Fluconazole Ratiopharm: detailed information

Package Leaflet: Information for the User

Fluconazole ratiopharm 50 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Generic Medicine
Please 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 questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Fluconazole ratiopharm is and what it is used for.
What you need to know before taking Fluconazole ratiopharm.
How to take Fluconazole ratiopharm.
Possible side effects.
How to store Fluconazole ratiopharm.
Contents of the pack and other information.

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

Fluconazolo ratiopharm belongs to a group of medicines called "antifungals". The active substance is
fluconazole.
Fluconazolo ratiopharm is used to treat fungal infections and can also be used to prevent
Candida infections. The most common cause of fungal infections is a yeast called Candida.
Adults
Your doctor may prescribe this medicine to treat the following fungal infections:

Cryptococcal meningitis – a fungal infection of the brain
Coccidioidomycosis – a disease affecting the bronchopulmonary system
Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs) or urinary tract
Mucosal candidiasis – infection of the oral mucosa, throat infection, and denture-related stomatitis
Genital candidiasis – infection of the vagina or penis
Skin infections – e.g. athlete's foot, ringworm, genital itching, nail infections

Fluconazolo ratiopharm may be prescribed to:

prevent recurrence of cryptococcal meningitis
prevent recurrence of mucosal candidiasis
reduce recurrences of vaginal candidiasis
prevent Candida infections (if your immune system is weakened or not functioning properly)

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

Mucosal candidiasis – infection of the oral mucosa, throat infection
Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs) or urinary tract
Cryptococcal meningitis – a fungal infection of the brain

Fluconazolo ratiopharm may be prescribed to:

prevent Candida infections (if the immune system is weakened or not functioning properly)
prevent recurrence of cryptococcal meningitis

2. What you should know before taking Fluconazole ratiopharm

Do not take Fluconazole ratiopharm:
if you are allergic to fluconazole, to other medicines you have used to treat fungal infections, or to any of the excipients of this medicine (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing;
if you are taking astemizole, 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 cardiac arrhythmias);
if you are taking erythromycin (an antibiotic used to treat bacterial infections).

Warnings and precautions
Tell your doctor or pharmacist before taking Fluconazole ratiopharm
if you have liver or kidney problems;
if you suffer from heart diseases, including cardiac arrhythmia;
if you have abnormal levels of potassium, calcium, or magnesium in your blood;
if severe skin reactions occur (such as itching, skin redness, or difficulty breathing);
if you have ever developed a severe rash or skin peeling, blisters and/or mouth ulcers after taking Fluconazole ratiopharm;
if serious skin reactions have been reported, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), associated with Fluconazole ratiopharm treatment. Discontinue taking Fluconazole ratiopharm and contact your doctor immediately if you notice any of the symptoms related to serious skin reactions described in section 4.
if signs of "adrenal insufficiency" develop, where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or long-term fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain);
if the fungal infection does not improve, alternative antifungal therapy may be required.

Other medicines and Fluconazole ratiopharm
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Inform your doctor immediately if you are taking astemizole, terfenadine (antihistamines used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat mental disorders), quinidine (used to treat cardiac arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with Fluconazole ratiopharm (see section: "Do not take Fluconazole ratiopharm").

Some medicines may interact with Fluconazole ratiopharm. Inform your doctor if you are taking any of the following medicines:
rifampicin or rifabutin (antibiotics used to treat bacterial infections);
alfentanil, fentanyl (anaesthetics);
amitriptyline, nortriptyline (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 you sleep or for anxiety;
carbamazepine, phenytoin (used to treat epileptic 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 (a 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 in kidney function;
vitamin A (dietary supplement);
ivacaftor (used to treat cystic fibrosis);
amiodarone (used to treat heart problems);
hydrochlorothiazide (a diuretic);
ibrutinib (used to treat blood cancers).

