Terbinafine Tecnigen

Package leaflet: Information for the patient

Terbinafina Tecnigen 250 mg tablets

Terbinafine
Please read this leaflet carefully before 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 only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

2. What you need to know before taking Terbinafina Tecnigen

3. How to take Terbinafina Tecnigen

4. Possible side effects

5. How to store Terbinafina Tecnigen

6. Contents of the pack and other information

7. What Terbinafina Tecnigen is and what it is used for

Terbinafina Tecnigen contains the active substance terbinafine, which belongs to a group of medicines known as "antifungals". Terbinafina Tecnigen is used to treat fungal infections and works by killing a wide range of fungi.
Therefore, Terbinafina Tecnigen is indicated for the treatment of:

• fungal nail infections caused by fungi known as "dermatophytes";
• tinea capitis, a fungal infection of the scalp;
• fungal skin infections caused by "dermatophytes" (Tinea corporis, Tinea cruris, Tinea pedis) and by yeasts such as Candida (Candida albicans), for which the doctor has decided that oral treatment is appropriate.

2. What you need to know before taking Terbinafine Tecnigen

Do not take Terbinafine Tecnigen

• if you are allergic to terbinafine or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
• if the patient is a child under 2 years of age;
• if you have liver problems (active or chronic liver disease).

Warnings and precautions
Talk to your doctor or pharmacist before taking Terbinafine Tecnigen.
Inform your doctor before taking Terbinafine Tecnigen:

• if you have a skin disease called psoriasis or systemic lupus erythematosus (an autoimmune disease), as these conditions may worsen during treatment with Terbinafine Tecnigen;
• if you have kidney problems.

If you are elderly, your doctor will assess whether you have liver or kidney problems before prescribing Terbinafine Tecnigen.
Be especially careful during treatment with Terbinafine Tecnigen and inform your doctor immediately:

• if you experience persistent nausea without a known cause, loss of appetite, fatigue, vomiting, abdominal pain, yellowing of the skin, mucous membranes or eyes, dark urine and pale stools, as these are signs of liver problems. Your doctor will evaluate your condition and decide whether to discontinue treatment with Terbinafine Tecnigen;
• if you develop skin reactions (rash) that progressively worsen. Your doctor will evaluate your condition and decide whether to discontinue treatment with Terbinafine Tecnigen;
• if you develop changes in blood characteristics detectable by blood tests (e.g. reduction in white blood cells, platelets and red blood cells). Your doctor will evaluate your condition and decide whether to adjust the dose or stop treatment with Terbinafine Tecnigen;
• if you are taking other medicines (see section “Other medicines and Terbinafine Tecnigen”).

During treatment with Terbinafine Tecnigen, your doctor will periodically monitor your liver function.
Children
Terbinafine Tecnigen must not be administered to children under 2 years of age.
Other medicines and Terbinafine Tecnigen
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Be particularly careful when taking Terbinafine Tecnigen with the following medicines:

• cimetidine (used to treat gastric and duodenal ulcers);
• fluconazole and ketoconazole (used to treat fungal infections);
• amiodarone (used to treat heart rhythm disorders);
• rifampicin (an antibiotic used to treat bacterial infections);
• antidepressants (used to treat depression);
• beta-blockers (used to treat high blood pressure);
• selective serotonin reuptake inhibitors;
• antiarrhythmics (used to treat heart rhythm disorders);
• monoamine oxidase B inhibitors;
• desipramine (used to treat depression);
• dextromethorphan (used to treat cough);
• caffeine (when administered intravenously);
• cyclosporine (used to prevent transplant rejection).

Terbinafine Tecnigen tablets also interfere in a non-significant way with:

• terfenadine (used for allergies);
• triazolam (used to promote sleep and reduce anxiety);
• tolbutamide (used to treat diabetes);
• oral contraceptives.

Terbinafine Tecnigen with food and drink
You may take Terbinafine Tecnigen on an empty stomach or after meals.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are pregnant, this medicine will be prescribed only if strictly necessary and under direct medical supervision.
Breastfeeding
Do not take Terbinafine Tecnigen while breastfeeding, as terbinafine may pass into breast milk.
Driving and using machines
Terbinafine Tecnigen may cause dizziness. If this occurs, avoid driving or operating machinery.
Terbinafine Tecnigen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Terbinafine Tecnigen

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment depends on the type and severity of the condition. Your doctor will tell you how long to take Terbinafine Tecnigen.
Take the tablets orally with water, on an empty stomach or after meals. Take the tablets at approximately the same time each day.
The tablets can be divided to allow administration to children according to their body weight.
Use in adults
The recommended dose is 1 tablet of 250 mg once daily.
Use in children weighing more than 20 kg
The 250 mg tablets are not suitable for treating children weighing less than 20 kg.
The recommended doses are shown in the table below.

Treatment of skin infections
Recommended duration of treatment

• Tinea pedis (infection between the toes, on the sole of the foot, and/or moccasin type): 2 - 6 weeks
• Tinea corporis: 2 - 4 weeks
• Cutaneous candidiasis: 2 - 4 weeks

Complete disappearance of signs and symptoms of the disease may occur several weeks after
fungal infection has resolved.

