DUTASTERIDE/TAMSULOSIN OLPHA 0.5 mg/0.4 mg HARD CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

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

dutasteride / tamsulosin hydrochloride

Read the entire summary of product characteristics carefully before starting to take this medication, as it contains important information for you.

• Keep this summary of product characteristics, as you may need to read it again.
• 1. If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this summary of product characteristics. See section 4.

Contents of the Summary of Product Characteristics

1. What is Dutasteride/Tamsulosina Olpha and what is it used for
2. What you need to know before taking Dutasteride/Tamsulosina Olpha
3. How to take Dutasteride/Tamsulosina Olpha
4. Possible side effects

5. Storage of Dutasteride/Tamsulosina Olpha

1. Package contents and additional information

1. What is Dutasteride/Tamsulosina Olpha and what is it used for

Dutasteride/Tamsulosina Olphais 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/Tamsulosina is a combination of two different medications called dutasteride and tamsulosin.

Dutasteride belongs to a group of medications called 5-alpha reductase enzyme inhibitors, and tamsulosin belongs to a group of medications called alpha blockers.

As the prostate grows in size, 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 urine stream to be weaker and less forceful. If left untreated, benign prostatic hyperplasia can lead to a risk of the urine flow 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 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 it easier to urinate and quickly improving symptoms.

2. What you need to know before taking Dutasteride/Tamsulosina Olpha

Do not takeDutasteride/Tamsulosina Olpha

• 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 allergicto dutasteride, other 5-alpha reductase enzyme 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 suffer from any of these conditions, do not takethis medication until you have consulted your doctor.

Warnings and precautions

Consult your doctor before starting to take Dutasteride/Tamsulosina:

• 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 who took 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 disease that affects your liver, you may need additional checks during your treatment with Dutasteride/Tamsulosina.

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

• Cataract surgery (cloudy lens). If you are going to have cataract surgery, your doctor may ask you to stop taking Dutasteride/Tamsulosina for a while before the operation. Before the operation, inform your ophthalmologist that you are taking this medication or tamsulosin (or if you have taken it previously). Your specialist will need to take the necessary precautions to avoid complications during the operation.

• Women, children, and adolescentsshould avoid contact with broken Dutasteride/Tamsulosina Olphacapsules, 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 sexual intercourse. Dutasteride has been found in the semen of men taking Dutasteride/Tamsulosina. 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 a male baby. Dutasteride causes a decrease in sperm count, motility, and semen volume. This may reduce your fertility.

• Dutasteride/Tamsulosinaaffects the PSA serum analysis(prostate-specific antigen) used to detect prostate cancer. Your doctor can 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 Dutasteride/Tamsulosina. Men being treated withthis medicationshould have regular PSA checks.
• In a clinical study conducted in men at high risk of prostate cancer, men who took dutasteride had a higher frequency of a severe type of prostate cancer than those who did not take dutasteride. The effect of dutasteride on this severe type of prostate cancer is unclear.

• Dutasteride/Tamsulosinamay cause breast enlargement and pain. If this causes you discomfort, or if you notice breast lumpsor nipple discharge, consult your doctor, as these changes can be signs of a serious disease, such as breast cancer.

?Consult your doctor or pharmacistif you have any questions related to taking Dutasteride/Tamsulosina.

Taking Dutasteride/Tamsulosina Olpha with other medications

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

Do not take Dutasteride/Tamsulosina with these medications:

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

It is not recommended to take Dutasteride/Tamsulosina with these medications:

• ketoconazole (used to treat fungal infections)

Certain medications may interact with Dutasteride/Tamsulosinaor increase the risk of side effects. Some of these medications 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 AIDS)
• 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(used to treat fungal infections)
• diclofenac(used to treat pain and inflammation)

?Tell your doctorif you are taking any of these medications.

Taking Dutasteride/Tamsulosina Olpha with food and drinks

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

Pregnancy, breastfeeding, and fertility

Women should not takeDutasteride/Tamsulosina.

Pregnant women (or those who may be pregnant) should avoid contact with brokenDutasteride/Tamsulosina 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.

?Consult your doctorif a pregnant woman has been in contact with Dutasteride/Tamsulosina.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking this medication. If your partner is pregnant or thinks she may be pregnant, you should avoid exposing her to your semen.

Dutasteride/Tamsulosina has been shown to decrease sperm count, motility, and semen volume. This may reduce your fertility.

