Leaflet: information for the patient

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

Dutasteride/hydrochloride of tamsulosin

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

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

1. What isDutasteride/Tamsulosin Aristoand what it is used for

2. What you need to know before you start takingDutasteride/Tamsulosin Aristo

3. How to takeDutasteride/Tamsulosin Aristo

4. Possible side effects

5. Storage ofDutasteride/Tamsulosin Aristo

6. Contents of the pack and additional information

This medicationis 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.

Dutasterida/Tamsulosina Aristo is a combination of two different medications called dutasteride and tamsulosin. Dutasteride belongs to a group of medications called5-alpha reductase inhibitorsand tamsulosin belongs to a group of medications calledalpha blockers.

As the prostate enlarges, it may produce urinary problems such as difficulty in urinating and a need to urinate more frequently. It may 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.

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

Do not take dutasteride/tamsulosin:

• if you are awoman(becausethis medication is only for men)
• if you are achild or adolescent under 18 years of age
• if you are allergic to dutasteride, to other5-alpha reductase inhibitors, to tamsulosin, to soy, peanutsor to any of the other components of this medication (listed in section 6)
• if you havelow blood pressure, which makes you feel dizzy, lightheaded, or faint (orthostatic hypotension)
• if you have anyserious liver disease

?If you think you have any of these conditions,do not takethis medication until you have consulted with your doctor.

Warnings and precautions

Consult your doctor before starting to take dutasteride/tamsulosin.

• In some clinical studies,there was a higher number of patients taking dutasteride and another medication called an alpha blocker, such as tamsulosin, who experienced heart failure compared to patients taking only dutasteride or only an alpha blocker. Heart failure means that your heart is not pumping 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 monitoring during your treatment with dutasteride/tamsulosin.

• Make sure your doctor knows if you have severe kidney problems

• Cataract surgery (opaque lens). If you are going to have cataract surgery, your doctor may ask you to stop taking dutasteride/tamsulosin for a while before the surgery. Before the surgery, inform your ophthalmologist that you are taking dutasteride/tamsulosin or have taken it before. Your specialist will need to take the necessary precautions to avoid complications during the surgery.

• Women, children, and adolescentsshould 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 immediatelywith water and soap.

• Use a condom during sex. 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.

• Dutasteride/tamsulosin 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 he or she should know about this effect. If you have a blood test to determine your PSA, inform your doctor that you are taking dutasteride/tamsulosin.

Men taking dutasteride/tamsulosin should have regular PSA checks.

• In a clinical study conducted in men at increased risk of developing prostate cancer, men taking dutasteride presented withmore frequently a type of severe prostate cancerthan those not taking dutasteride. The effect of dutasteride on this type of severe prostate cancer is unclear.

• Dutasteride/tamsulosin 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 breast cancer.

?Consult your doctor or pharmacist if you have any doubts related to taking dutasteride/tamsulosin.

Use of dutasteride/tamsulosin with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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 cause you to experience adverse effects. Some of these medications are:

• inhibitors of the enzyme PDE5(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/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)
• terbinafineafin(used to treat fungal infections)
• diclofenac(used to treat pain and inflammation).

??Inform your doctorif you are taking any of these medications.

Taking Dutasteride/Tamsulosin Aristo with food and drinks

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

Pregnancy, breastfeeding, and fertility

Women should not takedutasteride/tamsulosin.

Women who are pregnant (or may be pregnant) should avoid contact with brokencapsules. 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.

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

Use a condom during sex. 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 your fertility.

Driving and operating machinery

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

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

This medication containsyellow orange S (E110), soy lecithin, and sodium.

It may cause allergic reactions because it contains yellow orange S (E110). It may provoke asthma,especially in patients allergic to acetylsalicylic acid.

Dutasteride/Tamsulina Aristo contains soy lecithin. It should not be used in case of allergy to peanuts or soy.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.If you do not take dutasteride/tamsulosin 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 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 dutasteride/tamsulosin 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 dutasteride/tamsulosin

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

Do not interrupt dutasteride/tamsulosin treatment without advice

Do not interrupt treatment with dutasteride/tamsulosin 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 can 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 immediatelyif you experience any of these symptoms andstop taking dutasteride/tamsulosin.

Dizziness, lightheadedness, and fainting

Dutasteride/tamsulosin may cause dizziness, lightheadedness, and, in rare cases, fainting. You should be cautious when standing 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 immediatelyif you experience any of these symptoms andstop taking dutasteride/tamsulosin.

Common side effects(may affect up to 1 in 10 patients):

• impotence (inability to achieve or maintain an erection)*
• decreased libido*
• difficulty with ejaculation, such as a decrease in the amount of semen released during sexual intercourse*
• enlargement of the breasts and tenderness to the touch (gynecomastia)
• dizziness

* In a small number of people, some of these adverse events may continue after stopping dutasteride/tamsulosin.

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

• heart failure (the heart becomes less efficient at pumping blood throughout the body. This could cause symptoms such as difficulty breathing, excessive fatigue, and swelling in the ankles and legs)
• reduced blood pressure when standing up
• abnormal heart rhythm (palpitations)
• constipation, diarrhea, vomiting, discomfort (nausea)
• weakness or loss of strength
• headache
• itching, congestion, or discharge from the nose (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 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 occurred in a reduced number of patients, but the exact frequency is not known (the frequency cannot be estimated from the available data):

• abnormal or accelerated heart rhythm (arrhythmia, tachycardia, or atrial fibrillation)
• difficulty breathing (shortness of breath)
• depression
• pain and swelling in the testicles
• nosebleed
• severe skin rash
• changes in vision (blurred vision or visual problems)
• dry mouth

Reporting 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 blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications 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 medications you no longer need. By doing so, you will help protect the environment.

Dutasteride/Tamsulosin Aristo 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:

• Capsule hard shell:hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), iron oxide red (E172), yellow-orange S (E110).

• Inside the hard capsule:monocaprilocaprate of glycerol (Type I), butylhydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), iron oxide yellow (E172), medium-chain triglycerides, soy lecithin (may contain soy oil) (E322), microcrystalline cellulose, copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion at 30%, copolymer of methacrylic acid-ethyl acrylate (1:1), magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E171).

Product appearance and packaging contents

This medication is presented in hard, oblong capsules, approximately 24 mm in length, with a brown body and orange cap.

It is available in blister packs of 9, 30, and 90 capsules, made of aluminum/aluminum.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer:

SAG MANUFACTURING, S.L.U.

Ctra. N-I, km 36,

San Agustín de Guadalix,

28750, Madrid, Spain.

or

Galenicum Health S.L.U.

Calle Sant Gabriel, 50,

Esplugues de Llobregat,

08950, Barcelona, Spain.

For more information about this medication, please contact the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medication is authorized in the member states of the European Economic Area with the following names:

MaltaDutasteride/Tamsulosin Aristo 0.5 mg/0.4 mg hard capsules

Republic of CzechiaMarumax 0.5 mg/0.4 mg tvrdé tobolky

GermanyDutalosin 0.5 mg/0.4 mg Hartkapseln

ItalyDutasteride e Tamsulosina Aristo 0.5 mg/0.4 mg capsule rigide

PortugalDutasterida/Tansulosina Aristo 0.5 mg/0.4 mg cápsula

PolandMarumax 0.5mg + 0.4 mg kapsulki twarde

SpainDutasterida/Tamsulosina Aristo 0.5 mg/0.4 mg cápsula duras

United KingdomDutasteride/Tamsulosin hydrochloride 0.5 mg/0.4 mg hard capsules

Last review date of this leaflet: February 2020.

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