Package leaflet: Information for the user

Symlosin SR, 0.4 mg, prolonged-release capsules, hard
Tamsulosini hydrochloridum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

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 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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Symlosin SR is and what it is used for
What you need to know before taking Symlosin SR
How to take Symlosin SR
Possible side effects
How to store Symlosin SR
Contents of the pack and other information

1. What Symlosin SR is and what it is used for

Symlosin SR is used in the treatment of functional symptoms associated with benign prostatic hyperplasia, such as difficulty in urination.
The active substance in Symlosin SR is tamsulosin. Tamsulosin is an alpha-adrenergic receptor blocker that reduces muscle tension in the prostate gland and the urethra. As a result, it facilitates urine flow through the urethra and urination.

2. Important information before using Symlosin SR

When not to use Symlosin SR

if the patient is allergic to tamsulosin hydrochloride or any of the other ingredients of this medicine (listed in section 6),
if the patient has orthostatic hypotension,
if the patient has severe hepatic impairment.

Warnings and precautions

Before starting treatment with Symlosin SR, discuss the following with your doctor or pharmacist:

if the patient has orthostatic hypotension (dizziness caused by low blood pressure when sitting or standing up),
if the patient is taking other alpha-adrenergic receptor blocking medicines,
if the patient has severe renal impairment,
if the patient is scheduled for cataract surgery (clouding of the eye's lens), the patient should inform the ophthalmologist that they are currently or have previously taken Symlosin SR. The specialist will then be able to take appropriate precautions regarding appropriate treatment and surgical techniques. Please consult your doctor whether you should withhold starting treatment with this medicine or temporarily discontinue its use prior to cataract surgery,
if the patient is concurrently taking a strong or moderate inhibitor of the CYP3A4 enzyme.

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Children and adolescents
Symlosin SR must not be given to children and adolescents under 18 years of age, as it is not indicated in this patient group.

Symlosin SR and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
Concomitant use of tamsulosin with other alpha-adrenergic receptor blocking agents (e.g. prazosin, alfuzosin) may lead to hypotension.
It is particularly important to inform the doctor if the patient is being treated simultaneously with medicines that may reduce the elimination of Symlosin SR from the body (medicines known as "strong CYP3A4 inhibitors", for example, ketoconazole, erythromycin).

Symlosin SR with food and drink
Symlosin SR should be taken after breakfast or after the first meal of the day, with a glass of water.

Pregnancy, breastfeeding and fertility
Symlosin SR is not intended for use in women.
Cases of ejaculation disorders, including retrograde ejaculation and anejaculation, have been reported.

Driving and operating machinery
There are no data indicating a negative effect of tamsulosin on the ability to drive or operate machinery. However, it should be noted that Symlosin SR may cause dizziness.

Symlosin SR contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release hard capsule, i.e. this medicine is considered "sodium-free".

3. How to use Symlosin SR

This medicine should always be taken exactly as directed by the physician. In case of doubts, consult
a doctor or pharmacist.
The recommended dose is one capsule per day.
Symlosin SR should be taken after breakfast or after the first meal of the day, with a glass of water.
The capsule should be swallowed whole, with a glass of water, while sitting or standing (do not take it while lying down).
The capsules must not be chewed or crushed, as this affects the sustained release of the active substance. However, the capsule may be opened and the contents swallowed without chewing.
If the effect of Symlosin SR seems too strong or too weak, consult a doctor or pharmacist.
Taking more than the recommended dose of Symlosin SR
If more than the prescribed dose of Symlosin SR has been taken, contact a doctor or go to hospital immediately.
Missing a dose of Symlosin SR
If a patient forgets to take the medicine after breakfast, they may take it later the same day. Do not take a double dose to make up for a missed dose.
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4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported during the use of Symlosin SR:
Common (occur in 1 to 10 people out of 100)
dizziness, ejaculation disorders, retrograde ejaculation, absence of ejaculation.
Uncommon (occur in 1 to 10 people out of 1,000)
headache, palpitations, orthostatic hypotension (when sitting or standing up from a lying position), nasal mucositis, gastrointestinal reactions (constipation, diarrhoea, nausea, vomiting), allergic reactions (rash, itching, urticaria), feeling of weakness.
Rare (occur in 1 to 10 people out of 10,000)
fainting, sudden swelling of the skin and mucous membranes (angioedema).
Very rare (occur in less than 1 person out of 10,000)
priapism (persistent and painful penile erection), Stevens-Johnson syndrome (a severe type of allergic reaction).
Frequency not known (frequency cannot be estimated from available data)
nosebleeds, erythema multiforme (irregular red patches on the skin of hands and feet), skin inflammation (exfoliative dermatitis), blurred vision and visual disturbances, dry mouth.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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, 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Symlosin SR

Keep in the original packaging.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the label after: EXP. The expiry date refers to the last day of the stated month.
Keep the medicine out of sight and reach of children.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Symlosin SR contains
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The active substance is tamsulosin in the form of hydrochloride. Each prolonged-release capsule contains 0.4 mg of tamsulosin hydrochloride.
Other components are: Excipients: sodium alginate, methacrylic acid and ethyl acrylate copolymer (1:1), glyceryl dibehenate, maltodextrin, sodium lauryl sulfate, macrogol 6000, polysorbate 80, sodium hydroxide, simethicone, emulsion (containing simethicone, methylcellulose, sorbic acid), anhydrous colloidal silicon dioxide. Capsule shell components: gelatin, iron oxide, red (E172), titanium dioxide (E171), iron oxide, yellow (E172).

What Symlosin SR looks like and contents of the pack
Orange, gelatin capsules size 2, containing white or yellowish granules. Symlosin SR is available in packages of 30 capsules (3 blisters of 10 capsules). Symlosin SR is available in packages of 90 capsules (9 blisters of 10 capsules).

Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw

Manufacturer/Importer
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw

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