Duitam

Package leaflet: Information for the user

DUITAM, 0.5 mg + 0.4 mg, hard capsules
Dutasteridum + Tamsulosini hydrochloridum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• 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 for you personally. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What DUITAM is and what it is used for
2. What you need to know 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 DUITAM is and what it is 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 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 may lead to problems with urination, such as difficulty passing urine and increased frequency of urination. There may also be reduced urine flow and a weak urine stream. If left untreated, complete blockage of urine flow may occur (acute urinary retention). This situation requires immediate treatment. In some cases, surgery may be needed to remove the prostate gland or reduce its size.
Dutasteride reduces the production of a hormone called dihydrotestosterone, which leads to a reduction in the size of the prostate gland and relief of symptoms. Thus, it reduces the likelihood of acute urinary retention and the need for surgical intervention. Tamsulosin works by relaxing the muscles in the prostate gland, which facilitates urine flow and provides rapid symptom relief.

2. Important information before using DUITAM

When not to use DUITAM

• if the patient is a woman, because this medicine is intended only 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 inhibitors, tamsulosin, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has low blood pressure causing dizziness, lightheadedness, or fainting (orthostatic hypotension)
• if the patient has severe liver disease

➔ If any of the above applies to the patient, this medicine must not be taken
until consultation with a doctor.
Warnings and precautions
Before starting treatment with DUITAM, discuss this with your doctor.

• In some clinical studies, heart failure occurred more frequently in patients taking dutasteride together with a medicine belonging to a group called alpha-adrenergic receptor antagonists (such as tamsulosin) than in patients taking dutasteride alone or the alpha-adrenergic receptor antagonist alone. Heart failure means the heart does not pump blood properly.
• Inform your doctor if the patient has liver disease. If liver disease occurs, additional tests may be required during treatment with DUITAM.
• Inform your doctor if the patient has kidney disease.
• Cataract surgery (cloudy lens). If cataract surgery is planned, your doctor may advise stopping DUITAM for a period of time before the procedure. Inform the ophthalmologist before surgery if the patient is taking or has previously taken DUITAM or tamsulosin. The doctor will take appropriate precautions to prevent complications during surgery.
• Women, children and adolescents must not touch damaged capsules of DUITAM, as the active substance may be absorbed through the skin. In case of skin contact, the contaminated area should be washed immediately with soap and water.
• Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking DUITAM. If the partner is pregnant or may be pregnant, exposure to semen should be avoided, as dutasteride may impair the development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility.
• DUITAM affects the measurement of prostate-specific antigen (prostate specific antigen - PSA), which is sometimes tested to detect prostate cancer. Despite this, your doctor may intentionally order this test to detect prostate cancer. If the patient undergoes PSA testing, he should inform the doctor about taking DUITAM. Patients taking DUITAM should have PSA levels regularly monitored.
• In a clinical trial involving patients with an increased risk of prostate cancer, high-grade prostate cancer was diagnosed more frequently in patients taking DUITAM than in those not taking DUITAM. The effect of DUITAM on the potential to cause high-grade prostate cancer is not clear.
• DUITAM may cause breast enlargement and tenderness. If these symptoms become bothersome or if lumps in the breast or nipple discharge occur, contact a doctor, as these may be signs of a serious condition such as breast cancer.

Mood changes and depression
Depressed mood, depression, and rarely suicidal thoughts have been reported in patients taking orally another medicine from the same therapeutic group (5-alpha-reductase inhibitor). If any of these symptoms occur, seek immediate medical advice from a doctor.
➔ If you have any questions about using DUITAM, contact your doctor or pharmacist.
DUITAM and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take DUITAM with the following medicines:

• other medicines from the group of alpha-adrenergic receptor antagonists (used to treat benign prostatic hyperplasia or high blood pressure)

Concomitant use of DUITAM with the following medicines is not recommended:

• ketoconazole (used to treat fungal infections)

Some medicines taken together with DUITAM may increase the likelihood of adverse effects. These include:

• PDE5 inhibitors [used to induce or maintain erection (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 peptic ulcer disease)
• 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)

➔ Inform your doctor if any of these medicines are being used.
DUITAM and food
Take DUITAM 30 minutes after the same meal each day.
Pregnancy, breastfeeding and effect on fertility
Taking DUITAM by women is contraindicated.
Pregnant women (or women who may be pregnant) must not handle damaged capsules. Dutasteride
is absorbed through the skin and may impair the development of a male fetus. The risk is particularly high
during the first 16 weeks of pregnancy.
Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking DUITAM. If the partner is pregnant or may be pregnant, exposure to semen should be avoided.
It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.
➔ If a pregnant woman has been exposed to DUITAM, contact a doctor.
Driving and operating machinery
In some patients, DUITAM may cause dizziness, which could negatively affect the ability to drive or operate machinery.
➔ If such symptoms occur, do not drive or operate machinery.
DUITAM contains soy lecithin, propylene glycol and sodium
This medicine contains soy lecithin derived from soy, which may contain soy oil. Do not use if hypersensitivity to peanuts or soy has been diagnosed.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, meaning the medicine is considered "sodium-free".
Each capsule of this medicine contains 299 mg of propylene glycol.

