Trimikos

Package leaflet: Information for the user

Trimikos 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, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Trimikos is and what it is used for

Trimikos belongs to a group of medicines known as "antifungals". The active substance is fluconazole.
Trimikos is used to treat fungal infections and may 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;
• Candida infections 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 – for example, athlete's foot, ringworm, genital itching, nail infections.

Trimikos may be prescribed to you to:

• prevent recurrence of cryptococcal meningitis;
• prevent recurrence of mucosal candidiasis;
• reduce recurrences of vaginal candidiasis;
• 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;

• Candida infections found in the bloodstream, organs (e.g. heart, lungs), or urinary tract;

• cryptococcal meningitis – a fungal infection of the brain. Trimikos may be prescribed to you to:

• prevent Candida infections (if your immune system is weakened or not functioning properly);

• prevent recurrence of cryptococcal meningitis.

2. What you need to know before taking Trimikos

Do not take Trimikos

• 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 (antihistamine medicines 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 Trimikos:

• if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Trimikos. Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Trimikos treatment. Stop taking Trimikos and contact your doctor immediately if you notice any of the symptoms related to serious skin reactions described in section 4.
• if the fungal infection does not improve, alternative antifungal therapy may be necessary.

Tell your doctor especially if

• you have liver or kidney problems;
• you suffer from heart diseases, including cardiac arrhythmia;
• you have abnormal levels of potassium or magnesium in your blood;
• you experience severe skin reactions (itching, skin redness, or difficulty breathing);
• you develop signs of "adrenal insufficiency", in which the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic fatigue, prolonged tiredness, muscle weakness, loss of appetite, weight loss, abdominal pain).

Other medicines and Trimikos
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, 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 Trimikos (see section: "Do not take Trimikos").
Some medicines may interact with Trimikos. Inform your doctor if you are taking any of the following medicines:

• rifampicin or rifabutin (antibiotics used to treat bacterial infections);
• alfentanil, fentanyl (anesthetics);
• amitriptyline, nortriptyline (antidepressants);
• amphotericin B, voriconazole (antifungals);
• medicines that thin the blood to prevent clotting (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);
• medicines for diabetes such as chlorpropamide, glipizide, or tolbutamide;
• theophylline (used to control asthma);
• vitamin A (dietary supplement);
• amiodarone (used to treat irregular heartbeat "arrhythmias");
• hydrochlorothiazide (a diuretic).

Trimikos with food and drinks
You may take this medicine with or without food.
Pregnancy and breastfeeding
Do not take Trimikos if you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, unless otherwise instructed by your doctor.
Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage. Low-dose fluconazole taken during the first trimester may slightly increase the risk of the baby being born with bone and/or muscle malformations.
Driving and using machines
Please be aware that dizziness or seizures may occur during treatment with Trimikos; therefore, driving vehicles or operating machinery is not recommended if you experience these symptoms.
Trimikos contains lactose
This medicine contains a small amount of lactose. If your doctor has diagnosed you with an intolerance to certain sugars, please consult them before taking this medicine.

3. How to take Trimikos

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 recommended doses of this medicine, depending on the infection, are listed below:
Adults

Use in adolescents from 12 to 17 years of age
Always take the dose prescribed by your doctor (either the adult dose or the children's dose).
Use in children up to 11 years of age
The maximum dose in children is 400 mg per day.
The dose will be based on the child's weight in kilograms.

Use in neonates aged 0 to 4 weeks
Use in neonates aged 3 to 4 weeks:
The same dosage described above, administered once every 2 days. The maximum dose is
12 mg per kg of body weight every 48 hours.
Use in neonates younger than 2 weeks of age:
The same dosage described above, administered once every 3 days. The maximum dose is
12 mg per kg of body weight every 72 hours.

Use in elderly patients
The same dose as recommended for adults should be used, unless the patient has renal problems.

Use in patients with renal impairment
The doctor may adjust the dosage according to renal function.

If you take more Trimikos than you should
Taking too many capsules at once could cause problems. Contact your doctor immediately or go to the nearest hospital.
In case of accidental overdose, symptoms may include experiencing sensations, seeing, hearing, or 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 Trimikos
Do not take a double dose to make up for a missed capsule. 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 dose at the regular time.

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, inform 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).

Trimikos may affect the liver. Symptoms of liver problems include:

• Tiredness;
• Loss of appetite;
• Vomiting;
• Yellowing of the skin and whites of the eyes (jaundice). If you experience any of these symptoms, stop taking Trimikos and inform your doctor immediately.

Stop taking Trimikos 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).

Other side effects:
Common side effects (may affect up to 1 in 10 people):

• 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):

• Reduction in red blood cells, which may cause paleness, weakness or breathlessness;
• Decreased appetite;
• Insomnia, drowsiness;
• Seizures, dizziness, sensation of vertigo, tingling, prickling or numbness;
• Taste disturbances;
• 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 malaise, fever.

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

• Lower than normal levels of white blood cells, which help defend against infections, and of platelets, which are necessary for blood clotting;
• Skin discolouration (red or purplish), which may be caused by a reduction in platelets, 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 rhythm and heart rate;
• 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.

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 through the national reporting system at the website 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 Trimikos

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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Trimikos contains

• The active substance is fluconazole. Each hard capsule contains fluconazole 100 mg, 150 mg or 200 mg.
• The other components are: Capsule contents: monohydrate lactose, maize starch, anhydrous colloidal silica, magnesium stearate and sodium lauryl sulfate. Capsule shell contents: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) (only in 100 mg capsules).

Description of the appearance of Trimikos and package contents
Trimikos 100 mg hard capsules are yellow. The pack contains 10 capsules of 100 mg.
Trimikos 150 mg hard capsules are white. The pack contains 2 capsules of 150 mg.
Trimikos 200 mg hard capsules are white. The pack contains 7 capsules of 200 mg.
Marketing Authorization Holder
Euro-Pharma S.r.l. - Via Garzigliana, 8 - 10127 Turin
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (Imperia)