Package Insert: Information for the User

Tamsulosin Sandoz 0.4 mg Extended-Release Tablets EFG

Tamsulosin hydrochloride

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this package insert. See section 4.

Tamsulosina relaxes the muscles in the prostate and urinary tract. By relaxing the muscles, tamsulosina allows urine to pass more easily and facilitatesurination. Additionally, it reduces the sensation of urgency.

Tamsulosina 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 at night and during the day.

Do not take Tamsulosina Sandoz:

• if you are allergic to tamsulosina or any of the other ingredients of this medication (listed in section 6). Hypersensitivity may present as sudden swelling of the soft tissues of the body (e.g. the throat or tongue), difficulty breathing and/or itching and skin rash (angioedema),
• if you have a history of a drop in blood pressure when standing up, which causesdizziness orpassing out,
• if you have severeliver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosina Sandoz

• if you experience dizziness or passing out, especially after standing up. Tamsulosina may lower your blood pressure causing this. You should lie down or sit until the symptoms have disappeared,
• if you have severe kidney problems, consult your doctor,
• if you are about to undergo eye surgery due to a clouding of the lens (cataracts) or an increase in eye pressure (glaucoma). You may develop a condition called Intraoperative Floppy Iris Syndrome (see section 4). Please inform your ophthalmologist if you are taking or have taken tamsulosina previously. The specialist will then take the necessary precautions regarding medication and surgical techniques to be used. Consult your doctor if you should or should not postpone or temporarily discontinue taking this medication if you are about to undergo eye surgery due to a clouding of the lens or an increase in eye pressure (glaucoma).

Regular medical check-ups are necessary to monitor the development of the disease for which you are being treated.

You may observe remnants of tablets in your stool. Since the active ingredient of the tablet has already been released, there is no risk that the tablet will be less effective.

Children and adolescents

Do not give this medication to children or adolescents under 18 years old because it has no effect on this population.

Taking Tamsulosina Sandoz with othermedicines

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

Taking tamsulosina with other medications of the same class (α1-adrenergic receptor antagonists) may produce an undesirable decrease in blood pressure.

It is especially important to inform your doctor if you are being treated at the same time with medications that can reduce the elimination of tamsulosina from the body (e.g. ketokonazol, eritromicina).

Diclofenaco (an analgesic anti-inflammatory) and warfarin (used to prevent platelet aggregation) may influence the rate of elimination of tamsulosina from the body.

TakingTamsulosina Sandozwith food and drinks

Tamsulosina Sandoz can be taken regardless of meals.

Pregnancy, breastfeeding and fertility

Tamsulosina is not indicated for use in women.

Fertility

In men, abnormal ejaculation (ejaculation disorders) has been detected. This means that semen does not come out of the body through the urethra, but instead goes to the bladder (retrograde ejaculation) or the volume of ejaculation is reduced or absent (ejaculatory failure).

Driving and operating machinery

There is no evidence that tamsulosina affects the ability to drive and use machines. However, tamsulosina may cause dizziness. Only drive or operate machines if you feel well.

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

Therecommended doseis 1 tablet per day. You can take tamsulosina with or without food, preferably at the same time every day.

The tablet must be swallowedwhole. It is essentialthat you do not break or chew the tabletas this may affect the proper functioning of Tamsulosina Sandoz.

Tamsulosina is not indicated for children.

If you take moreTamsulosina Sandozthan you should

If you have taken more Tamsulosina Sandoz than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you take more tamsulosina than you should, your blood pressure may drop suddenly. 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 forgot to takeTamsulosina Sandoz

If you have forgotten to take Tamsulosina Sandoz as recommended, you can take your dose later in the same day. If you have missed a day's dose, take the next dose at the usual time. Do not take a double dose to make up for the missed doses.

If you interrupt treatment withTamsulosina Sandoz

When treatment with tamsulosina is discontinued prematurely, your original symptoms may return. Therefore, take Tamsulosina Sandoz for the entire time your doctor prescribes, even if your symptoms have disappeared. Always consult your doctor if you decide to stop treatment.

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

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

It is rare for serious adverse reactions to occur.Contact your doctor immediatelyif you experience asevere allergic reaction that causes swelling of the face or throat(angioedema).

Frequent(may affect up to 1 in 10 people)

• Dizziness.
• Abnormal ejaculation (ejaculation alteration). This means that semen does not release through the urethra, but rather goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculation failure). This phenomenon is harmless.

Possibly frequent(may affect up to 1 in 100 people)

• Headache.
• Perceptible heartbeats (palpitations).
• Reduced blood pressure when standing, which causes dizziness or fainting (orthostatic hypotension).
• Swelling and irritation in the nose (rhinitis).
• Constipation.
• Diarrhea.
• Nausea.
• Vomiting.
• Rash.
• Itching.
• Hives (urticaria).
• Feeling weak (asthenia).

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

• Faintingand local inflammation of soft body tissues (e.g. throat or tongue).
• Difficulty breathing and/or itching and rash, sometimes as an allergic reaction (angioedema).

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

• Painduring erection (priapism).
• Severe disease with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

Frequency unknown(cannot be estimated from available data)

• Altered heart rhythm.
• Irregular heartbeat.
• Increased heart rate.
• Difficulty breathing.
• Blurred vision.
• Difficulty seeing.
• Nasal bleeding.
• Rash.
• Inflammation and blisters on the skin (erythema multiforme, exfoliative dermatitis).
• Dry mouth.

During eye surgery, a condition called Flaccid Iris Syndrome (IFIS) may occur: The pupil may dilate poorly and the iris (the colored part of the eye) may become flaccid during the surgery. For more information, see section 2.

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 that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

By reporting adverse 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.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the 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 packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofTamsulosina Sandoz 0.4 mg

•The active ingredient 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, red iron oxide (E172), magnesium stearate. Outer tablet: microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the packaging

Tamsulosina Sandoz is presented in the form of round, white tablets, with the inscription “T9SL” on one face and “0.4” on the other.

They are presented in packaging of10, 18, 20, 28, 30, 50, 60, 90, 98 and 100tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Synthon Hispania, S.L.

Castello, 1

Poligono Las Salinas

08830 Sant Boi de Llobregat

Spain

SYNTHON BV

Microweg, 22, P.O.Box 7071 (Nijmegen)

NL-6545 - Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

NetherlandsTamsulosine HCL Sandoz Retard 0.4 mg, tablets with prolonged release

SpainTamsulosina Sandoz 0.4 mg prolonged-release tablets EFG

Last review date of this leaflet: June 2015

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