TERBINAFINE NORMON 250 mg TABLETS

2. What you need to know before you take Terbinafina Normon

Read the following information before taking Terbinafina Normon.

Do not take Terbinafina Normon

• If you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6).
• If you have or have had liver problems.
• If you have kidney problems,

Warnings and precautions

Consult your doctor or pharmacist before taking Terbinafina Normon if:

If any of these cases apply to you, inform your doctor before taking Terbinafina Normon.

• If you have kidney problems, consult your doctor before taking this medicine.

• If you experience symptoms such as persistent and unexplained nausea, vomiting, stomach pain, loss of appetite, unusual tiredness, if your skin or the whites of your eyes turn yellow, if your urine is unusually dark or if your stools are unusually pale (signs of liver problems).
• If you experience any skin problems such as rash, redness of the skin, blisters on the lips, eyes, or mouth, peeling of the skin (signs of severe skin reactions).
• If you experience weakness, unusual bleeding, bruising, or frequent infections (signs of blood disorders).
• If you have psoriasis or lupus erythematosus.

Use in children

Experience with Terbinafina Normon in children is limited; therefore, its use is not recommended in this type of patient.

Use in elderly patients

Terbinafina Normon can be administered to patients over 65 years of age. If there is a pre-existing kidney problem, a lower dose than usual may be prescribed. Terbinafina Normon is not recommended in patients who have or have had liver problems.

Other medicines and Terbinafina Normon

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines, including oral contraceptives, herbal medicines, and those obtained without a prescription.

There are other medicines that can modify the effect of Terbinafina Normon, such as:

• Some antibiotics (e.g., rifampicin).
• Caffeine.
• Some antidepressants (e.g., desipramine).
• Some medicines used to treat heart problems (e.g., propafenone, amiodarone).
• Some medicines used to treat high blood pressure (e.g., metoprolol)
• Some medicines used to treat stomach ulcers (e.g., cimetidine).
• Some medicines used to treat fungal infections (e.g., fluconazole, ketoconazole).
• Some medicines used to treat cough (e.g., dextromethorphan).
• Some medicines used to prevent organ rejection in transplant patients (e.g., cyclosporine).

Pregnancy and breastfeeding

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

Pregnancy

Terbinafina Normon should not be used during pregnancy unless your doctor considers it strictly necessary. In such cases, your doctor will inform you of the possible risks of taking Terbinafina Normon during pregnancy.

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Breastfeeding

Terbinafine passes into breast milk; therefore, mothers taking Terbinafina Normon should not breastfeed.

Driving and using machines

If you feel dizzy while taking Terbinafina Normon, do not drive or use machines.

Terbinafina Normon 250 mg film-coated tablets contain sodium

Terbinafina Normon contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Terbinafina Normon

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

How much to take

Take Terbinafina Normon as your doctor has told you. He will determine the dose you need.

The recommended dose in adults is one tablet (250 mg) once a day.

How to take Terbinafina Normon

Terbinafina Normon is for oral use. Swallow the tablets whole, without chewing, with a glass of water.

How long to take Terbinafina Normon

The duration of treatment will be determined by your doctor. Do not stop treatment before, as it could worsen your illness.

It is possible that the complete remission of the symptoms of the infection may not occur until a few weeks (skin and scalp) or months (nails) after the disappearance of the fungus causing the infection.

If you take more Terbinafina Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. Your doctor will establish the best possible treatment for the overdose.

The main symptoms of acute poisoning can be gastrointestinal, e.g., nausea, abdominal pain, or vomiting, but can also include headache or a feeling of instability (dizziness). If you experience any of these effects or any other unusual effect, consult your doctor.

If you forget to take Terbinafina Normon

Do not take a double dose to make up for forgotten doses.

Take another as soon as you remember unless it is less than 6 hours before the next dose.

4. Possible side effects

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

Some side effects can be serious:

Rarely, Terbinafina Normon can cause liver problems, and in very rare cases, these problems can be serious. Serious adverse reactions also include a decrease in certain blood cells, lupus (an autoimmune disease), severe skin reactions, severe allergic reactions, inflammation of blood vessels, pancreatitis, or muscle necrosis.

Tell your doctor immediately:

• If you experience symptoms such as persistent and unexplained nausea, stomach problems, loss of appetite, or unusual tiredness or weakness.
• If you notice that your skin or the whites of your eyes turn yellow, that your urine is unusually dark, or that you have pale stools (possible signs of liver problems).
• If you have fever, chills, sore throat, or mouth ulcers caused by infections and weakness or if you have infections more frequently or if you experience unusual bleeding or bruising (possible signs of diseases affecting blood cell counts).
• If you experience difficulty breathing, dizziness, swelling mainly of the face and throat, redness, abdominal pain, or loss of consciousness or if you experience symptoms such as joint pain, stiffness, skin rash, fever, or swelling/thickening of lymph nodes (possible signs of severe allergic reactions).
• If you experience 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 blood vessel inflammation).
• If you develop any skin problem such as skin rash, redness of the skin, blisters on the lips, eyes, or mouth, peeling of the skin, fever.
• If you experience severe pain in the upper abdomen radiating to the back (possible signs of pancreatitis).
• If you experience muscle pain and weakness or dark-colored urine (brown-red) (possible signs of muscle necrosis).

Other side effects:

Very common (affects more than 1 in 10 patients):headache, nausea, mild abdominal pain, gastric discomfort after meals (acidity), diarrhea, bloating or abdominal distension (feeling of fullness in the stomach), loss of appetite, skin rash (with itching), hives, joint or muscle pain.

Common (affects 1 to 10 users in 100):mood disorder (depression), disturbance or loss of taste, dizziness, visual disturbances.

Uncommon (affects 1 to 10 users in 1,000):

If you notice an unusual pale color of the skin, mucous membranes, or nail bed, unusual tiredness or weakness, or difficulty breathing during exercise (possible signs of a disease affecting red blood cell levels), anxiety, sensation of tingling or numbness, and decreased sensitivity of the skin, increased sensitivity of the skin to the sun, noises (e.g., ringing) in the ears, fever, and weight loss.

Rare (affects 1 to 10 users in 10,000):

Yellow eyes or skin (liver problems) and abnormal liver function test results.

Very rare (affects less than 1 user in 10,000):decrease in certain blood cells (mainly white blood cells and platelets), lupus (autoimmune disease characterized by general or skin disorders), severe skin reactions, allergic reactions, psoriasis-like skin eruptions (silvery scales), worsening of psoriasis, skin rash with peeling, hair loss.

The following side effects have also been reported:

Severe allergic reactions or infections, blood vessel inflammation, alterations in smell including permanent loss, decreased ability to smell, blurred vision, decreased visual acuity, pancreatitis, skin rash caused by elevated levels of a specific type of white blood cells, muscle necrosis, flu-like symptoms (e.g., tiredness, chills, sore throat, muscle or joint pain), and increased levels of a muscle enzyme (creatine phosphokinase) in the blood.

Reporting of side effects

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

5. Storage of Terbinafina Normon

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

Store in the original package to protect from light.

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 shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Terbinafina Normon

The active substance is terbinafine. Each tablet contains 250 mg of terbinafine (as hydrochloride).

The other ingredients (excipients) are: microcrystalline cellulose, sodium starch glycolate (potato starch), hypromellose, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and pack contents:

Terbinafina Normon 250 mg are film-coated tablets. The tablets are white or almost white, round, flat, and scored. The tablets can be divided into equal doses.

They are available in packs of 14 and 28 tablets.

Marketing authorization holder and manufacturer:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of last revision of the leaflet:November 2022.

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