DUTASTERIDE CHEMO IBERICA 0.5 mg SOFT CAPSULES

1. What is Dutasteride Chemo Ibérica and what is it used for

Dutasteride is 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.

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

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 to 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 may also be used with another medicine called tamsulosin (used to treat symptoms of an enlarged prostate).

2. What you need to know before you take Dutasteride Chemo Ibérica

Do not take Dutasteride Chemo Ibérica:

• if you are allergic to dutasteride, other 5-alpha reductase inhibitors, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver disease.
• If you think you may be in one of these situations, do not takethis medicine until you have consulted your doctor.
• This medicine is only for men. Women, children, and adolescents must not take it.

Warnings and precautions

Consult your doctor before starting to take Dutasteride Chemo Ibérica.

• Make sure your doctor knows if you have liver problems. You may need additional monitoring during your treatment with dutasteride if you have any liver disease.
• Women, children, and adolescents must avoid contact with broken Dutasteride Chemo Ibérica capsules because the active substance can be absorbed through the skin. If there is any contact with the skin, the affected area must be washed immediately with water and soap.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride. If your partner is pregnant or thinks she may be pregnant, she must avoid exposure to your semen because dutasteride may affect the normal development of a male baby. Dutasteride has been shown to decrease sperm count, motility, and semen volume. This may reduce fertility.
• Dutasteride affects the PSA blood test (prostate-specific antigen) used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but must be aware of this effect. If you have a blood test for PSA, inform your doctor that you are taking this medicine. Men treated with dutasteride should have regular PSA monitoring.
• In a clinical study in men at increased 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 these serious types of prostate cancer is not clear.
• Dutasteride may cause breast enlargement and tenderness. If this causes 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 about taking this medicine.

Taking Dutasteride Chemo Ibérica with other medicines

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Certain medicines may interact with dutasteride, which may increase the risk of side effects. Some of these medicines are:

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

??Inform your doctor if you are taking any of these medicines. It may be necessary to reduce the dose of dutasteride

Taking Dutasteride Chemo Ibérica with food and drink

Dutasteride Chemo Ibérica can be taken with or without food.

Pregnancy, breast-feeding, and fertility

Pregnant women (or those who may be pregnant) must avoid contact with 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 must avoid exposure to your semen.

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

??Consult your doctor if a pregnant woman has been in contact with dutasteride.

Driving and using machines

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

Dutasteride Chemo Ibérica contains soy lecithin and propylene glycol

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

This medicine contains 299.46 mg of propylene glycol in each capsule.

3. How to take Dutasteride Chemo Ibérica

Take this medicine exactly as your doctor or pharmacist has told you.

If you do not take dutasteride regularly, your PSA levels may be affected.

What dose should you take

The recommended dose is one capsule (0.5 mg) once a day. The capsules of Dutasteride Chemo Ibérica 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. The capsules can be taken with or without food.

Treatment with this medicine 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 for as long as your doctor has told you.

If you take more Dutasteride than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915620420, indicating the medicine and the amount taken.

If you forget to take Dutasteride

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

Do not stop taking Dutasteride

Do not stop taking this medicine without consulting your doctor first. It may be necessary to take it for 6 months or more to see an effect.

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

Symptoms of an allergic reaction can include:

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

??You must immediately contact your doctor if you experience any of these symptoms and stop taking dutasteride.

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

• inability to achieve or maintain an erection (impotence), which may continue after stopping dutasteride
• decreased sex drive (libido), which may continue after stopping dutasteride
• difficulty with ejaculation, such as a decrease in the amount of semen released during sex, which may continue after stopping dutasteride
• breast tenderness or enlargement (gynecomastia)
• dizziness, when taken with tamsulosin

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

• heart failure (the heart becomes less efficient at pumping blood through the body, which may cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs)
• hair loss (usually from the body) or increased hair growth

Rare side effects(frequency not known):

• depression
• testicular pain and swelling

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride Chemo Ibérica

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date is the last day of the month stated.

Do not store above 30°C. Keep the blister in the original carton to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Dutasteride Chemo Ibérica

• The active substance is dutasteride. Each soft capsule contains 0.5 mg of dutasteride.
• The other ingredients are:

• capsule content: propylene glycol monocaprylate and butylhydroxytoluene
• capsule shell: gelatin, glycerol, titanium dioxide (E171), medium-chain triglycerides, and lecithin (may contain soybean oil (E-322))

Appearance and packaging

Dutasteride Chemo Ibérica are yellow, oblong, soft gelatin capsules (approximately 16.5 x 6.5 mm) filled with a clear liquid. Available in transparent, triple-layer (PVC-PE-PVCD/Aluminum) blisters in packs of 10, 30, 50, 60, and 90 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Marketing authorization holder:

CHEMO IBÉRICA, S.A.

Gran Vía Carlos III, 98, 7th floor,

08028 Barcelona (Spain)

Manufacturer

Laboratorios LEÓN FARMA, SA

Navatejera Industrial Estate

C/La Vallina, s/n

24193 Villaquilambre - León, Spain

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

Denmark Dutasterid Laboratorios León Farma

United Kingdom Durasteride 0.5 mg Soft Capsules

Spain Dutasterida Chemo Ibérica 0.5 mg soft capsules EFG

Sweden Dutasteride León Farma

Norway Dutasteride León Farma

Date of last revision of this leaflet:September 2021

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