Tamsulosin medreg

Package leaflet: Information for the user

Tamsulosin Medreg, 0.4 mg, modified-release capsules, hard
Tamsulosini hydrochloridum
Please read the entire leaflet carefully before starting to use the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Tamsulosin Medreg is and what it is used for

Tamsulosin is an alpha-adrenergic receptor antagonist. It relaxes the muscles of 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 enables easier urination and helps in passing urine.

2. Important information before using Tamsulosin Medreg

When not to use Tamsulosin Medreg:

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

Warnings and precautions
Before starting treatment with Tamsulosin Medreg, discuss this with your doctor or
pharmacist:

• if the patient experiences dizziness or sensitivity to light, especially after standing up. Tamsulosin may lower blood pressure, causing these symptoms. Sit or lie down until symptoms subside.

• if the patient has severe kidney function disorders . The standard dose of tamsulosin may not produce the expected effect if the kidneys are not functioning normally.

• if the patient is undergoing eye surgery due to cataract
  or increased eye pressure (glaucoma). A condition called
  intraoperative floppy iris syndrome (IFIS) may occur (see section 4, "Possible side effects"). Inform your ophthalmologist that the patient is taking or has taken tamsulosin hydrochloride. The ophthalmologist may take necessary precautions regarding treatment and surgical technique. Ask your doctor whether discontinuation or temporary interruption of this medicine is recommended if cataract surgery or glaucoma surgery is planned.
  Before starting treatment with tamsulosin, the doctor should examine the patient to ensure that
  the symptoms are indeed caused by an enlarged prostate.
  Children and adolescents
  This medicine should not be used in children and adolescents under 18 years of age, as the medicine is not effective in this population.
  Tamsulosin Medreg with other medicines
  Tamsulosin may affect the action of certain other medicines in the body, and some other medicines may affect the action of tamsulosin. Therefore, it is important to inform your doctor if the patient is taking:

• medicines that lower blood pressure (e.g. verapamil and diltiazem);

• medicines used to treat HIV (e.g. ritonavir or saquinavir);

• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole, voriconazole or fluconazole);

• medicines preventing blood clotting (warfarin);

• anti-inflammatory medicines (e.g. diclofenac);

• medicines used to treat infections (e.g. erythromycin, clarithromycin);

• immunosuppressants (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 take, including over-the-counter medicines.
Tamsulosin Medreg with food and drink
Tamsulosin should be taken after breakfast or after the first meal of the day, with a glass of water.
Pregnancy, breastfeeding and fertility
Tamsulosin is not indicated for use in women.
In men, disorders of ejaculation (ejaculation disorders) have been reported. This means that semen does not leave the body through the urethra, but enters the urinary bladder (retrograde ejaculation), or the volume of ejaculate is reduced or ejaculation does not occur at all (absence of ejaculation).
Driving and operating machinery
There are no data on the effect of tamsulosin on the ability to drive and operate machinery. Consider that tamsulosin may cause dizziness and sensitivity to light.
Driving and operating machinery should only be performed if the patient feels well.
Tamsulosin Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Tamsulosin Medreg

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
The usual dose is one capsule daily, taken after breakfast or after the first meal of the day.
The capsule should be swallowed whole with a glass of water, while standing or sitting (not lying
down). It is important not to break or crush the capsule, as this may affect the action of tamsulosin.
If the patient has mild to moderate kidney or liver disease, tamsulosin may be taken at the usual dose.
Taking more Tamsulosin Medreg than prescribed
If more Tamsulosin Medreg is taken than prescribed, a sudden drop in blood pressure may occur.
Dizziness, weakness, fainting, vomiting, and diarrhoea may occur. You should lie down to minimize
the effects of low blood pressure and then contact your doctor. The doctor may prescribe medicines
to restore blood pressure and fluid levels and monitor bodily functions. If necessary, the doctor may
empty the stomach and administer a laxative to remove any tamsulosin not yet absorbed into the
bloodstream.
Missing a dose of Tamsulosin Medreg
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Tamsulosin Medreg treatment
If treatment with tamsulosin is stopped too early, the original symptoms of the disease may return.
Therefore, tamsulosin should be taken for as long as recommended by the doctor, even if symptoms
have improved. Consult your doctor if you are considering stopping treatment.
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 should stop taking Tamsulosin Medreg and contact your doctor immediately if any of the following symptoms occur:

• Rare adverse reactions (may affect up to 1 in 1,000 people): 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 (may affect up to 1 in 10,000 people): rash, inflammation and blisters on the skin and (or) mucous membranes of the lips, eyes, mouth, nasal passages or genital organs (Stevens-Johnson syndrome).
• Adverse reactions with unknown frequency (frequency cannot be determined from available data): severe skin inflammation and blistering known as erythema multiforme.

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

• Dizziness
• Ejaculation disorder
• Retrograde ejaculation
• Absence of ejaculation

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

• Headache
• Palpitations
• Drop in blood pressure upon standing, causing dizziness, light-headedness or fainting (orthostatic hypotension)
• Nasal congestion and irritation (nasal mucositis)
• Constipation
• Diarrhea
• Malaise (nausea)
• Vomiting
• Rash
• Urticaria
• Feeling of weakness (asthenia)
• Itching

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

• Fainting

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

• Painful erection (priapism)

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

• Blurred vision
• Loss of vision
• Nosebleeds
• Dry mouth During eye surgery due to cataract or increased intraocular pressure (glaucoma), a condition called intraoperative floppy iris syndrome (IFIS) may occur: the pupil may dilate poorly and the iris may become floppy during surgery. For more 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 of the 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
Reporting adverse reactions helps to provide more information on the safety of this medicine.
Adverse reactions may also be reported to the marketing authorization holder.

5. How to store Tamsulosin Medreg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or container after: EXP. The expiry date refers to the last day of the specified month.
Store blisters in the original packaging.
Keep the container tightly closed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer used. Such measures will help protect the environment.

6. Contents of the pack and other information

What Tamsulosin Medreg contains

• The active substance is tamsulosin hydrochloride, 0.4 mg.
• The other components are:
  Capsule contents: microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc
  Capsule shell: gelatin, indigocarmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172)

What Tamsulosin Medreg looks like and contents of the pack
Tamsulosin Medreg is an orange-olive-green modified-release capsule. The capsules contain white or almost white pellets.
It is supplied 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:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
Tel.: (+420) 516 770 199

Manufacturers:
Medis International a.s.
Výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic

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

Synthon B.V.
Microweg 22
6545 CM, Nijmegen
The Netherlands

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicinal product is authorised in the European Economic Area under the following names:
Finland: Tamsupli 0.4 mg prolonged-release capsule, hard
Germany: TADIN 0.4 mg modified-release hard capsules
Czech Republic: Tamsulosin Medreg
Slovakia: Tamsulosin Medreg
Poland: Tamsulosin Medreg
Romania: Tamsulosin Gemax Pharma 0.4 mg prolonged-release capsules
Spain: ZUANTRIP 0.4 mg (Tamsulosina DCI clorhidrato) Cápsulas duras de liberación modificada
Italy: Tamsulosina Medreg