Finasterida normon 1 mg comprimidos recubiertos con pelicula efg

PATIENT INFORMATION LEAFLET

Finasteride Normon 1 mg Film-Coated Tablets

Finasteride

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.

• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4

1. What Finasteride Normon is and what it is used for

2. Before taking Finasteride Normon

3. How to take Finasteride Normon

4. Possible side effects

5. Storage of Finasteride Normon

6. Further information

Finasterida Normon 1 mg contains an active ingredient called finasteride. Finasteride belongs to a group of medicines called 5-alpha reductase inhibitors.

Your doctor has prescribed Finasterida Normon 1 mg for the treatment of male hair loss (also known as androgenetic alopecia). Finasteride 1 mg prevents additional hair loss in men. Men with mild to moderate hair loss (but not complete), may benefit from the use of Finasteride 1 mg. Finasteride 1 mg blocks an important enzyme (5α-reductase Type II), which is involved in the regulation of the hair follicle.On the scalp, finasteride 1 mg specifically reduces levels of DHT, one of the main causes of male hair loss.

In this way, finasteride 1 mg helps to reduce the process of baldness and prevent additional hair loss.

Do not take Finasterida Normon 1 mg:

• If you are allergic (hypersensitive) to finasteride or to any of the other components of Finasterida 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 studies, Finasterida Normon 1 mg tablets have not been shown to be effective in the treatment of hair loss (androgenetic alopecia) in women.

• If you are already taking finasteride or dutasteride used for a condition known as benign prostatic hyperplasia (BPH).

Warnings and precautions

Consult your doctor or pharmacist before taking Finasterida Normon 1 mg

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

Effects on fertility

Cases of infertility have been reported in adult males who took finasteride for a long period of time 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 males.

Breast cancer

See section 4.

Mood changes and depression

Cases of mood changes, such as depressed mood, depression, and less frequently, suicidal thoughts, have been reported in patients treated with Finasterida 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

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

Other medicines and Finasterida Normon 1mg:

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

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

• No information is available on the use of Finasterida Normon 1 mg tablets with topical minoxidil (applied to the skin) in male pattern hair loss. Concomitant use is not recommended.

Use of Finasterida Normon 1 mg with food and drink:

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

Pregnancy, breastfeeding and fertility:

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

• Women cannot use Finasterida Normon 1 mg.
• Women who are pregnant or may be pregnant should not touch crushed or broken Finasterida Normon 1 mg tablets (the intact tablets are coated to prevent contact with the drug during normal use). This is because this medicine could affect the reproductive organs of the baby.
• If a pregnant woman comes into contact with a crushed or broken Finasterida Normon 1 mg tablet, she should consult a doctor.

Driving and operating machinery:

There is no evidence to indicate that Finasterida Normon 1 mg affects the ability to drive and operate machinery.

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

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

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially “sodium-free”.

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

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

Tablets with a film coating can be taken with or without food. The 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 condition that takes a long time to develop. In general, daily use for three to six months may be necessary before noticing any increase in hair thickness or reduction in hair loss.

• Your doctor will help you evaluate if finasteride is working. It is essential to continue taking finasteride for the complete 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 Finasterida 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Go to your nearest hospital and bring with you all remaining tablets or the empty packaging to facilitate identification.

If you forget to take Finasterida 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 compensate for a missed dose.

If you interrupt treatment with Finasterida Normon:

It is recommended to continue using finasteride 1 mg to achieve the maximum effect. If treatment is interrupted, it is likely that you will lose the regained hair within the next 9 or 12 months.

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

Like all medications, Finasteride Normon 1 mg may cause side effects, although not everyone will experience them. Side effects have usually been temporary with continued treatment or have disappeared once treatment has been stopped.

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

You must inform your doctor immediately of any changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as they may be signs of a serious disease, such as breast cancer.

Rare (affects up to 1 in 100 patients):

• Decreased libido

• Difficulty achieving an erection

• Problems with ejaculation, such as decreased semen volume during sexual intercourse.

• Depression.

Unknown frequency:

• Allergic reactions, such as skin rash, itching, skin bumps (urticaria), and swelling of the lips and face

• Breast inflammation or sensitivity

• Palpitations

• Testicular pain

• Increased heart rate

• Persistent difficulty achieving an erection after stopping treatment

• Persistent decrease in libido after stopping treatment

• Persistent problems with ejaculation after stopping treatment

• Cases of infertility have been reported in men who took finasteride for a long period of time and had other risk factors that could affect fertility. Normalization or improvement of semen quality has been observed after stopping finasteride treatment. No long-term clinical studies have been conducted on the effect of finasteride on male fertility.

• Changes in liver function, which can be detected with a blood test.

• Anxiety.

Reporting side effects

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

• 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 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.Deposit the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Finasterida Normon:

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

The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E460), maize starch pregelatinized, sodium starch glycolate type A, lauroyl macrogolglycerides, magnesium stearate (E572).

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

Appearance of the product and contents of the package of Finasterida Normon:

Film-coated tablet.

Finasterida Normon 1 mg tablets are film-coated tablets, brownish-red in color, round, biconvex, and have 'F1' engraved on one face.

Finasterida Normon 1 mg tablets are presented 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)

Responsible for manufacturing:

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 medicinal product is authorized in the EEA Member States with the following names:

Last review date of this leaflet: September 2022.

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