Leaflet: information for the user

Tamsulosina Aurovitas 0.4 mg prolonged-release EFG tablets

Tamsulosin hydrochloride

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

-Keep this leaflet, 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 you must not give it 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 leaflet. See section 4.

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

2.What you need to know before you start taking Tamsulosina Aurovitas

3.How to take Tamsulosina Aurovitas

4.Possible side effects

5.Storage of Tamsulosina Aurovitas

6.Contents of the pack and additional information

The active ingredient of Tamsulosina Aurovitas is hydrochloride of tamsulosina. It is a selective antagonist of adrenergic receptors alpha 1A/1D.1A/1D. It reduces the tension of the smooth muscles of the prostate and of the urethra allowing the urine to pass more easily through the urethra and facilitating urination. Additionally, it decreases the sensation of urgency.

Tamsulosina is used in men for the treatment of lower urinary tract symptoms associated with an enlargement of the prostate gland (benign prostatic hyperplasia).These symptoms may includedifficulty urinating (weak urine stream), dripping, urgency, and the need to urinate frequently both at night and during the day.

Do not take Tamsulosina Aurovitas

•If you are allergic to hydrochloride tamsulosin or to any of the other components 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 severe liver problems.

•If you have dizziness due to a drop in blood pressure when changing position (sitting or standing up).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeTamsulosina Aurovitas.

•Because regular medical check-ups are necessary to monitor the progression of the disease you are being treated for.

•Because, rarely, dizziness may occur during the use of tamsulosin, as with other medications of this type. Sit or lie down until the symptoms have disappeared.

•If you have severe kidney problems.

•If you are about to undergo eye surgery due to a cloudy lens (cataract) or increased eye pressure (glaucoma). Inform your ophthalmologist if you have taken, are taking, or plan to take tamsulosin. The specialist will then take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should or should not postpone or temporarily discontinue taking this medication if you are about to undergo such an operation due to a cloudy lens (cataract) or increased eye pressure (glaucoma).

Children and adolescents

Do not administer this medication to children or adolescents under 18 years old because it does not work in this population.

Other medications and Tamsulosina Aurovitas

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

The use oftamsulosinwith other medications of the same group (alpha 1-adrenergic receptor blockers1) may cause an undesirable drop 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 tamsulosin from the body (e.g., ketoconazole, erythromycin).

Taking Tamsulosina Aurovitas with food and drinks

You can take tamsulosin with or without food.

Pregnancy and breastfeeding

Tamsulosin is not indicated for use in women.

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 ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machinery

There is no evidence thattamsulosinaffects the ability to drive or operate machinery. However, you should be aware that dizziness may occur, in which case, you should not perform activities that require attention.

Tamsulosina Aurovitas contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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

The recommended dose is 1 tablet per day. You can take tamsulosina with or without food, preferably at the same time every day.

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

Tamsulosina Aurovitas is a tablet designed specifically for the active ingredient to be released gradually once ingested. It is possible that you may observe a remainder of the tablet in your stool. There is no risk of loss of efficacy since the active ingredient has already been released.

Tamsulosina is usually prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with tamsulosina.

If you take more Tamsulosina Aurovitas than you should

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.

Taking too many tamsulosina tablets can lead to an undesirable decrease in blood pressure and an increase in heart rate, with a feeling of dizziness. Consult your doctor immediately if you have taken too many tablets of tamsulosina.

If you forgot to take Tamsulosina Aurovitas

If you have forgotten to take tamsulosina as recommended, you can take your daily dose of tamsulosina later in the same day. If you have forgotten a dose one day, simply continue taking your daily tablet as prescribed. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Tamsulosina Aurovitas

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Frequent(may affect up to 1 in 10 people)

•Dizziness, especially when sitting or standing up.

•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 (ejaculatory insufficiency). This phenomenon is harmless.

Infrequent(may affect up to 1 in 100 people)

•Headache,palpitations (the heart rate is faster than normal and also perceptible), decrease in blood pressure, for example, when standing up quickly after being seated or lying down, sometimes associated with dizziness, dripping or nasal congestion (rhinitis), diarrhea, nausea and vomiting sensation, constipation, weakness (asthenia), skin rash, itching and rashes (urticaria).

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

•Swelling and sudden inflammation 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 (unwanted, prolonged, and painful erection that requires 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 unknown(the frequency cannot be estimated from the available data)

•Blurred vision.

•Visual alteration.

•Nosebleed (epistaxis).

•Severe skin eruptions (erythema multiforme, exfoliative dermatitis).

•Irregular and abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea).

•If you are about to undergo eye surgery due to a clouding of the lens (cataracts) or an increase in eye pressure (glaucoma), and you are taking or have taken tamsulosin previously, during the surgery, the pupil may dilate slightly and the iris (the colored part of the eye), may become flaccid.

•Dry mouth.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Tamsulosina Aurovitas Composition

-The active ingredient 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), hydroxypropyl cellulose,monohydrate lactose, polyethylene oxide,hypromellose(type 2208),anhydrous colloidal silica andmagnesium stearate.

Tablet coating:hypromellose2910,macrogol, titanium dioxide (E171), yellow iron oxide (E172),red iron oxide(E172).

Product appearance and packaging contents

Prolonged-release tablet.

Yellow-coated tablets, round (9.1 mm in diameter), biconvex, with the marks “T” above and “0.4” below on one face and smooth on the other.

Tamsulosina Aurovitasprolonged-release tabletsare available in:

-Triple-laminated blister packs in cold (Alu-Alu) and bottles (opaque white HDPE bottles with a white opaque polypropylene cap containing silica gel as a desiccant).

Blister pack sizes:

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

Bottle sizes:

250 prolonged-release tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible 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

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

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

Germany:Tamsulosin PUREN 0.4 mg Retardtabletten

Belgium:Tamsulosin AB 0.4 mg tablets with prolonged release / comprimés à libération prolongée / Retardtabletten

Spain:Tamsulosina Aurovitas 0.4 mg prolonged-release tablets EFG

France:TAMSULOSINE ARROW LP 0.4 mg, prolonged-release tablet

Netherlands:Tamsulosine HCl Aurobindo Retard 0.4 mg, tablets with prolonged release

Poland:Tamsulosin Aurovitas

Portugal:Tansulosina Generis

Czech Republic:Tamsulosin Aurovitas

Romania:Tamsulosin Aurobindo 0.4 mg tabletswith prolonged release

Last review date of this leaflet: November 2020

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