Dutasteride/tamsulosin Aurovitas 0.5 mg/0.4 mg hard capsules EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

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

Dutasteride/tamsulosin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Dutasteride/Tamsulosin Aurovitas is and what it is used for
2. What you need to know before taking Dutasteride/Tamsulosin Aurovitas
3. How to take Dutasteride/Tamsulosin Aurovitas
4. Possible adverse effects
5. How to store Dutasteride/Tamsulosin Aurovitas
6. Contents of the pack and other information

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

Dutasteride/tamsulosin is used in men to treat enlarged prostate (benign prostatic hyperplasia) – a non-cancerous enlargement of the prostate caused by overproduction of a hormone called dihydrotestosterone.

This medicine is a combination of two different medicines called dutasteride and tamsulosin. Dutasteride belongs to a group of medicines known as 5-alpha reductase inhibitors, and tamsulosin belongs to a group of medicines known as alpha-blockers.

As the prostate enlarges, it may cause urinary problems such as difficulty in passing urine and increased need to urinate. It may also cause the urine flow to become weaker and less forceful. If benign prostatic hyperplasia is not treated, there is a risk that urine flow may become completely blocked (acute urinary retention), which requires immediate medical treatment. In some cases, surgery may be needed to reduce the size of the prostate or to remove it.

Dutasteride reduces the production of dihydrotestosterone, helping to shrink 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 urination easier and rapidly improving symptoms.

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

Do not take dutasteride/tamsulosin:

• If you are a woman (because this medicine is only for men).

• If you are a child or adolescent under 18 years of age.

• If you are allergic to dutasteride, to other 5-alpha reductase enzyme inhibitors, to tamsulosin, or to any of the other ingredients of this medicine (listed in section 6).

• If you have low blood pressure, which makes you feel dizzy, lightheaded, or causes fainting (orthostatic hypotension).

• If you have severe liver disease.

• If you think you fall into any of these categories, do not take this medicine until you have consulted your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking this medicine:

• In some clinical studies, there were more patients taking dutasteride and another medicine 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 does not pump blood properly.

• Make sure your doctor knows if you have liver problems. If you have had any illness affecting your liver, you may need additional monitoring during treatment with dutasteride/tamsulosin.

• Make sure your doctor knows if you have severe kidney problems.

• Cataract surgery (cloudy lens). If you are scheduled for cataract surgery, your doctor may ask you to stop taking dutasteride/tamsulosin for a period of time before the procedure. Before the surgery, inform your ophthalmologist that you are taking dutasteride/tamsulosin or tamsulosin (or have taken them previously). Your specialist will need to take appropriate precautions to avoid complications during surgery.

• Women, children, and adolescents must avoid contact with broken capsules of dutasteride/tamsulosin, as the active ingredient can be absorbed through the skin. If any contact with the skin occurs, the affected area should be washed immediately with soap and water.

• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride/tamsulosin. If your partner is pregnant or suspects she might be pregnant, you must avoid exposing her to your semen, as dutasteride may affect the normal development of a male baby. Dutasteride causes a decrease in sperm count, sperm motility, and semen volume. This may reduce your fertility.

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

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

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

Mood changes and depression

Depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with another medicine in the same therapeutic class (5-alpha-reductase inhibitor) taken orally. If you experience any of these symptoms, contact your doctor for medical advice as soon as possible.

• Consult your doctor or pharmacist if you have any doubts regarding the use of dutasteride/tamsulosin.

Taking dutasteride/tamsulosin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take dutasteride/tamsulosin with the following medicines:

• Other alpha blockers (for enlarged prostate or high blood pressure).

The use of dutasteride/tamsulosin is not recommended with the following medicines:

• Ketoconazole (used to treat fungal infections).

Certain medicines may interact with dutasteride/tamsulosin, increasing the risk of adverse 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 clotting).

• Erythromycin (an antibiotic used to treat infections).

• Paroxetine (an antidepressant).

• Terbinafine (for fungal infections).

• Diclofenac (used to treat pain and inflammation).

• Inform your doctor if you are taking any of these medicines.

Taking dutasteride/tamsulosin with food, drinks, and alcohol

Take this medicine 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

Women must not take dutasteride/tamsulosin.

