DUTASTERIDE/TAMSULOSIN CINFA 0.5 mg/0.4 mg HARD CAPSULES

2. What you need to know before taking dutasteride/tamsulosin cinfa

Do not take dutasteride/tamsulosin cinfa:

• if you are a woman (as this medication is only for men)
• if you are a child or adolescent under 18 years of age
• if you are allergic to dutasteride, other 5-alpha reductase enzyme inhibitors, tamsulosin, soy, peanut, or any of the other components of this medication (listed in section 6)
• this medication contains lecithin that may contain soy oil. It should not be used in case of peanut or soy allergy
• 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 suffer from any of these conditions, do not take this medication until you have consulted your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take dutasteride/tamsulosin cinfa.

• 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/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, inform your ophthalmologist that you are taking dutasteride/tamsulosin 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 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 can affect the normal development of a male fetus. 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, 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 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 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 doubts related to taking dutasteride/tamsulosin.

Other medications and dutasteride/tamsulosin cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Do not take dutasteride/tamsulosin with these medications:

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

It is not recommended to take dutasteride/tamsulosin with these medications:

• ketoconazole (used to treat fungal infections).

Certain medications may interact with dutasteride/tamsulosin, which can 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 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 doctor if you are taking any of these medications.

Taking dutasteride/tamsulosin cinfa with 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 those who may be pregnant) should avoid contact with broken capsules. dutasteride is absorbed through the skin and can affect the normal development of a male fetus. 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 can affect their ability to drive or operate machinery safely.

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

dutasteride/tamsulosin cinfa contains orange yellow S (E-110).

This medication can cause allergic reactions because it contains orange yellow S (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

dutasteride/tamsulosin cinfa contains sodium.

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

3. How to take dutasteride/tamsulosin cinfa

Follow the administration instructions for this medication 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. 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 more dutasteride/tamsulosin cinfa 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 medication and the amount ingested.

If you forget to take dutasteride/tamsulosin cinfa

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

If you stop treatment with dutasteride/tamsulosin cinfa

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

If you have any other doubts 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 all people 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 takingdutasteride/tamsulosin.

Dizziness, lightheadedness, and fainting

dutasteride/tamsulosin 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 usingdutasteride/tamsulosin.

Common side effects

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

• impotence (inability to achieve or maintain an erection)*
• decreased libido (sexual desire)*
• difficulty ejaculating, 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)
• 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 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 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, consult 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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of dutasteride/tamsulosin cinfa

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

Do not use this medication after the expiration date stated on the packaging or bottle after CAD. The expiration date is the last day of the month indicated.

In the case of HDPE bottles, do not use for more than 6 weeks for the 30-capsule package and more than 18 weeks for the 90-capsule package, after the first opening.

Do not store above 30°C.

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

6. Container Content and Additional Information

Composition ofdutasteride/tamsulosin cinfa

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

• The other components (excipients) are:

• hard capsule shell: hypromellose, carrageenan (E-407), potassium chloride, titanium dioxide (E-171), red iron oxide (E-172), and orange yellow S (E-110).

• soft capsule content: glycerol monocaprylocaprate, butylhydroxytoluene (E-321).

soft capsule shell: gelatin, glycerol, titanium dioxide (E-171), yellow iron oxide (E-172), medium-chain triglycerides, lecithin (may contain soybean oil) (E-322).

tamsulosin pellets: 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 (E-171).

Appearance of the Product and Container Content

The medication is presented in hard, oblong capsules with a brown body and orange cap.

Each hard capsule contains pellets of modified-release tamsulosin hydrochloride and a soft gelatin capsule with dutasteride.

It is available in high-density polyethylene (HDPE) bottles and aluminum-aluminum blisters containing 7, 30, and 90 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - 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.

Calle Sant Gabriel, 50, Esplugues de Llobregat, 08950, Barcelona (Spain)

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

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

Dutasteride/Tamsulosin Cinfa 0.5 mg/0.4 mg hard capsules EFG - Spain

Date of the Last Revision of this Prospectus:December 2021

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84641/P_84641.html

QR code to: https://cima.aemps.es/cima/dochtml/p/84641/P_84641.html