Tedim

PACKAGE LEAFLET: INFORMATION FOR THE USER

TEDIM 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Fluconazole
Please read all of 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

What TEDIM is and what it is used for
TEDIM belongs to a group of medicines called "antifungals".
The active substance is fluconazole.
TEDIM 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

TEDIM 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

TEDIM 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 TEDIM

Do not take TEDIM

• 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 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 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 Tedim

• if you have liver or kidney problems
• if you suffer from heart diseases, including cardiac 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, 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, skin peeling, blisters, and/or mouth ulcers after taking fluconazole.

Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported with fluconazole treatment. Stop taking Tedim and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.

Other medicines and TEDIM
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 cardiac arrhythmias), or erythromycin (an antibiotic used to treat bacterial infections), as these must not be taken with TEDIM (see section: “Do not take TEDIM”).

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

• 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 hypertension - 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 "arrhythmias", irregular heartbeats)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used to treat blood cancer)
• lurasidone (used to treat schizophrenia).

TEDIM with food and drinks
You may take this medicine with or without food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or 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 assess the need for appropriate contraception during treatment, which should continue for one week after the last dose.

Do not take TEDIM if you are pregnant, think you may be pregnant, or are planning a pregnancy, unless instructed by 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 of congenital malformations affecting the baby's heart, bones, and/or muscles.

Cases of infants born with birth defects involving 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 daily) of fluconazole for coccidioidomycosis. The causal link between fluconazole and these cases is not fully established.

You may continue breastfeeding after taking a single 150 mg dose of Tedim.

You must not breastfeed if you are taking repeated doses of Tedim.

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

TEDIM contains lactose (milk sugar) and sodium (salt)
This medicine contains a small amount of lactose (milk sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Tedim capsules contain less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially 'sodium-free'.

3. How to take TEDIM

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. It is best 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 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.
Use in elderly patients
The same dose as that recommended for adults should be used, unless you have renal problems.
Patients with renal impairment
Your doctor may adjust the dosage according to kidney function.
If you take more TEDIM 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, seeing, hearing, or thinking things that are not real (hallucinations and paranoid behavior). Symptomatic treatment may be required (with appropriate supportive measures and, if necessary, gastric lavage).
If you forget to take TEDIM
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 almost time for your next dose, skip the missed dose and take the next dose at the regular scheduled 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.
Stop taking TEDIM 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 serious allergic reactions are rare.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. If you develop 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 patches
• skin rashes
• severe skin reactions, for example rashes causing blisters (which may affect the mouth and tongue).

TEDIM 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 TEDIM 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 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, difficulty digesting, 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 defend against infections, and of platelets, which enable blood clotting
• altered skin colouration (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 rashes with widespread blistering and skin peeling, 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, consult your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TEDIM

• 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. PACK CONTENTS AND OTHER INFORMATION

What TEDIM contains
TEDIM 100 mg hard capsules
1 capsule contains:
Active substance: fluconazole 100 mg
Excipients: lactose monohydrate, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.
Capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172).

TEDIM 150 mg hard capsules
1 capsule contains:
Active substance: fluconazole 150 mg
Excipients: lactose monohydrate, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.
Capsule shell: gelatin, titanium dioxide (E 171).

TEDIM 200 mg hard capsules
1 capsule contains:
Active substance: fluconazole 200 mg
Excipients: lactose monohydrate, pregelatinized starch, magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.
Capsule shell: gelatin, titanium dioxide (E 171).

Description of the appearance and pack contents
Hard capsules.

• Box containing 10 capsules of 100 mg.
• Box containing 2 capsules of 150 mg.
• Box containing 7 capsules of 200 mg.

Marketing Authorization Holder
Dymalife Pharmaceutical Srl – Via Bagnulo, 95 – 80063 Piano di Sorrento NA

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l.
Via Dante Alighieri, 71
18038 Sanremo (Imperia)
Lachifarma Srl
S.S. 16 Adriatica
Zona Industriale I-
73010 Zollino (LE)

Final Controller
Laboratorio Farmaceutico C.T. S.r.l.
Via Ariosto, 17
18038 Sanremo (Imperia)
Lachifarma Srl
S.S. 16 Adriatica
Zona Industriale I-
73010 Zollino (LE)

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