Prospecto: information for the user

Dutasteride/Tamsulosin Normogen 0.5mg/0.4mg hard EFG capsules

Dutasteride/hydrochloride of tamsulosin

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Dutasteride/Tamsulosin Normogen and for what it is used

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

3. How to take Dutasteride/Tamsulosin Normogen

4. Possible adverse effects

5. Storage of Dutasteride/Tamsulosin Normogen

6. Contents of the package and additional information

Dutasterida/Tamsulosina Normogen 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.

Dutasterida/Tamsulosina Normogen is a combination of two different medications called dutasteride and tamsulosin. Dutasteride belongs to a group of medications called5-alpha reductase inhibitorsand tamsulosin belongs to a group of medications calledalpha blockers.

As the prostate grows in size, it can produce urinary problems such as difficulty in urinating and a need to urinate more frequently. It can also cause a smaller and weaker urine stream. If benign prostatic hyperplasia is not treated, there is a risk of complete blockage of the urine flow (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. Tamsulosin acts by relaxing the muscles of the prostate, making urination easier and rapidly improving symptoms.

Do not take dutasteride/tamsulosin Normogen

• If you are awoman(since this medication is only for men).
• If you are achild or adolescent under 18years of age.

-If you areallergicto dutasteride, other5-alpha reductase inhibitors, to tamsulosinor to any of the other components of this medication (listed in section6).

• If you havelow blood pressure,which makes you feel dizzy, lightheaded, or faint(orthostatic hypotension).
• If you have anyserious liver disease.
• This medication may contain soy oil. Do not use it if you are allergic to peanuts or soy.

If you think you have any of these conditions,do not takethis medication until you have consulted with your doctor.

Warnings and precautions

Consult your doctor before starting to take this medication.

• In some clinical studies, the number of patients who experienced heart failure was higher in those who took dutasteride and another medication called an alpha blocker, such as tamsulosin, than in those who took only dutasteride or only an alpha blocker. Heart failure means that your heart is not pumping blood as it should.
• Make sure your doctor knows if you have liver problems.If you have any liver disease, you may need additional monitoring during your treatment with dutasteride/tamsulosin.

-Make sure your doctor knows if you have any 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 surgery. Before the surgery, inform your eye surgeon that you are taking dutasteride/tamsulosin or have taken it before. Your specialist will need to take the necessary precautions to avoid complications during the surgery.
• 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 skin contact,the affected area should be washed immediatelywith water and soap.
• Use a condom during sex.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 the male fetus. Dutasteride causes a decrease in sperm count, motility, and semen volume, which may reduce your fertility.
• Dutasteride/tamsulosin affects the PSA blood test(prostate-specific antigen) used sometimes to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, but they should know about this effect. If you have a blood test to determine your PSA, inform your doctor that you are taking dutasteride/tamsulosin.Men taking dutasteride/tamsulosin should have regular PSA monitoring.
• In a clinical study conducted in men at increased risk of developing prostate cancer, men who took dutasteride had a higher frequency of aserious type of prostate cancerthan those who did not take dutasteride. The effect of dutasteride on this serious type of prostate cancer is unclear.
• Dutasteride/tamsulosin may cause breast enlargement and tenderness.If this causes you discomfort, or if you notice lumps in your breast or nipple discharge, consult your doctor, as these changes may be signs of a serious disease, such as breast cancer.

Consult your doctor or pharmacistif you have any questions related to taking dutasteride/tamsulosin.

Other medications and dutasteride/tamsulosin

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not take dutasteride/tamsulosin with these medications:

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

Do not take dutasteride/tamsulosin with these medications:

• Ketoconazole(used to treat fungal infections).

Certain medications may interact with dutasteride/tamsulosin, which may cause you to experience adverse effects. Some of these medications are:

• Phosphodiesterase type 5 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/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).

Inform your doctorif you are taking any of these medications.

Taking dutasteride/tamsulosin with food and drinks

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

Pregnancy, breastfeeding, and fertility

Women should not takethis 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 the male fetus. This risk is especially important in the first 16weeks of pregnancy.

Use a condom during sex.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.

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

Driving and operating machinery

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 Normogen contains propylene glycol and propylene glycol monocaprylate

This medication contains 299.46 mg of propylene glycol in each hard capsule, equivalent to 4.27 mg/kg in weight.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If you do not take this medication 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 every day.

How to take it

The capsules should be swallowed whole, with water. Do not chew or break the capsules. Contact with the contents of the capsules may irritate your mouth or throat.

If you take more dutasterida/tamsulosina than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take dutasterida/tamsulosina

Do not take a double dose to compensate for the missed doses. Take the next dose at the usual time.

