KLAIDER 100 mg Kapsułka Twarda

Treść ulotki

1. Klaider 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. What Klaider is and what it is used for
   2. What you need to know before taking Klaider
   3. How to take Klaider
   4. Possible side effects
   5. How to store Klaider
   6. Contents of the pack and other information

Klaider 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole
“Generic medicine”

Read this leaflet carefully before taking 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Klaider is and what it is used for

Klaider belongs to a group of medicines called "antifungals”. The active ingredient
is fluconazole.
Klaider is used for the treatment of fungal infections and can be used to
prevent Candidainfections. The most common cause of fungal infections is a yeast
called Candida.

Adults
Your doctor may prescribe this medicine for the treatment of the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain
• Coccidioidomycosis - a disease of the bronchopulmonary system
• Infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• Candidiasis of the mucous membranes - infection of the oral mucosa, throat infection and inflammation of the mouth from dentures
• Genital candidiasis - infection of the vagina or penis
• Skin infections - e.g. athlete's foot, ringworm, itching in the genital area, nail infections.

Klaider may be prescribed for:

• preventing the recurrence of cryptococcal meningitis
• preventing the recurrence of candidiasis of the mucous membranes
• reducing recurrences of vaginal candidiasis
• preventing Candidainfections (if your immune system is weak or not functioning properly).

Children and adolescents (from 0 to 17 years)
Your doctor may prescribe this medicine for the treatment of the following fungal infections:

• Candidiasis of the mucous membranes - infection of the oral mucosa, throat infection
• Infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• Cryptococcal meningitis - a fungal infection of the brain.

Klaider may be prescribed for:

• preventing Candidainfections (if your immune system is weak or not functioning properly)
• preventing the recurrence of cryptococcal meningitis .

2. What you need to know before taking Klaider

Do not take Klaider

• if you are allergic to fluconazole, to other medicines that you have used for the treatment of fungal infections or to any of the other components of this medicine (listed in section 6). The symptoms may be itching, redness of the skin or difficulty in 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 heart arrhythmias)
• if you are taking erythromycin (antibiotic used to treat bacterial infections).

Warnings and precautions
Talk to your doctor or pharmacist before taking Klaider.

• if you have liver or kidney problems
• if you suffer from heart disease, including heart arrhythmia
• if you have abnormal levels of potassium, calcium or magnesium in your blood
• if severe skin reactions appear (itching, redness of the skin or difficulty in breathing)
• if signs of “adrenal insufficiency” appear, where 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)
• if you have ever developed a severe rash or skin exfoliation, blisters and/or ulcers in the mouth after taking Klaider.

Severe skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) related to treatment with Klaider have been reported. Stop taking Klaider and contact your doctor immediately if you notice any of the symptoms related to the severe skin reactions described in section 4.
Talk to your doctor or pharmacist if the fungal infection does not improve, an alternative antifungal therapy may be necessary

Other medicines and Klaider
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor immediatelyif you are taking astemizole, terfenadine (antihistamine used to treat allergies) or cisapride (used to treat stomach disorders) or pimozide (used to treat mental disorders) or quinidine (used to treat heart arrhythmias) or erythromycin (antibiotic used to treat bacterial infections), as they cannot be taken with Klaider (see section: ''Do not take Klaider").
There are some medicines that can interact with Klaider. Tell your doctor if you are taking any of the following medicines as a dose adjustment or monitoring may be necessary to ensure the medicines continue to have the desired effect:

• rifampicin or rifabutin (antibiotics for the treatment of bacterial infections)
• abrocitinib (used for the treatment of atopic dermatitis, also known as atopic eczema)
• 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 seizures)
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (used to treat high blood pressure)
• olaparib (used for the treatment of ovarian cancer)
• cyclosporine, everolimus, sirolimus or tacrolimus (used to prevent transplant rejection)
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for the treatment of 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 (steroid)
• zidovudine, also known as AZT; saquinavir (used in patients with HIV)
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• theophylline (used for asthma control)
• tofacitinib (used for the treatment of rheumatoid arthritis)
• tolvaptan, used to treat hyponatremia (low sodium levels in the blood) or to slow the decline of kidney function
• vitamin A (dietary supplement)
• ivacaftor (alone or in combination with other medicines used to treat cystic fibrosis)
• amiodarone (used to treat irregular heartbeat, “arrhythmia”)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used for the treatment of blood cancers).
• lurasidone (used for the treatment of schizophrenia).

Klaider with food and drink
You can take the medicine with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
If you are planning a pregnancy you should wait one week after a single dose of fluconazole before trying to start a pregnancy.
For longer cycles of therapy with fluconazole, ask your doctor to assess the need for adequate contraception during treatment, which should continue for one week after the last dose.
Do not take Klaider if you are pregnant, suspect you may be pregnant or are breastfeeding, unless your doctor tells you to. If you become pregnant while taking this medicine or within 1 week of the most recent dose, contact your doctor.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken during the first trimester may increase the risk that the newborn will have birth defects affecting the heart, bones and/or muscles.
Cases of children with birth defects 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 per day) of fluconazole for coccidioidomycosis. The link between fluconazole and these cases is unclear.
You can continue to breastfeed after taking a single dose of Klaider up to 150 mg.
You should not breastfeed if you are taking repeated doses of Klaider.

