DUTASTERIDE/TAMSULOSIN NORMOGEN 0.5 mg/0.4 mg HARD CAPSULES

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

Do not take dutasteride/tamsulosin normogen

• If you are a woman(since this medicine is only for men).
• If you are a child or adolescent under 18 years of age.

-,to other 5-alpha reductase inhibitors, to tamsulosinor to 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.
• This medicine may contain soybean oil. It should not be used in case of peanut or soy allergy.

If you think you may have any of these conditions, do not takethis 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 that affects your liver, you may need some additional checks during your treatment with dutasteride/tamsulosina.

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• Cataract surgery (cloudy lens). If you are going to have cataract surgery, your doctor may ask you to stop taking dutasteride/tamsulosina for a while before the operation. Before the operation, inform your ophthalmologist that you are taking dutasteride/tamsulosina or tamsulosin (or if you have taken them before). Your specialist will need to take the necessary precautions to avoid complications during the operation.
• Women, children, and adolescentsshould avoid contact with broken dutasteride/tamsulosina capsules, as the active ingredient can be absorbed through the skin. If there is any contact with the skin, the affected area should be washed immediatelywith water and soap.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride/tamsulosina. 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 a male baby. Dutasteride causes a decrease in sperm count, motility, and semen volume. This may reduce your fertility.
• Dutasteride/tamsulosina affects the PSA blood test(prostate-specific antigen) that is sometimes 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 dutasteride/tamsulosina. Men taking dutasteride/tamsulosina 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 high-grade prostate cancerthan those who did not take dutasteride. The effect of dutasteride on this type of high-grade prostate cancer is not clear.
• Dutasteride/tamsulosina may cause breast enlargement and breast tenderness. 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 pharmacistif you have any questions related to taking dutasteride/tamsulosina.

Other medicines and dutasteride/tamsulosina

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

Do not take dutasteride/tamsulosina with these medicines:

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

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

• Ketoconazole(used to treat fungal infections).

Certain medicines may interact with dutasteride/tamsulosina, which can increase the risk of 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 doctorif you are taking any of these medicines.

Taking dutasteride/tamsulosina with food and drinks

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

Pregnancy, breastfeeding, and fertility

Women should not takethis medicine.

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 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 dutasteride/tamsulosina. If your partner is pregnant or thinks she may be pregnant, you should avoid exposing her to your semen.

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

Consult your doctorif a pregnant woman has come into contact with dutasteride/tamsulosina.

Driving and using machines

Some people may experience dizziness during treatment with dutasteride/tamsulosina, 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 medicine contains 299.46 mg of propylene glycol in each hard capsule, equivalent to 4.27 mg/kg in weight.

3. How to take Dutasteride/Tamsulosin Normogen

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. If you do not take this medicine 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 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 more dutasteride/tamsulosina than you should

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

If you forget to take dutasteride/tamsulosina

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/tamsulosina without advice

Do not stop taking dutasteride/tamsulosina without consulting your doctor first.

If you have any other 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

The symptoms of an allergic reaction can include:

• Rash(which can itch).
• Hives(like nettle rash).

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

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, especially around the mouth, nose, eyes, and genitals(Stevens-Johnson syndrome).

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

Common side effects

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

• 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 *.
• Enlarged breasts and breast tenderness (gynaecomastia).
• Dizziness.

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

Uncommon side effects

May affect up to 1 in 100 patients:

• Heart failure (the heart becomes less efficient at pumping blood around the body. This could cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs).
• Low blood pressure when standing up.
• Fast heart rate (palpitations).
• Constipation, diarrhea, vomiting, nausea.
• Weakness or loss of strength.
• Headache.
• Itching, stuffy or runny nose (rhinitis).
• Rash, hives, itching.
• Hair loss (usually from the body) or excessive hair growth.

Rare side effects

May affect up to 1 in 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 side effects

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

• Abnormal or rapid heart rhythm (arrhythmia or tachycardia or atrial fibrillation).
• Difficulty breathing (dyspnoea).
• 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Dutasteride/Tamsulosin Normogen

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

Do not use this medicine after the expiry date which is stated on the carton and blister.

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dutasteride/Tamsulosin Normogen

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

Hard capsule shell:

• Black iron oxide (E172).
• Red iron oxide (E172).
• Titanium dioxide (E171).
• Yellow iron oxide (E172).
• Gelatin.

Soft capsule of dutasteride:

Content of the soft capsule:

• Propylene glycol monocaprylate.
• Butylhydroxytoluene type II (E321).

Soft capsule shell:

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

Tamsulosin pellets:

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

Black ink:

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

Appearance of the product and pack contents

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

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

Not all 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 last revision of this leaflet: January 2022

Other sources of information

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

You can access detailed and updated information about this medicinal product by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83699/P_83699.html