Package leaflet: Information for the patient

Tamur, 0.4 mg, modified-release capsules, hard
Tamsulosini hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Tamur is and what it is used for
Important information before taking Tamur
How to take Tamur
Possible adverse reactions
How to store Tamur
Contents of the pack and other information

1. What Tamur is and what it is used for

Tamsulosin is a selective alpha-adrenergic receptor antagonist. Tamsulosin reduces the tone of smooth muscles in the prostate gland and urinary tract.
Tamsulosin is prescribed to relieve urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia).
By relaxing the muscles, it allows for easier urination.

2. Important information before taking Tamur

When not to take Tamur:

if the patient is allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6) (symptoms may include: swelling of the face and throat (angioedema));
if the patient has previously experienced a drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting;
if the patient has severe liver disease.

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

if the patient experiences dizziness or lightheadedness, especially upon standing. Tamsulosin may lower blood pressure, which can cause these symptoms. In such cases, the patient should sit or lie down and remain in this position until symptoms subside;
if the patient has severe kidney disease. Administering the usual dose of tamsulosin to a patient with impaired kidney function may not achieve the desired effect.
if the patient is scheduled for eye surgery due to cataract or increased intraocular pressure (glaucoma). There may be an increased risk of intraoperative floppy iris syndrome (IFIS) (see section 4. Possible side effects). The ophthalmologist should be informed if tamsulosin hydrochloride has been used in the past, is currently being used, or is planned to be used. The specialist will then be able to take appropriate precautions regarding treatment and surgical techniques. Ask your doctor whether you should delay starting Tamur or temporarily discontinue it before cataract removal or surgical treatment of increased intraocular pressure (glaucoma).

Before starting treatment with tamsulosin, the doctor should examine the patient to confirm that symptoms are indeed caused by an enlarged prostate gland.
Children and adolescents
Tamur must not be used in children and adolescents under 18 years of age, as it is not effective in this population.
Tamur and other medicines
Tamsulosin may affect the action of other medicines, and some other medicines may affect the action of tamsulosin. Therefore, it is important to tell your doctor if the patient is taking:

medicines that lower blood pressure (e.g. verapamil and diltiazem);
medicines used to treat HIV infection (e.g. ritonavir or indinavir);
medicines used to treat fungal infections (e.g. ketoconazole, itraconazole, voriconazole, or fluconazole);
medicines that prevent blood clotting (warfarin);
anti-inflammatory medicines (e.g. diclofenac);
medicines used to treat infections (e.g. erythromycin, clarithromycin);
medicines that suppress the immune system (e.g. cyclosporine).

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use, including those available without a prescription.
Tamur with food and drink
Tamsulosin should be taken with a glass of water, after breakfast or after the first meal of the day.
Pregnancy, breastfeeding and fertility
Tamsulosin 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 there is reduced ejaculate volume or absence of ejaculation (anejaculation).
Driving and operating machinery
There are no data on the effect of tamsulosin on the ability to drive or operate machinery. However, patients should consider that tamsulosin may cause dizziness or lightheadedness. Patients may drive or operate machinery only when they feel well.
Tamur contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is considered "sodium-free".

3. How to take Tamur

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult your doctor or pharmacist.
The usual recommended dose is one capsule once daily after breakfast or after the first meal of the day.
The capsule should be taken with a glass of water, while standing or sitting (not lying down), and must be swallowed whole. It is important not to break or crush the capsule, as this may alter the proper release and action of tamsulosin.
If the patient has mild to moderate kidney or liver impairment, the usual dose of tamsulosin may generally be used.

Taking more Tamur than recommended
Taking more than the recommended dose of Tamur may cause a sudden drop in blood pressure. The patient may experience dizziness, weakness, fainting, vomiting, and diarrhea. To reduce symptoms of low blood pressure, the patient should lie down and then contact a doctor immediately. The doctor may administer medications to restore blood pressure to normal levels and monitor vital functions. If necessary, the doctor may perform gastric lavage and administer laxatives to remove the portion of the medicine not yet absorbed from the gastrointestinal tract into the bloodstream.

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

Stopping treatment with Tamur
If treatment is stopped prematurely, symptoms of the disease may return. Therefore, tamsulosin should be taken for as long as prescribed by the doctor, even if symptoms have improved. Any decision to stop treatment should always be discussed with the doctor.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking the medicine immediately and contact your doctor if the patient experiences:

Rare adverse reactions (occur in less than 1 in 1,000 patients): sudden swelling of any or all of the following parts of the body: hands, feet, lips, tongue or throat, causing difficulty in breathing and (or) itching and rash due to an allergic reaction (angioedema)
Very rare adverse reactions (occur in less than 1 in 10,000 patients): rash, redness, blistering and peeling of the skin and (or) mucous membranes of the lips, eyes, mouth, nose or genitals (Stevens-Johnson syndrome)
Adverse reactions with unknown frequency (frequency cannot be determined from available data): severe redness and severe peeling of the skin (erythema multiforme).

Common adverse reactions (occur in less than 1 in 10 patients):
dizziness, impaired ejaculation, retrograde ejaculation, absence of ejaculation
Uncommon adverse reactions (occur in less than 1 in 100 patients):
headache, palpitations (awareness of rapid heartbeat), low blood pressure
experienced, for example, when changing position from lying down to standing, sometimes causing dizziness, feeling of faintness or fainting (orthostatic hypotension), nasal swelling and irritation (rhinitis), constipation, diarrhoea, nausea, vomiting, rash, itchy rash (urticaria), feeling of weakness (asthenia), itching
Rare adverse reactions (occur in less than 1 in 1,000 patients):
fainting
Very rare adverse reactions (occur in less than 1 in 10,000 patients):
prolonged and painful erection (priapism)
Frequency not known (frequency cannot be determined from available data):
blurred vision, loss of vision, nosebleeds, dry mouth.
During eye surgery due to clouding of the eye lens (cataract) or increased intraocular pressure (glaucoma), a condition called intraoperative floppy iris syndrome (IFIS) may occur: the pupil may dilate poorly, and the iris (the coloured part of the eye) may become floppy. For additional information, see section 2. "Warnings and precautions".

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 provide more information on the safety of the medicine.

5. How to store the medicine Tamur

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack,
and container following: EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Store blisters in the original packaging.
Keep the container tightly closed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Proper disposal helps protect the environment.

6. Contents of the packaging and other information

What Tamur contains

The active substance is 0.4 mg of tamsulosin hydrochloride.
Excipients: Capsule contents: microcrystalline cellulose, copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion: polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.

Pellet coating: copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion:
polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.
Capsule shell - cap: indigo carmine (E132), black iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), gelatin.
Capsule shell - body: red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), gelatin.

What Tamur looks like and contents of the pack
Tamur is an orange/olive-green capsule containing white or almost white pellets.
Pack sizes: 30, 60 or 90 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański, Poland

Manufacturer
Synthon Hispania S.L.
Castelló no 1, Pol. Las Salinas
Sant Boi de Llobregat
08830 Barcelona, Spain

Synthon BV
Microweg 22
6545 CM Nijmegen, Netherlands

For more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
POLPHARMA Biuro Handlowe Sp. z o.o.
Bobrowiecka 6 Street, 00-728 Warsaw, Poland
Tel. 22 364 61 01