Dutasteride + Tamsulosin hidrohloride Leun Farma

Package Leaflet: Information for the User

Dutasteride + Tamsulosin hydrochloride León Farma, 0.5 mg + 0.4 mg, hard capsules
Dutasteride + Tamsulosin hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Dutasteride + Tamsulosin hydrochloride León Farma and what is it used for
• 2. Important information before taking Dutasteride + Tamsulosin hydrochloride León Farma
• 3. How to take Dutasteride + Tamsulosin hydrochloride León Farma
• 4. Possible side effects
• 5. How to store Dutasteride + Tamsulosin hydrochloride León Farma
• 6. Contents of the pack and other information

1. What is Dutasteride + Tamsulosin hydrochloride León Farma and what is it used for

Dutasteride + Tamsulosin hydrochloride León Farma is used in men with an enlarged

prostate gland( benign prostatic hyperplasia) – a non-cancerous enlargement of the prostate gland caused by excessive production of a hormone called dihydrotestosterone.
Dutasteride + Tamsulosin hydrochloride León Farma is a combination of two different medicines:
dutasteride and tamsulosin.
Dutasteride belongs to a group of medicines called 5-alpha-reductase inhibitors, and tamsulosin belongs to a group of medicines called alpha-adrenergic receptor antagonists.
Enlargement of the prostate gland can lead to problems with urination, such as difficulty urinating and frequent urination. There may also be a decrease in urine flow and a weak urine stream. If left untreated, it can lead to complete blockage of urine flow ( acute urinary retention). This situation requires immediate treatment. In some cases, surgical intervention is necessary to remove the prostate gland or reduce its size.
Dutasteride reduces the production of the hormone dihydrotestosterone, which leads to a reduction in the size of the prostate gland and alleviation of symptoms. By doing so, dutasteride reduces the risk of acute urinary retention and the need for surgical intervention. The action of tamsulosin is to relax the muscles in the prostate gland, making it easier to urinate and quickly alleviating symptoms.

2. Important information before taking Dutasteride + Tamsulosin hydrochloride León Farma

When not to take Dutasteride + Tamsulosin hydrochloride León Farma

• if the patient is a woman, as this medicine is only intended for men,
• if the patient is a child or adolescent under 18 years of age,
• if the patient is allergic to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, soy, or peanutsor any of the other ingredients of this medicine (listed in section 6.),
• if the patient has low blood pressure, causing dizziness, fainting, or lightheadedness ( orthostatic hypotension),
• if the patient has severe liver disease.

➔ If any of the above applies to you, do not take this medicineuntil you have consulted your doctor.

Warnings and precautions

Before taking Dutasteride + Tamsulosin hydrochloride León Farma, discuss it with your doctor.

• In some clinical trials, an increased incidence of heart failure was observed in patients taking dutasteride in combination with an alpha-adrenergic receptor antagonist (such as tamsulosin) compared to patients taking dutasteride or an alpha-adrenergic receptor antagonist alone. Heart failure means that the heart is not pumping blood as well as it should.
• Tell your doctor if you have liver disease.If you have had liver disease, you may need to have additional tests while taking Dutasteride + Tamsulosin hydrochloride León Farma.
• Tell your doctor if you have kidney disease.
• Cataract surgery (cloudy lens).If you are going to have cataract surgery, your doctor may advise you to stop taking Dutasteride + Tamsulosin hydrochloride León Farma for a certain period before surgery. You should tell your ophthalmologist that you are taking or have taken Dutasteride + Tamsulosin hydrochloride León Farma. Your doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescentsshould not handle damaged capsules of Dutasteride + Tamsulosin hydrochloride León Farma, as the active substance may be absorbed through the skin. If contact with the skin occurs, wash the affected area immediately with soap and water.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking Dutasteride + Tamsulosin hydrochloride León Farma. If your partner is pregnant or may become pregnant, you should avoid exposing her to your semen. Dutasteride may affect the development of a male baby. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility, which may reduce fertility in men.
• Dutasteride + Tamsulosin hydrochloride León Farma affects the measurement of prostate-specific antigen (PSA), which is sometimes used to diagnose prostate cancer. However, your doctor may still decide to perform this test. If you are having a PSA test, tell your doctor that you are taking Dutasteride + Tamsulosin hydrochloride León Farma. Patients taking Dutasteride + Tamsulosin hydrochloride León Farma should have their PSA levels checked regularly.

