Finasteride AHCL

Package leaflet: Information for the user

Finasteride AHCL 1 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Finasteride AHCL 1 mg is and what it is used for

Finasteride AHCL 1 mg contains finasteride. Finasteride belongs to a group of medicines called
5-α-reductase inhibitors.
Your doctor has prescribed Finasteride AHCL 1 mg because you have male pattern hair loss
(also known as androgenetic alopecia). Finasteride AHCL 1 mg prevents further hair loss in men.
Men with mild to moderate, but not complete, hair loss may benefit from the use of Finasteride AHCL 1 mg. Finasteride AHCL 1 mg blocks an important enzyme (Type II 5α-reductase) involved in the regulation of hair follicles.
In the scalp, Finasteride AHCL 1 mg specifically reduces levels of dihydrotestosterone (DHT), one of the main causes of male pattern hair loss. In this way, Finasteride AHCL 1 mg helps reverse the process of hair loss and prevent further hair loss.

2. What you should know before taking Finasteride AHCL 1 mg

Do not take Finasteride AHCL 1 mg:

• If you are a woman (since this medicine is intended for men only; see the Pregnancy section). Clinical studies have shown that finasteride 1 mg tablets are not effective in women with hair loss.
• If you are allergic (hypersensitive) to finasteride or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride AHCL 1 mg.
Effect on Prostate-Specific Antigen (PSA)
Propecia may affect a blood test called PSA (Prostate-Specific Antigen) used for prostate cancer screening. If you undergo a PSA test, you must inform your doctor or pharmacist that you are taking Propecia, as it reduces PSA levels.
Effects on fertility
Infertility has been reported in men who have taken finasteride for a long time and who had other risk factors that could affect fertility. After stopping finasteride, normalization or improvement in semen quality has been reported. Long-term clinical studies in men on the effects of finasteride on fertility have not been conducted.
Breast cancer
See section 4.
Mood changes and depression
Mood changes such as mood depression, depression, and less frequently, suicidal thoughts have been reported in patients treated with Finasteride AHCL 1 mg. If you experience any of these symptoms, stop taking Finasteride AHCL 1 mg and contact your doctor for further advice as soon as possible.
In some patients, impaired sexual function has been reported, which may contribute to mood disturbances, including suicidal thoughts. If you experience symptoms of impaired sexual function, contact your doctor for further medical advice. Your doctor may consider discontinuing treatment (see section 4 below for further information on these side effects).
A patient reminder card containing the above information is provided with the packaging of Finasteride 1 mg tablets.
Children and adolescents
Finasteride AHCL 1 mg must not be used in children. There are no data demonstrating the efficacy or safety of finasteride in children under 18 years of age.
Other medicines and Finasteride AHCL 1 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Finasteride AHCL 1 mg with food and drink
Finasteride AHCL 1 mg can be taken with or without food.
Pregnancy, breastfeeding and fertility:
Finasteride AHCL 1 mg is intended for the treatment of male pattern hair loss in men only. For effects on male fertility, see section 2.

• Women must not use Finasteride due to the risk to pregnancy.
• If you are a pregnant woman or a woman who could potentially become pregnant, do not handle crushed or broken Finasteride AHCL 1 mg tablets.
• If the active substance in Finasteride 1 mg Tablets is absorbed following oral intake or through the skin by a pregnant woman carrying a male fetus, it may result in the birth of a male baby with abnormalities of the external genital organs.
• If a pregnant woman comes into contact with the active substance in Finasteride 1 mg Tablets, medical advice must be sought.
• Finasteride 1 mg tablets are film-coated, which prevents contact with the active substance during normal handling.

Driving and using machines:
There is no information suggesting that Finasteride AHCL 1 mg affects the ability to drive or use machinery.
Important information about some excipients in Finasteride AHCL 1 mg:
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Finasteride AHCL 1 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take Finasteride AHCL 1 mg

Always take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one Finasteride 1 mg tablet per day (equivalent to 1 mg of finasteride).
The film-coated tablets can be taken on an empty stomach or with food. The film-coated tablets must be swallowed whole and must not be divided or crushed.

