FINASTERIDE NORMON 1 mg FILM-COATED TABLETS

2. Before taking Finasteride Normon 1 mg tablets

Do not take Finasteride Normon 1 mg:

• If you are allergic (hypersensitive) to finasteride or any of the other components of Finasteride Normon 1 mg.

Finasteride Normon 1 mg.

• If you are a child or adolescent.
• If you are a woman (also see the section 'Pregnancy, breastfeeding, and fertility'). In clinical trials, it has been shown that Finasteride Normon 1 mg tablets are not effective in the treatment of hair loss (androgenetic alopecia) in women.
• If you are already taking finasteride or dutasteride used for a prostate problem known as benign prostatic hyperplasia (BPH).

Warnings and precautions

Consult your doctor or pharmacist before taking Finasteride Normon 1 mg.

If you are going to have blood tests for prostate cancer, known as PSA (prostate-specific antigen). This is because Finasteride Normon 1 mg may affect the result of this test.

Effects on fertility

There have been reports of infertility in adult men who took finasteride for a long period and had other risk factors that could affect fertility. Normalization or improvement of semen quality has been reported after discontinuation of finasteride treatment. No long-term clinical studies have been conducted on the effects of finasteride on fertility in adult men.

Breast cancer

See section 4.

Mood changes and depression

There have been reports of mood changes, such as depressed mood, depression, and less frequently, suicidal thoughts, in patients treated with Finasteride Normon 1 mg tablets.

If you experience any of these symptoms, contact your doctor for further medical advice as soon as possible.

Children and adolescents

Finasteride Normon 1 mg should not be used in children. There are no data to demonstrate the efficacy or safety of finasteride in children under 18 years of age.

Other medications and Finasteride Normon 1 mg:

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. Finasteride Normon 1 mg does not usually interfere with other medications.

• Do not take Finasteride Normon 1 mg if you are already taking finasteride or dutasteride used for a prostate problem known as benign prostatic hyperplasia (BPH).

• There is no information available on the use of Finasteride Normon 1 mg tablets in combination with topical minoxidil (applied to the skin) for male hair loss. Concomitant use is not recommended.

Use of Finasteride Normon 1 mg with food and beverages:

Finasteride Normon 1 mg can be taken with or without food.

Pregnancy, breastfeeding, and fertility:

Finasteride Normon 1 mg is indicated for the treatment of male hair loss exclusively. For effects on fertility in men, see section 2.

• Women cannot use Finasteride Normon 1 mg.
• Women who are or may be pregnant should not touch crushed or broken Finasteride Normon 1 mg tablets (whole tablets are coated to prevent contact with the medication during normal use). This is because the medication could affect the baby's sex organs.
• If a pregnant woman comes into contact with a crushed or broken Finasteride Normon 1 mg tablet, she should consult a doctor.

Driving and using machines:

There are no data to indicate that Finasteride Normon 1 mg affects the ability to drive or use machinery.

Important information about some of the components of Finasteride Normon 1 mg:

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Finasteride Normon

Follow the administration instructions of this medication indicated by your doctor exactly. If you have any doubts, consult your doctor or pharmacist again.

The recommended dose is one Finasteride Normon 1 mg tablet per day (equivalent to 1 mg of finasteride).

The film-coated tablets can be taken with or without food. The film-coated tablets should be swallowed whole and not broken or crushed.

• Finasteride does not work better or faster by taking more than one tablet per day.
• Male hair loss is a disorder that takes a long time to develop. In general, daily use between three and six months may be necessary before noticing any increase in hair thickness or reduction in hair loss.

• Your doctor will help you assess whether finasteride is working. It is essential to continue taking finasteride for the full period indicated by your doctor.

Patients with liver disorders

There are no data on the use of finasteride in patients with liver disorders.

Patients with kidney disorders

No dose adjustment is necessary in patients with kidney disorders.

If you take more Finasteride Normon 1 than you should:

If you have taken more finasteride than prescribed, or if someone else has taken any amount of finasteride, call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Go to your nearest hospital and bring all the remaining tablets or the empty package to facilitate identification.

If you forget to take Finasteride Normon:

If you forget to take a dose of finasteride 1 mg, continue with the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you interrupt treatment with Finasteride Normon:

Continuous use of finasteride 1 mg is recommended to achieve the maximum effect. If treatment is interrupted, it is likely that the regained hair will be lost within the next 9 to 12 months.

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

4. Possible adverse effects

Like all medications, Finasteride Normon 1 mg can cause adverse effects, although not everyone will experience them. Normally, the adverse effects have been temporary with continued treatment or have disappeared once treatment was discontinued.

• Stop taking Finasteride Normon 1 mg and contact your doctor immediately if you experience any of the following episodes: Symptoms of an allergic reaction: swelling of the lips, face, tongue, and throat; difficulty swallowing; lumps under the skin (hives) and difficulty breathing.
• Depression (feeling of important sadness and lack of interest).

You should inform your doctor immediately of any change in breast tissue, such as lumps, pain, increased breast tissue, or nipple discharge, as these may be signs of a serious disease, such as breast cancer.

Uncommon (affects up to 1 in 100 patients):

• decreased sexual desire
• difficulty getting an erection
• problems with ejaculation, such as decreased semen volume released during sexual intercourse.
• depression.

Frequency unknown:

• allergic reactions, such as skin rash, itching, lumps under the skin (hives), and swelling of the lips and face
• breast inflammation or tenderness
• palpitations
• testicular pain
• increased heart rate
• persistent difficulty getting an erection after discontinuing treatment
• persistent decreased sexual desire after discontinuing treatment
• persistent problems with ejaculation after discontinuing treatment
• there have been reports of infertility in men who took finasteride for a long period and had other risk factors that could affect fertility. Normalization or improvement of semen quality has been observed after discontinuation of finasteride treatment. No long-term clinical studies have been conducted on the effect of finasteride on fertility in men.
• changes in liver function, which can be detected with a blood test.
• anxiety.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Finasteride Normon

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

• This medication does not require special storage conditions.

• Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or trash. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Finasteride Normon:

The active ingredient is finasteride. One film-coated tablet contains 1 mg of finasteride.

The other components are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, sodium starch glycolate (type A), lauroyl macrogolglycerides, magnesium stearate (E572).

Coating: hypromellose (E464), titanium dioxide (E171), macrogol 6000, red iron oxide (E172), yellow iron oxide (E172).

Appearance of the product and package contents of Finasteride Normon:

Film-coated tablet.

The Finasteride Normon 1 mg tablets are film-coated, brown-red, round, biconvex, and have 'F1' engraved on one side.

The Finasteride Normon 1 mg tablets are available in aluminum/aluminum blister packs of 28, 30, 84, and 98 tablets.

Only some package sizes may be marketed.

Marketing authorization holder:

LABORATORIOS NORMON, S.A.

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

Manufacturer:

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

or

Laboratorios Normon, S.A.

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

or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia, 32009, Greece

This medication is authorized in the EEA Member States with the following names:

Date of the last revision of this prospectus: September 2022.

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