Dutasteride + Tamsulosin hydrochloride León Farma and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

• other alpha-adrenergic receptor antagonists(used to treat enlarged prostate or high blood pressure)

It is not recommended to take Dutasteride + Tamsulosin hydrochloride León Farma with the following medicines:

• ketoconazole(used to treat fungal infections)

Some medicines may interact with Dutasteride + Tamsulosin hydrochloride León Farma and increase the risk of side effects. These include:

• PDE5 inhibitors[used to induce or maintain an erection (erection)], such as vardenafil, sildenafil citrate, and tadalafil
• verapamil or diltiazem(used to treat high blood pressure)
• ritonavir or indinavir(used to treat HIV infection)
• itraconazole or ketoconazole(used to treat fungal infections)
• nefazodone(an antidepressant)
• cimetidine(used to treat stomach ulcers)
• warfarin(used to treat blood clots)
• erythromycin(an antibiotic used to treat infections)
• paroxetine(an antidepressant)
• terbinafine(used to treat fungal infections)
• diclofenac(used to treat inflammatory conditions and pain)

➔ Tell your doctorif you are taking any of these medicines.

Dutasteride + Tamsulosin hydrochloride León Farma with food

Dutasteride + Tamsulosin hydrochloride León Farma should be taken 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

It is contraindicatedto take Dutasteride + Tamsulosin hydrochloride León Farma during pregnancy.

Pregnant women (or women who may be pregnant) should not handle damaged capsules.

Dutasteride is absorbed through the skin and may affect the development of a male baby. There is a special risk 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 hydrochloride León Farma. If your partner is pregnant or may become pregnant, you should avoid exposing her to your semen.
It has been shown that Dutasteride + Tamsulosin hydrochloride León Farma reduces sperm count, semen volume, and sperm motility, which may reduce fertility in men.
➔ If a pregnant woman has come into contact with Dutasteride + Tamsulosin hydrochloride León Farma, she should consult a doctor.

Driving and using machines

Dutasteride + Tamsulosin hydrochloride León Farma may cause dizziness, which can negatively affect the ability to drive and operate machinery.
➔ If you experience such symptoms, do not drive or operate machinery.

Dutasteride + Tamsulosin hydrochloride León Farma contains soy lecithin, propylene glycol, and sodium

This medicine contains soy lecithin, may contain soybean oil. Do not take if you are allergic to peanuts or soy.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.
This medicine contains 299 mg of propylene glycol in each capsule.

3. How to take Dutasteride + Tamsulosin hydrochloride León Farma

Always take this medicine exactly as your doctor or pharmacist has told you.Irregular intake of the medicine may affect the results of PSA tests. If you are unsure, consult your doctor or pharmacist.

How much to take

The recommended dose is one capsule taken once a day, 30 minutes after the same meal each day.

How to take the medicine

Swallow the capsule whole with water.Do not chew or open the capsules. Contact with the contents of the capsules can cause mouth or throat pain.

Taking more than the recommended dose of Dutasteride + Tamsulosin hydrochloride León Farma

If you have taken more than the recommended number of capsules of Dutasteride + Tamsulosin hydrochloride León Farma, consult your doctor or pharmacist.

Missing a dose of Dutasteride + Tamsulosin hydrochloride León Farma

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

Stopping treatment with Dutasteride + Tamsulosin hydrochloride León Farma

Do not stop taking Dutasteride + Tamsulosin hydrochloride León Farma unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions

Signs of an allergic reaction may include:

• skin rash(which may be itchy)
• hives
• swelling of the eyelids, face, lips, hands, or feet.

➔ If you experience any of these symptoms, contact your doctor immediately and stop taking Dutasteride + Tamsulosin hydrochloride León Farma.

Dizziness, lightheadedness, and fainting

Dutasteride + Tamsulosin hydrochloride León Farma may cause dizziness, lightheadedness, or fainting. Until you know how the medicine affects you, be careful when changing positions from lying down or sitting to standing, especially when getting up in the middle of the night. If you experience dizziness or lightheadedness at any time during treatment, sit or lie down and wait for the symptoms to pass.

Severe skin reactions

Signs of a severe skin reaction may include:

• widespread rash with blisters and peeling skin, especially on the mouth, nose, eyes, and genitals(Stevens-Johnson syndrome) ➔ If you experience any of these symptoms, contact your doctor immediately and stop taking Dutasteride + Tamsulosin hydrochloride León Farma.

Common side effects

May occur in up to 1 in 10 men taking Dutasteride + Tamsulosin hydrochloride León Farma:

• impotence (inability to achieve or maintain an erection)*
• decreased sex drive (libido)*
• difficulty with ejaculation, including reduced semen volume during ejaculation*
• enlargement or tenderness of the breast tissue (gynecomastia)
• dizziness. * In a small number of patients, these side effects may persist even after stopping Dutasteride + Tamsulosin hydrochloride León Farma.

