Ficha técnica de Fluconazol pharmathen 200 mg capsulas duras efg – Espanha

Como usar Fluconazol pharmathen 200 mg capsulas duras efg

Introduction

Leaflet: information for the user

Fluconazol Pharmathen 50 mg hard capsules EFG

Fluconazol Pharmathen 100 mg hard capsules EFG

Fluconazol Pharmathen 150 mg hard capsules EFG

Fluconazol Pharmathen 200 mg hard capsules EFG

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isFluconazol Pharmathenand what it is used for

2. What you need to know before you start takingFluconazol Pharmathen

3. How to takeFluconazol Pharmathen

4. Possible side effects

5. Storage ofFluconazol Pharmathen

6. Contents of the pack and additional information

1. What is Fluconazol Pharmathen and what is it used for

Fluconazol Pharmathen capsules belong to a group of medications called antifungals. The active ingredient is fluconazol.

Fluconazol is used to treat infections caused by fungi and may also be used to prevent contracting a Candida infection. The most common cause of fungal infections is a type of yeast calledCandida.

Adults

Your doctor may prescribe this medication to treat the following types of fungal infections:

Cryptococcal meningitis - a fungal infection of the brain
Coccidioidomycosis - a disease of the bronchopulmonary system
Infections caused byCandidalocated in the bloodstream, organs of the body (e.g., heart, lungs) or the urinary tract
Mucosal Candidiasis - an infection that affects the inside of the mouth, throat, and mouth sores caused by dentures
Genital Candidiasis - vaginal or penile infection
Skin infections - e.g., athlete's foot, ringworm, scabies, nail infection

Your doctor may also prescribe fluconazol for:

To prevent the recurrence of cryptococcal meningitis
To prevent the recurrence of mucosal Candidiasis
To reduce the recurrence of vaginal Candidiasis
To prevent contracting a Candida infection (if your immune system is weak and not functioning correctly)

Children and adolescents (0 to 17 years)

Your doctor may prescribe this medication to treat the following types of fungal infections:

Mucosal Candidiasis - an infection that affects the lining of the mouth, throat
Infections caused byCandidathat affect the bloodstream, organs of the body (e.g., heart, lungs) or the urinary tract
Cryptococcal meningitis - a fungal infection of the brain

Your doctor may also prescribe fluconazol for:

To prevent contracting a Candida infection (if your immune system is weak and not functioning correctly)

To prevent the recurrence of cryptococcal meningitis

2. What you need to know before starting Fluconazol Pharmathen

Do not take Fluconazol Pharmathen

If you are allergic to fluconazole or any of the other ingredients in this medicine (listed in section 6) or to other medicines you have taken to treat fungal infections. Symptoms may include itching, skin redness, or difficulty breathing.
If you are taking astemizole, terfenadine (antihistamines for allergies)
If you are taking cisapride (for stomach discomfort)
If you are taking pimozide (for mental health treatment)
If you are taking quinidine (to treat heart arrhythmias)
If you are taking erythromycin (an antibiotic to treat infections)

Warnings and precautions

Consult your doctor or pharmacist before taking fluconazole if:

You have liver or kidney problems
You have heart problems, including irregular heart rhythms
You have abnormal levels of potassium, calcium, and magnesium in your blood
You develop severe skin reactions (itching, skin redness, or difficulty breathing)
You have symptoms of “adrenal insufficiency” where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
You have ever had a severe skin rash or skin peeling, blisters, and/or mouth sores after taking fluconazole.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with fluconazole treatment. Stop taking fluconazole and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Consult your doctor or pharmacist if the fungal infection does not improve, as an alternative antifungal treatment may be necessary.

Other medicines and Fluconazol Pharmathen

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, as it may be necessary to adjust the dose or monitor to ensure the medicine still has the desired effect.

Inform your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for allergies) or cisapride (used to treat stomach discomfort) or pimozide (used to treat mental health) or quinidine (used to treat heart arrhythmias) or erythromycin (an antibiotic to treat infections) as these medicines should not be taken with fluconazole (see section “Do not take Fluconazol Pharmathen”).

