Dutasteride Alter

Package leaflet: Information for the user

Dutasteride Alter 0.5 mg soft capsules

Dutasteride
Please read all of this leaflet carefully before you start 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 others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Dutasteride Alter is and what it is used for

Dutasteride Alter is used to treat men with enlarged prostate (benign prostatic hyperplasia) – a non-cancerous increase in prostate size caused by excessive production of a hormone called dihydrotestosterone.
The active substance is dutasteride. It belongs to a class of medicines known as 5-alpha reductase inhibitors.
When the prostate enlarges, it may cause urinary problems such as difficulty in passing urine and the need to urinate frequently. This may also result in a slower and weaker urine flow. If left untreated, there is a risk that urine flow may become completely blocked (acute urinary retention), which requires immediate medical treatment. In some cases, surgery may be needed to remove or reduce the size of the prostate. Dutasteride Alter reduces the production of dihydrotestosterone, thereby helping to decrease prostate size and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention.
Dutasteride Alter may be used in combination with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate).

2. What you should know before taking Dutasteride Alter

Do not take Dutasteride Alter

• if you are allergic to dutasteride, to other 5-alpha reductase inhibitors, to soy, to peanuts, or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease. If you think any of the above conditions apply to you, do not take this medicine without first consulting your doctor.
• this medicine is intended only for men. It must not be taken by women, children, or adolescents.

Warnings and precautions
Talk to your doctor before taking Dutasteride Alter.

• Make sure your doctor is aware of any liver problems you may have. If you have had any liver disease, additional monitoring may be necessary while taking Dutasteride Alter.
• Women, children, and adolescents must avoid contact with damaged or leaking capsules of Dutasteride Alter, as the active substance can be absorbed through the skin. In case of skin contact, wash the affected area immediately with soap and water.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men being treated with dutasteride. If your partner is pregnant or could become pregnant, you must avoid exposing her to your semen, as dutasteride may impair the normal development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may reduce your fertility.
• Dutasteride Alter affects PSA (prostate-specific antigen) testing, which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may still recommend PSA testing to check for prostate cancer. If you are to have a PSA test, inform your doctor that you are taking Dutasteride Alter. Men taking Dutasteride Alter should have regular PSA tests.
• In a clinical study conducted in men at increased risk of prostate cancer, men taking dutasteride were found to have a higher incidence of high-grade prostate cancer compared to men not taking dutasteride. The effect of dutasteride on this high-grade form of prostate cancer is not fully understood.
• Dutasteride Alter may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice breast lumps or nipple discharge, speak to your doctor about these changes, as they may be signs of a serious condition, such as breast cancer.
• Talk to your doctor or pharmacist if you have any questions about taking Dutasteride Alter.

Other medicines and Dutasteride Alter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with Dutasteride Alter and increase the likelihood of side effects. These include:

• verapamil or diltiazem (for high blood pressure)
• ritonavir or indinavir (for HIV)
• itraconazole or ketoconazole (for fungal infections)
• nefazodone (an antidepressant)
• alpha-blockers (for enlarged prostate or hypertension).

Inform your doctor if you are taking any of these medicines. It may be necessary to reduce the dose of Dutasteride Alter you are taking.

Dutasteride Alter with food and drink
Dutasteride Alter can be taken with or without food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, or are planning pregnancy, you must not handle damaged capsules. Dutasteride is absorbed through the skin and may interfere with the normal development of a male fetus. This is particularly risky during the first 16 weeks of pregnancy.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutasteride Alter. If your partner is pregnant or suspects she may be pregnant, you must avoid exposing her to your semen.
Dutasteride has been shown to reduce sperm count, semen volume, and sperm motility. Therefore, male fertility may be reduced.

• Ask your doctor for advice if a pregnant woman has been exposed to dutasteride.

Driving and using machines
It is unlikely that Dutasteride Alter will affect your ability to drive or operate machinery.

Dutasteride Alter contains soy lecithin and propylene glycol
This medicine contains soy lecithin, which may contain soybean oil. If you are allergic to peanuts or soy, do not use this medicine.
This medicine contains 299.46 mg of monocapryl propylene glycol in each capsule.

3. How to take Dutasteride Alter

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
If you do not take it regularly, monitoring of PSA levels may be affected.

Recommended dose
The recommended dose is one capsule (0.5 mg) taken once daily. Swallow the capsules whole with water. Do not chew or open the capsules. Contact with the capsule contents may irritate the mouth or throat. The capsules may be taken with or without food.

Treatment with Dutasteride Alter is long-term. Some individuals may notice early symptom improvement. However, others may need to take Dutasteride Alter for 6 months or longer before it starts to work. Continue taking Dutasteride Alter for as long as your doctor tells you to.

If you take more Dutasteride Alter than you should
If you take more capsules than prescribed, contact your doctor or pharmacist for advice.

If you forget to take Dutasteride Alter
Do not take a double dose to make up for the missed dose. Take the next dose at your usual time.

If you stop taking Dutasteride Alter
Do not stop taking Dutasteride Alter without first consulting your doctor. It may take 6 months or longer before you notice an improvement.

• If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Allergic reaction
Signs of allergic reactions may include:

• skin rash (which may be itchy)
• hives (such as redness and itching)
• swelling of the eyelids, face, lips, arms or legs.
  Contact your doctor immediately if you experience any of these symptoms and stop taking Dutasteride Alter.

Common side effects (may affect up to 1 in 10 men):

• inability to achieve or maintain an erection (impotence), which may continue even after stopping Dutasteride Alter
• decreased sexual desire (libido), such as a reduction in the amount of semen released during sexual intercourse, which may continue even after stopping Dutasteride Alter
• problems with ejaculation, which may continue even after stopping Dutasteride Alter
• breast enlargement or tenderness (gynecomastia)
• dizziness with tamsulosin intake.

Uncommon side effects (may affect up to 1 in 100 men):

• Heart failure (the heart reduces its efficiency in pumping blood around the body. Symptoms may include shortness of breath, extreme tiredness, and swelling of the ankles and legs).
• loss of body hair or excessive hair growth.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• depression.
• Testicular pain and swelling.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: http://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 Dutasteride Alter

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or aluminium blister pack. The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep the blister pack in the outer packaging to protect it from light.
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 Dutasteride Alter contains

• The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
• The excipients are:
  • Inside the capsule: propylene glycol monocaprylate and butylhydroxytoluene.
  • Capsule shell: gelatin, glycerol, titanium dioxide (E171), medium-chain triglycerides, lecithin (may contain soybean oil) (E322).

Description of the appearance of Dutasteride Alter and contents of the pack
Dutasteride Alter soft capsules are oblong, soft gelatin capsules (approximately 16.5 x 6.5 mm), light yellow in colour, filled with clear liquid. They are available in packs containing three transparent blisters (PVC-PE-PVDC)/aluminum blisters of 10, 30, 50, 60 and 90 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratori Alter S.r.l.
Via Egadi 7
20144 Milano
Italy

Manufacturer:
Laboratorios LEÓN FARMA, S.A.
Polígono Industrial Navatejera
C/La Vallina, s/n - 24008 Navatejera - León
SPAIN

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark: Tasdurit
Italy: Dutasteride Alter