TERBINAFINA 250 mg Coated Tablet

Зміст інструкції

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

Terbinafina Alter 250 mg tablets

Terbinafina

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

1. What is Terbinafina Alter and what is it used for

Terbinafina Alter contains terbinafine, a substance that belongs to the group of medicines
called antifungals, which inhibits the growth of fungi. This medicine is indicated in the
treatment of the following fungal infections of the skin and nails:
Tinea corporis (ringworm)
Tinea cruris (groin ringworm)
Tinea pedis (athlete's foot)
Onychomycosis (fungal nail infection).

2. What you need to know before you take Terbinafina Alter

Do not take Terbinafina Alter :

• if you are allergic to terbinafine or to any of the other ingredients of this medicine (listed in section 6). Warnings and Precautions:Talk to your doctor or pharmacist before taking Terbinafina Alter:
• if you are taking other medicines;
• if you have had problems with your liver or kidneys;
• if you have or have had red, raised patches/silvery skin (psoriasis) or rash on your face, joint pain, muscle problems, fever (cutaneous and systemic lupus erythematosus). Terbinafine may worsen these problems;
• if you have immunodeficiency problems;
• oral administration of terbinafine is not effective against Pityriasisversicolorand against skin infection caused by a fungus called Candida;
• if you are breastfeeding;
• if you are pregnant or trying to become pregnant.

Children and adolescents
The use of Terbinafina Alter is not recommended in children or adolescents.

Other medicines and Terbinafina Alter
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including oral contraceptives and medicines obtained without
prescription.
Some other medicines can interact with Terbinafina Alter. These include:

• rifampicin - used to treat infections
• cimetidine - used to treat stomach problems such as indigestion or stomach ulcers
• cyclosporine - used to control your immune system after a transplant
• antidepressants - including tricyclic antidepressants such as desipramine, SSRIs (selective serotonin reuptake inhibitors, or MAOIs monoamine oxidase inhibitors)
• oral contraceptives (as menstrual irregularities may occur in female patients)
• antifungals - used to treat fungal infections such as fluconazole or ketoconazole
• beta-blockers or antiarrhythmics - used to treat heart problems such as metoprolol, propafenone or, amiodarone
• Dextromethorphan - a medicine used to treat cough
• Caffeine - used as a pain reliever or cold remedy.

Terbinafina Alter with food and drink
The tablets can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Terbinafine passes into breast milk. Therefore, you should not breastfeed during
treatment with this medicine.

Driving and operating machinery
Terbinafine does not alter, or alters negligibly, the ability to drive vehicles or operate
machinery. However, some people have reported feeling dizzy during
treatment with Terbinafina Alter. If you experience these symptoms, you should not drive or
operate machinery.

3. How to take Terbinafina Alter

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
Take the number of tablets as indicated by your doctor. The doctor will decide which dose you need.
The recommended dose is one tablet (250 mg) taken once a day.

Use in children and adolescents
The medicine is not recommended for children and adolescents (age <18 years) due to
the lack of experience in this age group.
Swallow the tablet whole with water. Do not chew the tablet. The tablet
can be taken with or without food.
The tablet can be divided into two equal doses.

Skin infections
The following treatment periods are recommended:

• Tinea pedis (athlete's foot - interdigital, plantar/moccasin type): from 2 to 4 weeks. The recommended treatment periods can be up to 6 weeks
• Tinea corporis (ringworm): from 2 to 4 weeks
• Tinea cruris (jock itch): from 2 to 4 weeks Onychomycosis (fungal nail infection)

For most patients, effective treatment ranges from 6 to 12 weeks.
Onychomycosis of the hand
Six weeks of treatment are sufficient in most cases of fingernail infections.
Onychomycosis of the foot
Twelve weeks of treatment are sufficient in most cases of toenail infections.
Patients who have slow nail growth may require longer treatment periods.
It is possible that the symptoms of the infection do not disappear completely until a few
weeks (skin) or a few months (nails) after the disappearance of the fungus that caused
the infection.

Use in patients with hepatic impairment
Use is not recommended in this group of patients.

Use in patients with renal impairment
Use is not recommended in this group of patients.
Do not change the dose or stop treatment without consulting your doctor.

If you take more Terbinafina Alter than you should
If you have accidentally taken an excessive number of tablets, consult your doctor immediately.
The main symptoms of acute intoxication are nausea, stomach pain, dizziness or headache. If you experience any of these symptoms or any other abnormal adverse effect,
consult your doctor immediately.

If you forget to take Terbinafina Alter
If you forget to take a tablet, take it as soon as you remember.
Do not take a double dose to make up for the missed tablet.

