Prospecto:Information for the Patient

Dutasteride/Tamsulosin pensa 0.5 mg/0.4 mg Hard Capsules EFG

Dutasteride/hydrochloride of tamsulosin

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

- Keep this prospectus, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1. What is Dutasteride/Tamsulosin Pensa and what is it used for

2. What you need to know before starting to take Dutasteride/Tamsulosin Pensa

3. How to take Dutasteride/Tamsulosin Pensa

4. Possible side effects

5. Storage of Dutasteride/Tamsulosin Pensa

6. Contents of the pack and additional information

Dutasterida/Tamsulosina Pensa is used in men to treat an enlarged prostate(benign prostatic hyperplasia)- a non-cancerous growth of the prostate caused by excessive production of a hormone called dihydrotestosterone.

Dutasterida/Tamsulosina Pensa is a combination of two different medications called dutasteride and tamsulosin.

Dutasteride belongs to a group of medications called5-alpha reductase inhibitorsand tamsulosin belongs to a group of medications calledalpha blockers.

As the prostate grows in size, it can produce urinary problems such as difficulty in urinating and a need to urinate more frequently. It can also cause the urine stream to be smaller and less forceful. If benign prostatic hyperplasia is not treated, there is a risk of complete blockage of the urine flow(acute urinary retention). This requires immediate medical treatment. In some cases, surgery may be necessary to reduce the size of the prostate or remove it.

Dutasteride reduces the production of dihydrotestosterone, which helps to reduce the size of the prostate and alleviate symptoms. This reduces the risk of acute urinary retention and the need for surgery. Tamsulosin acts by relaxing the muscles of the prostate, making urination easier and rapidly improving symptoms.

Do not take Dutasterida/Tamsulosina Pensa:

• if you are a woman (because this medication is only for men)
• if you are a child or adolescent under 18 years of age
• if you are allergic to dutasteride, other 5-alpha reductase inhibitors, tamsulosin, soy, peanuts or any of the other components of this medication (listed in section 6)
• if you have low blood pressure, which makes you feel dizzy, lightheaded or faint (orthostatic hypotension)
• if you have a severe liver disease

?If you think you have any of these conditions, do not take this medication until you have consulted with your doctor.

Warnings and precautions

Consult your doctor before starting to take dutasteride/tamsulosin:

• In some clinical studies, there was a higher number of patients taking dutasteride and another medication called an alpha blocker, such as tamsulosin, who experienced heart failure compared to patients taking only dutasteride or only an alpha blocker. Heart failure means that your heart is not pumping blood as it should.

• Make sure your doctor knows if you have liver problems. If you have any liver disease, you may need additional monitoring during your treatment with dutasteride/tamsulosin.

• Make sure your doctor knows if you have severe kidney problems

• Cataract surgery (opaque crystalline lens). If you are going to have cataract surgery, your doctor may ask you to stop taking dutasteride/tamsulosin for a while before the surgery. Before the surgery, inform your ophthalmologist that you are taking dutasteride/tamsulosin or have taken it in the past. Your specialist will need to take the necessary precautions to avoid complications during the surgery.

• Women, children and adolescents should avoid contact with broken dutasteride/tamsulosin capsules, as the active ingredient can be absorbed through the skin. If there is any contact with the skin, the affected area should be washed immediately with water and soap.

• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride/tamsulosin. If your partner is pregnant or thinks she may be pregnant, you should avoid exposing her to your semen, as dutasteride can affect the normal development of the male fetus. Dutasteride reduces sperm count, motility and semen volume, which can reduce fertility.

• Dutasteride/tamsulosin affects the PSA blood test (prostate-specific antigen) used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but they should know about this effect. If you have a blood test to determine your PSA, inform your doctor that you are taking dutasteride/tamsulosin.

Men taking dutasteride/tamsulosin should have regular PSA checks.

• In a clinical study conducted in men at increased risk of developing prostate cancer, men taking dutasteride presented with a higher frequency of a type of severe prostate cancer than those not taking dutasteride. The effect of dutasteride on this type of severe prostate cancer is unclear.

• Dutasteride/tamsulosin may cause breast enlargement and tenderness. If this causes you discomfort, or if you notice lumps in your breast or nipple discharge, consult your doctor, as these changes can be signs of a serious disease, such as breast cancer.

??Consult your doctor or pharmacistif you have any doubts related to taking dutasteride/tamsulosin.

Use of Dutasterida/Tamsulosina Pensa with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Do not take dutasteride/tamsulosin with these medications:

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

Do not take dutasteride/tamsulosin with these medications:

-ketoconazole(used to treat fungal infections).

Certain medications may interact with dutasteride/tamsulosin, which may cause you to experience adverse effects. Some of these medications are:

-phosphodiesterase type 5 inhibitors(used to achieve or maintain an erection) such as vardenafil, sildenafil citrate and tadalafil

-verapamil or diltiazem(for high blood pressure)

-ritonavir or indinavir(for HIV/AIDS)

-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).

??Inform your doctorif you are taking any of these medications.

Taking dutasteride/tamsulosin with food and drinks

You should take dutasteride/tamsulosin 30 minutes after the same meal every day.

Pregnancy, breastfeeding and fertility

Women should not take dutasteride/tamsulosin

Women who are pregnant (or may be pregnant) should avoid contact with broken dutasteride/tamsulosin capsules. Dutasteride can be absorbed through the skin and may affect the normal development of the male fetus. This risk is especially important in the first 16 weeks of pregnancy.

