Label: Information for the Patient

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

Dutasteride/Hydrochloride of Tamsulosin

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others who 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 are not listed in this label. See section 4.

Dutasterida/Tamsulosina Cinfalab is 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 Cinfalabis 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 Cinfalab

• if you are awoman(because this medication is only for men)
• if you are achild or adolescent under 18 years of age
• if you are allergic to dutasteride,to other5-alpha reductase inhibitors, to tamsulosin,to soy, peanutsor to any of the other components of this medication (listed in section 6)
• if you havelow blood pressure, which makes you feel dizzy, lightheaded, or faint (orthostatic hypotension)
• if you have anyserious liver disease.
• This medication contains traces of soy oil. Do not use it in case of allergy to peanuts or soy.

??If you think you have any of these situations, do not take this medication until you have consulted with your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dutasterida/Tamsulosina Cinfalab.

• 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 disease that affects your liver, you may need some additional review during your treatment with Dutasterida/Tamsulosina Cinfalab.

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

• Cataract surgery (opaque crystalline lens).If you are going to have cataract surgery, your doctor may ask you to stop taking dutasteride/tamsulosin for a while before the surgery. Before the surgery, inform your ophthalmologist that you are taking dutasteride/tamsulosin or have taken it 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/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 the male fetus. Dutasteride causes a decrease in sperm count, motility, and semen volume. This may reduce your fertility.

• Dutasteride/Tamsulosin affects the PSA blood test (prostatic specific antigen)(prostatic specific antigen) that is sometimes used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, although he should know about this effect. If you have a blood test to determine your PSA, inform your doctor that you are taking Dutasterida/Tamsulosina Cinfalab.Men taking dutasteride/tamsulosin should have regular PSA checks..

• In a clinical study conducted in men at high risk of developing prostate cancer, men who took dutasteride presented withmore frequently a severe type of prostate cancercompared 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.If this causes you discomfort, or if you notice lumps in your breast or nipple discharge, 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 doubts related to taking Dutasterida/Tamsulosina Cinfalab.

Use of Dutasterida/Tamsulosina Cinfalab 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/tamsulosin with these medications:

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

Do not recommend taking Dutasterida/Tamsulosina Cinfalab with these medications:

• ketoconazole(used to treat fungal infections).

Certain medications may interact with dutasteride/tamsulosin, 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/AIDS)
• itraconazole or ketoconazole(for fungal infections)
• nefazodone(an antidepressant)
• cimetidine(for stomach ulcers)
• warfarin(for blood coagulation)
• 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 Dutasterida/Tamsulosina Cinfalab with food and drinks

You should take Dutasterida/Tamsulosina Cinfalab 30 minutes after the same meal every day.

Pregnancy, breastfeeding, and fertility

Women should not takeDutasterida/Tamsulosina Cinfalab.

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 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 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 Dutasterida/Tamsulosina Cinfalab.

Driving and operating machinery

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

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

Dutasterida/Tamsulosina Cinfalab contains sodium.

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

Dutasterida/Tamsulosina Cinfalab contains propylene glycol.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

If you do not take Dutasterida/Tamsulosina Cinfalab regularly, the control of your PSA levels 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,30 minutes 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 Cinfalab 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 Cinfalab

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

Do not interrupt the treatment of Dutasterida/Tamsulosina Cinfalab without advice.

Do not interrupt the treatment with Dutasterida/Tamsulosina Cinfalab without 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 may cause side effects, although not everyone will experience them.

Allergic reaction

The symptoms of an allergic reaction may include:

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

??Contact your doctor immediatelyif you experience any of these symptoms and stop taking Dutasterida/Tamsulosina Cinfalab.

Dizziness, lightheadedness, and fainting

Dutasterida/Tamsulosina Cinfalab may cause dizziness, lightheadedness, and in rare cases, fainting. You should be cautious 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 Dutasterida/Tamsulosina Cinfalab.

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

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

*In a small number of people, some of these side effects may continue after stopping Dutasterida/Tamsulosina Cinfalab.

(may affect up to 1 in 100 patients)

• failing heart (the heart becomes less efficient at pumping blood throughout the body. This could cause symptoms such as difficulty breathing, excessive fatigue, and inflammation in the ankles and legs)
• reduced blood pressure when standing up
• rapid heartbeat (palpitations)
• constipation, diarrhea, vomiting, discomfort (nausea)
• weakness or loss of strength
• headache
• itching, congestion, or dripping nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually on the body) or 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 reduced number of patients, but the exact frequency is unknown (the frequency cannot be estimated from the available data):

• abnormal or rapid heartbeat (arrhythmia or tachycardia or atrial fibrillation)
• difficulty breathing (shortness of breath)
• depression
• testicular pain and swelling
• nasal bleeding
• severe skin rash
• changes in vision (blurred vision or visual problems)
• dry mouth.

Reporting of 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 Vigilance of Medicinal Products 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 packaging and on the bottle label after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. The product must be used within 90 days after opening.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines 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 medicines you no longer need. By doing so, you will help protect the environment.

Dutasteride/Tamsulosin Cinfalab Composition

• The active principles are dutasteride and tamsulosin hydrochloride.Cada cápsula contiene0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride (equivalent to 0.367 mg of tamsulosin).
• The other components are:
• • Hard capsule coating: iron oxide black (E-172), iron oxide red (E-172), iron oxide yellow (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) 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, calcium stearate.

Product Appearance and Packaging Contents

This medication is presented in hard, oblong, brown-colored capsules with orange caps, marked with C001 in black ink. Each hard capsule contains a soft gelatin capsule of dutasteride and modified-release pellets of tamsulosin.

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

30 hard capsules in a 100 ml bottle.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible Manufacturer

LEÓN FARMA, SA Laboratories

Navatejera Industrial Estate

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

Spain

or

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last Review Date of this Leaflet:April 2020

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)