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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

dutasteride/tamsulosin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents:

1. What Dutasteride/Tamsulosin Viatris is and what it is used for
2. What you need to know before taking Dutasteride/Tamsulosin Viatris
3. How to take Dutasteride/Tamsulosin Viatris
4. Possible side effects
5. How to store Dutasteride/Tamsulosin Viatris
6. Contents of the pack and other information

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

Dutasteride/tamsulosin is used in men to treat an enlarged prostate (benign prostatic hyperplasia) – a non-cancerous growth of the prostate caused by overproduction of a hormone called dihydrotestosterone.

Dutasteride/tamsulosin is a combination of two different medicines called dutasteride and tamsulosin. Dutasteride belongs to a group of medicines known as 5-alpha reductase inhibitors, and tamsulosin belongs to a group of medicines known as alpha-blockers.

As the prostate enlarges, it may cause urinary problems such as difficulty in passing urine and a need to urinate more frequently. It may also cause the urine stream to become weaker and less forceful. If benign prostatic hyperplasia is not treated, there is a risk that urine flow may become completely blocked (acute urinary retention), which requires immediate medical treatment. In some cases, surgery may be needed to reduce the size of the prostate or to remove it.

Dutasteride reduces the production of dihydrotestosterone, helping to shrink the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery. Tamsulosin works by relaxing the muscles in the prostate, making urination easier and rapidly improving symptoms.

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

Do not take Dutasteride/Tamsulosin Viatris

• if you are a woman (because this medicine is for men only).

• if you are a child or adolescent under 18 years of age.

• if you are allergic to dutasteride, to other 5-alpha reductase enzyme inhibitors, to tamsulosin, soy, peanut, or to any of the other ingredients of this medicine (listed in section 6).

• if you have low blood pressure causing dizziness, lightheadedness, or fainting (orthostatic hypotension).

• if you have severe liver disease.

• If you think you may be in any of these situations, do not take this medicine until you have consulted your doctor.

Warnings and precautions

Talk to your doctor before starting dutasteride/tamsulosin

• In some clinical studies, there was a higher number of patients taking dutasteride and another medicine called an alpha blocker, such as tamsulosin, who developed heart failure compared to patients taking only dutasteride or only an alpha blocker. Heart failure means that your heart does not pump blood properly.

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

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

• Cataract surgery (cloudy lens). If you are scheduled for cataract surgery, your doctor may ask you to stop taking dutasteride/tamsulosin for a period of time before the operation. Before the surgery, inform your ophthalmologist that you are taking dutasteride/tamsulosin or tamsulosin (or have taken them previously). Your specialist will need to take appropriate precautions to prevent complications during surgery.

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

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

• Dutasteride/tamsulosin affects the serum PSA test (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor may still use this test to screen for prostate cancer, but must be aware of this effect. If you have a blood test to measure 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 developed a higher frequency of high-grade prostate cancer than those not taking dutasteride. The effect of dutasteride on this type of high-grade prostate cancer is not fully understood.

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

• Talk to your doctor or pharmacist if you have any questions about taking dutasteride/tamsulosin.

Mood changes and depression

Depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with another medicine in the same therapeutic class (oral 5-alpha-reductase inhibitor). If you experience any of these symptoms, contact your doctor as soon as possible for further medical advice.

Taking Dutasteride/Tamsulosin Viatris with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Do not take dutasteride/tamsulosin with these medicines:

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

It is not recommended to take dutasteride/tamsulosin with these medicines:

• ketoconazole (used to treat fungal infections)

Certain medicines may interact with dutasteride/tamsulosin, increasing the risk of side effects. Some of these medicines are:

• PDE5 enzyme 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 doctor if you are taking any of these medicines.

Taking Dutasteride/Tamsulosin Viatris with food

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

Pregnancy, breastfeeding, and fertility

Women must not take dutasteride/tamsulosin.

Pregnant women (or those who may be pregnant) must avoid contact with broken capsules. Dutasteride can be absorbed through the skin and may affect the normal development of a male baby. This risk is particularly important during the first 16 weeks of pregnancy.

