LAMISIL 250 mg Coated Tablets

Зміст інструкції

1. Lamisil 250 mg tablets
   1. What is Lamisil and what is it used for
   2. What you need to know before taking Lamisil
   3. How to take Lamisil
   4. Possible side effects
   5. How to store Lamisil
   6. Contents of the pack and other information
2. Lamisil 1% cream
   1. What is Lamisil and what is it used for
   2. What you need to know before using Lamisil
   3. How to use Lamisil
   4. Possible side effects
   5. How to store Lamisil
   6. Contents of the pack and other information

Lamisil 250 mg tablets

terbinafine

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 only. Do not pass it on to others, even if their symptoms are the same as yours, as it may 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 Lamisil is and what it is used for
• 2. What you need to know before you take Lamisil
• 3. How to take Lamisil
• 4. Possible side effects
• 5. How to store Lamisil
• 6. Contents of the pack and other information

1. What is Lamisil and what is it used for

Lamisil contains the active ingredient terbinafine which belongs to a group of medicines
called “antifungals”. Lamisil is used to treat fungal infections and works
by destroying a large number of fungi.
Lamisil is therefore indicated for the treatment of:

• nail infections caused by fungi called “dermatophytes”
• tinea capitis, a scalp infection caused by fungi
• skin infections caused by fungi called “dermatophytes” (Tinea corporis, Tinea cruris, Tinea pedis) and by yeasts such as Candida (Candida albicans) for which the doctor has deemed it appropriate to administer oral therapy.

Unlike Lamisil cream, Lamisil tablets are not effective in the treatment of Pityriasis
versicolor, a superficial skin infection also known as “tinea versicolor”.

2. What you need to know before taking Lamisil

Do not take Lamisil

• if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6)
• if you are 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 Lamisil.
Tell your doctor before taking Lamisil:

• if you have a skin condition called psoriasis or lupus erythematosus (an autoimmune disease), because these conditions may worsen during treatment with Lamisil
• if you have kidney problems.

If you are elderly, your doctor will assess the presence of liver or kidney problems before prescribing
Lamisil.
Pay particular attention during treatment with Lamisil and immediately inform your
doctor:

• if you experience nausea that persists over time without a known cause, loss of appetite, fatigue, vomiting, abdominal pain, yellowing of the skin, mucous membranes and eyes, dark urine and pale stools because these are signs of liver problems. The doctor will assess your condition and decide whether to stop treatment with Lamisil
• if you experience skin reactions (rash) that progressively worsen. The doctor will assess your condition and decide whether to stop treatment with Lamisil
• if you experience a change in blood characteristics detectable through a blood test (e.g. reduction of white blood cells, platelets and red blood cells). The doctor will assess your condition and decide whether to modify the dose or stop treatment with Lamisil
• if you are taking other medicines (see section “Other medicines and Lamisil”).

During treatment with Lamisil, your doctor will perform periodic checks of liver function.

Children
Lamisil should not be administered to children under 2 years of age.

Other medicines and Lamisil
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Pay particular attention when taking Lamisil with the following medicines:

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

Lamisil tablets also interfere insignificantly with:

• terfenadine (used for allergies)
• triazolam (used to promote sleep and reduce anxiety)
• tolbutamide (used for the treatment of diabetes)
• oral contraceptives.

Lamisil with food and drink
You can take Lamisil on an empty stomach or after meals.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
Pregnancy
If you are pregnant or think you may be, tell your doctor. Lamisil will only be prescribed in cases of
actual necessity and under the direct control of the doctor.
Breastfeeding
Do not take Lamisil while breastfeeding as terbinafine may pass into
breast milk.

Driving and using machines
Lamisil may cause dizziness, if this occurs avoid driving vehicles and using
machinery.

Lamisil contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially ‘sodium-free’.

3. How to take Lamisil

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
The duration of treatment depends on the type and severity of the disease. Your doctor will tell you for
how long to take Lamisil.
Take the tablets by mouth with water, on an empty stomach or after meals. Take the
tablets every day at approximately the same time.
The tablets are divisible to allow administration to children based on their body weight.

Use in adults
The recommended dose is 1 tablet of 250 mg 1 time a day.

Use in children weighing more than 20 kg
250 mg tablets are not suitable for treating children weighing less than 20 kg.
The recommended doses are reported 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, Tinea cruris: 2 - 4 weeks
• Candidiasis of the skin: 2 - 4 weeks

The complete disappearance of signs and symptoms of the disease may occur several weeks
after healing from the fungal infection.

