Duitam

Package Leaflet: Information for the User

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

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

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is DUITAM and what is it used for

DUITAM is used in men with an enlarged prostate gland (benign prostatic hyperplasia) - a non-cancerous enlargement of the prostate gland caused by an excessive production of a hormone called dihydrotestosterone.
DUITAM is a combination of two different 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.
An enlarged prostate gland can cause 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, surgery may be necessary to remove the prostate gland or reduce its size.
Dutasteride reduces the production of the hormone dihydrotestosterone, which causes the prostate gland to shrink and alleviates symptoms. It also reduces the likelihood of acute urinary retention and the need for surgical intervention. Tamsulosin works by relaxing the muscles in the prostate gland, making it easier to urinate and quickly relieving symptoms.

2. Important information before taking DUITAM

When not to take DUITAM

• if you are a woman, as this medicine is only for men;
• if you are a child or adolescent under 18 years of age;
• if you are allergic to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, soy, or peanuts, or any of the other ingredients of this medicine (listed in section 6);
• if you have low blood pressurethat causes dizziness, lightheadedness, or fainting (orthostatic hypotension);
• if you have severe liver disease.

➔ If any of the above statements apply to you, do not take this medicineuntil you have consulted your doctor.

Warnings and precautions

Before taking DUITAM, discuss it with your doctor.

• In some clinical trials, it was found that more patients taking dutasteride with a medicine from the group called 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 DUITAM.
• 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 DUITAM for a while before the surgery. Be sure to tell your eye doctor if you are taking or have taken DUITAM or tamsulosin. Your doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescentsshould not handle damaged DUITAM 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 DUITAM. If your partner is pregnant or may become pregnant, avoid exposing her to contact with 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 can lead to reduced fertility.
• DUITAM affects the measurement of prostate-specific antigen (PSA), which is sometimes performed to detect prostate cancer. However, your doctor may still order this test to detect prostate cancer. If you are having a PSA test, you should inform your doctor that you are taking DUITAM. Men taking DUITAM should have their PSA levels checked regularly.
• In a clinical trial involving men at high risk of prostate cancer, more men taking DUITAM were diagnosed with high-grade prostate cancerthan men not taking DUITAM. The effect of DUITAM on the risk of developing high-grade prostate cancer is not clear.
• DUITAM may cause breast enlargement and tenderness.If these symptoms become bothersome or if you experience breast lumpsor discharge from the nipple, contact your doctor, as these may be signs of a serious condition such as breast cancer.

➔ Consult your doctorif you have any questions about taking DUITAM.

DUITAM and other medicines

Tell your doctor about all the medicines you are taking, have recently taken, or plan to take.
Do not take DUITAM with the following medicines:

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

It is not recommended to take DUITAM with the following medicines:

• ketoconazole(used to treat fungal infections).

Some medicines taken with DUITAM may 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(used to treat depression)
• 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 inflammation and pain).

➔ Tell your doctorif you are taking any of these medicines.

DUITAM with food

Take DUITAM 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

It is contraindicatedto take DUITAM during pregnancy.
Pregnant women (or women who may be pregnant) should not handle damaged DUITAM 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.
Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking DUITAM. If your partner is pregnant or may become pregnant, avoid exposing her to contact with semen.
It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility, which can lead to reduced fertility in men.
➔ If a pregnant woman has come into contact with DUITAM, consult a doctor.

Driving and using machines

DUITAM may cause dizziness in some patients, which may negatively affect the ability to drive and use machines.
➔ If you experience such symptoms, do not drive or operate machinery.

DUITAM contains soy lecithin, propylene glycol, and sodium

The medicine contains soy lecithin, which may contain soybean oil. Do not take if you are hypersensitive to peanuts or soy.
The medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means it is considered "sodium-free".
Each capsule of this medicine contains 299 mg of propylene glycol.

3. How to take DUITAM

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 you are unsure, 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.

Take more than the recommended dose of DUITAM

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

Miss a dose of DUITAM

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

Stop taking DUITAM

Do not stop taking DUITAM 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 DUITAM.

Dizziness, lightheadedness, and fainting

DUITAM may cause dizziness, lightheadedness, 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 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 around the mouth, nose, eyes, and genitals(Stevens-Johnson syndrome) ➔ If you experience any of these symptoms, contact your doctor immediately and stop taking DUITAM.

Common(may affect up to 1 in 10 men taking DUITAM):

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

Some men may experience these side effects even after stopping DUITAM.

Uncommon(may affect up to 1 in 100 men taking DUITAM):

• heart failure (less efficient heart function, which may cause symptoms such as shortness of breath, extreme fatigue, and swelling in the ankles and legs)
• 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(may affect up to 1 in 1,000 men taking DUITAM)

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

Very rare(may affect up to 1 in 10,000 men taking DUITAM)

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

Other side effects

Other side effects have occurred in a small number of men, but their frequency is not known (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 those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store DUITAM

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month.
The batch number is stated on the carton and blister pack after "Lot".
There are no special storage instructions for this medicine.
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 DUITAM contains

• The active substances are dutasteride and tamsulosin hydrochloride. Each hard capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride, which corresponds to 0.367 mg of tamsulosin. The other ingredients are:

Capsule shell:
Black iron oxide (E 172)
Red iron oxide (E 172)
Titanium dioxide (E 171)
Yellow iron oxide (E 172)
Gelatin
Soft gelatin capsules with dutasteride
Capsule contents:
Propylene glycol monocaprylate, type II
Butylhydroxytoluene (E 321)
Capsule shell:
Gelatin
Glycerol
Titanium dioxide (E 171)
Saturated fatty acid triglycerides
Lecithin (may contain soybean oil)
Tamsulosin pellets:
Methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion (contains sodium lauryl sulfate, polysorbate 80)
Microcrystalline cellulose
Dibutyl sebacate
Polysorbate 80
Silica, colloidal, hydrated
Calcium stearate
Black ink:
Shellac
Black iron oxide (E 172)
Propylene glycol
Ammonium hydroxide, concentrated
Potassium hydroxide
See section 2 "DUITAM contains soy lecithin and propylene glycol".

What DUITAM looks like and contents of the pack

The medicine is in the form of elongated hard capsules, 24.2 mm x 7.7 mm in size, with a brown body and a beige cap, with the inscription C001 printed in black ink.
Inside each hard capsule, there are pellets with a modified release, containing tamsulosin hydrochloride, and one soft gelatin capsule containing dutasteride.
DUITAM is available in packs of 7, 30, 90, 98, or 100 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria

Manufacturer

Laboratorios LEÓN FARMA, SA
Polígono Industrial Navatejera
C/La Vallina, s/n
24193 Villaquilambre (León)
Spain
Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
8054 Graz
Austria
To obtain information about the names of this medicine, under which it has been authorized in other European Economic Area countries, or to obtain more detailed information, please contact the representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel. +48 12 262 32 36
e-mail: [email protected]
Date of last revision of the package leaflet:July 2024