TAMSULOSIN ALMUS 0.4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Tamsulosina Almus 0.4 mg prolonged-release tablets EFG

Tamsulosine hydrochloride

Read the package leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this package leaflet, as 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, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet

1. What is Tamsulosina Almus and what is it used for
2. What you need to know before taking Tamsulosina Almus
3. How to take Tamsulosina Almus
4. Possible side effects
5. Storage of Tamsulosina Almus
6. Package contents and further information

1. What is Tamsulosina Almus and what is it 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. It also reduces the feeling of urgency.

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

2. What you need to know before taking Tamsulosina Almus

Do not take Tamsulosina Almus if:

• you are allergic (hypersensitive) to tamsulosin or any of the other ingredients of Tamsulosina Almus. Hypersensitivity may present as sudden local swelling of the soft tissues of the body (e.g., throat or tongue), difficulty breathing, and/or itching and skin rash (angioedema);
  • you have a drop in blood pressure when standing up, which causes dizziness or fainting;
  • you have severe liver problems.

Warnings and precautions

Be particularly careful withTamsulosina Almusif:

• you experience dizziness or fainting, especially after standing up. Tamsulosin may lower your blood pressure, causing this. Lie down or sit until the symptoms have disappeared;
• you have severe kidney problems, consult your doctor;
• you are going to undergo eye surgery due to cataracts. A condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur (see section 4, Possible side effects). Please inform your ophthalmologist if you are taking or have taken tamsulosin before. The specialist will then be able to take the necessary precautions regarding the medication and surgical techniques to be used. Consult your doctor if you should postpone or temporarily suspend taking this medicine if you are going to undergo this surgery.

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

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

Using Tamsulosina Almus with other medicines

Tell your doctor or pharmacistif you are using or have recently used other medicines, including those obtained without a prescription.

Other medicines may be affected by tamsulosin. These medicines, in turn, may affect the proper functioning of tamsulosin. Tamsulosin may interact with:

• Diclofenac, a pain-relieving and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, shortening the time of effectiveness of tamsulosin.
• Warfarin, a medicine to prevent blood clotting. This medicine may accelerate the elimination of tamsulosin from the body, shortening the time of effectiveness of tamsulosin.
• Otheralpha-1A adrenergic receptor blockers. The combination may cause a drop in blood pressure, leading to dizziness.

TakingTamsulosina Almuswith food and drinks

Tamsulosin can be taken independently of meals.

Driving and using machines

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

3. How to take Tamsulosina Almus

Follow the instructions for administration of Tamsulosina Almus indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The normal 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 not to break or chew the tablet, as this may affect the proper functioning of tamsulosin.

Tamsulosin is not indicated for children.

If you take moreTamsulosina Almusthan you should

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

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 takeTamsulosina Almus

If you have forgotten to take Tamsulosina Almus as recommended, you can take your dose later on the same day. If you have missed a dose for one 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 takingTamsulosina Almus

When treatment with tamsulosin is discontinued prematurely, your original symptoms may return. Therefore, take Tamsulosina Almus 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tamsulosina Almus can cause side effects, although not everyone gets 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 patients):

Dizziness • Abnormal ejaculation.

Uncommon(may affect up to 1 in 100 patients):

Headache • Heartbeat perceptible (palpitations) • Reduction of blood pressure when standing up, which causes dizziness or fainting (orthostatic hypotension) • Swelling and irritation in the nose (rhinitis) • Constipation • Diarrhea • Nausea • Vomiting • Rash • Hives (urticaria) • Feeling of weakness (asthenia).

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

Fainting (syncope).

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

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 the available data):

Abnormal heart rhythm • Irregular heartbeat • Faster heartbeat • Difficulty breathing • 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, Be particularly careful.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosina Almus

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

Store in the original package to protect from light.

Do not use Tamsulosina Almus after the expiry date stated on the package after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package contents and further information

Composition of Tamsulosina Almus 0.4 mg

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

Appearance of the product and package contents

Tamsulosina Almus 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:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer:

Synthon Hispania, S.L.

Castello, 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

Synthon BV

Microweg 22,

6545 CM Nijmegen

Netherlands

Date of the last revision of this package leaflet:December 2013

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