Prospect: Information for the user

Terbinafine Aurovitas 250 mg tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Terbinafine Aurovitas

3.How to take Terbinafine Aurovitas

4.Possible adverse effects

5.Storage of Terbinafine Aurovitas

6.Contents of the package and additional information

Terbinafinabelongs to a group of medicines called antifungals. It is used to treat fungal skin infections (including those between the fingers of the hands and the toes) and nail infections.

Do not takeTerbinafineAurovitas

•If you are allergic to terbinafine or any of the other components of this medication (listed in section 6).

•If you are breastfeeding.

•If you are pregnant or planning to become pregnant.

•If you have or have had severe liver problems.

•If you have severe kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Terbinafine Aurovitas if any of the following cases apply to you:

•If you have liver or kidney problems.

•If you have psoriasis.

•If you have lupus erythematosus (an autoimmune disease).

•If you need to be treated with this medication for more than 6 weeks and your immune system is suppressed, your doctor will need to analyze your blood.

Your doctor should monitor your liver function before starting to take terbinafine and every 4-6 weeks during treatment.

Children and adolescents

Terbinafine is not recommended for use in children.

Other medications andTerbinafine Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Some medications may interfere with your treatment. Inform your doctor if you are taking any of the following:

•Rifampicin, for infections.

•Cimetidine, for stomach problems such as indigestion and ulcers.

•Some medications used to treat behavioral changes (some antidepressants such as tricyclic antidepressants, selective serotonin reuptake inhibitors, monoamine oxidase B inhibitors, desipramine), some medications used to treat irregular heartbeats (some antiarrhythmics including class 1A, 1B, and 1C such as propafenone, amiodarone).

•Some medications used to treat fungal infections (such as fluconazole, ketoconazole).

•Dextromethorphan, to treat cough.

•Oral contraceptives (as they may cause irregularities in the cycle, light bleeding, intermenstrual bleeding, and absence of menstrual period in some patients).

•Some beta-blockers (medications for some heart or blood vessel problems with active ingredients whose names end in “-lol”, such as metoprolol) or medications to treat heart rhythm alterations.

•Caffeine.

•Ciclosporin, to produce immunosuppression.

•Warfarin, a medication used to make the blood more liquid.

Pregnancy, breastfeeding, and fertility

Pregnancy:Do not take terbinafine if you are pregnant or planning to become pregnant. Inform your doctor if you become pregnant while taking this medication.

Breastfeeding:Terbinafine passes into breast milk. Do not take terbinafine if you are breastfeeding.

If you are pregnant or breastfeeding, or think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Some people have reported feeling dizzy while taking terbinafine. If you feel dizzy, do not drive or operate machinery.

Terbinafine Aurovitas contains sodium

Terbinafine Aurovitas contains sodium. This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dose

Adults

The dose prescribed will depend on the type and severity of the infection.

The recommended dose is 250 mg of terbinafine per day. Swallow the tablet whole with a glass of water. Tablets can be taken with or without food.

If you have kidney problems, your doctor may prescribe half the recommended dose.

Treatment duration

Your doctor will indicate the duration of your treatment with terbinafine.

•In the case of general skin infections caused by fungi, treatment will likely last 4 weeks.

•Treatment of skin infections affecting the toes or body will normally last 2 to 4 weeks, and those affecting the feet may last 2 to 6 weeks.

•Treatment of nail infections may last between 6 weeks and 3 months, although treatment of foot nail infections may continue for 6 months or more.

It is possible that the complete resolution of the signs and symptoms of the infection will not occur until several weeks after stopping treatment and the infection has been cured.

Children and adolescents (under 18 years)

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

If you take moreTerbinafine Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring this leaflet or some tablets with you so that the doctor knows what you have taken. You may feel dizzy, nauseous, and have headaches and/or stomach pain.

If you forget to takeTerbinafine Aurovitas

If you forget to take terbinafine at the time it is due, take it as soon as you remember. Do not take a double dose to make up for the missed dose.

If you interrupt treatment withTerbinafine Aurovitas

Do not stop taking terbinafine without consulting your doctor, even if the infection is cured.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious.

