DUTASTERIDE COMBIX 0.5 mg SOFT CAPSULES

1. What is Dutasteride Combix and what is it used for

Dutasteride Combix is used in men to treat an enlarged prostate(benign prostatic hyperplasia)- a non-cancerous growth of the prostate caused by excessive production of a hormone called dihydrotestosterone.

The active substance is dutasteride. Dutasteride Combix belongs to a group of medications called 5-alpha reductase enzyme inhibitors.

As the prostate grows, it can cause urinary problems such as difficulty in urinating and a need to urinate more frequently. It can also cause the urine stream to be weaker and less forceful. If left untreated, benign prostatic hyperplasia can lead to 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.

Dutasteride Combix can also be used with another medication called tamsulosin (used to treat symptoms of an enlarged prostate).

2. What you need to know before taking Dutasteride Combix

Do not take Dutasteride Combix

• if you are allergic to dutasteride, other 5-alpha reductase inhibitors,or any of the other components of this medication (listed in section 6).
• if you have severe liver disease.

Tell your doctorif you think you are in any of these situations.

This medication is only for men. Women, children, and adolescents should not take it.

Warnings and precautions

• Make sure your doctor knows if you have liver problems. You may need additional monitoring during treatment with Dutasteride Combix if you have any liver disease.
• Women, children, and adolescentsshould avoid contact with broken Dutasteride Combix capsules, as the active substance can be absorbed through the skin. If skin contact occurs, the affected area should be washed immediatelywith soap and water.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutasteride Combix. If your partner is pregnant or may become pregnant, she should avoid exposure to your semen, as dutasteride may affect the normal development of a male fetus. Dutasteride has been shown to decrease sperm count, motility, and semen volume, which may reduce fertility.
• Dutasteride Combix may affect the PSA blood test(prostate-specific antigen) used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but should be aware of this effect. If you have a blood test for PSA, inform your doctor that you are taking Dutasteride Combix.

Consult your doctor or pharmacist before starting to take Dutasteride Combix.

Taking Dutasteride Combix with other medications

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

Certain medications may interact with Dutasteride Combix, which can increase the risk of side effects. Some of these medications include:

• verapamil or diltiazem(for high blood pressure)
• ritonavir or indinavir(for AIDS)
• itraconazole or ketoconazole(for fungal infections)
• nefazodone(an antidepressant)
• Alpha-blockers(for enlarged prostate or high blood pressure)

Tell your doctor if you are taking any of these medications. It may be necessary to reduce the dose of Dutasteride Combix.

Taking Dutasteride Combix with food, drinks, and alcohol

Dutasteride Combix can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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 a male fetus. 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 dutasteride. If your partner is pregnant or may become pregnant, she should avoid exposure to your semen.

Dutasteride Combix has been shown to decrease sperm count, motility, and semen volume, which may reduce fertility.

Consult your doctorif a pregnant woman has been in contact with dutasteride.

Driving and using machines

It is unlikely that Dutasteride Combix will affect your ability to drive or use machines.

Dutasteride Combix contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).

3. How to take Dutasteride Combix

Follow the instructions for administration of this medication indicated by your doctor or pharmacist exactly.In case of doubt, consult your doctor or pharmacist again.

• The usual dose is one capsule (0.5 mg) once a day.The capsules of Dutasteride Combix 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.
• Treatment with Dutasteride Combix is long-term. Some men may experience rapid improvement in symptoms. However, others may need to continue treatment for 6 months or more before an effect is seen. Continue taking Dutasteride Combix for the time indicated by your doctor.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

If you take more Dutasteride Combix than you should

If you take too many Dutasteride Combix capsules, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Dutasteride Combix

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

If you stop taking Dutasteride Combix

Do not stop treatment with Dutasteride Combix without consulting your doctor first. It may take up to 6 months or more to notice an effect.

If you have any further questions on 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 everyone gets them.

Very rare allergic reaction

Symptoms of an allergic reaction can include:

• skin rash(which can itch)
• hives
• swelling of the eyelids, face, lips, arms, and legs.

You should contact your doctor immediatelyif you experience any of these symptoms and stop taking Dutasteride Combix.

Common side effects

These can affect up to 1 in 10 men taking dutasteride:

• impotence (inability to achieve or maintain an erection)
• decreased libido (sex drive)
• difficulty ejaculating
• breast tenderness or swelling (gynecomastia)
• dizziness, when taken with tamsulosin

Uncommon side effects

These can affect up to 1 in 100 men taking dutasteride:

• hair loss (usually from the body) or hair growth.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Surveillance 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 Combix

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

Do not store above 30°C.

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

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to a pharmacy or a designated collection point. This will help protect the environment.

6. Contents of the pack and further information

Composition of Dutasteride Combix

The other components are: glycerol monocaprylate, butylhydroxytoluene (E321), gelatin, glycerol (E422), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), titanium dioxide (E171), yellow iron oxide (E172), and purified water.

Appearance of the product and pack contents

Soft gelatin capsules, oblong, yellow, opaque, containing a clear or pale yellow oily liquid.

PVC/PVDC-Aluminum blisters with desiccant and OPA/Aluminum/PVC-Aluminum (standard and perforated). Dutasteride Combix is available in packs of 30 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d’activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of last revision of this package leaflet:August 2014

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