Dutamsol

Patient Information Leaflet: Information for the Patient

Dutamsol, 0.5 mg + 0.4 mg, hard capsules
Dutasteride + Tamsulosin hydrochloride

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

• 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 specifically for you. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Dutamsol and what is it used for

Dutamsol 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.
Dutamsol is a combination of two other 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. It can also cause 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 may be 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 providing quick relief from symptoms.

2. Important information before taking Dutamsol

When not to take Dutamsol:

• if the patient is a woman(since 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 pressurethat causes dizziness, lightheadedness, or fainting (orthostatic hypotension).
• if the patient has severe liver disease.
• If any of the above applies to the patient, do not take this medicineuntil you have consulted your doctor.

Warnings and precautions:

Before taking Dutamsol, discuss it with your doctor or pharmacist.

• In some clinical trials, an increased incidence of heart failure was observed in patients taking dutasteride with a medicine belonging to the group of alpha-adrenergic receptor antagonists (such as tamsulosin), compared to patients taking dutasteride or alpha-adrenergic receptor antagonists alone. Heart failure means that the heart does not pump blood as well as it should.
• Tell your doctor if you have liver disease. If you have had liver disease, additional tests may be necessary while taking Dutamsol.

Tell your doctor if you have kidney disease.

• Cataract surgery (cloudy lens). If you are scheduled to have cataract surgery, your doctor may recommend stopping Dutamsol for a certain period before surgery. Tell your ophthalmologist if you are taking or have taken Dutamsol or tamsulosin. Your doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescentsshould not handle damaged Dutamsol capsules, as the active substance may be absorbed through the skin. In case of skin contact, 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 Dutamsol. If your partner is pregnant or may become pregnant, avoid exposing her to contact with semen, as dutasteride may affect the development of a male child. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility, which may lead to reduced fertility.
• Dutamsol affects the measurement of prostate-specific antigen (PSA)levels, which is sometimes performed to diagnose prostate cancer. Nevertheless, your doctor may still order this test. If you are having a PSA test, tell your doctor that you are taking Dutamsol.

Patients taking Dutamsol should have their PSA levels checked regularly.

• In a clinical trial involving patients with an increased risk of prostate cancer, patients taking dutasteride were diagnosed with high-grade prostate cancer more oftenthan patients not taking dutasteride. The impact of dutasteride on high-grade prostate cancer is unclear.
• Dutamsol may cause breast enlargement and tenderness. If these symptoms become troublesome or if you experience breast lumps or nipple discharge, contact your doctor, as these may be signs of a serious condition, such as breast cancer.

In case of questions about taking Dutamsol, contact your doctor or pharmacist.

Dutamsol and other medicines

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

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

Do not take Dutamsol with the following medicines:

• ketokonazole(used to treat fungal infections)

Some medicines may interact with Dutamsol and increase the risk of side effects. These include:

• PDE5 inhibitors[used to induce or maintain an 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)
• paroxetine(an antidepressant)
• terbinafine(used to treat fungal infections)
• diclofenac(used to treat inflammation and pain)
• Tell your doctorif you are taking any of these medicines.

Dutamsol with food and drink

Take Dutamsol 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

It is contraindicated to take Dutamsol during pregnancy.

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

Dutasteride is absorbed through the skin and may affect the development of a male child. There is a particular risk during the first 16 weeks of pregnancy.

• If a pregnant woman has come into contact with Dutamsol, she should contact her doctor.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutamsol. If your partner is pregnant or may become pregnant, avoid exposing her to contact with 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 using machines

Dutamsol may cause dizziness in some patients, which may negatively affect the ability to drive or operate machinery.

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

Dutamsol contains the dye – orange yellow FCF (E 110), which may cause allergic reactions.
Dutamsol contains soybean lecithin. Do not take if you are hypersensitive to peanuts or soy.
Dutamsolcontains less than 1 mmol of sodium (23 mg) per capsule, i.e., the medicine is considered "sodium-free".

3. How to take Dutamsol

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 in doubt, consult your doctor or pharmacist.

How much Dutamsol to take

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

How to take Dutamsol

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.

What to do if you take more Dutamsol than you should

If you have taken more than the recommended dose of Dutamsol, contact your doctor or pharmacist.

What to do if you forget to take Dutamsol

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

What to do if you stop taking Dutamsol

Do not stop taking Dutamsol unless your doctor tells you to

If you have any further questions about taking this medicine, 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

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 Dutamsol

Dizziness, lightheadedness, and fainting

Dutamsol may cause dizziness, lightheadedness, or fainting. Until you know how the medicine affects you, be careful when changing positions from lying or sitting to sitting or standing, especially when getting up at 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

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 Dutamsol

Common side effects(may affect up to 1 in 10 men taking Dutamsol):

• impotence (inability to achieve or maintain an erection)
• reduced libido (sex drive)
• difficulty with ejaculation, including reduced semen volume during ejaculation
• breast enlargement or tenderness (gynecomastia)
• dizziness

These side effects may persist in some men even after stopping Dutamsol.

Uncommon side effects(may affect up to 1 in 100 men taking Dutamsol):

• heart failure (the heart does not pump blood as 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 blocked 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 men taking Dutamsol):

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

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

• prolonged and 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 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 or pharmacist, or nurse.
Side effects can be reported 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
https://smz.ezdrowie.gov.pl"
Side effects can also be reported 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 Dutamsol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or bottle, or blister after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 Dutamsol contains

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: hypromellose, carrageenan, 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, iron oxide yellow (E 172), triglycerides of saturated fatty acids with a medium chain length, soybean lecithin, microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, magnesium stearate, triacetin, talc, titanium dioxide (E 171), sodium hydroxide.

The capsule has a brown body and an orange cap.

What Dutamsol looks like and contents of the pack

The medicine is in the form of hard capsules with a brown body and an orange cap.
Dutamsol is available in packs of 7, 30, or 90 capsules in HDPE bottles or aluminum/aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Solinea Sp. z o.o. Sp. K.
Elizówka 65
21-003 Ciecierzyn
Phone: 81-4634882
Fax: 81-4634886
e-mail: info@solinea.pl

Manufacturer

SAG MANUFACTURING S.L.U.
Crta. N-I, Km 36
28750 San Agustin de Guadalix, Madrid
Spain
Galenicum Health, S.L.
Avda. Cornellá 144, Edificio LEKLA,
Esplugues de Llobregat,
08950, Barcelona, Spain

Date of last revision of the leaflet: