DUTASTERIDE 0,5 MG/0,4 MG Hard capsule

Зміст інструкції

1. DUTASTERIDE E TAMSULOSINA PENSA 0.5 mg/0.4 mg hard capsules
   1. What is DUTASTERIDE AND TAMSULOSIN PENSA and what it is used for
   2. What you need to know before taking DUTASTERIDE AND TAMSULOSIN PENSA
   3. How to take DUTASTERIDE and TAMSULOSINA PENSA
   4. Possible side effects
   5. How to store DUTASTERIDE and TAMSULOSINA PENSA
   6. Package contents and other information

DUTASTERIDE E TAMSULOSINA PENSA 0.5 mg/0.4 mg hard capsules

Dutasteride and tamsulosin hydrochloride

Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What DUTASTERIDE E TAMSULOSIN PENSA is and what it is used for
• 2. What you need to know before you take DUTASTERIDE E TAMSULOSINA PENSA
• 3. How to take DUTASTERIDE E TAMSULOSINA PENSA
• 4. Possible side effects
• 5. How to store DUTASTERIDE E TAMSULOSINA PENSA
• 6. Contents of the pack and other information

1. What is DUTASTERIDE AND TAMSULOSIN PENSA and what it is used for

DUTASTERIDE AND TAMSULOSIN PENSA is used to treat male subjects with enlarged prostate( benign prostatic hyperplasia) – a non-cancerous growth of the prostate, caused by excessive production of a hormone called dihydrotestosterone.
DUTASTERIDE AND TAMSULOSIN PENSA is a combination of two different medicines called dutasteride and tamsulosin.
Dutasteride belongs to a group of medicines called 5-alpha reductase inhibitorsand tamsulosin belongs to a group of medicines called alpha blockers.
If the prostate increases in volume, it can lead to urinary problems such as difficulty passing urine and the need to urinate frequently. This can also result in a slower and weaker urine flow. If left untreated, there is a risk that the urine flow may be completely blocked ( acute urinary retention). This requires immediate medical treatment.
In some cases, surgery may be necessary to remove or reduce the size of the prostate.
Dutasteride reduces the production of a hormone called dihydrotestosterone, which helps to decrease prostate volume and relieve symptoms. This will reduce the risk of acute urinary retention and the need for surgery. Tamsulosin works by relaxing the muscles of the prostate gland, making it easier to pass urine and quickly improving your symptoms.

2. What you need to know before taking DUTASTERIDE AND TAMSULOSIN PENSA

Do not take DUTASTERIDE AND TAMSULOSIN PENSA

• if you are a woman(because this medicine is only indicated for men).
• if you are a child or adolescent under 18 years of age.
• if you are allergicto dutasteride,to other 5 alpha reductase inhibitors,to tamsulosin,to

soy,to peanutsor to any of the other ingredients of this medicine (listed in section 6).

• if you have low blood pressurethat causes dizziness, lightheadedness or fainting (orthostatic hypotension).
• if you have severe liver disease.
• If you think any of the above applies to you, do not takethis medicine until you have consulted your doctor.

Warnings and precautions
Talk to your doctor before taking DUTASTERIDE AND TAMSULOSIN PENSA:

• In some clinical studies, more patients taking dutasteride and another medicine called an alpha blocker, such as tamsulosin, developed heart failure compared to patients treated with dutasteride alone or an alpha blocker alone. Heart failure means that the heart does not pump blood as well as it should.
• Make sure your doctor is aware of any liver problems you have.If you have had any liver disease, further checks may be needed while you are taking DUTASTERIDE AND TAMSULOSIN PENSA.
• Make sure your doctor is aware if you have severe kidney problems.

Cataract surgery (cloudy lens).If you are about to have cataract surgery, your doctor may ask you to stop taking
DUTASTERIDE AND TAMSULOSIN PENSA for a period before the operation.
Tell your ophthalmologist if you are taking DUTASTERIDE AND
TAMSULOSIN PENSA or tamsulosin (or have taken them previously) before the operation. The specialist will
need to take appropriate precautions to help prevent complications during
surgery.

• Women, children and adolescents must nothandle broken capsules of DUTASTERIDE AND TAMSULOSIN PENSA, because the active ingredient is absorbed through the skin. If contact with the skin occurs, immediately wash the affected areawith water and soap.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men treated with DUTASTERIDE AND TAMSULOSIN PENSA. If your partner is or may be pregnant, she must avoid exposure to your semen as dutasteride may impair the normal development of a male child. Dutasteride has been shown to reduce sperm count, semen volume and sperm motility. This may decrease your fertility.
• DUTASTERIDE AND TAMSULOSIN PENSA affects a blood test forPSA(prostate-specific antigen), which is used in some cases to detect prostate cancer. Your doctor must be aware of this effect and may continue to prescribe the test to detect prostate cancer. If you need to have a PSA test, tell your doctor that you are taking DUTASTERIDE AND TAMSULOSIN PENSA. Men taking DUTASTERIDE AND TAMSULOSIN PENSA should havethe PSA test regularly.
• In a clinical study conducted on men at increased risk of prostate cancer, men taking dutasteride had more frequently a severe form of prostate cancercompared to men who were not taking dutasteride. The effect of dutasteride on

this severe form of prostate cancer is unclear.

