinavir (used in HIV-infected patients)
medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
theophylline (used to control asthma)
vitamin A (nutritional supplement)
ivacaftor (used for treating cystic fibrosis)
amiodarone (used for treating uneven heartbeats ‘arrhythmias’)
hydrochlorothiazide (a diuretic)

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

Fluconazol Krka with food and drink

You can take your medicine with or without a meal.

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 taking this medicine.

You should not take Fluconazol Krka while you are pregnant unless your doctor has told you to.

You can continue breast-feeding after taking a single dose of Fluconazol Krka up to 200 mg.

You should not breast-feed if you are taking a repeated dose of Fluconazol Krka.

Driving and using machines

When driving vehicles or using machines, it should be taken into account that occasionally dizziness or fits may occur.

Fluconazol Krkacontains lactose and azorubine

The capsules contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Fluconazol Krka 200 mg capsules also contain Azorubine (E122) which may cause allergic reactions.

How to take Fluconazol Krka

Always take this medicine exactly as your doctor has told you.Check with your doctor or pharmacist if you are not sure.

Swallow the capsule whole with a glass of water. It is best to take your capsules at the same time each day.

The usual doses of this medicine for different infections are below:

Adults

Condition	Dose
To treat cryptococcal meningitis	400 mg on the first day then 200 mg to 400 mg once daily for 6 to 8 weeks or longer if needed. Sometimes doses are increased up to 800 mg
To stop cryptococcal meningitis from coming back	200 mg once daily until you are told to stop
To treat coccidioidomycosis	200 mg to 400 mg once daily from 11 months for up to 24 months or longer if needed. Sometimes doses are increased up to 800 mg
To treat internal fungal infections caused by Candida	800 mg on the first day then 400 mg once daily until you are told to stop
To treat mucosal infections affecting the lining of mouth, throat and denture sore mouth	200 mg to 400 mg on the first day then 100 mg to 200 mg until you are told to stop
To treat mucosal thrush – dose depends on where the infection is located	50 mg to 400 mg once daily for 7 to 30 days until you are told to stop
To stop mucosal infections affecting the lining of mouth, throat	100 mg to 200 mg once daily, or 200 mg 3 times a week, while you are at risk of getting an infection
To treat genital thrush	150 mg as a single dose
To reduce recurrence of vaginal trush	150 mg every third day for a total of 3 doses (day 1, 4 and 7) and then once a week for 6 months while you are at risk of getting an infection
To treat fungal skin and nail infections	Depending on the site of the infection 50 mg once daily, 150 mg once weekly, 300 to 400 mg once weekly for 1 to 4 weeks (Athlete’s foot may be up to 6 weeks, for nail infection treatment until infected nail is replaced)
To stop you from getting an infection caused by Candida (if your immune system is weak and not working properly)	200 mg to 400 mg once daily while you are at risk of getting an infection

Adolescents from 12 to 17 years old

Follow the dose prescribed by your doctor (either adults or children posology).

Children to 11 years old

The maximum dose for children is 400 mg daily.

The dose will be based on the child’s weight in kilograms.

Condition	Daily dose
Mucosal thrush and throat infections caused by Candida – dose and duration depends on the severity of the infection and on where the infection is located	3 mg per kg of body weight (6 mg per kg of body weight might be given on the first day)
Cryptococcal meningitis or internal fungal infections caused by Candida	6 mg to 12 mg per kg of body weight
To stop children from getting an infection caused by Candida (if their immune system is not working properly)	3 mg to 12 mg per kg of body weight

Use in children 0 to 4 weeks of age

Use in children of 3 to 4 weeks of age:

The same dose as above but given once every 2 days. The maximum dose is 12 mg per kg of body weight every 48 hours.

Use in children less than 2 weeks old:

The same dose as above but given once every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.

Doctors sometimes prescribe different doses to these. Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Elderly

The usual adult dose should be given unless you have kidney problems.

Patients with kidney problems

Your doctor may change your dose, depending on your kidney function.

If you take more Fluconazol Krka than you should

Taking too many capsules at once may make you unwell. Contact your doctor or your nearest hospital casualty department at once. The symptoms of a possible overdose may include hearing, seeing, feeling and thinking things that are not real (hallucination and paranoid behaviour). Symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate.

If you forget to take Fluconazol Krka

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the dose that you missed.

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

4. Possible side effects

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

A few people develop allergic reactions although serious allergic reactions are rare. If you get any of the following symptoms, tell your doctor immediately.

sudden wheezing, difficulty in breathing or tightness in the chest
swelling of eyelids, face or lips
itching all over the body reddening of the skin or itchy red spots
skin rash
severe skin reactions such as a rash that causes blistering (this can affect the mouth and tongue).

Fluconazol Krka may affect your liver. The signs of liver problems include:

tiredness
loss of appetite
vomiting
yellowing of your skin or the whites of your eyes (jaundice)

If any of these happen, stop taking Fluconazol Krka and tell your doctor immediately.

Fluconazol Krkamay affect your adrenal glands and the levels of steroid hormones produced. The signs of adrenal problems include:

tiredness
muscle weakness
loss of appetite
weight loss
abdominal pain

If any of these happen, tell your doctor immediately.

Other side effects:

Additionally, if any of the following side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Common: may affect up to 1 in 10 people

headache
stomach discomfort, diarrhoea, feeling sick, vomiting
increases in blood tests of liver function
rash

Uncommon: may affect up to 1 in 100 people

reduction in red blood cells which can make skin pale and cause weakness or breathlessness
decreased appetite
inability to sleep, feeling drowsy
fit, dizziness, sensation of spinning, tingling, pricking or numbness, changes in sense of taste
constipation, difficult digestion, wind, dry mouth
muscle pain
liver damage and yellowing of the skin and eyes (jaundice)
wheals, blistering (hives), itching, increased sweating
tiredness, general feeling of being unwell, fever

Rare: may affect up to 1 in 1,000 people

lower than normal white blood cells that help defend against infections and blood cells that help to stop bleeding
red or purple discoloration of the skin which may be caused by low platelet count, other blood cell changes
blood chemistry changes (high blood levels of cholesterol, fats)
low blood potassium
shaking
abnormal electrocardiogram (ECG), change in heart rate or rhythm
liver failure
allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips or face
hair loss

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fluconazol Krka

Keep this medicine out of the sight and reach of children.

This medical product does not require any special storage conditions.

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

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 Fluconazol Krka contains

The active substance is fluconazole: 50, 100, 150 or 200 mg.
The other ingredients are lactose monohydrate, sodium laurilsulfate, magnesium stearate, colloidal anhydrous silica and maize starch.
Capsule shell of Fluconazol Krka 50 mg, 100 mg and 150 mg contains: patent blue V (E131), titanium dioxide (E171) and gelatin.
Capsule shell of Fluconazole Krka 200 mg contains: titanium dioxide (E171), azorubine (E122), indigo Carmine (E132) and gelatin.

What Fluconazol Krka looks like and contents of the pack

50 mg: blue/white capsules

100 mg: blue/white capsules

150 mg: blue/blue capsules

200 mg: purple/white capsules

Blister

50 mg: 100x1, 7, 10, 20, 28, 50 and 98 capsules

100 mg: 100x1, 7, 10, 20, 28, 50, 60 capsules

150 mg: 1, 2, 4, 6, 12 capsules

200 mg: 100x1, 7, 10, 20, 28, 30, 50 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

KRKA Sverige AB, Göta Ark 175, 118 72 Stockholm, Sweden.

Phone: +46 8 643 67 66.

Manufacturer:

KRKA d.d., Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This leaflet was last revised in 2016-08-04