Prospecto:information for the user

Dutasteride/Tamsulosin Combix Pharma0.5 mg/0.4 mg hard EFG capsules

dutasteride/hydrochloride of tamsulosin

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

• Keep this prospect, as you may need to read it again.
• 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 if they havethe same symptomsas you, as it may harm them.

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

1.What is Dutasteride/Tamsulosin Combix Pharmaand for what it is used

2.What you need to knowbeforestarting totake Dutasteride/Tamsulosin Combix Pharma

3.How to take Dutasteride/Tamsulosin Combix Pharma

4.Possible adverse effects

5Storage of Dutasteride/Tamsulosin Combix Pharma

6.Contents of the package and additional information

Dutasterida/Tamsulosina Combix Pharmais 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 Combix Pharmais a combination of two different medications called dutasteride and tamsulosin. Dutasteride belongs to a group of medications called 5-alpha reductase inhibitors and tamsulosin belongs to a group of medications called alpha blockers.

As the prostate grows in size, it may produce urinary problems such as difficulty in urinating and a need to urinate more frequently. It may 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, 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 takeDutasteride/Tamsulosin Combix Pharma:

• 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 allergic to dutasteride,other5-alpha reductase inhibitors, to tamsulosin, to soy, peanutsor to 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 have aserious 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 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 have liver problems. If you have any disease that affects your liver, you may need additional monitoring during your treatment with this medication.

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

• Surgery for cataracts (opaque crystalline lens).If you are going to have cataract surgery, your doctor may ask you to stop taking this medication for a while before the surgery. Before the surgery, inform your ophthalmologist that you are taking this medication or tamsulosin (or if you have taken them before). Your specialist will need to take the necessary precautions to avoid complications during the surgery.

• Women, children, and adolescentsshould avoid contact with broken capsules of this medication, 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 this medication. If your partner is pregnant or thinks she 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.

• This medication affects the PSA blood test (prostate-specific antigen) used sometimes to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but they should be aware of this effect. If you have a blood test to determine your PSA, inform your doctor that you are taking this medication.Men taking this medication should have regular PSA monitoring.

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

• This medication 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 ofDutasteride/Tamsulosin Combix Pharmawith 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 increase the risk of 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.

Administration ofDutasteride/Tamsulosin Combix Pharmawith food and beverages

You should take this medication 30 minutes after the same meal every day.

Pregnancy, breastfeeding, and fertility

Women should not take this 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 taking this medication. If your partner is pregnant or thinks she may be pregnant, you should avoid exposing her to your semen.

This medication 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 this medication.

Driving and operating machinery

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

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

Dutasteride/Tamsulosin Combix Pharmacontains lecithin from soy, propylene glycol, and sodium

This medication contains lecithin from soy, so it may contain soy oil. Do not use this

medication if you are allergic to peanuts or soy.

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

This medication contains 299 mg of propylene glycol per capsule.

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

If you take more Dutasterida/Tamsulosina Combix Pharma 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 Dutasterida/Tamsulosina Combix Pharma

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

If you interrupt the treatment with Dutasterida/Tamsulosina Combix Pharma

Do not interrupt treatment with this medication 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 may 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 immediately if you experience any of these symptoms and stop taking this medicine.

Dizziness, lightheadedness, and fainting

This medicine may cause dizziness, lightheadedness, and, in rare cases, fainting. You should be careful 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 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 peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)

• Contact your doctor immediately if you have these symptoms and stop using this medicine.

Common side effects

These may affect up to 1 in 10 men taking this medicine:

• 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 breasts and pain on palpation (gynecomastia)
• dizziness

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

Uncommon side effects

These may affect up to 1 in 100 men:

• 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 (palpitations)
• constipation, diarrhea, vomiting, discomfort (nauseas)
• weakness or loss of strength
• headache
• itching, congestion, or dripping nasal (rhinitis)
• skin rash, hives, itching
• hair loss (usually on the body) or hair growth

Rare side effects

These may affect up to 1 in 1,000 men:

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

Very rare side effects

These may affect up to 1 in 10,000 men:

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

Other side effects

Other side effects have occurred in a reduced number of men 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 (dyspnea)
• 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 the Spanish 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.

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.

This medication does not require special storage conditions.

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

Composition ofDutasteride/Tamsulosin Combix Pharma

The active principles are dutasteride and hydrochloride of tamsulosin.Each capsule contains0.5 mg of dutasteride and 0.4 mg of hydrochloride of tamsulosin (equivalent to 0.367 mg of tamsulosin). The other components are:

Capsule hard shell:

Black iron oxide (E172)

Red iron oxide (E172)

Titanium dioxide (E171)

Yellow iron oxide (E172)

Gelatin

Content of the soft capsule of dutasteride:

Propylene glycol monocaprylate type II

Butylhydroxytoluene (E321)

Capsule soft shell:

Gelatin

Glycerol

Titanium dioxide (E171)

Medium-chain triglycerides

Soy lecithin (may contain soy oil) (see section 2)

Tamsulosin pellets:

Copolymer of methylacrylic acid and ethyl acrylate (1:1) dispersion 30 percent (also contains polysorbate 80 and sodium lauryl sulfate)

Microcrystalline cellulose

Dibutyl sebacate

Polysorbate 80

Colloidal hydrated silica

Calcium stearate

Tintas negras:

Shellac (E904)

Black iron oxide (E172)

Propylene glycol (E1520)

Concentrated ammonia solution (E527)

Potassium hydroxide (E525)

Section 2 “Dutasteride/Tamsulosin Combix Pharmacontains soy lecithin and propylene glycol”

Appearance of the product and contents of the package

This medicine is a hard gelatin capsule, oblong, approximately 24.2 mm x 7.7 mm, with a brown body and beige cap, engraved with C001 in black ink.

Each hard capsule contains modified-release pellets of hydrochloride of tamsulosin and a soft gelatin capsule with dutasteride.

It is available in packages of 7, 30, and 90 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible for manufacturing

Marketing authorization holder

Combix Laboratories, S.L.U.

C/ Badajoz 2, Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Leon Pharma Laboratories, SA

C/ La Vallina, s/n, Industrial Park Navatejera

Villaquilambre-24193 (León)

Spain

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

DenmarkDutatex

GreeceZYTODUR 0.5 mg/0.4 mg,σκληρ?καψ?κια

PolandDutasteride + Tamsulosin hydrochloride León

Farma, 0.5 mg + 0.4 mg, hard capsules

PortugalDutasterida + Tansulosina Bluepharma

CroatiaAtekago 0,5 mg/0,4 mg hard capsules

Last review date of thisleaflet:August 2019

The 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.es/