Do not interrupt dutasterida/tamsulosina treatment without advice

Do not interrupt treatment with dutasterida/tamsulosina without consulting your doctor first.

If you have any other questions about the use of this medication, consult your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Allergic reaction

The symptoms of an allergic reaction may include:

• Skin rash(which may itch).
• Hives(such as urticaria).

-Swelling of the eyelids, face, lips, arms, or legs.

Contact your doctor immediatelyif you experience any of these symptoms andstop taking dutasteride/tamsulosin.

Dizziness, lightheadedness, and fainting

This medication may cause dizziness, lightheadedness, and, in rare cases, fainting. 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 medication affects you. If you feel dizzy or experience lightheadedness during treatment,sit or lie down until these symptoms have disappeared.

Severe skin reactions

The signs of severe skin reactions may include:

• Widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals(Stevens-Johnson syndrome).

Contact your doctor immediatelyif you experience any of these symptoms andstop taking dutasteride/tamsulosin.

Common side effects

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

• Impotence (inability to achieve or maintain an erection)*.
• Decreased libido*.
• Difficulty with ejaculation, such as a decrease in the amount of semen released during sexual intercourse*.
• Enlargement of the breasts and pain on palpation (gynecomastia).
• Dizziness.

* In a small number of people, some of these adverse events may continue after stopping Dutasteride/Tamsulosin Normogen.

Rare side effects

May affect up to 1 in 100patients:

• Heart failure (the heart becomes less efficient at pumping blood throughout the body. This could cause symptoms such as difficulty breathing, excessive fatigue, and inflammation in the ankles and legs).
• Decreased blood pressure when standing.
• Abnormal heart rhythm (arrhythmia or tachycardia or atrial fibrillation).
• Constipation, diarrhea, vomiting, discomfort (nausea).
• Weakness or loss of strength.
• Headache.
• Itching, congestion, or dripping nasal discharge (rhinitis).
• Skin rash, hives, itching.
• Loss of hair (usually on the body) or hair growth.

Very rare side effects

May affect up to 1 in 1,000patients:

• Swelling of the eyelids, face, lips, arms, or legs (angioedema).
• Fainting.

Extremely rare side effects

May affect up to 1 in 10,000patients:

• Erection lasting more than 4 hours and painful (priapism).
• Severe skin reactions (Stevens-Johnson syndrome).

Other side effects

Other side effects have been reported in a reduced number of patients, but their exact frequency is unknown (the frequency cannot be estimated from the available data):

• Abnormal or rapid heart rhythm (arrhythmia or tachycardia or atrial fibrillation).
• Difficulty breathing (shortness of breath).
• Depression.
• Pain and swelling in the testicles.
• Nasal bleeding.
• Severe skin rash.
• Changes in vision (blurred vision or visual problems).
• Dry mouth.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and in the bottle.

The expiration date is the last day of the month indicated.Shelf life once opened: 90 days

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Dutasteride/Tamsulosin Normogen Composition

The active ingredients are dutasteride and hydrochloride of tamsulosin. Each capsule contains0.5mg of dutasteride and 0.4mg of hydrochloride of tamsulosin. The other components are:

Dura Capsule Coating:

• Iron oxide black (E172).
• Iron oxide red (E172).
• Titanium dioxide (E171).
• Iron oxide yellow (E172).
• Gelatin.

Dutasteride Soft Capsule:

Soft Capsule Content:

• Monocapryl propylene glycol.
• Butylhydroxytoluene typeII (E321).

Soft Capsule Coating:

• Gelatin.
• Glycerol (E422).
• Titanium dioxide (E171).
• Medium-chain triglycerides.
• Leithin (E322) (may contain soy oil).

Tamsulosin Pellets:

• Methacrylic acid-acrylate copolymer (1:1) dispersion at 30%(contains polisorbate80 and sodium lauryl sulfate).
• Microcrystalline cellulose (E460).
• Dibutyl sebacate.
• Polisorbate80 (E433).
• Colloidal hydrated silica.
• Calcium stearate.

Black Ink:

• Shellac (E904).
• Iron oxide black (E172).
• Propylene glycol (E1520).
• Concentrated ammonia solution (E527).
• Potassium hydroxide (E525).

Product Appearance and Packaging Content

This medication is presented in hard, oblong capsules, number0, with a brown body and beige cap printed with C001 in black ink.

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

Only some packaging sizes may be marketed in your country.

Marketing Authorization Holder

NORMON LABORATORIES, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Responsible for Manufacturing

Leon Farma Laboratories, S.A.

C/La Vallina, s/n

Navatejera Industrial Estate

24193 Villaquilambre (León), SPAIN

Last review date of this leaflet: January 2022

Other sources of information

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