TAMSULOSINA 0.4 MG Kapsułki o przedłużonym uwalnianiu

Treść ulotki

1. Tamsulosina Medreg 0.4 mg hard capsule with modified release

Tamsulosina Medreg 0.4 mg hard capsule with modified release

tamsulosin hydrochloride

Generic medicine

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. Even if their symptoms are the same as yours, it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What is Tamsulosina Medreg and what it is used for
• 2. What you need to know before you take Tamsulosina Medreg
• 3. How to take Tamsulosina Medreg
• 4. Possible side effects
• 5. How to store Tamsulosina Medreg
• 6. Contents of the pack and other information

1What is Tamsulosina Medreg and what it is used for
Tamsulosin is an alpha-adrenergic receptor blocker. It relaxes the muscles of the prostate and urinary tract.
Tamsulosin is prescribed to relieve urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). By relaxing the muscles, it allows urine to pass more easily and thus facilitates urination.

2What you need to know before you take Tamsulosina Medreg
Do not take Tamsulosina Medreg:

• if you are allergic to tamsulosin or any of the other ingredientsof this medicine (listed in section 6) (symptoms may include: swelling of the face and throat(angioedema).
• if you suffer from dizziness, lightheadedness orfainting when changing to an upright position due to a decrease in blood pressure.
• if you have severe liver problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tamsulosina Medreg

• if you experience dizziness or lightheadedness, especially after standing up. Tamsulosin can lower blood pressure, causing these symptoms. In such cases, you should sit or lie down until the symptoms disappear.
• if you suffer from severe kidney problems. The normal dose of tamsulosin may not have the expected effect when the kidneys are not functioning properly.
• if you are going to have eye surgeryfor cataracts (clouding of the lens) or glaucoma (increased eye pressure). A condition affecting the eyes called iris flag syndrome may occur during surgery (see section 4, Possible side effects). Inform your

eye doctor if you are taking or have previously taken tamsulosin hydrochloride. The specialist may
take appropriate precautions regarding the drug and the surgical techniques to be used. Ask your
doctor if you need to delay or temporarily stop taking this medicine before
undergoing surgery for cataracts (clouding of the lens) or increased
eye pressure (glaucoma).
Before starting therapy with tamsulosin, your doctor should examine you to verify that your symptoms are
really caused by an enlarged prostate.

Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age as it is not effective in this
population.

Other medicines and Tamsulosina Medreg
Tamsulosin can affect the action of other medicines in the body and these, in turn, can
affect the action of tamsulosin. Therefore, it is important to tell your doctor if you are taking:

• medicines for lowering blood pressure (e.g. verapamil and diltiazem);
• medicines for the treatment of HIV (e.g. ritonavir or saquinavir);
• medicines for the treatment of fungal infections (e.g. ketoconazole, itraconazole, voriconazole or fluconazole);
• medicines for blood clotting (e.g. warfarin);
• anti-inflammatory drugs (e.g. diclofenac);
• medicines for the treatment of infections (e.g. erythromycin, clarithromycin);
• immunosuppressants (e.g. cyclosporine).

Tell your doctor or pharmacistif you are taking, have recently taken or might take any other
medicines, including those available without a prescription.

Tamsulosina Medreg with food and drink
You should take tamsulosin with a glass of water after the first breakfast or after the first meal of the
day.

Pregnancy, breastfeeding and fertility
Tamsulosin is not indicated in women.
In men, abnormalities in ejaculation have been detected (ejaculation disorders). This means that semen
does not pass through the urethra but through the bladder (retrograde ejaculation) or that the volume
of ejaculate is reduced or absent (lack of ejaculation).

Driving and operating machinery
There is no information on the effects of tamsulosin on the ability to drive vehicles and operate
machinery. You should consider that tamsulosin can cause dizziness and lightheadedness. Drive or
operate machinery only if you feel well.

Tamsulosina Medregcontains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially “sodium-free”.

3How to take Tamsulosina Medreg
Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor
or pharmacist.
The usual doseis one capsule a day to be taken after the first breakfastor after the first meal of the
day.
Swallow the capsule wholewith a glass of water, in a sitting or upright position (not lying down). It is
important that you do not break or crush the capsuleto avoid interfering with the release of tamsulosin.
If you suffer from mild to moderate kidney or liver disease, your doctor will have you take the normal dose of
tamsulosin.

