Prospecto:Information for the Patient

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

dutasteride/hydrochloride of tamsulosin

Read this prospect carefully before starting to take this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this prospect. See section 4.

1.What is Dutasteride/Tamsulosin Stadafarmaand for what it is used

2.What you need to knowbeforestarting totake Dutasteride/Tamsulosin Stadafarma

3.How to take Dutasteride/Tamsulosin Stadafarma

4.Possible adverse effects

5Storage of Dutasteride/Tamsulosin Stadafarma

6.Contents of the package and additional information

Dutasterida/tamsulosinais 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.

Dutasterida/Tamsulosina Stadafarmais 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 the flow of urine 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 to remove it.

Dutasteride reduces the production of dihydrotestosterone and this 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 takeDutasteride/Tamsulosin Stadafarma

-if you are awoman(because this medication is only for men).

• if you are achild or adolescent under 18 years of age.
• if you are allergicto dutasteride,to other5-alpha reductase inhibitors, to tamsulosin, to soy, peanutsorto any of the other components of this medication(listed in section 6).
• if you havelow blood pressure, which makes you feel dizzy, lightheaded, or faint (orthostatic hypotension).
• if you havesevere liver disease.

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

Warnings and precautions

Consult your doctor before starting to takeDutasteride/Tamsulosin Stadafarma:

• 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 have liver problems. If you have any disease that affects your liver, you may need some additional review during your treatment with dutasteride/tamsulosin.

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

• Cataract surgery (opaque 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 adolescentsmust avoid contact with broken capsules ofdutasteride/tamsulosin,since the active ingredient can be absorbed through the skin.If there is any contact with the skin,the affected area must be washed immediatelywith water and soap.

• Use a condom during sex.The dutasteride has been found in the semen of men takingdutasteride/tamsulosin.If your partner is pregnant or may be pregnant, you must 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 PSA blood tests(prostate-specific antigen) used sometimes to detect prostate cancer.Sometimes your doctor may still use this test to detect prostate cancer, but they must know about this effect. If you have a blood test to determine your PSA, inform your doctor that you are takingdutasteride/tamsulosin.Men taking dutasteride/tamsulosin must have regular PSA checks.

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

• Dutasteride/tamsulosin may cause breast enlargement and tenderness.If this causes you discomfort, or if you noticelumps in the breastordischarge from the nipple, 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 takingdutasteride/tamsulosin.

Other medications and Dutasteride/Tamsulosin Stadafarma

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may need to take any other medication.

Do not takedutasteride/tamsulosinwith these medications:

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

Do not takedutasteride/tamsulosinwith these medications:

-ketoconazole(used to treat fungal infections)

Certain medications that may interact withdutasteride/tamsulosinor 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
• verapamilor diltiazem(for high blood pressure)
• ritonavir or indinavir(for 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 Stadafarma with food and drinks

You must takedutasteride/tamsulosin30 minutes after the same meal every day.

Pregnancy, breastfeeding, and fertility

Women should not takedutasteride/tamsulosin.

Pregnant women (or those who may be pregnant) must 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.

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

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

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

Driving and operating machines

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

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

Dutasteride/Tamsulosin Stadafarma contains yellow orange S (E110) and soy lecithin

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

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

This medication contains less than 1 mmol of sodium (23 mg) 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 takedutasterida/tamsulosinaregularly, 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. Contact with the contents of the capsules may irritate your mouth or throat.

If you take moreDutasterida/Tamsulosina Stadafarmathan 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 Dutasterida/Tamsulosina Stadafarma

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 ofDutasterida/Tamsulosina Stadafarmawithout advice

Do not interrupt the treatment withdutasterida/tamsulosinawithout 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(such as urticaria)
• swelling of the eyelids, face, lips, arms, or legs

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

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 using dutasteride/tamsulosin.

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

• impotence(inability to achieve or maintain an erection)*
• decreased libido(sex drive)decreased*
• difficulty with ejaculation, such as a decrease in the amount of semen released during sexual intercourse*
• enlargement of the breasts and breast tenderness)
• dizziness.

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

(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 swelling in the ankles and legs)
• drop in blood pressure when standing
• abnormal heart rhythm (palpitations)
• constipation, diarrhea, vomiting, discomfort (nausea)
• weakness or loss of strength
• headache
• itching, congestion, or discharge from the nose (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 small number of patients, but their frequency cannot be estimated from the available data (the frequency cannot be estimated from the available data):

• abnormal or rapid heartbeat (arrhythmia or tachycardia or atrial fibrillation)
• difficulty breathing (shortness of breath)
• depression
• pain and swelling in the testicles
• nosebleed
• 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 theSpanish System for the Pharmacovigilance of Medicines for Human Use: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 use this medication after the expiration date that appears on the packaging or bottle or blister pack after CAD.The expiration date is the last day of the month indicated.

For high-density polyethylene (HDPE) bottles, after the first opening, do not use for more than 6 weeks for 30-capsule bottles, and for more than 18 weeks for 90-capsule bottles.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition ofDutasteride/Tamsulosin Stadafarma

• The active principles aredutasteride and hydrochloride of tamsulosin.Each capsule contains0.5 mg of dutasteride and 0.4 mg of hydrochloride of tamsulosin.
• The other components(excipients)are:
• Capsule hard shell coating:hypromellose, carrageenan(E407),potassium chloride,titanium dioxide(E171),red iron oxide(E172),yellow-orange S(E110).
• Inside the hard capsule shell:monocaprilocapratoofglyceryl andbutilhydroxytoluene(E321),gelatin, glycerol, titanium dioxide(E171),yellow iron oxide(E172),medium-chain triglycerides,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 as hard, oblong capsules, approximately 24 mm in length, with a brown body and orange cap.

They are available in packages of 7, 30, and 90 capsules in high-density polyethylene (HDPE) bottles or in aluminum/aluminum blisters.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Responsible manufacturer:

SAG MANUFACTURING, S.L.U.

Highway N-I, km 36

28750 San Agustín de Guadalix

Madrid – Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona - Spain

Last review date of this leaflet:May 2020.

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