• Finasteride AHCL 1 mg does not work faster or better if taken more than once a day.
• Male pattern hair loss is a condition that develops over a long period of time. Usually, daily use for three to six months may be necessary before you notice an increase in hair density or a reduction in hair loss.
• Your doctor will help you assess whether Finasteride AHCL 1 mg is working. It is important to continue taking Finasteride AHCL 1 mg for as long as your doctor prescribes it.

Patients with impaired liver function
There is no experience with the use of Finasteride AHCL 1 mg in patients with impaired liver function.
Patients with impaired kidney function
Dose adjustment is not required in patients with impaired kidney function.

If you take more Finasteride AHCL 1 mg than you should:
If you take more Finasteride AHCL 1 mg tablets than you have been told to take, or if someone else takes any of the tablets, contact your nearest hospital emergency department immediately. Take the tablets or the empty packaging with you to make identification of the medicine easier.

If you forget to take Finasteride AHCL 1 mg:
If you forget to take a dose of Finasteride AHCL 1 mg, take the next dose at your usual time. Do not take a double dose to make up for the missed tablet.

If you stop taking Finasteride AHCL 1 mg:
Continuous use of Finasteride AHCL 1 mg is recommended to achieve maximum benefit. If treatment is stopped, you are likely to lose the hair you have gained within the next 9–12 months.
If you have any questions about the use of Finasteride AHCL 1 mg, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. Some of the side effects were temporary during continued treatment or disappeared when treatment was stopped.
Stop taking Finasteride AHCL 1 mg and contact your doctor immediately if you experience
any of the following

• Symptoms of an allergic reaction: swelling of the lips, face, tongue and throat; difficulty swallowing; swellings under the skin (urticaria) and breathing difficulties.
• Suicidal thoughts

You should promptly report to your doctor any changes in breast tissue, such as lumps, pain, enlargement or nipple discharge, as these may be signs of a serious condition, such as breast cancer.
Uncommon (may affect up to 1 in 100 people):

• reduced sexual desire
• difficulty in achieving or maintaining an erection
• ejaculation problems, such as reduced volume of semen produced during sexual intercourse
• depression

Not known: frequency cannot be estimated from the available data

• allergic reactions such as skin rash, itching, hives (urticaria) and swelling of the lips and face
• breast swelling or tenderness
• blood in the semen
• testicular pain
• rapid heartbeat
• persistent erectile dysfunction after stopping treatment
• persistent reduced sexual desire after stopping treatment
• persistent ejaculation problems after stopping treatment
• infertility has been reported in men who have taken finasteride for a long period of time and who had other risk factors that may affect fertility. Normalization or improvement in semen quality has been reported after discontinuation of finasteride. Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.
• changes in liver function, which may be detected through blood tests
• anxiety
• suicidal thoughts

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/how-to-report-a-suspected-adverse-reaction.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Finasteride AHCL 1 mg

• Keep this medicine out of the sight and reach of children.
• This medicine requires no special storage conditions.
• Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Finasteride AHCL 1 mg contains:
The active substance is finasteride. One film-coated tablet contains 1 mg of finasteride.
The other components are:
Tablet core: Lactose monohydrate, microcrystalline cellulose (E460), pregelatinized starch (from maize),
sodium carboxymethyl starch (type A), lauroyl macrogolglycerides, and magnesium stearate (E572).
Film coating: Hypromellose (E464), titanium dioxide (E171), macrogol 6000, iron oxide red (E172), iron oxide yellow (E172).

Description of the appearance of Finasteride AHCL 1 mg and package contents:
Film-coated tablet.
Finasteride AHCL 1 mg Tablets are film-coated, reddish-brown, round, biconvex tablets, marked with 'F1' on one side and smooth on the other side.
Finasteride AHCL 1 mg Tablets are packed in aluminium-aluminium blisters in packs of 28, 30, 84 and 98 tablets.