Uncommon side effects

May occur in up to 1 in 100 men taking Dutasteride + Tamsulosin hydrochloride León Farma:

• heart failure (less efficient pumping of blood by the heart. Possible symptoms include shortness of breath, extreme fatigue, and swelling in the ankles and feet)
• low blood pressure when standing up
• rapid heartbeat ( palpitations)
• constipation, diarrhea, vomiting, nausea
• weakness or loss of strength
• headache
• itching or stuffy nose, runny nose ( rhinitis)
• skin rash, hives, itching
• hair loss (usually body hair) or excessive hair growth.

Rare side effects

May occur in up to 1 in 1,000 men taking Dutasteride + Tamsulosin hydrochloride León Farma:

• swelling of the eyelids, face, lips, hands, or feet ( angioedema)
• fainting.

Very rare side effects

May occur in up to 1 in 10,000 men taking Dutasteride + Tamsulosin hydrochloride León Farma:

• prolonged, painful erection of the penis ( priapism)
• severe skin reactions ( Stevens-Johnson syndrome).

Other side effects

Other side effects have occurred in a small number of men, but their exact frequency is unknown (based on available data, the frequency cannot be estimated):

• abnormal or rapid heart rhythm ( arrhythmia, tachycardiaor atrial fibrillation)
• difficulty breathing ( dyspnea)
• depression
• testicular pain and swelling
• nosebleeds
• severe skin rash
• vision changes ( blurred vision or vision problems)
• dry mouth.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via the online reporting system. You can also report side effects to the manufacturer. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dutasteride + Tamsulosin hydrochloride León Farma

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 after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. 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

What Dutasteride + Tamsulosin hydrochloride León Farma contains

The active substances are dutasteride and tamsulosin hydrochloride. Each hard capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride (equivalent to 0.367 mg of tamsulosin).
Hard capsule shell
Black iron oxide (E 172)
Red iron oxide (E 172)
Titanium dioxide (E 171)
Yellow iron oxide (E 172)
Gelatin
Soft capsule with dutasteride
Propylene glycol monocaprylate, type II
Butylhydroxytoluene (E 321)
Soft capsule shell
Gelatin
Glycerol
Titanium dioxide (E 171)
Saturated fatty acid triglycerides
Lecithin (may contain soybean oil)
Tamsulosin pellets
Methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion (contains polysorbate 80 and sodium lauryl sulfate)
Microcrystalline cellulose
Dibutyl sebacate
Polysorbate 80
Hydrated silica
Calcium stearate
Black ink
Shellac (E 904)
Black iron oxide (E 172)
Propylene glycol (E 1520)
Concentrated ammonia (E 527)
Potassium hydroxide (E 525)
See section 2 "Dutasteride + Tamsulosin hydrochloride León Farma contains soy lecithin and propylene glycol".

What Dutasteride + Tamsulosin hydrochloride León Farma looks like and contents of the pack

This medicine is oval and hard gelatin capsules, approximately 24.2 mm x 7.7 mm in size, with a brown body and a beige cap, with "C001" printed in black ink.
Inside each hard capsule, there are pellets with modified release, containing tamsulosin hydrochloride, and one soft gelatin capsule containing dutasteride.
Dutasteride + Tamsulosin hydrochloride León Farma is available in packs of 7, 30, or 90 capsules.
Not all pack sizes may be available in your country.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorios LEÓN FARMA, SA
C/La Vallina, s/n, Polígono Industrial Navatejera
Villaquilambre-24008 (León)
Spain

Manufacturer

Laboratorios LEÓN FARMA, SA
C/La Vallina, s/n, Polígono Industrial Navatejera
Villaquilambre-24008 (León)
Spain
DEMO S.A. Pharmaceutical Industry
21 st km National Road Athens-Lamia, Krioneri, Attiki
GR-14568 Krioneri, Attiki
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Denmark
Dutatex
Czech Republic
Dutatex 0.5 mg/0.4 mg tvrdé tobolky
Greece
ZYTODUR 0.5 mg/0.4 mg, σκληρά καψάκια
Spain
Dutasterida/Tamsulosina Combix Pharma 0,5 mg/0,4 mg cápsulas duras EFG
Portugal
Dutasterida + Tansulosina Bluepharma
Croatia
Atekago 0,5 mg/0,4 mg tvrde kapsule

Date of last revision of the package leaflet: