Package Insert: Information for the Patient

Dutasteride/Tamsulosin Almus Pharma0.5 mg/0.4 mg Hard Capsules

Dutasteride/hydrochloride of tamsulosin

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Dutasterida/tamsulosina is used in men to treat an enlarged prostate (benign prostatic hyperplasia) - a non-cancerous growth of the prostate caused by producing an excess of a hormone called dihydrotestosterone, in patients already controlled with dutasterida and tamsulosina administered together.

This medication is a combination of two different medications called dutasterida and tamsulosina. Dutasterida belongs to the group of medications called 5-alpha reductase inhibitors and tamsulosina belongs to the group of medications called alpha blockers.

As the prostate enlarges, it can produce urinary problems such as difficulty in urinating and a need to urinate more frequently. It can also cause the urine stream to be smaller and less forceful. If benign prostatic hyperplasia is not treated, there is a risk of the urine flow being 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.

Dutasterida 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. Tamsulosina acts by relaxing the muscles of the prostate, making urination easier and rapidly improving symptoms.

Do not take dutasteride/tamsulosin:

- If you are allergic (hypersensitive) to dutasteride, other 5-alpha reductase inhibitors, tamsulosin, soy, peanuts, or any other component of this medication (listed in section 6).

- If you experience dizziness due to decreased blood pressure when changing positions (orthostatic hypotension).

- If you have a severe liver disease.

- If you are a woman, child, or adolescent.

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

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

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.

• If you have liver problems. If you have any liver disease, you may need additional monitoring during your treatment with this medication.

• If you have kidney problems.

• If you are about to undergo cataract surgery, inform your ophthalmologist that you are taking or have taken this medication previously. Your ophthalmologist 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 immediately with water and soap.

• Use a condom during sexual intercourse. 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. This may reduce your fertility.

• This medication 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 be aware of this effect. If you have a blood test to determine your PSA, inform your doctor that you are taking this medication. Men taking this medication should have regular PSA monitoring.

• In a clinical study conducted in men at high risk of developing prostate cancer, men who took dutasteride presented with more frequent severe prostate cancer than those who did not take dutasteride. The effect of dutasteride on this type of severe prostate cancer is unclear.

• This medication 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 male breast cancer.

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. This includes any medication purchased without a prescription.

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 increase the risk of 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)

• 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).

Inform your doctorif you are taking any of these medications.

Taking dutasteride/tamsulosin with food and drinks

You should take this medication 30 minutes after the same meal every day.

Do not take this medication with alcohol. Alcohol may worsen the adverse effects of this medication.

Pregnancy, breastfeeding, and fertility

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 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 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 male fertility.

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

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

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

This medication contains lecithin from soy, propylene glycol, and sodium.

This medication contains lecithin from soy, which may contain soy oil. It should not be used in case of allergy to peanuts or soy.

This medication contains 299.46 mg of propylene glycol (E1520) in each capsule, equivalent to 4.27 mg/kg.

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

If you do not take this medication 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 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 immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take this medication

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

Do not interrupt the treatment of this medication

Do not interrupt the treatment with this medication without consulting your doctor first.

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

Like all medicines, this medicine 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 (like urticaria)

•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, lightheadedness, and fainting

This medicine 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 medicine 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 immediately if you have these symptoms and stop using 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*

•enlargement of the breasts and breast tenderness (gynecomastia)

•dizziness

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

•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)

•reduced blood pressure when standing

•abnormal or rapid heartbeat (palpitations)

•constipation, diarrhea, vomiting, discomfort (nausea)

•weakness or loss of strength

•headache

•itching, congestion, or nasal discharge (rhinitis)

•skin rash, hives, itching

•hair loss (usually on the body) or hair growth

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

•sudden local swelling of soft body tissues (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

The frequency cannot be estimated from the available data:

•abnormal or accelerated heartbeat (arrhythmia or tachycardia or atrial fibrillation)

•difficulty breathing (dyspnea)

•depression

•testicular pain and swelling

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 the 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 medicine.

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.

Store below 25°C.

After the first opening of the packaging: 90 days.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Dutasteride/Tamsulosin Almus Pharma Composition

• The active ingredients are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.
• 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:propylene glycol monocaprylate, butylhydroxytoluene (E321).

Soft Capsule Coating:gelatin, glycerol (E422), titanium dioxide (E171).

Tamsulosin Pellets:copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion 30 percent (also contains 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).

Product Appearance and Packaging Content

This medication is presented inhard, oblong, 0el-numbered capsules, with a brown body and beige cap, printed with C001 in black ink.

It is available in high-density polyethylene (HDPE) bottles of 30 capsules.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible Manufacturer:

Laboratorios León Farma, S.A.

Navatejera Industrial Estate

C/La Vallina, s/n

24193 Villaquilambre (León), Spain

Last Review Date of this Leaflet: December 2018

For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es