Marketing Authorisation Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturers:
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Laboratorios Normon SA – Ronda de Valdecarrizo 6, 28760 Tres Cantones – Madrid – Spain
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Package leaflet: Information for the user

FINASTERIDE AHCL 5 mg FILM-COATED TABLETS

Equivalent medicine
Please read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Finasteride AHCL 5 mg is and what it is used for
2. What you need to know before taking Finasteride AHCL 5 mg
3. How to take Finasteride AHCL 5 mg
4. Possible side effects
5. How to store Finasteride AHCL 5 mg
6. Package contents and other information

1. What Finasteride AHCL 5 mg is and what it is used for

Finasteride belongs to a group of medicines called 5-alpha reductase inhibitors.
These medicines work by reducing the size of the prostate gland in men.
Finasteride AHCL reduces the prostate gland when it is enlarged. Finasteride AHCL is used in the treatment and management of benign (i.e. non-cancerous) enlargement of the prostate (benign prostatic hyperplasia – BPH). The prostate gland is located below the bladder (but only in men). It produces seminal fluid. Enlargement of the prostate gland can lead to a condition called "benign prostatic hyperplasia" (BPH). Finasteride AHCL causes shrinkage of the enlarged prostate, improves urinary flow and BPH-related symptoms, and reduces the risk of developing sudden inability to urinate (called acute urinary retention) and the need for surgical intervention.

What is BPH?
If you have BPH, it means your prostate gland is enlarged. It may compress the tubes through which urine passes out of your body.
This may cause the following problems:

• Needing to urinate more frequently, especially at night
• A sudden, urgent need to urinate
• Difficulty starting urination
• A weak urine stream when urinating
• A urine stream that starts and stops during urination
• A feeling that you cannot completely empty your bladder

In some men, BPH may lead to more serious problems, such as:

• Urinary tract infections
• Sudden inability to urinate
• Need for surgery

2. What you should know before taking Finasteride AHCL 5 mg

Do not take Finasteride AHCL 5 mg:

• If you are allergic to finasteride or to any of the excipients of Finasteride AHCL 5 mg.
• If you are a woman, as this medicine is intended only for men.
• If you are a child. Do not take Finasteride AHCL if any of the conditions listed above apply to you. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride AHCL 5 mg.

• If a large amount of residual urine is present in your bladder after urination and/or your urinary flow is severely reduced. If this is the case, you must be carefully monitored for urinary tract narrowing.
• If you have impaired liver function. In this case, blood levels of finasteride may be increased.
• If your partner is or may potentially be pregnant, you must avoid exposing her to your semen, which may contain a small amount of the drug.
• If you are undergoing a blood test called PSA (the test used to diagnose prostate cancer). Inform your doctor that you are taking finasteride. This medicine may affect PSA levels in the blood.

Mood changes and depression
Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride AHCL 5 mg tablets. If you experience any of these symptoms, contact your doctor for further advice as soon as possible.

Children
Finasteride AHCL must not be used in children.

Other medicines and Finasteride AHCL 5 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Finasteride AHCL 5 mg generally does not interfere with other medicines. No significant pharmacological interactions have been identified. Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.

Taking Finasteride AHCL 5 mg with food and drinks:
Finasteride AHCL 5 mg can be taken with or without food.

Pregnancy, breastfeeding and fertility:
Finasteride AHCL 5 mg is intended only for men.
Finasteride AHCL must not be taken by women.
Women who are or may potentially be pregnant must not handle Finasteride AHCL 5 mg, particularly if the tablets are broken or crushed. If finasteride is absorbed through the skin or taken orally by a pregnant woman carrying a male fetus, the baby may be born with malformed genital organs. If a pregnant woman comes into contact with crushed or broken tablets of Finasteride AHCL, she should consult her doctor.
When the patient's partner is or may become pregnant, the patient must avoid exposing her to semen (e.g. by using a condom) or discontinue treatment with finasteride.

Driving and using machines:
There is no information indicating that Finasteride AHCL 5 mg affects the ability to drive or use machinery.

Important information about some excipients of Finasteride AHCL 5 mg:
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

Finasteride AHCL 5 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take Finasteride AHCL 5 mg

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet per day (equivalent to 5 mg of finasteride).
The film-coated tablets may be taken on an empty stomach or with food. This medicine must be taken orally, swallowed whole, and must not be split or crushed. Your doctor may prescribe finasteride in combination with another medicine (called doxazosin) to help control your BPH.
Although initial improvement may be observed, treatment may be required for at least six months to assess whether a beneficial response has been achieved.
Your doctor will advise you on how long you should continue taking Finasteride AHCL 5 mg. Do not stop treatment prematurely, as symptoms may return.

