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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dutasteride/Tamsulosin Cinfalab 0.5 mg/0.4 mg 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Dutasteride/Tamsulosin Cinfalab 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 Cinfalab 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 can 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 left untreated, there is a risk that urine flow may become completely blocked (acute urinary retention), which requires immediate medical treatment. Surgery may sometimes be necessary to reduce the size of the prostate or remove it.

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

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

Do not take Dutasteride/Tamsulosin Cinfalab

• 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, which makes you feel dizzy, lightheaded, or causes fainting (orthostatic hypotension)
• if you have severe liver disease.
• This medicine contains traces of soybean oil. It should not be used if you are allergic to peanut or soy.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Dutasteride/Tamsulosin Cinfalab.

• In some clinical studies, there was a higher number of patients taking dutasteride and another medicine 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 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 Cinfalab.

• 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 before the operation. Before the 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 the procedure.

• 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, 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, as dutasteride may affect the normal development of a male fetus. 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) 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 Cinfalab. Men being treated with dutasteride/tamsulosin should have regular PSA monitoring.

• In a clinical study conducted in men at high risk of developing prostate cancer, men who took dutasteride had a higher frequency of a more serious type of prostate cancer compared to those who did not take dutasteride. The effect of dutasteride on this more serious type of prostate cancer is not fully understood.

• Dutasteride/Tamsulosin may cause breast enlargement and 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.

• 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 for medical advice as soon as possible.

??Talk to your doctor or pharmacist if you have any questions about taking Dutasteride/Tamsulosin Cinfalab.

Taking Dutasteride/Tamsulosin Cinfalab with other medicines

Tell 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 these medicines:

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

The use of Dutasteride/Tamsulosin Cinfalab is not recommended with these 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 AIDS)
• itraconazole or ketoconazole (for fungal infections)
• nefazodone (an antidepressant)
• cimetidine (for stomach ulcer)
• 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 Cinfalab with food and drink

You should take Dutasteride/Tamsulosin Cinfalab 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

Women must not take Dutasteride/Tamsulosin Cinfalab.

Pregnant women (or women 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 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 Cinfalab.

Driving and using 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 Cinfalab contains sodium.

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

Dutasteride/Tamsulosin Cinfalab contains propylene glycol.

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

3. How to take Dutasterida/Tamsulosina Cinfalab

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

If you do not take Dutasterida/Tamsulosina Cinfalab 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 Dutasterida/Tamsulosina Cinfalab 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 Dutasterida/Tamsulosina Cinfalab

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

Do not stop treatment with Dutasterida/Tamsulosina Cinfalab without advice.

Do not stop treatment with Dutasterida/Tamsulosina Cinfalab 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 will experience them.

Allergic reaction

Symptoms of an allergic reaction may include:

• skin rash (which may be itchy)
• 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 Dutasteride/Tamsulosin Cinfalab.

Dizziness, lightheadedness, and fainting

Dutasteride/Tamsulosin Cinfalab 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 lightheaded during treatment, sit or lie down until these symptoms have passed.

Serious skin reactions

Signs of serious 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 Dutasteride/Tamsulosin Cinfalab.

Frequent adverse effects (may affect up to 1 in 10 patients)

• impotence (inability to achieve or maintain an erection)*

• decreased sex drive (libido)*

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

• enlargement of the breast and tenderness to touch (gynecomastia)

• dizziness.

• In a small number of people, one or more of these adverse effects may continue after stopping Dutasteride/Tamsulosin Cinfalab.

Uncommon adverse effects (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)
• reduction in blood pressure upon standing
• faster than normal heartbeat (palpitations)
• constipation, diarrhoea, vomiting, feeling unwell (nausea)
• weakness or loss of strength
• headache
• itching, stuffiness or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually of the body) or hair growth.

Rare adverse effects (may affect up to 1 in 1,000 patients)

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

Very rare adverse effects (may affect up to 1 in 10,000 patients)

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

Other adverse effects

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

• abnormal or rapid heartbeat (arrhythmia, 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 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 Cinfalab

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 label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. The product must be used within 90 days of opening.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Dutasteride/Tamsulosin Cinfalab

• The active substances are dutasteride and tamsulosin hydrochloride. Each 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:

  • capsule shell: black iron oxide (E-172), red iron oxide (E-172), yellow iron oxide (E-172), titanium dioxide (E-171) and gelatin
  • inside the capsule:

• soft gelatin capsule composed of: propylene glycol monocaprylate type II, butylhydroxytoluene (E-321), gelatin, glycerol (E-422), titanium dioxide (E-171), triglycerides and lecithin (which may contain soybean oil).

• Tamsulosin hydrochloride pellets composed of methacrylic acid and ethyl acrylate (1:1) 30% dispersion containing sodium lauryl sulfate and polysorbate 80 (E-433), microcrystalline cellulose (E-460), dibutyl sebacate, polysorbate 80 (E-433), colloidal hydrated silica, calcium stearate.

• Black ink: shellac (E-904), black iron oxide (E-172), propylene glycol (E-1520), potassium hydroxide (E-525), concentrated ammonia solution (E-527).

Appearance of the medicine and contents of the pack

This medicine is presented as hard, oblong, size 0 capsules, with a brown body and orange cap, printed with "C001" in black ink. Each hard capsule contains a soft capsule of dutasteride and modified-release pellets of tamsulosin hydrochloride.

It is available in HDPE bottles with a silica gel desiccant insert in the cap.

30 hard capsules in a 100 ml bottle.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios LEÓN FARMA, S.A.

Polígono Industrial Navatejera

C/La Vallina, s/n - 24008 Navatejera - León

Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the latest revision 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) (http://www.aemps.gob.es)