50 mg, 100 mg, 200 mg capsules, hard
fluconazole

What Fluconazole Actavis is and what it is used for

Fluconazole Actavis belongs to a group of medicines used to treat fungal infections. The active substance is fluconazole.

Fluconazole Actavis 50 mg, 100 mg and 200 mg

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

Adults

You can get this medicine from a doctor for the treatment of the following fungal infections:

  • Meningitis caused by cryptococcus – a fungal infection of the brain
  • Coccidioidomycosis is – a lung disease
  • Infection is caused by Candida and is found in the bloodstream, internal organs (eg heart, lungs), or urinary tract.
  • Fungal infection of the mouth affects the lining of the mouth, throat and can cause inflammation of the oral mucosa when using a denture
  • Fungal infection of the vagina or penis (genital fungal infection)
  • Skin infections – e.g. athlete’s foot, ringworm, inguinal fungus, nail infection

You can also get Fluconazole Actavis to:

  • prevent recurrence of meningitis caused by cryptococci
  • prevent the recurrence of fungal infections in the mouth
  • prevent recurrent fungal infection in the vagina
  • prevent infection caused by Candida (if you have a weakened immune system)

Children and adolescents (0 to 17 years)

You can get this medicine from your doctor to treat these types of fungal infections:

  • Fungal infection in the mouth – an infection that affects the lining of the mouth and throat
  • Infection is caused by Candida and is found in the bloodstream, internal organs (eg heart, lungs), or urinary tract
  • Meningitis caused by cryptococcus – a fungal infection of the brain

You can also get Fluconazole Actavis to:

  • prevent infection caused by Candida (if you have a weakened immune system)
  • prevent recurrence of meningitis caused by cryptococci

Fluconazole contained in Fluconazole Actavis may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Fluconazole Actavis

Do not use Fluconazole Actavis if you:

  • is allergic to fluconazole, to any other medicines you have taken to treat fungal infection, or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, redness of the skin, or difficulty breathing.
  • taking astemizole or terfenadine ( antihistamine for the treatment of allergies )
  • taking cisapride (for stomach upset)
  • takes pimozide (used to treat mental illness)
  • takes quinidine (used to treat irregular heartbeat)
  • taking erythromycin ( antibiotic to treat infections ).

Warnings and cautions

Talk to your doctor or pharmacist before using Fluconazole Actavis if you :

  • have liver or kidney problems
  • have any heart disease, e.g. irregular heartbeat
  • have abnormal levels of potassium, calcium, or magnesium in the blood
  • develops severe skin reactions ( itching, redness of the skin, or difficulty breathing).
  • develops symptoms that may be signs of lower cortisol production from the adrenal glands ( chronic or prolonged fatigue, muscle weakness, decreased appetite, weight loss, abdominal pain).

Other medicines and Fluconazole Actavis

Tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for the treatment of allergies ) or cisapride (for stomach upset) or pimozide (used to treat mental illness) or quinidine, amiodarone (used to treat irregular heartbeat), or erythromycin (antibiotics for the treatment of infections ) as these should not be taken with Fluconazole Actavis (see section “Do not use Fluconazole Actavis if you”).

Some medicines can be affected by or affect Fluconazole Actavis.

Tell your doctor if you are taking any of the following medicines:

  • rifampicin, rifabutin ( antibiotics for infections )
  • hydrochlorothiazide (used to treat too much fluid in the body and for high blood pressure )
  • alfentanil, fentanyl (used as anesthetic)
  • amitriptyline, nortriptyline (used to treat depression)
  • amphotericin B, voriconazole (for fungal infections)
  • blood thinners (eg warfarin ) to prevent blood clots
  • benzodiazepines (eg midazolam, triazolam) used for insomnia or anxiety
  • carbamazepine, phenytoin (for epilepsy )
  • nifedipine, isradipine, amlodipine, felodipine or losartan (for high blood pressure )
  • ciclosporin, everolimus, sirolimus or tacrolimus (used after transplants)
  • cyclophosphamide, vinca alkaloids (eg vincristine, vinblastine) used to treat cancer
  • halofantrine (against malaria )
  • statins (atorvastatin, simvastatin, and fluvastatin) used to lower blood cholesterol
  • methadone (for pain)
  • celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs, NSAIDs )
  • birth control pills
  • prednisone ( steroid )
  • zidovudine (also known as AZT) or saquinavir (used to treat HIV )
  • drugs against diabetes as chlorpropamide, glibenclamide, glipizide or tolbutamide
  • theophylline (for asthma )
  • A vitamin (nutritional supplements)
  • ivacaftor (used to treat cystic fibrosis )
  • amiodarone (used to treat irregular heartbeat ( arrhythmias ).

