Leaflet: Information for the User

Terbinafine Normon 250 mg Tablets

Terbinafina belongs to a group of medications known as antifungals and acts by preventing the development of fungi.

Terbinafina Normon is used in the treatment of the following fungal skin, scalp, and nail infections:

• Tinea corporis(body ringworm).
• Tinea cruris(inguinal ringworm or jock itch).
• Tinea pedis(athlete's foot).
• Tinea capitis(scalp ringworm).
• Onychomycosis (nail ringworm).

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 medication (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 starting to take Terbinafina Normon:

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

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

• If you experience symptoms such as persistent and unexplained nausea, vomiting, stomach pain, loss of appetite, unusual fatigue, if your skin or the whites of your eyes turn yellow, if your urine has an unusual dark color, or if your stools have an unusual light color (signs of liver problems).
• If you experience any skin problems such as rashes, red skin, blisters on the lips, eyes, or mouth, skin peeling (signs of severe skin reactions).
• If you experience weakness, unusual bleeding, bruises, or frequent infections (signs of blood abnormalities).
• If you suffer from psoriasis or lupus erythematosus.

Use in children

The experience with Terbinafina Normon in children is limited, therefore, it is not recommended for use 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 renal problem, you may be prescribed a lower than usual dose.Terbinafina Normon is not recommended for patients who have or have had liver problems.

Other medications and Terbinafina Normon

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication, including oral contraceptives, herbal remedies, and over-the-counter medications.

There are other medications that may modify the effect of Terbinafina Normon, for example:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Terbinafina Normon should not be used during pregnancy, unless your doctor considers it strictly necessary. In this case, 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 who are being treated with Terbinafina Normon should not breastfeed.

Driving and operating machinery

If you feel dizzy while taking Terbinafina Normon, do not drive or operate machinery.

Terbinafina Normon 250 mg tablets contain sodium

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

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

Remember to take your medication.

How much to take

Take Terbinafina Normon as directed by your doctor. 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 are oral tablets. Swallow the tablets whole, without chewing, with a glass of water.

For how long to takeTerbinafina Normon

The duration of treatment will be established by your doctor. Do not stop treatment before, as it may worsen your condition.

It is possible that the complete remission of symptoms of the infection will not occur until several 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Your doctor will establish the best possible treatment for the overdose.

The main symptoms of acute poisoning may be gastrointestinal, e.g. nausea, abdominal pain or vomiting, but dizziness or headache may also occur. If you experience any of these effects or any other unusual effect, consult your doctor.

If you forgot to take Terbinafina Normon

Do not take a double dose to compensate for the missed doses

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

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

Some side effects can be serious:

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

Inform your doctor immediately:

• If you experience symptoms such as persistent and unexplained nausea, stomach problems, loss of appetite or unusual or unexplained fatigue or weakness or
• If you notice that your skin or the white of your eyes turns 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 ulcers in the mouth caused by infections and weakness or if you have infections more frequently or if you experience unusual bleeding or bruising (possible signs of diseases that affect the levels of certain blood cells).
• If you experience difficulty breathing, dizziness, swelling mainly of the face and throat, redness, abdominal pain like colic and loss of consciousness or if you experience symptoms such as joint pain, stiffness, skin rash, fever, or swelling/enlargement of lymph nodes (possible signs of severe allergic reactions).
• If you experience symptoms such as skin rash, fever, itching, fatigue or if you notice the appearance of red-purple patches under the surface of the skin (possible signs of inflammation of blood vessels).
• If you develop any skin problem such as skin rash, skin redness, formation of blisters on the lips, eyes or mouth, skin peeling, fever.
• If you experience severe pain in the upper part of the stomach radiating to the back (possible signs of pancreatitis).
• If you experience pain and muscle weakness inexplicably or dark urine (brown-red) (possible signs of muscle necrosis).

Other side effects:

Very frequent(affects more than 1 in 10 patients): Headache, nausea, mild abdominal pain, stomach upset after meals (heartburn), diarrhea, bloating or abdominal distension (feeling of fullness in the stomach), loss of appetite, skin rash (with itching), urticaria, joint or muscle pain.

Frequent(affects between 1 and 10 in 100 patients):Mood disorder (depression), taste disturbance or loss, dizziness, visual disturbances.

Rare (affects between 1 and 10 in 1000 patients):

If you notice a pale skin color, mucous membrane or nail bed that is not normal, fatigue or unusual weakness or difficulty breathing during exercise (possible signs of a disease that affects the levels of red blood cells), anxiety, sensation of tingling or numbness and decreased skin sensitivity, increased skin sensitivity to the sun, ringing in the ears, fever and weight loss.

Rare (affects between 1 and 10 in 10,000 patients):

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

Very rare (affects less than 1 in 10,000 patients): Decrease in certain blood cells (mainly white blood cells and platelets), lupus (autoimmune disease characterized by general or skin alterations), severe skin reactions, allergic reactions, skin rash type psoriasis (skin rash with silver appearance), worsening of psoriasis, skin rash with peeling, hair loss.

Also, the following side effects have been reported:

Severe allergic reactions or infections, inflammation of blood vessels, alterations of the sense of 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, pseudo-gripal symptoms (e.g. fatigue, chills, sore throat, muscle or joint pain), and increased blood levels of a muscle enzyme (creatine phosphokinase).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://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.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at 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 of Terbinafina Normon

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

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

Appearance of the product and content of the packaging:

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

It is presented in packaging of 14 and 28 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Normon Laboratories, S.A.

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

Date of the last review of the leaflet:November 2022.

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/