Fluconazole Pharmathen 100 mg hard capsules EFG
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What Fluconazol Pharmathen is and what it is used for
- 2. What you need to know before taking Fluconazole Pharmathen
- 3. How to take Fluconazole Pharmathen
- 4. Possible adverse effects
- 5. Storage of Fluconazole Pharmathen
- 6. Contents of the pack and other information
Patient Information Leaflet
Introduction
Patient Information Leaflet
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 the entire leaflet carefully before you start taking this medicine, as 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Fluconazole Pharmathen is and what it is used for
- What you need to know before taking Fluconazole Pharmathen
- How to take Fluconazole Pharmathen
- Possible side effects
- How to store Fluconazole Pharmathen
- Contents of the pack and other information
1. What Fluconazol Pharmathen is and what it is used for
Fluconazol 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 may 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 types of fungal infections:
- Cryptococcal meningitis – a fungal infection of the brain
- Coccidioidomycosis – a disease affecting the bronchopulmonary system
- Infections caused by Candida located in the bloodstream, body organs (e.g., heart, lungs), or urinary tract
- Mucosal candidiasis – infection affecting the lining of the mouth, throat, and denture-related mouth sores
- Genital candidiasis – infection of the vagina or penis
- Skin infections – e.g., athlete's foot, ringworm, pityriasis versicolor, nail infections
Your doctor may also prescribe fluconazole to:
- Prevent recurrence of cryptococcal meningitis
- Prevent recurrence of mucosal candidiasis
- Reduce the recurrence of vaginal candidiasis
- Prevent you from getting a Candida infection (if your immune system is weak and not working properly)
Children and adolescents (0 to 17 years)
Your doctor may prescribe this medicine to treat the following types of fungal infections:
- Mucosal candidiasis – infection affecting the lining of the mouth and throat
- Infections caused by Candida affecting the bloodstream, body organs (e.g., heart, lungs), or urinary tract
- Cryptococcal meningitis – a fungal infection of the brain
You may also be prescribed fluconazole to:
- Prevent you from getting a Candida infection (if your immune system is weak and not working properly)
- Prevent recurrence of cryptococcal meningitis
2. What you need to know before taking Fluconazole Pharmathen
Do not take Fluconazole Pharmathen
- If you are allergic to fluconazole or to any of the other ingredients of this medicine (listed in section 6), or to other antifungal medicines you have taken. Symptoms may include itching, skin redness, or difficulty breathing.
- If you are taking astemizole or terfenadine (antihistamine medicines for allergies)
- If you are taking cisapride (for stomach discomfort)
- If you are taking pimozide (for the treatment of a mental illness)
- If you are taking quinidine (to treat cardiac arrhythmias)
- If you are taking erythromycin (an antibiotic for treating 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 rhythm
- You have abnormal levels of potassium, calcium, or magnesium in your blood
- You develop severe skin reactions (itching, skin redness, or difficulty breathing)
- You have symptoms of “adrenal insufficiency,” in which 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)
- You have previously experienced a severe skin rash, 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 with fluconazole treatment. Stop taking fluconazole and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.
Talk to your doctor or pharmacist if your fungal infection does not improve, as alternative antifungal treatment may be needed.
Other medicines and Fluconazole Pharmathen
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, as dose adjustments or monitoring may be necessary to ensure the medicines remain effective.
Inform your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for treating allergies), cisapride (used for stomach discomfort), pimozide (used to treat a mental illness), quinidine (used to treat cardiac arrhythmias), or erythromycin (an antibiotic for treating infections), as these medicines must not be taken with fluconazole (see section “Do not take Fluconazole Pharmathen”).
Some medicines may interact with fluconazole. Make sure your doctor knows if 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 (antifungals)
- 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 hypertension – high blood pressure)
- Olaparib (used to treat ovarian cancer)
- Cyclosporine, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection)
- Cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medicines) used for cancer treatment
- Halofantrine (used to treat malaria)
- Statins (atorvastatin, simvastatin, fluvastatin, or similar medicines) used to reduce high cholesterol levels
- Methadone (used for 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 HIV-infected patients)
- 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 blood) or to slow the decline of 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 Fluconazole Pharmathen with food and drink
You may take this medicine with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant, 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 attempting pregnancy. For longer treatment courses with fluconazole, consult your doctor about the need to use appropriate 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 instructed you to do so. If you become pregnant while taking this medicine or within one week after the most recent dose, consult your doctor.
Breastfeeding may continue after a single 150 mg dose of fluconazole.
