Terbinafine Aurobindo Pharma Italia

Package leaflet: Information for the user

Terbinafine Aurobindo Pharma Italia 250 mg tablets

Equivalent medicine
Please read this leaflet carefully before you start 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. Do not give it to other people, even if their symptoms are the same as yours, as it could 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 Terbinafine Aurobindo Pharma Italia is and what it is used for
2. What you need to know before taking Terbinafine Aurobindo Pharma Italia
3. How to take Terbinafine Aurobindo Pharma Italia
4. Possible side effects
5. How to store Terbinafine Aurobindo Pharma Italia
6. Contents of the pack and other information

1. What Terbinafina Aurobindo Pharma Italia is and what it is used for

Terbinafina Aurobindo Pharma Italia belongs to a group of medicines called antifungals. It is used
for the treatment of fungal infections of the skin (including those between the fingers and toes) and of the
nails.

2. What you need to know before using Terbinafine Aurobindo Pharma Italia

Do not use Terbinafine Aurobindo Pharma Italia

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Terbinafine Aurobindo Pharma Italia

• if you have liver problems or a disease that may affect your liver.
• if you have psoriasis (a skin disease causing raised, red patches covered with silvery scales).
• if you have kidney problems.
• if you develop a severe reduction in white blood cells making infections more likely (agranulocytosis) or a serious illness with blisters on the skin (toxic epidermal necrolysis). You must stop taking Terbinafine Aurobindo Pharma Italia and contact your doctor immediately if you experience these side effects, which are known to occur very rarely (see section 4).
• if you have systemic lupus erythematosus.

If any of these warnings apply to you or have applied to you in the past, consult your doctor.
Other medicines and Terbinafine Aurobindo Pharma Italia
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

• the antibiotic rifampicin (reduces the level of terbinafine in the blood),
• cimetidine (a medicine used for ulcers and heartburn) increases the level of terbinafine in the blood,
• antidepressants including tricyclic antidepressants, SSRIs (selective serotonin reuptake inhibitors), or MAOIs (monoamine oxidase inhibitors),
• beta-blockers or antiarrhythmics for heart problems,
• oral contraceptives (the pill). In female patients, irregular cycles and abnormal menstrual bleeding between periods may occur,
• medicines used to treat heart problems (e.g. propafenone, amiodarone),
• ciclosporin (a medicine used to prevent rejection of organs or tissues after transplantation or to treat certain conditions such as psoriasis and eczema or rheumatoid arthritis),
• tolbutamide for diabetes,
• triazolam to relieve anxiety and/or sleep problems,
• terfenadine for hay fever and other allergies,
• medicines used to treat fungal infections (e.g. fluconazole, ketoconazole),
• caffeine.

Please note that the above-mentioned medicines may be known under other names. Always carefully check
the package leaflet of any medicines you are already using and consult your doctor or pharmacist
before taking Terbinafine Aurobindo Pharma Italia, if you are taking any of the medicines listed above.
Terbinafine Aurobindo Pharma Italia with food and drinks
Taking food and drinks does not affect treatment with terbinafine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are breastfeeding, you must not take Terbinafine Aurobindo
Pharma Italia unless instructed by your doctor. If you become pregnant while taking this
medicine, inform your doctor as soon as possible.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Some people have reported dizziness while taking Terbinafine. If you feel dizzy, you should not
drive or operate machinery.

3. How to take Terbinafina Aurobindo Pharma Italia

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
Adults:
The dose prescribed for you will depend on the type and severity of the infection.
The recommended dose is 250 mg of Terbinafina Aurobindo Pharma Italia once daily. Swallow the tablet whole with a glass of water. The tablets can be taken with or without food.
If you have kidney problems, your doctor may prescribe half the recommended dose.
Duration of treatment:
Your doctor will tell you how long your treatment with terbinafine should last.

• For general fungal skin infections, treatment will likely last 4 weeks.
• Treatment of skin infections affecting the groin or body usually lasts from 2 to 4 weeks, while infections involving the feet may last from 2 to 6 weeks.
• For nail infections, treatment may last from 6 weeks to 3 months; however, treatment for fungal infections of the toenails may continue for 6 months or longer.

