Dutasteride Tamsulosin Accord

Leaflet accompanying the packaging: patient information

Dutasteride + Tamsulosin Accord, 0.5 mg + 0.4 mg, hard capsules
Dutasteridum + Tamsulosini hydrochloridum

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

• Keep this leaflet, so you can read it again if needed.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Dutasteride + Tamsulosin Accord and what is it used for

Dutasteride + Tamsulosin Accord 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 Accord is a combination of two other medicines: dutasteride and tamsulosin. Dutasteride belongs to a group of medicines called 5-alpha-reductase enzyme 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 may 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 involves relaxing the muscles in the prostate gland, making it easier to urinate and quickly alleviating symptoms.

2. Important information before taking Dutasteride + Tamsulosin Accord

When not to take Dutasteride + Tamsulosin Accord

• if the patient is a woman(since this medicine is only intended for men),
• if the patient is a child or person under 18 years of age,
• if the patient is allergic to dutasteride, other 5-alpha-reductase enzyme inhibitors, tamsulosin, soy, or peanutsor any of the other ingredients of this medicine (listed in section 6),
• if the patient has low blood pressurethat causes dizziness or fainting (orthostatic hypotension),
• if the patient has severe liver disease.
• If any of the above applies to the patient, do not takethis medicine until consulting a doctor.

Warnings and precautions

Before starting to take Dutasteride + Tamsulosin Accord, discuss it with your doctor.

• In some clinical trials, it was found that more patients taking dutasteride with a medicine from the group of alpha-adrenergic receptor antagonists (such as tamsulosin) experienced heart failure than patients taking dutasteride alone or an alpha-adrenergic receptor antagonist alone. Heart failure means that the heart does not pump blood properly.
• 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 Accord.

Tell your doctor if you have severe kidney disease.

• Cataract surgery (cloudy lens).If you are scheduled to have cataract surgery, your doctor may advise you to stop taking Dutasteride + Tamsulosin Accord for a while before surgery. Before surgery, inform your ophthalmologist if you are taking or have taken Dutasteride + Tamsulosin Accord or tamsulosin. Your doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescentsshould not handle damaged Dutasteride + Tamsulosin Accord capsules, as the active substance may be absorbed through the skin. If skin contact 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 Accord. If your partner is pregnant or may become pregnant, avoid exposing her to your semen, as dutasteride may interfere with the development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility, which may lead to reduced fertility in men.

Dutasteride + Tamsulosin Accord affects the determination of prostate-specific antigen (PSA) levels

Prostate-specific antigen (PSA)is sometimes measured to diagnose prostate cancer. Despite this, your doctor may still order this test. If your PSA level is being measured, inform your doctor that you are taking Dutasteride + Tamsulosin Accord. Patients taking Dutasteride + Tamsulosin Accord should have their PSA levels checked regularly.

• In a clinical trial involving patients with an increased risk of prostate cancer, patients taking dutasteride were more likely to be diagnosed with high-grade prostate cancerthan patients not taking dutasteride.

High-grade prostate cancer was diagnosed more frequentlyin patients taking dutasteride than in patients not taking dutasteride. The effect of dutasteride on the development of high-grade prostate cancer is not clear.

Dutasteride + Tamsulosin Accord may cause breast enlargement and tenderness.

If these symptoms become troublesome or if you experience breast lumps or nipple discharge, consult your doctor, as these may be symptoms of a serious condition, such as breast cancer.

• If you have any questions about taking Dutasteride + Tamsulosin Accord, consult your doctor or pharmacist.

Dutasteride + Tamsulosin Accord and other medicines

Tell your doctor about all medicines you are currently 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 Accord with the following medicines:

• ketokonazole(used to treat fungal infections).

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

• PDE5 inhibitors[used to induce or maintain an erection (such as vardenafil, sildenafil citrate, and tadalafil)],
• verapamilor diltiazem(used to treat high blood pressure),
• ritonaviror indinavir(used to treat HIV infection),
• itraconazoleor ketokonazole(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 Accord with food and drink

Dutasteride + Tamsulosin Accord should be taken 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

Taking Dutasteride + Tamsulosin Accord is contraindicated in women.

Women who are pregnant (or may be pregnant) should not handle damaged capsules.

Dutasteride is absorbed through the skin and may interfere with the development of a male fetus. There is a special risk during the first 16 weeks of pregnancy.

