PATIENT INFORMATION LEAFLET

Tamsulosina Mabo 0.4 mg prolonged-release tablets EFG

Tamsulosina hydrochloride

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

2. Before taking Tamsulosina Mabo

3. How to take Tamsulosina Mabo

4. Possible side effects

5. Storage of Tamsulosina Mabo

6. Further information

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

Tamsulosina 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: difficulties with urination (weak urine stream), dripping, urgent urination, and the need to urinate frequently both at night and during the day.

Do not take Tamsulosina Mabo

- If you are allergic (hypersensitive) to tamsulosina or to any of the other components of this medication.

Hypersensitivity may present as sudden swelling of the soft tissues of the body (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 especially careful with Tamsulosina Mabo

• Regular medical check-ups are necessary to monitor the progression of the disease you are being treated for.

• Dizziness may rarely occur during the use of tamsulosina, as with other medications of this type. If you experience the first symptoms of dizziness or weakness, sit or lie down until they have disappeared.

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

• If you are undergoing eye surgery due to opacity in the crystalline lens (cataracts). Please inform your ophthalmologist if you are taking or have taken tamsulosina previously. The specialist will then take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should or should not postpone or temporarily discontinue taking this medication if you are to undergo this operation.

Use of other medications

Taking Tamsulosina Mabo with other medications of the same group (alpha1 adrenergic receptor blockers) may cause an undesirable drop in blood pressure.

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription.

Taking Tamsulosina Mabo with food and drinks

Tamsulosina Mabo can be taken with and without food.

Pregnancy and breastfeeding

This section is not applicable as Tamsulosina Mabo is only indicated for male patients.

Driving and operating machines

There is no evidence that Tamsulosina 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.

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

The usual dose is one tablet per day, taken orally, with or without food, preferably at the same time every day.

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

Tamsulosina Mabo is a tablet designed to release the active ingredient gradually once ingested. You may observe a remainder of the tablet in your stool. There is no risk of reduced efficacy due to the active ingredient having already been released.

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

If you estimate that the effect of Tamsulosina Mabo is too strong or too weak, inform your doctor or pharmacist.

If you take more Tamsulosina Mabo than you should

Taking too many Tamsulosina Mabo tablets may lead to an undesirable decrease in blood pressure and an increase in heart rate, with a sensation of dizziness.

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

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

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Tamsulosina Mabo

When treatment with Tamsulosina Mabo is discontinued prematurely, your original symptoms may return. Therefore, take Tamsulosina Mabo for the entire time your doctor prescribes it, even if your symptoms have disappeared. Consult your doctor at all times if you decide to discontinue treatment.

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

Like all medications, Tamsulosina Mabo may have adverse effects, although not all people will experience them.

Frequent adverse effects (may affect between 1 and 10 patients in every 100): dizziness, especially when sitting or standing up, abnormal ejaculation. This last one means that semen does not release through the urethra, but rather remains in the bladder. This phenomenon is harmless.

Less frequent adverse effects (may affect between 1 and 10 patients in every 1,000): headache, palpitations (the heart beats faster than normal and is also perceptible), reduction in blood pressure, for example, when standing up quickly after being seated or lying down, sometimes associated with dizziness, nasal dripping or obstruction (rhinitis), diarrhea, nausea and vomiting sensation, constipation, weakness (asthenia), skin rash, itching, and hives (urticaria).

Rare adverse effects (may affect between 1 and 10 patients in every 10,000): fainting and sudden swelling of soft body tissues (such as the throat or tongue), respiratory difficulty and/or itching and skin rash, often as an allergic reaction (angioedema).

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

Adverse effects of unknown frequency: Dry mouth

If you are to undergo eye surgery due to a cataract opacity, and you are already taking or have recently taken tamsulosina, during the surgery, the pupil may slightly dilate and the iris (the colored circular part of the eye), may become flaccid.

Reporting Adverse Effects

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

Keep out of reach and sight of children.

Do not use Tamsulosina Mabo after the expiration date that appears on the packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

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

Tamsulosin Mabo Composition

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

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

Product Appearance and Packaging Content

The tablets are round, white, and have the inscription “T9SL” on one face and 0.4 on the other.

Each package contains 30 prolonged-release tablets.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Responsible 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

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