Riflax
Italy
Table of Contents
Package leaflet: Information for the user
RIFLAX 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
Fluconazole
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
- If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Contents of this leaflet:
- What RIFLAX is and what it is used for
- What you need to know before taking RIFLAX
- How to take RIFLAX
- Possible side effects
- How to store RIFLAX
- Contents of the pack and other information
1. What RIFLAX is and what it is used for
RIFLAX belongs to a group of medicines called "antifungals". The active substance is fluconazole.
RIFLAX is used to treat fungal infections and can 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 fungal infections:
- Cryptococcal meningitis – a fungal infection of the brain
- Coccidioidomycosis – a disease affecting the bronchopulmonary system
- Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs) or urinary tract
- Mucosal candidiasis – infection of the oral mucosa, throat infection, and denture-related stomatitis
- Genital candidiasis – infection of the vagina or penis
- Skin infections – e.g. athlete's foot, ringworm, genital itching, nail infections
RIFLAX may be prescribed to you:
- to prevent recurrence of cryptococcal meningitis
- to prevent recurrence of mucosal candidiasis
- to reduce recurrences of vaginal candidiasis
- to prevent Candida infections (if your immune system is weakened or not functioning properly)
Children and adolescents (from 0 to 17 years of age)
Your doctor may prescribe this medicine to treat the following fungal infections:
- Mucosal candidiasis – infection of the oral mucosa, throat infection
- Infections caused by Candida found in the bloodstream, organs (e.g. heart, lungs) or urinary tract
- Cryptococcal meningitis – a fungal infection of the brain
RIFLAX may be prescribed to you:
- to prevent Candida infections (if your immune system is weakened or not functioning properly)
- to prevent recurrence of cryptococcal meningitis
2. What you should know before taking RIFLAX
Do not take RIFLAX
- if you are allergic to fluconazole, to other medicines you have used to treat fungal infections, or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing
- if you are taking astemizole, terfenadine (antihistamines used to treat allergies)
- if you are taking cisapride (used to treat stomach disorders)
- if you are taking pimozide (used to treat mental disorders)
- if you are taking quinidine (used to treat cardiac arrhythmias)
- if you are taking erythromycin (an antibiotic used to treat bacterial infections).
Warnings and precautions
Talk to your doctor or pharmacist before taking RIFLAX.
If you develop signs of "adrenal insufficiency", where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
Inform your doctor if:
- you have liver or kidney problems
- you suffer from heart disease, including cardiac arrhythmia
- you have abnormal levels of potassium, calcium, or magnesium in your blood
- severe skin reactions occur (itching, skin redness, or difficulty breathing).
Other medicines and RIFLAX
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, including those without a prescription.
Inform your doctor immediately if you are taking astemizole, terfenadine (antihistamines used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat mental disorders), quinidine (used to treat cardiac arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with RIFLAX (see section: "Do not take RIFLAX").
There are some medicines that may interact with RIFLAX. Always inform your doctor or pharmacist if you are taking any of the following medicines:
- rifampicin or rifabutin (antibiotics used to treat bacterial infections)
- alfentanil, fentanyl (anaesthetics)
- amitriptyline, nortriptyline (antidepressants)
- amphotericin B, voriconazole (antifungals)
- medicines that thin the blood to prevent blood clots (warfarin or similar medicines)
- benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety
- carbamazepine, phenytoin (used to treat epileptic seizures)
- nifedipine, isradipine, amlodipine, felodipine, and losartan (used to treat hypertension - high blood pressure)
- ciclosporin, everolimus, sirolimus, or tacrolimus (used to prevent transplant rejection)
- cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used to treat cancer
- halofantrine (used to treat malaria)
- statins (atorvastatin, simvastatin, fluvastatin, and similar medicines) used to reduce high cholesterol levels
- methadone (used to treat 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 patients)
- diabetes medicines such as chlorpropamide, glibenclamide, glipizide, or tolbutamide
- theophylline (used to control asthma)
- vitamin A (dietary supplement)
- amiodarone (used to treat irregular heartbeats, "arrhythmias")
- hydrochlorothiazide (a diuretic).
RIFLAX with food and drink
You may take this medicine with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You must not take RIFLAX during pregnancy or while breastfeeding unless your doctor has specifically prescribed it for you.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.
RIFLAX contains lactose
This medicine contains a small amount of lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
3. How to take RIFLAX
Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. It is preferable to take the capsules at the same time each day.
The usual doses of this medicine, depending on the infection, are listed below:
Adults
| Condition | Dose |
| Treatment of cryptococcal meningitis | 400 mg on the first day, then 200–400 mg once daily for 6–8 weeks or longer, if necessary. Sometimes doses are increased up to 800 mg |
| Prevention of recurrence of cryptococcal meningitis | 200 mg once daily until instructed to stop |
| Treatment of coccidioidomycosis | 200–400 mg once daily for 11 months up to 24 months. Sometimes doses are increased up to 800 mg |
| Endemic Candida fungal infections | 800 mg on the first day, then 400 mg once daily |
| Treatment of oral mucosal infections, throat infections, and denture-related stomatitis | 200–400 mg on the first day, then 100–200 mg until instructed to stop |
| Mucosal candidiasis – dose depends on site of infection | 50–400 mg once daily for 7–30 days until instructed to stop |
| Prevention of oral mucosal infections, throat infections | 100–200 mg once daily, or 200 mg three times weekly for as long as infection risk remains |
| Genital candidiasis | 150 mg as a single dose |
| Reducing recurrences of vaginal candidiasis | 150 mg every three days for a total of 3 doses (day 1, 4, and 7), then once weekly |
4/8
| for 6 months when at risk of contracting an infection | |
| Skin mycoses and nail infections | Depending on the site of infection, 50 mg once daily, 150 mg once weekly, or 300 mg to 400 mg once weekly for 1 to 4 weeks (Athlete's foot may require up to 6 weeks; treatment of nail infections continues until the infected nail is replaced) |
| Prevention of Candida infections (if your immune system is weakened or not functioning properly) | 200 - 400 mg once daily when at risk of contracting an infection |
Use in children and adolescents
Adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (either the adult dosage or the pediatric dosage).
