DUTASTERIDE/TAMSULOSIN CINFALAB 0.5 mg/0.4 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dutasteride/Tamsulosin Cinfalab 0.5 mg/0.4 mg Hard Capsules EFG

Dutasteride/Tamsulosin Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Dutasteride/Tamsulosin Cinfalab and what is it 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 called 5-alpha reductase inhibitorsand tamsulosin belongs to a group of medicines called alpha blockers.

As the prostate grows, it can cause urinary problems such as difficulty in the flow of urine and a need to urinate more frequently. It can also cause the stream of urine to be weaker. If left untreated, benign prostatic hyperplasia can lead to a risk of the flow of urine 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 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 it easier to urinate and improving symptoms quickly.

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

Do not take Dutasteride/Tamsulosin Cinfalab

• if you are a woman(because this medicine is 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 inhibitors, to tamsulosin,to soy, peanutsor 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 faint (orthostatic hypotension)
• if you have severe liver disease.
• This medicine contains traces of soybean oil. It must not be used in case of peanut or soy allergy.

If you think you may have any of these conditions, do not take this medicine until you have consulted your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Dutasteride/Tamsulosin Cinfalab.

• In some clinical studies, there were more patients taking dutasteride and another medicine called an alpha blocker, such as tamsulosin, who experienced heart failure compared to patients who took only dutasteride or only an alpha blocker. Heart failure means that your heart does not pump 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 checks during your treatment with Dutasteride/Tamsulosin Cinfalab.

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

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

• Women, children, and adolescentsshould avoid contact with broken dutasteride/tamsulosin capsules, 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 dutasteride/tamsulosin. 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 a male baby. Dutasteride causes a decrease in sperm count, motility, and semen volume. This may reduce your fertility.

• Dutasteride/tamsulosin affects the PSA blood test(prostate-specific antigen)used to detect prostate cancer. Your doctor can still use this test to detect prostate cancer, but should be aware of this effect. If you have a blood test to check your PSA, inform your doctor that you are taking Dutasteride/Tamsulosin Cinfalab. Men taking dutasteride/tamsulosin should have regular PSA checks.

• In a clinical study in men at high risk of 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 serious type of prostate cancer is not clear.

• Dutasteride/Tamsulosin Cinfalab may cause breast enlargement and breast tenderness. If this causes you discomfort, or if you notice lumps in your breast or nipple discharge, consult your doctor, as these changes can be signs of a serious disease, 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 group (5-alpha reductase inhibitor) by mouth. If you experience any of these symptoms, contact your doctor for additional medical advice as soon as possible.

If you have any doubts about taking Dutasteride/Tamsulosin Cinfalab, consult your doctor or pharmacist.

Using Dutasteride/Tamsulosin Cinfalab with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might 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 Cinfalab with these medicines:

• ketoconazole(used to treat fungal infections).

Certain medicines may interact with dutasteride/tamsulosin, which can increase the risk of you experiencing side effects. Some of these medicines are:

• PDE5 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 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).

If you are taking any of these medicines, tell your doctor.

Taking Dutasteride/Tamsulosin Cinfalab with food and drinks

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

Pregnancy, breast-feeding, and fertility

Women must not takeDutasteride/Tamsulosin Cinfalab.

Pregnant women (or women who may be pregnant) must avoid contact with broken capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male baby. This risk is especially 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 thinks she may be pregnant, you should avoid exposing her to your semen.

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

If a pregnant woman has been in contact with Dutasteride/Tamsulosin Cinfalab, consult your doctor.

Driving and using machines

Some people may experience dizziness during treatment with dutasteride/tamsulosin, 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 Cinfalab contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this 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 Dutasteride/Tamsulosin Cinfalab

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

If you do not take Dutasteride/Tamsulosin Cinfalab regularly, the control of your PSA levels may be affected. If you are unsure, 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 each day.

How to take it

The capsules should be swallowed whole, with water. Do not chew or open the capsules. Contact with the contents of the capsules can irritate your mouth or throat.

If you take more Dutasteride/Tamsulosin Cinfalab than you should

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

If you forget to take Dutasteride/Tamsulosin Cinfalab

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

Do not stop treatment with Dutasteride/Tamsulosin Cinfalab without advice.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reaction

The symptoms of an allergic reaction can include:

• skin rash(which can itch)
• hives(like nettle rash)
• swelling of the eyelids, face, lips, arms, or legs.

Contact your doctor immediatelyif you experience any of these symptoms and stop taking Dutasteride/Tamsulosin Cinfalab.

Dizziness, lightheadedness, and fainting

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

Severe skin reactions

The signs of severe skin reactions can include:

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

Contact your doctor immediatelyif you have these symptoms and stop using Dutasteride/Tamsulosin Cinfalab.

Common side effects(may affect up to 1 in 10 patients)

• impotence (inability to achieve or maintain an erection)*
• decreased sex drive (libido)*
• difficulty with ejaculation, such as a decrease in the amount of semen released during sex*
• breast enlargement and breast tenderness (gynecomastia)
• dizziness.

• In a small number of people, some of these side effects may continue after stopping Dutasteride/Tamsulosin Cinfalab.

Uncommon side effects(may affect up to 1 in 100 patients)

• heart failure (the heart becomes less efficient at pumping blood around the body. This could cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs)
• reduced blood pressure when standing up
• fast heart rate (palpitations)
• constipation, diarrhea, vomiting, nausea
• weakness or loss of strength
• headache
• itching, stuffy or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually from the body)or excessive hair growth.

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

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

Very rare side effects(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 been reported in a small number of patients, but their frequency is not known (the frequency cannot be estimated from the available data):

• abnormal or fast heart rate (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 problems)
• dry mouth.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister label after EXP. The expiry date is the last day of the month shown.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused capsules to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Dutasterida/Tamsulosina Cinfalab

• The active ingredients are dutasterida and tamsulosina hydrochloride. Each capsule contains 0.5 mg of dutasterida and 0.4 mg of tamsulosina hydrochloride (equivalent to 0.367 mg of tamsulosina).
• The other components are:
• • hard 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).
• Tamsulosina hydrochloride pellets composed of methacrylic acid and ethyl acrylate (1:1) dispersion at 30% containing sodium lauryl sulfate and polysorbate 80 (E-433), microcrystalline cellulose (E-460), Dibutyl sebacate, polysorbate 80 (E-433), hydrated colloidal silica, and calcium stearate.

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

Product Appearance and Container Content

This medication is presented in hard, oblong capsules, size 0, with a brown body and an orange cap, printed with C001 in black ink. Each hard capsule contains a soft dutasterida capsule and modified-release tamsulosina pellets.

It is available in HDPE bottles with a desiccant silica gel plug 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, SA

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 Last Revision of this Prospectus: September 2025

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