Prospecto: information for the user

Dutasteride/Tamsulosin Viatris 0.5mg/0.4mg hard EFG capsules

dutasteride/hydrochloride of tamsulosin

Read this prospectus carefully before starting to take this medication, 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 medication has been prescribed only to you, and you should 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 do not appear in this prospectus. See section4.

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

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

3.How to take Dutasteride/Tamsulosin Viatris

4.Possible adverse effects

5.Storage of Dutasteride/Tamsulosin Viatris

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 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, 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 Viatris

• if you are awoman(becausethis medication is only for men).
• if you are achild or adolescent under 18years of age.
• if you areallergic to dutasteride, to other5-alpha reductase inhibitors‑reductase inhibitors, to tamsulosin, to soy, peanutsor to any of the other components of this medication (listed in section6).
• if you havelow blood pressurethat makes you feel dizzy, lightheaded, or faint (orthostatic hypotension).
• if you have anyserious 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 take dutasteride/tamsulosina

• 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 liver disease, you may need additional monitoring during your treatment with dutasteride/tamsulosina.

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

• Surgery for cataracts (cloudy lens). If you are going to have cataract surgery, your doctor may ask you to stop taking dutasteride/tamsulosinafor a while before the surgery. Before the surgery, inform your eye surgeon that you are taking dutasteride/tamsulosinaor 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 dutasteride/tamsulosina capsules, as 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. Dutasteride has been found in the semen of men taking dutasteride/tamsulosina. 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.

• Dutasteride/tamsulosina affects PSA blood tests(prostate-specific antigen)that are sometimes 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/tamsulosina.Men taking dutasteride/tamsulosina should have regular PSA monitoring.

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

• Dutasteride/tamsulosina may cause breast enlargement and tenderness. If this causes you discomfort, or ifyou notice lumps in your breastordischarge from your 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 questions related to taking dutasteride/tamsulosina.

Use of Dutasteride/Tamsulosina Viatris 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/tamsulosina with these medications:

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

Do not take dutasteride/tamsulosina with these medications:

• ketoconazole(used to treat fungal infections)

Certain medications may interact with dutasteride/tamsulosina, 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)
• 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/Tamsulosina Viatris with food

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

Pregnancy, breastfeeding, and fertility

Women should not takedutasteride/tamsulosina.

Pregnant women (or those who 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 16weeks of pregnancy.

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

Dutasteride/tamsulosina 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/tamsulosina.

Driving and operating machinery

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

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

Dutasteride/Tamsulosina Viatriscontains lecithin from soy, propylene glycol, and sodium

This medication contains lecithin from soy, which may contain soy oil. It should not be used in case of allergy to peanuts or soy.

This medication contains 299.46 mg of propylene glycol in each capsule equivalent to 4.27 mg/kg.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If you do not take it regularly, your PSA level control 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, 30minutes 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 Viatris 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 Viatris

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

Do not interrupt treatment with Dutasterida/Tamsulosina Viatriswithout advice

Do not interrupt treatment with Dutasterida/Tamsulosina Viatriswithout 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 rashthat may itch
• hives
• swelling of the eyelids, face, lips, arms, or legs.

• You should contact your doctor immediatelyif you experience any of these symptoms andstop taking dutasteride/tamsulosin.

Dizziness, lightheadedness, and fainting

Dutasteride/tamsulosinmay 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 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

These may affect up to 1 in 10patients taking dutasteride/tamsulosin:

• impotence (inability to achieve or maintain an erection)*
• decreased libido*
• difficulty with ejaculation, as well as decreased semen volume*
• breast swelling or tenderness(gynecomastia)
• dizziness.
• * In a small number of people, some of these adverse events may continue after stopping dutasteride/tamsulosin.

Uncommon side effects

These 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 swelling in the ankles and legs).
• reduced blood pressure when standing up
• rapid heart rate(palpitations)
• constipation, diarrhea, vomiting, discomfort (nausea)
• weakness or loss of strength
• headache
• itching, nasal congestion or discharge(rhinitis)
• skin rash, hives, itching
• hair loss (usually on the body) or excessive hair growth.

Rare side effects

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

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

Very rare side effects

These 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 occurred in a reduced number of men, but their frequency is unknown (the frequency cannot be estimated from the available data):

• abnormal or rapid 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 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 box and the bottle after “CAD” or “EXP”. 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 containers 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 containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dutasteride/Tamsulosin Viatris

The active ingredients are dutasteride and tamsulosin hydrochloride. Each hard capsule contains 0.5mg of dutasteride and 0.4mg of tamsulosin hydrochloride (equivalent to 0.367mg of tamsulosin). The other components are:

Hard capsule coating:

Iron oxide black (E172)

Iron oxide red (E172)

Titanium dioxide (E171)

Iron oxide yellow (E172)

Gelatin

Content of the soft capsule with dutasteride:

Propylene glycol monocaprylate, typeII

Butylhydroxytoluene (E321)

Coating of the soft capsule:

Gelatin

Glycerol

Titanium dioxide (E171)

Medium-chain triglycerides

Soja lecithin (may contain soya oil) (see section2)

Tamsulosin pellets:

Acrylate/methacrylate copolymer (1:1), dispersion 30% (contains sodium lauryl sulfate and polisorbate 80)

Microcrystalline cellulose

Sebacic acid dibutyl ester

Polisorbate 80

Colloidal hydrated silica

Calcium stearate

Black ink:

Shellac (E904)

Iron oxide black (E172)

Propylene glycol (E1520)

Concentrated ammonia solution (E527)

Potassium hydroxide (E525)

Appearance of the product and contents of the package

The medicinal product is presented in hard gelatin capsules, oblong, approximately 21.4mm×7.4mm, with a brown body and an orange cap printed with C001 in black ink.

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer:

LABORATORIOS LEÓN FARMA S.A.

C/ La Vallina s/n, Polígono Industrial Navatejera

Villaquilambre 24193 (León)

Spain

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Last review date of this leaflet:August 2019.

More detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/