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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

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 other people, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

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

Dutasteride/Tamsulosin Sandoz is used in men to treat an enlarged prostate (benign prostatic hyperplasia) – a non-cancerous growth of the prostate caused by excessive production of a hormone called dihydrotestosterone.

Dutasteride/Tamsulosin Sandoz 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 can cause urinary problems such as difficulty in passing urine and a need to urinate more frequently. It may also cause the urine stream 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 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 Sandoz

Do not take Dutasteride/Tamsulosin

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

• 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, to soy, peanuts, or to any of the other components 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 are in any of these situations, do not take this medicine until you have consulted your doctor.

Warnings and precautions

Talk to your doctor before starting to take Dutasteride/Tamsulosin:

• 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 as it should.

• Make sure your doctor knows if you have liver problems. If you have any condition 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 if you 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 skin contact occurs, wash the affected area 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 fetus. Dutasteride causes a reduction in sperm count, sperm motility, and semen volume. This may reduce your fertility.

• Dutasteride/Tamsulosin affects the serum PSA (prostate-specific antigen) test, 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 Dutasteride/Tamsulosin. Men taking Dutasteride/Tamsulosin should have regular PSA monitoring.

• In a clinical study conducted in men at increased risk of developing prostate cancer, men taking dutasteride were more likely to develop a more serious type of prostate cancer than those not taking dutasteride. The effect of dutasteride on this serious type of prostate cancer is not fully understood.

• Dutasteride/Tamsulosin 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 may be signs of a serious condition, such as 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 group (oral 5-alpha-reductase inhibitor). If you experience any of these symptoms, contact your doctor for medical advice as soon as possible.

Talk to your doctor or pharmacist if you have any questions about taking Dutasteride/Tamsulosin.

Taking Dutasteride/Tamsulosin with other medicines

Inform 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 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 or may increase your risk of experiencing 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 (used to treat 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 and drinks

You should take Dutasteride/Tamsulosin 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) must avoid contact with broken capsules. Dutasteride can be absorbed through the skin and may affect the normal development of a male fetus. This risk is particularly important during the first 16 weeks of pregnancy.

Consult your doctor if a pregnant woman has been exposed to Dutasteride/Tamsulosin.

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. This may reduce your fertility.

Driving and using machines

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

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

Dutasteride/Tamsulosin Sandoz contains

This medicine may cause allergic reactions as it contains sunset yellow FCF (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Dutasteride/Tamsulosin contains soybean lecithin. Do not use this medicine if you are allergic to peanuts or soy.

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

3. How to take Dutasteride/Tamsulosin Sandoz

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

What dose should you take

The recommended dose is one capsule once daily, taken 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 capsule contents 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 at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dutasteride/Tamsulosin

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

If you stop taking Dutasteride/Tamsulosin

Do not stop treatment with Dutasteride/Tamsulosin 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 can cause adverse effects, although not everyone experiences them.

Allergic reaction

Symptoms of an allergic reaction may include:

• skin rash (which may be itchy)
• hives (such as urticaria)
• swelling of the eyelids, face, lips, arms or legs

Contact your doctor immediately if you experience any of these symptoms and stop taking Dutasteride/Tamsulosin.

Dizziness, lightheadedness and fainting

Dutasteride/Tamsulosin 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 these symptoms have passed.

Serious skin reactions

Signs of serious skin reactions may include:

• widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)

Contact your doctor immediately if you have these symptoms and stop using Dutasteride/Tamsulosin.

Frequent adverse effects (may affect up to 1 in 10 people)

• impotence (inability to achieve or maintain an erection)*
• decreased sex drive (libido)*
• problems with ejaculation, such as a decrease in the amount of semen released during sexual intercourse*
• breast enlargement and tenderness to touch
• dizziness

• In a small number of people, one or more of these adverse events may continue after stopping Dutasteride/Tamsulosin.

Uncommon adverse effects (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 swelling in the ankles and legs)
• drop in blood pressure upon standing
• faster than normal heartbeat (palpitations)
• constipation, diarrhoea, vomiting, feeling unwell (nausea)
• weakness or loss of strength
• headache
• itching, stuffy or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually of the body) or hair growth

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

• swelling of the eyelids, face, lips, arms or legs (angioedema)
• collapse

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

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

Other adverse effects

Other adverse effects have occurred in a small number of patients, but their frequency is unknown (frequency cannot be estimated from the available data):

• abnormal or rapid heartbeat (arrhythmia or tachycardia or atrial fibrillation)
• difficulty breathing (dyspnoea)
• depression
• pain and swelling in the testicles
• nosebleed
• severe skin rash
• changes in vision (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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride/Tamsulosin Sandoz

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

Do not use this medicine after the expiry date stated on the packaging, bottle, or blister after EXP. The expiry date refers to the last day of the month indicated.

For high-density polyethylene (HDPE) bottles, after first opening, do not use the 30-capsule bottles for longer than 6 weeks, and do not use the 90-capsule bottles for longer than 18 weeks.

Do not store above 30ºC.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dutasteride/Tamsulosin Sandoz

• 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 components (excipients) are:

• Capsule shell: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), iron oxide red (E172), orange yellow S (E110).

• Inside the hard capsule: glycerol monocaprylocaprate, butylhydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), iron oxide yellow (E172), medium-chain triglycerides, lecithin (may contain soybean oil) (E322), microcrystalline cellulose, methylacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, methylacrylic acid-ethyl acrylate copolymer (1:1), magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E171).

Appearance of the medicine and contents of the pack

This medicine is presented as hard, oblong capsules, approximately 24 mm in length, with a brown body and an orange cap.

Available pack sizes contain 7, 30, or 90 capsules, supplied in high-density polyethylene (HDPE) bottles or in aluminum/aluminum blisters.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

SAG MANUFACTURING, S.L.U.

Ctra. N-I, km 36

28750 San Agustín de Guadalix

Madrid – Spain

or

Galenicum Health, S.L.U

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona – Spain

or

Lek Pharmaceuticals d.d

Verovskova ulica 57,

Ljubljana, 1526

Slovenia

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

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