Some medicines may interact with fluconazole. Make sure your doctor knows that you are taking any of the following medicines:

Rifampicin or rifabutin (antibiotics for infections)
Alfentanil, fentanil (used as anesthetics)
Amitriptyline, nortriptyline (used as antidepressants)
Ampicillin B, voriconazole (antifungal)
Medicines that thin the blood to prevent blood clots (warfarin and 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 (for high blood pressure)
Olaparib (used to treat ovarian cancer)
Ciclosporin, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection)
Cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medicines) used to treat cancer
Halofantrine (used to treat malaria)
Statins (atorvastatin, simvastatin, and fluvastatin, or similar medicines) used to reduce high cholesterol levels
Methadone (used for pain)
Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (nonsteroidal anti-inflammatory drugs (NSAIDs))
Oral contraceptives
Prednisone (steroid)
Zidovudine, also known as AZT; saquinavir (used in patients infected with HIV)
Medicines for diabetes such as chlorpromazine, glibenclamide, glipizide, or tolbutamide
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
Theophylline (used to control asthma)
Vitamin A (nutritional supplement)
Ivacaftor (alone or in combination with other medicines, used to treat cystic fibrosis)
Amiodarone (used to treat irregular heartbeats “arrhythmias”)
Hydrochlorothiazide (a diuretic).
Ibrutinib (used to treat blood cancer)
Lurasidone (used to treat schizophrenia)

Taking Fluconazol Pharmathen with food and drink

You can take this medicine with or without food.

Pregnancy, breastfeeding, and fertility

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

If you are planning to become pregnant, it is recommended that you wait one week after a single dose of fluconazole before becoming pregnant. For longer courses of fluconazole treatment, consult your doctor about the need to use suitable contraceptive methods during treatment, which should be continued for one week after the last dose.

Do not take fluconazole if you are pregnant unless your doctor has told you to. If you become pregnant while taking this medicine or within one week of the most recent dose, consult your doctor.

You can continue breastfeeding after taking a single dose of 150 mg of fluconazole.

Do not take fluconazole if you are pregnant, think you may be pregnant, or plan to become pregnant or breastfeed unless your doctor has told you to.

Fluconazole taken during the first or second trimester of pregnancy may increase the risk of spontaneous abortion. Fluconazole taken in low doses during the first trimester may slightly increase the risk of a baby being born with congenital abnormalities affecting the heart, bones, and/or muscles.

Cases of babies born with congenital abnormalities affecting the skull, ears, and leg and arm 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 unclear.

Driving and operating machinery

When driving or operating machinery, be aware that in rare cases, it may cause dizziness or seizures.

Fluconazol Pharmathen 50 mg, 100 mg, 150 mg, and 200 mg contain lactose (a blood sugar) and sodium (salt)

Each capsule of Fluconazol Pharmathen 50 mg contains 16.6 mg of lactose monohydrate. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

Fluconazol Pharmathen 150 mg contains yellow-orange S (E-110)

Yellow-orange S (E-110) may cause allergic reactions.

3. How to take Fluconazol Pharmathen

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Swallow the capsule whole with a glass of water. It is best to take your capsules at the same time every day.

The recommended doses of this medication for different infections are listed below:

