TAMSULOSIN MABO 0.4 mg MODIFIED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tamsulosin MABO 0.4 mg prolonged-release hard capsules EFG

Tamsulosin hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tamsulosin MABO and what is it used for
2. What you need to know before taking Tamsulosin MABO
3. How to take Tamsulosin MABO
4. Possible side effects
5. Storage of Tamsulosin MABO
6. Package contents and further information

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

Tamsulosin is an alpha-1A adrenergic receptor blocker. It relaxes the muscles of the prostate and the urinary tract.

Tamsulosin MABO is used to relieve urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). Muscle relaxation allows for easier urination and helps with micturition.

2. What you need to know before taking Tamsulosin MABO

Do not take Tamsulosin MABO

• If you are allergic to tamsulosin or any other component of this medication (listed in section 6) (symptoms may include: swelling of the face and throat (angioedema)).
• If you have a history of low blood pressure when standing up, which manifests as dizziness, fainting, or loss of consciousness.
• If you have severe liver failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosin MABO

• If you experience dizziness or fainting, especially when standing up. Tamsulosin may lower blood pressure and cause these symptoms. You should sit or lie down until the symptoms disappear.
• If you have severe kidney failure. The normal dose of Tamsulosin may not have the expected effect if your kidneys are not functioning normally.
• If you are going to undergo eye surgery for cataracts or increased eye pressure (glaucoma). During surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur; inform your ophthalmologist if you are receiving or have received treatment with Tamsulosin MABO. The specialist may take appropriate precautions regarding medication and surgical techniques to be used. Ask your doctor if you should postpone or temporarily discontinue this medication when undergoing cataract or glaucoma surgery.

Before starting treatment with tamsulosin, your doctor should examine you to confirm that your symptoms are actually caused by an enlarged prostate.

Children and adolescents

Do not give this medication to children or adolescents under 18 years of age, as it does not work in this population.

Using Tamsulosin MABO with other medications

Tamsulosin may affect how other medications work in your body, and some medications may affect how Tamsulosin works. Therefore, it is essential that you inform your doctor if you are taking:

• medications to lower blood pressure (e.g., verapamil and diltiazem);
• medications to treat HIV (e.g., ritonavir or saquinavir);
• medications to treat fungal infections (e.g., ketoconazole, itraconazole, voriconazole, or fluconazole);
• medications to prevent blood clotting (warfarin);
• anti-inflammatory medications (e.g., diclofenac);
• medications to treat infections (e.g., erythromycin, clarithromycin);
• immunosuppressants (e.g., cyclosporine).

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those obtained without a prescription.

Taking Tamsulosin MABO with food and drinks

Tamsulosin MABO should be taken with a glass of water, after breakfast or the first meal of the day.

Pregnancy, breastfeeding, and fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen is not eliminated through the urethra but instead goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory failure).

Driving and using machines

There is no information on the effects of Tamsulosin on the ability to drive and use machines. You should keep in mind that Tamsulosin can cause dizziness and fainting. You can only drive or operate machines if you feel well.

Tamsulosin MABO contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule; it is essentially "sodium-free".

3. How to take Tamsulosin MABO

Follow the administration instructions for this medication exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The usual dose is one capsule per day, taken after breakfast or 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 essential that you do not break or crush the capsule, as this may affect the functioning of Tamsulosin MABO.

If you have mild to moderate liver or kidney disease, you can take the usual dose of tamsulosin.

If you take more Tamsulosin MABO than you should

If you take more Tamsulosin MABO than you should, you may experience a sudden drop in blood pressure. You may feel dizzy, weak, or faint, and you may experience vomiting and diarrhea. Lie down to minimize the effects of low blood pressure and contact your doctor. Your doctor may provide you with medication to restore blood pressure and fluid levels and may monitor your body function. If necessary, your doctor may empty your stomach and administer a laxative to eliminate the Tamsulosin that has not been absorbed into the bloodstream.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Tamsulosin MABO

Do not take a double dose to make up for forgotten doses. Just take the next dose when it is due.

If you stop taking Tamsulosin MABO

When treatment with tamsulosin is discontinued prematurely, your original symptoms may return. Therefore, take tamsulosin for the entire time your doctor prescribes it, even if your symptoms have disappeared. Always consult your doctor if you decide to stop treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Stop taking Tamsulosin and contact your doctor immediately if you experience any of the following symptoms:

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

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

dizziness, abnormal ejaculation, retrograde ejaculation, ejaculatory failure.

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

headache, feeling the heartbeat (palpitations), low blood pressure when standing up, which causes dizziness, fainting, or loss of consciousness (orthostatic hypotension), swelling and irritation inside the nose (rhinitis), constipation, diarrhea, nausea, vomiting, skin rash, hives, 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 of unknown frequency(cannot be calculated from 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 dilates poorly, and the iris (the colored part of the eye) may become unstable during surgery. For more information, see section 2, Warnings and precautions.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Tamsulosin MABO

Keep this medication out of the reach and sight of children.

Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Store the blisters in the original packaging.

Keep the container tightly closed.

Medications should not be disposed of through wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If in doubt, consult your pharmacist on how to dispose of unused medications. This will help protect the environment.

6. Package contents and further information

Composition of TAMSULOSIN MABO

• The active ingredient is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are:

Capsule content:microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 percent, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.

Body and cap of the capsule:gelatin, carmine indigo (E-132), titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172).

Appearance of the product and package contents

Prolonged-release hard capsules of orange/olive green color. The capsules contain white or off-white microgranules.

They are available in packages of 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

MABO-FARMA. S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

Synthon Hispania S.L.

Castelló, 1.

Polígono Las Salinas.

08830 Sant Boi de Llobregat.

Spain.

Or

Quinta-Analytica s.r.o.

Prazska 1486/18 c (Prague) - 102 00

Czech Republic.

Or

Synthon BV.

Microweg 22

6545 CM Nijmegen.

Netherlands.

Date of the last revision of this package leaflet: April 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es