Inform your doctor immediatelyif you notice any of the following rare or very rare symptoms:

•Yellowing of the skin or eyes, abnormally dark urine or pale stools, persistent unexplained nausea, stomach problems, upper right abdominal pain, loss of appetite, unusual fatigue or weakness (this may indicate liver problems).

•Severe skin reactions, including skin 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 can cause difficulty breathing, dizziness, redness, abdominal pain like colic, stiffness, swelling mainly of the face or throat, fever, or swelling/enlargement of lymph nodes.

•Unusual bleeding, petechiae, abnormal paleness of the skin, unusual fatigue or weakness, or difficulty breathing during exertion, sore throat with fever and chills, or frequent infections (this may be a sign of blood disorders).

•Symptoms such as skin rash, fever, itching, fatigue, or if you notice the appearance of red-purple patches under the skin's surface (possible signs of blood vessel inflammation).

•Intense pain in the upper part of the stomach that extends to the back (possible signs of pancreatitis).

•Unexplained muscle weakness or pain, or dark urine (reddish-brown) (possible signs of muscle necrosis).

This has been reported with terbinafine in tablets:

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

•Headache.

•Indigestion.

•Nausea.

•Stomach pain.

•Diarrhea.

•Fullness sensation.

•Loss of appetite.

•Itching, skin rash, or swelling.

•Muscle and joint pain.

Common (may affect up to 1 in 10 people)

•Depression.

•Alteration or loss of taste. This usually disappears slowly over several weeks after stopping the medication. However, in very rare cases, the alteration or loss of taste may continue for a longer period of time.

•Eye problems.

•Dizziness or feeling tired.

Uncommon (may affect up to 1 in 100 people)

•Decreased red blood cell count.

•Anxiety (with symptoms such as sleep disturbances, fatigue, loss of energy, or decreased ability to think or concentrate).

•Numbness or tingling.

•Tinnitus or ringing in the ears in the absence of sound.

•Increased skin sensitivity to the sun.

•Fever.

•Weight loss due to taste alterations.

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

•Liver problems such as liver insufficiency, liver inflammation, yellowing of the skin or eyes, increased liver enzymes in the blood. With terbinafine in tablets, there have been reported cases of severe liver insufficiency (some with fatal outcome or requiring liver transplant).

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

•Decreased count of some blood cells.

•Lupus erythematosus (an autoimmune disease).

•Severe skin reactions.

•Allergic reactions.

•Hair loss.

•Skin disease that causes skin cells to grow too quickly, resulting in thick, white, silver, or red patches of skin (skin eruptions like psoriasis, worsening of psoriasis).

Frequency not known (cannot be estimated from available data)

•Severe allergic reaction (anaphylactic reaction, serum sickness-like reaction).

•Decreased hearing, hearing deterioration.

•Blurred vision, decreased visual acuity.

•Blood vessel inflammation.

•Taste alterations, including permanent loss of taste.

•Depression symptoms (e.g., depressed mood) due to taste alterations.

•Pancreatitis.

•Drug reaction with increased some blood cells (eosinophilia) and internal organ inflammation called "Drug Reaction with Eosinophilia and Systemic Symptoms" (DRESS).

•Muscle cell damage process associated with severe cellular trauma in muscles leading to cell death (rhabdomyolysis), or increased muscle enzyme in the blood (creatine phosphokinase).

•Pseudo-gripal symptoms, such as fatigue, chills, sore throat, muscle or joint pain.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofTerbinafinaAurovitas

-The active ingredient is terbinafine. Each tablet contains 250 mg ofterbinafine (as 281,250 mg of hydrochloride of terbinafine).

-The other components are microcrystalline cellulose, carboxymethylstarch sodium (type A) (derived from potato starch), anhydrous colloidal silica, hypromellose, magnesium stearate.

Appearance of the product and content of the container

Uncoated white to almost white tablets, round, biconvex, bisected, scored, with the mark “D” on one face and “74” on the other. The tablet can be divided into equal doses.

Terbinafina Aurovitas tabletsare available in blister packs of 14, 28, 56, and 98 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: September 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).