Adatam Duo

Leaflet accompanying the packaging: patient information

Adatam Duo, 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, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Adatam Duo and what is it used for

Adatam Duo is used to treat benign prostatic hyperplasia (enlarged prostate gland) - a non-cancerous enlargement of the prostate gland in men who have previously taken tamsulosin and dutasteride.
Adatam Duo 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 a hormone called dihydrotestosterone, which causes the prostate gland to shrink and alleviates symptoms. By doing so, dutasteride reduces the risk 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 Adatam Duo

When not to take Adatam Duo

• If you are allergic(hypersensitive) to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, soy, or peanutsor any of the other ingredients of this medicine (listed in section 6).
• If you experience fainting due to low blood pressure when changing positions (when sitting and standing) (orthostatic hypotension).
• If you have severe liver disease.
• If you are a woman, child, or person under 18 years old. You should consult your doctor if any of the above points apply to you.

This medicine is intended only for men. It should not be taken by women, children, and adolescents.

Warnings and precautions

Before taking Adatam Duo, discuss it with your doctor or pharmacist.

• 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 alpha-adrenergic receptor antagonists alone. Heart failure means that the heart does not pump blood properly.
• If you have liver disease. If you have had liver disease, you may need to have additional tests while taking Adatam Duo.
• If you have severe kidney problems, inform your doctor.
• If you are scheduled to have cataract surgery, inform your ophthalmologist before the operation if you are taking or have taken Adatam Duo or tamsulosin in the past. The doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescents should not touch damaged Adatam Duo capsules, as the active substance can be absorbed through the skin. If skin contact occurs, wash the affected area with soap and water immediately.
• You should use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Adatam Duo. If your partner is pregnant or may become pregnant, you should 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. This may lead to reduced fertility in men.
• Adatam Duo 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 your PSA levels measured, inform your doctor that you are taking Adatam Duo. Patients taking Adatam Duo should have their PSA levels checked regularly.
• In a clinical trial involving men at high risk of prostate cancer, men taking dutasteride were diagnosed with high-grade prostate cancer more often than patients who did not take dutasteride. The effect of dutasteride on high-grade prostate cancer is unclear.
• Adatam Duo may cause breast enlargement and tenderness. If this becomes bothersome or if you experience breast lumps or nipple discharge, you should contact your doctor, as these may be symptoms of a serious condition, such as breast cancer.

Adatam Duo and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. This includes medicines available without a prescription.

• other medicines from the group of alpha-adrenergic receptor antagonists(used to treat enlarged prostate gland or high blood pressure).

It is not recommended to take Adatam Duo with the following medicines:

• ketokonazole(used to treat fungal infections).

Some medicines may interact with Adatam Duo, which may 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;
• 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 used to treat infections) in combination with paroxetine(an antidepressant) or terbinafine(used to treat fungal infections);
• terbinafine(used to treat fungal infections);
• diclofenac(used to treat pain and inflammation).

 Tell your doctor if you are taking any of these medicines.

Adatam Duo with food and drink

Adatam Duo should be taken 30 minutes after the same meal every day.

Pregnancy, breastfeeding, and fertility

Adatam Duo should not be taken by women.

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

Dutasteride is absorbed through the skin and may interfere with the development of a male fetus. There is a particular risk during the first 16 weeks of pregnancy.
You should use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking Adatam Duo. If your partner is pregnant or may become pregnant, you should avoid exposing her to contact with semen.
It has been shown that Adatam Duo reduces sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.
 Contact your doctorif a pregnant woman has come into contact with Adatam Duo.

Driving and using machines

Adatam Duo may cause dizziness in some patients, which may affect their ability to drive or operate machines safely.
 Do not drive or operate machinesif you experience such symptoms.

Adatam Duo contains soy lecithin and propylene glycol.

This medicine contains soy lecithin, which may contain soybean oil. If you are allergic to peanuts or soy, do not take this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".
This medicine contains 299 mg of propylene glycol in each capsule.

3. How to take Adatam Duo

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

If the medicine is not taken regularly, it may affect the results of PSA level tests.

