ZOLODER 100 mg Hard Capsule

Содержание инструкции

1. Zoloder 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. What Zoloder is and what it is used for
   2. What you need to know before you take Zoloder
   3. How to take Zoloder
   4. Possible side effects
   5. How to store Zoloder
   6. Contents of the pack and other information

Zoloder 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

fluconazole
Generic medicine

Read this leaflet carefully before taking 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 or pharmacist.
• 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 may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Zoloder is and what it is used for

Zoloder belongs to a group of medicines called "antifungals". The active ingredient is fluconazole.
Zoloder is used for the treatment of fungal infections and can be used to prevent infections from
Candida. 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 (for example heart, lungs) or in the urinary tract;
• candidiasis of the mucous membranes - infection of the oral mucosa, throat infection and inflammation of the mouth from dentures;
• genital candidiasis - infection of the vagina or penis;
• skin infections - for example athlete's foot, ringworm, itching in the genital area, nail infections.

Zoloder may be prescribed for:

• preventing the recurrence of cryptococcal meningitis;
• preventing the recurrence of candidiasis of the mucous membranes;
• reducing recurrences of vaginal candidiasis;
• 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:

• candidiasis of the mucous membranes - infection of the oral mucosa, throat infection;
• infections caused by Candidaand found in the bloodstream, in organs (for example heart, lungs) or in the urinary tract;
• cryptococcal meningitis - a fungal infection of the brain.

Zoloder may be prescribed for:

• preventing Candidainfections (if your immune system is weak or not functioning properly);
• preventing the recurrence of cryptococcal meningitis.

2. What you need to know before you take Zoloder

Do not take Zoloder

• if you are allergic to fluconazole, to other medicines that you have used for the treatment of fungal infections or to any of the other ingredients of this medicine (listed in section 6). The symptoms may be itching, redness of the skin or difficulty in 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 heart arrhythmias);
• if you are taking erythromycin (antibiotic used to treat bacterial infections).

Warnings and precautions
Talk to your doctor or pharmacist before taking Zoloder

• if you have ever developed a severe rash or skin exfoliation, blisters and/or ulcers in the mouth after using Zoloder;
• if you have problems with your liver or kidneys;
• if you suffer from heart disease, including heart arrhythmia;
• if you have abnormal levels of potassium, calcium or magnesium in your blood;
• if severe skin reactions occur (itching, redness of the skin or difficulty in breathing);
• if signs of adrenal insufficiency appear, a condition in which the adrenal glands do not produce adequate amounts of certain steroid hormones, such as cortisol (this causes chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).

Severe skin reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported related to treatment with Zoloder.
Stop taking Zoloder and contact your doctor immediately if you notice any of the symptoms related to the severe skin reactions described in section 4.
Talk to your doctor or pharmacist if the fungal infection does not improve, a different antifungal therapy may be necessary.

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

• rifampicin or rifabutin (antibiotics for the treatment of bacterial infections);
• abrocitinib (used for the treatment of atopic dermatitis, also known as atopic eczema);
• 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 seizures);
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (used to treat high blood pressure);
• olaparib (used for the treatment of 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 for the treatment of rheumatoid arthritis);
• tolvaptan, used to treat hyponatremia (low levels of sodium in the blood) or to slow the decline in kidney function;
• vitamin A (food supplement);
• ivacaftor (alone or in combination with other drugs used to treat cystic fibrosis);
• amiodarone (used to treat abnormal heartbeats - ‘arrhythmias’);
• hydrochlorothiazide (a diuretic);
• ibrutinib (used for the treatment of blood cancer);
• lurasidone (use for the treatment of schizophrenia).

Zoloder with food and drink
You can take the medicine with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Zoloder if you are pregnant, suspect you may be pregnant or are breastfeeding, unless your doctor tells you to.
If you are planning a pregnancy, you should wait one week after a single dose of fluconazole before trying to start pregnancy.
For longer cycles of therapy with fluconazole, ask your doctor to assess the need for adequate contraception during treatment, which should continue for one week after the last dose.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken during the first trimester of pregnancy may increase the risk that the baby is born with malformations of the heart, bones and/or muscles.
Cases of children with birth defects affecting the skull, ears and bones of the thigh and elbow 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 after taking a single dose of Zoloder 150 mg.
You should not breastfeed if you are taking repeated doses of Zoloder.

