TERBINAFINE MYLAN GENERICS

Package leaflet: Information for the patient

Terbinafine Mylan Generics 250 mg tablets

terbinafine (as hydrochloride)
Generic medicine
Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Terbinafine Mylan Generics is and what it is used for
2. What you need to know before taking Terbinafine Mylan Generics
3. How to take Terbinafine Mylan Generics
4. Possible side effects
5. How to store Terbinafine 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 substance terbinafine, which belongs to a group
of medicines called antifungals. It acts against certain fungi affecting the skin, hair, and
nails, as well as against certain yeasts.
Terbinafina Mylan Generics may have been prescribed by your doctor for certain fungal infections:

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

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

Do not take Terbinafine Mylan Generics:

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

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

• if you have other (not severe) liver problems: taking terbinafine may not be recommended. You will need to have 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 have psoriasis, a skin condition causing red, scaly patches: in very rare cases, this skin condition may worsen (see also section 4)
• if you have a condition called systemic lupus erythematosus (SLE).

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

• symptoms that may indicate a liver problem, such as persistent 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 itching, serious skin disorders, or skin disorders with severe blistering and peeling of the skin and bleeding of the lips, eyes, mouth, nose, and genitals
• symptoms suggesting an allergic condition that may 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 such cases, stop using Terbinafine Mylan Generics immediately and consult your doctor (see also section 4).

Other medicines and Terbinafine Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those 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
• certain antidepressants such as tricyclic antidepressants (e.g. desipramine, amitriptyline) and selective serotonin reuptake inhibitors (SSRIs) (e.g. citalopram, fluoxetine)
• certain medicines for high blood pressure, heart conditions, including heart rhythm disorders or increased eye pressure, such as beta-blockers (e.g. atenolol, propranolol) and antiarrhythmics (e.g. amiodarone, flecainide)
• certain medicines used for Parkinson’s disease such as monoamine oxidase type B inhibitors (e.g. selegiline)
• oral contraceptives ("the pill"): in some women, irregular menstrual periods and/or bleeding between periods may occur
• ciclosporin, a medicine used to suppress the immune system to prevent rejection of transplanted organs
• warfarin, a medicine used to thin the blood
• dextromethorphan, a medicine used to treat cough.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The effects of terbinafine during pregnancy are unknown. Therefore, Terbinafine Mylan Generics must not be taken during pregnancy unless specifically instructed by your doctor.
Breast-feeding
Terbinafine passes into breast milk; therefore, you must not take Terbinafine Mylan Generics while breast-feeding.
Fertility
Fertility studies in animals do not suggest any adverse effects.
Driving and using machines
If you feel dizzy or lightheaded, you should avoid driving or operating machinery.

3. How to take Terbinafine Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The tablet may be divided into equal doses.

Use in adults (including elderly people)
The recommended dose is one 250 mg tablet daily.

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

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

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

Body weight above 40 kg
The recommended dose is 250 mg daily (one 250 mg tablet).

Patients with impaired renal or hepatic function
The use of terbinafine is not recommended.

Follow the instructions above unless your doctor has prescribed otherwise.

Method of administration
Take one tablet by placing it at the back of the tongue and swallow it with a sufficient amount of water. Terbinafine Mylan Generics may be taken with or without food.

Frequency of administration
Remember to take the medicine and complete the full course of treatment to ensure that the fungal or yeast infection is completely treated. Taking the tablet at the same time each day provides the best effect and 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.
Treatment of skin infections usually lasts from 2 to 6 weeks. Treatment of hair and scalp infections usually lasts 4 weeks. Treatment of nail infections usually lasts from 6 to 12 weeks. In some patients, treatment for toenail infections may require up to six months or longer.
It may take several weeks after stopping treatment for symptoms and signs to completely disappear.

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

If you forget to take Terbinafine Mylan Generics
Take the missed dose if there is still enough time before the next scheduled dose. Do not take a double dose to make up for the forgotten dose. Terbinafine Mylan Generics should be taken only once daily.

If you stop taking Terbinafine Mylan Generics
Your doctor will advise you on how long you should take Terbinafine Mylan Generics. If you stop treatment too early, the fungal or yeast infection may not be fully cured and symptoms may persist.

If you have any doubts about how to use 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 Terbinafine Mylan Generics
and contact your doctor immediately or go to the nearest hospital emergency department:
Uncommon (may affect up to 1 in 100 people):

• reduction in red blood cells which may make the skin pale and cause weakness or breathlessness (anaemia).

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

• severe liver problems which may cause symptoms such as persistent feeling of being unwell (nausea), stomach ache, loss of appetite, tiredness, vomiting, yellowing of the skin or eyes, dark urine or pale stools, itchy skin, general feeling of being unwell
• severe skin disorders which may cause severe blisters and bleeding of the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome), or which may start with painful red areas, followed by large blisters and leading to peeling of layers of skin (toxic epidermal necrolysis)
• blood disorders 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 disorders which may affect the mouth and other parts of the body (erythema multiforme)
• blistering dermatitis (bullous dermatitis) or dermatitis with skin peeling or shedding (exfoliative dermatitis)
• severe allergic reactions with dizziness, swelling of the skin or face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing
• onset or worsening of systemic lupus erythematosus (SLE), an allergic reaction causing joint pain, skin rashes and fever
• high fever, severe sore throat and mouth ulcers (agranulocytosis) or a severe reduction in blood cells which may 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) which may lead to kidney problems (rhabdomyolysis)
• inflammation of the pancreas causing severe abdominal and back pain (pancreatitis)
• severe allergic reaction which may cause fever, swelling, rash, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms - DRESS).

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 swelling
• feeling unwell (nausea)
• indigestion
• stomach pain
• diarrhoea
• skin rash or hives
• muscle or joint pain.

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

• tiredness, 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 sensations (paraesthesia), reduced sensation (hypoesthesia)
• anxiety
• ringing in the ears (tinnitus)
• increased sensitivity of the skin to light, including skin rash
• fever
• weight loss, following taste disturbances.

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

• increased liver enzymes (may be detected in blood tests).

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

• acute generalised exanthematous pustulosis (symptoms appear as red skin with swollen areas covered with numerous small pustules)
• psoriasis-like skin rashes or worsening of psoriasis (rash with thickened patches of red skin, often with silvery scaling)
• hair loss
• in some women, irregular menstruation, bleeding between normal menstrual periods
• depression, following taste disturbances.

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

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

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

5. How to store Terbinafine Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label or the carton 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 medicines 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 Terbinafina Mylan Generics contains
The active substance 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 of Terbinafina Mylan Generics and pack contents
Terbinafina Mylan Generics tablets are round, white to off-white, marked with “TF line break 250” on one side and “G” on the other side. Terbinafina Mylan Generics is available in blisters containing 6, 7, 8, 14, 28, 30, 42, 50, 56, 60, 90 and 98 tablets or in bottles containing 100, 250 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Manufacturer
Mylan Hungary Kft./Mylan Hungary Ltd.,
Mylan utca 1., Komárom, 2900,
Hungary
This medicinal product is authorized in the European Economic Area countries
under the following names:
Netherlands Terbinafine Viatris 250 mg, tabletten
Italy Terbinafina Mylan Generics 250 mg
Slovakia Terbinafin Viatris 250 mg