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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Dutasteride/tamsulosin hydrochloride

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

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

Leaflet contents

1. What Dutasteride/Tamsulosin Normogen is and what it is used for
2. What you need to know before taking Dutasteride/Tamsulosin Normogen
3. How to take Dutasteride/Tamsulosin Normogen
4. Possible side effects
5. How to store Dutasteride/Tamsulosin Normogen
6. Contents of the pack and other information

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

Dutasteride/Tamsulosin 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.

Dutasteride/Tamsulosin Normogen is a combination of two different medicines called dutasteride and tamsulosin. Dutasteride belongs to a group of medicines known as 5-alpha reductase inhibitors, and tamsulosin belongs to a group of medicines known as alpha-blockers.

As the prostate enlarges, it may cause urinary problems such as difficulty in passing urine and a need to urinate more frequently. It may also cause the urine stream to become weaker and less forceful. If benign prostatic hyperplasia is not treated, there is a risk that urine flow may become completely blocked (acute urinary retention), which 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, helping to shrink the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery. Tamsulosin works by relaxing the muscles in the prostate, making urination easier and rapidly improving symptoms.

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

Do not take dutasteride/tamsulosin Normogen

• If you are a woman (since this medicine is intended for men only).

• If you are a child or adolescent under 18 years of age.

• If you are allergic to dutasteride, to other 5-alpha reductase enzyme inhibitors, to tamsulosin, or to any of the other ingredients of this medicine (listed in section 6).

• If you have low blood pressure, causing dizziness, lightheadedness, or fainting (orthostatic hypotension).

• If you have a severe liver disease.

• This medicine may contain soybean oil. It must not be used if you are allergic to peanuts or soy.

• If you think you are in any of these situations, 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, the number of patients who experienced heart failure was higher in those taking dutasteride and another medicine called an alpha-blocker, such as tamsulosin, than in 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 affecting your liver, you may need additional monitoring during treatment with dutasteride/tamsulosin.
• Make sure your doctor knows if you have severe kidney problems.
• Cataract surgery (cloudy lens). If you are scheduled for cataract surgery, your doctor may ask you to stop taking dutasteride/tamsulosin for a period of time before the operation. Before the surgery, inform your ophthalmologist that you are taking dutasteride/tamsulosin or tamsulosin (or if you have previously taken them). Your specialist will need to take appropriate precautions to avoid complications during the procedure.
• Women, children, and adolescents should avoid contact with broken capsules of dutasteride/tamsulosin, as the active ingredient can be absorbed through the skin. If any contact with the skin occurs, the affected area must be washed immediately with soap and water.
• Use a condom during sexual intercourse. Dutasteride has been found in semen of men taking dutasteride/tamsulosin. If your partner is pregnant or suspects she may be pregnant, you must avoid exposing her to your semen, since dutasteride can affect the normal development of a male baby. Dutasteride causes a decrease in sperm count, sperm motility, and semen volume. This may reduce your fertility.
• Dutasteride/tamsulosin affects the serum PSA test (prostate-specific antigen) sometimes used to detect prostate cancer. Your doctor may still use this test to screen for prostate cancer, but must be aware of this effect. If you have a blood test to measure your PSA, inform your doctor that you are taking dutasteride/tamsulosin. Men being treated with dutasteride/tamsulosin should have regular PSA monitoring.
• In a clinical study conducted in men at increased risk of prostate cancer, men who took dutasteride developed a higher frequency of a more serious type of prostate cancer than those who did not take dutasteride. The effect of dutasteride on this more serious type of prostate cancer is not clear.
• Dutasteride/tamsulosin may cause breast enlargement and breast tenderness. If this causes discomfort, or if you notice lumps in the breast or nipple discharge, consult your doctor, as these changes may be signs of a serious illness, such as breast cancer.
• Changes in mood and depression

Depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with another medicine in the same therapeutic class (5-alpha-reductase inhibitor) taken orally. If you experience any of these symptoms, contact your doctor as soon as possible for further medical advice.

• Consult your doctor or pharmacist if you have any questions regarding the use of dutasteride/tamsulosin.

Other medicines and dutasteride/tamsulosin

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

Do not take dutasteride/tamsulosin with the following medicines:

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

Taking dutasteride/tamsulosin with the following medicines is not recommended:

• Ketoconazole (used to treat fungal infections).

Certain medicines may interact with dutasteride/tamsulosin, increasing the risk of adverse 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.

Taking dutasteride/tamsulosin with food and drink

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

Pregnancy, breastfeeding and fertility

Women must not take this medicine.