Adults

Condition	Dose
To treat cryptococcal meningitis	400 mg on the first day, and then 200 mg to 400 mg once a day for 6 to 8 weeks or more as needed. In some cases, the dose is increased to 800 mg
Prevention of cryptococcal meningitis	200 mg once a day until further notice
To treat coccidioidomycosis	200 mg to 400 mg once a day for 11 to 24 months or more as needed. In some cases, the dose is increased to 800 mg
To treat internal fungal infections caused byCandida	800 mg on the first day, and then 400 mg once a day until further notice
To treat mucosal infections that affect the inside of the mouth, throat, and mouth sores caused by dentures	200 mg to 400 mg on the first day, and then 100 mg to 200 mg once a day until further notice
To treat mucosal candidiasis – the dose depends on the location of the infection	50 mg to 400 mg once a day for 7 to 30 days until further notice
To prevent the recurrence of mucosal infections that affect the lining of the mouth and throat	100 mg to 200 mg once a day, or 200 mg three times a week, as long as there is a risk of developing an infection
To treat genital candidiasis	150 mg as a single dose
To reduce the recurrence of vaginal candidiasis	150 mg every 3 days, for a total of 3 doses (day 1, 4, and 7) and then once a week for 6 months as long as there is a risk of developing an infection
To treat fungal infections of the skin and nails	Depending on where the infection develops, 50 mg once a day, 150 mg once a week, 300 to 400 mg once a week for 1 to 4 weeks (for athlete's foot, treatment may last up to 6 weeks, for nail infections, until the infected nail is replaced)
To prevent the risk of developing an infection caused byCandida(if your immune system is weakened and does not function properly)	200 mg to 400 mg once a day as long as there is a risk of developing an infection

Adolescents aged 12 to 17 years

Take the dose indicated by your doctor (pediatric or adult dose).

Children up to 11 years of age

The maximum dose for children is 400 mg per day.

The dose should be based on the child's weight in kilograms.

Condition	Dose
Mucosal candidiasis and oral infections caused byCandida– the dose and duration of treatment depend on the severity of the infection and its location	3 mg per kg of body weight once a day (on the first day, 6 mg per kg of body weight may be administered)
Cryptococcal meningitis or internal fungal infections caused byCandida	6 mg to 12 mg per kg of body weight once a day
To prevent the recurrence of cryptococcal meningitis	6 mg per kg of body weight once a day
To preventCandidainfections in children (if your immune system does not function properly)	3 mg to 12 mg per kg of body weight once a day

Use in children 0 to 4 weeks of age

Use in children 3 to 4 weeks of age: The same dose indicated above but once every 2 days. The maximum dose is 12 mg per kg of body weight every 48 hours.

Use in children under 2 weeks: The same dose indicated above but once every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.

Older adults

The usual adult dose will be administered unless you have kidney problems.

Patients with kidney problems

Your doctor may adjust the dose based on your renal function.

If you take more Fluconazol Pharmathen than you should

Taking too many capsules at once may make you feel unwell. Contact your doctor or the nearest hospital emergency department immediately. Symptoms of a possible overdose may include hearing, seeing, feeling, and thinking things that are not real (hallucinations and paranoid behavior). Symptomatic treatment (with supportive measures and gastric lavage if necessary) may be sufficient.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Fluconazol Pharmathen

Do not take a double dose to make up for the missed doses. If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose, do not take the missed dose.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Stop taking Fluconazol Pharmathen and seek medical attention immediately if you notice any of the following symptoms:

Generalized rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

A few people developallergic reactions, although severe allergic reactions are rare. If any side effect appears, speak with your doctor or pharmacist. This includes any possible side effect not mentioned in this leaflet. If you experience any of the following symptoms,inform your doctor immediately:

Sudden wheezing, difficulty breathing, or chest tightness
Swelling of the eyelids, face, or lips
Itching all over the body, skin redness, or red patches that itch
Skin eruptions
Severe skin reactions, such as a skin rash that causes blisters (this can affect the mouth and tongue).

Fluconazol may affect your liver. Signs of liver problems include:

Fatigue
Loss of appetite
Vomiting
Yellowing of the skin or white of the eyes (jaundice)

If any of this occurs, stop taking fluconazol andconsult your doctor immediately.

