Tamsulosin Vir 0.4 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read all of 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 and should not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1 What Tamsulosina Vir is and what it is used for

2 What you need to know before taking Tamsulosina Vir
3 How to take Tamsulosina Vir
4 Possible side effects
5 How to store Tamsulosina Vir
6 Contents of the pack and other information

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

The active substance of this medicine is tamsulosin. It is a selective antagonist of alpha1A/1D adrenergic receptors. It reduces the tone of the smooth muscles of the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. It also reduces the sensation of urgency.

Tamsulosin Vir is used in men for the treatment of lower urinary tract symptoms associated with enlargement of the prostate gland (benign prostatic hyperplasia). These are symptoms such as: difficulty urinating (weak urine stream), dribbling, urgent need to urinate, and frequent need to urinate both during the night and during the day.

2. Before taking Tamsulosina Vir

Do not take Tamsulosina Vir

• If you are allergic (hypersensitive) to tamsulosin or to any of the other components of this medicine. Hypersensitivity may present as sudden localized swelling of soft tissues in the body (e.g., throat or tongue), difficulty breathing and/or itching and skin rash (angioedema).
• If you have severe liver problems.
• If you suffer from 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 take Tamsulosina Vir.

• Periodic medical examinations are necessary to monitor the progression of the condition for which you are being treated.

• Fainting may rarely occur during the use of tamsulosin, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until symptoms have disappeared.

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

• If you are scheduled for or undergoing eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), please inform your ophthalmologist if you have previously taken, are currently taking, or are considering taking tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques to be used.

• Consult your doctor whether you should delay or temporarily discontinue taking this medicine if you are undergoing surgery due to a cloudy lens (cataract) or increased eye pressure (glaucoma).

Children and adolescents

Do not administer this medicine to children or adolescents under 18 years of age, as it is not effective in this population.

Other medicines and Tamsulosina Vir

Taking tamsulosin together with other medicines of the same class (alpha-adrenergic receptor antagonists) may cause an undesirable decrease in blood pressure.

It is especially important that you inform your doctor if you are simultaneously being treated with medicines that may reduce the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

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

Use of Tamsulosina Vir with food and drinks

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

Pregnancy, lactation and fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and use of machines

There is no evidence that tamsulosin affects the ability to drive or operate tools or machinery. However, you should bear in mind that dizziness may occur, and in such a case, you should not perform activities requiring attention.

3. How to take Tamsulosina Vir

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one capsule per day, to be taken after breakfast or the first meal of the day. The capsule must be swallowed whole and must not be broken or chewed. Tamsulosin is usually prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with tamsulosin.

If you take more Tamsulosina Vir than you should

Taking too much tamsulosin may lead to an undesirable drop in blood pressure and an increased heart rate, with a sensation of fainting. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Tamsulosina Vir

If you have forgotten to take tamsulosin as recommended, you may take your daily dose later on the same day.

If you have missed the dose for one day, you may simply continue taking your daily capsule as prescribed.

Do not take a double dose to make up for forgotten doses.

If you stop taking Tamsulosina Vir

When treatment with tamsulosin is stopped prematurely, your original symptoms may return. Therefore, take tamsulosin for as long as your doctor prescribes, even if your symptoms have disappeared. Always consult your doctor if you decide to discontinue treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

  • Dizziness, especially when sitting down or standing up.
  • Abnormal ejaculation (ejaculatory disorder). This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or that the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

• Uncommon (may affect up to 1 in 100 patients):

  • Headache, palpitations (heartbeat faster than normal and noticeable).
  • Reduction in blood pressure, for example when standing up quickly after sitting or lying down, sometimes associated with dizziness, nasal drip or nasal obstruction (rhinitis), diarrhoea, nausea and vomiting, constipation, weakness (asthenia), skin rash, itching and hives (urticaria).

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

  • Fainting and sudden localized 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 patients):

  • Priapism (unwanted, prolonged and painful erection requiring 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 not known (cannot be estimated from available data):

  • Blurred vision
  • Vision disturbance
  • Nosebleed (epistaxis)
  • Severe skin rashes (erythema multiforme, exfoliative dermatitis)
  • Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnoea)
  • If you are undergoing eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), and you are currently taking or have previously taken tamsulosin, during surgery the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy.

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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Vir

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Information for the User

Composition of Tamsulosina Vir

The active substance is tamsulosin hydrochloride.

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

The other components (excipients) are: Capsule contents:

Sodium alginate, ethyl acrylate-methacrylic acid copolymer, glyceryl dibehenate, maltodextrin, sodium lauryl sulfate, macrogol 6000, polysorbate 80, sodium hydroxide, simeticone emulsion 30%, and anhydrous colloidal silica.

Capsule shell:

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

Appearance of the product and pack contents

Tamsulosina Vir is presented as prolonged-release orange-colored, conical hard capsules containing white to yellowish granules.

Each package contains 30 capsules.

Marketing Authorization Holder

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
C/ Laguna 66-70. Polígono Industrial Urtinsa II
28923 Alcorcón (Madrid)
Spain

or

Manufacturer

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

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
C/ Laguna 66-70. Polígono Industrial Urtinsa II
28923 Alcorcón (Madrid)
Spain

Date of the most recent revision of this leaflet: July 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/