Terbinafine Aurovitas 250 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Terbinafine Aurovitas 250 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Terbinafine Aurovitas is and what it is used for
2. What you need to know before taking Terbinafine Aurovitas
3. How to take Terbinafine Aurovitas
4. Possible adverse effects
5. How to store Terbinafine Aurovitas
6. Contents of the pack and other information

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

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

2. What you need to know before taking Terbinafina Aurovitas

Do not take Terbinafina Aurovitas

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Terbinafina Aurovitas if any of the following apply to you:

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

Your doctor should check your liver function before starting terbinafine and every 4–6 weeks during treatment.

Children and adolescents

Terbinafine is not recommended for use in children.

Other medicines and Terbinafina Aurovitas

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

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

• Rifampicin, used for infections.
• Cimetidine, used for stomach problems such as indigestion and ulcers.
• Some medicines used to treat behavioural changes (certain antidepressants such as tricyclic antidepressants, selective serotonin reuptake inhibitors, monoamine oxidase inhibitors type B, desipramine), some medicines used to treat irregular heartbeats (certain antiarrhythmics including class 1A, 1B and 1C such as propafenone, amiodarone).
• Some antifungal medicines (such as fluconazole, ketoconazole).
• Dextromethorphan, used to treat cough.
• Oral contraceptives (as menstrual irregularities, light bleeding, intermenstrual bleeding, and absence of periods may occur in some patients).
• Certain beta-blockers (medicines for certain heart or blood vessel conditions with active substances whose names end in “-lol”, such as metoprolol) or medicines used to treat heart rhythm disorders.
• Caffeine.
• Cyclosporine, used to suppress the immune system.
• Warfarin, a medicine used to thin the blood.

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 medicine.

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

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

Driving and using machines

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

Terbinafina Aurovitas contains sodium

Terbinafina Aurovitas contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.

3. How to take Terbinafina Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

Adults

The dose prescribed to you 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. The tablets may be taken with or without food.

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

Duration of treatment

Your doctor will determine how long you should take terbinafine.

• For general fungal skin infections, treatment will probably last 4 weeks.
• Treatment of skin infections affecting the groin or body usually lasts 2 to 4 weeks, while infections affecting the feet may last 2 to 6 weeks.
• For nail infections, treatment may last from 6 weeks to 3 months, although treatment of toenail infections may continue for 6 months or longer.

Complete resolution of signs and symptoms of the infection may not occur until several weeks after treatment has ended and the infection has been cured.

Children and adolescents (under 18 years of age)

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

If you take more Terbinafina Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medication and the amount ingested. Take this leaflet or some tablets with you so the doctor knows what you have taken. You may experience dizziness, nausea, headache, and/or stomach pain.

If you forget to take Terbinafina Aurovitas

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

If you stop taking Terbinafina Aurovitas

Do not stop taking terbinafine without consulting your doctor, even if the infection appears to be healed.

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

4. Possible adverse effects

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

Some adverse effects may be serious.

Tell your doctor immediately if 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 (these may indicate liver problems).
• Serious skin reactions, including rash, sensitivity to light, blistering, 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 which may cause difficulty breathing, dizziness, redness, cramp-like abdominal pain, stiffness, swelling mainly of the face or throat, fever, or swelling/thickening of the lymph nodes.
• Unusual bleeding, bruising, abnormal paleness of the skin, unusual tiredness or weakness, or shortness of breath during exertion, sore throat with fever and chills, or frequent infections (these may be signs of blood disorders).
• Symptoms such as skin rash, fever, itching, tiredness, or if you notice the appearance of red-purple spots beneath the skin surface (possible signs of inflammation of blood vessels).
• Severe pain in the upper abdomen spreading to the back (possible signs of pancreatitis).
• Unexplained muscle weakness or pain, or dark (red-brown) urine (possible signs of muscle necrosis).

The following adverse effects have been reported with oral terbinafine:

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

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

Common (may affect up to 1 in 10 people)

• Depression.
• Disturbance or loss of taste sense. This usually resolves slowly over several weeks after stopping the medicine. However, in very rare cases, taste disturbance or loss may persist for a longer period.
• Vision problems.
• Feeling dizzy or tired.

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 reduced 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 sunlight.
• Fever.
• Weight loss due to disturbances in taste sense.

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 oral terbinafine, very rare cases of severe liver failure have been reported (some resulting in death or requiring liver transplantation).

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

• Decrease in the number of certain blood cells.
• Lupus erythematosus (an autoimmune disease).
• Serious skin reactions.
• Allergic reactions.
• Hair loss.
• Skin disease causing skin cells to grow too quickly, resulting in thick areas of white, silvery, or red skin (psoriasis-like skin eruptions, worsening of psoriasis).

Frequency not known (cannot be estimated from available data)

• Severe allergic reaction (anaphylactic reaction, serum sickness-like reaction).
• Hearing loss, deterioration of hearing.
• Blurred vision, decreased visual acuity.
• Inflammation of blood vessels.
• Olfactory disturbances including permanent loss of smell.
• Symptoms of depression (e.g., depressed mood) due to taste disturbance.
• Inflammation of the pancreas.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), a reaction to the drug associated with increased levels of certain blood cells (eosinophilia) and inflammation of internal organs.
• A pathological condition associated with severe cellular injury in muscles leading to cell death (muscle necrosis), known as rhabdomyolysis, or increased levels of a muscle enzyme in the blood (creatine phosphokinase).
• Pseudo-flu-like symptoms, such as tiredness, chills, sore throat, muscle or joint pain.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse 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 refers to the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Terbinafine Aurovitas

• The active substance is terbinafine. Each tablet contains 250 mg of terbinafine (as 281,250 mg of terbinafine hydrochloride).
• The other components are microcrystalline cellulose, sodium carboxymethylstarch (type A) (derived from potato starch), colloidal anhydrous silica, hypromellose, magnesium stearate.

Appearance of the product and contents of the container

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: September 2023

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