TERBINAFINA 250 mg Coated Tablet

Зміст інструкції

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

Terbinafina Mylan Generics 250 mg tablets

terbinafina (as hydrochloride)

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 their symptoms are the same as yours, as it could 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 Terbinafina Mylan Generics is and what it is used for
• 2. What you need to know before you take Terbinafina Mylan Generics
• 3. How to take Terbinafina Mylan Generics
• 4. Possible side effects
• 5. How to store Terbinafina Mylan Generics 6 Contents of the pack and other information

1. What Terbinafina Mylan Generics is and what it is used for

Terbinafina Mylan Generics contains the active ingredient terbinafina, which belongs to a group
of medicines called antifungals. It works against certain fungi of the skin, hair and nails and against some yeasts.
Terbinafina Mylan Generics may have been prescribed by your doctor for some fungal infections:

• of the skin, legs or groin, soles of the feet or skin between the toes
• if local treatment (e.g. with creams) is not sufficiently effective
• of the nails
• or of the scalp.

2. What you need to know before taking Terbinafina Mylan Generics

Do not take Terbinafina Mylan Generics:

• if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6)
• if you have a severe liver problem
• if you have a severe kidney problem

Warnings and precautions
Talk to your doctor or pharmacist before taking Terbinafina Mylan Generics

• if you have other (non-serious) liver problems: taking terbinafine may not be recommended. You need to undergo blood tests before and during treatment with terbinafine to monitor your liver function
• if you have reduced kidney function: taking terbinafine may not be recommended
• if you suffer from psoriasis, a skin condition that causes scaly red patches: in very rare cases this skin condition may worsen (see also section 4)
• if you have a condition called systemic lupus erythematosus (SLE).

Tell your doctor if any of these warnings apply to you or have applied to you in the past.
During treatment:
If you notice any of the following during treatment with Terbinafina Mylan Generics:

• symptoms that may indicate a liver problem such as a persistent feeling of unwellness (nausea), stomach pain, loss of appetite, fatigue, vomiting, yellowing of the skin or eyes, dark urine or pale stools.
• high fever or sore throat, severe stinging, severe skin diseases or skin diseases with severe blisters and peeling of the skin and bleeding in the lips, eyes, mouth, nose and genitals.
• symptoms that suggest an allergic condition that can cause joint pain, skin rashes and fever
• symptoms that may indicate a blood disorder, for example, if you bleed or bruise more easily than normal or if you are more prone to infections.

In these cases stopusing Terbinafina Mylan Generics immediately and consult your
doctor (see also section 4);

Other medicines and Terbinafina Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription or any of the
following:

• cimetidine, used to treat stomach ulcers
• other medicines used to treat fungal infections such as fluconazole, ketoconazole
• rifampicin, used to treat infections
• caffeine
• some medicines for depression such as tricyclic antidepressants (e.g. desipramine, amitriptyline) and selective serotonin reuptake inhibitors (SSRIs) (e.g. citalopram, fluoxetine)
• some medicines given for high blood pressure, some heart conditions, including problems with heart rhythm or increased pressure in the eye such as beta-blockers (e.g. atenolol, propranolol) and antiarrhythmics (e.g. amiodarone, flecainide)
• some medicines given for Parkinson's disease such as monoamine oxidase inhibitors type B (e.g. selegiline)
• oral contraceptives (the “pill”): in some women, irregular periods and/or bleeding between periods may occur
• cyclosporine, a medicine used to control the immune system in order to prevent rejection of transplanted organs
• warfarin, a medicine used to thin the blood
• dextromethorphan, a medicine used to treat cough.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning
to become pregnant, ask your doctor or pharmacist for advice before taking this
medicine.

Pregnancy
The effects of terbinafine during pregnancy are not known. Therefore, Terbinafina Mylan
Generics should not be taken during pregnancy, except on explicit instructions
from your doctor.

Breastfeeding
Terbinafine passes into breast milk, therefore you should not take Terbinafina Mylan Generics
while breastfeeding.

Fertility
Studies on fertility in animals have not shown any adverse effects.

Driving and using machines
If you feel dizzy or lightheaded, you should avoid driving vehicles or using
machinery.

3. How to take Terbinafina Mylan Generics

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The tablet can be divided into equal doses.

Use in adults (including the elderly)
The recommended dose is one 250 mg tablet per day.

Use in children starting from 2 years of age
Other forms of this medicine may be more suitable for children; ask your doctor or
pharmacist.

Body weight between 15 and 20 kg
The recommended dose is 62.5 mg per day. This dosage cannot be provided by
Terbinafina Mylan Generics 250 mg tablets. For this dose, other
products containing terbinafine must be used.

Body weight between 20 and 40 kg
The recommended dose is 125 mg per day (half a 250 mg tablet).

Body weight greater than 40 kg
The recommended dose is 250 mg per day (one 250 mg tablet).

Patients with reduced kidney or liver function
The use of terbinafine is not recommended.
Follow the above instructions unless your doctor has given you a different prescription.

Method of administration
Take a tablet placing it on the back of your tongue and swallow it with a sufficient amount of
water. Terbinafina Mylan Generics can be taken with or without food.

Frequency of administration
Remember to take the medicine and complete the treatment cycle to ensure that
the fungal or yeast infection has been completely treated. Taking the tablet every
day at the same time ensures the best effect. This helps you remember when to take
the tablets.

