FLUCONAZOLE PHARMATHEN 50 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Fluconazole Pharmathen 50 mg hard capsules EFG

Fluconazole Pharmathen 100 mg hard capsules EFG

Fluconazole Pharmathen 150 mg hard capsules EFG

Fluconazole Pharmathen 200 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Fluconazole Pharmathen capsules belong to a group of medicines called antifungals. The active substance is fluconazole.

Fluconazole is used to treat infections caused by fungi and can also be used to prevent you from getting a Candida infection. The most common cause of fungal infections is a yeast called Candida.

Adults

Your doctor may prescribe this medicine for you to treat the following types of fungal infections:

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

It may also be prescribed for you to:

• prevent the recurrence of cryptococcal meningitis
• prevent the recurrence of mucosal candidiasis
• reduce the recurrence of vaginal candidiasis
• prevent you from getting a Candidainfection (if your immune system is weak and not working properly)

Children and adolescents (0 to 17 years)

Your doctor may prescribe this medicine for you to treat the following types of fungal infections:

• Mucosal candidiasis - infection that affects the lining of the mouth and throat
• Infections caused by Candidathat affect the bloodstream, body organs (e.g. heart, lungs) or urinary tract
• Cryptococcal meningitis - a fungal infection in the brain

It may also be prescribed for you to:

• prevent you from getting a Candidainfection (if your immune system is weak and not working properly)

Prevent the recurrence of cryptococcal meningitis

2. What you need to know before you take Fluconazole Pharmathen

Do not take Fluconazole Pharmathen

• If you are allergic to fluconazole or any of the other ingredients of this medicine (listed in section 6) or to other medicines you have taken to treat fungal infections. The symptoms can include itching, redness of the skin or difficulty breathing.
• If you are taking astemizole, terfenadine (antihistamine medicines for allergies)
• If you are taking cisapride (for stomach upset)
• If you are taking pimozide (for the treatment of a mental illness)
• If you are taking quinidine (to treat heart arrhythmias)
• If you are taking erythromycin (an antibiotic to treat infections).

Warnings and precautions

Talk to 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 the blood
• You develop severe skin reactions (itching, redness of the skin 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 or weakness, muscle weakness, loss of appetite, weight loss, abdominal pain)
• You have ever had a severe skin rash or skin peeling and/or blisters and/or sores in the mouth after taking fluconazole.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to 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.

Talk to your doctor or pharmacist if the fungal infection does not improve, it may be necessary to use an alternative antifungal treatment.

Other medicines and Fluconazole Pharmathen

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, as a dose adjustment or monitoring may be necessary to check that the medicines are still working as they should.

Tell your doctor immediatelyif you are taking astemizole, terfenadine (an antihistamine for allergies) or cisapride (used to treat stomach upset) or pimozide (used to treat a mental illness) 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 Fluconazole 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)
• Amphotericin 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 lower high cholesterol levels
• Methadone (used for pain)
• Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory medicines (NSAIDs))
• Oral contraceptives
• Prednisone (steroid)
• Zidovudine, also known as AZT; saquinavir (used in patients infected with HIV)
• Medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• Tofacitinib (used to treat rheumatoid arthritis)
• Tolvaptan used to treat hyponatremia (low sodium levels in the blood) or to slow down kidney function deterioration
• 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 Fluconazole 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 are planning to have a baby, ask your doctor or pharmacist for advice 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 treatment cycles with fluconazole, consult your doctor about the need to use adequate 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 last 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 are planning 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 miscarriage. Fluconazole taken in low doses during the first trimester may slightly increase the risk of a baby being born with congenital anomalies affecting the heart, bones and/or muscles.

There have been reports of babies born with congenital anomalies affecting the skull, ears and bones of the thigh and elbow 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 using machines

When driving or using machines, you should bear in mind that you may occasionally experience dizziness or convulsions.

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

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

This medicine contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".

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

Orange yellow S (E-110) may cause allergic reactions.

3. How to take Fluconazole Pharmathen

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

The recommended doses of this medicine for the different infections are given below:

Adults

Adolescents from 12 to 17 years of age

Take the dose prescribed by your doctor (child 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 from 0 to 4 weeks of age

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

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

Elderly

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

Patients with kidney problems

Your doctor may adjust the dose depending on your kidney function.

If you take more Fluconazole Pharmathen than you should

Taking too many capsules at once can make you feel unwell. Contact your doctor or the nearest hospital emergency department immediately. The 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, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Fluconazole Pharmathen

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, take it as soon as you remember. If it is almost time for your 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 adverse effects, although not all people suffer from them. Stop taking Fluconazol Pharmathen and seek medical attention immediately if you notice any of the following symptoms:

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

A few people develop allergic reactions, although severe allergic reactions are rare. If any adverse effect appears, talk to your doctor or pharmacist. This includes any possible adverse effect not mentioned in this prospectus. 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 spots that itch
• Skin rashes
• 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 the whites of the eyes (jaundice)

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

Other Adverse Effects:

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

Frequent: may affect up to 1 in 10 people

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

Infrequent: may affect up to 1 in 100 people

• Reduction of red blood cells that can cause pale skin and weakness or difficulty breathing
• Decreased appetite
• Difficulty sleeping, drowsiness
• Seizures, dizziness, sensation of spinning, tingling, pinching, or numbness, 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, feeling of general discomfort, fever

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

• Lower than normal level of white blood cells that help defend against infections, and blood cells that help stop bleeding
• Loss of red or purple color of the skin that can be caused by low platelet count, other changes in blood cells
• Chemical changes in the blood (high cholesterol, fats)
• Low potassium in the blood
• Tremors
• Abnormal electrocardiogram (ECG), change in heart rate or rhythm - liver failure
• Allergic reactions (sometimes severe), including widespread 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

• Hypersensitivity reaction with skin rash, fever, inflamed glands, increased eosinophils, and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or eruption with eosinophilia and systemic symptoms [DRESS]).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Fluconazol Pharmathen

Keep out of sight and reach of children.

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

No special storage conditions are required.

Medicines should not be thrown away in drains or trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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), cornstarch, colloidal silicon dioxide (E551), magnesium stearate (E470b), and sodium lauryl sulfate. The bodies and caps of the hard capsule contain titanium dioxide (E171), quinoline yellow (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), cornstarch, colloidal silicon dioxide (E551), magnesium stearate (E470b), and sodium lauryl sulfate. The bodies and caps of the hard capsule 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), cornstarch, colloidal silicon dioxide (E551), magnesium stearate (E470b), and sodium lauryl sulfate. The bodies and caps of the hard capsule contain titanium dioxide (E171), quinoline yellow (E104), orange yellow S (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), cornstarch, colloidal silicon dioxide (E551), magnesium stearate (E470b), and sodium lauryl sulfate. The bodies and caps of the hard capsule contain titanium dioxide (E171) and gelatin.

Appearance of the Product and Package Contents

Aluminum/PVC transparent blister packs

Package Contents

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 package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Pharmathen S.A.,

6 Dervenakion str.,

15351 Pallini, Attiki,

Greece

Manufacturer

Pharmathen S.A.

6 Dervenakion str.

15344 Pallini, Attiki

Greece

or

Apotex Nederland B.V.

Archimedesweg 2

2333 CN Leiden

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Prospectus: February 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/