Complete resolution of infection signs and symptoms may not occur until several weeks after treatment has ended and the infection has been cured.
Children and adolescents (under 18 years of age)
Terbinafine is not recommended for use in children and adolescents under 18 years of age.
If you take more Terbinafina Aurobindo Pharma Italia than you should
If you or someone you know has taken more tablets than prescribed, contact your doctor or the nearest hospital emergency department immediately. Bring this leaflet or some tablets with you so the doctor knows what has been taken. You may experience dizziness, nausea, headache, and/or stomach discomfort.
If you forget to take Terbinafina Aurobindo Pharma Italia
If you forget to take your dose at the correct time, take it as soon as you remember. Do not take a double dose to make up for the forgotten dose.
If you stop taking Terbinafina Aurobindo Pharma Italia
Do not stop taking terbinafine without consulting your doctor, even if the infection appears to have healed.
If you have any questions 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.
The following side effects have been reported:
You must stop taking the tablets and go to the doctor immediately if:

• you experience symptoms of angioedema/anaphylaxis such as:
• swelling of the face, tongue or throat
• difficulty swallowing
• hives (urticaria)
• difficulty breathing
• feeling faint.
• if you experience skin reactions such as lumps, blisters or a progressive rash
• if you have abnormalities in liver function. Symptoms include yellowing of the skin, itching, persistent nausea without apparent cause (feeling unwell), fatigue, vomiting (feeling unwell), dark urine, pale stools and abdominal pain (stomach pain).

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

• Loss of appetite
• Stomach ache, feeling of fullness, diarrhoea, indigestion (dyspepsia), feeling unwell (nausea)
• Joint pain (arthralgia) and muscle pain (myalgia)
• Dermatitis, skin redness with itching and blisters (urticaria)

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

• Headache

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

• Loss or reduced sense of taste, which usually resolves slowly after stopping the medicine. Very rare cases of prolonged taste disturbances have been reported, sometimes leading to reduced food intake and significant weight loss.

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

• Increased liver enzyme levels or liver failure.

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

• Reductions in the number of different types of blood cells, which may increase the risk of serious infection, bleeding, or may cause shortness of breath and fatigue (agranulocytosis, neutropenia, thrombocytopenia, pancytopenia).
• A condition that may cause a wide range of symptoms such as joint pain, kidney problems, rash and fever (systemic lupus erythematosus).
• Stevens-Johnson syndrome (a serious illness with blisters on the skin, mouth, eyes and genitals).
• Hair loss.
• Toxic epidermal necrolysis (a serious illness with blisters and skin loss).
• Dizziness
• Tingling sensation (paraesthesia), numbness (hypoesthesia)
• Fatigue (tiredness)
• Severe allergic reactions causing swelling of the face or throat (angioedema).
• Psoriasiform rashes or worsening of psoriasis.

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

• Allergic reactions (including anaphylaxis)
• Decrease in the number of red blood cells in the blood (anaemia)
• Anxiety or depression
• Loss of smell (anosmia)
• Hearing loss or ringing in the ears (hypacusis, tinnitus)
• Swelling of blood vessels (vasculitis)
• Swelling of the pancreas (pancreatitis)
• Abnormal liver function, including inflammation of the liver (hepatitis) and jaundice (yellowing of the skin and eyes)
• Increased sensitivity of the skin to sunlight
• Breakdown of damaged muscles (rhabdomyolysis)
• Influenza-like illness or 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.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 Terbinafina Aurobindo Pharma Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
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 Terbinafina Aurobindo Pharma Italia contains

• The active substance is terbinafine. Each tablet contains 250 mg of terbinafine (as terbinafine hydrochloride).
• The other components are microcrystalline cellulose, sodium starch glycolate (type A), anhydrous colloidal silica, hypromellose and magnesium stearate.

Description of the appearance of Terbinafina Aurobindo Pharma Italia and package contents
Tablets.
250 mg:
White to off-white, round, uncoated, biconvex tablets with bevelled edges, marked with a score line, a "D" on one side and "74" on the other side. The tablet can be divided into two equal parts.
Terbinafina Aurobindo Pharma Italia tablets are available in PVC/PVDC/aluminium blister packs containing 6, 7, 8, 10, 12, 14, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, 100, 250 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
France: TERBINAFINE ARROW GENERIQUES 250 mg, comprimé sécable
Germany: Terbinafin Aurobindo 250 mg Tabletten
Italy: Terbinafina Aurobindo Pharma Italia
Malta: Terbinafine Aurobindo 250mg tablets
Netherlands: Terbinafine Aurobindo 250 mg, tabletten
Poland: Terbinafine Aurobindo
Spain: Terbinafina Aurobindo 250 mg comprimidos
United Kingdom: Terbinafine 250 mg tablets

This leaflet was last approved on