3. How to use DUITAM

This medicine should always be taken exactly as directed by your doctor or pharmacist. Irregular
use of this medicine may affect PSA level test results. If in doubt, consult your doctor or pharmacist.
How much medicine to take
The recommended dose is one capsule taken once daily, 30 minutes after the same meal each day.
How to take the medicine
The capsule should be swallowed whole with water. Do not chew or open the capsule. Contact with
the capsule contents may cause pain in the mouth or throat.
Taking more DUITAM than recommended
If you take more capsules than recommended, consult your doctor or pharmacist.
If you miss a dose of DUITAM
Do not take a double dose to make up for the missed dose.
Take the next capsule at your usual time.
Stopping DUITAM
Do not stop taking DUITAM unless instructed by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience 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 any of these symptoms occur, contact a doctor immediately
and discontinue use of DUITAM.

Dizziness, lightheadedness and fainting
DUITAM may cause dizziness, lightheadedness, or in rare cases fainting.
Until you are certain how the medicine affects you, take care when changing position from lying or sitting to standing, especially when getting up during the night. If dizziness or lightheadedness occurs at any time during treatment, sit or lie down and wait for symptoms to subside.

Serious skin reactions
Symptoms of a serious skin reaction may include:

• widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genital organs (Stevens-Johnson syndrome)
  ➔ If any of these symptoms occur, contact a doctor immediately
  and discontinue use of DUITAM.

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

• impotence (inability to achieve or maintain an erection)
• decreased sexual desire (libido)
• problems with ejaculation, including reduced volume of semen during ejaculation
• enlargement or tenderness of the breasts (gynaecomastia)
• dizziness

In a small number of individuals, these adverse reactions may persist even after stopping DUITAM.

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

• heart failure (reduced heart function. Possible symptoms include shortness of breath, extreme fatigue, and swelling in the ankles and lower limbs)
• low blood pressure when standing
• rapid heartbeat (palpitations)
• constipation, diarrhoea, vomiting, nausea
• weakness or loss of strength
• headache
• itching or nasal congestion, runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually body hair) or excessive hair growth

Rare (may occur in up to 1 in 1,000 men taking DUITAM)

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

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

• prolonged, painful erection (priapism)
• serious skin reactions (Stevens-Johnson syndrome)

Other adverse reactions
Other adverse reactions have been observed in a small number of men, but their exact frequency is unknown (based on available data, frequency cannot be estimated):

• irregular or rapid heartbeat (arrhythmia, tachycardia or atrial fibrillation)
• difficulty breathing (dyspnoea)
• depression
• pain and swelling of the testicles
• nosebleeds
• severe skin rash
• changes in vision (blurred vision or vision problems)
• dry mouth

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store DUITAM

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and on the bottle following the abbreviation "EXP". The expiry date refers to the last day of the stated month. The batch number is indicated on the cardboard box and on the bottle following the abbreviation "Lot".
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What DUITAM contains

• The active substances in DUITAM are dutasteride and tamsulosin hydrochloride. Each hard capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.

The other ingredients are:
Hard capsule shell
Iron oxide black (E 172)
Iron oxide red (E 172)
Titanium dioxide (E 171)
Iron oxide yellow (E 172)
Gelatin
Soft capsules with dutasteride
Contents of the soft capsule
Propylene glycol monocaprylate, Type II
Butylated hydroxytoluene (E 321)
Soft capsule shell
Gelatin
Glycerol
Titanium dioxide (E 171)
Medium-chain saturated triglycerides
Lecithin (may contain soybean oil)
Tamsulosin pellets
Methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion (containing sodium lauryl sulfate,
polysorbate 80)
Microcrystalline cellulose
Dibutyl sebacate
Polysorbate 80
Hydrated colloidal silica
Calcium stearate
Black ink
Shellac
Iron oxide black (E 172)
Propylene glycol
Concentrated ammonium hydroxide
Potassium hydroxide

See section 2: "DUITAM contains soy lecithin and propylene glycol."

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria

Manufacturers
Laboratorios LEÓN FARMA, S.A.
Polígono Industrial Navatejera
C/La Vallina, s/n
24193 Villaquilambre (León)
Spain

Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
8054 Graz
Austria

For information on the names under which this medicine is marketed in the European Economic Area countries, or for any further detailed information, please contact the representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
Tel. +48 12 262 32 36
E-mail: [email protected]