Tamsulosin Sandoz 0.4 mg modified-release capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tamsulosin Sandoz 0.4 mg modified-release hard capsules EFG

Tamsulosin hydrochloride

Read all of this 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. Do not give it to other people, even if they have the same symptoms as yours, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the 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. How to store Tamsulosin Sandoz
6. Contents of the pack and other information

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

Tamsulosin is used to treat urinary symptoms caused by benign prostatic hyperplasia (BPH – enlarged prostate).

The active ingredient in the capsules is known as an alpha-1A blocker, which reduces muscle contraction in the prostate and urethra. This action facilitates the flow of urine through the urethra and helps urination.

2. What you need to know before taking Tamsulosin Sandoz

Do not take Tamsulosin Sandoz

• if you are allergic to tamsulosin hydrochloride or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity or allergy to tamsulosin may manifest as sudden swelling of the hands and feet, swelling of the lips, tongue or throat causing difficulty in breathing and/or itching and pruritus (angioedema),
• if you have experienced dizziness or fainting due to a drop in blood pressure (e.g., when sitting down or standing up quickly),
• if you have had severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Tamsulosin Sandoz:

• if you have had severe kidney problems,
• if you experience dizziness or fainting while taking tamsulosin. You should sit or lie down until symptoms resolve,
• if you experience sudden swelling of the hands or feet, lips, tongue or throat causing difficulty in breathing and/or itching and pruritus, due to an allergic reaction (angioedema) during treatment with tamsulosin,
• if you are scheduled for or undergoing eye surgery due to cataracts (lens opacity) or increased intraocular pressure (glaucoma).

Inform your ophthalmologist if you have taken, are currently taking, or plan to take tamsulosin. The specialist may take necessary precautions regarding medication and surgical technique. Ask your doctor whether you should delay or discontinue treatment with this medicine prior to undergoing surgery for cataracts or increased intraocular pressure.

Before starting treatment with tamsulosin, you should be examined by your doctor to rule out other conditions that may cause symptoms similar to those of enlarged prostate (benign prostatic hyperplasia). A type of examination (digital rectal examination) should be performed. If necessary, prostate-specific antigen (PSA) blood testing should be carried out before treatment and subsequently at regular intervals.

Children and adolescents

This medicine must not be given to children or adolescents under 18 years of age, as it has no effect in this population.

Taking Tamsulosin Sandoz with other medicines:

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

Specifically, consult your doctor or pharmacist if you are taking:

• medicines to lower blood pressure such as verapamil and diltiazem,
• medicines for treating HIV such as ritonavir or indinavir,
• medicines for treating fungal infections such as ketoconazole or itraconazole,
• other alpha-blockers such as doxazosin, indoramin, prazosin or alfuzosin,
• erythromycin or clarithromycin, antibiotics used to treat infections,
• cyclosporine, an immunosuppressant used, for example, after organ transplantation.

Tamsulosin may cause a drop in blood pressure when administered with another alpha-1A blocker.

Some patients receiving alpha-blocker therapy for high blood pressure or enlarged prostate may experience dizziness or fainting, which may be caused by low blood pressure upon sitting or standing up quickly. Some patients have experienced these symptoms after taking medications for erectile dysfunction (impotence) together with alpha-blockers. To reduce the likelihood of these symptoms occurring, you should adjust the daily dose of your alpha-blockers before starting treatment for erectile dysfunction.

Diclofenac (an anti-inflammatory painkiller) and warfarin (used as an anticoagulant) may affect the rate at which tamsulosin is eliminated from the body.

Taking Tamsulosin Sandoz with food and drink

Tamsulosin should be taken after the first meal of the day. Taking tamsulosin on an empty stomach may increase the number of adverse effects or worsen their severity.

Pregnancy, breast-feeding and fertility

Tamsulosin is not indicated for use in women.

Fertility

In men, abnormal ejaculation (ejaculatory disorder) has been reported. This means that semen is not expelled through the urethra but instead enters the bladder (retrograde ejaculation), or the volume of ejaculate is reduced or absent (ejaculatory insufficiency). This may affect male fertility.

Driving and using machines

To date, there is no evidence that tamsulosin affects the ability to drive or operate machinery. However, patients should be aware that dizziness may occur.

Tamsulosin Sandoz contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per modified-release hard capsule; therefore, it is essentially “sodium-free”.