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Fluconazole Actavis with food and drink

The drug can be taken regardless of the meal.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take Fluconazole Actavis if you are pregnant or breast-feeding unless your doctor tells you to. You can continue breastfeeding after taking a single dose of Fluconazole Actavis up to 200 mg. You should not breast-feed if you are taking repeated dose s of Fluconazole Actavis.

Driving and using machines

When driving or using machines, keep in mind that you may experience dizziness or seizures during treatment.

You are always responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Fluconazole Actavis contains lactose

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

3. How to use Fluconazole Actavis

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Fluconazole Actavis 50 mg, 100 mg and 200 mg

Swallow the capsule whole with a glass of water. You should take the capsules at the same time each day.

The table below shows the recommended doses for different infections:

Adults

Infection Dose
To treat meningitis caused by cryptococci 400 mg on the first day, then 200 mg to 400 mg once daily for 6 to 8 weeks or longer as needed. Sometimes the dose is increased by up to 800 mg
To prevent meningitis caused by cryptococci 200 mg once daily until your doctor tells you to stop
To treat coccidioidomycosis 200 mg to 400 mg once daily from 11 months up to 24 months or longer if needed. Sometimes the dose is increased by up to 800 mg
To treat internal fungal infections caused by Candida 800 mg on the first day, then 400 mg once daily until your doctor tells you to stop
Fungal infection of the mouth affects the lining of the mouth, throat and can cause inflammation of the oral mucosa when using a denture 200 mg to 400 mg on the first day, then 100 mg to 200 mg until your doctor tells you to stop
To treat a fungal infection in the mouth – does one depends on where the infection is 50 mg to 400 mg once daily for 7 to 30 days until your doctor tells you to stop
To prevent fungal infections that affect the mucous membranes of the mouth and throat 100 mg to 200 mg once daily or 200 mg three times a week as long as you are at risk of getting an infection
To treat genital fungal infection 150 mg as a single dose
To prevent recurrent fungal infection in the vagina 150 mg every three days for a total of 3 doses (days 1, 4, and 7) and then once a week for 6 months as long as you are at risk of getting an infection
To treat fungal infections of the skin and nails Depending on the site of infection a 50 mg once daily, 150 mg once a week, 300 to 400 mg once a week for 1 to 4 weeks (up to 6 weeks for athlete’s foot, in the treatment of nail infection until the infected nail has been replaced )
To prevent infection caused by Candida (if you have a weakened immune system) 200 mg to 400 mg once daily as long as you are at risk of getting an infection

Use in adolescents between 12 and 17 years of age

Use dose one prescribed by your doctor (according to the recommendations for either adults or children).

Use in children up to 11 years

The maximum dose for children is 400 mg daily.

Dose one is based on the child’s weight in kg.

Infection Daily dose
Fungal infections of the mouth and throat infections caused by Candida – dose, and duration of treatment depends on how severe the infection is and where it is located 3 mg per kg body weight (6 mg per kg body weight can be given on the first day)
Meningitis caused by cryptococcus or internal fungal infections caused by Candida 6 mg to 12 mg per kg body weight
To prevent the child from getting an infection caused by Candida (if the child has a weakened immune system) 3 mg to 12 mg per kg body weight

Children between 0 and 4 weeks

Children between 3 and 4 weeks:

The same dose as above is given every other day. The maximum dose is 12 mg per kg body weight every other day (48 hours).

Children younger than 2 weeks:

The same dose as above is given every three days. The maximum dose is 12 mg per kg body weight every three days (72 hours).

Your doctor may prescribe you other doses than those listed here. Always take Fluconazole Actavis exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Older

The usual dose for adults can be used unless you have kidney problems.