Driving and using machines
You should be aware that dizziness or convulsions may occur while driving or using machines.

Klaider contains lactose and sodium
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, that is to say it is essentially ‘sodium-free’.

3. How to take Klaider

Take this medicine following exactly the instructions of your doctor. 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 every day
at the same time.
The recommended doses of this medicine to be taken depending on the infection are listed here
below:

Adults

Adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (either the adult dosage or the children's 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.

Use in children aged 0 to 4 weeks
Use in children aged 3 to 4 weeks:
The same dosage as described above but administered once every 2 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 dosage as described above but administered once every 3 days. The maximum dose is
12 mg per kg of body weight every 72 hours.

Elderly
The same dose as intended for adults should be used unless you have kidney problems.

Patients with kidney problems
Your doctor may adjust the dosage based on kidney function.

If you take more Klaider than you should
Taking too many capsules all at once may cause you problems. Immediately inform your
doctor or go to the nearest hospital.
In case of accidental overdose, symptoms may include seeing, hearing, feeling and thinking
things that are not real (hallucinations and paranoid behavior). Symptomatic treatment (with appropriate supportive measures and possibly gastric lavage) may be appropriate.

If you forget to take Klaider
Do not take a double dose to make up for the missed dose. If you forget to take
a dose, take it as soon as possible. If it is time to take the next dose, do not take the
forgotten dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking Klaider and contact your doctor immediately if you notice any of the following symptoms:

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

Some people experience allergic reactions, although severe allergic reactions occur
rarely. If you experience any side effect, including those not listed in this

leaflet, contact your doctor or pharmacist.
If you experience any of the following symptoms inform your doctor immediately:

• sudden shortness of breath, difficulty breathing or a feeling of tightness in the chest
• swelling of the eyelids, face or lips
• itching all over the body, redness of the skin or itchy red spots
• rashes
• severe skin reactions, such as rashes that cause blisters (may affect the mouth and tongue).

Klaider can have effects on the liver. Symptoms of liver problems include:

• fatigue
• loss of appetite
• vomiting
• yellowing of the skin and the white of the eyes (jaundice).

If you experience any of these symptoms, stop taking Klaider and inform your doctor immediately.
Other side effects:
If any of the side effects gets worse, or if you notice any side effect
Common side effects (may affect up to 1 in 10 people) are:

• headache
• stomach upset, diarrhea, nausea, vomiting
• increases in liver function values in blood tests
• rashes

Uncommon side effects (may affect up to 1 in 100 people) are:

• reduction in red blood cells which can cause paleness, weakness or shortness of breath
• decreased appetite
• insomnia, drowsiness
• convulsions, dizziness, feeling of spinning, tingling, prickling or numbness, altered taste
• constipation, difficulty digesting, flatulence, dry mouth
• muscle pain
• liver damage and yellowing of the skin and eyes (jaundice)
• swellings, blisters (urticaria), itching, increased sweating
• fatigue, general feeling of discomfort, fever.

Rare side effects (may affect up to 1 in 1000 people) are:

• lower than normal levels of white blood cells (which help fight infections), and platelets (which help blood to clot)
• altered skin color (red or purple) which may be caused by a reduction in platelets, other changes in blood cells
• changes in the chemical composition of the blood (high levels of cholesterol, fats)
• low levels of potassium in the blood
• chills
• altered electrocardiogram (ECG), changes in heart rate and rhythm
• liver failure
• allergic reactions (sometimes severe), including skin rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face
• hair loss.

Frequency not known, but may occur (frequency cannot be estimated on the basis of available data):

• hypersensitivity reaction with rash, fever, swollen glands, increased 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 side effects
If you get any side effects, talk to your doctor or pharmacist .You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Klaider

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 Scad.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Klaider contains

• The active ingredient is fluconazole. Each hard capsule contains 100 mg, 150 mg or 200 mg of fluconazole.
• The other ingredients are: Capsule content: Lactose monohydrate, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.

Capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E172) (only in the
100 mg capsules).

Description of the appearance of Klaider 100 mg, 150 mg and 200 mg hard capsules and pack contents
Klaider 100 mg hard capsules are available in blisters of 10 capsules containing 100 mg.
Klaider 150 mg hard capsules are available in blisters of 2 capsules containing 150 mg.
Klaider 200 mg hard capsules are available in blisters of 7 capsules containing 200 mg.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Konpharma S.r.l.
Via Pietro della Valle, 1

• 00193 – Rome

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l.
Via Dante Alighieri, 71
18038 Sanremo (IM)
Italy
Lachifarma S.r.l. – Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Adriatica - Zona Industriale
73010 Zollino (LE)