Package leaflet: Information for the patient

Suprostiv
0.4 mg, modified-release hard capsules
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 or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, 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.

Table of contents of the leaflet

What Suprostiv is and what it is used for
Important information before taking Suprostiv
How to take Suprostiv
Possible side effects
How to store Suprostiv
Contents of the pack and other information

1. What Suprostiv is and what it is used for

Tamsulosin is an alpha-adrenergic receptor blocker. Tamsulosin reduces the tone of smooth muscles in the prostate gland and urethra.
Suprostiv is used in the treatment of lower urinary tract symptoms associated with enlargement of the prostate gland (benign prostatic hyperplasia). The medicine reduces muscle tension, facilitating urine flow through the urethra and urination.

2. Important information before taking Suprostiv

When not to take Suprostiv:

if the patient is allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6) [symptoms may include: facial and throat swelling (angioedema)];
if the patient has previously experienced episodes of low blood pressure upon changing position, which may cause dizziness, lightheadedness, or fainting;
if the patient has severe liver disease.

Warnings and precautions
Before starting treatment with Suprostiv, discuss with your doctor:

if the patient experiences dizziness or lightheadedness, especially when standing up. Tamsulosin may lower blood pressure, causing these symptoms. In such cases, the patient should sit or lie down until feeling better;
if the patient has severe kidney disease. Administration of the standard dose of tamsulosin in patients with impaired kidney function may not provide the expected therapeutic effect;
if the patient is scheduled for eye surgery due to cataract (clouding of the eye lens). During surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur (see section 4 "Possible side effects"). The patient must inform the ophthalmologist that they are currently taking or have previously taken tamsulosin hydrochloride. The ophthalmologist may take appropriate precautions regarding treatment and surgical techniques. The patient should consult their doctor whether they should delay starting Suprostiv or temporarily discontinue it prior to 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.

Children and adolescents
Suprostiv must not be used in children and adolescents under 18 years of age, as it is not effective in this population.

Suprostiv with other medicines
Tamsulosin may affect the action of other medicines, and other medicines may affect the efficacy of tamsulosin.
Tamsulosin may interact with:

diclofenac, a pain-relieving and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, thereby shortening its duration of action;
warfarin, a medicine used to prevent blood clotting. This medicine may speed up the removal of tamsulosin from the body, thus shortening its duration of action;
other α-adrenergic receptor blockers. When used concomitantly with tamsulosin, they may lower blood pressure, causing dizziness or lightheadedness;
ketoconazole tablets (used in the treatment of Cushing's syndrome – when the body produces excess cortisol). This medicine may enhance the effects of tamsulosin.

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.

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

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

Driving and operating machinery
The effect of tamsulosin on the ability to drive and operate machinery has not been established. However, it should be remembered that tamsulosin may cause dizziness and lightheadedness. Driving and operating machinery should only be undertaken if the patient feels well.

Suprostiv contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning this medicine is considered "sodium-free".

3. How to take Suprostiv

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
The recommended dose is one capsule per day after breakfast or after the first meal of the day. The capsule
should be taken whole, with a glass of water, while standing or sitting (not lying down). Capsules must not be broken or crushed, as this may affect the efficacy of tamsulosin.
In patients with mild or moderate renal impairment or hepatic disease, no dose adjustment of tamsulosin is necessary.
Taking more Suprostiv than recommended
Taking too high a dose of tamsulosin may lead to unwanted, sudden lowering of blood pressure.
Other possible symptoms include dizziness, weakness, fainting, vomiting, and diarrhea.
In such case, lie down to reduce the effects of low blood pressure and contact your doctor immediately.
The doctor may administer medications to stabilize blood pressure and fluid levels, and recommend monitoring of vital functions. If removal of unabsorbed tamsulosin from the stomach is required, the doctor may perform gastric lavage and administer laxatives.
Missing a dose of Suprostiv
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time.
Stopping treatment with Suprostiv
If treatment is stopped too early, symptoms of the disease may return.
Therefore, continue taking the medicine for as long as your doctor has prescribed, even if symptoms have subsided. If a patient intends to discontinue treatment, this should always be discussed with the doctor beforehand.
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.
Severe adverse reactions are very rare. You should seek immediate medical advice if the following occur:

severe allergic reaction causing swelling of the face or throat (angioedema). Tamsulosin should not be taken again (see section 2 "When not to take Suprostiv").

Common adverse reactions (may affect up to 1 in 10 patients):

dizziness, especially when sitting down or standing up;
abnormal ejaculation. This means that semen does not exit the body through the urethra, but instead flows back into the bladder (retrograde ejaculation), or the volume of ejaculate is reduced or ejaculation does not occur (anejaculation). This phenomenon is not dangerous.

Uncommon adverse reactions (may affect up to 1 in 100 patients):

headache;
sensation of rapid heartbeat (palpitations);
low blood pressure upon standing, which may cause dizziness, feeling faint or fainting (orthostatic hypotension);
swelling or irritation of the nasal mucosa (nasal mucositis);
constipation;
diarrhoea;
malaise (nausea);
vomiting;
rash (itchy, red spots on the skin);
urticaria (pinkish, itchy blisters on the skin);
feeling of weakness (asthenia);
itching.

Rare adverse reactions (may affect up to 1 in 1,000 patients):

fainting.

Very rare adverse reactions (may affect up to 1 in 10,000 patients):

painful penile erection (priapism);
severe illness characterized by blistering of the skin, around the mouth, eyes and genital organs (Stevens-Johnson syndrome).

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

blurred vision;
visual disturbances;
nosebleeds;
severe skin reactions (erythema multiforme – swollen, reddish-purple skin or mucous membrane lesions, sometimes with blisters on the surface; exfoliative dermatitis);
irregular heartbeat [atrial fibrillation, arrhythmia (irregular heartbeat), tachycardia (rapid heartbeat)];
difficulty breathing (dyspnoea).

During eye surgery due to lens clouding (cataract) or increased intraocular pressure (glaucoma), a condition known as intraoperative floppy iris syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy. For further information, see section 2 "Warnings and precautions".

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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C
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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Suprostiv

The medicine should be stored out of sight and reach of children.
No special storage conditions required.
Do not use this medicine after the expiry date stated on the carton and blister after EXP:
(the abbreviation used to describe the expiry date). The expiry date refers to the last day of the
specified month.
Lot: means batch number
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 pack and other information

What the medicine Suprostiv contains

The active substance is tamsulosin hydrochloride in the amount of 0.4 mg.
The other ingredients are: Capsule: microcrystalline cellulose (PH 101), methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion (polysorbate 80 and sodium lauryl sulfate), triethyl citrate, talc. Capsule coating: gelatin, indigotine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Suprostiv looks like and contents of the pack
Orange/olive-green modified-release capsules (measuring 19.3 x 6.4 mm). The capsules contain white to off-white pellets.
The medicine is packed in blisters or containers containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 modified-release capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Manufacturer
Synthon Hispania, S.L.
C/ Castelló, 1, Sant Boi de Llobregat
08830 Barcelona
Spain