PACKAGE LEAFLET: INFORMATION FOR THE USER

VIVISTER 0.5 mg soft capsules

Dutasteride
Equivalent medicine
Please read 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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What VIVISTER is and what it is used for
What you need to know before taking VIVISTER
How to take VIVISTER
Possible side effects
How to store VIVISTER
Contents of the pack and other information

1. WHAT VIVISTER IS AND WHAT IT IS USED FOR

VIVISTER is used to treat men with an enlarged prostate (benign prostatic hyperplasia) – a non-cancerous increase in the size of the prostate gland caused by excessive production of a hormone called dihydrotestosterone.
The active substance is dutasteride. It belongs to a class of medicines called 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 weaker and less forceful 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 necessary to remove or reduce the size of the prostate. VIVISTER reduces the production of dihydrotestosterone, thereby helping to decrease prostate volume and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention.
VIVISTER may be used in combination with another medicine called tamsulosin (used in the treatment of symptoms of an enlarged prostate).

2. WHAT YOU SHOULD KNOW BEFORE TAKING VIVISTER

Do not take VIVISTER

If you are allergic to dutasteride, to other 5-alpha reductase inhibitors, to soy, to peanuts, or to any of the other ingredients of VIVISTER (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 until you have consulted your doctor.

This medicine is intended for men only. It must not be used by women, children, or
adolescents.

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Warnings and precautions
Talk to your doctor before taking Vivister
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 you are taking VIVISTER.
Women, children, and adolescents must avoid contact with damaged VIVISTER capsules, as the active substance can be absorbed through the skin. In case of skin contact, wash the affected area immediately with water and soap.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men being treated with dutasteride. If your partner is or could be 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.
VIVISTER affects the PSA (prostate-specific antigen) test, which is used in some cases to detect prostate cancer. Your doctor should be aware of this effect and may still recommend the test to determine whether you have prostate cancer. If you are due to have a PSA test, inform your doctor that you are taking VIVISTER. Men taking VIVISTER should have regular PSA testing.
In a clinical study conducted in men at increased risk of prostate cancer, men taking dutasteride developed more frequently a more aggressive form of prostate cancer compared to men not taking dutasteride. The effect of dutasteride on this aggressive form of prostate cancer is not fully understood.
VIVISTER may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice breast lumps or nipple discharge, you should 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 doubts about using VIVISTER.
Other medicines and VIVISTER
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with VIVISTER and increase the likelihood of side effects. These medicines 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 high blood pressure).

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

VIVISTER with food and drink
VIVISTER 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 VIVISTER. 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.

Consult your doctor if a pregnant woman has been exposed to dutasteride.

Driving and using machines
It is unlikely that VIVISTER will affect your ability to drive or operate machinery.
VIVISTER 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 propylene glycol monocaprylate per capsule.

3. HOW TO TAKE VIVISTER

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or
pharmacist.
If you do not take it regularly, PSA level monitoring may be affected.
Recommended dose
The usual 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 contents of the capsules may irritate the mouth or
throat. The capsules may be taken with or without food.
Treatment with VIVISTER is long-term. Some individuals may notice early improvement in
symptoms. However, others may need to take VIVISTER for 6 months or longer before it starts to work. Continue taking VIVISTER for as long as your doctor tells you to.
If you take more VIVISTER than you should
If you take more VIVISTER capsules than prescribed, contact your doctor or pharmacist for advice.
If you forget to take VIVISTER
Do not take a double dose to make up for the missed dose. Simply take the next dose at the usual time.
If you stop taking VIVISTER
Do not stop taking VIVISTER without first consulting your doctor. It may take 6 months or longer before you notice an improvement.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Allergic reaction
Signs of allergic reactions may include:

rash (which may be itchy)
hives
swelling of the eyelids, face, lips, arms or legs.

Contact your doctor immediately if you experience any of these symptoms and stop taking VIVISTER.
Common adverse reactions (may affect up to 1 in 10 people)
impotence (inability to achieve or maintain an erection); this symptom may persist even after stopping VIVISTER
decreased sexual desire (libido); this symptom may persist even after stopping VIVISTER
ejaculation disorders, such as reduced amount of semen released during sexual intercourse; this symptom may persist even after stopping VIVISTER
breast enlargement or tenderness (gynecomastia)
dizziness with tamsulosin intake.
Uncommon adverse reactions (may affect up to 1 in 100 people)

heart failure (the heart pumps blood around the body less efficiently; you may develop symptoms such as shortness of breath, extreme tiredness, and swelling of the ankles and legs)
hair loss (generally from the body) or hair growth
Adverse reactions with unknown frequency (frequency cannot be estimated from the available data)
depression
pain and swelling of the testicles

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE VIVISTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or on the aluminium sheet of the
blister packs. The expiry date refers to the last day of that month.
Do not store VIVISTER above 30°C. Store in the original packaging to protect the medicine 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. PACK CONTENT AND OTHER INFORMATION

What VIVISTER contains

The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
The other components are:
capsule core: propylene glycol monocaprylate and butylated hydroxytoluene.
capsule coating: gelatin, glycerol, titanium dioxide (E171), medium-chain triglycerides,

lecithin (may contain soybean oil) (E322).
Description of the appearance of VIVISTER and pack contents
VIVISTER 0.5 mg soft capsules are yellowish, oblong soft gelatin capsules (approximately 16.5 x 6.5 mm) filled with a clear liquid. Available in packs (PVC-PE-PVDC (TRIPLEX)/AL blisters) containing 10, 30, 50, 60 and 90 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
S.F. Group S.r.l.
Via Tiburtina, 1143, 00156 – Rome, Italy
Manufacturer:
Laboratorios LEÓN FARMA, S.A.
Polígono Industrial Navatejera
C/La Vallina, s/n
24008 Villaquilambre
León, Spain
This medicinal product is authorized in the European Economic Area Member States under the following
names:
DK Dutasteride Universal Farma
PL Davoster
SI Amdut 0.5 mg mehke kapsule
IT Vivister
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