Flukimex

Package leaflet: Information for the patient

FLUKIMEX 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole
Generic Medicine
Please read this leaflet carefully before taking 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 others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What FLUKIMEX is and what it is used for

FLUKIMEX belongs to a group of medicines called "antifungals". The active substance is fluconazole.
FLUKIMEX is used to treat fungal infections and may 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.

FLUKIMEX may be prescribed to you for:

• preventing recurrence of cryptococcal meningitis;
• preventing recurrence of mucosal candidiasis;
• reducing recurrences of vaginal candidiasis;
• preventing Candida infections (if your immune system is weakened or not functioning properly).

Children and adolescents (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.

FLUKIMEX may be prescribed to you for:

• preventing Candida infections (if your immune system is weakened or not functioning properly);
• preventing recurrence of cryptococcal meningitis.

2. What you need to know before taking FLUKIMEX

Do not take FLUKIMEX

• if you are allergic to fluconazole, to other medicines used to treat fungal infections, or to any of the other ingredients 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
Talk to your doctor or pharmacist before taking FLUKIMEX

• 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 (itching, skin redness or difficulty breathing);
• if you develop signs of "adrenal insufficiency", 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 you have ever developed a severe rash or skin peeling, blisters and/or mouth ulcers after taking FLUKIMEX;
• if the fungal infection does not improve, alternative antifungal therapy may be required.

Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported with FLUKIMEX treatment. Stop taking FLUKIMEX and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.

Other medicines and FLUKIMEX
Tell your doctor or pharmacist if you are 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 FLUKIMEX (see section: "Do not take FLUKIMEX").

Some medicines may interact with FLUKIMEX. Inform your doctor if you are taking any of the following medicines:

• rifampicin or rifabutin (antibiotics used to treat bacterial infections);
• alfentanil, fentanyl (anesthetics);
• amitriptyline, nortriptyline (antidepressants);
• amphotericin B, voriconazole (antifungals);
• medicines that thin the blood to prevent clotting (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, felodipine and losartan (used to treat hypertension - high blood pressure);
• olaparib (used to treat ovarian cancer);
• ciclosporin, 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);
• diabetes medicines such as chlorpropamide, glyburide, 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 "arrhythmias", irregular heartbeats);
• hydrochlorothiazide (a diuretic).

FLUKIMEX with food and drinks
You may take this medicine with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Do not take FLUKIMEX if you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, unless your doctor tells you to.

FLUKIMEX taken during the first trimester of pregnancy may increase the risk of miscarriage.

FLUKIMEX 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 FLUKIMEX up to 150 mg.

You must not breastfeed if you are taking repeated doses of FLUKIMEX.

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

FLUKIMEX contains lactose and sodium
This medicine contains a small amount of lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

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

3. How to take FLUKIMEX

Take this medicine exactly as directed by your doctor. 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 every day.
The recommended doses of this medicine to be taken depending on the infection are listed below:
Adults

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

Use in children aged 0 to 4 weeks
Use in children aged 3 to 4 weeks:
the same dose as described above, 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 dose as described above, administered once every 3 days. The maximum dose is 12 mg
per kg of body weight every 72 hours.
Elderly
The same dose as that recommended for adults should be used, unless you have renal problems.
Use in patients with renal impairment
The doctor may adjust the dose according to renal function.
If you take more FLUKIMEX than you should
Taking too many capsules at once could cause you problems. Immediately contact your doctor or go to the nearest hospital.
In case of accidental overdose, symptoms may include sensing, seeing, perceiving, and 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 FLUKIMEX
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 possible. If it is almost time for your next dose, skip the missed dose and take the next dose at the regular time.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, FLUKIMEX can cause side effects, although not everyone experiences them.
Some people may experience allergic reactions, although serious allergic reactions are rare.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
Stop taking FLUKIMEX and contact your doctor immediately if you notice any of the following symptoms:

• sudden breathlessness, difficulty breathing, or chest tightness;
• 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);
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

FLUKIMEX may affect the liver. Symptoms of liver problems include:

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

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 defend against infections, and platelets, which are necessary for blood clotting
• altered skin colouration (red or purplish), which may be caused by a reduction in platelets, other changes in blood cells
• changes in blood chemistry (high 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 skin rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face
• hair loss.

Frequency not known, but possible (frequency cannot be estimated from the available data):

• hypersensitivity reaction with skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and
  large intestine) (drug reaction or skin rash with eosinophilia and systemic symptoms (DRESS)).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse.
You can also report side effects directly via 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 FLUKIMEX

Keep this medicine out of the sight and reach of children.
Do not store above 30 °C.
Do not use this medicine after the expiry date stated on the carton after “Exp.”. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
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 FLUKIMEX contains

• The active substance is fluconazole.
• Each hard capsule contains fluconazole 100 mg, 150 mg or 200 mg.
• The other components are:

Capsule contents: monohydrate lactose, maize starch, silica, magnesium stearate and sodium lauryl sulfate (see section 2, “FLUKIMEX contains lactose and sodium”)
Capsule shell composition: gelatin, titanium dioxide (E171)
Additionally, for FLUKIMEX 150 mg and 200 mg hard capsules:
Indigo carmine (E132)
Additionally, for FLUKIMEX 200 mg hard capsules:
Black iron oxide (E172), erythrosine (E127)

Description of the appearance of FLUKIMEX and package contents
Hard capsules.
100 mg hard capsules, pack of 10 capsules
150 mg hard capsules, pack of 2 capsules
200 mg hard capsules, pack of 7 capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Theramex Ireland Limited
Kilmore House, Park Lane, Spencer Dock
D01 YE64, Dublin 1
Ireland

Manufacturer
Istituto Biochimico Italiano G. Lorenzini S.p.A: Via Fossignano, 2 04011 Aprilia (LT)