Package Insert: Information for the Patient

Dutasteride/Tamsulosin Sandoz 0.5 mg/0.4 mg Hard Capsules EFG

dutasteride/hydrochloride of tamsulosin

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

- Keep this package insert, 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 package insert. See section 4.

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

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

3. How to take Dutasteride/Tamsulosin Sandoz

4. Possible side effects

5. Storage of Dutasteride/Tamsulosin Sandoz

6. Contents of the pack and additional information

Dutasterida/Tamsulosina 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.

Dutasterida/Tamsulosina Sandoz is a combination of two different medications called dutasteride and tamsulosin.

Dutasteride belongs to a group of medications called 5-alpha reductase inhibitors and tamsulosin belongs to a group of medications called alpha 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 urine stream to be smaller and less forceful. If benign prostatic hyperplasia is not treated, there is a risk of complete blockage of the urine flow (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 to reduce the size of the prostate and alleviate symptoms. This reduces the risk of acute urinary retention and the need for surgery. Tamsulosin acts by relaxing the muscles of the prostate, making urination easier and rapidly improving symptoms.

Do not takeDutasteride/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, soy, peanuts, 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 have any of these situations, do not take this medication until you have consulted with your doctor.

Warnings and precautions

Consult your doctor before starting to takeDutasteride/Tamsulosin.:

- In some clinical studies, there were more 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 any liver disease, you may need additional monitoring during your treatment withDutasteride/Tamsulosin.

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

- Cataract surgery (opaque lens). If you are going to have cataract surgery, your doctor may ask you to stop takingDutasteride/Tamsulosinfor a while before the surgery. Before the surgery, inform your ophthalmologist that you are takingDutasteride/Tamsulosinor tamsulosin (or if you have taken them before). Your specialist will need to take the necessary precautions to avoid complications during the surgery.

- Women, children, and adolescents should avoid contact with brokenDutasteride/Tamsulosincapsules, as the active ingredient can be absorbed through the skin. If there is any contact with the skin, the affected area should be washed immediatelywith water and soap.

- Use a condom during sex. Dutasteride has been found in the semen of men takingDutasteride/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 your fertility.

-Dutasteride/Tamsulosinaffects the PSA blood test (prostate-specific antigen) used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but they should be aware of this effect. If you have a blood test to determine your PSA, inform your doctor that you are takingDutasteride/Tamsulosin. Men takingDutasteride/Tamsulosinshould have regular PSA monitoring.

- In a clinical study conducted in men at increased risk of developing prostate cancer, men taking dutasteride had prostate cancer more frequently than those not taking dutasteride. The effect of dutasteride on this type of severe prostate cancer is unclear.

-Dutasteride/Tamsulosinmay cause breast enlargement and tenderness. If this causes you discomfort, or if you noticelumps in your breast or nipple discharge, consult your doctor, as these changes may be signs of a serious disease, such as breast cancer.

Consult your doctor or pharmacist if you have any questions related to takingDutasteride/Tamsulosin.

TakingDutasteride/Tamsulosinwith other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not takeDutasteride/Tamsulosinwith these medications:

- other alpha blockers (for enlarged prostate or high blood pressure)

Do not takeDutasteride/Tamsulosinwith these medications:

- ketoconazole (used to treat fungal infections)

Certain medications may interact withDutasteride/Tamsulosinor may cause you to experience adverse effects. Some of these medications 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)

- 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 medications.

TakingDutasteride/Tamsulosinwith food and drinks

You should take Dutasteride/Tamsulosin30 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.

Consult your doctor if a pregnant woman has been in contact with Dutasteride/Tamsulosin.

Use a condom during sex.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/Tamsulosinhas been shown to reduce sperm count, motility, and semen volume. This may reduce your fertility.

Driving and operating machinery

Some people may experience dizziness during treatment withDutasteride/Tamsulosin, which may 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 medication may cause allergic reactions because it contains yellow-orange S (E110). It may cause asthma, especially in patients allergic to aspirin.

Dutasteride/Tamsulosincontains soy lecithin. Do not use this medication if you are allergic to peanuts or soy.

This medication contains less than 1 mmol of sodium (23 mg) per 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 takeDutasterida/Tamsulosinaregularly, the control of your PSA levels may be affected. In case of doubt, consult your doctor or pharmacist again.

What dose to take

The recommended dose is one capsule 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 moreDutasterida/Tamsulosinathan 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 takeDutasterida/Tamsulosina

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

If you interrupt the treatment with Dutasterida/Tamsulosina

Do not interrupt the treatment withDutasterida/Tamsulosinawithout 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 may 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 takingDutasteride/Tamsulosin.

Dizziness, lightheadedness, and fainting

Dutasteride/Tamsulosinmay cause dizziness, lightheadedness, and, in rare cases, fainting. Be cautious when standing 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 usingDutasteride/Tamsulosin.

Common side effects(may affect up to 1 in 10 people)

- 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*

- enlarged breasts and painful palpation)

- dizziness.

* In a small number of people, some of these adverse events may continue after stoppingDutasteride/Tamsulosin.

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

- 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)

- reduced blood pressure when standing up

- faster-than-normal heart rate (palpitations)

- constipation, diarrhea, vomiting, discomfort (nausea)

- weakness or loss of strength

- headache

- tickling, congestion, or dripping nasal discharge (rhinitis)

- skin rash, hives, itching

- hair loss (usually on the body) or hair growth.

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

- swelling of the eyelids, face, lips, arms, or legs (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

Other side effects have been reported in a reduced number of patients, but their exact frequency is unknown (the frequency cannot be estimated from the available data):

- abnormal or accelerated heart rhythm (arrhythmia or 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 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 Pharmacovigilance of Medicines for Human Use: 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 or bottle or blister pack after CAD. The expiration date is the last day of the month indicated.

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

Do not store at a temperature above 30º.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Dutasterida/Tamsulosina Sandoz

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

- The other components (excipients) are:

- Hard capsule coating: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), iron oxide red (E172), yellow-orange S (E110).

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

Appearance of the product and contents of the packaging

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

They are available in packaging of 7, 30, and 90 capsules in high-density polyethylene (HDPE) bottles or in aluminum/aluminum blisters.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

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

Last review date of this leaflet: August 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/