• If a pregnant woman has come into contact with Dutasteride + Tamsulosin Accord, she should consult a doctor.

Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking Dutasteride + Tamsulosin Accord. If your partner is pregnant or may become pregnant, avoid exposing her to your semen. It has been shown that the combination of dutasteride and tamsulosin reduces sperm count, semen volume, and sperm motility, which may lead to reduced fertility in men.

Driving and operating machinery

In some patients, Dutasteride + Tamsulosin Accord may cause dizziness, which may negatively affect the ability to drive or operate machinery safely.

• If such symptoms occur, do not drive or operate machinery.

Dutasteride + Tamsulosin Accord contains:

Dutasteride + Tamsulosin Accord contains the dye orange yellow FCF (E110), which may cause allergic reactions. Dutasteride + Tamsulosin Accord contains soy lecithin. Do not take if you are hypersensitive to peanuts or soy. Dutasteride + Tamsulosin Accord contains less than 1 mmol of sodium (23 mg) per capsule, which means the medicine is considered "sodium-free".

3. How to take Dutasteride + Tamsulosin Accord

Always take this medicine exactly as your doctor or pharmacist has told you.Irregular intake of the medicine may affect the results of PSA level tests. If in doubt, 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 may cause mouth or throat pain.

Taking more than the recommended dose of Dutasteride + Tamsulosin Accord

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

Missing a dose of Dutasteride + Tamsulosin Accord

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 Accord

Do not stop taking Dutasteride + Tamsulosin Accord without consulting your doctor. If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dutasteride + Tamsulosin Accord can cause side effects, although not everybody gets them.

Allergic reaction

Symptoms 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 Accord.

Dizziness, feeling of fainting, and fainting

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

Severe skin reactions

Symptoms 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 Accord.

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

• impotence (inability to achieve or maintain an erection)*
• decreased libido (sex drive)*
• difficulty ejaculating, including reduced semen volume during ejaculation*
• breast enlargement or tenderness (gynecomastia)
• dizziness.
• *In a small number of patients, some of these symptoms may persist after stopping treatment with Dutasteride + Tamsulosin Accord.

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

• heart failure (the heart does not pump blood efficiently; symptoms may include shortness of breath, extreme fatigue, and swelling of 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 affect up to 1 in 1,000 people)

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

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

• prolonged, painful erection of the penis (priapism)
• severe skin reaction (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, tachycardia, or atrial fibrillation)
• difficulty breathing (dyspnea)
• depression
• testicular pain and swelling
• nosebleeds
• severe skin rash
• vision changes (blurred vision or eye problems)
• dry mouth.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dutasteride + Tamsulosin Accord

Keep the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of the month stated. HDPE bottles: the packaging containing 30 capsules should not be used for more than 6 weeks, and the packaging containing 90 capsules should not be used for more than 18 weeks after opening the packaging. Do not store Dutasteride + Tamsulosin Accord above 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dutasteride + Tamsulosin Accord contains

• The active substances are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.
• Other ingredients are:
• hard capsule: hypromellose, carrageenan (E 407), potassium chloride, titanium dioxide (E 171), iron oxide red (E 172), orange yellow FCF (E 110).
• inside the hard capsule: glycerol monocaprylocaprate (type I) and butylhydroxytoluene (E 321), gelatin, glycerol, titanium dioxide (E 171), iron oxide yellow (E 172), triglycerides of saturated fatty acids with medium chain length, soy lecithin, microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30%, magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E 171).

What Dutasteride + Tamsulosin Accord looks like and contents of the pack

The medicine is in the form of elongated hard capsules (approximately 24 mm long) with a brown body and orange cap. The medicine is available in packs containing 7, 28, 30, or 90 capsules in HDPE bottles or aluminum/aluminum blisters. Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o., ul. Taśmowa 7, 02-677 Warsaw, Tel: +48 22 577 28 00

Manufacturer

SAG MANUFACTURING S.L.U., Crta. N-I, Km 36, 28750 San Agustin de Guadalix, Madrid, Spain, GALENICUM HEALTH, S.L., Avda. Cornellà 144, 7º-1ª, Edificio Lekla, 08950 Esplugues de Llobregat, Barcelona, Spain, Accord Healthcare Polska Sp.z.o.o., ul. Lutomierska 50, 95-200 Pabianice, Poland

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

Date of last revision of the leaflet: July 2022