MICUTAN 250 mg Coated Tablet

Зміст інструкції

1. MICUTAN 250 mg tablets
   1. What is MICUTAN and what is it used for
   2. What you need to know before taking MICUTAN
   3. How to take MICUTAN
   4. Possible side effects
   5. How to store MICUTAN
   6. Contents of the pack and other information

MICUTAN 250 mg tablets

terbinafine hydrochloride
generic medicine

Read this leaflet carefully before you start 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 MICUTAN is and what it is used for
• 2. What you need to know before you take MICUTAN
• 3. How to take MICUTAN
• 4. Possible side effects
• 5. How to store MICUTAN
• 6. Contents of the pack and other information

1. What is MICUTAN and what is it used for

MICUTAN contains the active substance terbinafine hydrochloride.
Terbinafine belongs to a group of medicines known as antimycotics.

MICUTAN is used in adults and children over 2 years of age for the treatment of:

• Skin infections of a fungal type caused by parasitic fungi that infect the skin (dermatophytes) such as: o Tinea corporis (fungal infection spread all over the skin except on the head, hands, feet or groin. This infection particularly affects glabrous areas of the skin); o Tinea cruris (fungal infection at the groin level) o Tinea pedis (commonly known as Athlete's Foot - a fungal infection of the foot. This infection particularly affects the skin areas between the toes). o Tinea capitis.
• Skin infections caused by yeasts, supported for example by the Candida genus.
• Nail infections (onychomycosis) caused by parasitic fungi that infect the skin (dermatophytes).

MICUTAN is not effective against Pityriasis versicolor (skin infection caused by yeasts).

2. What you need to know before taking MICUTAN

Do not take MICUTAN:

• If you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from active or chronic liver disease (when the disease persists for a long time and the liver does not work well)
• If you suffer from kidney disease, your doctor will tell you if you can take this medicine.
• If you are pregnant or if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
• The use of MICUTAN is contraindicated in children under 2 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking MICUTAN.
Before starting treatment with MICUTAN, the doctor must check for any pre-existing liver problems,
or establish if you currently suffer from a liver disease, because in very rare cases
MICUTAN can lead to liver failure in patients with or without previous liver disease (see
also sections 2. “Do not take MICUTAN” and 4. “Possible side effects”).
Contact your doctor immediately if you experience the following symptoms:

• itching (tingling);
• feeling unwell without an obvious cause (persistent unexplained nausea);
• loss of appetite (anorexia);
• fatigue;
• jaundice (yellowing of the skin or whites of the eyes);
• vomiting;
• abdominal pain (pain in the abdomen);
• dark urine;
• pale stools;
• severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms);
• blood disorders (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia).

Do not take MICUTAN if you have a history of psoriasis or lupus erythematosus.

Children
MICUTAN should not be administered to children under 2 years of age and weighing less than 12 kg.

Other medicines and MICUTAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
MICUTAN influences the way the liver removes certain other medicines from the body. These medicines
are listed in the following section. Your doctor is aware of these medicines and will adjust the dosage if
necessary.

Medicines that affect MICUTAN:

• rifampicin (antibiotic used to treat infections such as tuberculosis). Rifampicin can reduce the effect of terbinafine;
• cimetidine (used to treat certain diseases of the stomach or intestines). Cimetidine can enhance the effect of terbinafine;
• fluconazole or ketoconazole (medicines used to treat fungal infections);
• amiodarone (used in the treatment of heart rhythm).

Medicines that are affected by MICUTAN:

• some antidepressants:
• tricyclic antidepressants (e.g. amitriptyline, clomipramine, imipramine, desipramine);
• selective serotonin reuptake inhibitors (SSRIs, e.g. citalopram, escitalopram, fluoxetine);
• beta-blockers (used to treat high blood pressure) (e.g. atenolol, propranolol, bisoprolol);
• antiarrhythmics (used in the treatment of heart rhythm);
• monoamine oxidase inhibitors type B (used to treat Parkinson's disease);
• caffeine;
• cyclosporine (used to prevent transplant rejection).

The use of oral contraceptives simultaneously with terbinafine may cause irregular menstrual cycles.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
MICUTAN should not be used during pregnancy unless the woman's clinical condition makes
treatment with oral terbinafine necessary and the potential benefits to the mother outweigh the
potential risks to the fetus; the doctor will assess the risk/benefit.
Breastfeeding
Terbinafine is excreted in breast milk; therefore, terbinafine should not be used during breastfeeding.
Fertility
No adverse effects are known.

Driving and using machines
It is not known whether MICUTAN has a significant effect on your ability to drive or operate
machinery. If you experience dizziness while taking MICUTAN, do not drive or operate machinery.

MICUTAN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take MICUTAN

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor.

Adults
Fungal skin infections ( Tinea pedisinterdigitale, plantar and/or moccasin type, Tinea corporis, Tinea

crurisand Cutaneous Candidiasis): 1 tablet of 250 mg once a day, for 2 weeks.
Onychomycosis :1 tablet of 250 mg once a day. For most patients, the duration of
treatment is between 6 and 12 weeks: 6 weeks of therapy are generally sufficient in case of
onychomycosis of the fingers, 12 weeks for the treatment of onychomycosis of the toes.

Children over 2 years of age with a weight greater than 12 kg
Daily dose
Body weight Dosage
Less than 20 kg 62.5 mg
Between 20 and 40 kg 125 mg
More than 40 kg 250 mg
Recommended duration of treatment:

Tinea pedis(interdigitale, plantar and/or moccasin type): 2 - 6 weeks

Tinea corporis, cruris: 2 - 4 weeks
Cutaneous Candidiasis: 2 - 4 weeks

Tinea capitis:2 - 4 weeks
Onychomycosis: 6 - 12 weeks
Onychomycosis of the fingers: 6 weeks
Onychomycosis of the toes: 12 weeks
Note :in children, Tinea capitisis mainly found.
The duration of oral treatment varies depending on the type and severity of the infection and may
eventually be increased at the doctor's discretion. Complete resolution of signs and symptoms
of the infection may occur several weeks after mycological healing.

If you take more MICUTAN than you should
If you accidentally take too many tablets, seek immediate medical attention or go to the nearest Emergency Room.
In the most severe cases, gastric lavage may be necessary.
Some cases of overdose have been reported with the appearance of headache, nausea, pain in the
upper abdomen and dizziness.

If you forget to take MICUTAN
If you forget to take a dose of MICUTAN, take the next one at the usual time. Do not take a
double dose to make up for the missed dose.

If you stop taking MICUTAN
Do not stop or change your treatment without consulting your doctor, even if your
symptoms improve.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In general, terbinafina compresse is well tolerated. The side effects observed are usually mild to
moderate and transient. The following adverse reactions have been observed during clinical studies or
in post-marketing experience.

Very common (may affect up to 1 in 10 people):

• Reduced appetite
• Abdominal distension (feeling of fullness)
• Abdominal bloating
• Dyspepsia, nausea
• Abdominal pain
• Diarrhoea
• Skin rash, urticaria
• Arthralgia, myalgia

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

• Headache

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

• Hypogeusia, ageusia (inability to recognise tastes)

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

• Hepatic insufficiency, increased liver enzymes
• Hepatobiliary dysfunction (mostly of a cholestatic nature)
• Severe hepatic insufficiency (also with fatal outcome)

Very rare (may affect up to 1 in 10,000 people):

• Neutropenia, agranulocytosis, thrombocytopenia, pancytopenia
• Anaphylactoid reactions, including angioedema. Cutaneous and systemic lupus erythematosus
• Dizziness, paraesthesia and hypoesthesia
• Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis (AGEP)
• Psoriasiform eruptions or exacerbations of psoriasis
• Alopecia (hair loss)
• Fatigue

Not known (frequency cannot be estimated from available data):

• Anaemia
• Anaphylactic reactions, serum sickness-like reactions
• Anxiety, depression
• Anosmia (inability to smell odours)
• Hearing impairment, hearing disorders, tinnitus
• Vasculitis
• Pancreatitis
• Hepatitis, jaundice, cholestasis
• Photosensitivity reactions, photodermatosis, allergic photosensitivity reactions and polymorphous light eruption
• Rhabdomyolysis
• Flu-like syndrome, fever
• Increased blood creatine phosphokinase, decreased weight

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. 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 MICUTAN

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 use this medicine if you notice visible signs of deterioration.
This medicine does not require any particular storage conditions.
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 MICUTAN contains

• The active ingredient is terbinafine 250 mg (as terbinafine hydrochloride).
• The other ingredients are: hypromellose, microcrystalline cellulose, sodium starch glycolate Type A, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of MICUTAN and contents of the pack
MICUTAN tablets are white or almost white, round, biconvex, with a break line.
The notch on the tablet is to facilitate breaking it to make swallowing easier and not to divide it into equal doses.
MICUTAN is available in packs of 8 tablets of 250 mg in blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GIULIANI S.p. A – Via Palagi, 2 - 20129 - Milano

Manufacturer:
Special Product's Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)