Do not take fluconazole if you are pregnant, think you might be pregnant, plan to become pregnant, or intend to breastfeed, unless your doctor has instructed you to do so.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of spontaneous abortion. Low-dose fluconazole taken during the first trimester may slightly increase the risk of congenital abnormalities affecting the heart, bones, and/or muscles.
Cases of babies born with congenital abnormalities 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 daily) of fluconazole for coccidioidomycosis. The relationship between fluconazole and these cases is not clear.
Driving and using machines
When driving or operating machinery, bear in mind that dizziness or seizures may rarely occur.
Fluconazole Pharmathen 50 mg, 100 mg, 150 mg, and 200 mg contain lactose (a sugar) and sodium (salt)
Each Fluconazole Pharmathen 50 mg capsule contains 16.6 mg of lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free.”
Fluconazole Pharmathen 150 mg contains sunset yellow FCF (E-110)
Sunset yellow FCF (E-110) may cause allergic-type reactions.
3. How to take Fluconazole Pharmathen
Follow exactly the instructions for use of this medicine given 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 each day.
The recommended doses of this medicine for different infections are indicated below:
Adults
Condition | Dosage |
To treat cryptococcal meningitis | 400 mg on the first day, followed by 200 mg - 400 mg once daily for 6 to 8 weeks or longer if necessary. Occasionally, the dose may be increased up to 800 mg |
Prevention of cryptococcal meningitis | 200 mg once daily until otherwise directed |
To treat coccidioidomycosis | 200 mg to 400 mg once daily for 11 to 24 months or longer if necessary. Occasionally, the dose may be increased up to 800 mg |
For treatment of systemic fungal infections caused by Candida | 800 mg on the first day, followed by 400 mg once daily until otherwise directed |
To treat mucosal infections affecting the inside of the mouth, throat, and mouth sores caused by dentures | 200 mg to 400 mg on the first day, followed by 100 mg to 200 mg once daily until otherwise directed |
To treat mucosal candidiasis – dosage depends on the site of infection | 50 mg to 400 mg once daily for 7 to 30 days, or until otherwise directed |
To prevent recurrence of mucosal infections affecting the lining of the mouth and throat | 100 mg to 200 mg once daily, or 200 mg three times a week, for as long as the risk of developing an infection persists |
To treat genital candidiasis | 150 mg as a single dose |
To reduce recurrence of vaginal candidiasis | 150 mg every 3 days for a total of 3 doses (day 1, 4, and 7), followed by once weekly for 6 months while the risk of infection persists |
To treat fungal skin and nail infections | Depending on the site of infection: 50 mg once daily, 150 mg once weekly, or 300 to 400 mg once weekly for 1 to 4 weeks (for athlete's foot, treatment may last up to 6 weeks; for nail infections, until the infected nail is fully replaced) |
To prevent risk of developing Candida-related infection (if your immune system is weakened and not functioning properly) | 200 mg to 400 mg once daily for as long as the risk of developing an infection persists |
Adolescents aged 12 to 17 years
Take the dose indicated 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.
Condition | Dosage |
Oral mucosal candidiasis and mouth infections caused by Candida – dosage and duration of treatment depend on the severity and location of the infection | 3 mg per kg body weight once daily (on the first day, 6 mg per kg body weight may be administered) |
Cryptococcal meningitis or systemic fungal infections caused by Candida | 6 mg to 12 mg per kg body weight once daily |
To prevent recurrence of cryptococcal meningitis | 6 mg per kg body weight once daily |
To prevent Candida infections in children (if their immune system is not functioning properly) | 3 mg to 12 mg per kg body weight once daily |
Use in children from 0 to 4 weeks of age
Use in children from 3 to 4 weeks of age: The same dose indicated above, but administered once every two 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 dose indicated above, but administered once every three days. The maximum dose is 12 mg per kg of body weight every 72 hours.
Elderly patients
The usual adult dose should be administered unless you have kidney problems.
Patients with renal impairment
Your doctor may adjust the dose depending 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 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 missed doses. If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.
If you have any further 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 everyone will experience them. Stop taking Fluconazole Pharmathen and seek immediate medical attention if you notice any of the following symptoms:
- Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
A few people may develop allergic reactions, although severe allergic reactions are rare. If any adverse effect occurs, speak to your doctor or pharmacist. This includes any possible adverse effect not mentioned in this leaflet. If you experience any of the following symptoms, contact your doctor immediately:
- Sudden wheezing, difficulty breathing, or tightness in the chest
- Swelling of the eyelids, face, or lips
- Itching all over the body, skin redness, or red, itchy skin patches
- Skin rashes
- Severe skin reactions, such as a blistering skin rash (this may affect the mouth and tongue)
Fluconazole may affect your liver. Signs of liver problems include:
- Tiredness
- Loss of appetite
- Nausea and vomiting
- Yellowing of the skin or whites of the eyes (jaundice)
If any of these occur, stop taking fluconazole and contact your doctor immediately.