3. How to take Tamsulosin Sandoz

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

The recommended dose is one capsule per day after breakfast.

The capsule should be taken while standing or sitting upright (not lying down) and should be swallowed whole with a glass of water.

The capsule must not be chewed.

Your doctor has prescribed a dose appropriate for you and your condition, and has specified the duration of your treatment.

Do not change the dose on your own.

If you feel that the effect of tamsulosin is too strong or too weak, inform your doctor or pharmacist.

If you take more Tamsulosin Sandoz than you should

If you take more Tamsulosin Sandoz than you should, consult your doctor or pharmacist immediately.

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.

If you forget to take Tamsulosin Sandoz

If you forget to take tamsulosin after your first meal of the day, you may take it later on the same day after eating.

If you have missed a dose for one day, you may simply continue taking your daily capsule as prescribed.

Do not take a double dose to make up for forgotten doses.

If you stop taking Tamsulosin Sandoz

Do not stop treatment with Tamsulosin Sandoz unless your doctor has instructed you to do so, as stopping treatment may cause symptoms to return or worsen.

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 can cause adverse effects, although not everyone experiences them.

Stop taking Tamsulosin Sandoz and consult your doctor immediately if you experience any of the following:

• sudden swelling of some or all of the following parts: hands, feet, lips, tongue or throat causing difficulty breathing and/or itching and rash, due to an allergic reaction (angioedema),
• severe ulcers and lesions in the mucous membranes (Stevens-Johnson syndrome),
• severe skin inflammation with blisters known as erythema multiforme.

Common (may affect up to 1 in 10 people):

dizziness, ejaculation disorders including reduced or absent semen ejaculation.

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

headache, irregular heartbeat, dizziness especially when sitting or standing up, colds, constipation, diarrhoea, nausea, vomiting, rash, itching, hives, feeling of weakness.

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

fainting, swelling of hands or feet, swelling of lips, tongue or throat causing difficulty breathing and/or itching and rash (angioedema).

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

severe ulcers and lesions in the mucous membranes (Stevens-Johnson syndrome), painful and prolonged erection in the absence of sexual stimulation (priapism).

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

blurred vision, visual disturbance, nosebleed, severe skin inflammation with blisters (erythema multiforme), skin peeling (exfoliative dermatitis), irregular heartbeat (sometimes life-threatening), rapid heartbeat, difficulty breathing, dry mouth. If you are undergoing eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), and you are currently taking or have previously taken tamsulosin, the pupil may show poor dilation and the iris (the coloured circular part of the eye) may become floppy during surgery.

Reporting of adverse effects

If you experience any 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: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Sandoz

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

Blister pack: Store in the original packaging.

Bottle: Keep the container tightly closed.

Do not use this medicine after the expiry date stated on the blister, bottle, and outer cardboard package after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Tamsulosina Sandoz

• The active substance is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin hydrochloride.

• The other components are: microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc in the capsule contents; gelatin, indigo carmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and black iron oxide (E 172) in the capsule shell.

Nature and contents of the container

Modified-release hard capsules, orange/olive green in colour, containing white to off-white pellets.

The capsules are packaged in PVC/PE/PVDC/Al blisters or in HDPE bottles with child-resistant PP caps, and presented in cardboard boxes, or are packaged in HDPE bottles with child-resistant PP caps.

Pack sizes:

Blister: 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 200 modified-release hard capsules.

Bottles: 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 200 modified-release hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Synthon BV

Microweg 22, 6545

CM Nijmegen

The Netherlands

or

Synthon Hispania S.L.

Castello, 1, Polígono Las Salinas,

Sant Boi de Llobregat

Spain

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, 39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava

Slovenia

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

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

Austria Tamsulosin Sandoz retard 0.4 mg – Kapseln

Belgium Tamsulosine Sandoz 0.4 mg capsules met gereguleerde afgifte, hard

Denmark Masulin

Finland Tamsulosiinihydrokloridi Sandoz 0.4 mg depotkapseli, kova

France TAMSULOSINE SANDOZ LP 0.4 mg, gélule à libération prolongée

Germany Tamsulosin–Sandoz 0.4 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Italy TAMSULOSINA SANDOZ de

Portugal TAMSULOSINA SANDOZ 0.4 MG CÁPSULAS DE LIBERTAÇÃO PROLONGADA

Date of the most recent review of this leaflet: December 2019

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/