Pregnancy, breastfeeding, and fertility
Inform your doctor if you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding.
Do not take Fluconazole ratiopharm if you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, unless otherwise advised by your doctor.
Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage.
Fluconazole taken at low doses during the first trimester may slightly increase the risk of the baby being born with bone and/or muscle malformations.
You may continue breastfeeding after taking a single dose of fluconazole 150 mg.
You must not breastfeed if you are taking repeated doses of fluconazole.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.

Fluconazole ratiopharm hard capsules contain lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact him/her before taking this medicine.

Fluconazole ratiopharm hard capsules contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially "sodium-free".

Fluconazole ratiopharm 200 mg hard capsules contain Azorubine (E122)
May cause allergic reactions.

3. How to take Fluconazole ratiopharm

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. It is best to take the capsules at the same time each day.
You may take this medicine with or without food.
The recommended doses of this medicine, depending on the type of infection, are listed below:
Use in adults

Condition	Dose
Treatment of cryptococcal meningitis	400 mg on the first day, then 200–400 mg once daily for 6–8 weeks or longer, if necessary. Sometimes doses are increased up to 800 mg
Prevention of recurrence of cryptococcal meningitis	200 mg once daily until you are told to stop
Treatment of coccidioidomycosis	200–400 mg once daily for 11 months up to 24 months. Sometimes doses are increased up to 800 mg
Endemic Candida fungal infections	800 mg on the first day, then 400 mg once daily
Treatment of oral mucosal infections, throat infections, and denture-related stomatitis	200–400 mg on the first day, then 100–200 mg once daily until you are told to stop
Management of mucosal candidiasis – dose depends on site of infection	50–400 mg once daily for 7–30 days until you are told to stop
Prevention of recurrence of oral mucosal infections and throat infections	100–200 mg once daily, or 200 mg three times per week, for as long as you are at risk of developing an infection
Genital candidiasis	150 mg as a single dose
Reduction of recurrences of vaginal candidiasis	150 mg every three days for a total of 3 doses (day 1, 4, and 7), followed by once weekly for 6 months, when you are at risk of developing an infection
Skin mycoses and nail infections	Depending on the site of infection: 50 mg once daily, 150 mg once weekly, or 300–400 mg once weekly for 1 to 4 weeks (athlete’s foot may require up to 6 weeks; treatment of nail infections continues until the infected nail is fully replaced)
Prevention of Candida infections (if your immune system is weakened or not functioning properly)	200–400 mg once daily when you are at risk of developing an infection

Use in adolescents from 12 to 17 years of age
Always take the dose prescribed by your doctor (either the adult dose or the pediatric dose).
Use in children up to 11 years of age
The maximum dose in children is 400 mg per day.
The dose will be based on the child's weight in kilograms.

Condition	Daily dose
Oral and throat mucosal candidiasis – dosage and duration of treatment depend on the severity and site of infection	3 mg per kg of body weight once daily (on the first day, 6 mg per kg of body weight may be administered)
Cryptococcal meningitis or systemic fungal infections	From 6 mg to 12 mg per kg of body weight once
Endemic Candida infections	daily
Prevention of recurrence of cryptococcal meningitis	6 mg per kg of body weight once daily
Prevention of Candida infection in children (if their immune system is not functioning properly)	From 3 mg to 12 mg per kg of body weight once daily

Use in children aged 0 to 4 weeks
Use in children aged 3 to 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 children under 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.

Your doctor may sometimes prescribe doses different from those listed here. Always take this medicine exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Use in elderly patients
The same dose as that recommended for adults should be used, unless you have kidney problems.
Use in patients with kidney problems
Your doctor may adjust the dosage according to your kidney function.
If you take more Fluconazolo ratiopharm than you should
Taking too many capsules at once could cause you problems. Contact your doctor immediately or go to the nearest hospital.
In case of accidental overdose, symptoms may include experiencing sensations, seeing, hearing, or thinking things that are not real (hallucinations and paranoid behaviour). Symptomatic treatment may be appropriate (with adequate supportive measures and, if necessary, gastric lavage).
If you forget to take Fluconazolo ratiopharm
Do not take a double dose to make up for the missed dose. If you forget a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Fluconazole ratiopharm and contact your doctor immediately if you notice any of the
following symptoms:

Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome; frequency cannot be determined from available data).

