TAMSULOSIN SANDOZ 0.4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Tamsulosin Sandoz 0.4 mg prolonged-release tablets 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 Tamsulosin Sandoz is and what it is used for
2. What you need to know before taking Tamsulosin Sandoz
3. How to take Tamsulosin Sandoz
4. Possible side effects
5. Storage of Tamsulosin Sandoz
6. Package contents and additional information

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

Tamsulosin relaxes the muscles in the prostate and urinary tract. By relaxing the muscles, tamsulosin allows urine to flow more easily and facilitates urination. Additionally, it reduces the sensation of urgency.

Tamsulosin is used in men to alleviate urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak stream), dripping, urgency, and frequent need to urinate both at night and during the day.

2. What you need to know before taking Tamsulosin Sandoz

Do not take Tamsulosin Sandoz:

• if you are allergic to tamsulosin or any of the other ingredients of this medication (listed in section 6). Hypersensitivity may present as sudden local swelling of the body's soft tissues (e.g., throat or tongue), difficulty breathing, and/or itching and skin rash (angioedema),
• if you have a history of low blood pressure when standing up, which causes dizziness orfainting,
• if you have severe liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosin Sandoz

• if you experience dizziness or fainting, especially after standing up. Tamsulosin may lower your blood pressure, causing this. You should lie down or sit until the symptoms have disappeared,
• if you have severe kidney problems, consult your doctor,
• if you are going to undergo eye surgery due to cataracts or increased eye pressure (glaucoma). A condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur. Please inform your ophthalmologist if you are taking or have previously taken tamsulosin. The specialist can then take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should postpone or temporarily stop taking this medication if you are going to undergo eye surgery due to cataracts or increased eye pressure (glaucoma).

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

You may notice remnants of tablets in your stool. Since the active ingredient of the tablet has already been released, there is no risk that the tablet will be less effective.

Children and adolescents

Do not give this medication to children or adolescents under 18 years of age, as it has no effect in this population.

Taking Tamsulosin Sandoz with othermedications

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

Taking tamsulosin with other medications of the same class (alpha-1 adrenergic receptor antagonists) may cause an undesirable decrease in blood pressure.

It is especially important to inform your doctor if you are being treated with medications that may decrease the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Diclofenac (an anti-inflammatory pain reliever) and warfarin (used to prevent platelet aggregation) may influence the rate of elimination of tamsulosin from the body.

TakingTamsulosin Sandozwith food and drinks

Tamsulosin Sandoz can be taken independently of meals.

Pregnancy, breastfeeding, and fertility

Tamsulosin is not indicated for use in women.

Fertility

In men, abnormal ejaculation (ejaculation disorders) has been detected. This means that semen does not exit the body through the urethra but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure).

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive or use machines. You should be aware that tamsulosin may cause dizziness. Only drive or operate machines if you feel well.

3. How to take Tamsulosin Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended doseis 1 tablet per day. You can take tamsulosin with or without food, preferably at the same time each day.

The tablet should be swallowed whole. It is important that you do not break or chew the tablet, as this may affect the proper functioning of Tamsulosin Sandoz.

Tamsulosin is not indicated for children.

If you take moreTamsulosin Sandozthan you should

If you have taken more Tamsulosin Sandoz than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you take more tamsulosin than you should, your blood pressure may drop suddenly. You may experience dizziness, weakness, vomiting, diarrhea, and fainting. Lie down to minimize the effects of low blood pressure and consult your doctor.

If you forget to takeTamsulosin Sandoz

If you have forgotten to take Tamsulosin Sandoz as recommended, you can take your dose later on the same day. If you have missed a dose for a day, take the next dose at the usual time. Do not take a double dose to make up for the missed doses.

If you stop takingTamsulosin Sandoz

When treatment with tamsulosin is stopped prematurely, your original symptoms may return. Therefore, take Tamsulosin Sandoz 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.

It is rare for serious side effects to occur. Contact your doctor immediatelyif you experience a severe allergic reaction that causes swelling of the face or throat(angioedema).

Common(may affect up to 1 in 10 people)

• Dizziness.
• Abnormal ejaculation (ejaculation disorders). This means that semen does not exit the body through the urethra but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.

Uncommon(may affect up to 1 in 100 people)

• Headache.
• Perceptible heartbeat (palpitations).
• Decreased blood pressure when standing up, which causes dizziness or fainting (orthostatic hypotension).
• Nasal congestion and irritation (rhinitis).
• Constipation.
• Diarrhea.
• Feeling sick (nausea).
• Vomiting.
• Rash.
• Itching.
• Hives (urticaria).
• Feeling of weakness (asthenia).

Rare(may affect up to 1 in 1,000 people)

• Fainting and local swelling of the body's soft tissues (e.g., throat or tongue).
• Difficulty breathing and/or itching and skin rash, sometimes as an allergic reaction (angioedema).

Very rare(may affect up to 1 in 10,000 people)

• Painful erection (priapism).
• Severe skin condition with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

Frequency not known(cannot be estimated from available data)

• Altered heart rhythm.
• Irregular heartbeat.
• Faster heartbeat.
• Difficulty breathing.
• Blurred vision.
• Difficulty seeing.
• Nosebleeds.
• Rash.
• Skin inflammation and blisters (erythema multiforme, exfoliative dermatitis).
• Dry mouth.

During eye surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: The pupil may not dilate properly, and the iris (the colored part of the eye) may become floppy during surgery. For more information, see section 2.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, 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 Sandoz

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

Store in the original packaging to protect it from light.

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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition ofTamsulosin Sandoz 0.4 mg

• The active ingredient is 0.400 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
  • The other ingredients are: Inner tablet: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, red iron oxide (E172), magnesium stearate. Outer tablet: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and package contents

Tamsulosin Sandoz is presented in the form of round, white tablets with the inscription "T9SL" on one side and "0.4" on the other.

They are available in packages of 10, 18, 20, 28, 30, 50, 60, 90, 98, and 100 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Synthon Hispania, S.L.

Castello, 1

Poligono Las Salinas

08830 Sant Boi de Llobregat

Spain

SYNTHON BV

Microweg, 22, P.O.Box 7071 (Nijmegen)

NL-6545 - Netherlands

This medication is authorized in the Member States of the European Economic Area under the following names:

Netherlands Tamsulosine HCL Sandoz Retard 0,4 mg, tabletten met verlengde afgifte

Spain Tamsulosina Sandoz 0,4 mg comprimidos de liberación prolongada EFG

Date of the last revision of this package leaflet: June 2015

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/