BIDUTAM 0.5 mg/0.4 mg HARD CAPSULES

Introduction

• PATIENT INFORMATION LEAFLET

Patient Information Leaflet: Information for the patient

Bidutam 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 symptoms 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

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

1. What is Bidutam and what is it used for

This medicineis 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 inhibitorsand 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 stream of urine 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 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 Bidutam

Do not takeBidutam

• if you are a woman (because this medicine is only for men)
• if you are a child or adolescent under 18 years of age.
• if you are allergic(hypersensitive)to dutasteride,to other 5-alpha reductase inhibitors, to tamsulosin, to soy, peanutor to any of the other ingredients of this medicine (listed in section 6).
• if you experience fainting, dizziness or lightheadedness due to low blood pressure when changing positions (orthostatic hypotension).
• if you have severe liver disease.

• If you think you may be in one of these situations, do not take this medicine until you have consulted your doctor.

Warnings and precautions

Consult your doctor before starting to take this medicine.

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

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

• Tell your doctor if you have severe kidney problems.

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

• Women, children, and adolescentsshould avoid contact with the broken capsules of this medicine, 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 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 male fertility.

• This medicine affects the PSA blood test(prostate-specific antigen) that is sometimes used to detect prostate cancer. Your doctor may 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 this medicine. Men taking this medicine should have regular PSA checks.

• In a clinical study in men at high risk of prostate cancer, men who took dutasteride had a higher frequency 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.

• This medicine may cause breast enlargement and tendernessto the touch. 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 doubts about the administration of this medicine.

Other medicines and Bidutam

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 this medicine with these medicines:

• ketoconazole(used to treat fungal infections).

Certain medicines may interact with this medicine, which may increase the risk of side effects. Some of these medicines 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).

Tell your doctorif you are taking any of these medicines.

Taking Bidutam with food and drinks

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

Pregnancy, breastfeeding, and fertility

This medicine must not be taken by women.

Pregnant women (or women who may be pregnant) should avoid contact with the 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 doctorif a pregnant woman has come into 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 thinks she may be pregnant, she should avoid exposure to your semen.

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

Driving and using machines

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

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

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

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

This medicine contains soy lecithin, which may contain soybean oil. It should not be used in case of peanut or soy allergy.

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

3. How to take Bidutam

Always take this medicine exactly as your doctor or pharmacist has told you.If you do not take this medicine regularly, the control of 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 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 open the capsules. Contact with the contents of the capsules can 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bidutam

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

Do not stop taking Bidutam without advice

Do not stop taking this medicine without consulting your doctor first.

If you have any further questions on 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 taking this medicine.

Dizziness, lightheadedness, and fainting

This medicine 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 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, particularly around the mouth, nose, eyes, and genitals(Stevens-Johnson syndrome)

Contact your doctor immediatelyif you have these symptoms and stop using this medicine.

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

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

*In a small number of people, some of these side effects may continue after stopping this medicine.

Uncommon side 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)
• reduced blood pressure when standing up
• fast heart rate (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 men, but their exact frequency is unknown (the frequency cannot be estimated from the available data):

• abnormal or rapid heart rate (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 impairment)
• 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 via 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 Bidutam

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 packaging, blister, or bottle after EXP. The expiry date refers to the last day of the month shown.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused capsules to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Bidutam

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 are:

• Hard capsule shell: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), red iron oxide (E172), orange yellow S (E110).
• Hard capsule interior: 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 - ethyl acrylate copolymer (1:1) dispersion 30 percent, magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E171).

Appearance of the Product and Container Content

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATORIOS Q PHARMA S.L.

C/ Moratín, nº 15, Entlo. Oficinas 6-7

03008 Alicante

Spain

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 medication is authorized in the member states of the European Economic Area under the following names:

Date of the Last Revision of this Prospectus:February 2020.

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