ADATAM 0.4 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
2. What is ADATAM and what is it used for
3. Important information before taking ADATAM
   1. When not to take ADATAM:
   2. Warnings and precautions
   3. Children and adolescents
   4. ADATAM and other medicines
   5. Taking ADATAM with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. ADATAM contains sodium
4. How to take ADATAM
   1. Taking more than the recommended dose of ADATAM
   2. Missing a dose of ADATAM
   3. Stopping treatment with ADATAM
5. Possible side effects
   1. Reporting side effects
6. How to store ADATAM
7. Contents of the pack and other information
   1. What ADATAM contains
8. What ADATAM looks like and contents of the pack
   1. Marketing authorization holder and manufacturer
   2. Marketing authorization holder
   3. Manufacturer
   4. Date of last revision of the leaflet: 05.2024

Package Leaflet: Information for the User

ADATAM, 0.4 mg, prolonged-release hard capsules
Tamsulosin hydrochloride

Read the package 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 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 leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is ADATAM and what is it used for

Tamsulosin is an alpha-1A adrenergic receptor blocker.
ADATAM reduces the tension of the prostate and urinary tract muscles.
ADATAM is used in men to alleviate the symptoms of urinary tract disorders associated with an enlarged prostate (benign prostatic hyperplasia). The medicine reduces muscle tension, making it easier to urinate and pass urine through the urethra.

2. Important information before taking ADATAM

When not to take ADATAM:

• if you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6); symptoms may include facial and throat swelling(angioedema),
• if you experience low blood pressure when standing up, which may cause dizziness, fainting, or lightheadedness,
• if you have severe liver impairment.

Warnings and precautions

Before starting treatment with ADATAM, discuss it with your doctor or pharmacist:

• if you experience dizziness or lightheadedness, especially when standing up. The medicine may lower your blood pressure, causing such symptoms. If you experience symptoms of low blood pressure, you should sit or lie down until you feel better,
• if you have severe kidney problems. Taking the standard dose of ADATAM may not have the expected effect in patients with impaired kidney function,

ADATAM in patients with impaired kidney function may not have the expected effect.

• if you are to undergo cataract surgery. During the procedure, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur - see section 4 "Possible side effects". You should inform your ophthalmologist that you are taking or have recently taken ADATAM. The ophthalmologist may take appropriate precautions regarding the medications and surgical techniques used. If you are preparing for cataract surgery or increased eye pressure (glaucoma), you should ask your doctor if you should postpone taking ADATAM or temporarily stop it.

Before starting treatment with tamsulosin, your doctor should order tests to rule out other conditions that may cause symptoms similar to those of benign prostatic hyperplasia.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as it is not effective in this population.

ADATAM and other medicines

ADATAM may affect other medicines, and other medicines may affect the efficacy of ADATAM. The medicine may interact with:

• diclofenac, a pain-relieving and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, shortening its duration of action,
• warfarin, a medicine that prevents blood clot formation. This medicine may accelerate the elimination of tamsulosin from the body, shortening its duration of action,
• other alpha-adrenergic receptor blockers.Their combination with tamsulosin may lower blood pressure, causing dizziness or lightheadedness,
• ketokonazole, a medicine used to treat fungal skin infections. This medicine may enhance the effect of tamsulosin.

Tell your doctor or pharmacistabout all the medicines you are taking or have recently taken, as well as any medicines you plan to take.

Taking ADATAM with food and drink

Take the medicine after breakfast or after the first meal of the day, with a glass of water.

Pregnancy, breastfeeding, and fertility

ADATAM is not intended for use in women.
In men, there have been reports of abnormal ejaculation (ejaculation disorders). This means that semen is not expelled from the body through the urethra, but instead flows back into the bladder (retrograde ejaculation), or the volume of ejaculation is reduced or absent (absence of ejaculation). These symptoms are not harmful to the patient.

Driving and using machines

There is no data confirming the effect of the medicine on the ability to drive and use machines. However, keep in mind that ADATAM may cause dizziness or lightheadedness, so you can drive and use machines only if you do not experience such symptoms and feel well.

