TERBINAFINE 250 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Terbinafine Aurobindo, 250 mg, Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Terbinafine Aurobindo and what is it used for
4. Important information before taking Terbinafine Aurobindo
   1. When not to take Terbinafine Aurobindo
   2. Warnings and precautions
   3. Terbinafine Aurobindo with other medicines
   4. Terbinafine Aurobindo with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Terbinafine Aurobindo contains sodium
5. How to take Terbinafine Aurobindo
   1. Dosage
   2. Use in children and adolescents (under 18 years)
   3. Taking more than the recommended dose of Terbinafine Aurobindo
   4. Missing a dose of Terbinafine Aurobindo
   5. Stopping treatment with Terbinafine Aurobindo
6. Possible side effects
   1. Very common side effects (may affect more than 1 in 10 people):
   2. Common side effects (may affect up to 1 in 10 people):
   3. Uncommon side effects (may affect up to 1 in 100 people):
   4. Rare side effects (may affect up to 1 in 1,000 people):
   5. Very rare side effects (may affect up to 1 in 10,000 people):
   6. Reporting side effects
7. How to store Terbinafine Aurobindo
8. Contents of the pack and other information
   1. What Terbinafine Aurobindo contains
   2. What Terbinafine Aurobindo looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of revision of the leaflet: 10/2019

Package Leaflet: Information for the User

Terbinafine Aurobindo, 250 mg, Tablets

Terbinafine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• -Keep this leaflet, you may need to read it again.
• -If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Terbinafine Aurobindo and what is it used for
• 2. Important information before taking Terbinafine Aurobindo
• 3. How to take Terbinafine Aurobindo
• 4. Possible side effects
• 5. How to store Terbinafine Aurobindo
• 6. Contents of the pack and other information

1. What is Terbinafine Aurobindo and what is it used for

Terbinafine Aurobindo belongs to a group of medicines called antifungals. It is used to treat fungal infections of the skin, including infections of the fingers, toes, and nails.

2. Important information before taking Terbinafine Aurobindo

When not to take Terbinafine Aurobindo

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

Warnings and precautions

Before taking Terbinafine Aurobindo, discuss it with your doctor or pharmacist.

• if you have liver disease or diseases that affect liver function,
• if you have psoriasis (a skin disease with red, scaly patches on the skin),
• if you have kidney disease,
• if you have a significantly reduced number of white blood cells, which can lead to infections (agranulocytosis) or severe skin disease with blisters (toxic epidermal necrolysis). You should stop taking Terbinafine Aurobindo and immediately consult a doctor if you experience these very rare symptoms (see section 4),
• if you have systemic lupus erythematosus.

If any of the above warnings apply to you, consult your doctor.

Terbinafine Aurobindo with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines that are available without a prescription.

• Antibiotic, rifampicin (reduces the concentration of terbinafine in the blood).
• Cimetidine (a medicine used to treat stomach ulcers and heartburn) increases the concentration of terbinafine in the blood.
• Tricyclic antidepressants, selective serotonin reuptake inhibitors, and monoamine oxidase inhibitors.
• Beta-blockers and anti-arrhythmic drugs used to treat heart diseases.
• Oral contraceptives (the pill). Irregular periods or abnormal menstrual bleeding may occur between periods in women.
• Medicines used to treat heart diseases (e.g., propafenone, amiodarone).
• Cyclosporin (a medicine used to prevent organ or tissue rejection after transplantation, or to treat certain skin diseases, such as psoriasis, or to treat rheumatoid arthritis).
• Tolbutamide used in diabetes.
• Triazolam used to relieve anxiety and (or) sleep problems.
• Terfenadine used in hay fever or other allergies.
• Medicines used to treat fungal infections (e.g., fluconazole, ketoconazole).
• Caffeine.

Remember that the above medicines may be known under different names. Before taking Terbinafine Aurobindo, always carefully read the information leaflets of the medicines you are already taking and consult your doctor or pharmacist if you are taking any of the above medicines.

Terbinafine Aurobindo with food and drink

Taking the medicine with food and drink does not affect the action of terbinafine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take Terbinafine Aurobindo unless your doctor tells you to. If you become pregnant while taking this medicine, consult your doctor immediately.

Driving and using machines

Terbinafine Aurobindo is unlikely to affect your ability to drive or use machines.

Terbinafine Aurobindo contains sodium

Terbinafine Aurobindo tablets contain sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is considered to be essentially 'sodium-free'.

3. How to take Terbinafine Aurobindo

Always take Terbinafine Aurobindo exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Dosage

Adults:
The dose depends on the type and severity of the infection.
The usual dose is 250 mg of Terbinafine Aurobindo per day. The tablet should be taken with a full glass of water. The tablets can be taken with or without food.
In case of kidney disease, your doctor may prescribe half the recommended dose.
Duration of treatment:
Your doctor will tell you how long to take Terbinafine Aurobindo.

• Usually, the treatment of skin fungal infections lasts 4 weeks.
• Treatment of groin or body skin infections usually lasts 2 to 4 weeks, while treatment of foot infections may last 2 to 6 weeks.
• In the case of nail infections, treatment may last 6 weeks to 3 months, and in the case of treating nail infections of the feet, treatment may be continued for 6 months or longer.

