DUTASTERIDE/TAMSULOSIN TEVA 0.5 mg/0.4 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dutasteride/Tamsulosin Teva 0.5 mg/0.4 mg hard capsules

Dutasteride/Tamsulosin Hydrochloride

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

1. What is Dutasteride/Tamsulosin Teva and what is it used for

Dutasteride/Tamsulosin Teva is used in men to treat an 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.

Dutasteride/Tamsulosin Teva 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 stream of urine to be weaker and less forceful. If benign prostatic hyperplasia is not treated, there is a risk that the flow of urine will be 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 relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery. Tamsulosin works by relaxing the muscles in the prostate, making it easier to urinate and quickly improving symptoms.

2. What you need to know before you take Dutasteride/Tamsulosin Teva

Do not take Dutasteride/Tamsulosin Teva:

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

Consult your doctorif you think you may be in any of these situations.

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

Warnings and precautions

Consult your doctor before starting treatment with 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 dutasteride alone or an alpha blocker alone. 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 this medicine. Your ophthalmologist will need to take appropriate precautions to avoid complications during surgery.

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

• This medicine affects the blood test for PSA (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 must have regular PSA checks.

• In a clinical study in men at high risk of prostate cancer, men who took dutasteride more frequently had a serious type of prostate cancerthan those who did not take dutasteride. The effect of dutasteride on this serious type of prostate cancer is not clear.

• This medicine 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 can be signs of a serious disease, such as male breast cancer.

Using Dutasteride/Tamsulosin Teva 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 may increase the risk of you experiencing side effects. Some of these medicines are:

• PDE5 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 clotting)
• 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 Dutasteride/Tamsulosin Teva with food and drinks

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

Pregnancy, breast-feeding, and fertility

The use of Dutasteride/Tamsulosin Teva is contraindicated in women.

Pregnant women (or women who may be pregnant) must avoid contact with the contents of the capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male baby. 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 must 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 come into contact with dutasteride/tamsulosin.

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.

Dutasteride/Tamsulosin Teva contains soybean lecithin and propylene glycol.

This medicine contains soybean lecithin, which may contain soybean oil. It must not be used in case of peanut or soy allergy.

This medicine contains 299 mg of propylene glycol per capsule.

Dutasteride/Tamsulosin Teva contains sodium

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

3. How to take Dutasteride/Tamsulosin Teva

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

If you do not take Dutasteride/Tamsulosin Teva regularly, 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 Dutasteride/Tamsulosin Teva 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 Dutasteride/Tamsulosin Teva

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

Do not stop treatment with Dutasteride/Tamsulosin Teva

Do not stop treatment with this medicine without consulting your doctor first.

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

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, dizziness, and fainting

This medicine can cause dizziness, dizziness, 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 dizziness during treatment, sit or lie down until these symptoms have disappeared.

Severe skin reactions

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 libido (sex drive)*
• difficulty ejaculating*
• breast enlargement and tenderness (gynecomastia)
• dizziness

*In a small number of people, some of these adverse events may continue after stopping treatment with 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 cause 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 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., throat or tongue), difficulty breathing, and/or often as an allergic reaction (angioedema)
• fainting

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

testicular pain and swelling

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride/Tamsulosin Teva

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 after EXP. The expiry date refers to the last day of that month.

Store Dutasteride/Tamsulosin Teva below 25°C.

The product must 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. Container Contents and Additional Information

Composition of Dutasteride/Tamsulosin Teva

The active ingredients 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 of dutasteride:

Contents of the soft capsule:

Glycerol monocaprylate

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

Hydrated colloidal silica

Calcium stearate

Black ink:

Shellac

Black iron oxide (E172)

Propylene glycol

Concentrated ammonia solution

Potassium hydroxide

Appearance of the Product and Container Contents

This medicinal product is presented in hard, oblong capsules, 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.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva B.V.

Swensweg 5, Haarlem

2031 GA

Netherlands

You can request more information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11

Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Laboratorios LEÓN FARMA, SA

C/La Vallina, s/n - Polígono Industrial Navatejera

24193 Villaquilambre (León)

Spain

G.L.Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain Dutasteride/Tamsulosin Teva 0.5 mg/0.4 mg hard capsules

Poland Adatam Duo

Estonia Dutamsin

Latvia Dutamsin 0.5 mg/0.4 mg hard capsules

Bulgaria Aglandin comp

Austria Dutaglandin comp. 0.5 mg/0.4 mg-Hartkapseln

Date of the Last Revision of this Leaflet:May 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es