Women who are pregnant (or 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 particularly 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/tamsulosin. If your partner is pregnant or suspects she may be pregnant, she must avoid exposure to your semen.

It has been shown that dutasteride/tamsulosin decreases sperm count, sperm motility, and semen volume. This may reduce your fertility.

Consult your doctor if a pregnant woman has been exposed to dutasteride/tamsulosin.

Driving and using machines

Some people may experience dizziness during treatment with dutasteride/tamsulosin, which could affect their ability to drive or operate machinery safely.

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

Dutasteride/Tamsulosin Normogen contains propylene glycol and propylene glycol monocaprylate

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

3. How to take Dutasteride/Tamsulosin Normogen

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If you do not take this medicine regularly, monitoring 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 daily, 30 minutes after the same meal each day.

How to take it

The capsules must be swallowed whole, with water. Do not chew or open the capsules. Contact with the capsule contents may irritate your mouth or throat.

If you take more dutasteride/tamsulosin than you should

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

If you forget to take dutasteride/tamsulosin

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

Do not stop dutasteride/tamsulosin treatment without medical advice

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

Allergic reaction

Symptoms of an allergic reaction may include:

• Skin rash (which may be itchy).

• Hives (such as urticaria).

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

• Contact your doctor immediately if you experience any of these symptoms and stop taking dutasteride/tamsulosina.

Dizziness, lightheadedness, and fainting

This medicine may cause dizziness, lightheadedness, and, rarely, fainting. You should be cautious when getting up quickly after sitting or lying down, especially if you need to get up during the night, until you know how this medicine affects you. If you feel dizzy or experience lightheadedness during treatment, sit or lie down until these symptoms have passed.

Serious skin reactions

Signs of serious skin reactions may include:

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

• Contact your doctor immediately if you experience any of these symptoms and stop taking dutasteride/tamsulosine.

Frequent adverse effects

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

• Impotence (inability to achieve or maintain an erection)*.

• Decreased sexual desire (libido)*.

• Ejaculation disorders, such as reduced amount of semen released during sexual intercourse*.

• Enlargement of the breast and tenderness on palpation (gynecomastia).

• Dizziness.

• In a small number of individuals, some of these adverse events may persist after discontinuation of Dutasteride/Tamsulosin Normogen.

Uncommon adverse effects

May affect up to 1 in 100 patients:

• Heart failure (the heart becomes less efficient at pumping blood around the body. This may cause symptoms such as shortness of breath, excessive tiredness, and swelling in the ankles and legs).
• Drop in blood pressure upon standing.
• Faster than normal heartbeat (palpitations).
• Constipation, diarrhea, vomiting, feeling sick (nausea).
• Weakness or loss of strength.
• Headache.
• Itching, nasal congestion, or runny nose (rhinitis).
• Skin rash, hives, itching.
• Hair loss (usually body hair) or excessive hair growth.

Rare adverse effects

May affect up to 1 in every 1,000 patients:

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

Very rare side effects

May affect up to 1 in 10,000 patients:

• Prolonged and painful erection of the penis (priapism).
• Severe skin reactions (Stevens-Johnson syndrome).

Other adverse effects

Other adverse effects have occurred in a small number of patients, but their frequency is unknown (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 disturbances).
• Dry mouth.

Reporting of Adverse Reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride/Tamsulosin Normogen

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.

The expiry date refers to the last day of the month indicated. Shelf life after first opening: 90 days.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dutasteride/Tamsulosin Normogen

The active substances are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride. The other components are:

Hard capsule shell:

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

Soft capsule containing dutasteride:

Contents of the soft capsule:

• Monocaprylate propylene glycol.
• Butylhydroxytoluene type II (E321).

Soft capsule shell:

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

Tamsulosin pellets:

• Methylacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion (containing polysorbate 80 and sodium lauryl sulfate).
• Microcrystalline cellulose (E460).
• Dibutyl sebacate.
• Polysorbate 80 (E433).
• Hydrated colloidal silica.
• Calcium stearate.

Black ink:

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

Appearance of the product and contents of the container

This medicine is presented as hard, oblong capsules, size 0, with a brown body and beige cap, printed with C001 in black ink.

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

Only certain pack sizes may be marketed in your country.

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

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

Manufacturer

Laboratorios Leon Farma, S.A.

C/La Vallina, s/n

Polígono Industrial Navatejera

24193 Villaquilambre (León), SPAIN

Date of the most recent review of this leaflet: October 2025

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the package leaflet and outer packaging with your mobile phone (smartphone). You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85505/P_85505.html