Package Insert: Information for the Patient

Duprost 0.5 mg/0.4 mg Hard Capsules EFG

Dutasteride/hydrochloride of tamsulosin

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

This medicationis used in men to treat an enlarged prostate(benign prostatic hyperplasia)- a non-cancerous growth of the prostate caused by producing an excess of a hormone called dihydrotestosterone.

Duprost 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 the urine flow being completely blocked(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 and 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 takeDuprost

• 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, to other 5-alpha reductase inhibitors, to tamsulosin, to soy, peanuts orto 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 serious liver disease.
• this medication contains soy lecithin, which may contain soy oil. Do not use in case of allergy to peanuts or soy.

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

Warnings and precautions

Consult your doctor before starting to take this medication.

• In some clinical studies, there were more 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 haveliver 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 haveserious 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 before. Your specialist will need to take the necessary precautions to avoid complications during the surgery.

• Women, children and adolescents shouldavoid 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 immediatelywith 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 may be pregnant, you should avoid exposing her to your semen, as dutasteride may affect the normal development of the male fetus. Dutasteride causes a decrease in sperm count, motility and semen volume.This may reduce your fertility.

• Dutasteride/tamsulosin affects the PSA blood test(prostatic specific antigen) used sometimes to detect prostate cancer.Your doctor may still use this test to detect prostate cancer, but he or she should be aware of 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 monitoring.

• In a clinical study conducted in men at increased risk of developing prostate cancer, men taking dutasteride presented withmore frequently a serious type of prostate cancerthan those not taking dutasteride. The effect of dutasteride on this serious type of 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 may be signs of a serious disease, such as breast cancer.

?Consult your doctor or pharmacistif you have any doubts related to taking this medication.

Use of Dutasteride/tamsulosin with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take 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 coagulation)
• 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.

Pregnancy, breastfeeding and fertility

Women should not takethis medication.

Women who are pregnant (or may be pregnant) should avoid contact with broken capsules. Dutasteride is 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.

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

Dutasteride/tamsulosin has been shown to decrease sperm count, motility and semen volume. This may reduce your fertility.

?Consult your doctorif a pregnant woman has been in contact with dutasteride/tamsulosin.

Driving and operating machinery

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

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

Duprost contains soy lecithin

This medication contains soy lecithin. Do not use in case of allergy to peanuts or soy.

This medication contains 299.46 mg of propylene glycol monocaprylate (E1520) in each capsule, equivalent to 4.27 mg/kg.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If you do not take this medication 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 isone 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. Contact with the contents of the capsules may irritate your mouth or throat.

If you take more Duprost 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 Duprost

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

Do not interrupt Duprost treatment without advice

Do not interrupt 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 symptomsand stop taking this medicine.

Dizziness, Lightheadedness, and Fainting

Dutasteride/tamsulosin may cause dizziness, lightheadedness, and, in rare cases, fainting. You should be careful whengetting 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 lightheadedness 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 taking this medicine.

Common Side Effects(may affect up to 1 in 10 people)

• impotence(inability to achieve 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 breast and pain on palpation (gynecomastia)
• dizziness.

*In a small number of people, some of these adverse events may continue after stopping this medicine.

(may affect up to 1 in 100 people)

• 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)
• reduced blood pressure when standing up
• abnormal heart rhythm (arrhythmia or tachycardia or atrial fibrillation)
• constipation, diarrhea, vomiting, discomfort (nausea)
• weakness or loss of strength
• headache
• itching, 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 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)

• 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 their 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 of 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 the Spanish System for the Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the bottle after CAD. The expiration date is the last day of the month indicated.

Store below 25°C. Use within 90 days after the first opening of the packaging.

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

Composition of Duprost

Each capsule contains0.5 mg of dutasteride and 0.4 mg of hydrochloride of tamsulosin. The other components are:

Appearance of the product and contents of the packaging

This medicine is presented in hard, oblong capsules with a brown body and beige cap, engraved with C001 in black ink.

Available in packs of 30 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing

León Farma Laboratories, S.A.

Navatejera Industrial Estate

C/ La Vallina s/n

24193 Villaquilambre, León

Spain

Last review date of this leaflet: June 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es