TAMSULOSIN MABO 0.4 mg PROLONGED-RELEASE TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tamsulosin Mabo 0.4 mg prolonged-release tablets EFG

Tamsulosin hydrochloride

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Tamsulosin Mabo is and what it is used for
2. Before you take Tamsulosin Mabo
3. How to take Tamsulosin Mabo
4. Possible side effects
5. Storage of Tamsulosin Mabo
6. Further information

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

The active substance is tamsulosin. It belongs to a group of medicines called selective alpha-1A/1D adrenergic receptor antagonists. It reduces the tension of the smooth muscles of the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. Additionally, it decreases the sensation of urgency.

Tamsulosin Mabo is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate gland (benign prostatic hyperplasia). These symptoms include: difficulty urinating (weak urine stream), dripping, urgent urination, and frequent need to urinate both at night and during the day.

2. Before you take Tamsulosin Mabo

Do not take Tamsulosin Mabo

• If you are allergic (hypersensitive) to tamsulosin or any of the other ingredients of this medicine.

Hypersensitivity may present as sudden local swelling of the body's soft tissues (e.g., the throat or tongue), difficulty breathing, and/or itching and skin rash (angioedema).

• If you have severe liver problems.
• If you have dizziness due to a drop in blood pressure when changing position (sitting or standing up).

Be cautious with Tamsulosin Mabo

• Regular medical examinations are necessary to monitor the progression of the disease being treated.

• Rarely, fainting may occur during the use of tamsulosin, as with other medications of this type. At the first symptoms of dizziness or weakness, you should sit or lie down until they have disappeared.

• If you have severe kidney problems, consult your doctor.

• If you are going to undergo eye surgery due to a cataract. Please inform your ophthalmologist if you are taking or have taken tamsulosin previously. The specialist can then take the appropriate precautions regarding medication and surgical techniques to be used. Consult your doctor if you should or should not postpone or temporarily suspend taking this medication if you are going to undergo this operation.

Use of other medications

Taking Tamsulosin Mabo with other medications of the same group (alpha-1 adrenergic receptor blockers) may cause an undesirable drop in blood pressure.

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

Taking Tamsulosin Mabo with food and drinks

Tamsulosin Mabo can be taken with or without food.

Pregnancy and breastfeeding

This section is not applicable since Tamsulosin Mabo is indicated only in male patients.

Driving and using machines

There is no evidence that Tamsulosin Mabo affects the ability to drive or operate tools or machines. However, you should be aware that dizziness may occur, in which case you should not perform activities that require attention.

3. How to take Tamsulosin Mabo

Follow exactly the administration instructions of Tamsulosin Mabo indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

The normal dose is one tablet per day, administered orally, with or without food, preferably at the same time each day.

The tablet should be swallowed whole and not broken or chewed.

Tamsulosin Mabo is a tablet designed to release the active substance gradually once the tablet is ingested. You may observe a remainder of the tablet in your feces. There is no risk of loss of efficacy since the active substance has already been released.

Normally, Tamsulosin Mabo is prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with Tamsulosin Mabo.

If you think the action of Tamsulosin Mabo is too strong or too weak, tell your doctor or pharmacist.

If you take more Tamsulosin Mabo than you should

Taking too many Tamsulosin Mabo tablets may lead to an undesirable drop in blood pressure and an increase in heart rate, with a sensation of fainting.

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

If you forget to take Tamsulosin Mabo as recommended, you can take your daily dose later that day. If you have missed a dose one day, you can simply continue taking your daily tablet as prescribed.

Do not take a double dose to make up for forgotten doses.

If you stop taking Tamsulosin Mabo

When treatment with Tamsulosin Mabo is abandoned prematurely, your original symptoms may return. Therefore, take Tamsulosin Mabo 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 product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tamsulosin Mabo can cause side effects, although not everybody gets them.

Frequent side effects (may affect 1 to 10 patients in 100): dizziness, especially when sitting or standing up, abnormal ejaculation. The latter means that semen is not released through the urethra but remains in the bladder. This phenomenon is harmless.

Uncommon side effects (may affect 1 to 10 patients in 1,000): headache, palpitations (the heartbeat is faster than normal and also perceptible), reduction of blood pressure, for example, when standing up quickly after being in a seated or lying position, sometimes associated with dizziness, runny or stuffy nose (rhinitis), diarrhea, feeling of nausea and vomiting, constipation, weakness (asthenia), skin rash, itching, and hives (urticaria).

Rare side effects (may affect 1 to 10 patients in 10,000): fainting and sudden local swelling of the body's soft tissues (such as the throat or tongue), difficulty breathing, and/or itching and skin rash, often as an allergic reaction (angioedema).

Very rare side effects (may affect less than 1 patient in 10,000): priapism (undesired, prolonged, and painful erection that requires immediate medical treatment), Stevens-Johnson syndrome.

Side effects of unknown frequency: dry mouth

If you are going to undergo cataract surgery and are already taking or have recently taken tamsulosin, during the operation, the pupil may not dilate properly, and the iris (the colored part of the eye) may become flaccid.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Mabo

Keep out of the reach and sight of children.

Do not use Tamsulosin Mabo after the expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Tamsulosin Mabo

The active substance is tamsulosin hydrochloride. Each tablet contains 0.4 mg of tamsulosin hydrochloride.

The other ingredients are: microcrystalline cellulose, hypromellose, anhydrous colloidal silica, carbomer, magnesium stearate, and red iron oxide (E172).

Appearance and packaging of the product

The tablets are round, white, and have the inscription "T9SL" on one side and 0.4 on the other.

Each pack contains 30 prolonged-release tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

Synthon BV

Microweg, 22

P.O Box 7071

NL-6545 (Nijmegen)

or

Synthon Hispania, S.L.

Castelló, 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

This leaflet was approved in November 2013

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