TERBINAFINA 250 mg Tablet

Зміст інструкції

1. Terbinafina Aurobindo Pharma Italia 250 mg tablets
   1. What Terbinafina Aurobindo Pharma Italia is and what it is used for
   2. What you need to know before you use Terbinafina Aurobindo Pharma Italia
   3. How to take Terbinafina Aurobindo Pharma Italia
   4. Possible side effects
   5. How to store Terbinafina Aurobindo Pharma Italia
   6. Package Contents and Other Information

Terbinafina Aurobindo Pharma Italia 250 mg tablets

Generic medicine

Read this leaflet carefully before you start using 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 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 Aurobindo Pharma Italia is and what it is used for
• 2. What you need to know before you use Terbinafina Aurobindo Pharma Italia
• 3. How to use Terbinafina Aurobindo Pharma Italia
• 4. Possible side effects
• 5. How to store Terbinafina 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 toes of the hands and feet) and of the
nails.

2. What you need to know before you use Terbinafina Aurobindo Pharma Italia

Do not use Terbinafina 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 Terbinafina Aurobindo Pharma Italia

• if you have liver problems or a disease that can affect your liver.
• if you have psoriasis (a skin disease with raised red patches of skin covered with silvery scales).
• if you have kidney problems.
• if you develop a severe reduction in the number of white blood cells which makes infections more likely (agranulocytosis) or severe disease with blisters on the skin (toxic epidermal necrolysis). You must stop taking Terbinafina Aurobindo Pharma Italia and go to 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 Terbinafina Aurobindo Pharma Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.

• 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 two cycles may occur,
• medicines to treat heart problems (e.g. propafenone, amiodarone)
• cyclosporine (a medicine used to prevent rejection of organs or tissues following transplantation or for the treatment of certain conditions such as psoriasis and eczema or for the treatment of rheumatoid arthritis),
• tolbutamide for diabetics,
• 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 by other names. Always check
before taking Terbinafina Aurobindo Pharma Italia, if you are taking any of the above medicines.

Terbinafina Aurobindo Pharma Italia with food and drink
Taking food and drink does not affect treatment with terbinafine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are breastfeeding, you should not take Terbinafina Aurobindo
Pharma Italia unless your doctor tells you to. 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 Terbinafina. If you feel this way, you should not
drive vehicles or use machines.

3. How to take Terbinafina Aurobindo Pharma Italia

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.

Dosage
Adults:
The dose prescribed to you will depend on the type of infection and its severity.
The recommended dose is 250 mg of Terbinafina Aurobindo Pharma Italia per day. You must swallow the
tablet whole with a glass of water. The tablets can be taken with or without food.
If you suffer from kidney problems, your doctor may prescribe you half the recommended dose.
Duration of treatment:
Your doctor will tell you how long your treatment with terbinafine should last.

• For widespread fungal infections of the skin, treatment will probably last for 4 weeks.
• Treatment of skin infections affecting the groin or body will normally last from 2 to 4 weeks, and for those involving the feet may last from 2 to 6 weeks.
• For nail infections, treatment may last from 6 weeks to 3 months, even if treatment for nail infections of the feet may continue for 6 months and beyond.

Complete healing from the signs and symptoms of the infection may not occur until several weeks after
stopping treatment and after the infection has been cured.

Children and adolescents (under 18 years of age)
Terbinafina is not recommended 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 you should, consult your doctor immediately or
the emergency room of the nearest hospital. Bring this leaflet or some tablets with you so that the
doctor knows what you have taken. You may experience dizziness, nausea and have a headache and/or stomach ache.

If you forget to take Terbinafina Aurobindo Pharma Italia
If you forget to take Terbinafina Aurobindo Pharma Italia at the right time, take it as soon as you
remember. Do not take a double dose to make up for the missed dose.

If you stop taking Terbinafina Aurobindo Pharma Italia
Do not stop taking terbinafine without consulting your doctor, even if the infection
improves.
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 everybody gets them.
The following side effects have been observed:

• You must stop taking the tablets and see your doctor immediately if:
• you experience symptoms of angioedema/anaphylaxis such as:
• swelling of the face, tongue or throat
• difficulty swallowing
• urticaria (hives)
• difficulty breathing
• feeling faint.
• if you experience skin reactions such as blisters, vesicles or a progressive skin 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 pain, feeling of fullness, diarrhea, indigestion (dyspepsia), feeling unwell (nausea),
• Joint pain (arthralgia) and muscle pain (myalgia),
• Dermatitis, red skin 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 reduction of the sense of taste, which usually resolves slowly once the medicine is stopped. Very rare cases of prolonged taste disorders have been reported, which sometimes led to reduced food intake and significant weight loss.

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

• Increased levels of liver enzymes 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 that can increase the risk of serious infection, bleeding or can cause shortness of breath and fatigue (agranulocytosis, neutropenia, thrombocytopenia, pancytopenia).
• A condition that can cause a wide variety 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
• Sensation of tingling (paresthesia), numbness (hypoesthesia)
• Fatigue (asthenia)
• Serious allergic reactions, causing swelling of the face or throat (angioedema).
• Psoriasiform rashes or worsening of psoriasis.

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

• Allergic reactions (including anaphylaxis)
• Reduction in the number of red blood cells (anemia)
• Anxiety or depression
• Loss of smell (anosmia)
• Hearing loss or ringing in the ears (hypoacusis, tinnitus)
• Inflammation of blood vessels (vasculitis)
• Inflammation of the pancreas (pancreatitis)
• Abnormal liver function, including liver inflammation (hepatitis) and jaundice (yellowing of the skin and eyes)
• Increased sensitivity of the skin to sunlight
• Breakdown of damaged muscles (rhabdomyolysis)
• Flu-like illness or fever
• Weight loss.

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 through 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 which is 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 in 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 ingredient is terbinafine. Each tablet contains 250 mg of terbinafine (as terbinafine hydrochloride).
• The other ingredients 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, with a dividing line and a “D” imprinted on one side and “74” on the other side. The tablet can be divided into two equal halves.
Terbinafina Aurobindo Pharma Italia tablets are available in blister packs in
PVC/PVDC/aluminium 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 Authorisation 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 Member States of the European Economic Area under the following
names:
France: TERBINAFINE ARROW GENERIQUES 250 mg, divisible tablet
Germany: Terbinafin Aurobindo 250 mg Tablets
Italy: Terbinafina Aurobindo Pharma Italia
Malta: Terbinafine Aurobindo 250mg tablets
Netherlands: Terbinafine Aurobindo 250 mg, tablets
Poland: Terbinafine Aurobindo
Spain: Terbinafina Aurobindo 250 mg tablets
United Kingdom: Terbinafine 250 mg tablets