Driving and using machines

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

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

Dutasteride/Tamsulosina Olpha contains the following excipients

Orange Yellow S

This medication may cause allergic reactions because it contains Orange Yellow S (E110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

Soybean oil-derived lecithin

Dutasteride/Tamsulosina Olpha contains soybean oil-derived lecithin. Do not use this medication if you are allergic to peanuts or soy.

Sodium

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

3. How to take Dutasteride/Tamsulosina Olpha

Follow the instructions for administration of this medication indicated by your doctor or pharmacist exactly. If you do not take Dutasteride/Tamsulosina 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 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 moreDutasteride/Tamsulosina Olphathan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Dutasteride/Tamsulosina Olpha

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

Do not stop treatment withDutasteride/Tamsulosina Olphawithout advice

Do not stop 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Allergic reaction

The symptoms of an allergic reaction can include:

• skin rash(which can itch)
• hives(like urticaria)
• swelling of the eyelids, face, lips, arms, or legs

?Contact your doctor immediatelyif you experience any of these symptoms and stop taking Dutasteride/Tamsulosina Olpha.

Dizziness, lightheadedness, and fainting

This medication can cause dizziness, lightheadedness, and, in rare cases, fainting. You should be careful when getting up quickly after sitting or lying down, especially if you need to get up during the night, until you know how this medication affects you. If you feel dizzy or lightheaded during treatment, sit or lie down until these symptoms have disappeared

Severe skin reactions

The 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 Dutasteride/Tamsulosina Olpha.

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

• impotence (inability to achieve or maintain an erection)*
• decreased libido (sex drive)*
• difficulty ejaculating, such as a decrease in the amount of semen released during sexual intercourse*
• breast enlargement and pain (gynecomastia)
• dizziness

• In a small number of people, some of these adverse events may continue after stopping Dutasteride/Tamsulosina.

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

• heart failure (the heart becomes less efficient at pumping blood through the body, which can 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 excessive 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 occurred in a small number of patients, but their frequency is unknown (the frequency cannot be estimated from the available data):

• abnormal or rapid heartbeat (arrhythmia or tachycardia or atrial fibrillation)
• difficulty breathing (dyspnea)
• depression
• pain and swelling in the testicles
• nosebleeds
• severe skin rash
• changes in vision (blurred vision or visual problems)
• dry mouth

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this summary of product characteristics. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Dutasteride/Tamsulosina Olpha

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging or bottle or blister pack after the EXP date. 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 more than 18 weeks for 90-capsule bottles.

Store below 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition ofDutasteride/Tamsulosin Olpha

• 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 components (excipients) are:
• Hard capsule shell: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), red iron oxide (E172), orange yellow S (E110).
• Inside the hard capsule: glycerol monocaprylate, butylhydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, lecithin (may contain soybean oil) (E322), microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, methacrylic acid and ethyl acrylate copolymer (1:1), magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E171).

Appearance of the Product and Container Content

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

The available pack sizes are 30 and 90 capsules in an HDPE bottle or 7, 30, and 90 capsules in aluminum/aluminum blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Olpha AS,

Rupnicu iela 5,

Olaine, Olaines novads, LV-2114,

Latvia

Manufacturer:

SAG MANUFACTURING, S.L.U.

Ctra. N-I, km 36

28750 San Agustín de Guadalix

Madrid – Spain

Galenicum Health, S.L.U

Sant Gabriel, 50,

Esplugues de Llobregat

08950 Barcelona - Spain

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

Germany: Dutasteride/Tamsulosin Olpha 0.5mg/0.4mg Hartkapseln

Slovakia: Dutasteride/Tamsulosin Olpha 0.5 mg/0.4 mg tvrdé kapsuly

France: Dutasteride/Tamsulosin Olpha 0.5mg/0.4mg, gélule

Italy: Dutasteride and Tamsulosin Olpha 0.5 mg/0.4 mg capsule rigide

Malta: Dutasteride/Tamsulosin Olpha 0.5 mg/0.4 mg Hard Capsules

Poland: Dutasteride + Tamsulosin hydrochloride Olpha 0.5 mg + 0.4 mg kapsulki twarde

Czech Republic: Dutasteride/Tamsulosin Olpha 0.5mg/0.4mg Tvrdá tobolka

Date of the Last Revision of this Leaflet:

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