Other adverse effects:
Additionally, if any of the following adverse effects become severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Frequent: may affect up to 1 in 10 people
- Headache
- Stomach discomfort, diarrhoea, nausea, vomiting
- Increased liver function blood tests
- Rash
Uncommon: may affect up to 1 in 100 people
- Reduction in red blood cells, which may cause paleness, weakness, or difficulty breathing
- Decreased appetite
- Trouble sleeping, drowsiness
- Seizures, dizziness, spinning sensation, tingling, prickling, or numbness, changes in taste sensation
- Constipation, indigestion, flatulence, dry mouth
- Muscle pain
- Liver damage and yellowing of the skin and eyes (jaundice)
- Hives, blisters (urticaria), itching, increased sweating
- Tiredness, general feeling of being unwell, fever
Rare: may affect up to 1 in 1,000 people
- Lower than normal levels of white blood cells, which help fight infections, and blood cells that help stop bleeding
- Loss of red or purple color in the skin, possibly due to low platelet count, other changes in blood cells
- Chemical changes in the blood (high levels of cholesterol, fats)
- Low potassium levels in the blood
- Tremor
- Abnormal electrocardiogram (ECG), changes in heart rate or rhythm – liver failure
- Allergic reactions (sometimes severe), including widespread blistering rash with skin peeling, severe skin reactions, swelling of the lips or face
- Hair loss
Not known: cannot be estimated from available data
- Hypersensitivity reaction with skin rash, fever, swollen glands, increase in a 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 adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fluconazole Pharmathen
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after "EXP". The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fluconazole Pharmathen 50 mg hard capsules EFG
- The active substance is fluconazole. Each capsule contains 50 mg of fluconazole.
- The other excipients are monohydrate lactose, microcrystalline cellulose (E460), corn starch, colloidal silicon dioxide (E551), magnesium stearate (E470b) and sodium lauryl sulfate. The capsule shells and caps contain titanium dioxide (E171), quinoline yellow (E104), yellow iron oxide (E172), patent blue V (E131) and gelatin.
Composition of Fluconazole Pharmathen 100 mg hard capsules EFG
- The active substance is fluconazole. Each capsule contains 100 mg of fluconazole.
- The other excipients are monohydrate lactose, microcrystalline cellulose (E460), corn starch, colloidal silicon dioxide (E551), magnesium stearate (E470b) and sodium lauryl sulfate. The capsule shells and caps contain titanium dioxide (E171), yellow iron oxide (E172) and gelatin.
Composition of Fluconazole Pharmathen 150 mg hard capsules EFG
- The active substance is fluconazole. Each capsule contains 150 mg of fluconazole.
- The other excipients are monohydrate lactose, microcrystalline cellulose (E460), corn starch, colloidal silicon dioxide (E551), magnesium stearate (E470b) and sodium lauryl sulfate. The capsule shells and caps contain titanium dioxide (E171), quinoline yellow (E104), orange yellow S (E110) and gelatin.
Composition of Fluconazole Pharmathen 200 mg hard capsules EFG
- The active substance is fluconazole. Each capsule contains 200 mg of fluconazole.
- The other excipients are monohydrate lactose, microcrystalline cellulose (E460), corn starch, colloidal silicon dioxide (E551), magnesium stearate (E470b) and sodium lauryl sulfate. The capsule shells and caps contain titanium dioxide (E171) and gelatin.
Nature of the product and contents of the container
Aluminum/PVC transparent blister packs
Contents of the pack
Fluconazole Pharmathen 50 mg: 7, 10, 14, 20, 28, 30, 50 and 100 hard capsules
Fluconazole Pharmathen 100 mg: 7, 10, 14, 20, 28, 50 and 100 hard capsules
Fluconazole Pharmathen 150 mg: 1, 2 and 4 hard capsules
Fluconazole Pharmathen 200 mg: 7, 10, 14, 20, 28, 50 and 100 hard capsules
Only certain pack 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
The Netherlands
This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Member State | Name of the medicinal product |
Belgium | Fluconazole Aurobindo 50 mg Fluconazole Aurobindo 100 mg Fluconazole Aurobindo 150 mg Fluconazole Aurobindo 200 mg |
Spain | 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 |
Date of the most recent review of this leaflet: February 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/