ADATAM 0.4 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Adatam XR, 0.4 mg, prolonged-release tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of Contents of the Package Leaflet:
3. What Adatam XR is and what it is used for
4. Important information before taking Adatam XR
   1. When not to take Adatam XR:
   2. Warnings and precautions
   3. Children and adolescents
   4. Adatam XR and other medicines
   5. Adatam XR with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
5. How to take Adatam XR
   1. Taking more Adatam XR than prescribed
   2. Missing a dose of Adatam XR
   3. Stopping treatment with Adatam XR
6. Possible side effects
   1. Reporting side effects
7. How to store Adatam XR
8. Contents of the pack and other information
   1. What Adatam XR contains
   2. What Adatam XR looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer/Importer
   6. Date of last revision of the package leaflet: 05.2024

Package Leaflet: Information for the Patient

Adatam XR, 0.4 mg, prolonged-release tablets

Tamsulosin hydrochloride

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet:

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

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

The active substance of Adatam XR is tamsulosin. Tamsulosin is a selective alpha-1 adrenergic receptor antagonist. Tamsulosin reduces the tension of the smooth muscles of the prostate and urethra, facilitating the flow of urine through the urethra and urination. Additionally, tamsulosin reduces the feeling of pressure on the bladder. Adatam XR is used in men for the treatment of symptoms of lower urinary tract disorders associated with benign prostatic hyperplasia (enlargement of the prostate). These symptoms may include difficulty urinating (weak stream), urinating in drops, pressure on the bladder, and increased frequency of urination both at night and during the day.

2. Important information before taking Adatam XR

When not to take Adatam XR:

• if you are allergic to tamsulosin or any of the other ingredients of Adatam XR (listed in section 6). Allergic reactions may manifest as sudden swelling of soft tissues (e.g., throat or tongue), difficulty breathing, and/or itching and rash (angioedema).
• if you have severe liver problems.
• if you experience fainting spells associated with low blood pressure when changing body position (from lying down to sitting or standing).

Warnings and precautions

Before starting treatment with Adatam XR, discuss it with your doctor:

• because periodic tests are necessary to determine the progression of the disease being treated,

the degree of development of the disease for which the patient is being treated,

• because, as with other drugs in the same group, fainting spells may rarely occur. If symptoms such as dizziness or weakness occur, sit or lie down until the symptoms subside,
• if you have severe kidney disease,
• if you are being prepared for surgery or are scheduled for eye surgery (cataract or glaucoma), inform your ophthalmologist that you are taking, have taken, or plan to take Adatam XR. The specialist will then be able to take appropriate precautions in terms of treatment and surgical techniques. Ask your doctor if you should stop taking the medicine or temporarily discontinue it in connection with cataract surgery or glaucoma treatment.

Children and adolescents

Adatam XR should not be used in children and adolescents under 18 years of age, as it is not effective in this population.

Adatam XR and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Taking Adatam XR with other medicines in the same group (alpha-1 adrenergic receptor antagonists) may cause unintended low blood pressure. It is especially important to inform your doctor if you are taking medicines that may reduce the elimination of Adatam XR from the body (e.g., ketoconazole, erythromycin).

Adatam XR with food and drink

Adatam XR can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Adatam XR is not indicated for use in women. There have been reports of ejaculation disorders in men. This means that semen does not flow through the urethra but instead flows back into the bladder (retrograde ejaculation) or the volume of ejaculate (semen) is reduced or does not occur. This phenomenon is not a threat.

Driving and using machines

The effect of Adatam XR on the ability to drive and use machines has not been proven. However, you should be aware of the possibility of dizziness, and in such cases, you should not perform activities that require attention.

3. How to take Adatam XR

Always take Adatam XR exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist. The recommended dose is one tablet once a day, preferably at the same time each day. Adatam XR can be taken with or without food. Swallow the tablet whole. Do not chew or crush it. Adatam XR is a tablet designed to release the active substance slowly and evenly after swallowing. The remains of the tablet may appear in the stool. There is no reason to suspect that the tablet is ineffective because the active substance was previously released from the tablet. Adatam XR is usually prescribed for long-term use. The effect on the bladder and urination persists during long-term treatment with Adatam XR.

Taking more Adatam XR than prescribed

Taking too many Adatam XR tablets may lead to unintended low blood pressure and increased heart rate with a feeling of weakness. If you have taken too many Adatam XR tablets, contact your doctor immediately.

Missing a dose of Adatam XR

If you miss a dose of Adatam XR, you can take the tablet later that day. If the tablet was not taken on a given day, continue treatment according to the previous dosing schedule. Do not take a double dose to make up for the missed dose.

Stopping treatment with Adatam XR

If treatment is stopped prematurely, the symptoms of the disease may return. Therefore, you should take Adatam XR for as long as your doctor has prescribed, even if the symptoms of the disease have subsided. Stopping treatment should always be discussed with your doctor. If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Adatam XR can cause side effects, although not everybody gets them. Frequent(occurring in less than 1 in 10, more than 1 in 100 patients (1-10%)):

• dizziness, especially when changing position from lying down to sitting or standing,
• abnormal ejaculation (ejaculation disorders). Ejaculation disorders mean that semen does not flow through the urethra but instead flows back into the bladder (retrograde ejaculation) or the volume of ejaculate (semen) is reduced or does not occur. This phenomenon is not a threat.

Infrequent(occurring in more than 1 in 1000, less than 1 in 100 patients (0.1-1%)):

• headache, feeling of heart palpitations (palpitations, i.e., heartbeat felt and faster than usual), low blood pressure felt, e.g., when sitting or quickly getting up from a lying position, associated with dizziness, runny or stuffy nose (rhinitis), diarrhea, nausea, vomiting, constipation, weakness (asthenia), rash, itching, hives.

Rare(occurring in more than 1 in 10,000, less than 1 in 1,000 patients (0.01-0.1%)):

• fainting spells and sudden local swelling of soft tissues (e.g., throat, tongue), difficulty breathing, and/or itching and rash (angioedema), often as a result of an allergic reaction.

Very rare(occurring in less than 1 in 10,000 patients (<0.01%)):

• priapism (undesirable, painful, and prolonged erection, in which case immediate treatment should be sought),
• rash, inflammation, and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nose, or genitals (Stevens-Johnson syndrome).

Frequency not known(cannot be estimated from the available data):

• blurred vision, vision disturbances,
• nasal bleeding,
• severe skin reactions (erythema multiforme, exfoliative dermatitis),
• irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea),
• if you are being prepared for surgery or are scheduled for eye surgery (cataract or glaucoma) and are taking or have taken Adatam XR, consider that the patient's pupil may not dilate properly, and the iris (the colored, round part of the eye) may become flaccid during surgery,
• dry mouth.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products, ul. Al. Jerozolimskie 181C, PL - 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. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Adatam XR

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 EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. 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 XR contains

The active substance is tamsulosin hydrochloride. Each prolonged-release tablet contains 0.4 mg of tamsulosin hydrochloride. The other ingredients are:

• Core tablet: macrogol 7,000,000, microcrystalline cellulose, type 200, colloidal silicon dioxide, anhydrous, type 200, magnesium stearate.
• Coating Opadry 03F220088 yellow: hypromellose HPMC 2910 (E 464), titanium dioxide (E 171), macrogol 8000 (E 1521), yellow iron oxide (E 172).

What Adatam XR looks like and contents of the pack

Adatam XR prolonged-release tablets are yellow, film-coated, round (9 mm in diameter), and biconvex with "04" embossed on one side. The medicine is available in blisters of PA/Aluminum/PVC/Aluminum foil, containing 30, 60, 90, 100, or 120 prolonged-release tablets, packed in a cardboard box. 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/Importer

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

Date of last revision of the package leaflet: 05.2024