Package Insert: Information for the Patient

dutasteride/tamsulosin cinfa 0.5 mg / 0.4 mg hard capsules EFG

dutasteride/hydrochloride of tamsulosin

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for 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 package insert. See section 4.

dutasteride/tamsulosin cinfa 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.

Dutasteride/tamsulosin is 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 weaker. 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 dutasteride/tamsulosin cinfa:

• if you are a woman (because this medication is only for men)
• if you are a child or adolescent under 18 years of age
• if you are allergic to dutasteride, other 5-alpha reductase inhibitors, tamsulosin, soy, peanuts, or any of the other components of this medication (listed in section 6)
• this medication contains lecithin that may contain soy oil. Do not use in case of allergy to peanuts or soy
• if you have low blood pressure, which makes you feel dizzy, lightheaded, or faint (orthostatic hypotension)
• if you have a severe liver disease

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 dutasteride/tamsulosin cinfa.

• In some clinical studies, there was a higher number of 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 additional monitoring during your treatment with dutasteride/tamsulosin.

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

• Surgery for cataracts (opaque 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 tamsulosin (or if you have taken them before). Your specialist will need to take the necessary precautions to avoid complications during the surgery.

• Women, children, and adolescents should 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 immediately with 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 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 (prostate-specific antigen) used sometimes to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but they should be aware of this effect. If you have a blood test to determine 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 presented with more frequent severe prostate cancer than those not taking dutasteride. The effect of dutasteride on this type of severe prostate cancer is unclear.

• 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 pharmacist if you have any doubts related to taking dutasteride/tamsulosin.

Other medications and dutasteride/tamsulosin cinfa

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

Do not take dutasteride/tamsulosin with these medications:

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

Do not take dutasteride/tamsulosin 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)
• 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 doctor if you are taking any of these medications.

Taking dutasteride/tamsulosin cinfa with food and drinks

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

Pregnancy, breastfeeding, and fertility

Women should not take dutasteride/tamsulosin.

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.

Consult your doctor if a pregnant woman has come into contact with dutasteride/tamsulosin.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride/tamsulosin. If your partner is pregnant or 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.

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 machinery if you are affected in this way.

dutasteride/tamsulosin cinfa contains yellow orange S (E-110).

This medication may cause allergic reactions because it contains yellow orange S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

dutasteride/tamsulosin cinfa contains sodium.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If you do not take dutasteride/tamsulosin 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 dutasteride/tamsulosin cinfa 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 dutasteride/tamsulosin cinfa

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

If you interrupt the treatment with dutasteride/tamsulosin cinfa

Do not interrupt the treatment with dutasteride/tamsulosin 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 can 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 andstop takingdutasteride/tamsulosin.

Dizziness, lightheadedness, and fainting

Dutasteride/tamsulosinmay cause dizziness, lightheadedness, and in rare cases, fainting. 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 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 usingdutasteride/tamsulosin.

Common side effects

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

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

*In a small number of people, some of these adverse events may continue after stopping dutasteride/tamsulosin.

These may affect up to 1 in 100 patients:

• heart failure (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
• abnormal heart rhythm (arrhythmia or tachycardia or atrial fibrillation)
• constipation, diarrhea, vomiting, discomfort (nausea)
• weakness or loss of strength
• headache
• itching, nasal congestion or discharge (rhinitis)
• skin rash, hives, itching
• hair loss (usually on the body) or hair growth.

Rare side 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 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 their exact frequency cannot be estimated (the frequency cannot be estimated from the available data):

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

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directlyto theSpanish System for the Pharmacovigilance 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 appearson the packaging or bottle after CAD. The expiration date is the last day of the month indicated.

For HPDE bottles, do not use more than 6 weeks for the 30 capsule packaging and more than 18 weeks for the 90 capsule packaging, after the first opening.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy.In case of doubt, please ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofdutasteride/tamsulosin cinfa

• The active ingredients are dutasteride and hydrochloride of tamsulosin. Each hard capsule contains0.5 mg of dutasteride and 0.4 mg of hydrochloride of tamsulosin (equivalent to 0.367 mg of tamsulosin).

• The other components (excipients) are:

• hard capsule coating: hypromellose, carrageenan (E-407), potassium chloride, titanium dioxide (E-171), iron oxide red (E-172) and yellow-orange S (E-110).

• soft capsule content: monocaprilocaprate of glycerol, butylhydroxytoluene (E-321).

soft capsule coating: gelatin, glycerol, titanium dioxide (E-171), iron oxide yellow (E-172), medium-chain triglycerides, lecithin (may contain soy oil) (E-322).

tamsulosin pellets: microcrystalline cellulose, copolymer of methylacrylic acid and ethyl acrylate (1:1) dispersion 30%, copolymer of methacrylic acid and ethyl acrylate (1:1), magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E-171).

Appearance of the product and contents of the package

The medicine is presented in hard, oblong capsules with a brown body and an orange cap.

Each hard capsule contains modified-release pellets of hydrochloride of tamsulosin and a soft gelatin capsule with dutasteride.

It is available inhigh-density polyethylene (HDPE) bottles and in aluminum-aluminum blisters containing7, 30 and 90 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible manufacturer

SAG MANUFACTURING, S.L.U.

Km 36 National Highway

28750 San Agustín de Guadalix, Madrid (Spain)

or

Galenicum Health S.L.U.

Sant Gabriel Street, 50, Esplugues de Llobregat, 08950, Barcelona (Spain)

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Dutasteride/Tamsulosin Cinfa 0.5 mg/0.4 mg hard capsules EFG- Spain

Last review date of this leaflet:December 2021

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/84641/P_84641.html

QR code to:https://cima.aemps.es/cima/dochtml/p/84641/P_84641.html