Treatment of scalp infections
Treatment of Tinea capitis
Take Terbinafina Tecnigen for 2 – 4 weeks.

Treatment of fungal nail infections
For most patients, the duration of treatment ranges between 6 and 12 weeks:

• Fingernail infection: 6 weeks
• Toenail infection: 12 weeks

Some patients with reduced nail growth may require prolonged therapy.
Complete resolution of signs and symptoms of infection may take several months after treatment
has ended, i.e., until a new nail has fully grown.

Use in elderly people
If you are elderly, always consult your doctor, who will evaluate possible liver or kidney problems
before prescribing Terbinafina Tecnigen.

Use in patients with impaired hepatic function
If you have liver problems, you must not take Terbinafina Tecnigen (see section “Do not take
Terbinafina Tecnigen”).

Use in patients with impaired renal function
The use of Terbinafina Tecnigen is not recommended in patients with kidney problems.

If you take more Terbinafina Tecnigen than you should
In case of accidental overdose of Terbinafina Tecnigen, contact your doctor immediately or go to
the nearest hospital.
After ingestion of an excessive dose of Terbinafina Tecnigen (up to 5 g), the following adverse
effects have been reported:

• headache;
• nausea;
• upper abdominal pain;
• dizziness.

In case of overdose, your doctor will treat your condition according to your symptoms.

If you forget to take Terbinafina Tecnigen
Do not take a double dose to make up for the missed dose.

If you stop taking Terbinafina Tecnigen
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 everybody gets them.

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

• decreased appetite;
• headache;
• sensation of abdominal bloating;
• difficulty in digestion;
• nausea;
• abdominal pain;
• diarrhoea;
• skin rash;
• urticaria;
• joint and muscle pain.

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

• depression;
• reduced or loss of taste;
• dizziness;
• visual disturbances;
• reduced vision;
• fatigue.

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

• reduction in red blood cells (anaemia);
• anxiety;
• tingling and reduced sensitivity to stimuli;
• ringing or buzzing in the ears (tinnitus);
• skin reactions due to sunlight exposure;
• fever;
• weight loss due to reduced taste.

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

• liver failure;
• inflammation of the liver (hepatitis);
• yellowing of the skin, mucous membranes, and eyes (jaundice);
• bile stasis (cholestasis);
• increased liver enzymes.

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

• neutropenia (reduced number of neutrophils in the blood);

• agranulocytosis (reduced number of granulocytes in the blood);

• thrombocytopenia (reduced number of platelets in the blood);

• pancytopenia (reduced number of all blood cells);

• severe allergic reactions, even after the first dose (anaphylactoid reactions), and angioedema (swelling of the face, lips, mouth, tongue, or throat, which may cause
  difficulty breathing and swallowing);

• cutaneous and systemic lupus erythematosus, an autoimmune disease;

• various types of allergic reactions, even severe, characterized by redness, itching, skin peeling, and blistering (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, toxic skin eruption, exfoliative dermatitis, and bullous dermatitis);

• skin rashes similar to psoriasis or worsening of psoriasis;

• hair loss.

Side effects not known (frequency cannot be estimated from available data)

• severe allergic reactions, which may be fatal (anaphylactic reactions and serum-sickness-like reactions);
• reduced or lost sense of smell, even permanently;
• hearing loss;
• hearing disturbances;
• inflammation of blood vessels;
• inflammation of the pancreas;
• drug rash with eosinophilia and systemic symptoms (DRESS);
• skin disorders characterized by marked sensitivity to sunlight (photosensitivity);
• skin reactions to light and skin eruption after exposure to light;
• severe muscle damage associated with destruction of muscle tissue;
• influenza-like syndrome;
• increased blood levels of an enzyme called creatine phosphokinase.

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
http://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 Tecnigen

Keep this medicine out of the sight and reach of children.
Keep the blister pack in the outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the packaging after “Expires on”. 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Terbinafina Tecnigen contains

• The active substance is terbinafine hydrochloride. Each tablet contains 281.250 mg of terbinafine hydrochloride, equivalent to 250 mg of terbinafine base.
• The other components are Microcrystalline cellulose PH101, Hypromellose, Croscarmellose sodium, Anhydrous colloidal silica, Magnesium stearate.

Description of the appearance of Terbinafina Tecnigen and the contents of the pack
Terbinafina Tecnigen tablets are round, flat, white, with a score line on one side.
The tablets are available in a carton containing a PVC/Aluminum blister pack of 8 tablets.

Marketing Authorization Holder
TECNIGEN S.r.l., via Galileo Galilei, 40, 20092 Cinisello Balsamo (MI), Italy.

Manufacturer
Atlantic Pharma - Produções de Especialidades Farmacêuticas, S.A.
Rua da Tapada Grande, n. 2, Abrunheira, 2710-089 Sintra, Portugal.