Adatam duo

Package leaflet: Information for the patient

Adatam Duo, 0.5 mg + 0.4 mg, hard capsules
Dutasteridum + Tamsulosini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Adatam Duo is and what it is 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 pack and other information

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

Adatam Duo is used in the treatment of enlarged prostate gland (benign prostatic hyperplasia) – a non-cancerous enlargement of the prostate gland caused by excessive production of a hormone called dihydrotestosterone – in men who have previously been treated with both 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 may lead to problems with urination, such as difficulty passing urine, more frequent urination, reduced urine flow, or a weak urine stream. In some cases, complete blockage of urine flow may occur (acute urinary retention), which requires immediate treatment. In certain cases, surgery may be needed to remove or reduce the size of the prostate gland.
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. By this action, dutasteride reduces the risk of acute urinary retention and the need for surgical intervention. Tamsulosin works by relaxing the muscles in the prostate gland, which helps urine flow more easily and provides rapid symptom relief.

2. Important information before taking Adatam Duo

Do not take Adatam Duo if:

• you are allergic ( hypersensitive ) to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).
• you have episodes of fainting caused by low blood pressure when changing position (during sitting or standing up) (orthostatic hypotension).
• you have severe liver disease.
• you are a woman, child, or person under 18 years of age.
   Please consult your doctor if any of the above apply to you.

This medicine is intended for men only. It must not be used in women, children, or adolescents.

Warnings and precautions

Talk to your doctor or pharmacist before starting Adatam Duo.

• In some clinical studies, heart failure occurred more frequently in patients taking dutasteride together with a medicine from the group called alpha-adrenergic receptor antagonists (such as tamsulosin) than in patients taking dutasteride alone or an alpha-adrenergic receptor antagonist alone. Heart failure means the heart is unable to pump blood properly.
• If you have liver disease. If you have liver disease, additional tests may be required during treatment with Adatam Duo.
• If you have severe kidney problems, inform your doctor.
• If you are scheduled for cataract surgery, inform your ophthalmologist that you are taking or have previously taken Adatam Duo or tamsulosin. Your doctor will take appropriate precautions to prevent complications during surgery.
• Women, children, and adolescents must not touch damaged Adatam Duo capsules, as the active substance can be absorbed through the skin. If contact occurs, wash the affected area immediately with soap and water.
• Use a condom during sexual intercourse. Dutasteride has been detected in the semen of men taking Adatam Duo. If your partner is pregnant or could be pregnant, avoid exposing her to semen, as dutasteride may disrupt 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.
• Adatam Duo affects the measurement of prostate-specific antigen (PSA) levels, sometimes used to diagnose prostate cancer. Despite this, your doctor may still recommend this test. If your PSA level is being measured, inform your doctor that you are taking Adatam Duo. Regular PSA monitoring is recommended for patients taking Adatam Duo.
• In a clinical study involving men at increased risk of prostate cancer, men taking dutasteride were diagnosed with high-grade prostate cancer more frequently than men not taking dutasteride. The effect of dutasteride on high-grade prostate cancer is not fully understood.
• Adatam Duo may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice lumps in the breast or nipple discharge, contact your doctor, as these may be signs of a serious condition such as breast cancer.

Adatam Duo with other medicines

Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take, including those available without a prescription.

Do not take Adatam Duo with the following medicines:

• other alpha-adrenergic receptor antagonists (used to treat benign prostatic hyperplasia or high blood pressure).

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

• ketoconazole (used to treat fungal infections).

Some medicines may interact with Adatam Duo, increasing the risk of side effects. These include:

• PDE5 inhibitors (used to induce or maintain 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 peptic ulcer disease);
• 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).

 Please inform your doctor if you are taking any of the medicines listed above.

Adatam Duo with food and drink

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

Pregnancy, breastfeeding, and effects on fertility

Adatam Duo must not be taken by women.

Women who are pregnant (or who may be pregnant) must not touch damaged capsules.
Dutasteride can be absorbed through the skin and may disrupt 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 Adatam Duo. If your partner is pregnant or could be pregnant, avoid exposing her to semen.