Patients with kidney problems

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

If you use more Fluconazole Actavis then you should  

You may feel unwell if you take too many capsules at once. If you have ingested too much or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. The symptoms of a possible overdose may be that you begin to hear, see, feel and think things that are not real (hallucinations and paranoid behaviors). Treatment of symptoms and gastric lavage may be required in case of overdose.

If you forget to use Fluconazole Actavis

Do not take a double dose to make up for a forgotten dose. If you miss 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 further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fluconazole Actavis can cause side effects, although not everybody gets them.

Some people develop allergic reactions, although severe allergic reactions are rare. If you get any of the following symptoms, contact your doctor immediately.

  • sudden wheezing, difficulty breathing, or a tight feeling in the chest
  • swelling of the eyelids, face, or lips
  • itching all over the body, reddening of the skin or itchy, red spots
  • rash
  • severe skin reactions, e.g. a rash with blistering (this can affect the mouth and tongue).

Fluconazole Actavis may affect your liver. Signs of hepatic impairment include:

  • fatigue
  • decreased appetite
  • vomiting
  • yellowish skin or yellowish whites of the eyes (jaundice).

Fluconazole Actavis can affect your adrenal glands and the levels of steroid hormones produced. Signs of adrenal insufficiency include:

  • fatigue
  • muscle weakness
  • decreased appetite
  • weight loss
  • abdominal pain.

If any of these occur, stop taking Fluconazole Actavis and contact your doctor immediately.

Other side effects are

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Common side effects that affect between 1 to 10 users in 100:

  • headache
  • feeling uncomfortable in the stomach, diarrhea, nausea, vomiting
  • elevated liver values
  • rash

Uncommon side effects affecting 1 to 10 users in 1,000:

  • decreased amount of red blood cells which can lead to pale skin and cause weakness and shortness of breath
  • decreased appetite
  • difficulty sleeping, drowsiness
  • seizures, dizziness, tingling sensation, and crawling, tingling or numbness, taste changes
  • constipation, indigestion, gas tension, dry mouth
  • muscle pain
  • liver damage and yellowing of the skin and eyes (jaundice)
  • streaks in the skin, blistering ( hives ), itching, sweating
  • fatigue, general malaise, fever

Rare side effects affecting 1 to 10 users in 10,000:

  • reduced number of white blood cells that help defend the body against infection and reduced number of blood cells that help stop bleeding
  • red or purple discoloration of the skin that may be caused by decreased platelet count or other changes in the blood
  • elevated blood cholesterol and blood fat levels
  • decreased level of potassium in the blood
  • shaking
  • abnormal ECG, changes in heart rate or heart rate
  • liver failure
  • allergic reactions (sometimes severe), including widespread rash with blistering and flaky skin, severe skin reactions, and swelling of the lips or face
  • hair loss

5. How to store Fluconazole Actavis

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 carton after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is fluconazole . Each hard capsule contains 50 mg fluconazole , 100 mg fluconazole and 200 mg fluconazole respectively .
  • Other ingredients are: The contents of the capsule
  • Lactose monohydrate, pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate.
    Capsule sell fluconazole Actavis 50 mg and 100 mg: Gelatin, titanium dioxide (E171), indigo carmine (E132)
    Fluconazole Actavis 200 mg: Gelatin, titanium dioxide (E171), indigo carmine (E132), iron oxide yellow (E172), iron oxide black (E172)

What the medicine looks like and the contents of the pack

Hard capsules

Appearance

Fluconazole Actavis 50 mg: light blue top with the white capsule, hard gelatin capsules filled with white powder

Fluconazole Actavis 100 mg: light blue top with the white capsule, hard gelatin capsules filled with white powder

Fluconazole Actavis 200 mg: blue top with the white capsule, hard gelatin capsules filled with white powder

Pack sizes

1, 2, 4, 6, 7, 10, 12, 14, 20, 21, 28, 30, 50, 60, 90, 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjörður

Iceland

Manufacturer

Specifier SA

1, 28 Octovriou str.

123 51 Ag. Be careful

Athens

Greece

Muhammad Nadeem

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