Children up to 11 years
The maximum recommended dose in children is 400 mg per day.
The dose will be based on the child's weight in kilograms.
| Condition | Daily dose |
| Oral and throat candidiasis – dosage and duration of treatment depend on the severity and site of infection | 3 mg per kg of body weight (on the first day, 6 mg per kg of body weight may be administered) |
| Cryptococcal meningitis or endemic Candida fungal infections | From 6 mg to 12 mg per kg of body weight |
| Prevent Candida infection in children (if their immune system is not functioning properly) | From 3 mg to 12 mg per kg of body weight |
Children aged 0 to 4 weeks
Use in children aged 3 to 4 weeks:
The same dosage described above, but administered once every 2 days. The maximum recommended dose is 12 mg per kg of body weight every 48 hours.
Use in children under 2 weeks of age:
The same dosage described above, but administered once every 3 days. The maximum recommended dose is 12 mg per kg of body weight every 72 hours.
Your doctor may sometimes prescribe doses different from these. Always take the medicine as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Use in elderly patients
5/8
The same dose as that recommended for adults should be used, unless you have renal problems.
Use in patients with renal impairment
Your doctor may adjust the dosage according to kidney function.
If you take more RIFLAX than you should
Taking too many capsules at once could cause you problems. Contact your doctor immediately or go to the nearest hospital.
In case of accidental overdose, symptoms may include experiencing sensations, sights, thoughts, and perceptions of things that are not real (hallucinations and paranoid behavior).
Symptomatic treatment may be appropriate (with adequate supportive measures and, if necessary, gastric lavage).
If you forget to take RIFLAX
Do not take a double dose to make up for a missed dose.
If you forget to take a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and take the next one at the regular time.
If you stop taking RIFLAX
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some people may experience allergic reactions, although serious allergic reactions are rare. If you experience any of the following symptoms, contact your doctor immediately:
- sudden breathlessness, difficulty breathing, or tightness in the chest
- swelling of the eyelids, face, or lips
- itching all over the body, skin redness, or itchy red rash
- skin rashes
- severe skin reactions, for example rashes causing blisters (which may affect the mouth and tongue).
RIFLAX may affect the liver. Symptoms of liver problems include:
- fatigue
- loss of appetite
- vomiting
- yellowing of the skin and whites of the eyes (jaundice).
If you experience any of these symptoms, stop taking RIFLAX and contact your doctor immediately.
6/8
Other side effects:
Common side effects (may affect up to 1 in 100 people) are:
- headache
- stomach discomfort, diarrhoea, nausea, vomiting
- increased liver function test values in blood tests
- skin rashes
Uncommon side effects (may affect up to 1 in 1,000 people) are:
- reduction in red blood cells, which may cause paleness, weakness, or breathlessness
- decreased appetite
- insomnia, drowsiness
- seizures, dizziness, vertigo, tingling, pricking, numbness, altered taste
- constipation, indigestion, flatulence, dry mouth
- muscle pain
- liver damage and yellowing of the skin and eyes (jaundice)
- swellings, blisters (urticaria), itching, increased sweating
- fatigue, general malaise, fever.
Rare side effects (may affect up to 1 in 10,000 people) are:
- lower than normal levels of white blood cells (which help defend against infections) and platelets (which allow blood to clot)
- skin discoloration (red or purple), which may be caused by a reduction in platelets, or other changes in blood cells
- changes in blood chemistry (high levels of cholesterol, fats)
- low potassium levels in the blood
- chills
- abnormal electrocardiogram (ECG), changes in heart rate and rhythm
- liver failure
- allergic reactions (sometimes severe), including rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face
- hair loss.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store RIFLAX
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 label after Exp.
7/8
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What RIFLAX contains
- The active substance is fluconazole. Each hard capsule contains 100 mg, 150 mg or 200 mg of fluconazole.
- The other components are: Capsule core: lactose, maize starch, precipitated silica, magnesium stearate, sodium lauryl sulfate. Capsule coating: gelatin, titanium dioxide (E 171), indigotine (E 132) (only in 150 mg and 200 mg capsules), iron oxide black (E 172) (only in 200 mg capsules) and erythrosine (only in 200 mg capsules).
Description of the appearance of RIFLAX and package contents
RIFLAX 100 mg hard capsules are available in blisters of 10 capsules containing 100 mg each.
RIFLAX 150 mg hard capsules are available in blisters of 2 capsules containing 150 mg each.
RIFLAX 200 mg hard capsules are available in blisters of 7 capsules containing 200 mg each.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
MORGAN S.R.L.
VIA CANESTRELLO, 2B, 36050 MONTEVIALE (VI)
Manufacturer
Istituto Biochimico Italiano G. Lorenzini S.p.A
Via Fossignano, 2 04011
Aprilia (LT)
Italy
SPECIAL PRODUCT’S LINE S.r.l.
Strada Paduni 240, 03012
Anagni (FR)
Italy
8/8