Adatam xr

Patient Information Leaflet

Adatam XR, 0.4 mg, prolonged-release tablets
Tamsulosini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because 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, pharmacist or nurse.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet Contents:

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 in Adatam XR is tamsulosin. Tamsulosin is a selective α-adrenergic receptor antagonist. Tamsulosin reduces the tone of smooth muscles in the prostate gland and urethra, facilitating urine flow through the urethra and urination. Additionally, tamsulosin reduces the sensation of urinary urgency.
Adatam XR is used in men for the treatment of lower urinary tract symptoms associated with benign prostatic enlargement (benign prostatic hyperplasia). These symptoms may include difficulty in urinating (weak stream), dribbling after urination, urinary urgency, and increased frequency of urination both during the day and at night.

2. Important information before using Adatam XR

When not to use Adatam XR:

• if the patient is allergic to tamsulosin or any of the other ingredients of Adatam XR (listed in section 6). Hypersensitivity may manifest as sudden swelling of soft tissues (e.g. throat or tongue), breathing difficulties and/or itching and rash (angioedema).
• if the patient has severe liver problems.
• if the patient experiences fainting associated with low blood pressure upon changing body position (from lying down to sitting or standing).

Warnings and precautions
Before starting treatment with Adatam XR, discuss the following with your doctor:

• because periodic examinations are necessary to monitor the progression of the disease being treated,
• because, rarely, as with other drugs in the same class, fainting may occur. If symptoms such as dizziness or feeling weak occur, the patient should sit or lie down until symptoms subside,
• if the patient has severe kidney disease,
• if the patient is being prepared for surgery or has planned ophthalmic procedures due to cataract or increased intraocular pressure (glaucoma), the ophthalmologist must be informed that the patient is currently using, has previously used, or plans to use Adatam XR. The specialist will then be able to take appropriate precautions regarding treatment and surgical techniques. Please consult your doctor about whether to delay starting Adatam XR or temporarily discontinue it prior to cataract removal surgery or surgical treatment of increased intraocular pressure (glaucoma).

Children and adolescents
Adatam XR must not be used in children and adolescents under 18 years of age, as it has not been shown to be effective in this population.

Adatam XR and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Concomitant use of Adatam XR with other medicines from the same class (alpha-adrenergic receptor antagonists) may lead to unintended lowering of 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 may be taken regardless of meals.

Pregnancy, breastfeeding and fertility
Adatam XR is not indicated for use in women.
Cases of ejaculation disorders in men have been reported. This means that semen does not exit through the urethra but instead flows backward into the bladder (retrograde ejaculation), or the volume of ejaculate (semen) is reduced or ejaculation does not occur. This phenomenon is not dangerous.

Driving and operating machinery
The effect of Adatam XR on the ability to drive vehicles and operate machinery has not been established.
However, one should remain aware of the possibility of dizziness occurring; in such cases, activities requiring attention should not be performed.

3. How to take Adatam XR

Adatam XR must always be taken exactly as directed by the physician. In case of doubt, consult a doctor or pharmacist.

The recommended dose is 1 tablet once daily, preferably at the same time each day.
Adatam XR may be taken independently of meals.
The tablet should be swallowed whole. Do not crush or chew the tablet.

Adatam XR is a tablet formulated so that after swallowing, the active substance is released gradually and evenly. Remnants of the tablet shell may appear in the stool. There is no reason to suspect that the tablet was ineffective, as the active substance has already been released from the tablet prior to excretion.

Adatam XR is usually prescribed for long-term use. The effect on the bladder and urination is maintained during prolonged treatment with Adatam XR.

Overdose of Adatam XR
Taking too many Adatam XR tablets may lead to undesirable lowering of blood pressure and increased heart rate accompanied by a feeling of weakness.
In case of overdose, contact a physician immediately.

Missed dose of Adatam XR
If a dose of Adatam XR is missed, the patient may take the tablet later on the same 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 a missed dose.

Stopping Adatam XR treatment
If treatment is stopped prematurely, symptoms of the disease may return. Therefore, Adatam XR should be taken for as long as prescribed by the physician, even if symptoms have subsided.
Any discontinuation of treatment should always be discussed with the physician.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Common (occur in less than 1 in 10 and more than 1 in 100 patients (1-10%)):

• dizziness, particularly when changing position from lying to sitting or standing,
• abnormal ejaculation (ejaculation disorders). Ejaculation disorders mean that semen does not exit through the urethra but flows backward into the bladder (retrograde ejaculation), or the volume of ejaculate (semen) is reduced, or ejaculation does not occur (absence of ejaculation). This phenomenon is not dangerous.

Uncommon (occur in more than 1 in 1,000 and less than 1 in 100 patients (0.1-1%)):

• headache, sensation of heart pounding (palpitations, i.e. noticeable and faster than usual heartbeat), low blood pressure felt for example when sitting down or quickly standing up from a lying position, associated with dizziness, nasal congestion or runny nose (rhinitis), diarrhoea, nausea, vomiting, constipation, weakness (asthenia), rash, itching, urticaria.

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

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

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

• priapism (undesirable, painful and prolonged erection, which requires immediate treatment),
• rash, inflammation and formation of blisters on the skin and (or) mucous membranes of the lips, eyes, mouth, nose or genital organs (Stevens-Johnson syndrome).

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

• blurred vision, visual disturbances,
• nosebleeds,
• severe skin reactions (erythema multiforme, exfoliative dermatitis),
• irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulties (dyspnoea),
• if the patient is being prepared for a procedure or surgery is planned due to lens opacity (cataract) or elevated intraocular pressure (glaucoma), and the patient is currently taking or has previously taken Adatam XR, consider that the patient's pupil may dilate poorly and the iris (the coloured, circular part of the eyeball) may become floppy during the procedure,
• dry mouth.

Reporting of side effects

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor, pharmacist or nurse.

Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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.

Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Adatam XR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
blister after the word EXP. The expiry date refers to the last day of the specified month.
No special storage instructions apply.
Medicines must 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:

• Tablet core: polyethylene glycol 7 000 000, microcrystalline cellulose type 200, colloidal silicon dioxide anhydrous type 200, magnesium stearate.
• Tablet coating Opadry 03F220088 yellow: hypromellose HPMC 2910 (E 464), titanium dioxide (E 171), polyethylene glycol 8000 (E 1521), iron oxide yellow (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), biconvex, with "04" embossed on one side.
The medicine is available in blisters made of PA/Aluminium/PVC/Aluminium foil, containing 30, 60, 90, 100 or 120 prolonged-release tablets, packed in cardboard boxes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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