ZAMIZOL <100 mg Hard capsule

Зміст інструкції

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

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

1. What is ZAMIZOL and what it is used for

ZAMIZOL belongs to a group of medicines called “antifungals”. The active ingredient is
fluconazole.
ZAMIZOL is used for the treatment of fungal infections and can 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;
• 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 - e.g. athlete's foot, ringworm, itching in the genital area, nail infections.

ZAMIZOL 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 (e.g. heart, lungs) or in the urinary tract
• cryptococcal meningitis - a fungal infection of the brain

ZAMIZOL 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 taking ZAMIZOL

Do not take ZAMIZOL

• if you are allergic to fluconazole, to other medicines you have used for the treatment of fungal infections or to any of the other components 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 ZAMIZOL:

• if you have liver or kidney problems;
• 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 appear (itching, redness of the skin or difficulty in breathing);
• if signs of “adrenal insufficiency” appear, caused by the inability of the adrenal glands to produce an adequate amount of certain steroid hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain);
• if you have ever developed a severe rash or skin exfoliation, blisters and/or ulcers in the mouth after taking fluconazole. Severe skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) related to treatment with fluconazole have been reported. Stop taking Zamizol 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, alternative antifungal therapy may be necessary.

Other medicines and ZAMIZOL
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);
• erythromycin (antibiotic used to treat bacterial infections), as they cannot be taken with ZAMIZOL (see section: “Do not take ZAMIZOL”).

There are some medicines that can interact with ZAMIZOL. Tell your doctor if you are taking any of the following medicines, as 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);
• hydrochlorothiazide (a diuretic);
• 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 hypertension - 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);
• amiodarone (used to treat “arrhythmias”, irregular heartbeats);
• 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 in kidney function;
• vitamin A (dietary supplement);
• ivacaftor (alone or in combination with other drugs used to treat cystic fibrosis);
• ibrutinib (used to treat blood cancer);
• lurasidone (used to treat schizophrenia).

ZAMIZOL 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 a pregnancy, or if you are breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
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, consult your doctor to assess the need for adequate contraception during treatment, which should continue for one week after the last dose.
Do not take fluconazole if you are or think you might be pregnant or are trying to become pregnant, unless your doctor has told you to. If you become pregnant while taking this medicine or within 1 week of the most recent dose, contact your doctor.
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 of the newborn having birth defects affecting the heart, bones and/or muscles.
Cases of children with birth 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 after taking a single dose of ZAMIZOL 150 mg. You should not breastfeed if you are taking repeated doses of ZAMIZOL.

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

ZAMIZOL contains lactose
This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take ZAMIZOL

Take this medicine following exactly the instructions of 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 every day at the
same time.
The recommended doses of ZAMIZOL to be taken depending on the infection are listed below:

Use in adults

Use in adolescents from 12 to 17 years
Always take the dose prescribed by your doctor. It will be up to the doctor to advise either the recommended 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 from 0 to 4 weeks
Use in infants 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 infants 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.
The doctor may sometimes prescribe doses different from these. Always take the medicine as
indicated by your doctor. If you have any doubts, consult your doctor or pharmacist.

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

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

If you take more ZAMIZOL than you should
Taking too many capsules all at once may cause you problems. Immediately inform your
doctor or go to the nearest hospital.
In case of accidental overdose, symptoms may include feeling, seeing, 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 ZAMIZOL
Do not take a double dose to make up for a missed dose. 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
forgotten dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking Zamizol 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 reactionsalthough severe allergic reactions occur
rarely.
If you experience any of the following symptoms inform your doctor immediately.

• sudden shortness of breath, difficulty breathing or a 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).

ZAMIZOL may 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 ZAMIZOL and inform your doctor
immediately.
Other side effects
If any of the side effects worsen, or if you notice any effect

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

• headache;
• abdominal pain, diarrhea, nausea, vomiting;
• increases in liver function values in blood tests;
• rash.

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

• reduction in red blood cells which can cause paleness, weakness or shortness of breath;
• decreased appetite;
• insomnia, drowsiness;
• convulsions, dizziness, tingling, prickling or numbness, altered taste;
• vertigo;
• constipation, difficulty digesting, flatulence, dry mouth;
• muscle pain;
• liver damage and yellowing of the skin and eyes (jaundice);
• drug rashes, 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 to defend against infections, and platelets, which enable blood to clot;
• altered skin color (red or purple) which may be caused by a reduction in platelets, other blood cell alterations;
• 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 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 may occur (frequency cannot be estimated on the basis of
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 colon) (drug reaction or rash with eosinophilia and systemic symptoms (DRESS)).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 ZAMIZOL

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 packaging after Exp. The
expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Do not dispose of any medicine in waste water 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 ZAMIZOL contains

• The active ingredient is fluconazole.
• Each hard capsule contains 100 mg, 150 mg or 200 mg of fluconazole.
• The other ingredients are: capsule content:
• lactose
• starch
• anhydrous colloidal silica
• magnesium stearate
• sodium lauryl sulfate. capsule shell content:
• 100 mg hard capsules: gelatin, titanium dioxide (E171);
• 150 mg hard capsules: gelatin, titanium dioxide (E171), indigotine (E132);
• 200 mg hard capsules: gelatin, titanium dioxide (E171), indigotine (E132), black iron oxide (E172), erythrosine (E127)

Description of the appearance of ZAMIZOL and contents of the pack

• ZAMIZOL 100 mg hard capsules have a white body and a white cap. Pack containing 10 capsules of 100 mg
• ZAMIZOL 150 mg hard capsules have a blue body and a blue cap. Pack containing 2 capsules of 150 mg
• ZAMIZOL 200 mg hard capsules have a white body and a purple cap. Pack containing 7 capsules of 200 mg

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
FG S.r.l. - Via San Rocco, 6 – 85033 Episcopia (Potenza)

Manufacturer
Special Product’s Line S.p.A - Via Fratta Rotonda Vado Largo, 1 - 03012- Anagni (FR)