DUTAMSIN 0.5 mg/0.4 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dutamsin 0.5 mg/0.4 mg Hard Capsules

Dutasteride/Hydrochloride Tamsulosin

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

1. What is Dutamsin and what is it used for

Dutamsin is used in men to treat enlarged prostate (Benign Prostatic Hyperplasia)- a non-cancerous growth of the prostate caused by overproduction 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 medicines called dutasteride and tamsulosin. Dutasteride belongs to a group of medicines called 5-alpha reductase enzyme 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 urine stream to be weaker and less forceful. If left untreated, benign prostatic hyperplasia can lead to 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 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 quickly improving symptoms.

2. What you need to know before you take Dutamsin

Do not take Dutamsin:

• if you are allergic (hypersensitive)to dutasteride, to other 5-alpha reductase enzyme inhibitors, to tamsulosin, to soy, peanuts, or to any of the other ingredients of this medicine (listed in section 6).
• if you have fainting spells due to low blood pressure when changing posture (orthostatic hypotension).
• if you have severe liver disease.
• if you are a woman, child, or adolescent.

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

This medicine 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 medicine.

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

• Tell your doctor if you have kidney problems.

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

• Women, children, and adolescents must avoid contactwith the broken capsules of this medicine, as the active ingredient can be absorbed through the skin. If there is any contact with the skin, the affected area must 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, she should avoid exposure to your semen, as dutasteride may affect the normal development of a male fetus. Dutasteride causes a decrease in sperm count, motility, and semen volume. This may reduce male fertility.

• This medicine affects the PSA blood test (Prostate-Specific Antigen)used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, although they should be aware of this effect. If you have a blood test to determine your PSA, inform your doctor that you are taking this medicine. Men taking this medicine 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 serious type of prostate cancer than those who did not take dutasteride. The effect of dutasteride on this serious type of prostate cancer is unclear.

• This medicine may cause breast enlargement and tenderness. If this causes you discomfort, or if you notice lumps in the breast or nipple discharge, consult your doctor, as these changes can be signs of a serious disease, such as male breast cancer.

Using Dutamsin with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This includes any medicines bought without a prescription.

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 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 enzyme 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)in combination with paroxetine(an antidepressant)or in combination with terbinafine(used to treat fungal infections)
• terbinafine (for fungal infections)
• diclofenac (used to treat pain and inflammation)

Tell your doctorif you are taking any of these medicines.

Taking Dutamsin with food and drinks

You should take this medicine 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

Pregnant women (or those who may be pregnant) should avoid contact with the broken capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male fetus. 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, she should avoid exposure 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 are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Some people may experience dizziness during treatment with this medicine, which may affect their 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 medicine contains soy lecithin, which may contain soybean oil. It should not be used in case of peanut or soy allergy.

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

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

3. How to take Dutamsin

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

If you do not take Dutamsin regularly, the control of your PSA levels may be affected.

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 Dutamsin 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 ingested.

If you forget to take Dutamsin

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

Do not stop taking Dutamsin

Do not stop taking this medicine without consulting your doctor first.

If you have any further questions on the use of this product, 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 this medicine.

Dizziness, fainting, and fainting spells

This medicine can cause dizziness, fainting, and, in rare cases, fainting spells. 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 faint 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 this medicine.

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

• impotence (inability to achieve or maintain an erection)*
• decreased sex drive (libido)*
• difficulty ejaculating*
• breast enlargement and tenderness (gynaecomastia)
• dizziness

*In a small number of people, some of these adverse events may continue after stopping this medicine.

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

• heart failure (the heart becomes less efficient at pumping blood through the body. This could lead to symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs)
• reduced blood pressure when standing up
• rapid heartbeat (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 people)

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

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

Frequency cannot be estimated from the available data:

• abnormal or rapid heartbeat (arrhythmia or tachycardia or atrial fibrillation)
• difficulty breathing (dyspnea)
• depression
• pain and swelling in the testicles

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS)website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutamsin

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. The expiry date refers to the last day of the month shown.

Store below 25°C.

The product should be used within 90 days of opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Dutamsin

The active substances are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.

The other ingredients are:

Hard capsule shell:

Black iron oxide (E172)

Red iron oxide (E172)

Titanium dioxide (E171)

Yellow iron oxide (E172)

Gelatin

Soft capsule shell:

Contents of the soft capsule shell:

Propylene glycol monicaprylate, type II, Butylhydroxytoluene (E321)

Soft capsule shell:

Gelatin

Glycerol

Titanium dioxide (E171)

Tamsulosin pellets:

Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 percent (also contains polysorbate 80 and sodium lauryl sulfate)

Microcrystalline cellulose

Dibutyl sebacate

Polysorbate 80

Silica, colloidal anhydrous

Calcium stearate

Black ink:

Shellac

Black iron oxide (E172)

Propylene glycol

Concentrated ammonia solution

Potassium hydroxide

Appearance of the product and pack contents

This medicine is presented in hard capsules, oblong, size 0EL, with a brown body and a beige cap, printed with C001 in black ink.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Exeltis Healthcare, S.L.

Miralcampo Avenue 7,

19200 Azuqueca de Henares

Guadalajara

Spain

Manufacturer:

Laboratorios LEÓN FARMA, SA

Navatejera Industrial Estate

La Vallina, s/n

24193 Villaquilambre - León

Spain

or

GENERICON PHARMA GMBH

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

This medicine is authorised in the Member States of the European Economic Area under 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

Date of last revision of this leaflet:May 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS): http://www.aemps.gob.es