Complete disappearance of infection symptoms may occur only after many weeks after the end of treatment.

Use in children and adolescents (under 18 years)

Terbinafine is not recommended for children and adolescents under 18 years.

Taking more than the recommended dose of Terbinafine Aurobindo

If you have taken too many tablets, contact your doctor or the nearest hospital emergency department immediately. Bring this leaflet with you so that the doctor knows what medicine you have taken. You may experience dizziness, nausea, headaches, and (or) stomach pain.

Missing a dose of Terbinafine Aurobindo

If you forget to take a dose of Terbinafine Aurobindo, take the missed dose as soon as you remember. Do not take a double dose to make up for the missed dose.

Stopping treatment with Terbinafine Aurobindo

Do not stop taking the medicine without consulting your doctor, even if the infection has been cured.
If you have any doubts about taking the 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 may occur:
You should stop taking the tablets and contact your doctor immediately if you experience

• symptoms of angioedema/anaphylaxis, such as:
• swollen face, tongue, or throat
• difficulty swallowing
• hives
• difficulty breathing
• feeling of fainting
• skin reactions, such as blisters, vesicles, or progressive rash
• abnormal liver function, the symptoms of which include yellowing of the skin, itching, unexplained and persistent nausea (feeling sick), feeling tired, vomiting, dark urine, pale stools, and abdominal pain.

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

• Joint pain (arthralgia) and muscle pain (myalgia), which may occur together with allergic skin rashes
• Rash, redness of the skin with itching and hives (urticaria). If a progressive skin rash appears, treatment must be discontinued.

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

• Headache.
• Lack of appetite
• Abdominal pain, feeling of fullness in the stomach, diarrhea, indigestion (dyspepsia), nausea (nausea).
• Increased liver enzyme levels.

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

• Loss or decrease of taste (ageusia, dysgeusia), these disorders disappear slowly after stopping the medicine. In very rare cases, long-term taste disorders have been reported, sometimes leading to a decrease in food intake and significant weight loss.

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

• Occurrence of allergic reactions (including anaphylaxis).
• Feeling of tingling and numbness (paresthesia), decreased sensitivity (hypesthesia), dizziness
• Liver function disorders, including hepatitis and jaundice (yellowing of the skin and eyes).
• Fatigue, malaise.

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

• Decrease in the number of different types of blood cells, which can lead to an increased risk of serious infections, bleeding, or shortness of breath and fatigue (agranulocytosis, neutropenia, thrombocytopenia, pancytopenia).
• A condition that can cause a wide range of symptoms, such as joint pain, kidney problems, rash, and fever (systemic lupus erythematosus).
• Anxiety, depression
• Stevens-Johnson syndrome (a severe disease with symptoms including blisters on the skin, mouth, eyes, and genitals),
• Hair loss.
• Toxic epidermal necrolysis (a severe disease with symptoms including blisters and peeling of the skin).
• Menstrual disorders, such as irregular menstrual bleeding, which may occur between periods, and irregularity of the menstrual cycle.
• Dizziness.
• Severe allergic reactions, which cause swelling of the face and throat (angioedema).
• Increased sensitivity of the skin to sunlight.
• Occurrence or worsening of psoriasis.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Terbinafine Aurobindo

Keep the medicine out of the sight and reach of children.
Do not use Terbinafine Aurobindo after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Store in the original package to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Terbinafine Aurobindo contains

• The active substance is terbinafine. Each tablet contains 250 mg of terbinafine (as terbinafine hydrochloride).
• The other ingredients are: microcrystalline cellulose, sodium carboxymethyl cellulose (Type A), colloidal anhydrous silica, hypromellose, and magnesium stearate.

What Terbinafine Aurobindo looks like and contents of the pack

Tablets.
The tablets are white to almost white, round, uncoated, biconvex with beveled edges, with the letter D embossed on one side and the number 74 on the other.
The tablets can be divided into two halves.
The tablets are available in PVC/PVDC/Aluminum blisters, placed in a cardboard box.
Packaging:
6, 7, 8, 10, 12, 14, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, 100, 250, and 500 tablets.

Marketing authorization holder

Aurobindo Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana FRN 1913
Malta

Manufacturer

APL Swift Services (Malta) Limited
HF 26, Hal Far Industrial Estate, Hal Far
Birzebbugia BBG 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France:
TERBINAFINE ARROW GENERIQUES 250 mg, comprimé sécable
Germany:
Terbinafin Aurobindo 250 mg Tabletten
Italy:
Terbinafina Aurobindo Pharma Italia 250 mg compresse
Malta:
Terbinafine Aurobindo 125 mg/ 250mg tablets
Netherlands:
Terbinafine Aurobindo 125/ 250 mg, tabletten
Poland:
Terbinafine Aurobindo
Spain:
Terbinafina Aurobindo 250 mg comprimidos
United Kingdom:
Terbinafine 250 mg tablets

Date of revision of the leaflet: 10/2019