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

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

• Consult your doctor if a pregnant woman has been exposed to dutasteride/tamsulosin.

Driving and operating machinery

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

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

Dutasteride/Tamsulosin Viatris contains soy lecithin, propylene glycol, and sodium

This medicine contains soy lecithin, which may contain soybean oil. It must not be used in patients with peanut or soy allergy.

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

This medicine contains less than 23 mg of sodium (1 mmol) per capsule, i.e., essentially “sodium-free”.

3. How to take Dutasteride/Tamsulosin Viatris

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you do not take it regularly, the monitoring of your PSA levels may be affected. If in doubt, consult your doctor or pharmacist again.

What dose should you take

The recommended dose is one capsule once daily, taken 30 minutes after the same meal each day.

How to take it

The capsules must be swallowed whole, with water. Do not chew or open the capsules. Contact with the capsule contents may irritate your mouth or throat.

If you take more Dutasteride/Tamsulosin Viatris than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dutasteride/Tamsulosin Viatris

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

Do not stop treatment with Dutasteride/Tamsulosin Viatris without advice

Do not stop treatment with Dutasteride/Tamsulosin Viatris without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Allergic reaction

Symptoms of an allergic reaction may include:

• skin rash, which may be itchy

• hives

• swelling of the eyelids, face, lips, arms, or legs.

• You must contact your doctor immediately if you experience any of these symptoms and stop taking dutasteride/tamsulosin.

Dizziness, lightheadedness, and fainting

Dutasteride/tamsulosin may cause dizziness, lightheadedness, and, rarely, fainting. You should be cautious when rising quickly after sitting or lying down, especially if you need 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 the symptoms have passed.

Serious skin reactions

Signs of serious skin reactions may include:

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

• Contact your doctor immediately if you have these symptoms and stop using dutasteride/tamsulosin.

Frequent adverse effects

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

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

Uncommon adverse effects

These may affect up to 1 in 100 patients:

• heart failure (the heart becomes less efficient at pumping blood around the body. This may cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs).
• drop in blood pressure upon standing
• fast heartbeat (palpitations)
• constipation, diarrhea, vomiting, discomfort (nausea)
• weakness or loss of strength
• headache
• itching, nasal congestion, or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually of the body) or hair growth.

Rare adverse effects

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

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

Very rare adverse 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 adverse effects

Other adverse effects have been reported in a small number of men, but their exact frequency is unknown (frequency cannot be estimated from the available data):

• abnormal or rapid heartbeat (arrhythmia or tachycardia or atrial fibrillation)
• difficulty breathing (dyspnea)
• depression
• pain and swelling in the testicles
• nosebleeds
• severe skin rash
• changes in vision (blurred vision or visual disturbances)
• dry mouth.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride/Tamsulosin Viatris

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the bottle after "CAD" or "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dutasteride/Tamsulosin Viatris

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

Hard capsule shell:

Iron oxide black (E172)
Iron oxide red (E172)
Titanium dioxide (E171)
Iron oxide yellow (E172)
Gelatin

Soft capsule content of dutasteride:

Propylene glycol monocaprylate, type II
Butylhydroxytoluene (E321)

Soft capsule shell:

Gelatin
Glycerol
Titanium dioxide (E171)
Medium-chain triglycerides
Soy lecithin (may contain soybean oil) (see section 2)

Tamsulosin pellets:

Methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion (containing sodium lauryl sulfate and polysorbate 80)
Microcrystalline cellulose
Dibutyl sebacate
Polysorbate 80
Colloidal hydrated silica
Calcium stearate

Black printing 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 pack

The medicine is presented as hard gelatin capsules, oblong, approximately 21.4 mm × 7.4 mm, 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 containing dutasteride.

Available in packs of 7, 30 and 90 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

LABORATORIOS LEÓN FARMA S.A.
C/ La Vallina s/n, Polígono Industrial Navatejera
Villaquilambre 24193 (León)
Spain

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of latest review of this leaflet: September 2025.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): https://www.aemps.gob.es/