• DUTASTERIDE AND TAMSULOSIN PENSA can cause enlargement andtenderness of the breasts.If this becomes problematic, or if you notice the presence of breast lumpsor nipple discharge, you should talk to your doctor about these changes as they may be signs of a serious condition, such as breast cancer.
• Ask your doctor or pharmacistif you have any questions about taking DUTASTERIDE AND TAMSULOSIN PENSA.

Other medicines and DUTASTERIDE AND TAMSULOSIN PENSA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take DUTASTERIDE AND TAMSULOSIN PENSA with these medicines:

• other alpha blockers(for enlarged prostate or high blood pressure).

DUTASTERIDE AND TAMSULOSIN PENSA is not recommended with these medicines:

• ketoconazole(used to treat fungal infections).

Some medicines can interact with DUTASTERIDE AND TAMSULOSIN PENSA and can
increase the possibility of having unwanted effects. These medicines include:

• PDE5 inhibitors(used to help achieve or maintain an erection) such as vardenafil, sildenafil citrate and tadalafil
• verapamil or diltiazem(for high blood pressure)
• ritonavir or indinavir(for HIV)
• itraconazole or ketoconazole(for fungal infections)
• nefazodone(an antidepressant)
• cimetidine(for stomach ulcers)
• warfarin(for blood clotting)
• erythromycin(an antibiotic used to treat infections)
• paroxetine(an antidepressant)
• terbinafine(used to treat fungal infections)
• diclofenac(used to treat pain and inflammation)
• Tell your doctorif you are taking any of these medicines.

DUTASTERIDE AND TAMSULOSIN PENSAwith food and drink
DUTASTERIDE AND TAMSULOSIN PENSA should be taken 30 minutes after the same meal
every day.

Pregnancy, breastfeeding and fertility
DUTASTERIDE AND TAMSULOSIN PENSA must not be taken by women.
Women who are pregnant (or may become pregnant) must not handle broken capsules.Dutasteride is absorbed through the skin and can interfere with the normal development of a
male child. This is particularly risky in the first 16 weeks of pregnancy.

• Ask your doctorif a pregnant woman has come into contact with DUTASTERIDE AND TAMSULOSIN PENSA.

Use a condom during sexual intercourse.Dutasteride has been found in the semen
of men who were taking dutasteride/tamsulosin. If your partner is pregnant or may become pregnant,
she must avoid contact with your semen.
Dutasteride and tamsulosin have been shown to reduce sperm count, semen volume and
sperm motility. Therefore, male fertility may be reduced.

Driving and using machines
DUTASTERIDE AND TAMSULOSIN PENSA can cause dizziness in some people, so it may
affect your ability to drive or operate machines safely.

• Do not drive or operate machineryif you feel this way.

DUTASTERIDE AND TAMSULOSIN PENSAcontains
DUTASTERIDE AND TAMSULOSIN PENSA contains the yellow sunset dye (E110) which may
cause allergic reactions.
DUTASTERIDE AND TAMSULOSIN PENSA contains soy lecithin. If you are allergic to peanuts or
soy, do not use this medicine.
DUTASTERIDE AND TAMSULOSIN PENSA contains less than 1 mmol of sodium (23 mg) per capsule,
which is essentially ‘sodium-free’.

3. How to take DUTASTERIDE and TAMSULOSINA PENSA

Always take this medicine exactly as your doctor or pharmacist has told you. If you do not take it regularly, the control of PSA levels may be affected. If you have any doubts, ask your doctor or pharmacist.

How much to take
The recommended dose is one capsule to be taken once a day, 30 minutes after the same meal, every day.
How to take Swallow the capsules whole with water.Do not chew or open the capsules. Contact with the capsule contents may irritate the mouth or throat.

If you take more DUTASTERIDE and TAMSULOSINA PENSAthan you should
Contact your doctor or pharmacist for advice if you take more capsules of DUTASTERIDE and TAMSULOSINA PENSA.

If you forget to take DUTASTERIDE and TAMSULOSINA PENSA
Do not take a double dose to make up for a missed dose. Take the next dose as usual.

