DUTASTERIDE/TAMSULOSIN STADAFARMA 0.5 mg/0.4 mg HARD CAPSULES

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

Do not takeDutasteride/Tamsulosin Stadafarma

• 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 allergicto dutasteride,to other 5-alpha reductase enzyme inhibitors, to tamsulosin, to soy, peanutsor to any of the other ingredients of this medicine(listed in section 6).
• if you have low blood pressure, which makes you feel dizzy, lightheaded or faint (orthostatic hypotension).
• if you have severe liver disease.

?If you think you may have any of these conditions, do not takethis medicine until you have consulted your doctor.

Warnings and precautions

Talk to your doctor before starting to take Dutasteride/Tamsulosin Stadafarma:

• 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 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 ophthalmologist 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 adolescentsshould avoid contact with broken dutasteride/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 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, 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/tamsulosinaffects the PSA serum analysis(prostate-specific antigen) that is sometimes 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 being treated with dutasteride/tamsulosin should have regular PSA checks.

• In a clinical study in men at high risk of prostate cancer, men who took dutasteride had a higher incidence of a more 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/tamsulosinmay cause breast enlargement and pain on palpation. 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.

?Talk to your doctor or pharmacistif you have any questions about taking dutasteride/tamsulosin.

Other medicines and Dutasteride/Tamsulosin Stadafarma

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 or increase the risk of 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 AIDS)
• 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 Dutasteride/Tamsulosin Stadafarma with food and drink

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

Pregnancy, breast-feeding, and fertility

Women should not takedutasteride/tamsulosin.

Pregnant women (or women who may be pregnant) should avoid contact with brokendutasteride/tamsulosin 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.

?Talk to your doctorif 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, you should avoid exposing her to your semen.

Dutasteride/tamsulosin 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/tamsulosin, which may affect their ability to drive or operate machinery safely.

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

Dutasteride/Tamsulosin Stadafarma contains orange yellow S (E110) and soy lecithin

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

This medicine contains soy lecithin. Do not use this medicine if you are allergic to peanuts or soy.

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

3. How to take Dutasteride/Tamsulosin Stadafarma

Follow the instructions for taking this medicine exactly as indicated by your doctor or pharmacist. If you do not take dutasteride/tamsulosin 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 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 Stadafarmathan 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 take Dutasteride/Tamsulosin Stadafarma

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

Do not stop takingDutasteride/Tamsulosin Stadafarmawithout advice

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

If you have any further 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

?Contactyour doctor immediatelyif you experience any of these symptoms and stop taking dutasteride/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, particularly around the mouth, nose, eyes, and genitals(Stevens-Johnson syndrome).

?Contact your doctor immediatelyif you have these symptoms and stop using dutasteride/tamsulosin.

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 pain on palpation)
• dizziness.

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

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

• 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)
• reduced blood pressure when standing up
• rapid heartbeat (palpitations)
• constipation, diarrhea, vomiting, nausea (nausea)
• weakness or loss of strength
• headache
• itching, stuffy or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually from 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 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 side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. 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 medicine.

5. Storage of Dutasteride/Tamsulosin Stadafarma

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

Do not use this medicine after the expiry date that appears on the packaging or bottle or blister after EXP. The expiry 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 above 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition ofDutasteride/Tamsulosine Stadafarma

• 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-ethyl acrylate copolymer (1:1) dispersion 30%, methacrylic acid-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.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer:

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

Date of the Last Revision of this Leaflet:May 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