Leaflet: information for the user

Tamsulosina Aurovitas 0.4 mg prolonged-release hard capsules EFG

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 tamsulosin. It is a selective antagonist of α1A/1D adrenergic receptors.It reduces the tension of the smooth muscles of the prostate and the urethra, allowing urine to pass more easily through the urethra and facilitating urination. Additionally, it decreases the sensation of urgency.

Tamsulosin is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate gland (benign prostatic hyperplasia).These symptoms may include difficulty 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 any of the other ingredients of this medication (listed in section 6). Hypersensitivity may manifest 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).

Warnings and precautions

Consult your doctor or pharmacist before starting to take tamsulosin.

• Regular medical check-ups are necessary to monitor the development of the disease you are being treated for.
• Rarely, dizziness may occur during the use of tamsulosin, as with other medications of this type. Sit or lie down at the first symptoms of dizziness or weakness until they have disappeared.
• If you have severe kidney problems, consult your doctor.
• If you are undergoing eye surgery due to cataracts or increased eye pressure (glaucoma). Please 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 undergoing surgery due to cataracts or increased eye pressure (glaucoma).

Children and adolescents

Do not administer this medication to children or adolescents under 18 years old as it is not effective in this population.

Taking Tamsulosina Aurovitas with other medications

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

Taking tamsulosin with other medications of the same group (α1-adrenergic receptor antagonists) 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

Take the medication after the first meal of the day.

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 that tamsulosin affects 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 concentration.

Tamsulosina Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

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 dose is 1 capsule per day to be taken after breakfast or the first meal of the day.

The capsule must be swallowed whole and not broken or chewed. Tamsulosina 0.4 mg is usually prescribed for long periods of time.

The effects on the bladder and urination are maintained during long-term treatment with tamsulosina 0.4 mg.

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 capsules of tamsulosina may 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 capsules of tamsulosina.

If you forgot to takeTamsulosina Aurovitas

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

If you interrupt the 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. Consult your doctor at all times if you decide to discontinue treatment.

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

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

Stop taking your medication and seek medical attention immediately, if you experience any of the following allergic reactions:

• Difficulty breathing.
• Swelling of the face, tongue, or throat (angioedema).
• Itching and skin rash.

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.

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

• Headache.
• Palpitations (the heart rate is faster than normal and is perceivable).
• Low blood pressure, for example, when standing up quickly after being seated or lying down, sometimes associated with dizziness.
• Runny or congested nose (rhinitis).
• Constipation.
• Diarrhea.
• Sensation ofnausea and vomiting.
• Weakness (asthenia).
• Skin rash.
• Itching and hives (urticaria).

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

• Loss of consciousness and sudden swelling of soft body tissues (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 not known (the frequency cannot be estimated from available data):

• Blurred vision.
• Visual disturbance.
• 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 a possible adverse effect that does not appear in this prospectus.You can also report them directly through the Spanish System for the 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 medication.

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

This medication does not require special storage conditions.

Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the box, blister pack, and bottle label 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 packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tamsulosina Aurovitas

• The active ingredient is hydrochloride of tamsulosin. Each prolonged-release hard capsule contains 0.4 mg of hydrochloride of tamsulosin.
• The other components (excipients) are:

Content of the capsule: Microcrystalline cellulose, talc, copolymer of methacrylic acid and ethyl acrylate, sodium lauryl sulfate, polysorbate 80, triacetin, and calcium stearate.

Capsule coating: Carmine (E 132), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), sodium lauryl sulfate, gelatin.

Printing ink:Shellac (lacquer resin), propylene glycol, iron oxide black (E 172), potassium hydroxide.

Appearance of the product and contents of the package

Prolonged-release hard capsule.

Hard gelatin capsules of size “1EL” of greenish-yellow opaque / orange opaque color, filled with white to off-white granules, and marked with edible black ink with “D” on the cap and “53” in the body.

Tamsulosina Aurovitas is available in:

PVC/PE/PVDC/Aluminum blisters: 1, 2, 4, 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100, or 200 hard capsules.

High-density polyethylene (PEAD) round white opaque bottles with polypropylene white opaque closures: 10 and 250 hard capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19, Venda Nova

2700-487 Amadora

Portugal

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

France:TAMSULOSINE ARROW LP 0.4 mg, prolonged-release gelatin capsule

Germany:Tamsulosin Aurobindo 0.4 mg Retardkapseln

Malta:Tamsulosin Aurobindo 0.4 mg prolonged-release capsules

Italy:Tamsulosina Aurobindo 400 microgrammi hard capsules with prolonged release

Netherlands:Tamsulosine HCl Aurobindo 0.4 mg, hard capsules with regulated release

Poland:Tamsulosin Aurovitas

Portugal:Tansulosina Aurovitas

Spain:Tamsulosina Aurovitas 0.4 mg prolonged-release hard capsules EFG

Last review date of this leaflet:February 2019

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