Duration of treatment
The duration of treatment with terbinafine depends on the type and severity of the fungal
infection. The treatment of skin infections usually lasts from 2 to 6 weeks. The treatment of
hair and scalp infections usually lasts 4 weeks. The treatment of
nail infections usually lasts from 6 to 12 weeks. In some patients, treatment for
foot nail infections may require treatment for up to six months or more.
Several weeks may pass after stopping treatment for the complete disappearance
of symptoms and signs.

If you take more Terbinafina Mylan Generics than you should
If you take more tablets than you should, contact your doctor or pharmacist immediately. The
most common symptoms of an overdose of up to 5 grams are: headache, feeling
unwell, stomach pain and dizziness.

If you forget to take Terbinafina Mylan Generics
Take the dose if there is still time before the next dose. Do not take a double dose to
make up for a missed dose. Terbinafina Mylan Generics can only be taken
once a day.

If you stop taking Terbinafina Mylan Generics
Your doctor will tell you how long you need to take Terbinafina Mylan Generics. If you stop too
early, the infection caused by the fungus or yeast may not be completely cured. In this
case, the symptoms will not disappear.
If you have any doubts 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.

If you notice any of the following symptoms, stop taking Terbinafina Mylan Generics
and immediately tell your doctor or go to the nearest hospital emergency room:
Uncommon (may affect up to 1 in 100 people):

• reduction in red blood cells which can make the skin pale and cause weakness or shortness of breath (anemia).

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

• serious liver problems that can cause symptoms such as persistent feeling unwell (nausea), stomach pain, loss of appetite, fatigue, vomiting, yellowing of the skin or eyes, dark urine or pale stools, itchy skin, general feeling of being unwell
• severe skin conditions that can cause severe blisters and bleeding on the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome) or that may start with painful red areas, then with large blisters and end with peeling off layers of skin (toxic epidermal necrolysis)
• blood abnormalities associated with increased susceptibility to infections (neutropenia), reduced platelet count which increases the risk of bleeding or bruising (thrombocytopenia).

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

• severe skin conditions that can affect the mouth and other parts of the body (erythema multiforme)
• blistering dermatitis (bullous dermatitis) or dermatitis with scaling or flaking of the skin (exfoliative dermatitis)
• severe allergic reactions with dizziness, swelling of the skin or face, lips, tongue and/or throat, which can cause difficulty breathing or swallowing
• onset or worsening of systemic lupus erythematosus (SLE), an allergic reaction that causes joint pain, skin rash and fever
• high fever, severe sore throat and ulcers in the mouth (agranulocytosis) or a severe reduction in blood cells that can cause weakness, bruising or make infections more likely (pancytopenia).

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

• abnormal muscle breakdown (weakness or pain) that can lead to kidney problems (rhabdomyolysis)
• inflammation of the pancreas that causes severe pain in the abdomen and back (pancreatitis)
• severe allergic reaction that can cause fever, swelling, rash, enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms).

These side effects are serious. You may need medical attention.

Other possible side effects
Very common(may affect more than 1 in 10 people):

• headache
• loss of appetite
• stomach bloating
• feeling unwell (nausea)
• indigestion
• stomach pain
• diarrhoea
• skin rash or hives
• muscle or joint pain.

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

• fatigue, general feeling of being unwell
• depression
• reduced vision
• taste disturbances, including reduced or loss of taste, usually reversible after stopping treatment
• dizziness

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

• tingling (paresthesia), decreased sensitivity (hypoesthesia)
• anxiety
• ringing in the ears (tinnitus)
• increased sensitivity of the skin to light, including rash
• fever
• weight loss, following taste disturbances.

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

• increased liver enzymes (can be detected by blood tests)

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

• acute generalized pustular psoriasis (symptoms manifest with skin becoming red with swollen areas covered with numerous small pustules)
• skin rashes similar to psoriasis or worsening of psoriasis (rash with thickened patches of red skin, often with silvery scaling)
• hair loss
• in some women irregular periods, bleeding between normal periods
• depression, following taste disturbances.

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

• reduced sense of smell or loss of smell which can sometimes be permanent
• loss or reduction of hearing
• blurred vision
• inflammation of blood vessels, often with skin rash (vasculitis)
• flu-like illness
• increased levels in the blood of an enzyme called creatine phosphokinase (can be measured with a blood test).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly to
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Terbinafina Mylan Generics

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 or the packaging
after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special 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 Terbinafina Mylan Generics contains
The active ingredient is: terbinafine hydrochloride equivalent to 250 mg of terbinafine.
The other ingredients (excipients) are: microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silicon dioxide, magnesium stearate, povidone and talc.

Description of the appearance ofTerbinafina Mylan Genericsand contents of the pack
The tablets of Terbinafina Mylan Generics are round and white to off-white in colour
marked with “TF fracture line 250” on one side and “G” on the other side. Terbinafina Mylan
Generics is available in blisters of 6, 7, 8, 14, 28, 30, 42, 50, 56, 60, 90 and 98 tablets or in
bottles of 100, 250 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan

Manufacturer
Mylan Hungary Kft./Mylan Hungary Ltd.,
Mylan utca 1., Komárom, 2900,
Hungary

This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:
Netherlands Terbinafine Viatris 250 mg, tablets
Italy Terbinafina Mylan Generics 250 mg
Slovakia Terbinafin Viatris 250 mg