Prospecto: information for the patient

TTamsulosin Sandoz 0.4 mg hard capsules with modified release EFG

Tamsulosin hydrochloride

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people, 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 not listed in this prospect. See section 4.

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

2. What you need to know before starting to takeTamsulosin Sandoz

3. How to take Tamsulosin Sandoz

4. Possible adverse effects

5. Storage of Tamsulosin Sandoz

6. Contents of the pack and additional information

Tamsulosinais used to treat the symptoms of urination caused bybenign prostatic hyperplasia (BPH - enlarged prostate).

The active ingredient contained in the capsules is called 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 with urination.

Do not take Tamsulosina Sandoz

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

Warnings and precautions

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

• if you have had severe kidney problems,
• if you have dizziness or fainted 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 prickling, caused by an allergic reaction (angioedema) during the use of tamsulosin,
• if you are scheduled to undergo or have scheduled eye surgery due to opacity of the crystalline lens (cataracts) or increased intraocular 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 medication when you are to undergo surgery due to opacity of the crystalline lens or increased intraocular 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 (digital rectal examination) should be performed. If necessary, the determination of the specific prostate antigen (PSA) in your blood should be performed before treatment and, subsequently, at regular intervals.

Children and adolescents

This medication should not be administered to children or adolescents under 18 years of age as it has no effect on this population.

Taking Tamsulosina Sandoz with other medications

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

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

• blood pressure-lowering medications such as verapamil and diltiazem,
• medications for treating HIV such as ritonavir or indinavir,
• medications 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,
• ciclosporin, an immunosuppressant used, for example, after an organ transplant.

Tamsulosin may cause a decrease in blood pressure when administered with another alpha1A-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 quickly. Some patients have experienced these symptoms after taking medications used for erectile dysfunction (impotence) with alpha-blockers. To reduce the likelihood of these symptoms, you should regulate the daily dose of your alpha-blockers before starting your treatment for erectile dysfunction.

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

Taking Tamsulosina 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 adverse effects or increase the severity of adverse effects.

Pregnancy, breastfeeding, and fertility

Tamsulosin is not indicated for use in women.

Fertility

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen does not release through the urethra, but goes to the bladder (retrograde ejaculation) or that the volume of ejaculated semen is reduced or non-existent (ejaculatory insufficiency). This may affect male fertility.

Driving and operating machinery

There is currently no evidence that tamsulosin affects the ability to drive and operate machinery. However, patients should be aware that they may experience dizziness.

Tamsulosina Sandoz contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per modified-release hard capsule; that is, it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated 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 should not be chewed.

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

Do not change the dose on your own.

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

If you take more Tamsulosina Sandoz than you should

If you take more Tamsulosina 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeTamsulosina Sandoz

If you forget to take tamsulosina after the first meal of the day, you can take it later in the day after eating.

In case you have missed a dose one day, simply continue taking your daily capsule as prescribed.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Tamsulosina Sandoz

Do not interrupt treatment with Tamsulosina Sandoz unless your doctor has indicated so, as interruption may cause symptoms to reappear or worsen.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Tamsulosina Sandoz and consult your doctor immediatelyif you experience the following:

-sudden inflammation of any or all of the following: hands, feet, lips, tongue, or throat, causing difficulty breathing and/or itching and rash, caused by an allergic reaction (angioedema),

-severe ulcers and lesions on mucous membranes (Stevens-Johnson syndrome),

-severe inflammation and blisters on the skin known as erythema multiforme.

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

dizziness, ejaculation disorders including reduced or undetectable semen ejaculation.

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

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

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

syncope, swelling of the hands or feet, swelling of the 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 on mucous membranes (Stevens-Johnson syndrome), painful and persistent erection in the absence of sexual excitement (priapism).

Unknown frequency (frequency cannot be estimated from available data):

blurred vision, visual impairment, nasal bleeding, severe inflammation and blisters on the skin (erythema multiforme), skin peeling (dermatitis exfoliativa), irregular heartbeat (sometimes life-threatening), rapid heartbeat, difficulty breathing, dry mouth. If you are about to undergo eye surgery due to opacity of the lens (cataracts) or increased pressure in the eye (glaucoma), and you are taking or have taken tamsulosina, the pupil may dilate slightly and the iris (the colored part of the eye) may become flaccid during surgery.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Blister: Store in the original packaging.

Bottle: Keep the container perfectly closed.

Do not use this medication after the expiration date that appears on the blister, bottle, and carton packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tamsulosina Sandoz

-The active ingredient is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin hydrochloride.

-The other components are: microcrystalline cellulose, copolymer of methacrylic acid and ethyl acrylate (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 contents of the package

Modified-release hard capsules of orange/green olive color that contain white to off-white pellets.

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

Package sizes:

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

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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

AustriaTamsulosin Sandoz retard 0.4 mg – Kapseln

BelgiumTamsulosine Sandoz 0.4 mg capsules met gereguleerde afgifte, hard

DenmarkMasulin

FinlandTamsulosiinihydrokloridi Sandoz 0.4 mg depotkapseli, kova

FranceTAMSULOSINE SANDOZLP 0.4 mg, gélule a libération prolongée

GermanyTamsulosin–Sandoz 0.4 mg hartkapseln mit veränderter Wirkstofffreisetzung

ItalyTAMSULOSINA SANDOZ de

PortugalTAMSULOSINA SANDOZ 0.4 MG CÁPSULAS DE LIBERTAÇÃO PROLONGADA

Last review date of this leaflet:December 2019

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/