Package Insert: Information for the Patient

Dutamsin 0.5 mg/0.4 mg Hard Capsules

Dutasteride/Hydrochloride of Tamsulosin

Read this entire 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 refer to 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 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 package insert. See section 4.

1. What is Dutamsin and how is it used

2. What you need to know before starting to take Dutamsin

3. How to take Dutamsin.

4. Possible adverse effects

5. Storage of Dutamsin.

6. Contents of the package and additional information

Dutamsin 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, in patients already controlled with dutasteride and tamsulosin administered at the same time.

Dutamsin is a combination of two different medications called dutasteride and tamsulosin. Dutasteride belongs to the group of medications known as5-alpha reductase inhibitorsand tamsulosin belongs to the group of medications known asalpha blockers.

As the prostate grows in size, it can produce urinary problems such as difficulty in the flow of urine 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 to 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 takeDutamsin:

- if you are allergic(hypersensitive)to dutasteride,to other5-alpha reductase inhibitors, to tamsulosin, to soy, peanutsorto any of the other components of this medication(listed in section 6).

-if you experience dizziness due to a decrease in blood pressure when changing position (orthostatic hypotension).

-if you have anyserious liver disease..

-if you arewoman, child or adolescent.

Consult your doctorif you think you are in any of these situations.

This medication is only for men. It should not be taken by women, children or adolescents.

Warnings and precautions

Consult your doctor before starting to take this medication.

• In some clinical studies, the number of patients who experienced heart failure was higher in those who took dutasteride and another medication called an alpha blocker, such as tamsulosin, than in those who took only dutasteride or only an alpha blocker. Heart failure means that your heart is not pumping blood as it should.

• if you have liver problems. If you have any disease that affects your liver, you may need some additional review during your treatment with this medication.

• Inform your doctor if you have kidney problems.

• If you are going to have cataract surgery, inform your eye doctor that you are taking or have previously taken Dutamsin or tamsulosin. Your eye doctor will need to take the necessary precautions to avoid complications during the surgery.

• Women, children and adolescentsshould avoid contact with broken capsules of this medication, 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.

• This medication affects the PSA blood test(prostate-specific antigen) that is sometimes used to detect prostate cancer.Your doctor may still use this test to detect prostate cancer, but he or she should be aware of this effect. If you have a blood test to determine your PSA, inform your doctor that you are taking this medication. Men taking this medication should have regular PSA checks.

• In a clinical study conducted in men at high risk of developing prostate cancer, men who took dutasteride had a higher frequency of a type of severe prostate cancerthan those who did not take dutasteride. The effect of dutasteride on this type of severe prostate cancer is unclear.

• This medication 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 male breast cancer.

Use of Dutamsin with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication. This includes any medication purchased without a prescription.

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:

• PDE5 inhibitors(used to achieve or maintain an erection) such as vardenafil, sildenafil citrate and tadalafil
• verapamilor 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 clotting)
• erythromycin(an antibiotic used to treat infections) in combination withparoxetine(an antidepressant) or in combination withterbinafine(used to treat fungal infections)
• terbinafine (for fungal infections)
• diclofenac(used to treat pain and inflammation).

Inform your doctorif you are taking any of these medications.

Taking Dutamsin with food and drinks

You should take this medication 30 minutes after the same meal every day.

Pregnancy, breastfeeding and fertility

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 takingdutasteride/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 male fertility.

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

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

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

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

Dutamsin contains soy lecithin and propylene glycol.

This medication contains soy lecithin, which may contain soy oil. It should not be used in case of allergy to peanuts or soy.

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

This medication contains 299 mg of propylene glycol in each capsule.

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 Dutamsin regularly, the control of your PSA levels may be affected.

What dose to take

The recommended dose is one capsule once a day, 30 minutes after the same meal every day.

How to take it

The capsules must 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 Dutamsin 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 Dutamsin

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

Do not interrupt Dutamsin treatment

Do not interrupt treatment with this medication 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 andstop takingthis medicine.

Dizziness, lightheadedness, and fainting

This medicine 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)s

Contact your doctor immediatelyif you have these symptoms andstop using this medicine.

Common side effects (may affect more than 1 in 10 people)

• impotence(inability to achieve or maintain an erection)*
• decreased libido(sex drive)decreased*
• difficulty with ejaculation*
• 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 this medicine.

(may affect up to 1 in 100 people)

• heart failure (the heart becomes less efficient at pumping blood around the body. This could cause symptoms such as difficulty breathing, excessive tiredness, and inflammation in the ankles and legs)
• reduction in blood pressure when standing up
• abnormal heart rhythm (palpitations)
• constipation, diarrhea, vomiting, discomfort (nausea)
• weakness or loss of strength
• headache
• itching, congestion, or discharge (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 people)

• sudden local swelling of soft body tissues (e.g., the throat or tongue), difficulty breathing, and/or itching and rash, often as an allergic reaction (angioedema)desfallecimiento

Very rare side effects (may affect up to 1 in 10,000 people)

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

Other side effects

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

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 the 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 in the bottle. The expiration date is the last day of the month indicated.

Store below 25°C.

The product must be used within 90 days after opening.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.

Dutamsin Composition

The active ingredients are dutasteride and tamsulosin hydrochloride.Each capsule contains0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.

The other components are:

Durable capsule coating:

Iron oxide black (E172)

Iron oxide red (E172)

Titanium dioxide (E171)

Iron oxide yellow (E172)

Gelatin

Dutasteride soft capsule::

Soft capsule content:

Propylene glycol monocaprylate, type IIButylhydroxytoluene (E321)

Soft capsule coating:

Gelatin

Glycerol

Titanium dioxide (E171)

Tamsulosin pellets:

Acrylic acid-methyl methacrylate copolymer (1:1) dispersion 30 percent (also contains polysorbate 80 and sodium lauryl sulfate)

Microcrystalline cellulose

Dibutyl sebacate

Polysorbate 80

Hydrated colloidal silica

Calcium stearate

Tint: black

Shellac

Iron oxide black (E172)

Propylene glycol

Concentrated ammonia solution

Potassium hydroxide

Product appearance and packaging content

This medication is presented indurable, oblong capsules, number 0EL, with a brown body and beige cap, printed with C001 in black ink.

It is available in packaging of 7, 30, and 90 capsules.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Exeltis Healthcare, S.L.

Avenida Miralcampo 7,

19200 Azuqueca de Henares

Guadalajara

Spain

Manufacturer:

Laboratorios LEÓN FARMA, SA

Navatejera Industrial Estate

C/La Vallina, s/n

24193 Villaquilambre - León

Spain

or

GENERICON PHARMA GMBH

Hafnerstrasse, 211 - Graz-Austria - A-8054 - Austria

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

Netherlands: Dutasteride/Tamsulosine HCl 0.5 mg/0.4 mg Focus, hard capsules

Portugal: Sarix 0.5 mg + 0.4 mg capsules

Austria: Du Tamsul 0.5/0.4 mg Hartkapseln

Last review date of this leaflet:May 2023

For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es