TRIMIKOS 100 mg Hard Capsule

Содержание инструкции

1. Trimikos 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   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 Undesirable Effects
   5. How to store Trimikos
   6. Contents of the pack and other information

Trimikos 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole
Generic Medicine

Read this leaflet carefully before taking this medicine as 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 Trimikos is and what it is used for
• 2. What you need to know before you take 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 called “antifungals”. The active substance is
fluconazole.
Trimikos 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 (for example heart, lungs) or in the urinary tract;
• oral candidiasis - infection of the oral mucosa, throat infection and inflammation of the mouth from dentures;
• genital candidiasis - infection of the vagina or penis;
• skin infections - for example athlete's foot, ringworm, itching in the genital area, nail infections.

Trimikos may be prescribed for:

• preventing the recurrence of cryptococcal meningitis;
• preventing the recurrence of oral candidiasis;
• 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:

• oral candidiasis - infection of the oral mucosa, throat infection;
• infections caused by Candidaand found in the bloodstream, in organs (for example heart, lungs) or in the urinary tract;
• cryptococcal meningitis - a fungal infection of the brain. Trimikos 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 Trimikos

Do not take Trimikos

• 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 ingredients 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 Trimikos:

• if you have ever developed a severe rash or skin exfoliation, blisters and/or mouth ulcers after taking Trimikos. Severe skin reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) related to treatment with Trimikos have been reported. Stop taking Trimikos and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.
• if the fungal infection does not improve, an alternative antifungal therapy may be necessary.

Tell your doctor especially if

• you have problems with your liver or kidneys;
• you suffer from heart disease, including heart arrhythmia;
• you have abnormal levels of potassium or magnesium in your blood;
• severe skin reactions appear (itching, redness of the skin or difficulty in breathing);
• you develop signs of “adrenal insufficiency” where the adrenal glands do not produce an adequate amount of certain steroid hormones such as cortisol (chronic, or prolonged fatigue, 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, even those available without a prescription.
Tell your doctor immediately if 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 Trimikos (see section: “Do not
take Trimikos”).
There are some medicines that can interact with Trimikos. Tell your doctor if you are taking
any of the following medicines:

• rifampicin or rifabutin (antibiotics for the treatment of 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 seizures);
• nifedipine, isradipine, amlodipine, felodipine and losartan (used to treat hypertension - high blood pressure);
• cyclosporine, everolimus, sirolimus or tacrolimus (used to prevent organ 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 (steroid);
• zidovudine, also known as AZT; saquinavir (used in patients with HIV);
• 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 (diuretic).

Trimikos with food and drink
You can take this medicine with or without food.

Pregnancy and breastfeeding
Do not take Trimikos if you are pregnant, suspect you may be pregnant or are planning a pregnancy, or
if you are breastfeeding, unless your doctor tells you to.
Fluconazole taken during the first trimester of pregnancy may increase the risk of
miscarriage. Fluconazole taken at low doses during the first trimester may slightly increase
the risk that the baby is born with malformations of bones and/or
muscles.

Driving and using machines
You should be aware that dizziness or convulsions may occur during therapy with
Trimikos, therefore it is not recommended to drive vehicles or use machines if
you experience these symptoms.

Trimikos contains lactose
This medicine contains a small amount of lactose. If you have been diagnosed with
lactose intolerance, contact your doctor before taking this medicine.

3. How to take Trimikos

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have 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
below:

Adults

Use in adolescents aged 12 to 17 years
Always take the dose prescribed by your doctor (either the adult dose or the children's dose).

Use in children up to 11 years
The maximum dose in children is 400 mg per day.
The dose will be based on the child's weight in kilograms.

Use in newborns aged 0 to 4 weeks
Use in newborns 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 newborns 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.

Use in the elderly
The same dose as provided for adults should be used unless you have kidney problems.

Use in patients with kidney damage
Your doctor may adjust the dosage based on kidney function.

If you take more Trimikos than you should
Taking too many capsules all at once could cause you problems. Immediately warn
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 may be appropriate (with adequate supportive measures and possibly
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 time to take the next dose,
do not take the dose you forgot.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible Undesirable Effects

Like all medicines, this medicine can cause undesirable effects, although not everybody gets them.
Some people experience allergic reactionsalthough serious allergic reactions are rare. 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;
• skin rashes;
• severe skin reactions, for example, rashes that cause blisters (may affect the mouth and tongue).

Trimikos may 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 Trimikos and inform your doctor immediately.

Stop taking Trimikos and see 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).

Other Undesirable Effects:
Undesirable effects common(may affect up to 1 in 10 people):

• headache;
• stomach discomfort, diarrhea, nausea, vomiting;
• increases in liver function values in blood tests;
• skin rashes.

Undesirable effects uncommon(may affect up to 1 in 100 people):

• 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.

Undesirable effects rare(may affect up to 1 in 1,000 people):

• lower than normal levels of white blood cells, which help defend against infections, and platelets, which make blood clotting possible;
• 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;
• shivering;
• 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.

Reporting of Undesirable Effects
If you get any side effects, even those not listed in this leaflet, tell 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 Trimikos

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. 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 wastewater 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 Trimikos contains

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

Description of the appearance of Trimikos and contents of the pack
Trimikos 100 mg hard capsules are yellow in colour. 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 Authorisation Holder
Euro-Pharma S.r.l. - Via Garzigliana, 8 - 10127 Torino

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - 18038 Sanremo (Imperia)