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

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

• Hand nail infection: 6 weeks
• Foot nail infection: 12 weeks

Some patients with reduced nail growth may require an extension of the
therapy.
The complete disappearance of signs and symptoms of the infection requires several months
after stopping treatment, i.e. until a new nail has grown.

Use in elderly people
If you are an elderly person, always consult your doctor who will assess the presence of problems with the
liver or kidneys before prescribing you Lamisil

Use in people with impaired liver function
If you are a person with liver problems, you should not take Lamisil (see the paragraph “Do not
take Lamisil”).

Use in people with impaired kidney function
In people with kidney problems, the use of Lamisil is not recommended.

If you take more Lamisil than you should
In case of accidental ingestion of an excessive dose of Lamisil, immediately inform your
doctor or go to the nearest hospital.
The following adverse effects have been reported after taking an excessive dose of Lamisil (up to 5 g):

• headache
• nausea
• pain in the upper abdomen
• dizziness. In case of an overdose, the doctor will treat your condition according to your symptoms.

If you forget to take Lamisil
Do not take a double dose to make up for a missed dose.

If you stop taking Lamisil
If you have any doubts 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.

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

• decreased appetite
• headache
• feeling of abdominal bloating
• difficulty in digestion
• nausea
• abdominal pain
• diarrhoea
• skin rash
• urticaria (hives)
• joint and muscle pain

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

• depression
• decrease or loss of taste
• dizziness
• impaired vision
• reduced vision
• fatigue

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

• reduction of red blood cells in the blood (anaemia)
• anxiety
• tingling and decreased sensitivity to a stimulus
• ringing and buzzing in the ears
• skin reactions due to sunlight
• fever
• weight loss due to decreased 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 eye (jaundice)
• bile stasis (cholestasis)
• increased liver enzymes

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

• neutropenia (reduction in the number of neutrophils in the blood)
• agranulocytosis (reduction in the number of granulocytes in the blood)
• thrombocytopenia (reduction in the number of platelets in the blood)
• pancytopenia (reduction in the 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 that can cause difficulty breathing and swallowing)
• cutaneous and systemic lupus erythematosus, an autoimmune disease
• allergic reactions of various types, even severe, characterized by redness, itching, skin loss and blistering (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, toxic skin eruption, exfoliative dermatitis and bullous dermatitis)
• skin eruptions similar to psoriasis or worsening of psoriasis
• hair loss

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• severe allergic reactions that can be fatal (anaphylactic reactions and reactions similar to serum sickness)
• reduction or loss, even permanent, of the ability to perceive smells
• hearing loss
• altered hearing
• inflammation of blood vessels
• inflammation of the pancreas
• drug eruption with a high number of eosinophils in the blood and symptoms at the organism level
• skin diseases characterized by a marked sensitivity to sunlight (photodermatoses)
• sun reactions and skin rash after exposure to light
• severe muscle damage associated with muscle tissue destruction
• flu-like syndrome
• increase in the blood of an enzyme called creatine phosphokinase

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
You can also report side effects directly through 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 Lamisil

Keep this medicine out of the sight and reach of children.
Keep the blister in the outer packaging to protect the medicine from light
Do not use this medicine after the expiry date which is reported on the packaging after
“Exp.”. The expiry date refers to the last day of that month.
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. Contents of the pack and other information

What Lamisil contains

• The active ingredient is terbinafine hydrochloride. Each tablet contains 281.250 mg of terbinafine hydrochloride equivalent to 250 mg of terbinafine base.
• The other ingredients are magnesium stearate, anhydrous colloidal silica, hypromellose, sodium carboxymethylcellulose A, microcrystalline cellulose.

Description of the appearance of Lamisil and contents of the pack
Each pack of Lamisil 250 mg tablets contains 8 or 14 tablets of 250 mg for oral use.

Marketing Authorisation Holder
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy

Manufacturer
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy
Novartis Pharma Produktions GmbH
Öflinger Strasse 44,
79664 Wehr
Germany
Lek d.d., PE PROIZVODNJA LENDAVA
Trimlini 2D, Lendava,
9220
Slovenia
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcellona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Norimberga
Germany

Lamisil 1% cream

terbinafine hydrochloride

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 only. Do not pass it on to others, 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 Lamisil is and what it is used for
• 2. What you need to know before you use Lamisil
• 3. How to use Lamisil
• 4. Possible side effects
• 5. How to store Lamisil
• 6. Contents of the pack and other information

1. What is Lamisil and what is it used for

Lamisil contains the active substance terbinafine, which belongs to a group of medicines
called “broad-spectrum antifungals”. Lamisil is used to treat fungal infections
and acts on a wide number of fungi.
Lamisil is indicated for the treatment of:

• skin, nail, scalp, etc. infections caused by fungi called “dermatophytes”
• skin infections caused by yeasts such as Candida
• Tinea versicolor, a superficial skin infection also known as “pityriasis versicolor”.