??Consult your doctorif a pregnant woman has come into contact with dutasteride/tamsulosin.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride/tamsulosin. If your partner is pregnant or thinks she may be pregnant, you should avoid exposing her to your semen.

Dutasteride has been shown to reduce sperm count, motility and semen volume, which can reduce fertility.

Driving and operating machinery

Some people may experience dizziness during treatment with dutasteride/tamsulosin, which may affect their ability to drive or operate machinery safely.

?Do not drive or operate machinery if you are affected in this way.

Dutasterida/Tamsulosina Pensa contains yellow orange S, soy lecithin and sodium

This medication may cause allergic reactions because it contains yellow orange S (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medication contains soy lecithin. It should not be used in cases of allergy to peanuts or soy.

This medication contains less than 23 mg of sodium (1 mmol) per capsule; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If you do not take dutasteride/tamsulosin regularly, the control of your PSA levels may be affected. In case of doubt, consult your doctor or pharmacist again.

What dose should you take

The recommended dose is one capsule once a day, 30 minutes after the same meal every day.

How to take it

The capsules should be swallowed whole with water. Do not chew or break the capsules. The contact with the contents of the capsules may irritate your mouth or throat.

If you take more dutasteride/tamsulosin than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take dutasteride/tamsulosin

Do not take a double dose to compensate for the missed doses. Take the next dose at the usual time.

Do not interrupt the treatment of dutasteride/tamsulosin without advice

Do not interrupt the treatment with dutasteride/tamsulosin without consulting your doctor first.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reaction

The symptoms of an allergic reaction may include:

-skin rash(which may itch)

-hives(like urticaria)

-swelling of the eyelids, face, lips, arms, or legs

??Contact your doctor immediatelyif you experience any of these symptoms andstop takingdutasteride/tamsulosin.

Dizziness, lightheadedness, and fainting

Dutasteride/tamsulosinmay cause dizziness, lightheadedness, and, in rare cases, fainting. You should be cautious when getting up quickly after sitting or lying down, especially if you have to get up during the night, until you know how this medicine affects you. If you feel dizzy or experience a spell during treatment,sit or lie down until these symptoms have disappeared.

Severe skin reactions

The signs of severe skin reactions may include:

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

??Contact your doctor immediatelyif you have these symptoms andstop usingdutasteride/tamsulosin.

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

• impotence(inability toachieve or maintain an erection)*
• decreased libido*
• difficulty with ejaculation, such as a decrease in the amount of semen released during sexual intercourse*
• enlargement of the breasts and pain on palpation (gynecomastia)*
• dizziness

*In a small number of people, some of these adverse events may continue after stopping dutasteride/tamsulosin.

(may affect up to 1 in 100 patients)

- heart failure (the heart becomes less efficient at pumping blood throughout the body. This could cause symptoms such as difficulty breathing, excessive fatigue, and inflammation in the ankles and legs)

- reduction in blood pressure when standing

- abnormally fast heart rate (palpitations)

- constipation, diarrhea, vomiting, discomfort (nausea)

- weakness or loss of strength

- headache

- tickling, congestion, or nasal discharge (rhinitis)

- skin rash, hives, itching

- hair loss (usually on the body) or hair growth

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

- swelling of the eyelids, face, lips, arms, or legs (angioedema)

- fainting

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

- prolonged and painful erection of the penis (priapism)

- severe skin reactions (Stevens-Johnson syndrome)

Other side effects

Other side effects have been reported in a reduced number of patients but the exact frequency is unknown (the frequency cannot be estimated from the available data):

- abnormal or accelerated heart rhythm (arrhythmia or tachycardia or atrial fibrillation)

- difficulty breathing (shortness of breath)

- depression

- pain and swelling in the testicles

- nasal bleeding

- severe skin rash

- changes in vision (blurred vision or visual problems)

- dry mouth

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box or inthecontainer or in the blister pack after CAD. The expiration date is the last day of the month indicated.

Once opened, do not use the HPDE bottles for more than 6 weeks for bottles containing 30 capsules, or more than 18 weeks for bottles containing 90 capsules.

Do not store at a temperature above 30 °C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition ofDutasteride/Tamsulosin Pensa

• The active principles are dutasteride and hydrochloride of tamsulosin. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of hydrochloride of tamsulosin.
• The other components (excipients) are:

• hard capsule coating: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), red iron oxide (E172), yellow-orange S (E110).
• inside the hard capsule: glyceryl monocaprylate and butylhydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), triglycerides (medium chain), lecithin (may contain soy oil) (E322), microcrystalline cellulose, copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion 30%, copolymer of methacrylic acid and ethyl acrylate (1:1), magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E171).

Appearance of the product and contents of the package

This medication is presented in hard, oblong capsules, approximately 24 mm in length, with a brown body and an orange cap.

It is available in packages of 7, 30, and 90 capsules in HDPE Frasco or aluminum/aluminum blister.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

SAG Manufaturing, S.L.U

Ctra. N-I, Km 36, San Agustín de Guadalix

28750 Madrid, Spain

Or

Galenicum Health, S.L.U.

San Gabriel, 50

08950 Esplugues de Llobregat, Barcelona

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Spain: Dutasteride/Tamsulosin Pensa 0.5 mg/0.4 mg hard capsules EFG

Italy: Dutasteride and tamsulosin Pensa 0.5 mg /0.4 mg rigid capsules

Malta: Dutasteride/Tamsulosin GLN 0.5 mg/0.4 mg Hard Capsules

Portugal: Dutasteride + Tansulosina toLife 0.5 mg + 0.4 mg Capsules

Revision date of this prospectus:August 2019

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)