FLUCONAZOLO 50 mg Hard Capsules

Содержание инструкции

1. Fluconazole Tecnigen 50 mg hard capsules
2. Fluconazole Tecnigen 200 mg hard capsules
   1. What is Fluconazolo Tecnigen and what is it used for
   2. What you need to know before you take
   3. How to take Fluconazolo Tecnigen
   4. Possible side effects
   5. How to store Fluconazolo Tecnigen
   6. Package contents and other information

Fluconazole Tecnigen 50 mg hard capsules

FluconazoleTecnigen 150 mg hard capsules

Fluconazole Tecnigen 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Fluconazolo Tecnigen belongs to a group of medicines called “antifungals”. The
active ingredient is fluconazole.
Fluconazolo Tecnigen is used for the treatment of fungal infections and may 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 (oral mucosal infection, 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).

Fluconazolo Tecnigen 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, oral mucosal infection, 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. Fluconazolo Tecnigen 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

Fluconazolo Tecnigen Do not take Fluconazolo Tecnigen

• 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 Fluconazolo Tecnigen

• 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, where the adrenal glands do not 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 exfoliation, blisters and/or mouth ulcers after taking fluconazole;
• if the fungal infection does not improve, an alternative antifungal therapy may be necessary.

Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) related to treatment with fluconazole have been reported. Stop taking Fluconazolo Tecnigen and contact your doctor immediately if you notice any of the symptoms related to the serious skin reactions described in section 4.
Talk to your doctor or pharmacist if the fungal infection does not improve, an alternative antifungal therapy may be necessary.

Other medicines and Fluconazolo Tecnigen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Immediatelytell your doctor if 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 Fluconazolo Tecnigen (see section: “Do not take Fluconazolo Tecnigen”).
There are some medicines that can interact with Fluconazolo Tecnigen. 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);
• amiodarone (used to treat “arrhythmias”, irregular heartbeats);
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema);
• hydrochlorothiazide (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 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 (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 (food supplement);
• ivacaftor (alone or in combination with other medicines used to treat cystic fibrosis);
• amiodarone (used to treat “arrhythmias”, irregular heartbeats);
• hydrochlorothiazide (a diuretic);
• ibrutinib (used to treat blood cancer);
• lurasidone (used to treat schizophrenia).

Fluconazolo Tecnigen 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, 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 Fluconazolo Tecnigen if you are pregnant, suspect you may be pregnant or are planning a pregnancy, unless your doctor tells 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 may increase the risk that the baby will be born with malformations affecting the heart, bones and/or muscles.
Cases of babies 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 Fluconazolo Tecnigen 150 mg.
You should not breastfeed if you are taking repeated doses of Fluconazolo Tecnigen.

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

Fluconazolo Tecnigen contains lactose (milk sugar)
This medicine contains a minimal amount of lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Fluconazolo Tecnigen

Always take this medicine exactly as your doctor has told you.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 this medicine to be taken depending on the infection are listed here
below:

Adults

Adolescents from 12 to 17 years
Always take the dose prescribed by the doctor (or the adult dosage or that of children).

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 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.

Elderly
The same dose as provided for adults should be used unless you have kidney problems.

Patients with kidney problems
The doctor may adjust the dosage based on kidney function.

If you take more Fluconazolo Tecnigen than you should
Taking too many capsules all at once could cause you problems. Immediately warn your
doctor or go to the nearest hospital.
In case of accidental overdose, symptoms may include 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 Fluconazolo Tecnigen
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
dose you forgot.
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 everybody gets them.
Some people experience allergic reactionsalthough serious allergic reactions occur
rarely. 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
• skin rashes
• severe skin reactions, for example, rashes that cause blisters (may affect the mouth and tongue).

Fluconazolo Tecnigen may have effects on the liver. Symptoms of liver problems include:

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

If you experience any of these symptoms, stop taking Duflucan and inform your
doctor immediately.
Stop taking Fluconazolo Tecnigen and tell 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 reaction).

Other side effects:
If any of these side effects gets serious, or if you notice any side effect not listed here, tell your
doctor or pharmacist. The common side effects (may affect up to 1 in 10 people) are:

• headache;
• stomach discomfort, diarrhoea, nausea, vomiting;
• increases in liver function values in blood tests;
• skin rashes.

The 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, 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.

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

• lower than normal levels of white blood cells, which help to fight infections, and platelets, which help the blood to clot;
• altered skin colour (red or purple) which can 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 serious), 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 which 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 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, pharmacist or nurse. 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 Fluconazolo Tecnigen

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 label 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. Package contents and other information

information
Contents of Fluconazolo TecniGen

• The active ingredient is fluconazole.
• Each hard capsule contains 50 mg, 150 mg or 200 mg of fluconazole.

The other ingredients are: lactose monohydrate, microcrystalline cellulose, pregelatinized starch,
corn starch, sodium lauryl sulfate, magnesium stearate, titanium dioxide (E171), gelatin, quinoline yellow (E104) only for the 50 mg capsules and indigo carmine (E132) and erythrosine (E127) only for the
capsules of 150 mg.

Description of the appearance of Fluconazolo Tecnigen and package contents

• Fluconazolo Tecnigen 50 mg hard capsules are size nº3 hard capsules with a yellow coating and a white core containing powder from white to almost white.
• Fluconazolo Tecnigen 150 mg hard capsules are size nº1 hard capsules with a blue coating and a pink core containing powder from white to almost white.
• Fluconazolo Tecnigen 200 mg hard capsules are size nº0 hard capsules with a white coating and a core containing powder from white to almost white.

Fluconazolo Tecnigen 50 mg hard capsules are available in packs of 7 capsules.
Fluconazolo TecniGen 150 mg hard capsules are available in packs of 2 capsules.
Fluconazolo TecniGen 200 mg hard capsules are available in packs of 7 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AIC Holder:
TECNIGEN S.r.l.
viale Tunisia 50, 20124 Milano (MI), Italy

Manufacturers responsible for batch release:
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal.
Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares, Rua Outeiro da Armada, 5, 3150-194 Sebal – Portugal