Klaider

Package leaflet: Information for the user

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

Fluconazole
“Generic medicine”
Please 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 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 you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 substance is fluconazole.
Klaider is used to treat fungal infections and can 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 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

Klaider 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 (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

Klaider 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 need to know before taking Klaider

Do not take Klaider

• if you are allergic to fluconazole, to other medicines 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 or 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 (an 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 conditions, including heart arrhythmia
• if you have abnormal levels of potassium, calcium, or magnesium in your blood
• if severe skin reactions occur (such as itching, skin redness, or difficulty breathing)
• if signs of "adrenal insufficiency" appear, meaning your adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (symptoms include chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
• if you have ever developed a severe rash, skin peeling, blisters, and/or mouth ulcers after taking Klaider.

Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported with Klaider treatment. Stop taking Klaider and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.
Contact your doctor or pharmacist if your fungal infection does not improve, as alternative antifungal therapy may be needed.

Other medicines and Klaider
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
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 heart arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with Klaider (see section: "Do not take Klaider").

Some medicines may interact with Klaider. Inform your doctor if you are taking any of the following medicines, as dose adjustment or monitoring may be necessary to ensure these medicines remain effective:

• rifampicin or rifabutin (antibiotics used to treat bacterial infections)
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
• alfentanil, fentanyl (anesthetics)
• amitriptyline, nortriptyline (antidepressants)
• amphotericin B, voriconazole (antifungals)
• blood-thinning medicines 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, verapamil, felodipine, and losartan (used to treat high blood pressure)
• olaparib (used to treat ovarian cancer)
• 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 lower 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 patients with HIV)
• diabetes medicines such as chlorpropamide, glibenclamide, glipizide, or tolbutamide
• theophylline (used to control asthma)
• tofacitinib (used to treat rheumatoid arthritis)
• tolvaptan, used to treat hyponatremia (low sodium levels in the blood) or to slow the decline in 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 to treat blood cancers)
• lurasidone (used to treat schizophrenia).

Klaider with food and drink
You may take this medicine with or without food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are planning a pregnancy, you should wait one week after a single dose of fluconazole before trying to conceive.
For longer treatment cycles with fluconazole, consult your doctor to evaluate 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, think you might be pregnant, are planning a pregnancy, or are breastfeeding, unless instructed by your doctor. If you become pregnant while taking this medicine or within one week of the most recent dose, contact your doctor immediately.
Taking fluconazole during the first or second trimester of pregnancy may increase the risk of miscarriage. Taking fluconazole during the first trimester may increase the risk of birth defects affecting the baby’s heart, bones, and/or muscles.
Cases of babies born with craniofacial, ear, femur, and elbow bone abnormalities have been reported in women treated for three months or more with high doses (400–800 mg daily) of fluconazole for coccidioidomycosis. The causal relationship between fluconazole and these cases is unclear.
You may continue breastfeeding after a single dose of Klaider up to 150 mg.
You must not breastfeed if you are taking repeated doses of Klaider.

Driving and using machines
Be aware that dizziness or seizures may occur while driving or operating machinery.

Klaider contains lactose and sodium
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e., essentially "sodium-free".

3. How to take Klaider

Take this medicine exactly as directed by 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 at the same time each day.
The recommended doses of this medicine, depending on the infection, are listed below:
Adults

Adolescents from 12 to 17 years
Always take the dose prescribed by your doctor (either the adult dose or the pediatric dose).
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 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 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 recommended for adults should be used unless you have renal problems.

Patients with renal impairment
The doctor may adjust the dosage according to renal function.

If you take more Klaider than you should
Taking too many capsules at once could cause you problems. Immediately contact your doctor or go to the nearest hospital.
In case of accidental overdose, symptoms may include hearing, seeing, sensing, and thinking 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 Klaider
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, do not take the missed dose.

If you have any doubts 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.
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 syndrome).

Some people may experience allergic reactions, although severe allergic reactions are rare. If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
If you experience any of the following symptoms, contact your doctor immediately:

• sudden shortness of breath, difficulty breathing, or chest tightness
• swelling of the eyelids, face, or lips
• itching all over the body, skin redness, or itchy red patches
• skin rashes
• severe skin reactions, for example rashes causing blisters (which may affect the mouth and tongue).

Klaider 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 Klaider and contact your doctor immediately.
Other side effects:
If any of the side effects worsen, or if you notice any side effect not listed in this patient information leaflet, inform your doctor or pharmacist.
Common side effects (may affect up to 1 in 10 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 100 people) are:

• reduction in red blood cells, which may cause paleness, weakness, or breathlessness
• decreased appetite
• insomnia, drowsiness
• seizures, dizziness, vertigo, tingling, prickling, or numbness, altered taste
• constipation, indigestion, flatulence, dry mouth
• muscle pain
• liver damage and yellowing of the skin and eyes (jaundice)
• swelling, blisters (urticaria), itching, increased sweating
• tiredness, general malaise, fever.

Rare side effects (may affect up to 1 in 1,000 people) are:

• lower than normal levels of white blood cells (which help fight infections) and platelets (which allow blood to clot)
• skin discoloration (red or purplish), which may be caused by reduced platelets, or other changes in blood cells
• changes in blood chemistry (high cholesterol, high fat levels)
• low potassium levels in the blood
• chills
• abnormal electrocardiogram (ECG), changes in heart rhythm and rate
• 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.

Frequency not known, but possible (frequency cannot be estimated from the available data):

• hypersensitivity reaction with rash, fever, swollen glands, increase in a type of white blood cell (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 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects 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 stated on the label after "Exp.".
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 no longer required. This will help protect the environment.

6. Package contents and other information

What Klaider 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 monohydrate, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.

Capsule coating: gelatin, titanium dioxide (E 171), iron oxide yellow (E172) (only in
100 mg capsules).
Description of the appearance of Klaider 100 mg, 150 mg and 200 mg hard capsules and contents of the
pack
Klaider 100 mg hard capsules are available in blisters of 10 capsules of 100 mg.
Klaider 150 mg hard capsules are available in blisters of 2 capsules of 150 mg.
Klaider 200 mg hard capsules are available in blisters of 7 capsules of 200 mg.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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)