TAMSULOSIN ALMUS 0.4 MG PROLONGED-RELEASE TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tamsulosina Almus 0.4 mg prolonged-release tablets EFG

Tamsulosin hydrochloride

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

• Keep this leaflet. 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet.

Contents of the leaflet

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

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

Tamsulosin relaxes the muscles in the prostate and urinary tract. By relaxing these muscles, tamsulosin allows urine to pass more easily and facilitates urination. It also reduces the sensation 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 the need to urinate frequently both during the 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 to any of the other components of Tamsulosina Almus. Hypersensitivity may manifest as sudden localized swelling of 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 upon standing, causing dizziness or fainting;
• you have severe liver problems.

Warnings and precautions

Exercise special caution with Tamsulosina Almus if:

• you experience dizziness or fainting, especially after standing up. Tamsulosin may lower your blood pressure, causing these symptoms. You should lie down or sit until symptoms have passed;
• you have severe kidney problems, consult your doctor;
• you are scheduled for eye surgery due to lens opacity (cataract). A condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur (see section 4, Possible side effects). Please inform your ophthalmologist if you are currently taking or have previously taken tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor whether you should delay or temporarily discontinue this medicine prior to such surgery.

Periodic medical examinations are necessary to monitor the progression of the condition for which you are being treated.

You may notice tablet remnants in your stools. Since the active ingredient of the tablet has already been released, there is no risk of reduced effectiveness of the tablet.

Use of Tamsulosina Almus with other medicines

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

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

• Diclofenac, an analgesic and anti-inflammatory medicine. This medicine may accelerate the elimination of tamsulosin from the body, shortening the duration of tamsulosin's effectiveness.
• Warfarin, a medicine used to prevent blood clotting. This medicine may accelerate the elimination of tamsulosin from the body, shortening the duration of tamsulosin's effectiveness.
• Other alpha1A-adrenergic receptor blockers. The combination may cause a drop in blood pressure, leading to dizziness.

Taking Tamsulosina Almus with food and drink

Tamsulosin may be taken regardless of meals.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive or operate machinery. However, you should bear in mind that tamsulosin may cause dizziness. Only drive or operate machinery if you feel well.

3. How to take Tamsulosina Almus

Follow exactly the instructions for using Tamsulosina Almus provided by your doctor. If you are unsure, consult your doctor or pharmacist again.

The usual dose is 1 tablet per day. You may take tamsulosin with or without food, preferably at the same time each day.

The tablet must 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 use in children.

If you take more Tamsulosina Almus than you should

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

If you take more tamsulosin than you should, your blood pressure may suddenly decrease. 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 take Tamsulosina Almus

If you forget to take Tamsulosina Almus as directed, you may take your dose later on the same day. If you have missed the dose for a day, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Tamsulosina Almus

If treatment with tamsulosin is stopped prematurely, your original symptoms may return. Therefore, take Tamsulosina Almus 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, Tamsulosin Almus may cause adverse effects, although not everyone experiences them.

Serious adverse reactions are rare. Contact your doctor immediately if you experience a severe allergic reaction causing swelling of the face or throat (angioedema).

Common (may affect up to 1 in 10 people):
Dizziness • Abnormal ejaculation.

Uncommon (may affect up to 1 in 100 people):
Headache • Noticeable heartbeat (palpitations) • Drop in blood pressure when standing up, causing dizziness or fainting (orthostatic hypotension) • Nasal swelling and irritation (rhinitis) • Constipation • Diarrhea • Nausea • Vomiting • Rash • Hives (urticaria) • Feeling of weakness (asthenia).

Rare (may affect up to 1 in 1,000 people):
Fainting (syncope).

Very rare (may affect up to 1 in 10,000 people):
Painful erection (priapism) • Serious illness with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

Frequency not known (cannot be estimated from available data):
Abnormal heart rhythm • Irregular heartbeat • Faster heartbeat • Breathing difficulty • Dry mouth.

During eye surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the colored circular part of the eye) may become floppy during surgery. For further information, see section 2, Special warnings and precautions.

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

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, 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 Almus

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

Store in the original packaging to protect from light.

Do not use Tamsulosin Almus after the expiry date stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other 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 components are: Inner tablet: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, iron oxide red (E172), magnesium stearate. Outer tablet: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, magnesium stearate.

Appearance of the medicine and contents of the pack

Tamsulosina Almus is presented as white, round tablets, with the imprint “T9SL” on one side and “0.4” on the other.

It is available in packs of 10, 18, 20, 28, 30, 50, 60, 90, 98 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

Synthon Hispania, S.L.

Castello, 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

Synthon BV

Microweg 22,

6545 CM Nijmegen

The Netherlands

Date of the most recent revision of this leaflet: December 2013

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/.