Tamsulosin Mabo 0.4 mg modified-release hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tamsulosina MABO 0.4 mg modified-release hard capsules EFG

Tamsulosin hydrochloride

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

• Keep this leaflet, as 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 they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

Tamsulosin MABO is used to relieve urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). Muscle relaxation allows urine to be passed more easily and improves urination.

2. What you need to know before taking Tamsulosin MABO

Do not take Tamsulosin MABO

• 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 have a history of low blood pressure upon standing, which may present as dizziness, lightheadedness, or fainting.
• If you have severe liver impairment.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tamsulosin MABO

• If you experience dizziness or fainting, especially when standing up. Tamsulosin may lower blood pressure and cause these symptoms. Sit or lie down until symptoms resolve.
• If you have severe renal impairment. The standard dose of Tamsulosin may not have the expected effect if your kidneys are not functioning properly.
• If you are scheduled for eye surgery due to cataracts or increased eye pressure (glaucoma). During surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur (see section 4, Possible side effects). Inform your ophthalmologist if you are currently taking or have previously taken Tamsulosin MABO. The specialist may take appropriate precautions regarding medication and surgical techniques. Ask your doctor whether you should delay or temporarily discontinue this medicine prior to 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 give this medicine to children or adolescents under 18 years of age, as it is not effective in this population.

Taking Tamsulosin MABO with other medicines

Tamsulosin may affect how other medicines work in your body, and some medicines may affect how tamsulosin works. Therefore, it is important to inform your doctor if you are taking:

• Medicines to lower blood pressure (e.g. verapamil and diltiazem);
• Medicines for HIV treatment (e.g. ritonavir or saquinavir);
• Medicines for fungal infections (e.g. ketoconazole, itraconazole, voriconazole or fluconazole);
• Medicines to prevent blood clotting (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 need to take any other medicines, including those obtained without a prescription.

Taking Tamsulosin MABO with food and drink

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 does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or the volume of ejaculate is reduced or absent (ejaculatory insufficiency).

Driving and using machines

There is no information available on the effects of Tamsulosin on the ability to drive or operate machinery. However, you should bear in mind that tamsulosin may cause dizziness and fainting. You should only drive or operate machinery if you feel well.

Tamsulosin MABO contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; therefore, it is essentially “sodium-free”.

3. How to take Tamsulosin MABO

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist.

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 important not to break or crush the capsule, as this may affect the way Tamsulosin MABO works.

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

If you take more Tamsulosin MABO than you should

If you take more Tamsulosin MABO than prescribed, you may experience a sudden drop in blood pressure. You may feel dizzy, weak, or faint, and may also have vomiting and diarrhea. Lie down to minimize the effects of low blood pressure and contact your doctor immediately. Your doctor may give you medications to restore your blood pressure and fluid levels and may monitor your body functions. If necessary, your doctor may empty your stomach and administer a laxative to remove any tamsulosin that has not yet entered the bloodstream.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tamsulosin MABO

Do not take a double dose to make up for missed doses. Simply take the next dose at the scheduled time.

If you stop taking Tamsulosin MABO

If treatment with tamsulosin is stopped prematurely, your original symptoms may return. Therefore, continue taking tamsulosin for as long as your doctor prescribes, even if your symptoms have disappeared. Always consult your doctor if you decide to discontinue treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• Rare adverse 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 causing difficulty breathing and/or itching and skin rash due to an allergic reaction (angioedema).
• Very rare adverse 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).
• Adverse effects with unknown frequency (cannot be estimated from available data): severe inflammation and blistering of the skin known as erythema multiforme.

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

dizziness, abnormal ejaculation, retrograde ejaculation, ejaculatory failure.

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

headache, awareness of heartbeat (palpitations), decrease in blood pressure upon standing, causing dizziness, lightheadedness or fainting (orthostatic hypotension), swelling and irritation inside the nose (rhinitis), constipation, diarrhoea, nausea, vomiting, skin rash, urticaria, feeling of weakness (asthenia), itching.

Rare adverse effects (may affect up to 1 in 1,000 patients)

fainting (syncope).

Very rare adverse effects (may affect up to 1 in 10,000 patients)

painful erection (priapism).

Adverse effects with unknown frequency (cannot be estimated from available data): blurred vision, loss of vision, nosebleed, dry mouth.

During eye surgery for lens opacity (cataract) or increased eye pressure (glaucoma), a condition called intraoperative floppy iris syndrome (IFIS) may occur: the pupil dilates poorly and the iris (the circular colored part of the eye) may become unstable during surgery. For more information, see section 2, Warnings and precautions.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin MABO

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Store the blisters in the original packaging.

Keep the container tightly closed.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of TAMSULOSIN MABO

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

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

Capsule shell and cap: 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 contents of the pack

Modified-release orange/olive-green gelatin capsules. The capsules contain white or almost white microgranules.

Packaged in containers containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 modified-release capsules.

Only certain 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 B.V.

Microweg 22

6545 CM Nijmegen.

The Netherlands.

Date of the most recent revision of this leaflet: April 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es /