Simlosin Sr

Package Leaflet: Information for the User

Symlosin SR, 0.4 mg, prolonged-release hard capsules
Tamsulosin hydrochloride

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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Symlosin SR is and what it is used for
• 2. Before you take Symlosin SR
• 3. How to take Symlosin SR
• 4. Possible side effects
• 5. How to store Symlosin SR
• 6. Contents of the pack and other information

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

Symlosin SR is used to treat the symptoms of benign prostatic hyperplasia (a non-cancerous enlargement of the prostate gland), such as difficulty urinating.
The active substance of Symlosin SR is tamsulosin. Tamsulosin is an alpha-adrenergic receptor blocker that reduces the tension in the prostate and urethra. This makes it easier for urine to flow through the urethra and urinate.

2. Before you take Symlosin SR

When not to take Symlosin SR

• if you are allergic to tamsulosin hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if you have orthostatic hypotension (a fall in blood pressure when standing up),
• if you have severe liver impairment.

Warnings and precautions

Before taking Symlosin SR, discuss with your doctor or pharmacist:

• if you have orthostatic hypotension (dizziness due to low blood pressure when sitting or standing),
• if you are taking other alpha-adrenergic receptor blockers,
• if you have severe kidney impairment,
• if you are going to have cataract surgery, you should tell your ophthalmologist that you are taking or have taken Symlosin SR. The specialist will then be able to take appropriate precautions with regard to the treatment and surgical techniques. You should ask your doctor if you should stop taking the medicine or temporarily discontinue it in connection with the cataract surgery,
• if you are taking strong or moderate CYP3A4 inhibitors.

PL/H/0159/001/IA/045/G

Children and adolescents

This medicine should not be given to children and adolescents under 18 years of age, as it is not intended for use in this patient group.

Symlosin SR and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Concomitant use of tamsulosin with other alpha-adrenergic receptor blockers (prazosin, alfuzosin) may cause hypotension.
It is particularly important to inform your doctor if you are being treated with medicines that may reduce the elimination of Symlosin SR from the body (medicines known as "strong CYP3A4 inhibitors", e.g. 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.
There have been reports of ejaculation disorders, retrograde ejaculation, and failure to ejaculate.

Driving and using machines

There are no data on the negative impact of tamsulosin on the ability to drive and use machines. However, you should remember 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, which means it is essentially "sodium-free".

3. How to take Symlosin SR

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your 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 (not while lying down).
The capsules should not be chewed or crushed, as this affects the gradual release of the active substance. However, the capsule can be opened and its contents swallowed without chewing.
If you feel that the effect of Symlosin SR is too strong or too weak, talk to your doctor or pharmacist.

If you take more Symlosin SR than you should

If you have taken more Symlosin SR than prescribed by your doctor, contact your doctor or go to the hospital.

If you forget to take Symlosin SR

If you forget to take the medicine after breakfast, you can take it later the same day. Do not take a double dose to make up for the forgotten dose.
PL/H/0159/001/IA/045/G

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with Symlosin SR:

Common (may affect up to 1 in 10 people)

dizziness, ejaculation disorders, retrograde ejaculation, failure to ejaculate.

Uncommon (may affect up to 1 in 100 people)

headache, palpitations, orthostatic hypotension (when sitting or standing up from a lying position), nasal congestion, gastrointestinal reactions (constipation, diarrhea, nausea, vomiting), allergic reactions (rash, itching, hives), feeling of weakness.

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

fainting, sudden swelling of the skin and mucous membranes (angioedema).

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

priapism (prolonged and painful erection), Stevens-Johnson syndrome (a severe form of allergic reaction).

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

nosebleeds, erythema multiforme (irregular red patches on the skin of the hands and feet), skin rash (exfoliative dermatitis), blurred vision and vision disturbances, dry mouth.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, Tel.: + 48 22 49 21 301, Faks: + 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 this medicine.

5. How to store Symlosin SR

Store in the original package.
Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Symlosin SR contains

PL/H/0159/001/IA/045/G

• The active substance is tamsulosin hydrochloride. Each prolonged-release hard capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are: Excipients:sodium alginate, methacrylic acid and ethyl acrylate copolymer (1:1), dibehenic glyceride, maltodextrin, sodium lauryl sulfate, macrogol 6000, polysorbate 80, sodium hydroxide, simethicone, emulsion (contains simethicone, methylcellulose, sorbic acid), colloidal anhydrous silica. Cap contents: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 No. 2, which contain white or yellowish granules.
Symlosin SR is available in packs of 30 capsules (3 blisters of 10 capsules).
Symlosin SR is available in packs of 90 capsules (9 blisters of 10 capsules).

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warszawa

Manufacturer/Importer

Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warszawa
Date of last revision of the leaflet:May 2025
PL/H/0159/001/IA/045/G