Tamsulosin Aurovitas 0.4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tamsulosin Aurovitas 0.4 mg prolonged-release tablets EFG

Tamsulosin hydrochloride

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

• Keep this leaflet, as 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 you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The active substance of Tamsulosin Aurovitas is tamsulosin hydrochloride. It is a selective alpha1A/1D-adrenergic receptor antagonist. It reduces the tone of the smooth muscles in the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. In addition, it decreases the sensation of urgency.

Tamsulosin is used in men for the treatment of lower urinary tract symptoms associated with enlargement of the prostate gland (benign prostatic hyperplasia). These symptoms may include difficulty in urination (weak urinary stream), dribbling, urgency, and the need to urinate frequently both during the night and during the day.

2. What you need to know before starting Tamsulosin Aurovitas

Do not take Tamsulosin Aurovitas

• If you are allergic to tamsulosin hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• Hypersensitivity may present as sudden localized swelling of soft tissues in the body (e.g., throat or tongue), difficulty breathing, and/or itching and skin rash (angioedema).
• If you have severe liver problems.
• If you experience dizziness due to a drop in blood pressure when changing position (sitting or standing up).

Warnings and precautions

Talk to your doctor or pharmacist before starting Tamsulosin Aurovitas.

• because periodic medical examinations are necessary to monitor the progression of the condition being treated.
• because fainting may rarely occur during treatment with tamsulosin, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until symptoms have passed.
• if you have severe kidney problems.
• if you are scheduled for eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma). Inform your ophthalmologist if you have previously taken, are currently taking, or plan to take tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor about whether you should delay or temporarily discontinue taking this medicine if undergoing surgery for cataracts or glaucoma.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as it is not effective in this population.

Other medicines and Tamsulosin Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking tamsulosin together with other medicines of the same class (alpha1-adrenergic receptor blockers) may cause an undesirable drop in blood pressure.

It is especially important that you inform your doctor if you are also taking medicines that may reduce the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Taking Tamsulosin Aurovitas with food and drinks

You may take tamsulosin with or without food.

Pregnancy and breastfeeding

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or the volume of ejaculate is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

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 dizziness may occur, in which case you should not perform activities requiring alertness.

Tamsulosin Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Tamsulosina Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The tablet should be swallowed whole and must not be crushed or chewed.

Tamsulosina Aurovitas is a specially designed tablet that releases the active substance gradually after the tablet has been swallowed. You may notice a residue of the tablet in your stools. There is no risk of loss of efficacy, as the active substance has already been released.

Tamsulosin is usually prescribed for long periods. The effects on the bladder and urination are maintained during long-term treatment with tamsulosin.

If you take more Tamsulosina Aurovitas than you should

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

Taking too many tamsulosin tablets may lead to an undesirable drop in blood pressure and an increased heart rate, with a sensation of fainting. Contact your doctor immediately if you have taken too many tamsulosin tablets.

If you forget to take Tamsulosina Aurovitas

If you have forgotten to take tamsulosin as recommended, you may take your daily dose later on the same day. If you have forgotten the dose for a whole day, simply continue taking your daily tablet as prescribed. Do not take a double dose to make up for missed doses.

If you stop taking Tamsulosina Aurovitas

When treatment with tamsulosin is stopped prematurely, your original symptoms may return. Therefore, take tamsulosin for as long as your doctor has prescribed, 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, this medicine may cause adverse effects, although not everyone experiences them.

Frequent (may affect up to 1 in 10 people)

• Dizziness, especially when sitting or standing up.
• Abnormal ejaculation (ejaculation disorder). This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or the ejaculate volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Uncommon (may affect up to 1 in 100 people)

• Headache, palpitations (heart beats faster than normal and is noticeable), drop in blood pressure, for example, when standing up quickly after sitting or lying down, sometimes associated with dizziness, nasal drip or congestion (rhinitis), diarrhoea, feeling of nausea and vomiting, constipation, weakness (asthenia), skin rash, itching and hives (urticaria).

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

• Fainting and sudden localized swelling of the soft tissues of the body (such as the throat or tongue), difficulty breathing and/or itching and skin rash, often as an allergic reaction (angioedema).

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

• Priapism (undesired, prolonged and painful erection requiring immediate medical treatment).
• Skin rash, inflammation and blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome).

Frequency not known (frequency cannot be estimated from the available data)

• Blurred vision.
• Vision disturbance.
• Nosebleed (epistaxis).
• Severe skin rashes (erythema multiforme, exfoliative dermatitis).
• Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnoea).
• If you are undergoing eye surgery due to cataracts (clouding of the lens) or increased eye pressure (glaucoma), and you are currently taking or have previously taken tamsulosin, during surgery the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy.
• Dry mouth.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Aurovitas

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

Do not use this medicine after the expiry date stated on the outer carton, blister pack, or bottle after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosina Aurovitas

• The active substance is tamsulosin hydrochloride. Each prolonged-release tablet contains 0.4 mg of tamsulosin hydrochloride.
• The other components are:

Tablet core: microcrystalline cellulose (grades 101 and 102), hydroxypropylcellulose, lactose monohydrate, polyethylene oxide, hypromellose (type 2208), colloidal anhydrous silica, and magnesium stearate.

Tablet coating: hypromellose 2910, macrogol, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Nature of the product and contents of the pack

Prolonged-release tablet.

Yellow, film-coated, round (9.1 mm in diameter), biconvex tablets, marked with “T” above and “0 4” below on one side and smooth on the other.

Tamsulosina Aurovitas prolonged-release tablets are available in:

• Triple-layer cold-form blister packs (Alu-Alu) and bottles (HDPE opaque white bottles with opaque white polypropylene caps containing silica gel as desiccant).

Blister pack sizes:

20, 30, 50, 90, 100, and 200 prolonged-release tablets.

Bottle pack sizes:

250 prolonged-release tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

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

Germany: Tamsulosin PUREN 0.4 mg Retardtabletten

Belgium: Tamsulosin AB 0.4 mg tabletten met verlengde afgifte / comprimés à libération prolongée / Retardtabletten

Spain: Tamsulosina Aurovitas 0.4 mg prolonged-release tablets EFG

France: TAMSULOSINE ARROW LP 0.4 mg, comprimé à libération prolongée

Netherlands: Tamsulosine HCl Aurobindo Retard 0.4 mg, tabletten met verlengde afgifte

Poland: Tamsulosin Aurovitas

Portugal: Tansulosina Generis

Czech Republic: Tamsulosin Aurovitas

Romania: Tamsulosin Aurobindo 0.4 mg comprimate cu eliberare prelungita

Date of the most recent revision of this leaflet: November 2020

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