Leaflet: information for the user

Tamsulosina MABO 0.4 mg modified-release hard capsules EFG

Tamsulosin hydrochloride

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

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

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

2. What you need to know before you start taking Tamsulosina MABO

3. How to take Tamsulosina MABO

4. Possible side effects

5. Storage of Tamsulosina MABO

6. Contents of the pack and additional information

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

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

Do not take Tamsulosina MABO

• If you are allergic to tamsulosina or any of the other components of this medication (including those 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 passing out.
• If you have severe liver failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosina MABO

• If you experience dizziness or fainting, especially after standing up. Tamsulosina may lower your 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 Tamsulosina may not have the expected effect if your kidneys do not function normally.
• If you are about to undergo an eye procedure for cataract or increased eye pressure (glaucoma). During the procedure, a condition called floppy iris syndrome (see section 4, Possible side effects) may occur; inform your ophthalmologist if you receive or have received treatment with Tamsulosina MABO. The specialist may take the necessary precautions regarding medication and surgical techniques to be used. Ask your doctor if you should postpone or temporarily discontinue this medication when undergoing a cataract or glaucoma procedure.

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

Children and adolescents

Do not administer this medication to children or adolescents under 18 years old because it does not work in this population.

Use of Tamsulosina MABO with other medications

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

• blood pressure-lowering medications (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);
• blood thinners (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 used recently, or may need to use any other medication, including those acquired without a prescription.

Taking Tamsulosina MABO with food and drinks

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

Pregnancy, breastfeeding, and fertility

Tamsulosina is not indicated for use in women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen is not eliminated through the urethra, but rather goes to the bladder (retrograde ejaculation) or the volume of semen is reduced or non-existent (ejaculatory insufficiency).

Driving and operating machinery

There is no information on the effects of Tamsulosina on the ability to drive and operate machinery. You should be aware that Tamsulosina may cause dizziness and fainting. You can only drive or operate machinery if you feel well.

Tamsulosina MABO contains sodium

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

Follow exactly the administration instructions for this medication 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 the patient remains standing or sitting (not lying down). It is essential not to break or crush the capsule, as this may affect the functioning of Tamsulosina MABO.

If you have a mild to moderate liver or kidney disease, you may take the usual dose of tamsulosina.

If you take more Tamsulosina MABO than you should

If you take more Tamsulosina MABO than you should, you may experience a sudden drop in blood pressure. You may experience dizziness, weakness, or fainting, vomiting, and diarrhea. Lie down to minimize the effects of the drop in blood pressure and contact your doctor. Your doctor may provide you with medications to restore blood pressure and fluid levels and monitor your bodily functions. When necessary, your doctor may empty your stomach and administer a laxative to help you eliminate the Tamsulosina that has not been absorbed into your blood.

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

If you forget to take Tamsulosina MABO

Do not take a double dose to compensate for the missed doses. Limit yourself to taking the next dose when it is due.

If you interrupt treatment with Tamsulosina MABO

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Tamsulosina 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 inflammation and blistering of the skin known as erythema multiforme.

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

dizziness, abnormal ejaculation, retrograde ejaculation, ejaculatory incompetence.

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

headache, feeling the heartbeat (palpitations), decrease in blood pressure when standing, which causes dizziness, fainting, or fainting (orthostatic hypotension), nasal congestion and irritation (rhinitis), constipation, diarrhea, 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 of unknown frequency(cannot be calculated from available data) Blurred vision, loss of vision, nasal bleeding, dry mouth.

During eye surgery for cataract or increased eye pressure (glaucoma) a condition called iris floppiness syndrome (IFIS) may occur: the pupil does not dilate properly and the iris (the circular and colored part of the eye) may become unstable during the procedure. For more information see section 2, Warnings and precautions.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Store the blisters in the original packaging.

Keep the packaging perfectly closed.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused medications. By doing so, you will help protect the environment.

Composition of TAMSULOSINA MABO

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

Content of the capsule:microcrystalline cellulose, copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion at 30 percent, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.

Body and cap of the capsule:gelatin, indigo carmine (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 content of the container

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

They are presented in containers with 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 modified-release capsules.

Only some container sizes may be commercially marketed.

Marketing authorization holder

MABO-FARMA. S.A

Calle Rejas 2, 1st floor

28821 Coslada.

Madrid.

Responsible for manufacturing

Synthon Hispania S.L.

Castelló, 1.

Polígono Las Salinas.

08830 Sant Boi de Llobregat.

Spain.

Or

Qinta-Analytica s.r.o.

Prazska 1486/18 c (Prague) - 102 00

Republic of Czech.

Or

Synthon BV.

Microweg 22

6545 CM Nijmegen.

Netherlands.

Last review date of this leaflet: April 2021

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