Adatam Duo has been shown to reduce sperm count, semen volume, and sperm motility. This may lead to reduced fertility in men.

 Contact your doctor if a pregnant woman has been exposed to Adatam Duo.

Driving and operating machinery

Adatam Duo may cause dizziness in some patients, which may impair the ability to drive or operate machinery safely.

 If you experience such symptoms, do not drive or operate machinery.

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

3. How to take Adatam Duo

This medicine should always be taken exactly as directed by your doctor. In case of doubt, please
consult your doctor or pharmacist.
If this medicine is not taken regularly, it may affect PSA monitoring results.
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, crush, or open the capsule.
Contact with the capsule contents may cause pain in the mouth or throat.
Taking more Adatam Duo than recommended
If you have taken more Adatam Duo than recommended, 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 your usual time.
Stopping Adatam Duo treatment
Do not stop taking this medicine without consulting 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);
• urticaria (hives);
• swelling of the eyelids, face, lips, hands or feet.

 Seek immediate medical advice and discontinue Adatam Duo if the patient experiences any of these symptoms.

Dizziness, lightheadedness and fainting
Adatam Duo may cause dizziness, lightheadedness, and, in rare cases, fainting. Until you are certain how the medicine affects the patient, caution should be taken when changing from a sitting or lying position to standing, especially when getting up at night. If dizziness or lightheadedness occurs during treatment, the patient should sit or lie down and wait until symptoms subside.

Serious skin reactions
Symptoms of serious skin reactions may include:

• widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome).

 Seek immediate medical advice and discontinue Adatam Duo if the patient develops such symptoms.

Common adverse reactions (may occur in up to 1 in 10 patients)

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

*In a small number of individuals, some of these adverse reactions may persist even after discontinuation of Adatam Duo.

Uncommon adverse reactions (may occur in up to 1 in 100 patients)

• heart failure (the heart pumps blood less effectively. The patient may experience shortness of breath, extreme tiredness, and swelling of the ankles and legs);
• low blood pressure when standing;
• rapid heartbeat (palpitations);
• constipation, diarrhoea, vomiting, nausea;
• weakness or loss of strength;
• headache;
• itchy nose, nasal congestion, runny nose;
• skin rash, urticaria, itching;
• hair loss (usually affecting body hair) or excessive hair growth.

Rare adverse reactions (may occur in up to 1 in 1,000 patients)

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

Very rare adverse reactions (may occur in up to 1 in 10,000 patients)

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

Other adverse reactions
Frequency cannot be estimated from the available data:

• irregular or fast heartbeat (arrhythmia, tachycardia or atrial fibrillation);
• shortness of breath (dyspnoea);
• depression;
• pain and swelling of the testicles.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. 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 181 C
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 or its representative.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Adatam Duo

Keep this 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 stated month.
Store below 25°C.
The shelf life after first opening the container is 90 days.
Medicines should 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 pack and other information

What Adatam Duo 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 components 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 capsule with dutasteride
Contents of the capsule:
Mono-di-glycerides of caprylic acid, Type II
Butylhydroxytoluene (E 321)
Capsule shell:
Gelatin (Type B, 150 Bloom)
Titanium dioxide (E 171)
Glycerol
Medium-chain saturated triglycerides
Soy lecithin
Tamsulosin pellets
Microcrystalline cellulose
Methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion (containing sodium lauryl sulfate,
polysorbate 80)
Dibutyl sebacate
Polysorbate 80
Colloidal hydrated silica
Calcium stearate
Black ink:
Shellac
Propylene glycol
Iron oxide black (E 172)
Potassium hydroxide
Concentrated ammonium hydroxide

What Adatam Duo looks like and contents of the pack
Adatam Duo is an elongated hard capsule of size 0el, with a brown body and beige cap, printed in black ink with the code C001.
The medicine is available in packs containing 30 capsules.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturers
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland
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

For further information and information on the medicinal product names in the European Economic Area countries, please contact the marketing authorisation holder's representative:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Tel.: +48 22 732 77 00
Fax: +48 22 732 78 00