Some people may experience allergic reactions, although severe allergic reactions are rare.
If you experience any side effect, including those not listed in this leaflet, talk to your
doctor or pharmacist. If you experience any of the following symptoms, contact your doctor immediately.

Sudden breathlessness, difficulty breathing, or tightness in the chest
Swelling of the eyelids, face, or lips
Itching all over the body, skin redness, or itchy red patches
Skin rashes
Severe skin reactions, for example rashes causing blisters (which may affect the mouth and tongue)

Fluconazole ratiopharm may affect the liver. Symptoms of liver problems include:

Tiredness
Loss of appetite
Vomiting
Yellowing of the skin and whites of the eyes (jaundice)

If you experience any of these symptoms, stop taking Fluconazole ratiopharm and contact your doctor immediately.

Other side effects:
If any of the side effects worsen, or if you notice any side effect not listed in this patient information leaflet, inform your doctor or pharmacist.

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

Headache
Stomach discomfort, diarrhoea, nausea, vomiting
Increased liver function test values in blood tests
Skin rashes

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

Reduction in red blood cells, which may cause paleness, weakness, or breathlessness
Decreased appetite
Insomnia, drowsiness
Seizures, dizziness, vertigo, tingling, prickling, or numbness, altered taste
Constipation, indigestion, flatulence, dry mouth
Muscle pain
Liver damage and yellowing of the skin and eyes (jaundice)
Swelling, blisters (urticaria), itching, increased sweating
Fatigue, general malaise, fever

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

Lower than normal levels of white blood cells (which help fight infections) and platelets (which allow blood to clot)
Abnormal skin colouration (red or purplish), which may be caused by a reduction in platelets or other changes in blood cells
Changes in blood chemistry (elevated levels of cholesterol, fats)
Low potassium levels in the blood
Chills
Abnormal electrocardiogram (ECG), changes in heart rhythm and rate
Liver failure
Allergic reactions (sometimes severe), including rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face
Hair loss

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at 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 ratiopharm

Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Do not transfer the capsules to another container.
Do not use this medicine after the expiry date stated on the packaging after “EXP”.
The expiry date refers to the last day of the month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fluconazolo ratiopharm contains

The active substance is fluconazole 50 mg, 100 mg, 150 mg and 200 mg. The other components are: monohydrate lactose, maize starch, anhydrous colloidal silica, sodium lauryl sulfate and magnesium stearate. The capsule shell contains gelatin and the following colouring agents:
50 mg, 100 mg and 150 mg capsules: titanium dioxide (E171) and brilliant blue (E133).
200 mg capsules: titanium dioxide (E171), azorubine (E122) and brilliant blue (E133).

Description of the appearance of Fluconazolo ratiopharm and contents of the pack

Fluconazolo ratiopharm 50 mg: hard gelatin capsules with an opaque blue cap and an opaque white body.
Fluconazolo ratiopharm 100 mg: hard gelatin capsules with an opaque blue cap and an opaque white body.
Fluconazolo ratiopharm 150 mg: hard gelatin capsules with an opaque blue cap and an opaque blue body.
Fluconazolo ratiopharm 200 mg: hard gelatin capsules with an opaque purple cap and an opaque white body.
50 mg capsules are available in packs of: 1, 7, 10, 20, 28, 30, 50, 100 and 500 capsules.
100 mg capsules are available in packs of: 7, 10, 28, 30, 50 (1x50), 60 and 100 capsules.
150 mg capsules are available in packs of: 1, 2, 4 and 12 capsules.
200 mg capsules are available in packs of: 1, 4, 7, 10, 12, 20, 30, 50 and 100 capsules.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna 4 – 20123 Milano, Italy
Manufacturer
Pharmachemie B.V. – Swensweg, 5 – P.O. Box 552 - 2003 RN Haarlem (The Netherlands)
Teva Pharmaceutical Works Co. Ltd. – Pallagi út 13 – 4042 Debrecen (Hungary)