TERBINAFINE AUROVITAS 250 mg TABLETS

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

Do not takeTerbinafineAurovitas

• if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6).
• if you are breast-feeding.
• if you are pregnant or trying to become pregnant.
• if you have severe liver problems.
• if you have severe kidney problems.

Warnings and precautions

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

• if you have kidney or liver problems.
• if you have psoriasis.
• if you have lupus erythematosus (an autoimmune disease).
• if you are to be treated with this medicine for more than 6 weeks and your immune system is suppressed, your doctor will need to check your blood.

Your doctor should monitor your liver function before you start taking terbinafine and every 4-6 weeks during treatment.

Children and adolescents

Terbinafine is not recommended for use in children.

Other medicines andTerbinafineAurovitas

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

• Rifampicin, for infections.
• Cimetidine, for stomach problems such as indigestion and ulcers.
• Certain medicines used to treat changes in behavior (certain antidepressants such as tricyclic antidepressants, selective serotonin reuptake inhibitors, monoamine oxidase type B inhibitors, desipramine), certain medicines used to treat irregular heartbeats (certain antiarrhythmics including class 1A, 1B and 1C such as propafenone, amiodarone).
• Certain medicines used to treat fungal infections (such as fluconazole, ketoconazole).
• Dextromethorphan, to treat cough.
• Oral contraceptives (as irregularities in the cycle, light bleeding, intermenstrual bleeding, and absence of menstrual period may occur in some patients).
• Certain beta-blockers (medicines for certain heart or blood vessel problems with active ingredients whose names end in "-lol", such as metoprolol) or drugs to treat heart rhythm disorders.
• Caffeine.
• Ciclosporin, to produce immunological suppression.
• Warfarin, a medicine used to make the blood more fluid.

Pregnancy, breast-feeding 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 medicine.

Breast-feeding:terbinafine passes into breast milk. Do not take terbinafine if you are breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Some people have reported feeling dizzy while taking terbinafine. If you feel this way, do not drive or use machines.

Terbinafine Aurovitas contains sodium

Terbinafine Aurovitas contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Terbinafine Aurovitas

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

Dose

Adults

The dose that will be prescribed to you will depend on the type and severity of the infection.

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

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

Duration of treatment

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

• In case of general fungal skin infections, treatment will probably last 4 weeks.
• Treatment of skin infections that affect the groin or body will normally last 2 to 4 weeks and those that affect the feet may last 2 to 6 weeks.
• In case of nail infections, treatment may last between 6 weeks and 3 months, although treatment of toenail 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 moreTerbinafineAurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine 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 a headache and/or stomach pain.

If you forget to takeTerbinafineAurovitas

If you forget to take terbinafine at the right time, take it as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop takingTerbinafineAurovitas

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious.

Tell 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, unexplained persistent nausea, stomach problems, upper right abdominal pain, loss of appetite, unusual tiredness 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 colic-type pain, stiffness, swelling mainly of the face or throat, fever or swelling/thickening of the lymph nodes.
• Unusual bleeding, bruising, unusual paleness of the skin, unusual tiredness or weakness or shortness of breath 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, tiredness or if you notice the appearance of red-purple spots under the skin surface (possible signs of inflammation of the blood vessels).
• Severe pain in the upper part of the stomach that spreads to the back (possible signs of pancreatitis).
• Unexplained muscle weakness or dark-colored urine (red-brown) (possible signs of muscle necrosis).

The following side effects have been reported with terbinafine tablets:

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

• Headache.
• Indigestion.
• Nausea.
• Stomach pain.
• Diarrhea.
• Feeling of fullness.
• Loss of appetite.
• Itching, skin rash or swelling.
• Pain in muscles and joints.

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 medicine. However, in very rare cases, the alteration or loss of taste may continue for a longer period.
• Vision problems.
• Feeling of dizziness or tiredness.

Uncommon (may affect up to 1 in 100 people)

• Decrease in the number of red blood cells.
• Anxiety (with symptoms such as sleep disturbances, fatigue, loss of energy or decreased ability to think or concentrate).
• Numbness or tingling.
• Ringing or noise in the ears in the absence of sound (tinnitus)
• Increased sensitivity of the skin to the sun.
• Fever.
• Weight loss due to taste disturbances.

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

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

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

• Decrease in the number of certain blood cells.
• Lupus erythematosus (an autoimmune disease).
• Severe skin reactions.
• Allergic reactions.
• Hair loss.
• Skin disease that causes skin cells to grow too quickly, leading to thick, white, silver or red skin patches (psoriasis-like skin eruptions, worsening of psoriasis).

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

• Severe allergic reaction (anaphylactic reaction, serum sickness-like reaction).
• Hearing loss, hearing impairment.
• Blurred vision, decreased visual acuity.
• Inflammation of the blood vessels.
• Disturbances of smell including permanent loss of smell.
• Symptoms of depression (e.g. depressed mood) due to taste disturbance.
• Pancreatitis.
• Drug reaction with eosinophilia and systemic symptoms (DRESS).
• Pathological process associated with severe muscle cell trauma leading to cell death (rhabdomyolysis), or increased muscle enzyme in the blood (creatine phosphokinase).
• Flu-like symptoms, such as fatigue, chills, sore throat, muscle or joint pain.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Terbinafine Aurovitas

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 carton after EXP. The expiry date is the last day of the month stated.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition ofTerbinafineAurovitas

• The active substance is terbinafine. Each tablet contains 250 mg of terbinafine (as 281.250 mg of terbinafine hydrochloride).
• The other ingredients are microcrystalline cellulose, sodium carboxymethyl starch (type A) (derived from potato starch), anhydrous colloidal silica, hypromellose, magnesium stearate.

Appearance of the product and contents of the pack

White to almost white, uncoated, round, biconvex, scored tablets with "D" marked on one face and "74" on the other. The tablet can be divided into equal doses.

Terbinafine Aurovitas tablets are available in blister packs of 14, 28, 56 and 98 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: September 2023

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