If you stop taking Terbinafina Alter
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
It is very important that you immediately inform your doctor:

• If you experience an infection with symptoms such as fever and a significant worsening of your general condition, or fever with symptoms of local infection such as sore throat/pharyngitis/problems with the mouth or problems with urination, you should see a doctor immediately. The medicine may cause a reduction in the number of white blood cells in the blood and your resistance to infections may decrease.

A blood test will be performed to check if there is a reduction in white blood cells (agranulocytosis). It is important to inform your doctor that you are taking the medicine.

• If a progressive skin rash appears. Stop treatment immediately and inform your doctor.
• If you notice that your skin or the whites of your eyes become yellowish, or that your urine is darker or your stools are paler. Stop treatment immediately and inform your doctor.
• If you develop a sore throat accompanied by fever and chills, mild or abnormal bleeding, any serious skin problems, as well as fatigue, dizziness, depression, anxiety or vertigo.
• If you experience symptoms such as unexplained and persistent nausea, stomach problems, loss of appetite, unusual fatigue, or a feeling of weakness during treatment with this medicine.
• If you experience symptoms of angioedema, such as: swelling of the face, tongue or pharynx, difficulty swallowing; or hives and difficulty breathing, stop treatment immediately and inform your doctor.

If any of these side effects worsen, or if you notice the appearance of any side effect not listed in this leaflet, inform your doctor or pharmacist.
The following side effects have been reported for Terbinafina Alter:

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

• a feeling of fullness, loss of appetite, stomach discomfort (indigestion), nausea, mild abdominal pain and diarrhea.
• allergic skin reactions, such as irritating rash or hives, joint or muscle pain.

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

• headache Uncommon((may affect up to 1 in 100 people):
• loss of taste, which usually disappears after several weeks after stopping treatment with the medicine.
• a decrease in food intake that can lead to significant weight loss has been observed in very few severe cases. Rare (may affect up to 1 in 1,000 people):
• numbness or tingling.
• decreased sensitivity.
• dizziness.
• liver problems.

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

• serious liver problems,
• serious skin reactions (with sudden onset, which can recur, which can spread, which can appear as raised papules, which may be accompanied by itching and fever), worsening of psoriasis, reduction of certain types of blood cells (neutropenia, agranulocytosis, thrombocytopenia), hair loss, fatigue,
• serious hypersensitivity reactions (swelling of the face, eyes or tongue, difficulty swallowing, nausea and vomiting, weakness, dizziness, difficulty breathing).
• worsening and exacerbation of cutaneous and systemic lupus erythematosus.
• Menstrual disorders (bleeding and irregular cycles) have also been reported in patients taking terbinafine concurrently with oral contraceptives (see section 4.5).

The following side effects have also been reported, whose precise frequency has not been identified and for this reason they are classified with frequency not known:

• reduction in the number of red blood cells
• allergic reactions
• anxiety, depression
• loss of smell
• hearing impairment, ringing in the ears
• yellowing of the skin and eyes
• skin sensitive to light
• release of muscle cells into the bloodstream
• flu-like symptoms, fever
• weight loss. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Terbinafina Alter

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use the medicine after the expiry date which is stated on the packaging and blister
after Exp.
The expiry date refers to the last day of that month.
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 Alter contains

• The active ingredient is terbinafine. Each tablet contains 250 mg of terbinafine (as hydrochloride).
• The other ingredients are sodium carboxymethylamide (type A), microcrystalline cellulose (E460), hypromellose (E464), anhydrous colloidal silica, magnesium stearate (E572). Description of the appearance of Terbinafina Alter and pack contentsTerbinafina Alter 250 mg tablets are white, oblong tablets with an inscription on both sides, presented in packs of 8 ,14, 28 and 42 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and ManufacturerMarketing Authorisation HolderLABORATORI ALTER S.r.L. Via Egadi, 7 20144 Milano

ITALY

Manufacturer
Laboratorios Liconsa S.A.
Avda. Miralcampo, Nº 7, Pol. Ind. Miralcampo
19200 Azuqueca de Henares (Guadalajara)
SPAIN

This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:

• Portugal: Termycol250 mg Comprimidos
• Czech Republic: Terfimed 250
• Estonia: Terbinafine Olainfarm 250 mg
• France: Terbinafine Liconsa 250mg divisible tablet
• Germany: Terbinafin Heumann 250 mg Tablets
• Netherlands: Terbinafine Liconsa 250 mg Tablet
• Hungary: Terbinafine Liconsa 250 mg Tablet
• Ireland: Terbinafine Liconsa 250 mg
• Italy: Terbinafina Alter 250 mg Tablets
• Latvia: Terbinafine Olainfarm 250 mg
• Slovenia: Ferbitan 250 mg tablets
• Slovakia: Terfimed 250

This leaflet was last updated on: