Tamsulosin Medreg

Package Leaflet: Information for the User

Tamsulosin Medreg, 0.4 mg, prolonged-release hard capsules
Tamsulosini hydrochloridum

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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the package leaflet:

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

Tamsulosin is an alpha-adrenergic receptor antagonist. It relaxes the muscles of the prostate and the urethra.
Tamsulosin is used to improve the symptoms of benign prostatic hyperplasia (enlargement of the prostate gland). By relaxing the muscles, it makes it easier to urinate and helps with urination.

2. Important information before taking Tamsulosin Medreg

When not to take Tamsulosin Medreg:

• if you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6) (hypersensitivity symptoms may include: facial and laryngeal oedema) (angioedema).
• if you have had a drop in blood pressure when standing up, which causes dizziness, fainting or lightheadedness.
• if you have severe liver function disorders.

Warnings and precautions

Before starting treatment with Tamsulosin Medreg, discuss it with your doctor or pharmacist:

• if you experience dizziness or lightheadedness, especially when standing up. Tamsulosin may lower your blood pressure, causing these symptoms. You should sit or lie down until the symptoms go away.
• if you have severe kidney function disorders. The normal dose of tamsulosin may not have the expected effect if your kidneys are not functioning normally.
• if you are undergoing eye surgeryfor cataracts or increased eye pressure (glaucoma).

(Cataract) or increased eye pressure (glaucoma). 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 taken tamsulosin hydrochloride. The eye doctor may take necessary precautions regarding the treatment and surgical technique. You should ask your doctor if you should stop or temporarily discontinue taking this medicine if you are planning to have cataract surgery or increased eye pressure (glaucoma).
Before starting treatment with tamsulosin, your doctor should examine you to make sure that your symptoms are really caused by an enlarged prostate.

Children and adolescents

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

Tamsulosin Medreg and other medicines

Tamsulosin may affect the way other medicines work, and other medicines may affect the way tamsulosin works. Therefore, it is important to tell your doctor if you are taking:

• blood pressure-lowering medicines (e.g. verapamil and diltiazem);
• HIV medicines (e.g. ritonavir or saquinavir);
• antifungal medicines (e.g. ketoconazole, itraconazole, voriconazole or fluconazole);
• blood-thinning medicines (warfarin);
• anti-inflammatory medicines (e.g. diclofenac);
• antibiotics (e.g. erythromycin, clarithromycin);
• immunosuppressants (e.g. cyclosporin).

Tell your doctor or pharmacistabout all the medicines you are taking, or have recently taken, and about any medicines you plan to take, including those obtained without a prescription.

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, ejaculation disorders (ejaculation disorders) have been reported. This means that semen does not leave the body through the urethra, but instead enters the bladder (retrograde ejaculation) or the volume of ejaculation is reduced or does not occur at all (absence of ejaculation).

Driving and using machines

There is no data on the effect of tamsulosin on the ability to drive and use machines. You should take into account that tamsulosin may cause dizziness and lightheadedness. You can drive and use machines only if you feel well.

Tamsulosin Medreg contains sodium

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

3. How to take Tamsulosin Medreg

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual doseis one capsule per day, taken after breakfastor 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 way tamsulosin works.
If you have mild to moderate kidney or liver disease, you can take tamsulosin at the usual dose.

If you take more Tamsulosin Medreg than you should

If you take more Tamsulosin Medreg than you should, you may experience a sudden drop in blood pressure. You may feel dizzy, weak, and faint, and you may vomit and have diarrhea. You should lie down to minimize the effects of low blood pressure, and then contact your doctor. Your doctor may prescribe medicines to restore blood pressure and fluid levels, and monitor your body's functions. If necessary, your doctor may empty your stomach and give you a laxative to remove tamsulosin from your body that has not yet been absorbed into the bloodstream.

Forget to take Tamsulosin Medreg

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

Stopping treatment with Tamsulosin Medreg

If you stop taking tamsulosin too early, your original symptoms may return. Therefore, you should take tamsulosin for as long as your doctor has prescribed, even if your symptoms have disappeared. You should consult your doctor if you are considering stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop taking Tamsulosin Medreg and contact your doctor immediately if you experience any of the following symptoms:

• Rare side effects (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 breathing and (or) itching and rash, caused by an allergic reaction (angioedema).
• Very rare side effects (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 genitals (Stevens-Johnson syndrome).
• Unknown frequency side effects (frequency cannot be estimated from the available data): severe skin inflammation and blistering known as erythema multiforme.

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

• Dizziness
• Abnormal ejaculation
• Retrograde ejaculation
• Absence of ejaculation

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

• Headache
• Palpitations
• Low blood pressure when standing up, which causes dizziness, lightheadedness, or fainting (orthostatic hypotension)
• Nasal congestion and irritation (rhinitis)
• Constipation
• Diarrhea
• Nausea
• Vomiting
• Rash
• Urticaria
• 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)

Side effects of unknown frequency(frequency cannot be estimated from the available data)

• Blurred vision
• Loss of vision
• Nosebleeds
• Dry mouth 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 may become floppy during surgery. For more information, see section 2, "Warnings and precautions".

Reporting side effects

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

Side effects can be reported directly to the Department of Drug Monitoring 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
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can 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 which is stated on the carton and blister or container after: EXP. The expiry date refers to the last day of that month.
Store the blisters in the original package.
Keep the container tightly closed.
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 Tamsulosin Medreg contains

• The active substance is tamsulosin hydrochloride, 0.4 mg.
• The other ingredients 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, indigo carmine (E 132), titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172), iron oxide black (E 172)

What Tamsulosin Medreg looks like and contents of the pack

Orange-olive-green capsule with prolonged release. The capsules contain white or almost white pellets.
They are available in blisters or containers containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, or 200 prolonged-release capsules.
Not all pack sizes may be marketed.

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer:

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
Netherlands
Pharmazet Group s.r.o.
Třtinová 260/1
Čakovice
196 00 Prague 9
Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Finland:

Tamsupli 0.4 mg sustained-release hard capsules
Germany:
TADIN 0.4 mg Hartkapseln mit veränderter Wirkstofffreisetzung
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

Date of last revision of the leaflet: