Label: information for the patient

Dutasteride/Tamsulosin ratio 0.5 mg/0.4 mg hard EFG capsules

Dutasteride/hydrochloride of tamsulosin

Read this label carefully before starting to take this medicine, 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 medicine has been prescribed only for you, and you should not give it to others 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 they are not listed in this label. See section 4.

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

Dutasteride/Tamsulosinis a combination of two different medications called dutasteride and tamsulosin. Dutasteride belongs to a group of medications called 5-alpha reductase inhibitorsand tamsulosin belongs to a group of medications called alpha blockers.

As the prostate enlarges, it can produce urinary problems such as difficulty in urinating and a need to urinate more frequently. It can also cause a smaller and weaker urine stream. If benign prostatic hyperplasia is not treated, there is a risk of complete urine flow blockage (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 dihydrotestosterone production, which helps to reduce prostate size and alleviate symptoms. This reduces the risk of acute urinary retention and the need for surgery. Tamsulosin acts by relaxing prostate muscles, making urination easier and rapidly improving symptoms.

Do not takeDutasteride/Tamsulosin ratio:

-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, orany of the other components of this medication(listed in section 6)

-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 takethis medication until you have consulted with your doctor.

Warnings and precautions

Consult your doctor before starting to take dutasteride/tamsulosin.

• 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 liver disease, you may need additional monitoring during your treatment with dutasteride/tamsulosin.

• 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 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 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 (prostate-specific antigen) blood test that is sometimes used to detect prostate cancer.Your doctor may still use this test to detect prostate cancer, but they should know about 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 who took dutasteride presented with prostate cancer more frequently than those who did not take 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.

Use of dutasteride/tamsulosin 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 take dutasteride/tamsulosin with these medications:

• ketoconazole (used to treat fungal infections).

Certain medications may interact with dutasteride/tamsulosin ratio, 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 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 ratio.

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

Consult your doctor if a pregnant woman has been in contact with dutasteride/tamsulosin.

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 ratio contains lecithin from soy

This medication contains lecithin from soy. Do not use it in case of allergy to peanuts or soy.

Dutasteride/Tamsulosin ratio contains propylene glycol

This medication contains 299.46 mg of propylene glycol monocaprylate, type II in each capsule (equivalent to more than 1 mg/kg/day, but less than 50 mg/kg/day of propylene glycol) and traces of propylene glycol in the black ink.

Dutasteride/Tamsulosin ratio contains sodium

This medication contains less than 23 mg of sodium (1 mmol) 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 takedutasterida/tamsulosinaregularly, 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 moredutasterida/tamsulosinathan 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 takedutasterida/tamsulosina

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 ofdutasterida/tamsulosinawithout advice

Do not interrupt the treatment withdutasterida/tamsulosinawithout 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 immediately if you experience any of these symptoms and stop taking this medicine.

Dizziness, lightheadedness, and fainting

Dutasteride/tamsulosin may 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 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 immediately if you have these symptoms and stop using this medicine.

Common side effects

These may affect up to 1 in 10 men:

• impotence(inability to achieve or maintain an erection)*
• decreased libido*
• 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 adverse events may continue after stopping this medicine.

These may affect up to 1 in 100 men:

• 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 up
• 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 men:

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

Very rare side effects

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

• 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 men but the exact frequency is unknown (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
• nosebleed
• 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 theSpanish System for Pharmacovigilance of Medicines 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 after CAD. The expiration date is the last day of the month indicated.

Store below 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 point at the pharmacy. If in doubt, 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 ratio

The active ingredients are dutasteride and hydrochloride of tamsulosin.Each capsule contains0.5 mg of dutasteride (in a soft capsule) and 0.4 mg of hydrochloride of tamsulosin (as modified-release pellets).

The other components are:

Hard capsule shell:

Iron oxide black (E172)

Iron oxide red (E172)

Titanium dioxide (E171)

Iron oxide yellow (E172)

Gelatin

Black ink (shellac, iron oxide black (E172), propylene glycol, ammonium solution, concentrated potassium hydroxide.

Soft capsule content of dutasteride:

Propylene glycol monocaprylate, type II (see section 2 “Dutasteride / Tamsulosin ratio contains propylene glycol”)

Butylhydroxytoluene (E321)

Gelatin

Glycerol

Titanium dioxide (E171)

Triglycerides (medium chain)

Lecithin (may contain soy oil) (see section 2 “Dutasteride / Tamsulosin ratio contains soy lecithin”)

Content of tamsulosin pellets:

Acrylate/methacrylate copolymer (1:1) dispersion 30 percent (contains sodium lauryl sulfate and polysorbate 80,see section 2 “Dutasteride / Tamsulosin ratio contains sodium”)

Microcrystalline cellulose

Dibutyl sebacate

Polysorbate 80

Colloidal hydrated silica

Calcium stearate

Appearance of the product and contents of the package

This medicine is presented inhard, oblong capsules with a brown body and beige cap printed with C001 in black ink of approximately 24 mm in length.

Package sizes:

HDPE bottles: 7, 30, 90, and 180 (2 bottles of 90) capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11

Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible manufacturer:

Laboratorios LEON FARMA, S.A.

Navatejera Industrial Estate

C/ La Vallina, s/n 24193 Navatejera – León

Spain

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

Netherlands:Dutasteride/Tamsulosinehydrochloride Teva 0.5 mg/0.4 mg, hard capsules

Spain:Dutasterida/Tamsulosina ratio 0.5 mg/0.4 mg hard capsules EFG

Portugal:Dutasterida + Tansulosina ratiopharm

Last review date of this leaflet:July 2019

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