Terbinafine Alter

Package Leaflet: Information for the User

Terbinafina Alter 250 mg tablets

Terbinafine
Generic 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, inform 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 taking 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 Terbinafina Alter is and what it is used for

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

2. What you need to know before taking Terbinafine Alter

Do not take Terbinafine 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 Terbinafine Alter:
• if you are taking other medicines;
• if you have had liver or kidney problems;
• if you have or have had raised red patches with silvery skin (psoriasis) or a rash on the face, joint pain, muscle problems, fever (cutaneous and systemic lupus erythematosus). Terbinafine may worsen these conditions;
• if you have immune system disorders;
• oral administration of terbinafine is not effective against Pityriasis versicolor and skin infections 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 Terbinafine Alter is not recommended in children or adolescents.
Other medicines and Terbinafine 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 a prescription.
Some other medicines may interact with Terbinafine Alter. These include:

• rifampicin – used to treat infections
• cimetidine – used to treat stomach problems such as indigestion or stomach ulcers
• ciclosporin – 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.

Terbinafine Alter with food and drink
The tablets can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Terbinafine passes into breast milk. Therefore, you should not breastfeed during treatment with this medicine.
Driving and using machines
Terbinafine does not affect, or has a negligible effect on, the ability to drive or operate machinery. However, some people have reported dizziness during treatment with Terbinafine Alter. If you experience these symptoms, you should not drive or operate machinery.

3. How to take Terbinafina Alter

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, you must consult your doctor or pharmacist.
Take the number of tablets as indicated by your doctor. Your doctor will decide which dose is right for you.
The recommended dose is one tablet (250 mg) taken once daily.

Use in children and adolescents
This medicine is not recommended for children and adolescents (under 18 years of age) due to lack of experience in this age group.

Swallow the tablet whole with water. Do not chew the tablet. The tablet may be taken with or without food.
The tablet can be divided into two equal doses.

Skin infections
The following treatment durations are recommended:

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

For most patients, effective treatment lasts from 6 to 12 weeks.

Fingernail onychomycosis
Six weeks of treatment are sufficient in most cases of finger nail infections.

Toenail onychomycosis
Twelve weeks of treatment are sufficient in most cases of big toe nail infections.

Patients with slow nail growth may require longer treatment periods.

It is possible that symptoms of infection do not completely disappear until several weeks (skin) or several months (nails) after the causative fungus has been eliminated.

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

Use in patients with renal impairment
Use is not recommended in this patient group.

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 unusual adverse effects, 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 using this medicine, consult 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 inform your doctor immediately:

• If you develop an infection with symptoms such as fever and a severe worsening of your general condition, or fever with signs of local infection such as sore throat/pharyngitis/oral problems or difficulty urinating, you should see your doctor immediately. This medicine may reduce the number of white blood cells in your blood, and your resistance to infections may decrease.

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

• If you develop a progressive skin rash. 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 becomes darker or your stools become paler. Stop treatment immediately and inform your doctor.
• If you develop a sore throat accompanied by fever and chills, minor or unusual 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 tiredness, or a feeling of weakness during treatment with this medicine.
• If you experience symptoms of angioedema, such as: swelling of the face, tongue, or throat, difficulty swallowing; or hives and difficulty breathing. Stop treatment immediately and inform your doctor.

If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
The following side effects have been reported for Terbinafina Alter:
Very common (may affect more than 1 in 10 people):

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

Common (may affect more than 1 in 10 people):

• Headache

Uncommon (may affect more than 1 in 100 people):

• Loss of taste, which usually resolves several weeks after stopping treatment with the medicine.
• Reduced food intake leading to significant weight loss has been observed in very few severe cases.

Rare (may affect more than 1 in 1,000 people):

• Numbness or tingling.
• Decreased sensitivity.
• Dizziness.
• Liver problems.

Very rare (may affect more than 1 in 10,000 people):

• Severe liver problems,
• Severe skin reactions (with sudden onset, which may recur, may spread, may appear as raised papules, and may be accompanied by itching and fever), worsening of psoriasis, reduction in certain types of blood cells (neutropenia, agranulocytosis, thrombocytopenia), hair loss, fatigue,
• Severe 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 cycle) have also been reported in patients taking terbinafine concomitantly with oral contraceptives (see section 4.5).

The following side effects have also been reported, but their exact frequency is unknown and therefore they are classified as frequency not known:

• Decreased number of red blood cells
• Allergic reactions
• Anxiety, depression
• Loss of smell
• Hearing impairment, ringing in the ears (tinnitus)
• Yellowing of the skin and eyes
• Skin sensitivity to light
• Release of muscle cells into the bloodstream
• Influenza-like symptoms, fever
• Weight loss.

Reporting of side effects
If you experience any side effect, 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: 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 Terbinafine Alter

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

• The active substance is terbinafine. Each tablet contains 250 mg of terbinafine (as hydrochloride).
• The other components are sodium carboxymethyl starch (type A), microcrystalline cellulose (E460), hypromellose (E464), colloidal anhydrous silica, magnesium stearate (E572). Description of the appearance of Terbinafina Alter and contents of the pack Terbinafina Alter 250 mg tablets are white, oblong tablets, scored on both sides, available in packs of 8, 14, 28 and 42 tablets. Not all pack sizes may be marketed. Marketing Authorization Holder and Manufacturer Marketing Authorization Holder LABORATORI 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 European Economic Area countries
under the following names:

• Portugal: Termycol 250 mg Comprimidos
• Czech Republic: Terfimed 250
• Estonia: Terbinafine Olainfarm 250 mg
• France: Terbinafine Liconsa 250 mg comprimé sécable
• Germany: Terbinafin Heumann 250 mg Tabletten
• Netherlands: Terbinafine Liconsa 250 mg Tablet
• Hungary: Terbinafine Liconsa 250 mg Tabletta
• Ireland: Terbinafine Liconsa 250 mg
• Italy: Terbinafina Alter 250 mg Compresse
• Latvia: Terbinafine Olainfarm 250 mg
• Slovenia: Ferbitan 250 mg tablete
• Slovakia: Terfimed 250

This leaflet was last updated on: