DUTASTERIDE/TAMSULOSIN MABO 0.5 mg/0.4 mg HARD CAPSULES EFG

Introduction

Package Leaflet: Information for the User

Dutasteride/Tamsulosin Mabo 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 others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Dutasteride/Tamsulosin Mabo and what is it used for
2. What you need to know before you take Dutasteride/Tamsulosin Mabo
3. How to take Dutasteride/Tamsulosin Mabo
4. Possible side effects
   1. Storage of Dutasteride/Tamsulosin Mabo

1. Contents of the pack and further information

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

This medicine is used in men to treat an enlarged prostate (benign prostatic hyperplasia) - a non-cancerous growth 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 called 5-alpha reductase enzyme inhibitors and tamsulosin belongs to a group of medicines called alpha blockers.

As the prostate grows, 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 benign prostatic hyperplasia is not treated, there is a risk that the flow of urine will be 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.

Dutasteride reduces the production of dihydrotestosterone, which helps to reduce 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 it easier to urinate and quickly improving symptoms.

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

Do not takeDutasteride/Tamsulosin Maboif:

• you are a woman (because this medicine is only for men)
• you are a child or adolescent under 18 years of age
• you are allergic to dutasteride, other 5-alpha reductase enzyme inhibitors, tamsulosin, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6)
• you have low blood pressure, which makes you feel dizzy, lightheaded, or faint (orthostatic hypotension)
• you have severe liver disease.

If you think you may have any of these conditions, do not take this medicine until you have spoken to your doctor.

Warnings and precautions

Consult your doctor before starting to take 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 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 some additional checks during your treatment with dutasteride/tamsulosin.
• 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/tamsulosin for a while before the operation. Before the operation, tell your eye specialist that you are taking dutasteride/tamsulosin or tamsulosin (or if you have taken them before). Your specialist will need to take the necessary precautions to avoid complications during the operation.
• 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, she should avoid exposure 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/tamsulosin affects the PSA serum test (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, tell your doctor that you are taking dutasteride/tamsulosin.

Men taking dutasteride/tamsulosin should have regular PSA checks.

• In a clinical study in men at increased risk of prostate cancer, men who took dutasteride had a higher incidence of a serious type of prostate cancer than those who did not take dutasteride. The effect of dutasteride on this serious type of prostate cancer is not clear.
• dutasteride/tamsulosin may cause breast enlargement and pain on palpation. If this causes you discomfort, or if you notice lumps in the breast or nipple discharge, consult your doctor, as these changes can be signs of a serious disease, such as breast cancer.

Consult your doctor or pharmacist if you have any questions about taking dutasteride/tamsulosin

TakingDutasteride/Tamsulosin Mabowith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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, which may increase the risk of you experiencing side 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).

Tell your doctor if you are taking any of these medicines.

TakingDutasteride/Tamsulosin Mabowith food and drinks

You should take dutasteride/tamsulosin 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

Women should not take dutasteride/tamsulosin.

Pregnant women (or women who may be pregnant) should avoid contact with broken 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 doctor if a pregnant woman has been in contact with 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 thinks she may be pregnant, she should avoid exposure to your semen.

It has been shown that dutasteride/tamsulosin decreases sperm count, motility, and semen volume. This may reduce your fertility.

Driving and using machines

Some people may experience dizziness during treatment with dutasteride/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 Mabocontains lecithin, which may contain soybean oil and propylene glycol.

It should not be used in case of peanut or soy allergy.

This medicine contains 299.46 mg of propylene glycol in each capsule.

3. How to take Dutasteride/Tamsulosin Mabo

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you do not take dutasteride/tamsulosin 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/Tamsulosin Mabothan you should

In case of overdose or accidental ingestion, consult 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 takeDutasteride/Tamsulosin Mabo

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

If you stop takingDutasteride/Tamsulosin Mabo

Do not stop treatment with dutasteride/tamsulosin without consulting your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reaction

The symptoms of an allergic reaction can include:

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

Contact your doctor immediatelyif you experience any of these symptoms and stop takingdutasteride/tamsulosin.

Dizziness, lightheadedness, and fainting

Dutasteride/tamsulosin 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 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, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).

Contact your doctor immediatelyif you have these symptoms and stop usingdutasteride/tamsulosin.

Common side effects

These can affect up to 1 in 10 patients who take dutasteride/tamsulosin:

• impotence (inability to achieve or maintain an erection)*
• decreased libido (sex drive)*
• difficulty with ejaculation, with a decrease in the amount of semen released during sex *
• breast enlargement and pain on palpation (gynecomastia)
• dizziness.

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

Uncommon side effects

These can affect up to 1 in 100 patients:

• heart failure (the heart becomes less efficient at pumping blood through the body. This could cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs).
• reduction in blood pressure when standing up
• rapid heartbeat (palpitations)
• constipation, diarrhea, vomiting, nausea (feeling sick)
• weakness or loss of strength
• headache
• itching, stuffy or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually from the body) orexcessive hair growth.

Rare side effects

These can affect up to 1 in 1,000 patients:

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

Very rare side effects

These can affect up to 1 in 10,000 patients:

• 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 small number of patients, but their frequency is not known (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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride/Tamsulosin MABO

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

Do not use this medicine after the expiry date which is stated on the carton or bottle after EXP. The expiry date is the last day of the month shown.

Shelf life after first opening of the container: 90 days.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition ofDutasteride/Tamsulosin MABO

• The active ingredients are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride (equivalent to 0.367 mg of tamsulosin).

• The other ingredients are:

• hard capsule shell: black iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), gelatin
• contents of the soft capsule: propylene glycol monocaprylate (type II), butylhydroxytoluene (E321),
• components of the soft capsule: gelatin, glycerol, titanium dioxide (E171), medium-chain triglycerides, soy lecithin (may contain soybean oil),
• tamsulosin pellets: methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30 percent, microcrystalline cellulose, dibutyl sebacate, polysorbate 80, anhydrous colloidal silica, calcium stearate.
• printing inks: shellac (E904), propylene glycol, black iron oxide (E172), strong ammonia solution, potassium hydroxide.

Appearance of the product and contents of the pack

This medicine is presented in hard capsules, oblong, with a brown body and an orange cap, printed with C001 in black ink.

It is available in packs of 30 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3,

Edificio 6, 28033 Madrid,

Spain.

Manufacturer

Laboratorios LEÓN FARMA, SA

Polígono Industrial Navatejera

C/La Vallina, s/n -24193 Navatejera -León

Spain

Date of last revision of this leaflet:April 2020

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