Terbinafine Sandoz GmbH: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Terbinafina Sandoz GmbH 125 mg tablets, 250 mg tablets

Terbinafine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult 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:

What Terbinafina Sandoz GmbH is and what it is used for
What you need to know before taking Terbinafina Sandoz GmbH
How to take Terbinafina Sandoz GmbH
Possible side effects
How to store Terbinafina Sandoz GmbH
Contents of the pack and other information

1. WHAT TERBINAFINE SANDOZ GMBH IS AND WHAT IT IS USED FOR

Terbinafine, the active substance of Terbinafine Sandoz GmbH, is an antifungal medicine.
Terbinafine Sandoz GmbH is used to treat certain fungal infections of the skin and nails.

2. WHAT YOU SHOULD KNOW BEFORE TAKING TERBINAFINE SANDOZ GMBH

Do not take Terbinafine Sandoz GmbH

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

If any of these conditions apply to you, inform your doctor before taking terbinafine.
If you think you are having an allergic reaction, consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Terbinafine Sandoz GmbH if any of the following conditions apply to you:

You suffer from any kidney or liver disorder
You already have psoriasis
You have lupus erythematosus (an autoimmune disease)

Your doctor should monitor your liver function tests before starting treatment with Terbinafine Sandoz GmbH and every 4–6 weeks during treatment.
Children
Children should not take Terbinafine Sandoz GmbH tablets, as there is limited data on its use in children.
Other medicines and Terbinafine Sandoz GmbH
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of terbinafine may be affected by concomitant treatment with the medicines or groups of medicines listed below. Ask your doctor or pharmacist if you are unsure whether your medicine belongs to any of the listed groups.

The effect of terbinafine may be increased when used concomitantly with medicines that inhibit the breakdown of terbinafine (e.g., cimetidine [a gastrointestinal medicine], fluconazole [an antifungal medicine], ketoconazole [an antifungal medicine], amiodarone [an antiarrhythmic medicine]).
The effect of terbinafine may be reduced if taken simultaneously with drugs that enhance the breakdown of terbinafine (e.g., rifampicin [an antibiotic]).

The effect of the following medicines may be influenced by concomitant intake of terbinafine:

Some medicines used to treat high blood pressure (some beta-blockers such as metoprolol)
Some medicines used to treat cardiac arrhythmias and cardiovascular disorders (some antiarrhythmic drugs including class 1A, 1B, and 1C, such as propafenone, amiodarone)
Caffeine
Cough suppressants (e.g., dextromethorphan)
Some medicines used to treat mood disorders (some antidepressants such as tricyclic antidepressants, selective serotonin reuptake inhibitors [SSRIs], monoamine oxidase inhibitors type B, desipramine)
Cyclosporine (a medicine used to prevent rejection of transplanted organs)

Make sure to inform your doctor about these or any other medicines you are taking. Your doctor will adjust the dose if necessary.
When terbinafine is taken together with medicines that are metabolized by the same enzyme system as terbinafine (e.g., terfenadine, triazolam, tolbutamide, ethinylestradiol [e.g., in oral contraceptives]), no interaction usually occurs.
Terbinafine also has no effect on the elimination of phenazone or digoxin.
When terbinafine is taken concomitantly with certain oral medicines that inhibit blood coagulation (e.g., warfarin), changes in blood clotting time may occur under certain circumstances. However, a causal relationship has not been established.
Menstrual disorders (e.g., irregular menstruation, unexpected bleeding, intermenstrual bleeding, and absence of menstruation) have been observed in some women who took terbinafine concomitantly with oral contraceptive tablets ("the pill"). However, these disorders did not occur more frequently than in women who took only oral contraceptives for pregnancy prevention.
Please note that the information above may also apply to medicines recently used.
Terbinafine with food and drinks
Terbinafine tablets should be taken before or after meals.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Since clinical experience in pregnant women is very limited, Terbinafine Sandoz GmbH should not be used during pregnancy unless your doctor has specifically advised you to do so.
Terbinafine Sandoz GmbH should not be used during breastfeeding, as the active substance terbinafine passes into breast milk and could harm the infant.
Driving and using machines
Some people have reported dizziness during treatment with Terbinafine Sandoz GmbH. If this applies to you, do not drive or operate machinery.
Terbinafine Sandoz GmbH contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially 'sodium-free'.

