SUPROSTIV 0.4 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Suprostiv
3. 4 mg, modified-release hard capsules
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Suprostiv and what is it used for
5. Important information before taking Suprostiv
   1. When not to take Suprostiv:
   2. Warnings and precautions
   3. Children and adolescents
   4. Suprostiv and other medicines
   5. Suprostiv with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Suprostiv contains sodium
6. How to take Suprostiv
   1. Taking a higher dose of Suprostiv than recommended
   2. Missing a dose of Suprostiv
   3. Stopping treatment with Suprostiv
7. Possible side effects
   1. Reporting side effects
   2. If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.
8. How to store Suprostiv
9. Contents of the pack and other information
   1. What Suprostiv contains
   2. What Suprostiv looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet: 01.2021

Package Leaflet: Information for the Patient

Suprostiv

0.4 mg, modified-release hard capsules

Tamsulosin hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Suprostiv and what is it used for
• 2. Important information before taking Suprostiv
• 3. How to take Suprostiv
• 4. Possible side effects
• 5. How to store Suprostiv
• 6. Contents of the pack and other information

1. What is Suprostiv and what is it used for

Tamsulosin is an alpha-adrenergic receptor blocker. Tamsulosin reduces the tension of the smooth muscles of the prostate gland (prostate) and the urethra. Suprostiv is used to treat the symptoms of lower urinary tract disorders associated with an enlarged prostate gland (benign prostatic hyperplasia). The medicine reduces muscle tension, making it easier to urinate and pass urine through the urethra.

2. Important information before taking Suprostiv

When not to take Suprostiv:

• if you are 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 you have a history of low blood pressure when changing positions, which can cause dizziness, fainting, or lightheadedness;
• if you have severe liver disease.

Warnings and precautions

Before starting to take Suprostiv, discuss it with your doctor:

• if you experience dizziness or lightheadedness, especially when standing up. Tamsulosin may lower blood pressure, causing these symptoms. In this case, sit or lie down until you feel better;
• if you have severe kidney disease. Taking the standard dose of tamsulosin in patients with impaired kidney function may not have the expected effect;
• if you are scheduled to have eye surgery for cataracts. During surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur (see section 4 "Possible side effects"), inform your ophthalmologist that you are taking or have taken tamsulosin. The ophthalmologist may take appropriate precautions regarding treatment and surgical techniques. You should ask your doctor if you should stop taking the medicine or temporarily discontinue it in connection with cataract surgery or surgical treatment of increased eye pressure (glaucoma).

Before starting treatment with tamsulosin, your doctor should examine you to confirm that the symptoms are actually caused by an enlarged prostate.

Children and adolescents

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

Suprostiv and other medicines

Tamsulosin may affect the action of other medicines, and other medicines may affect the effectiveness 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 that prevents blood clotting. This medicine may accelerate the elimination of tamsulosin from the body, thereby shortening its duration of action;
• - other alpha-adrenergic receptor blockers. Their combination with tamsulosin may lower blood pressure, causing dizziness or lightheadedness;
• - ketoconazolein tablets (used to treat Cushing's syndrome - when the body produces too much cortisol). This medicine may enhance the effect of tamsulosin.

Tell your doctor or pharmacistabout all medicines you are taking or have recently taken, as well as any medicines you 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. There have been reports of ejaculation disorders in men. 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 ejaculation is reduced or does not occur (absence of ejaculation). This phenomenon does not pose a risk.

Driving and using machines

The effect of tamsulosin on the ability to drive and use machines has not been proven. However, keep in mind that tamsulosin may cause dizziness and lightheadedness. You can drive and use machines only if you feel well.

Suprostiv contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Suprostiv

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended doseis one capsule per day after breakfastor 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). The capsule must not be broken or crushed, as this may affect the effectiveness of tamsulosin. In patients with mild or moderate kidney impairment and liver disease, there is no need to change the dosage of tamsulosin.

Taking a higher dose of Suprostiv than recommended

Taking too much tamsulosin may lead to unwanted, sudden low blood pressure. Dizziness, weakness, and fainting, nausea, and diarrhea may also occur. Lie down to reduce the effects of low blood pressure, and then contact your doctor. Your doctor may prescribe medications to stabilize blood pressure and fluid levels, and recommend monitoring vital functions. If necessary, your doctor may perform gastric lavage and administer laxatives to remove unabsorbed tamsulosin from the stomach.

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 you stop taking the medicine too early, the symptoms of the disease may return. Therefore, take the medicine for as long as your doctor has prescribed, even if the symptoms of the disease have disappeared. If you plan to stop treatment, always consult your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Suprostiv can cause side effects, although not everybody gets them. Serious side effects are very rare. You should immediately contact your doctorif you experience:

• severe allergic reaction with facial or throat swelling(angioedema). Do not take tamsulosin again (see section 2 "When not to take Suprostiv").

Common side effects(may affect up to 1 in 10 people):

• dizziness, especially when sitting or standing;
• abnormal ejaculation (ejaculation disorders). 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 ejaculation is reduced or does not occur (absence of ejaculation). This phenomenon does not pose a risk.

Uncommon side effects(may affect up to 1 in 100 people):

• headache;
• heart palpitations;
• low blood pressure when standing up, which can cause dizziness, lightheadedness, or fainting (orthostatic hypotension);
• swelling or irritation of the nasal mucosa (rhinitis);
• constipation;
• diarrhea;
• nausea;
• vomiting;
• rash (itchy, red bumps on the skin);
• hives (itchy, pink bumps on the skin);
• weakness;
• itching.

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

• fainting.

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

• painful erection (priapism);
• severe disease characterized by blistering of the skin, around the mouth, eyes, and genitals (Stevens-Johnson syndrome).

Side effects with unknown frequency(frequency cannot be estimated from available data):

• -blurred vision;
• vision disturbances;
• nasal bleeding;
• severe skin reactions (erythema multiforme - swollen, reddish-purple patches on the skin or mucous membranes of the mouth, sometimes with blisters on the surface; exfoliative dermatitis);
• irregular heartbeat [atrial fibrillation, arrhythmia (irregular heartbeat), tachycardia (rapid heartbeat)];
• breathing difficulties (dyspnea).

During eye surgery for cataracts or increased eye pressure (glaucoma), a condition called intraoperative floppy iris syndrome (IFIS) may occur: the pupil may not dilate well, and the iris (the colored part of the eye) may become floppy. For more information, see section 2 "Warnings and precautions".

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring of 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Suprostiv

Keep this medicine out of the sight and reach of children. There are no special storage conditions. Do not use this medicine after the expiry date stated on the carton and blister after EXP: (abbreviation used to describe the expiry date). The expiry date refers to the last day of the month stated. Batch: means batch number. Medicines should 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 Suprostiv contains

• The active substance is tamsulosin hydrochloride, 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 shell: gelatin, indigo carmine (E 132), titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172), iron oxide black (E 172).

What Suprostiv looks like and contents of the pack

Orange/olive-green capsules with modified release (19.3x6.4mm). The capsules contain white to off-white pellets. The medicine is packaged 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 authorization holder and manufacturer

Marketing authorization 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

Date of last revision of the leaflet: 01.2021