DUTASTERIDE/TAMSULOSIN QUALIGEN 0.5 mg/0.4 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dutasteride/Tamsulosin Qualigen0.5 mg/0.4 mg hard capsules

Dutasteride/tamsulosin hydrochloride

Read all of this 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Dutasteride/tamsulosin 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, in patients already controlled with dutasteride and tamsulosin administered at the same time.

This medicine is a combination of two different medicines called 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 blockers.

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 and this helps to reduce the size of the prostate and relieve symptoms. This will reduce the risk of acute urinary retention and the need for surgery. Tamsulosin acts by relaxing the muscles of the prostate, making it easier to urinate and quickly improving symptoms.

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

Do not take dutasteride/tamsulosin:

• if you are allergic (hypersensitive) to dutasteride, other 5-alpha reductase inhibitors, tamsulosin or any of the other ingredients of this medicine (listed in section 6).
• this medicine contains soya lecithin, which may contain soya oil. It must not be used in case of peanut or soya allergy.
• if you have fainting spells due to low blood pressure when changing posture (sitting and standing) (orthostatic hypotension).
• if you have severe liver disease.
• if you are a woman, child or adolescent.

Consult your doctorif you think you are in any of these situations.

This medicine is only for men. It must not be taken by women, children or adolescents.

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.

• if you have liver problems. If you have any disease that affects your liver, you may need additional checks during your treatment with this medicine.

• if you have kidney problems.

• if you are going to have cataract surgery, inform your ophthalmologist that you are taking or have previously taken this medicine. Your ophthalmologist will need to take appropriate precautions to avoid complications during 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 contact with the skin, the affected area should be washed immediately with water and soap.

• use a condom in your sexual relations. Dutasteride has been found in the semen of men taking dutasteride/tamsulosin. If your partner is pregnant or thinks she may be pregnant, she should avoid exposure 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 male fertility.

• this medicine affects the PSA blood test (prostate-specific antigen) 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 this medicine. Men taking this medicine should have regular PSA checks.

• this medicine may cause breast enlargement and 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 male breast cancer.

Using dutasteride/tamsulosin with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This includes any medicines bought without a prescription.

Do not take dutasteride/tamsulosin with these medicines:

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

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

• ketoconazole (used to treat fungal infections).

Certain medicines may interact with dutasteride/tamsulosin, which may increase the risk of you experiencing 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 HIV)
• itraconazole or ketoconazole (for fungal infections)
• nefazodone (an antidepressant)
• cimetidine (for stomach ulcers)
• warfarin (for blood clotting)
• erythromycin (an antibiotic used to treat infections) in combination with paroxetine (an antidepressant) or in combination with terbinafine (used to treat fungal infections)
• terbinafine (for fungal infections)
• diclofenac (used to treat pain and inflammation)

Tell your doctorif you are taking any of these medicines.

Taking dutasteride/tamsulosin with food and drinks

You should take this medicine 30 minutes after the same meal each day.

Do not take this medicine with alcohol. Alcohol may worsen the side effects of this medicine.

Pregnancy, breast-feeding and fertility

Pregnant women (or women 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 in your sexual relations. Dutasteride has been found in the semen of men taking dutasteride/tamsulosin. If your partner is pregnant or thinks she may be pregnant, she should avoid exposure to your semen.

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

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Some people may experience dizziness during treatment with this medicine, which may affect their ability to drive or operate machinery safely.

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

This medicine contains propylene glycol (E1520).This medicine contains 299.46 mg of propylene glycol monocaprylate (E1520) per capsule, which is equivalent to 4.27 mg/kg.

3. How to take Dutasteride/Tamsulosin Qualigen

Always take this medicine exactly as your doctor has told you.If you are not sure, check with your doctor or pharmacist.

If you do not take this medicine regularly, the control of your PSA levels may be affected.

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/tamsulosin than you should

If you have taken too much of this medicine, contact your doctor or pharmacist immediately or go to the emergency department at your nearest hospital. Take the medicine pack with you.

If you forget to take this medicine

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

Do not stop taking this medicine

Do not stop taking this medicine without talking to your doctor first.

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 reaction

The symptoms of an allergic reaction can include:

• skin rash (which may itch)
• hives (like nettle rash)
• swelling of the eyelids, face, lips, arms or legs

Contact your doctor immediately if you experience any of these symptoms and stop taking this medicine.

Dizziness, fainting and fainting spells

This medicine may cause dizziness, fainting and, in rare cases, fainting spells. 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 faint 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, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)

Contact your doctor immediately if you have these symptoms and stop taking this medicine.

Common side effects (may affect more than 1 in 10 people)

• impotence (inability to achieve or maintain an erection)*
• decreased libido*
• difficulty with ejaculation*
• breast enlargement and tenderness (gynaecomastia)
• dizziness

*In a small number of people, some of these side effects may continue after stopping this medicine.

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

• heart failure (the heart becomes less efficient at pumping blood around the body. This could lead to symptoms such as difficulty breathing, excessive tiredness and swelling in the ankles and legs)
• reduced blood pressure when standing up
• fast heart rate (palpitations)
• constipation, diarrhoea, vomiting, nausea
• weakness or loss of strength
• headache
• itching, stuffy or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually from the body) or hair growth

Rare side effects (may affect up to 1 in 1,000 people)

• sudden swelling of the soft tissues of the body (e.g. the throat or tongue) difficulty breathing and/or itching and rash, often as an allergic reaction (angioedema)
• fainting

Very rare side effects (may affect up to 1 in 10,000 people)

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

Other side effects

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

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 via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dutasteride/Tamsulosin Qualigen

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.

Store below 25°C.

After first opening of the container: 90 days.

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 to protect the environment.

6. Contents of the pack and other information

Composition of Dutasteride/Tamsulosin Qualigen

• 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 ingredients are:

Hard capsule shell:iron oxide black (E172), iron oxide red (E172), titanium dioxide (E171), iron oxide yellow (E172), gelatin.

Soft capsule shell:

Contents of the soft capsule shell:propylene glycol monocaprylate, butylhydroxytoluene (E321).

Soft capsule shell:gelatin, glycerol (E422), titanium dioxide (E171).

Tamsulosin pellets:methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 percent (also contains polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose (E460), dibutyl sebacate, polysorbate 80 (E433), colloidal hydrated 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 pack

This medicine is available in hard capsules, oblong, No. 0EL, with a brown body and a beige cap, printed with C001 in black ink.

Dutasteride/Tamsulosin Qualigen is available in high-density polyethylene (HDPE) bottles of 30 capsules.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí – (Barcelona) Spain

Manufacturer:

Laboratorios LEÓN FARMA, SA

Polígono Industrial Navatejera

C/La Vallina, s/n -24193 Villaquilambre -León

Spain

Date of last revision of this leaflet: September 2021

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