3. HOW TO TAKE TERBINAFINE SANDOZ GMBH

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Terbinafine Sandoz GmbH 125 mg tablets
The recommended dose for adults , including elderly patients, is 2 tablets per day .
Terbinafine Sandoz GmbH 250 mg tablets
The recommended dose for adults , including elderly patients, is 1 tablet per day .
Method of administration
Swallow the tablet with a glass of water, preferably at the same time each day.
The tablets may be taken before or after meals.
Duration of treatment

For skin infections , continue taking the tablets for a period of 2 to 6 weeks .
For nail infections , treatment usually lasts between 6 weeks and 3 months , although some patients with toe nail infections may require treatment for 6 months or longer .

Use in children
Due to limited experience with terbinafine in children, its use is not recommended.
Treatment of elderly patients
There is no evidence that elderly patients require a different dosage or experience adverse effects not seen in younger patients. If you are 65 years of age or older, you may take Terbinafine Sandoz GmbH at the same dosage as younger adults.
If you think that the effect of Terbinafine Sandoz GmbH is too strong or too weak, consult your doctor or pharmacist.
If you take more Terbinafine Sandoz GmbH than you should
Seek immediate advice from your doctor or go to the hospital. Clinical treatment may be necessary. This also applies if someone else has accidentally taken your medicine. The doctor may first administer activated charcoal to remove the active substance and take further actions if needed.
The following symptoms have been observed following overdose of Terbinafine Sandoz GmbH:
Headache, nausea, upper abdominal pain, and dizziness.
If you forget to take Terbinafine Sandoz GmbH
Do not take a double dose to make up for the missed dose.
Take the tablet as soon as you remember. However, if less than 4 hours remain before your next scheduled dose, wait and take your next tablet at the usual time.
If you stop taking Terbinafine Sandoz GmbH
To treat a fungal infection, long-term treatment is required. Complete resolution of signs and symptoms may not be evident for several months after treatment ends, because healthy nails take time to grow. You can recognize the response to therapy by the regrowth of healthy nail. Normally, fingernails grow about 2 mm per month and toenails about 1 mm per month. The infected area gradually grows out. Irregular use or premature discontinuation of treatment may result in risk of reinfection. Therefore, always consult your doctor before stopping treatment.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious.
Contact your doctor immediately if you notice any of the following rare or very rare symptoms:

yellowing of the skin or eyes, unusually dark urine, or unusually pale stools, persistent unexplained nausea, stomach upset, pain in the upper right side of the abdomen, loss of appetite, unusual fatigue or weakness (these may be signs of liver problems)
severe skin reactions, such as rash, sensitivity to light, blisters, peeling, or hives
symptoms such as facial rash, fever, feeling unwell or tired, joint or muscle pain (possible signs of lupus erythematosus, an autoimmune disease)
severe allergic reaction that may cause difficulty breathing, dizziness, flushing, cramping abdominal pain, stiffness, rash, swelling (especially of the face or throat), fever, or swelling/enlargement of the lymph nodes
unusual bleeding, bruising, abnormally pale skin, unusual fatigue or weakness, or shortness of breath on exertion, sore throat with fever and chills, or frequent infections (these may be signs of blood disorders)
symptoms such as rash, fever, itching, fatigue, or if you notice red-purple spots under the skin (possible signs of inflammation of blood vessels)
severe pain in the upper abdomen spreading to the back (possible signs of inflammation of the pancreas)
unexplained muscle weakness and pain, or dark (red-brown) urine (possible signs of breakdown of muscle proteins).

Other side effects that have been reported
Very common – may affect more than 1 in 10 people

Headache
Indigestion
Nausea
Stomach ache
Diarrhea
Feeling bloated
Loss of appetite
Itching, rash, or swelling
Muscle and joint pain.

Common – may affect up to 1 in 10 people

Depression
Taste disturbances and loss of taste. These effects usually resolve slowly over several weeks after stopping the medicine. However, very rarely, taste disturbances or loss of taste may persist for a long time.
Vision problems
Dizziness or tiredness.

Uncommon – may affect up to 1 in 100 people

Decrease in red blood cell count
Anxiety (with symptoms such as sleep disturbances, fatigue, loss of energy, or reduced thinking or concentration ability)
Numbness or tingling
Ringing or noise in the ears in the absence of external sounds (tinnitus)
Increased sensitivity of the skin to sunlight
Fever
Weight loss secondary to hypogeusia.

Rare – may affect up to 1 in 1,000 people

Liver disorders such as liver failure, liver inflammation, yellowing of the skin or eyes, increased liver enzyme levels.

Very rare – may affect up to 1 in 10,000 people

Decrease in the count of certain blood cells
Lupus erythematosus (an autoimmune disease)
Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
Allergic reactions
Hair loss
Skin disorders causing excessive growth of skin cells, leading to thickened areas of white, silvery, or red skin (rash resembling psoriasis, worsening of psoriasis)
Liver impairment, leading to liver transplantation or death. In most of these cases, patients had severe underlying conditions.

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

Severe allergic reaction (anaphylactic reaction, serum sickness-like reaction)
Hearing loss, impaired hearing
Blurred vision, reduced visual acuity
Inflammation of blood vessels
Smell disorders, including permanent loss of smell
Depressive symptoms (e.g. depressed mood) due to taste disturbances
Inflammation of the pancreas
Drug rash with eosinophilia and systemic symptoms (DRESS), a skin reaction associated with increased levels of certain white blood cells (eosinophilia) and internal organ inflammation
A pathological condition associated with severe muscle cell damage leading to cell death (rhabdomyolysis), or increased levels of a muscle enzyme in the blood (creatine phosphokinase)
Influenza-like symptoms such as fatigue, chills, sore throat, joint or muscle pain.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TERBINAFINE SANDOZ GMBH

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or on the blister/bottle, following the word "Exp". The expiry date refers to the last day of that month.
Blister: store the blister in the outer carton to protect the medicine from light.
Bottle: 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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Terbinafina Sandoz GmbH contains

The active substance is: terbinafine.
Terbinafina Sandoz GmbH 125 mg tablets: Each tablet contains 125 mg of terbinafine as terbinafine hydrochloride.

Terbinafina Sandoz GmbH 250 mg tablets
Each tablet contains 250 mg of terbinafine as terbinafine hydrochloride.

The other components are: sodium starch glycolate (type A), hypromellose, anhydrous colloidal silica, potato starch, magnesium stearate.

Description of the appearance of Terbinafina Sandoz GmbH and contents of the pack
Terbinafina Sandoz GmbH 125 mg tablets
White or almost white, round, biconvex tablets with a score line on one side, marked “TER 125” on one side, packaged in blisters or bottles.
Pack sizes: 10, 14, 16, 20, 28, 30, 42, 98 and 100 tablets.
Terbinafina Sandoz GmbH 250 mg tablets
Terbinafina Sandoz GmbH 250 mg tablets are white or almost white, round tablets, with a score line on both sides, marked “TER 250” on one side, packaged in blisters or bottles.
Pack sizes: 8, 10, 14, 20, 28, 30, 42, 56, 98 and 100 tablets.
The tablets can be divided into equal doses.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH – Biochemiestrasse 10 – 6250 Kundl (Austria)
Representative in Italy: Sandoz S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Responsible manufacturers for batch release
ROWA Pharmaceuticals Ltd., Bantry, Co Cork (Ireland)
SALUTAS Pharma GmbH, Otto-von-Guericke Allee, 1, 39179 Barleben (Germany)
LEK S.A., Ul. Domaniewska, 50 C, PIL-02-672 Warszawa (Poland)
LEK Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava (Slovenia)
Lek Pharmaceuticals d.d., Verovskova ulica 57, 1526 Ljubljana (Slovenia)

This medicinal product has been authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Germany: Terbinafin - 1 A Pharma 125 mg Tabletten
Terbinafin - 1 A Pharma 250 mg Tabletten
Italy: TERBINAFINA SANDOZ GMBH

This summary of product characteristics was last approved on