Driving and using machines
You should be aware that dizziness or convulsions may occur while driving or operating machinery.

Zoloder contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, that is to say it is essentially ‘sodium-free’.

3. How to take Zoloder

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Swallow the capsule whole with a glass of water. It is best to take the capsules every day at the same
time.
The recommended doses of this medicine to be taken depending on the infection are listed here
below:

Adults

Use in adolescents aged 12 to 17 years
Always take the dose prescribed by your doctor (either the adult dose or the children's dose).

Use in 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 infants aged 0 to 4 weeks
Use in infants aged 3 to 4 weeks:
The same dosage as described above but given once every 2 days. The maximum dose is 12 mg
per kg of body weight every 48 hours.
Use in infants under 2 weeks of age:
The same dosage as described above but given once every 3 days. The maximum dose is 12 mg
per kg of body weight every 72 hours.

Use in the elderly
The same dose as intended for adults should be used unless you have kidney problems.

Use in patients with kidney problems
Your doctor may adjust the dosage based on kidney function.

If you take more Zoloder than you should
Taking too many capsules all at once could cause you problems. Immediately inform your doctor or
go to the nearest hospital.
In case of accidental overdose, symptoms may include seeing, hearing, perceiving and thinking things
that are not real (hallucinations and paranoid behavior). Symptomatic treatment may be appropriate
(with adequate supportive measures and possibly gastric lavage).

If you forget to take Zoloder
Do not take a double dose to make up for missed doses. If you forget to take a dose, take it
as soon as possible. If it is time to take the next dose, do not take the dose you have
forgotten.
If you have any doubts about 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.
Stop taking ZOLODER 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).

Some people experience allergic reactions, although serious allergic reactions are rare. If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. 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;
• rashes;
• severe skin reactions, such as rashes that cause blisters (may affect the mouth and tongue).

Zoloder can have effects on the liver. Symptoms of liver problems include:

• fatigue;
• loss of appetite;
• vomiting;
• yellowing of the skin and the whites of the eyes (jaundice). If you experience any of these symptoms, stop taking Zoloder and inform your doctor immediately.

Other side effects
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects common(may affect up to 1 in 10 people):

• headache;
• stomach upset, diarrhea, nausea, vomiting;
• increases in liver function values in blood tests;
• rashes.

Side effects uncommon(may affect up to 1 in 100 people):

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

Side effects rare(may affect up to 1 in 1,000 people):

• lower than normal levels of white blood cells, which help to fight infections, and platelets, which help the blood to clot;
• altered skin color (red or purple) which may be caused by a reduction in platelets, 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;
• chills;
• altered electrocardiogram (ECG), changes in heart rate and rhythm;
• liver failure;
• allergic reactions (sometimes severe), including skin rashes with widespread blisters and peeling skin, severe skin reactions, swelling of the lips and face;
• hair loss.

Frequency not known, but may occur (frequency 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 or rash with eosinophilia and systemic symptoms (DRESS)).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 Zoloder

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the label after Exp.. The expiry
date refers to the last day of that month.
Do not store at a temperature above 30°C.
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 Zoloder contains

• The active ingredient is fluconazole. Each hard capsule contains fluconazole 100 mg, 150 mg or 200 mg.
• The other ingredients are: Capsule content: lactose monohydrate, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate. Capsule shell content:gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) (only in 100 mg capsules).

Description of the appearance of Zoloder and contents of the pack
Zoloder 100 mg hard capsules are yellow. Pack containing 10 capsules of 100 mg.
Zoloder 150 mg hard capsules are white. Pack containing 2 capsules of 150 mg.
Zoloder 200 mg hard capsules are white. Pack containing 7 capsules of 200 mg.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EFFIK ITALIA S.p.A.
Via dei Lavoratori, 54, 20092 Cinisello Balsamo, Milano

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (Imperia)