If you take more Tamsulosina Medreg than you should
If you take more tamsulosin than you should, your blood pressure may drop suddenly. You may
experience dizziness, weakness, and fainting, vomiting and diarrhea. Lie down to minimize the effects of
low blood pressure and consult your doctor. The doctor may give you medicines to
restore normal blood pressure values and fluid levels, and monitor your body functions. If necessary, the doctor may empty your stomach and give you a laxative to eliminate
all the tamsulosin that has not yet entered the bloodstream.

If you forget to take Tamsulosina Medreg
Do not take a double dose to make up for a forgotten dose. Simply take the next dose at the usual time.

If you stop taking Tamsulosina Medreg
When treatment with tamsulosin is stopped prematurely, the original symptoms may
reappear. Therefore, use tamsulosin for the entire time indicated by the doctor, even if the symptoms may
already seem to have disappeared. Always consult your doctor if you think of stopping therapy.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone
gets them.
Do not take Tamsulosin and contact your doctor immediately if you experience the following effects:

• Rare side effects (may affect up to 1 in 1,000 patients): sudden swelling of one or all of the following parts: hands, feet, lips, tongue or throat, which may cause difficulty breathing and/or itching, rash, due to an allergic reaction (angioedema).
• Very rare side effects (may affect up to 1 in 10,000 patients): rash, inflammation and rash with blisters and/or on the mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).
• Side effects with unknown frequency (frequency cannot be estimated based on available data): a severe inflammation and rash with blisters known as erythema multiforme.

Common side effects(may affect up to 1 in 10)
Dizziness • Abnormal ejaculation • Retrograde ejaculation • Lack of ejaculation

Uncommon side effects(may affect up to 1 in 100)
Headache • Feeling the heartbeat (palpitations) • Lowering of blood pressure in an upright position
causing dizziness, lightheadedness or fainting (orthostatic hypotension) • Swelling and irritation of the nose
(rhinitis)• Constipation • Diarrhea • Feeling unwell (Nausea) • Vomiting • Rash • Hives • Feeling
of weakness (asthenia) • Itching

Rare side effects(may affect up to 1 in 1,000)
Fainting (syncope).

Very rare side effects(may affect up to 1 in 10,000)
Painful erection (priapism)

Side effects with unknown frequency(frequency cannot be estimated based on available data)
Blurred vision • vision loss • Nosebleeds • Dry mouth
During eye surgery due to clouding of the lens (cataracts) or increased
eye pressure (glaucoma), a condition called iris flag syndrome (IFS) may occur: the pupil may dilate insufficiently and the iris (the colored circular part of the eye)
may wave during surgery. For more information, see section 2, Warnings and
precautions.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this
medicine.

5How to store Tamsulosina Medreg
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated on the packaging and blister after 'EXP'. The date of
expiry refers to the last day of that month.
Store the blisters in the original packaging.
Keep the container tightly closed.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6Contents of the pack and other information
What Tamsulosina Medreg contains

• The active ingredient is tamsulosin hydrochloride 0.4 mg.
• The other ingredients are: Capsule:Microcrystalline cellulose, Acrylic acid-ethyl acrylate copolymer dispersion 30 percent, Polysorbate 80, Sodium lauryl sulfate, Triethyl citrate, Talc Capsule body:Gelatin, Indigo carmine (E 132), Titanium dioxide (E 171), Yellow iron oxide (E 172), Red iron oxide (E 172), Black iron oxide (E 172)

Description of Tamsulosina Medreg and contents of the pack
Hard capsules with modified release, orange/olive green in color. The capsules are filled with pellets from
white to off-white in color.
The capsules are packaged in blisters or bottles of 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 and Manufacturer

Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

Manufacturer:
Medis International a.s.
Prumyslova 961/16
Bolatice
747 23
Czech Republic
Synthon Hispania, S.L.
Calle de Castello 1
Sant Boi de Llobregat
Barcelona
08830
Spain
Synthon B.V.
Microweg 22
Nijmegen
Gelderland
6545CM
Netherlands
Pharmazet Group s.r.o.
Trtinova 260/1
Cakovice
19600 Prague
Czech Republic

This medicine is authorised in the Member States of the European Economic Area with the following
names:
Czech Republic, Poland, Slovakia Tamsulosin Medreg
Finland Tamsupli 0.4 mg säädellysti vapauttava kapseli, kova
Germany TADIN 0.4 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Romania Tamsulosin Gemax Pharma 0.4 mg capsule cu eliberare prelungită
Spain ZUANTRIP 0.4 mg Cápsulas duras de liberación modificada EFG
Italy Tamsulosina Medreg