Do not stop taking DUTASTERIDE and TAMSULOSINA PENSA without your doctor's advice
Do not stop taking DUTASTERIDE and TAMSULOSINA PENSA without consulting your doctor first.
If you have any further questions on 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 everyone will experience them.
Allergic reaction
Signs of allergic reactions may include:

• skin rash(which may be itchy)
• urticaria
• swelling of the eyelids, face, lips, arms or legs.
• Contact your doctor immediatelyif you experience any of these symptoms and stop taking DUTASTERIDE AND TAMSULOSIN PENSA.

Dizziness, mild confusion and fainting
DUTASTERIDE AND TAMSULOSIN PENSA may cause dizziness, mild confusionand
in rare cases fainting. Be careful when moving from a lying or sitting position to a
sitting or standing position, especially if you wake up at night, until you know how this medicine
affects you. If you feel dizzy or experience mild confusionat any time during
treatment, sit or lie down until these symptoms pass.
Severe skin reactions
Signs of severe skin reactions may include:

a widespread rash with blisters and peeling skin, especially
around the mouth, nose, eyes and genitals(Stevens-Johnson syndrome).

• Contact your doctor immediatelyif you experience these symptoms and stop takingDUTASTERIDE AND TAMSULOSIN PENSA.

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

• impotence ( inability to achieve or maintain an erection) *
• decreased sexual desire ( libido)*
• difficulty ejaculating, such as a decrease in the amount of semen released during sexual intercourse*
• breast enlargement or tenderness ( gynecomastia)
• dizziness. * In a small number of people, some of these effects may persist after stopping DUTASTERIDE AND TAMSULOSIN PENSA.

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

• heart failure (the heart becomes less efficient at pumping blood around the body. You may experience symptoms such as shortness of breath, extreme fatigue and swelling of the ankles and legs)
• low blood pressure when standing
• fast heartbeat ( palpitations)
• constipation, diarrhea, vomiting, feeling sick (nausea)
• weakness or loss of strength
• headache
• itchy, blocked or runny nose ( rhinitis)
• skin rash, urticaria, itching
• hair loss (usually from the body) or hair growth.

Rare side effects( may affect up to 1 in 1,000 people)

• swelling of the eyelids, face, lips, arms or legs ( angioedema)
• fainting.

Very rare side effects( may affect up to 1 in 10,000 people)

• painful, prolonged erection of the penis ( priapism)
• severe skin reactions ( Stevens-Johnson syndrome).

Other side effects
Other side effects have been reported in a small number of patients but their exact frequency
is unknown (frequency cannot be estimated based on available data):

• irregular or fast heartbeat ( arrhythmia or tachycardia or atrial fibrillation)
• shortness of breath ( dyspnea)
• depression
• pain and swelling of the testicles
• nosebleeds
• severe skin rash
• changes in vision ( blurred vision or impaired vision)
• dry mouth.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at the address: 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 and TAMSULOSINA PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack, bottle or blister
after Exp.. The expiry date refers to the last day of that month.
For HDPE bottles, do not use after 6 weeks from first opening for the 30 capsule pack
and after 18 weeks from first opening for the 90 capsule pack.
Do not store DUTASTERIDE and TAMSULOSINA PENSA at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Package contents and other information

What DUTASTERIDE AND TAMSULOSIN PENSA contains

• The active ingredients are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.
• The other ingredients (excipients) are:
• hard capsule shell: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), red iron oxide (E172), sunset yellow FCF (E110).
• inside the hard capsule: caprylic/capric acid monoglycerides and butylated hydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), triglycerides (medium chain), lecithin (may contain soybean oil) (E322), microcrystalline cellulose, 30% dispersion of methacrylic acid-ethyl acrylate copolymer (1:1), copolymer

of methacrylic acid-ethyl acrylate (1:1), magnesium stearate, sodium hydroxide, triacetin,
talc, titanium dioxide (E171).

Description of the appearance of DUTASTERIDE AND TAMSULOSIN PENSA and package contents
This medicine is presented in the form of oblong hard capsules, approximately 24 mm in length, with a
brown body and an orange cap.
Packs of 7, 30 and 90 capsules are available placed inside HDPE bottles or aluminum/aluminum blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pensa Pharma SpA
Via Ippolito Rosellini, 12
20124 Milan
Italy

Manufacturer
SAG MANUFACTURING S.L.U.
Crta. N-I, Km 36
28750 San Agustin de Guadalix, Madrid
Spain
GALENICUM HEALTH, S.L.
Avda. Cornellà 144, 7º-1ª, Edificio Lekla
08950 Esplugues de Llobregat, Barcelona
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy: Dutasteride e Tamsulosina Pensa
Portugal: Dutasterida + Tansulosina toLife
Spain: Dutasterida/Tamsulosina Pensa 0.5 mg/0.4 mg Hard Capsules EFG
Malta: Dutasteride/Tamsulosin GLN 0.5 mg/0.4 mg Hard Capsules