• Patients with reduced liver function There is no experience with the use of Finasteride AHCL 5 mg in patients with impaired liver function
  (see also ‘Take special care with Finasteride AHCL 5 mg’)

• Patients with reduced kidney function Dose adjustments are not required. The use of Finasteride AHCL 5 mg in patients undergoing haemodialysis has not yet been studied.

• Elderly patients Dose adjustments are not required.

Consult your doctor or pharmacist if you think the effects of Finasteride AHCL 5 mg are too strong or too weak.
If you take more Finasteride AHCL 5 mg than you should:
If you take more tablets than you have been instructed to take, or if someone else takes your medicine, contact the nearest hospital emergency department immediately. Take the tablets or the empty packaging with you to make identification of the medicine easier.
If you forget to take Finasteride AHCL 5 mg:
If you forget to take a dose of Finasteride AHCL 5 mg, take it as soon as you remember, unless it is almost time for your next dose, in which case continue with your regular dosing schedule. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Finasteride AHCL 5 mg:
After taking Finasteride AHCL, your condition may show improvement within a short time. However, it may take at least 6 months before the full effect develops. It is important to continue taking Finasteride AHCL for the entire duration prescribed by your doctor, even if you do not feel any benefit.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Finasteride AHCL 5 mg can cause side effects, although not everyone experiences them.
Stop taking finasteride and contact your doctor immediately if you experience any of the following symptoms (angioedema):

• swelling of the face, tongue or throat
• difficulty swallowing
• hives and breathing difficulties

The most common side effects are impotence and reduced sexual desire. These effects usually occur at the beginning of treatment, but typically do not last long in most patients if treatment continues.
Common: (may affect up to 1 in 10 people)

• You may have problems with ejaculation, for example a decrease in the amount of semen released during sexual intercourse. This decrease in semen volume does not appear to affect normal sexual function.
• You may be unable to achieve an erection (impotence)
• You may have reduced sexual desire

Uncommon: (may affect up to 1 in 100 people)

• Rash
• Problems with ejaculation that may continue after stopping treatment
• Swelling or tenderness of the breast

Frequency not known:

• Itching, hives
• Palpitations (feeling your heartbeat)
• Swelling of the face, lips, tongue or throat, difficulty swallowing and breathing difficulties (angioedema)
• Changes in liver function, which may be shown by a blood test
• Testicular pain
• Inability to achieve an erection that may continue after stopping the medicine
• Male infertility and/or reduced semen quality. Improvement in semen quality has been reported after stopping the medicine
• Depression
• Decreased sexual desire that may continue after stopping the medicine
• Anxiety

You should promptly report to your doctor any changes in breast tissue, such as lumps, pain, enlargement of breast tissue or nipple discharge, as these may be symptoms of a serious condition, such as breast cancer.
Reporting of suspected adverse reactions
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You may also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Finasteride AHCL 5 mg

• Keep this medicine out of the sight and reach of children.
• This medicine does not require any special storage conditions.
• Do not use Finasteride AHCL 5 mg after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Finasteride AHCL 5 mg contains:
The active substance is finasteride. One film-coated tablet contains 5 mg of finasteride.
The other components are:
Tablet core: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized starch (from maize), sodium starch glycolate (type-A), lauroyl macrogol glycerides, and magnesium stearate (E572).
Film coating: hypromellose (E464), titanium dioxide (E171), indigo carmine (E132), macrogol 6000.

Description of the appearance of Finasteride AHCL 5 mg and contents of the pack:
Film-coated tablet.
Finasteride AHCL 5 mg are blue, round, biconvex, film-coated tablets, marked with 'F5' on one side and smooth on the other.
Finasteride AHCL 5 mg tablets are packaged in white opaque PVC/PVdC – Alu blisters in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturers:
Laboratorios Normon SA
Ronda de Valdecarrizo 6,
28760 Tres Cantos – Madrid –
Spain
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, 32009,
Greece

This medicinal product is authorized in the European Economic Area countries under the following names: