TAMSULOSIN SANDOZ 0.4 mg MODIFIED-RELEASE CAPSULES

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tamsulosin Sandoz and what is it used for
2. What you need to know before you take Tamsulosin Sandoz
3. How to take Tamsulosin Sandoz
4. Possible side effects
5. Storage of Tamsulosin Sandoz
6. Contents of the pack and further information

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

Tamsulosin is used to treat the symptoms of an enlarged prostate (Benign Prostatic Hyperplasia, BPH).

The active substance in the capsules is an alpha 1A blocker, which reduces muscle contraction in the prostate and in the urethra. This action facilitates the flow of urine through the urethra and helps to urinate.

2. What you need to know before you take Tamsulosin Sandoz

Do not take Tamsulosin Sandoz

• if you are allergic to tamsulosin hydrochloride or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity or allergy to tamsulosin can be expressed as sudden swelling of hands and feet, swelling of lips, tongue or throat causing difficulty breathing and/or itching and rash (angioedema),
• if you have had dizziness or fainted due to a decrease in blood pressure (for example when sitting or standing up quickly),
• if you have had severe liver problems.

Warnings and Precautions

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

• if you have had severe kidney problems,
• if you have dizziness or fainting during the use of tamsulosin. You should sit or lie down until the symptoms have disappeared,
• if you experience sudden swelling of hands or feet, lips, tongue or throat causing difficulty breathing and/or itching and rash, caused by an allergic reaction (angioedema) during the use of tamsulosin,
• if you are going to undergo or have scheduled eye surgery due to cataracts or increased eye pressure (glaucoma).

Inform your ophthalmologist if you have taken, are taking or plan to take tamsulosin. The specialist may take necessary precautions regarding the medication and surgical technique to be used. Ask your doctor if you should or should not postpone or interrupt your treatment with this medicine when you are going to undergo surgery due to cataracts or increased eye pressure.

Before starting treatment with tamsulosin, you should be examined by your doctor to rule out the presence of other pathologies that may cause symptoms similar to those of an enlarged prostate (Benign Prostatic Hyperplasia). A type of examination (rectal examination) should be carried out. If necessary, the determination of prostate-specific antigen (PSA) in your blood should be carried out before treatment and at regular intervals thereafter.

Children and Adolescents

This medicine should 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:

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

In particular, consult your doctor or pharmacist if you are taking:

• medicines to lower blood pressure such as verapamil and diltiazem,
• medicines to treat HIV such as ritonavir or indinavir,
• medicines to treat 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,
• cyclosporin, an immunosuppressant used e.g. after organ transplantation.

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

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

Diclofenac (an anti-inflammatory pain reliever) and warfarin (used as an anticoagulant) may affect the elimination rate of tamsulosin.

Taking Tamsulosin Sandoz with food and drinks

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

Pregnancy, Breast-feeding and Fertility

Tamsulosin is not indicated for use in women.

Fertility

In men, abnormal ejaculation (altered ejaculation) has been reported. This means that semen is not released through the urethra, but goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory failure). This may affect male fertility.

Driving and using machines

So far, there is no evidence that tamsulosin affects the ability to drive and use machines. However, patients should be aware that they may experience dizziness.

Tamsulosin Sandoz contains sodium

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

3. How to take Tamsulosin Sandoz

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one capsule per day after breakfast.

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

The capsule should not be chewed.

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

Do not change the dose on your own.

If you think the action of tamsulosin is too strong or too weak, tell 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 the first meal of the day, you can take it later during the same day after eating.

In case you have missed the dose one day, you can simply follow 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 taking Tamsulosin Sandoz unless your doctor has told you to do so, as stopping the treatment may cause the symptoms to reappear or worsen.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Tamsulosin Sandoz and consult your doctor immediatelyif you experience 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, caused by an allergic reaction (angioedema),
• severe ulcers and lesions in the mucous membranes (Stevens-Johnson syndrome),
• a severe and blistering skin condition known as erythema multiforme.

Frequent (may affect up to 1 in 10 patients):

dizziness, ejaculation disorders including reduced or undetectable ejaculation of semen.

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

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

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

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 patients):

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

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

blurred vision, visual impairment, nosebleeds, severe and blistering skin condition (erythema multiforme), skin peeling (exfoliative dermatitis), irregular heartbeat (sometimes life-threatening), fast heartbeat, difficulty breathing, dry mouth. If you are going to undergo eye surgery due to cataracts or increased eye pressure (glaucoma), and you are already taking or have previously taken tamsulosin, the pupil may not dilate properly and the iris (the colored part of the eye) may become flaccid during surgery.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es.

By reporting side 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: Store in the original package.

Bottle: Keep the container tightly closed.

Do not use this medicine after the expiry date which is stated on the blister, bottle and carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help to protect the environment.

6. Contents of the pack and further information

Composition of Tamsulosin Sandoz

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

• The other ingredients are: microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc in the capsule content; 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 body.

Appearance of the product and packaging

Modified release hard capsules of orange/greenish color containing white to off-white pellets.

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

Package 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.

Not all 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

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 medicine 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 a libération prolongée

Germany Tamsulosin–Sandoz 0.4 mg hartkapseln mit veränderter Wirkstofffreisetzung

Italy TAMSULOSINA SANDOZ

Portugal TAMSULOSINA SANDOZ 0.4 MG CÁPSULAS DE LIBERTAÇÃO PROLONGADA

Date of last revision of this leaflet:December 2019

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