DUTASTERIDE/TAMSULOSIN TECNIGEN 0.5 MG/0.4 MG HARD CAPSULES EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Dutasteride/Tamsulosin hydrochloride Tecnigen 0.5 mg/0.4 mg hard capsules EFG

Dutasteride/Tamsulosin hydrochloride

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do 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 the effects are not listed in this leaflet. See section 4.

Package leaflet contents

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

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

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

Dutasteride/Tamsulosin Tecnigen 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 called 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 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 starting to take Dutasteride/Tamsulosin Tecnigen

Do not take dutasteride/tamsulosin Tecnigen:

• if you are a woman (because this medicine is intended 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 enzyme inhibitors, to tamsulosin, soy, peanuts, 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 have any of these conditions, do not take this medicine until you have consulted your doctor.

Warnings and precautions

Talk to your doctor before starting to take dutasteride/tamsulosin

• In some clinical studies, a higher number of patients taking dutasteride and another medicine called an alpha-blocker, such as tamsulosin, experienced 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 procedure. Before surgery, inform your ophthalmologist that you are taking dutasteride/tamsulosin or tamsulosin (or if you have taken them previously). Your specialist will need to take appropriate precautions to avoid 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 with the skin occurs, the affected area should 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 might be pregnant, you must avoid exposing her to your semen, since dutasteride may affect the normal development of a male baby. Dutasteride causes a decrease in sperm count, sperm motility, and semen volume. This may reduce your fertility.

• Dutasteride/tamsulosin affects the serum PSA (prostate-specific antigen) test, 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 being treated with dutasteride/tamsulosin should have regular PSA monitoring.

• In a clinical study conducted in men at increased risk of developing prostate cancer, men who took dutasteride were found to have a higher incidence of a more severe type of prostate cancer compared to those who did not take dutasteride. The effect of dutasteride on this severe type of prostate cancer is not clear.

• Dutasteride/tamsulosin may cause breast enlargement and tenderness to palpation. 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.

Mood changes and depression

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

Consult your doctor or pharmacist if you have any questions regarding the use of dutasteride/tamsulosin.

Use of dutasteride/tamsulosin Tecnigen with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Dutasteride/tamsulosin with the following medicines:

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

The use of Dutasteride/tamsulosin is not recommended with the following medicines:

• ketoconazole (used to treat fungal infections).

Certain medicines may interact with Dutasteride/tamsulosin, increasing the risk of adverse 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).

Tell your doctor if you are taking any of these medicines.

Taking dutasteride/tamsulosin Tecnigen with food and beverages

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 women who may be pregnant) must avoid contact with opened capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male fetus. 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 might 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 use of machines

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 Tecnigen contains sunset yellow FCF (E110) and soybean lecithin

This medicine can cause allergic reactions because it contains sunset yellow FCF (E110). It may cause asthma, particularly in patients allergic to acetylsalicylic acid.

Dutasteride/Tamsulosin Tecnigen contains soybean lecithin. It must not be used in patients with allergy to peanuts or soy.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule and is therefore considered essentially "sodium-free".

3. How to take Dutasterida/tamsulosina Tecnigen

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If you do not take Dutasterida/tamsulosina regularly, 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 should 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 Tecnigen than you should

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

If you forget to take dutasteride/tamsulosin Tecnigen

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 Tecnigen

Do not stop treatment with dutasteride/tamsulosin 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 may cause adverse effects, although not everyone will experience them.

Allergic reaction

Symptoms of an allergic reaction may include:

• skin rash (which may be itchy)
• hives (like a rash similar to urticaria)
• swelling of the eyelids, face, lips, arms, or legs

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, in rare cases, 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 lightheaded during treatment, sit or lie down until these symptoms have passed.

Severe skin reactions

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 experience 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)*

• ejaculation difficulty, such as a decrease in the amount of semen released during sexual intercourse)*

• breast enlargement and tenderness to touch (gynecomastia)

• dizziness

• In a small number of people, some 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 shortness of breath, excessive tiredness, and swelling in the ankles and legs)
• reduction in blood pressure upon standing
• faster than normal heartbeat (palpitations)
• constipation, diarrhea, vomiting, stomach discomfort (nausea)
• weakness or loss of strength
• headache
• itching, nasal congestion or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually body hair) 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 side effects

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

• prolonged and painful penile erection (priapism)
• severe skin reactions (Stevens-Johnson syndrome)

Other adverse effects

Other adverse effects have occurred in a small number of patients, but their 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
• nosebleed
• severe skin rash
• changes in vision (blurred vision or visual disturbances)
• dry mouth

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride/Tamsulosin Tecnigen

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

Do not use this medicine after the expiry date stated on the packaging and on the bottle. The expiry date refers to the last day of the month indicated.

After first opening, for 30-capsule bottles, do not use beyond 6 weeks.

Do not store above 30 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Dutasteride/Tamsulosin Tecnigen

The active substances are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride. The other components are:

• hard capsule shell: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), iron oxide red (E172), orange yellow S (E110).
• contents of the hard capsule: glyceryl monocaprylocaprate, butylated hydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, soybean lecithin (may contain soybean oil) (E322), microcrystalline cellulose, copolymer of methylacrylic acid and ethyl acrylate (1:1) dispersion 30%, copolymer of methylacrylic acid and ethyl acrylate (1:1), magnesium stearate, sodium hydroxide, triacetin, talc.

Appearance of the product and contents of the container

Hard capsules (approximately 24 mm in length), oblong, with a brown body and orange cap.

Available in packs of 7 and 30 capsules in HDPE bottles or aluminum/aluminum blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D.
28108 Alcobendas (Madrid), Spain

Manufacturer:

SAG Manufacturing, S.L.U.
Ctra. N-I, km 36
28750 San Agustín de Guadalix (Madrid), Spain

or

Galenicum Health S.L.U.
Calle Sant Gabriel, 50
08950 Esplugues de Llobregat (Barcelona), Spain

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

Malta: Dutasterida+Tansulosina Farmoz
Portugal: Dutasterida+Tansulosina Farmoz

Date of the most recent review of this leaflet: November 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/