How much to take

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

How to take the medicine

Swallow the capsule whole with water.Do not chew, crush, or open the capsules. Contact with the contents of the capsule may cause mouth or throat pain.

Taking more than the recommended dose of Adatam Duo

If you take more than the recommended dose of Adatam Duo, contact your doctor or pharmacist.

Missing a dose of Adatam Duo

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

Stopping treatment with Adatam Duo

Do not stop taking Adatam Duo 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, Adatam Duo 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.

 Contact your doctor immediately and stop taking Adatam Duoif you experience any of these symptoms.

Dizziness, drowsiness, and fainting

Adatam Duo may cause dizziness, drowsiness, and in rare cases, fainting. Until you know how the medicine affects you, be careful when changing positions from sitting or lying down to standing, especially when getting up at night. If you experience dizziness or drowsiness during treatment, sit or lie down and wait for the symptoms to pass.

Severe skin reactions

Symptoms of severe skin reactions may include:

• widespread rash with blisters and peeling skin, especially on the mouth, nose, eyes, and genitals(Stevens-Johnson syndrome).

 Contact your doctor immediately and stop taking Adatam Duoif you experience such symptoms.
Common side effects (may affect up to 1 in 10 people)

• impotence (inability to achieve or maintain an erection), which may persist after stopping Adatam Duo;
• decreased libido (sex drive)*;
• ejaculation disorders*;
• breast enlargement or tenderness;
• dizziness.

*In a small number of people, some of these side effects may persist even after stopping Adatam Duo.
Uncommon side effects (may affect up to 1 in 100 people)

• heart failure (the heart does not pump blood efficiently, which may cause shortness of breath, extreme fatigue, and swelling of the ankles and feet);
• low blood pressure when standing;
• rapid heartbeat (palpitations);
• constipation, diarrhea, vomiting, nausea;
• weakness or loss of strength;
• headache;
• nasal congestion, runny nose, sneezing;
• skin rash, hives, itching;
• hair loss (usually affecting body hair) or excessive hair growth.

Rare side effects (may affect up to 1 in 1,000 people)

• sudden swelling of the soft tissues (e.g., throat or tongue), difficulty breathing, and (or) itching and rash, often as an allergic reaction (angioedema);
• fainting.

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

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

Other side effects

The frequency cannot be estimated from the available data:

• abnormal or rapid heart rhythm (arrhythmia, tachycardia, or atrial fibrillation);
• shortness of breath (dyspnea);
• depression;
• testicular pain and swelling.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 181 C
02-222 Warsaw
Phone: +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 or its representative.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Adatam Duo

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.
The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
The shelf life after first opening the packaging is 90 days.
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 packaging and other information

What Adatam Duo contains

• The active substances of Adatam Duo 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 shell:
Black iron oxide (E 172)
Red iron oxide (E 172)
Titanium dioxide (E 171)
Yellow iron oxide (E 172)
Gelatin
Soft capsule with dutasteride
Contents of the capsule:
Monodiglycerides of caprylic acid, Type II
Butylhydroxytoluene (E 321)
Capsule shell:
Gelatin (Type B, 150 Bloom)
Titanium dioxide (E 171)
Glycerol
Triglycerides of saturated fatty acids with medium chain length
Soy lecithin
Tamsulosin pellets
Microcrystalline cellulose
Methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion (contains sodium lauryl sulfate, polysorbate 80)
Dibutyl sebacate
Polysorbate 80
Colloidal anhydrous silica
Calcium stearate
Black ink:
Shellac
Propylene glycol
Black iron oxide (E 172)
Potassium hydroxide
Concentrated ammonia

What Adatam Duo looks like and contents of the pack

Adatam Duo is a hard capsule, size 0el, with a brown body and a beige cap, with the black ink print "C001".
Adatam Duo is available in packs of 30 capsules.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
Laboratorios León Farma, S.A.
C/La Vallina, s/n, Polígono Industrial Navatejera
24193 Villaquilambre, León
Spain