2. What you need to know before using Lamisil

Do not use Lamisil

• if you are allergic to terbinafine or 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 the age of 12 years.

Warnings and precautions
Talk to your doctor or pharmacist before using Lamisil.
Pay particular attention:

• Do not ingest Lamisil, because it is for external use only
• Do not apply the cream near the eyes, as it may be irritating. If contact occurs, rinse your eyes thoroughly with running water.

Children
Lamisil should not be used in children under the age of 12 years.

Other medicines and Lamisil
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
To date, no interactions with other medicines are known when terbinafine is used locally
on the skin.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
There is no clinical experience with terbinafine in pregnant women. If you are pregnant, your
doctor will prescribe Lamisil only if absolutely necessary.
Breastfeeding
Do not use Lamisil during breastfeeding as terbinafine passes into breast milk. Also
be careful that the newborn does not come into contact with the areas of skin treated with the
medicine, including the breast.

Driving and using machines
Lamisil does not impair the ability to drive vehicles or use machines.

Lamisil contains cetyl alcohol, stearyl alcohol
Cetyl alcohol and stearyl alcohol may cause localized skin reactions (e.g. contact dermatitis).

Lamisil contains benzyl alcohol
This medicine contains 1 g/100 g of benzyl alcohol.
Benzyl alcohol may cause allergic reactions and mild local irritation.

3. How to use Lamisil

Use this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
Lamisil can be applied to the skin one or two times a day, depending on the indication for
which it is used. Your doctor will tell you how many times you should apply Lamisil.

• Clean and dry the affected areas carefully before applying the cream
• apply a thin layer of cream to the affected area and the surrounding area and massage gently
• if the infections are located in skin folds (e.g. under the breast, between the fingers, between the buttocks or at the groin level) you can protect the affected area with a gauze, especially during the night.

Use in adults
Treatment of Tinea corporis, cruris
Apply Lamisil once a day for 1 week.
Treatment of Tinea pedis (infection that occurs between the toes)
Apply Lamisil once a day for 1 week.
Treatment of cutaneous candidiasis
Apply Lamisil one or two times a day for 1 week.
Treatment of Pityriasis versicolor
Apply Lamisil one or two times a day for 2 weeks.
After a few days, an improvement of the disease is already observed. Irregular use or
premature interruption of treatment may entail the risk of relapses.
In particularly severe cases, your doctor may decide to continue the therapy.
Contact your doctor if you do not notice any improvement after two weeks of treatment.

Use in children
Lamisil should not be used in children under 12 years of age.

If you use more Lamisil than you should
In case of accidental ingestion or use of an excessive dose of Lamisil, immediately inform
your doctor or go to the nearest hospital.
After application to the skin, the amount of terbinafine that reaches the blood is very low
so it is unlikely that an overdose will occur. In case of accidental ingestion of a
dose of terbinafine hydrochloride greater than 300 mg, the following adverse effects may occur
:

• headache
• nausea
• stomach pain
• dizziness. The doctor will treat the accidental ingestion or use of an excessive dose of Lamisil based on your condition.

If you forget to use Lamisil
Do not use a double dose to make up for a missed dose.

If you stop using Lamisil
Do not stop Lamisil abruptly because the disease may recur.
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.

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

• skin scaling
• itching

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

• skin lesions
• scabs
• skin alteration
• skin spots
• erythema
• burning sensation
• pain
• pain and irritation at the application site

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

• eye irritation
• skin dryness
• skin reactions characterized, for example, by redness, itching and the appearance of blisters (contact dermatitis and eczema)
• worsening of the infection

Side effects with unknown frequency (the frequency cannot be estimated from available data)

• skin rash
• hypersensitivity

Allergic reactions occur rarely, but in these cases you must stop treatment with Lamisil.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 Lamisil

This medicine does not require any special storage conditions.
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 packaging after
“Expires by”. The expiry date refers to the last day of that month.
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. Contents of the pack and other information

What Lamisil contains

• The active ingredient is terbinafine hydrochloride. One gram of cream contains 10 mg of terbinafine hydrochloride equivalent to 8.8 mg of terbinafine base.
• The other ingredients are sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, demineralized water.

Description of the appearance of Lamisil and contents of the pack
Each pack of Lamisil 1% cream contains a tube of 20 g of 1% cream.

Marketing Authorisation Holder
Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio VA
Italy

Manufacturer
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy
Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio VA
Italy