DUTASTERIDE/TAMSULOSIN COMBIX PHARMA 0.5 mg/0.4 mg HARD CAPSULES

2. What you need to know before you take Dutasteride/Tamsulosine Combix Pharma

Do not takeDutasteride/Tamsulosine Combix Pharma:

• 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 to dutasteride, other 5-alpha reductase inhibitors, tamsulosine, soy, peanuts, or any of the other components 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 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, there were more patients taking dutasteride and another medicine called an alpha-blocker, such as tamsulosine, 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 this medicine.

• 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 this medicine for a while before the operation. Before the operation, inform your ophthalmologist that you are taking this medicine or tamsulosine (or if you have taken it before). Your specialist will need to take the necessary precautions to avoid complications during the operation.

• Women, children, and adolescents should 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 immediately with water and soap.

• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking this medicine. 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.

• This medicine affects the PSA blood 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, 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 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.

• This medicine 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 related to taking this medicine.

UsingDutasteride/Tamsulosine Combix Pharma with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Do not take dutasteride/tamsulosine with these medicines:

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

It is not recommended to take dutasteride/tamsulosine with these medicines:

• ketoconazole (used to treat fungal infections).

Certain medicines may interact with dutasteride/tamsulosine, which may increase the risk of you experiencing 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 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 doctor if you are taking any of these medicines.

TakingDutasteride/Tamsulosine Combix Pharma with food and drinks

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

Pregnancy, breastfeeding, and fertility

Women should not take this medicine

Pregnant women (or those 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.

Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking this medicine. If your partner is pregnant or thinks she may be pregnant, she should avoid exposure to your semen.

This medicine has been shown to decrease sperm count, motility, and semen volume. This may reduce your fertility.

• Consult your doctor if a pregnant woman has come into contact with this medicine.

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 machinery if you are affected in this way.

Dutasteride/Tamsulosine Combix Pharma contains soybean lecithin, propylene glycol, and sodium

This medicine contains soybean lecithin, which may contain soybean oil. Do not use this medicine if you are allergic to peanuts or soy.

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

This medicine contains 299 mg of propylene glycol in each capsule.

3. How to take Dutasteride/Tamsulosine Combix Pharma

Follow the instructions for taking this medicine exactly as indicated by your doctor or pharmacist. If you do not take dutasteride/tamsulosine 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/Tamsulosine Combix Pharma 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 takeDutasteride/Tamsulosine Combix Pharma

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

If you stop takingDutasteride/Tamsulosine Combix Pharma Do not stop taking this medicine without consulting your doctor first.

If you have any other questions about taking 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 immediately if 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 immediately if you have these symptoms and stop using this medicine.

Common side effects

These can affect up to 1 in 10 men who take this medicine:

• impotence (inability to achieve or maintain an erection)*
• decreased sex drive (libido)*
• difficulty with ejaculation, such as 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 this medicine.

Uncommon side effects

These can affect up to 1 in 100 men:

• 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 (feeling sick)
• 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

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

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

Very rare side effects

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

• 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 men, 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 (shortness of breath)
• 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, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Information System: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Dutasteride/Tamsulosine Combix Pharma

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

Do not use this medicine after the expiry date stated on the packaging and on the bottle after EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the 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/Tamsulosin Combix Pharma

The active ingredients are dutasteride and tamsulosin hydrochloride. Each capsule contains0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride (equivalent to 0.367 mg of tamsulosin). The other components are:

Hard capsule shell:

Black iron oxide (E172)

Red iron oxide (E172)

Titanium dioxide (E171)

Yellow iron oxide (E172)

Gelatin

Content of the soft dutasteride capsule:

Propylene glycol monocaprylate type II

Butylhydroxytoluene (E321)

Soft capsule shell:

Gelatin

Glycerol

Titanium dioxide (E171)

Medium-chain triglycerides

Soy lecithin (may contain soybean oil) (see section 2)

Tamsulosin pellets:

Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 percent (also contains polysorbate 80 and sodium lauryl sulfate)

Microcrystalline cellulose

Dibutyl sebacate

Polysorbate 80

Colloidal hydrated silica

Calcium stearate

Black inks:

Shellac (E904)

Black iron oxide (E172)

Propylene glycol (E1520)

Concentrated ammonia solution (E527)

Potassium hydroxide (E525)

Section 2 "Dutasteride/Tamsulosin Combix Pharma contains soy lecithin and propylene glycol"

Appearance of the Product and Container Content

This medication is hard gelatin capsules, approximately 24.2 mm x 7.7 mm in size, with a brown body and a beige cap, printed with C001 in black ink.

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

It is available in packs of 7, 30, and 90 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Combix Laboratories, S.L.U.

Badajoz Street 2, Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

LEÓN FARMA Laboratories, SA

La Vallina Street, s/n, Navatejera Industrial Estate

Villaquilambre-24193 (León)

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Denmark Dutatex

Greece ZYTODUR 0.5 mg/0.4 mg, σκληρ? καψ?κια

Poland Dutasteride + Tamsulosin hydrochloride León Farma, 0.5 mg + 0.4 mg, kapsulki twarde

Portugal Dutasterida + Tansulosina Bluepharma

Croatia Atekago 0.5 mg/0.4 mg tvrde kapsule

Date of the Last Revision of thisLeaflet:August 2019

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.es/