TAMSULOSIN MEDREG

Patient Information Leaflet

Tamsulosina Medreg 0.4 mg modified-release hard capsule

tamsulosin hydrochloride
Generic medicine
Please read this leaflet carefully before taking this medicine because 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 give it to other people. Even if their symptoms are the same as yours, it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Tamsulosina Medreg is and what it is used for
2. What you need to know before taking 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

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

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

• if you are 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 you experience dizziness, vertigo, or fainting upon changing to an upright position due to low 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 vertigo, especially when standing up. Tamsulosin may lower blood pressure, causing these symptoms. In such cases, you should sit or lie down until symptoms resolve.
• if you have severe kidney problems. The standard dose of tamsulosin may not have the expected effect when kidney function is impaired.
• if you are scheduled for eye surgery due to cataract or increased intraocular pressure (glaucoma). You may develop a condition affecting the eyes known as intraoperative floppy iris syndrome (see section 4, Possible side effects). Inform your ophthalmologist if you are currently taking or have previously taken tamsulosin hydrochloride. The specialist may take appropriate precautions regarding the medication and surgical techniques. Ask your doctor whether you should postpone or temporarily discontinue taking this medicine before undergoing cataract or glaucoma surgery.
• Before starting treatment with tamsulosin, your doctor should examine you to confirm that your symptoms are indeed caused by an enlarged prostate.

Children and adolescents
Do not administer 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 may affect the action of other medicines in your body, and these, in turn, may affect the action of tamsulosin. Therefore, it is important to inform your doctor if you are taking:

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

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

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

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

Driving and using machines
There is no information on the effects of tamsulosin on the ability to drive or use machines. You should bear in mind that tamsulosin may cause dizziness and vertigo. Drive or operate machinery only if you feel well.

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

3 How to take Tamsulosina Medreg
Take this medicine exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
The usual dose is one capsule daily taken after breakfast or after the first meal of the day.
Swallow the capsule whole with a glass of water, while sitting or standing (not lying down). It is important not to break or crush the capsule, as this may interfere with the release of tamsulosin.
If you have mild to moderate kidney or liver disease, your doctor will prescribe the standard dose of tamsulosin.

If you take more Tamsulosina Medreg than you should
If you take more tamsulosin than recommended, your blood pressure may drop suddenly. You may experience dizziness, weakness, fainting, vomiting, and diarrhea. Lie down to minimize the effects of low blood pressure and contact your doctor. Your doctor may administer medicines to restore normal blood pressure and fluid levels and monitor your bodily functions. If necessary, your doctor may empty your stomach and give you a laxative to eliminate any tamsulosin not yet absorbed into the bloodstream.

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

If you stop taking Tamsulosina Medreg
If treatment with tamsulosin is stopped prematurely, the original symptoms may return. Therefore, continue using tamsulosin for the full duration prescribed by your doctor, even if symptoms appear to have disappeared. Always consult your doctor if you are considering stopping treatment.
If you have any doubts about using this medicine, contact your doctor or pharmacist.

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

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

Common side effects (may affect up to 1 in 10 patients)
Dizziness • Abnormal ejaculation • Retrograde ejaculation • Absence of ejaculation
Uncommon side effects (may affect up to 1 in 100 patients)
Headache • Awareness of heartbeat (palpitations) • Drop in blood pressure upon standing causing dizziness, vertigo, or fainting (orthostatic hypotension) • Nasal swelling and irritation (rhinitis) • Constipation • Diarrhea • Feeling unwell (nausea) • Vomiting • Skin rash • Urticaria • Feeling of weakness (asthenia) • Itching
Rare side effects (may affect up to 1 in 1,000 patients)
Fainting (syncope)
Very rare side effects (may affect up to 1 in 10,000 patients)
Painful erection (priapism)
Side effects with unknown frequency (frequency cannot be estimated from available data)
Blurred vision • Vision loss • 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 not dilate adequately and the iris (the colored circular part of the eye) may undulate during surgery. For further information, see section 2, Warnings and precautions.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via 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.

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

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

• The active substance is tamsulosin hydrochloride 0.4 mg.
• The other ingredients are: Capsule: Microcrystalline cellulose, Methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, 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)

Description of the appearance of Tamsulosina Medreg and contents of the pack
Modified-release hard capsules, orange/olive green in color. The capsules are filled with white to off-white pellets.
The capsules are packaged in blisters or bottles containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, or 200 modified-release hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Medreg s.r.o.
Na Florenci 2139/2
Nové Město
110 00 Prague 1
Czech Republic
Manufacturer:
Medis International a.s.
Průmyslová 961/16
Bolatice
747 23
Czech Republic
Synthon Hispania, S.L.
Calle de Castello 1
Sant Boi de Llobregat
Barcelona
Spain
Synthon B.V.
Microweg 22
Nijmegen
Gelderland
6545CM
Netherlands
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicine is authorized in the European Economic Area Member States under 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