Micutan

Package leaflet: Information for the user

MICUTAN 250 mg tablets

terbinafine hydrochloride
equivalent 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 taking 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 MICUTAN is and what it is used for

MICUTAN contains the active substance terbinafine hydrochloride.
Terbinafine belongs to a group of medicines known as antifungal agents.
MICUTAN is used in adults and children over 2 years of age for the treatment of:

• Fungal skin infections caused by parasitic fungi that infect the skin (dermatophytes), such as:
  o Tinea corporis (fungal infection affecting any part of the skin except the scalp, hands, feet or groin. This infection particularly affects smooth skin areas);
  o Tinea cruris (fungal infection of the groin area);
  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, for example, species of the genus Candida.
• Nail infections (onychomycosis) caused by parasitic fungi that infect the skin (dermatophytes).

MICUTAN is not effective against Pityriasis versicolor (a 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 to any of the other ingredients of this medicine (listed in section 6).
• If you have active or chronic liver disease (when the disease has persisted for a long time and the liver does not function properly).
• If you have kidney disease, your doctor will advise you whether you can take this medicine.
• If you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
• The use of MICUTAN is contraindicated in children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking MICUTAN.
Before starting treatment with MICUTAN, your doctor must check for any pre-existing liver problems or determine whether you currently have liver disease, as in very rare cases MICUTAN may 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 any of the following symptoms:

• itching (pruritus);
• general feeling of illness without an obvious cause (unexplained persistent nausea);
• loss of appetite (anorexia);
• fatigue;
• jaundice (yellowing of the skin or whites of the eyes);
• vomiting;
• abdominal pain;
• 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 systemic lupus erythematosus.
Children
MICUTAN must not be administered to children under 2 years of age and weighing less than 12 kg.
Other medicines and MICUTAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
MICUTAN affects how the liver removes certain other medicines from the body. These medicines are listed in the section below. Your doctor is aware of these medicines and will adjust the dosage if necessary.
Medicines that affect MICUTAN:

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

Medicines affected by MICUTAN:

• certain antidepressants:
• tricyclic antidepressants (e.g. amitriptiline, 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 disorders);
• monoamine oxidase type B inhibitors (used to treat Parkinson’s disease);
• caffeine;
• ciclosporin (used to prevent transplant rejection).

The use of oral contraceptives together with terbinafine may lead to irregular menstrual cycles.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
MICUTAN must not be used during pregnancy unless the woman’s clinical condition requires oral treatment with terbinafine and the potential benefits to the mother outweigh the potential risks to the fetus; your doctor will evaluate the risk/benefit ratio.
Breastfeeding
Terbinafine is excreted in breast milk; therefore, terbinafine must not be used during breastfeeding.
Fertility
Adverse effects are unknown.
Driving and using machines
It is unknown whether MICUTAN has a significant effect on your ability to drive or use 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 exactly as directed by your doctor. If you have any doubts, consult your doctor.

Adults
Cutaneous fungal infections (Tinea pedis interdigital, plantar and/or moccasin type, Tinea corporis, Tinea cruris, and cutaneous candidiasis): 1 tablet of 250 mg once daily for 2 weeks.

Onychomycosis: 1 tablet of 250 mg once daily. For most patients, the duration of treatment ranges between 6 and 12 weeks: 6 weeks of therapy are generally sufficient for onychomycosis of the fingernails, 12 weeks for toenail onychomycosis.

Children over 2 years of age and weighing more than 12 kg
Daily dose
Body weight Dosage
Less than 20 kg 62.5 mg
Between 20 and 40 kg 125 mg
Over 40 kg 250 mg

Recommended duration of treatment:
Tinea pedis (interdigital, plantar and/or moccasin type): 2–6 weeks
Tinea corporis, Tinea cruris: 2–4 weeks
Cutaneous candidiasis: 2–4 weeks
Tinea capitis: 2–4 weeks
Onychomycosis: 6–12 weeks
Fingernail onychomycosis: 6 weeks
Toenail onychomycosis: 12 weeks

Note: Tinea capitis is the most common fungal infection in children.

The duration of oral treatment may vary depending on the type and severity of the infection and may be extended at the discretion of the physician. Complete resolution of signs and symptoms of infection may occur several weeks after mycological cure.

If you take more MICUTAN than you should
If you accidentally take too many tablets, contact your doctor or the nearest Emergency Department immediately. In severe cases, gastric lavage may be required.
Cases of overdose have been reported, with symptoms including headache, nausea, upper abdominal pain, and dizziness.

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

If you stop taking MICUTAN
Do not stop or modify 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.
Generally, terbinafine tablets are well tolerated. The adverse effects observed are usually mild to moderate and transient. The following adverse reactions have been reported during clinical studies or from post-marketing experience.

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

• Decreased appetite
• Abdominal distension (feeling of gastric fullness)
• Abdominal swelling
• 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 (loss of ability to taste)

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

• Hepatic failure, increased liver enzymes
• Hepatobiliary dysfunction (mostly of cholestatic nature)
• Severe hepatic failure (including fatal outcomes)

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, paresthesia and hypoesthesia
• Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP)
• Psoriasiform rashes or exacerbations of psoriasis
• Alopecia (hair loss)
• Fatigue

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

• Anaemia
• Anaphylactic reactions, serum sickness-like reactions
• Anxiety, depression
• Anosmia (loss of ability to smell)
• Hypacusis, hearing disorders, tinnitus
• Vasculitis
• Pancreatitis
• Hepatitis, jaundice, cholestasis
• Photosensitivity reactions, photodermatitis, allergic photosensitivity reactions and polymorphic light eruption
• Rhabdomyolysis
• Influenza-like syndrome, fever
• Increased blood creatine phosphokinase, weight decreased

Reporting of side effects
If you experience any side effects, 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.
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 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 any visible signs of deterioration.
This medicine requires no special storage conditions.
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 MICUTAN contains

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

Description of the appearance of MICUTAN and package contents
MICUTAN tablets are white or almost white, round, biconvex, with a breakline.
The score line on the tablet is intended to facilitate breaking for easier swallowing and is not intended to divide the tablet into equal doses.
MICUTAN is available in packs of 8 tablets of 250 mg in blister packs.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GIULIANI S.p.A. – Via Palagi, 2 - 20129 - Milan
Manufacturer:
Special Product's Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)