Prostamnic

Package leaflet: Information for the user

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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.

Leaflet contents

1. What Prostamnic is and what it is used for
2. What you need to know 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 a substance that blocks alpha-1A adrenergic receptors.
Prostamnic reduces the tone of the muscles of the prostate gland and urinary tract.
Prostamnic is used in men to relieve symptoms of urinary dysfunction associated with an enlarged prostate gland (benign prostatic hyperplasia). The medicine reduces muscle tension, thereby facilitating urine flow through the urethra and urination.

2. Important information before taking Prostamnic

When not to take Prostamnic

• 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 experiences drops in blood pressure upon standing, which may cause dizziness, lightheadedness or fainting
• if the patient has severe liver impairment.

Warnings and precautions
Before starting Prostamnic, discuss this with your doctor or pharmacist

• if the patient experiences dizziness or lightheadedness, especially when standing up. The medicine may lower blood pressure, causing these symptoms. If symptoms of low blood pressure occur, the patient should sit or lie down until feeling better.
• if the patient has severe kidney function disorders. Administering the standard dose of Prostamnic in patients with impaired kidney function may not achieve the desired effect.
• if the patient is scheduled for cataract surgery. During the procedure, intraoperative floppy iris syndrome (IFIS, Intraoperative Floppy Iris Syndrome) may occur – see section 4 "Possible side effects". The patient should inform the ophthalmologist that they are currently taking or have recently taken Prostamnic. The ophthalmologist may take appropriate precautions regarding medications and surgical techniques. If preparing for cataract surgery or for eye pressure disorders (glaucoma), the patient should consult their doctor whether to delay or temporarily discontinue Prostamnic treatment.

Before initiating tamsulosin treatment, the doctor should order tests to rule out other conditions that may cause symptoms similar to benign prostatic hyperplasia.

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

Prostamnic and other medicines
Prostamnic may affect other medicines, and other medicines may affect the efficacy of Prostamnic. Prostamnic 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 clots. This medicine may accelerate the elimination of tamsulosin from the body, thereby shortening its duration of action
• other medicines blocking α-adrenergic receptors. Combining these with tamsulosin may lower blood pressure, causing dizziness or lightheadedness
• ketoconazole, a medicine used to treat fungal skin infections. This medicine may enhance the effect of tamsulosin.

You should tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you 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 in women.
In men, abnormal ejaculation (ejaculation disorders) has been reported. This means that semen is not expelled from the body through the urethra, but enters the urinary bladder (retrograde ejaculation), or the volume of ejaculate is reduced or absent (anejaculation). These symptoms are not harmful to the patient.

Driving and operating machinery
There are no data confirming the effect of the medicine on the ability to drive or operate machinery. However, it should be remembered that Prostamnic may cause dizziness or lightheadedness; therefore, driving and operating machinery should only be undertaken when the patient does not experience such symptoms and feels well.

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

3. How to take Prostamnic

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
The recommended dose is one capsule daily 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 in a lying position).
Capsules must not be broken or crushed, as this may affect the efficacy of the medicine.
In patients with mild or moderate renal impairment or liver disease, dose adjustment is not
required.
Taking more than the recommended dose of Prostamnic
If more than the recommended dose of Prostamnic is taken, a sudden drop in blood pressure may
occur. Symptoms may include: dizziness, weakness, vomiting, diarrhoea, and fainting. The patient
should lie down to reduce the effect of low blood pressure and then contact a doctor. The doctor may
administer drugs to stabilize blood pressure and fluid levels and recommend monitoring of vital
functions. If removal of unabsorbed tamsulosin from the stomach is necessary, the doctor may perform
gastric lavage and administer activated charcoal.
Missing a dose of Prostamnic
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Prostamnic treatment
If treatment is stopped too early, symptoms of the disease may return. Therefore, the medicine should
be taken for as long as directed by the doctor, even if symptoms have resolved. If a patient plans to
discontinue treatment, this 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.
Serious adverse reactions are rare. You should seek immediate medical advice
if the patient experiences a severe allergic reaction with swelling of the
face or throat (angioedema). Tamsulosin must not be administered again
(see section 2 "When not to take Prostamnic").

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

• Dizziness, especially when sitting down or standing up
• Ejaculation disorders. This means that semen does not exit the body through the urethra but instead flows backward into the bladder (retrograde ejaculation), or the volume of ejaculate is reduced, or ejaculation cannot be achieved (inability to achieve ejaculation). These symptoms are not dangerous for the patient.

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

• Headache
• Palpitations
• Drop in blood pressure upon standing, which may cause dizziness, lightheadedness, or fainting (orthostatic hypotension)
• Nasal congestion or irritation of the nasal mucosa (rhinitis)
• Constipation
• Diarrhea
• Nausea
• Vomiting
• Rash
• Urticaria
• Weakness (asthenia)
• Itching.

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

• Fainting

Very rare adverse reactions (may occur in 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 of unknown frequency (frequency cannot be determined from available data)

• Blurred vision
• Visual disturbances
• Nosebleeds
• Dry mouth
• Severe skin rashes (erythema multiforme, exfoliative dermatitis)
• Irregular heart rhythm (atrial fibrillation), irregular heartbeat (arrhythmia), rapid heartbeat (tachycardia), breathing difficulties (dyspnea).

During eye surgery due to lens clouding (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 colored ring 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 Drug Reactions of 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 this medicine.

5. How to store the medicine 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 pack
following "EXP". The expiry date refers to the last day of the specified month.
The medicine should be stored in its original packaging.
Medicines must 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, copolymer of methacrylic acid and ethyl acrylate (1:1)
dispersion 30%, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc
Capsule shell: gelatin, indigotine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172)
What Prostamnic looks like and contents of the pack
Orange-olive coloured capsules (measuring 19.3 mm x 6.4 mm). The capsules contain white or almost white pellets.
Prostamnic, modified release capsules, is available in packs containing 30, 60 or 90 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria
Manufacturer
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania S.L.
Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat
Spain
Genericon Pharma GmbH
Hafnerstraße 211
8054 Graz
Austria
For detailed information about this medicine and its brand names in the European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków
Poland
tel. +48 12 262 32 36