Label: information for the user

Tamsulosina Vir 0.4 mg prolonged-release hard capsules EFG Hydrochloride of Tamsulosina

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

-Keep this label, 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 should not be given to others 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 label. See section 4.

1What Tamsulosina Vir is and for what it is used

2. What you need to know before starting to take Tamsulosina Vir

3. How to take Tamsulosina Vir

4. Possible adverse effects

5. Storage of Tamsulosina Vir

6. Contents of the pack and additional informationl

The active ingredient of this medication is tamsulosina. It is a selective antagonist of alpha 1A/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. It also decreases the sensation of urgency.

Tamsulosina Vir is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate gland (benign prostatic hyperplasia). These symptoms include: difficulty urinating (weak urine stream), dripping, urgent urination, and frequent urination both at night and during the day.

Do not take Tamsulosina Vir

•If you are allergic (hypersensitive) to tamsulosina or any of the other components of this medication. Hypersensitivity may present as sudden swelling of the soft tissues of the body (for example, the throat or tongue), difficulty breathing and/or itching and skin rash (angioedema).

•If you have severe liver problems

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

Warnings and precautions

Consult with your doctor or pharmacist before starting to take Tamsulosina Vir

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

•Dizziness may rarely occur during the use of tamsulosina, as with other medications of this type. If you experience the first symptoms of dizziness or weakness, sit or lie down until they have disappeared.

•If you have severe kidney problems, consult your doctor.

•If you are scheduled to undergo or have scheduled eye surgery due to a cloudy lens (cataracts) or increased eye pressure (glaucoma). Please inform your ophthalmologist if you have taken, are taking, or are thinking of taking tamsulosina. 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 suspend taking this medication if you are scheduled to undergo eye surgery due to a cloudy lens (cataracts) or increased eye pressure (glaucoma).

Children and adolescents

This medication should not be administered to children or adolescents under 18 years of age because it does not work in this population.

Other medications and Tamsulosina Vir

The use of tamsulosina with other medications of the same group (alpha-adrenergic receptor antagonists) may produce 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 tamsulosina from the body (for example, ketoconazole, erythromycin).

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those acquired without a prescription.

Use of tamsulosina Vir with food and beverages

Tamsulosina should be taken after breakfast or the first meal of the day.

Pregnancy, lactation, and fertility

Tamsulosina 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 rather goes to the bladder (retrograde ejaculation) or the volume of semen is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machinery

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

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

The recommended dose is one capsule per day and it should be taken after breakfast or the first meal of the day. The capsule should be swallowed whole and not broken or chewed. 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 Vir than you should

Taking too much tamsulosina can lead to an unwanted drop in blood pressure and an increase in heart rate, with a feeling of dizziness. 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 forgot to take Tamsulosina Vir

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 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 Vir

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

• Frequent (may affect up to one in 10 patients)

• 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 one in 100 patients)

Headache, palpitations (the heartbeat is faster than normal and more noticeable)

Reduced blood pressure, for example, when standing up quickly after being seated or lying down, sometimes associated with dizziness, dripping, or nasal obstruction (rhinitis), diarrhea, sensation of nausea and vomiting, constipation, weakness (asthenia), skin rash, itching, and hives (urticaria)

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

Fainting 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 one in 10,000 patients)

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, nasal passages, or genitals (Stevens-Johnson syndrome).

• Frequency unknown (cannot be estimated from available data):

• Blurred vision
• Visual alteration
• Nosebleed (epistaxis)
• Severe skin eruptions (erythema multiforme, exfoliative dermatitis)
• Abnormal heart rhythm (fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea)
• If you are undergoing 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, during the surgery, the pupil may dilate slightly and the iris (the colored part of the eye) may become flaccid.

Dry mouth

Reporting 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 Pharmacovigilance of Medicines for Human Use: 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.

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 collection point at the 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 of Tamsulosina Vir

The active ingredient is tamsulosin hydrochloride.

Each prolonged-release hard capsule contains 0.4 mg of hydrochloride of tamsulosin equivalent to 0.367 mg of tamsulosin.

The other components (excipients) are: Content of the capsule:

Sodium alginate, methacrylic acid copolymer of ethyl acrylate, glyceryl dibehenate, maltodextrin,

Sodium lauryl sulfate, macrogol 6000, polysorbate 80, sodium hydroxide, simethicone emulsion 30%, and anhydrous colloidal silica.

Capsule body:

Gelatin, iron oxide red (E-172), titanium dioxide (E-171), iron oxide yellow (E-172).

Appearance of the product and contents of the package

Tamsulosina Vir is presented in the form of prolonged-release hard capsules of orange color and conical shape, containing white-yellowish granules

Each package contains 30 capsules.

Holder of the marketing authorizationINDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A. C/ Laguna 66-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

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Responsible for manufacturing

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A. Carretera Cazoña-Adarzo s/n- 39011 Santander

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INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Last review date of this prospectus: July 2019

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS)https://www.aemps.gob.es/