B.PROSPECTUS

Prospectus: information for the patient

Bidutam 0.5 mg/0.4 mg hard capsules EFG

Dutasteride/tamsulosin hydrochloride

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

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

This medicationis used in men to treat an enlarged prostate(benign prostatic hyperplasia)- a non-cancerous growth of the prostate caused by producing an excess of a hormone called dihydrotestosterone.

This medication is a combination of two different medications called dutasteride and tamsulosin. Dutasteride belongs to a group of medications called5-alpha reductase inhibitorsand tamsulosin belongs to a group of medications calledalpha 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 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 urination easier and rapidly improving symptoms.

Do not takeBidutam

• if you are a woman (becausethis medication is only for men)
• if you are a child or adolescent under 18 years old.
• if you are allergic(hypersensitive)to dutasteride,to other5-alpha reductase enzyme inhibitors, to tamsulosin, to soy, peanutsor to any of the other components of this medication (listed in section 6).
• if you experience dizziness, lightheadedness, or fainting due to a decrease in blood pressure when changing position (orthostatic hypotension).
• if you have a severe liver disease.

• Ifyou think you are in 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 take this medication.

• In some clinical studies, the number of patients who experienced heart failure was higher in those who took dutasteride and another medication called an alpha blocker, such as tamsulosin, than in those who took only dutasteride or only an alpha blocker. Heart failure means that your heart is not pumping blood as it should.

• if you have liver problems. If you have any disease that affects your liver, you may need additional monitoring during your treatment with this medication.

• Inform your doctor if you have severe kidney problems.

• Cataract surgery (opaque crystalline lens). If you are going to have cataract surgery, your doctor may tell you to stop taking this medication for a while before your surgery. Inform your ophthalmologist before the surgery that you are taking or have previously taken this medication or tamsulosin. Your ophthalmologist should take the necessary precautions to avoid complications during your surgery.

• Women, children, and adolescentsshould avoid contact with broken capsules of this medication, 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/tamsulosin. If your partner is pregnant or may be pregnant, you should avoid exposing her to your semen, as dutasteride may affect the normal development of the male fetus. Dutasteride causes a decrease in sperm count, motility, and semen volume. This may reduce your fertility.

• This medication affects PSA blood tests(prostate-specific antigen) that are sometimes 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 taking this medication.Men taking this medication should have regular PSA checks.

• In a clinical study conducted in men at high risk of developing prostate cancer, men who took dutasteride presented withmore frequently a severe type of prostate cancerthan those who did not take dutasteride. The effect of dutasteride on this severe type of prostate cancer is unclear.

• This medication may cause breast enlargement and tendernessto palpation. If this causes you discomfort, or if you noticelumps in the breastordischarge from the nipple, consult your doctor, as these changes may be signs of a serious disease, such as breast cancer.

Consult your doctor or pharmacistif you have any doubts about the administration of this medication.

Other medications and Bidutam

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not take dutasteride/tamsulosin with these medications:

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

Do not take this medication with these medications:

• ketoconazole(used to treat fungal infections).

Certain medications may interact with this medication, which may cause you to experience adverse effects. Some of these medications are:

• phosphodiesterase type 5 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 coagulation)
• 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 doctorif you are taking any of these medications.

Taking Bidutam with food and drinks

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

Pregnancy, breastfeeding, and fertility

This medication should not be taken by women.

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 doctorif a pregnant woman has been in contact with Bidutam.

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

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

Driving and operating machinery

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

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

Bidutam containssoy lecithin, yellow orange S (E110), and sodium

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

This medication contains soy lecithin, which may contain soy oil. It should not be used in cases of allergy to peanuts or soy.

This medication contains less than 23 mg of sodium (1 mmol) 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 take this medication 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 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 more Bidutam than 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 take Bidutam

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

Do not interrupt Bidutam treatment without advice

Do not interrupt 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.

This medication, like all others, 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 immediatelyif you experience any of these symptoms andstop taking this medication.

Dizziness, lightheadedness, and fainting

This medication may cause dizziness, lightheadedness, and, in rare cases, fainting. 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 medication 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 immediatelyif you have these symptoms andstop using this medication.

Common side effects (may affect more than 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*
• enlargement of the breasts and pain on palpation (gynecomastia)*
• dizziness

*In a small number of people, some of these adverse events may continue after stopping this medication.

• 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
• abnormal heart rhythm (palpitations)
• constipation, diarrhea, vomiting, discomfort (nausea)
• weakness or loss of strength
• headache
• itching, congestion, or 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 occurred in a small number of men, 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 (shortness of breath)
• depression
• pain and swelling in the testicles
• nasal bleeding
• severe skin rash
• changes in vision (blurred vision or visual impairment)
• 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 the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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, blister, or bottle after CAD or EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Bidutam

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 are:

• Capsule hard shell coating: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), iron oxide red (E172), yellow orange S (E110).
• Hard capsule interior: 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 percent, magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E171).

Appearance of the product and contents of the package

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

They are available in HDPE bottles or aluminum/aluminum blisters of 30 and 90 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

LABORATORIOS Q PHARMA S.L.

C/ Moratín, nº 15, Entlo. Offices 6-7

03008 Alicante

Spain

Responsible manufacturer

SAG MANUFACTURING, S.L.U.

Ctra. N-I, km 36

28750 San Agustín de Guadalix (Madrid)

Spain

GALENICUM HEALTH, S.L.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:February 2020.

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.gob.es