Other side effects:

Additionally, if any of the following side effects become severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Frequent: may affect up to 1 in 10 people

Headache
Stomach upset, diarrhea, discomfort, vomiting
Increased blood tests for liver function
Rash

Occasional: may affect up to 1 in 100 people

Reduction of red blood cells that can cause pale skin and weakness or difficulty breathing
Loss of appetite
Inability to sleep, drowsiness
Seizures, dizziness, sensation of spinning, tingling, pins and needles, changes in taste
Constipation, difficult digestion, gas, dry mouth
Muscle pain
Liver damage and yellowing of the skin and eyes (jaundice)
Hives, blisters (urticaria), itching, increased sweating
Fatigue, general feeling of discomfort, fever

Rare: may affect up to 1 in 1,000 people

Low levels of white blood cells, which help fight infections, and blood cells that help stop bleeding
Loss of red or purple skin color that can be caused by low platelet count, other blood cell changes
Changes in blood chemistry (high cholesterol, fats)
Low potassium in the blood
Trembling
Abnormal electrocardiogram (ECG), change in heart rate or rhythm - liver insufficiency
Allergic reactions (sometimes severe), including generalized skin rash with blisters and skin peeling, severe skin reactions, inflammation of the lips or face
Hair loss

Unknown: cannot be estimated from available data

Drug hypersensitivity reaction with skin rash, fever, swollen glands, increased eosinophils, 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 experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Fluconazol Pharmathen

Keep out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and the blister pack after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of in the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Fluconazol Pharmathen 50 mg hard capsules EFG

• The active ingredient is fluconazol. Each capsule contains 50 mg of fluconazol.

• The other excipients are lactose monohydrate, microcrystalline cellulose (E460), maize starch, colloidal silicon dioxide (E551), magnesium stearate (E470b) and sodium lauryl sulfate. The hard capsule shells contain titanium dioxide (E171), yellow quinoline (E104), yellow iron oxide (E172), patent blue V (E131) and gelatin.

Composition of Fluconazol Pharmathen 100 mg hard capsules EFG

• The active ingredient is fluconazol. Each capsule contains 100 mg of fluconazol.

Composition of Fluconazol Pharmathen 150 mg hard capsules EFG

• The active ingredient is fluconazol. Each capsule contains 150 mg of fluconazol.

Composition of Fluconazol Pharmathen 200 mg hard capsules EFG

• The active ingredient is fluconazol. Each capsule contains 200 mg of fluconazol.

Appearance of the product and contents of the pack

Aluminium/PVC transparent blister packs

Contents of the pack

Fluconazol Pharmathen 50 mg: 7, 10, 14, 20, 28, 30, 50 and 100 hard capsules

Fluconazol Pharmathen 100 mg: 7, 10, 14, 20, 28, 50 and 100 hard capsules

Fluconazol Pharmathen 150 mg: 1, 2 and 4 hard capsules

Fluconazol Pharmathen 200 mg: 7, 10, 14, 20, 28, 50 and 100 hard capsules

The product may only be marketed in some pack sizes.

Marketing authorisation holder and manufacturer responsible

Marketing authorisation holder

Pharmathen S.A.,

6 Dervenakion str.,

15351 Pallini, Attiki,

Greece

Manufacturer responsible

Pharmathen S.A.

6 Dervenakion str.

15344 Pallini, Attiki

Greece

Apotex Nederland B.V.

Archimedesweg 2

2333 CN Leiden

Netherlands

This medicinal product is authorised in the Member States of the European Economic Area with the following names:

Member State

Medicinal product name

Belgium

Fluconazol Aurobindo 50 mg

Fluconazol Aurobindo 100 mg

Fluconazol Aurobindo 150 mg

Fluconazol Aurobindo 200 mg

Spain

Fluconazol Pharmathen 50 mg hard capsules EFG

Fluconazol Pharmathen 100 mg hard capsules EFG

Fluconazol Pharmathen 150 mg hard capsules EFG

Fluconazol Pharmathen 200 mg hard capsules EFG

Last revision date of this leaflet: February 2024

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

Quanto custa o Fluconazol pharmathen 200 mg capsulas duras efg em Espanha em 2025?

O preço médio do Fluconazol pharmathen 200 mg capsulas duras efg em julho de 2025 é de cerca de 30 EUR. Os valores podem variar consoante a região, a farmácia e a necessidade de receita. Confirme sempre com uma farmácia local ou fonte online para obter informações atualizadas.