Pregnant women (or women who may be pregnant) should avoid contact with broken capsules. Dutasteride can be absorbed through the skin and may affect the normal development of a male baby. This risk is particularly 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 suspects she might be pregnant, you must avoid exposing her to your semen.

Dutasteride/tamsulosin has been shown to reduce sperm count, sperm motility, and semen volume. Therefore, it may reduce male fertility.

• Consult your doctor if a pregnant woman has been exposed to dutasteride/tamsulosin.

Driving and using machines

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

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

This medicine contains orange-yellow dye S (E110) and sodium

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

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

3. How to take Dutasteride/Tamsulosin Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If you do not take this medicine regularly, the monitoring of your PSA levels may be affected. In case of doubt, consult your doctor or pharmacist again.

What dose should be taken

The recommended dose is one capsule taken once daily, 30 minutes after the same meal each day.

How to take it

The capsules must be swallowed whole with water. Do not chew or open the capsules. Contact with the contents of the capsules may irritate your mouth or throat.

If you take more dutasteride/tamsulosin than you should

In case of overdose or accidental ingestion, contact 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 Aurovitas

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 Aurovitas without consent

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Allergic reaction

Symptoms of an allergic reaction may include:

• Skin rash (which may be itchy).
• Hives (similar to 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, rarely, fainting. You should be cautious when standing up quickly after sitting or lying down, especially if you need to get up during the night, until you know how this medicine affects you. If you feel dizzy or lightheaded during treatment, sit or lie down until the symptoms pass.

Severe skin reactions

Signs of severe skin reactions may include:

• Widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
  • Contact your doctor immediately if you experience these symptoms and stop using this medicine.

Common adverse effects (may affect up to 1 in 10 men)

• Erectile dysfunction (inability to achieve or maintain an erection)*.
• Decreased sex drive (libido)*.
• Ejaculation difficulties, such as reduced amount of semen released during sexual intercourse*.
• Enlargement of the breast or tenderness upon touch (gynecomastia).
• Dizziness.
  • *In a small number of people, some of these events may continue after stopping this medicine.

Uncommon adverse effects (may affect up to 1 in 100 men)

• Heart failure (the heart becomes less efficient at pumping blood around the body. This may cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs).
• Drop in blood pressure upon standing.
• Faster than normal heartbeat (palpitations).
• Constipation, diarrhea, vomiting, discomfort (nausea).
• Weakness or loss of strength.
• Headache.
• Itching, nasal congestion, or runny nose (rhinitis).
• Skin rash, hives, itching.
• Hair loss (usually body hair) or excessive hair growth.

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

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

Very rare adverse 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 adverse effects

Other adverse effects have been reported in a small number of men, but their exact frequency is unknown (frequency cannot be estimated from available data):

• Abnormal or rapid heartbeat (arrhythmia, tachycardia, or atrial fibrillation).
• Difficulty breathing (dyspnea).
• Depression.
• Pain and swelling in the testicles.
  • Nosebleeds.
  • Severe skin rash.
  • Vision changes (blurred vision or visual disturbances).
  • Dry mouth.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride/Tamsulosin Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dutasteride/Tamsulosin Aurovitas

• The active substances 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 shell:

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

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

Contents of the dutasteride soft capsule:

Glyceryl monocaprylocaprate (Type-I) and butylated hydroxytoluene (E321).

Soft capsule shell: gelatin (160 bloom), glycerol, titanium dioxide (E171) and yellow iron oxide (E172).

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

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

Appearance of the product and contents of the pack

Hard capsules, size “00”, with an opaque orange cap printed with “DTT” in black ink and an opaque brown body printed with “0.5/0.4” in black ink. The capsule is approximately 23.5 mm in length.

Each hard capsule contains a dutasteride soft capsule, oblong, opaque, made of soft yellowish gelatin, containing a clear colourless to pale yellow viscous oil, and tamsulosin hydrochloride pellets, white to off-white in colour.

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

Pack sizes:

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

HDPE bottles: 30, 90 and 500 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

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

Manufacturer Responsible:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorized in the European Economic Area member states under 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

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

Portugal: Dutasterida + Tansulosina Aurovitas

Date of the most recent review of this leaflet: October 2025

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