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 taking 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

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

Fluconazole 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 fluconazole to:

• Prevent the recurrence of cryptococcal meningitis
• Prevent the recurrence of mucosal Candidiasis
• Reduce the recurrence of vaginal Candidiasis
• 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 fluconazole to:

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

Prevent the recurrence of cryptococcal meningitis

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 “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, fentanyl (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 drinks

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 maintained 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 a certain sugar intolerance, 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.

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

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

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

Adults

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.

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.

Like all medicines, this medicine may 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 reactionsalthough 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 may 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:

Furthermore, if any of the following side effects becomes 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 may cause pale skin and cause 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 defend against infections, and blood cells that help stop bleeding
• Loss of red or purple skin color that may be caused by low platelet count, other changes in blood cells
• Changes in blood chemistry (high cholesterol, fats)
• Low potassium in the blood
• Tremors
• 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.

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. In this way, you will help protect the environment.

Composition of Fluconazol Pharmathen 50 mg Hard Capsules EFG

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

• 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 fluconazole. Each capsule contains 100 mg of fluconazole.

• 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 iron oxide (E172), and gelatin.

Composition of Fluconazol Pharmathen 150 mg Hard Capsules EFG

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

• 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), sunset yellow FCF (E110), and gelatin.

Composition of Fluconazol Pharmathen 200 mg Hard Capsules EFG

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

• 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) and gelatin.

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

Only some pack sizes may be marketed.

Holder of the marketing authorisation and manufacturer responsible

Holder of the marketing authorisation

Pharmathen S.A.,

6 Dervenakion str.,

15351 Pallini, Attiki,

Greece

Manufacturer responsible

Pharmathen S.A.

6 Dervenakion str.

15344 Pallini, Attiki

Greece

or

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:

Last update of this leaflet: February 2024

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