Label: information for the patient

Dutasteride/Tamsulosin Aurovitas 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 side effects, consult your doctor or pharmacist even if they are not listed in this label. See section 4.

Dutasterida/tamsulosina 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.

This medication is a combination of two different medications called dutasterida and tamsulosina. Dutasterida belongs to the group of medications called5-alpha reductase inhibitorsand tamsulosina belongs to the 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 flow of urine to be smaller and weaker. If benign prostatic hyperplasia is not treated, there is a risk of the flow of urine 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.

Dutasterida reduces the production of dihydrotestosterone and this helps to reduce the size of the prostate and alleviate symptoms. This reduces the risk of acute urinary retention and the need for surgery. Tamsulosina acts by relaxing the muscles of the prostate, making urination easier and rapidly improving symptoms.

Do not take dutasteride/tamsulosin:

• 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, or any 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 are in any of these situations, do not take this medication until you have consulted with your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication:

•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 had 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.

•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 have taken it 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 reduces sperm count, motility, and semen volume, which may reduce male fertility.

•This medication affects PSA blood tests (prostate-specific antigen) used sometimes 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 this medication. Men taking this medication should have regular PSA checks.

•In a clinical study in men at high risk of developing prostate cancer, men taking dutasteride had a higher frequency of a severe type of prostate cancer than those not taking dutasteride. The effect of dutasteride on this severe type of 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.

• 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 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 adverse effects. Some of these medications are:

•Inhibitors of the PDE5 enzyme (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 (for fungal infections).

•Diclofenac (used to treat pain and inflammation).

• Inform your doctorif you are taking any of these medications.

Taking dutasteride/tamsulosin with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Women should not takedutasteride/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.

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 has been shown to reduce sperm count, motility, and semen volume, which may reduce male 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 this medication, which may affect their ability to drive or operate machinery safely.

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

This medication contains yellow-orange S (E110) colorant and sodium

This medication may cause allergic reactions because it contains yellow-orange S (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medication contains less than 23 mg of sodium (1mmol) per hard capsule; 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 this medication 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 taken 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 dutasterida/tamsulosina 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 Dutasterida/Tamsulosina Aurovitas

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 of Dutasterida/Tamsulosina Aurovitas without consent

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 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

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).

• Contact your doctor immediately if you have these symptoms and stop using this medicine.

Common side effects(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 or pain on palpation (gynecomastia).

•Dizziness.

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

(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).

•Decreased blood pressure when standing.

•Abnormal heart rhythm (palpitations).

•Constipation, diarrhea, vomiting, discomfort (nausea).

•Weakness or loss of strength.

•Headache.

•Itching, congestion, or dripping nasal discharge (rhinitis).

•Skin rash, hives, itching.

•Loss of hair (usually on the body) or hair growth.

Rare side effects(may affect up to 1 in 1,000 men)

•Swelling of the eyelids, face, lips, arms, or legs (angioedema).

•Fainting.

Very rare side effects(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 their frequency is unknown (the frequency cannot be estimated from the available data):

•Abnormal or accelerated heart rhythm (arrhythmia, tachycardia, or atrial fibrillation).

•Difficulty breathing (dyspnea).

•Depression.

•Pain and swelling in the testicles.

• Nasal bleeding.
• 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 the Spanish 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 blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Dutasteride/Tamsulosin Aurovitas

• The active ingredients are dutasteride and tamsulosin hydrochloride. Each hard capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.

• The other components are:

Composition of the hard capsule coating:

Crown:hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), yellow iron oxide (E110), and red iron oxide (E172).

Body: hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), black iron oxide (E172), and red iron oxide (E172).

Content of dutasteride soft capsule:

Monocaprilocaprato of glycerol (Type-I) and butylhydroxytoluene (E321).

Coating of the soft capsule:gelatin (160 bloom), glycerol, titanium dioxide (E171), and yellow iron oxide (E172).

Tamsulosin hydrochloride pellets:microcrystalline cellulose (Grade-101), talc, copolymer of methyl acrylate and ethyl acrylate (1:1) dispersion 30 percent (contains 0.7 % of sodium lauryl sulfate and 2.3 % of polysorbate 80), triacetin, and calcium stearate.

Black ink:shellac (E904), black iron oxide (E172), and potassium hydroxide.

Appearance of the product and contents of the package

Hard capsules, size “00”, with opaque orange-colored crown marked with “DTT” in black ink and opaque brown-colored body marked with “0.5/0.4” in black ink. The size is approximately 23.5 mm.

Each capsule contains a dutasteride soft capsule, oblong, gelatinous, opaque, yellowish in color that contains a clear, colorless to pale yellowish viscous oil and tamsulosin hydrochloride pellets, white to off-white in color.

Dutasteride/Tamsulosin Aurovitas is available in blister packs and HDPE bottles.

Package sizes:

Blister pack:7, 30, 50, and 90 hard capsules.

HDPE bottle:30, 90, and 500 hard capsules.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

Germany:Dutasterid/Tamsulosin PUREN 0.5 mg/0.4 mg Hartkapseln

Belgium:Dutasteride/Tamsulosine HCl AB 0.5 mg/0.4 mg, harde capsules

Spain:Dutasterida/Tamsulosina Aurovitas 0.5 mg/0.4 mg cápsulas duras EFG

France:Dutastéride/Tamsulosine Arrow 0.5 mg/0.4 mg, gélule

Czech Republic:Dutasterid/Tamsulosin Aurovitas

Netherlands:Dutasteride/Tamsulosine HCl Aurobindo 0.5/0.4 mg, harde capsules

Portugal:Dutasterida + Tansulosina Aurovitas

Romania:Dutasterida/Tamsulosin Aurobindo 0.5 mg/0.4 mg capsule

Date of the last review of this leaflet:June 2019

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)