Zamizol

Patient Information Leaflet

ZAMIZOL 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole
Generic medicine
Please read all of this leaflet carefully before you take 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 taking 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 ZAMIZOL is and what it is used for

ZAMIZOL belongs to a group of medicines known as "antifungals". The active substance is
fluconazole.
ZAMIZOL 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.

ZAMIZOL may be prescribed to you 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.

ZAMIZOL may be prescribed to you to:

• prevent Candida infections (if your immune system is weakened or not functioning properly);
• prevent 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 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 or 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 ZAMIZOL:

• if you have liver or kidney problems;
• if you have heart conditions, including cardiac arrhythmia;
• if you have abnormal levels of potassium, calcium, or magnesium in your blood;
• if you develop severe skin reactions (itching, skin redness, or difficulty breathing);
• if you experience signs of “adrenal insufficiency”, caused by the inability of the adrenal glands to produce adequate amounts 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 peeling, blisters, and/or mouth ulcers after taking fluconazole. Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported with fluconazole treatment. Stop taking ZAMIZOL and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.

Contact your doctor or pharmacist if the fungal infection does not improve, as alternative antifungal therapy may be required.
Other medicines and ZAMIZOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor immediately if you are taking:

• astemizole or terfenadine (antihistamines used to treat allergies);
• cisapride (used to treat stomach disorders);
• pimozide (used to treat mental disorders);
• quinidine (used to treat cardiac arrhythmias);
• erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with ZAMIZOL (see section: “Do not take ZAMIZOL”).

There are some medicines that may interact with ZAMIZOL. Inform your doctor if you are taking any of the following medicines, as dose adjustment or monitoring may be necessary to ensure these medicines continue to have the desired effect:

• rifampicin or rifabutin (antibiotics used to treat bacterial infections);
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema);
• hydrochlorothiazide (a diuretic);
• alfentanil, fentanyl (anesthetics);
• amitriptyline, nortriptyline (antidepressants);
• amphotericin B, voriconazole (antifungals);
• blood-thinning medicines used 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 carcinoma);
• 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 lower 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 (alone or in combination with other medicines used to treat cystic fibrosis);
• ibrutinib (used to treat blood cancer);
• lurasidone (used to treat schizophrenia).

ZAMIZOL with food and drink
You may take this medicine with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are planning a pregnancy, you should wait one week after a single dose of fluconazole before trying to conceive.
For longer treatment cycles with fluconazole, consult your doctor to evaluate 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 may be pregnant, or if you are trying to become pregnant, unless specifically instructed by your doctor. If you become pregnant while taking this medicine or within one week after the most recent dose, contact your doctor.
Taking fluconazole during the first or second trimester of pregnancy may increase the risk of spontaneous abortion. Taking fluconazole during the first trimester of pregnancy may increase the risk of congenital malformations affecting the baby’s heart, bones, and/or muscles.
Cases of infants with birth defects involving 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 daily) of fluconazole for coccidioidomycosis. The relationship between fluconazole and these cases is not clear.
You may continue breastfeeding after a single 150 mg dose of ZAMIZOL. You should not breastfeed if you are taking repeated doses of ZAMIZOL.
Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.
ZAMIZOL contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take ZAMIZOL

Take this medicine exactly as directed 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.
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 of age
Always take the dose prescribed by your doctor. Your doctor will decide whether to recommend 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.

Use in children from 0 to 4 weeks of age
Use in children aged 3 to 4 weeks:
The same dosage 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 dosage described above, 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 those indicated. Always take the medicine as
directed by the doctor. 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 renal problems.
Use in patients with renal impairment
The doctor may adjust the dosage according to renal function.
If you take more ZAMIZOL 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, sights, thoughts, or perceptions of things that are not real (hallucinations and paranoid behaviour). Symptomatic treatment may be required (with appropriate supportive measures and, if necessary, gastric lavage).
If you forget to take ZAMIZOL
Do not take a double dose to make up for the missed 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 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 Zamizol and contact your doctor immediately if you notice any of the following symptoms:

• widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Some people may experience allergic reactions, although serious allergic reactions are rare.
If you experience any of the following symptoms, contact your doctor immediately:

• sudden shortness of breath, 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).

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

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

If you experience any of these symptoms, stop taking ZAMIZOL 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 leaflet, inform your doctor or pharmacist.
Common side effects (may affect up to 1 in 10 people) are:

• headache;
• abdominal pain, diarrhoea, nausea, vomiting;
• increased liver function test values in blood tests;
• skin rash.

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, 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-related skin rashes, swellings, 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 of platelets, which are necessary for blood clotting;
• skin discoloration (red or purplish), which may be caused by a reduction in platelets or other changes in blood cells;
• changes in blood chemistry (elevated cholesterol, elevated fat levels);
• low potassium levels in the blood;
• tremor;
• abnormal electrocardiogram (ECG), changes in heart rhythm and heart 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, talk to your doctor or pharmacist. 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 ZAMIZOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of medicines 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 ZAMIZOL contains

• The active substance is fluconazole.
• Each hard capsule contains 100 mg, 150 mg or 200 mg of fluconazole.
• The other components are: capsule content:
• lactose
• starch
• anhydrous colloidal silica
• magnesium stearate
• sodium lauryl sulfate.
  Capsule shell components:
• 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 package contents

• 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 Authorization Holder and Manufacturer
Marketing Authorization 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)