Prostamnic

Package Leaflet: Information for the User

Prostamnic, 0.4 mg, prolonged-release hard capsules
Tamsulosin hydrochloride

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

• Keep this package 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 package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents

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

1. What Prostamnic is and what it is used for

Tamsulosin is an alpha-1A adrenergic receptor blocker.
Prostamnic reduces the tension of the prostate and urinary tract muscles.
Prostamnic is used in men to alleviate the symptoms of urinary tract disorders associated with an enlarged prostate (benign prostatic hyperplasia). The medicine reduces muscle tension, making it easier to urinate and pass urine through the urethra.

2. Important information before taking Prostamnic

When not to take Prostamnic

• 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 low blood pressure when standing up, which can cause dizziness, fainting, or lightheadedness
• if you have severe liver impairment.

Warnings and precautions

Before starting treatment with Prostamnic, discuss it with your doctor or pharmacist

• if you experience dizziness or lightheadedness, especially when standing up. The medicine may lower your blood pressure, causing such symptoms. If you experience symptoms of low blood pressure, you should sit or lie down until you feel better.
• if you have severe kidney problems. Taking the standard dose of Prostamnic may not be effective if your kidneys do not function properly.
• if you are going to have cataract surgery. During the procedure, a condition called intraoperative floppy iris syndrome (IFIS) may occur - see section 4 "Possible side effects". You should inform your ophthalmologist that you are taking or have recently taken Prostamnic. The ophthalmologist may take appropriate precautions regarding the medications and surgical techniques used. If you are preparing for cataract surgery or increased eye pressure (glaucoma), you should ask your doctor if you should postpone taking Prostamnic or temporarily stop taking it.

Before starting treatment with tamsulosin, your doctor should order tests to rule out other conditions that may cause symptoms similar to those of benign prostatic hyperplasia.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as there is no appropriate indication for the use of tamsulosin in this age group.

Prostamnic and other medicines

Prostamnic may interact with other medicines, and other medicines may interact with Prostamnic. The medicine may interact with:

• diclofenac, a pain reliever and anti-inflammatory. This medicine may accelerate the elimination of tamsulosin from the body, shortening its duration of action
• warfarin, a medicine that prevents blood clotting. This medicine may accelerate the elimination of tamsulosin from the body, shortening its duration of action
• other alpha-adrenergic receptor blockers.Their combination with tamsulosin may lower blood pressure, causing dizziness or lightheadedness
• ketokonazole, a medicine used to treat fungal skin infections. This medicine may enhance the effect of tamsulosin.

Tell your doctor or pharmacistabout all the medicines you are taking, have recently taken, or plan to take.

Prostamnic with food and drink

Take the medicine after breakfast or after the first meal of the day, with a glass of water.

Pregnancy, breastfeeding, and fertility

Prostamnic is not intended for use by women.
In men, there have been reports of abnormal ejaculation (ejaculation disorders).
This means that semen is not expelled from the body through the urethra, but instead flows back into the bladder (retrograde ejaculation), or the volume of ejaculation is reduced or absent (absence of ejaculation). These symptoms are not harmful to the patient.

Driving and using machines

There is no data confirming the effect of the medicine on the ability to drive and use machines. However, remember that Prostamnic may cause dizziness or lightheadedness, so you can drive and use machines only if you do not experience such symptoms and feel well.

Prostamnic contains sodium

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

3. How to take Prostamnic

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended doseis one capsule per day after breakfast or after the first meal of the day.
Swallow the capsule wholewith a glass of water, while standing or sitting (not lying down). Do not break or crushthe capsule, as this may affect the efficacy of the medicine.
In patients with mild or moderate kidney impairment and liver disease, there is no need to adjust the dose.

If you take more Prostamnic than you should

If you take more Prostamnic than you should, you may experience a sudden drop in blood pressure. Symptoms may include: dizziness, weakness, nausea, vomiting, diarrhea, and fainting. Lie down to reduce the effect 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.

If you forget to take Prostamnic

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

If you stop taking Prostamnic

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, Prostamnic can cause side effects, although not everybody gets them.
Serious side effects are rare. You should immediately contact your doctor
if you experiencea severe allergic reaction with facial or throat swelling
(angioedema). Do not take tamsulosin again (see section 2 "When not to take Prostamnic").
Common side effects(may affect up to 1 in 10 people)

• dizziness, especially when sitting or standing up
• 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 absent (absence of ejaculation). These symptoms are not harmful to the patient.

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

• headache
• heart palpitations
• low blood pressure when standing up, which may cause dizziness, lightheadedness, or fainting (orthostatic hypotension)
• nasal congestion or runny nose (rhinitis)
• constipation
• diarrhea
• nausea
• vomiting
• rash
• hives
• weakness (asthenia)
• 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)
• a severe condition 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
• dry mouth
• severe skin rashes (erythema multiforme, exfoliative dermatitis)
• abnormal heart rhythm (atrial fibrillation), irregular heartbeat (arrhythmia), rapid heartbeat (tachycardia), difficulty breathing (dyspnea).

During cataract surgery or increased eye pressure (glaucoma), a condition called intraoperative floppy iris syndrome (IFIS) may occur: the pupil may not dilate properly, 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 package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Prostamnic

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
Store the medicine in its original packaging.
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 Prostamnic contains

The active substance is tamsulosin hydrochloride 0.4 mg.
The other ingredients are:
Capsule:microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, polysorbate 80, 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 Prostamnic looks like and contents of the pack

Orange-olive capsules (19.3 mm x 6.4 mm). The capsules contain white or almost white pellets.
Prostamnic, prolonged-release hard capsules are available in packs of 30, 60, or 90 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer

Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Synthon Hispania S.L.
Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat
Spain
Genericon Pharma GmbH
Hafnerstraße 211
8054 Graz
Austria
To obtain detailed information on the medicine and its names in the Member States of the European Economic Area, contact the representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków
phone: +48 12 262 32 36
Date of last revision of the package leaflet:January 2021