ADATAM contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take ADATAM

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended doseis one capsule per day after breakfast or after the first meal of the day.
Swallow the capsule wholewith a glass of water, while standing or sitting (not lying down). Do not break or crushthe capsule, as this may affect the efficacy of the medicine.
In patients with mild or moderate kidney impairment and liver disease, there is no need to adjust the dose.

Taking more than the recommended dose of ADATAM

If you take more than the recommended dose of ADATAM, you may experience a sudden drop in blood pressure. Symptoms such as dizziness, weakness, nausea, vomiting, diarrhea, and fainting may occur. Lie down to reduce the effect of low blood pressure, and then contact your doctor. Your doctor may prescribe medications to stabilize blood pressure and fluid levels, and recommend monitoring vital functions. If necessary, your doctor may perform gastric lavage and administer laxatives to remove unabsorbed tamsulosin from the stomach.

Missing a dose of ADATAM

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

Stopping treatment with ADATAM

If you stop taking ADATAM too early, your symptoms may return. Therefore, take the medicine for as long as your doctor has prescribed, even if your symptoms have disappeared. If you plan to stop treatment, always consult your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, ADATAM can cause side effects, although not everybody gets them.
Serious side effects are rare. Seek medical attention immediatelyif you experience:

• severe allergic reaction with facial or throat swelling(angioedema). Do not take tamsulosin again (see section 2 "When not to take ADATAM").

Common side effects(may affect up to 1 in 10 people)

• dizziness, especially when sitting or standing up,
• abnormal ejaculation (ejaculation disorders). This means that semen is not expelled from the body through the urethra, but instead flows back into the bladder (retrograde ejaculation),

or the volume of ejaculation is reduced or absent (absence of ejaculation). These symptoms are not harmful to the patient.
Uncommon side effects(may affect up to 1 in 100 people)

• headache,
• heart palpitations,
• low blood pressure when standing up, which may cause dizziness, lightheadedness, or fainting (orthostatic hypotension),
• nasal congestion or irritation (rhinitis),
• constipation,
• diarrhea,
• nausea,
• vomiting,
• rash,
• hives,
• weakness (asthenia),
• itching.

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

• fainting.

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

• painful erection (priapism),
• severe skin condition with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

Side effects with unknown frequency(frequency cannot be estimated from available data)

• blurred vision,
• vision disturbances,
• nasal bleeding,
• dry mouth,
• severe skin rashes (erythema multiforme, exfoliative dermatitis),
• abnormal heart rhythm (atrial fibrillation), irregular heartbeat (arrhythmia), rapid heartbeat (tachycardia), breathing difficulties (dyspnea).

During cataract surgery or increased eye pressure (glaucoma), a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may not dilate properly, and the iris (the colored part of the eye) may become floppy. For more information, see section 2 "Warnings and precautions".

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the 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 the medicine.

5. How to store ADATAM

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 after "Expiry date" or "EXP". The expiry date refers to the last day of the month.
Store the medicine in its original packaging.
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 ADATAM contains

The active substance is tamsulosin hydrochloride 0.4 mg.
The other ingredients are:
Capsule:microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.
Capsule shell:gelatin, indigo carmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

7. What ADATAM looks like and contents of the pack

Orange-olive capsules (19.3 mm x 6.4 mm). The capsules contain white or almost white pellets.
ADATAM, prolonged-release hard capsules are available in packs of 30, 60, or 90 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
A.Menarini Manufacturing and Logistics and Services S.r.l.
Via Campo di Pile
67100 L’Aquila, Italy
Menarini - von Heyden GmbH
Leipziger Str. 7-13
01097 Dresden, Germany
Quinta-Analytica s.r.o.
Pražská 1486/18c
102 00 Praga 10, Czech Republic
Synthon Hispania S.L.
Castello, 1, Poligono las Salinas
08830 Sant Boi de Llobregat, Spain
Synthon BV
Microweg 22
6545 CM Nijmegen, Netherlands
HGA Biomed Kft.
Nagygat u. 1.
7400, Kaposvár, Hungary

Date of last revision of the leaflet: 05.2024