TAMSULOSIN CINFA 0.4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

tamsulosina cinfa 0.4 mg prolonged-release tablets EFG

tamsulosina hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is tamsulosina cinfa and what is it used for
2. What you need to know before taking tamsulosina cinfa
3. How to take tamsulosina cinfa
4. Possible side effects
5. Storage of tamsulosina cinfa
6. Package contents and additional information

1. What is tamsulosina cinfa and what is it used for

The active ingredient is tamsulosin. It is a selective antagonist of alpha1A/1D adrenergic receptors. It reduces the tension of the smooth muscles of the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. Additionally, it decreases the sensation of urgency.

tamsulosina cinfa 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 need to urinate both at night and during the day.

2. What you need to know before taking tamsulosina cinfa

Do not take tamsulosina cinfa

• if you are allergic to tamsulosin hydrochloride or any of the other components of this medication (listed in section 6). Hypersensitivity may present as sudden local swelling of the body's soft tissues (e.g., 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 take tamsulosina cinfa

• because regular medical check-ups are necessary to monitor the progression of the disease being treated.
• because, rarely, fainting can occur during the use of tamsulosin, as with other medications of this type. At the first symptoms of dizziness or weakness, you should sit or lie down until they have disappeared.
• if you have severe kidney problems.
• if you are going to undergo or have scheduled eye surgery due to cataracts or increased pressure in the eye (glaucoma). Please inform your ophthalmologist if you have recently taken, are taking, or are planning to take tamsulosina cinfa. The specialist can then take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should postpone or temporarily suspend taking this medication if you are going to undergo such surgery due to cataracts or increased pressure in the eye (glaucoma).

Children and adolescents

Do not administer this medication to children or adolescents under 18 years of age, as it does not work in this population.

Other medications and tamsulosina cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

Taking tamsulosin with other medications in the same group (alpha1 adrenergic receptor blockers) may cause an undesirable drop in blood pressure.

It is especially important that you inform your doctor if you are being treated at the same time with medications that can decrease the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Taking tamsulosina cinfa with food and drinks

You can take tamsulosin with or without food.

Pregnancy, breastfeeding, and fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (altered ejaculation) has been reported. This means that semen is not released through the urethra, but rather into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

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

3. How to take tamsulosina cinfa

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

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

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

Tamsulosin is a tablet designed to release the active ingredient gradually after ingestion. You may observe a residue of the tablet in your stool. There is no risk of loss of efficacy, as the active ingredient has already been released.

Normally, tamsulosin is prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with tamsulosin.

If you think the effect of tamsulosin is too strong or too weak, inform your doctor or pharmacist.

If you take more tamsulosina cinfa than you should

Taking too many tamsulosin tablets can lead to an undesirable drop in blood pressure and an increase in heart rate, with a feeling of fainting.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take tamsulosina cinfa

If you have forgotten to take tamsulosin as recommended, you can take your daily dose of tamsulosin later that day. If you have missed a dose for a day, you can simply continue taking your daily tablet as prescribed.

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

If you stop taking tamsulosina cinfa

When treatment with tamsulosin is abandoned prematurely, your original symptoms may return. Therefore, take tamsulosin for the entire time your doctor prescribes it, 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Common (may affect up to 1 in 10 patients):

• dizziness, especially when sitting or standing up
• abnormal ejaculation (altered ejaculation). This means that semen is not released through the urethra, but rather into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory insufficiency). This phenomenon is harmless

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

• headache, palpitations (the heartbeat is faster than normal and also perceptible), decreased blood pressure, for example, when standing up quickly after sitting or lying down, sometimes associated with dizziness, nasal dripping or obstruction (rhinitis), diarrhea, feeling of 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 local swelling of the body's soft 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 (undesired, 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 not known (cannot be estimated from available data):

• blurred vision
• vision changes
• nasal bleeding (epistaxis)
• severe skin rashes (erythema multiforme, exfoliative dermatitis)
• abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea)
• if you are going to undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma), and you are taking or have taken tamsulosin, during the operation, the pupil may dilate poorly, and the iris (the colored part of the eye) may become flaccid.
• dry mouth

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of tamsulosina cinfa

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of tamsulosina cinfa

The active ingredient is tamsulosin hydrochloride. Each tablet contains 0.4 mg of tamsulosin hydrochloride.

The other components are:

• Inner tablet: hypromellose, microcrystalline cellulose, carbomers, anhydrous colloidal silica, red iron oxide (E-172), and magnesium stearate.
• Outer tablet: microcrystalline cellulose, hypromellose, carbomers, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and package contents

tamsulosina cinfa tablets are cylindrical, uncoated, white, with the inscription "T9SL" on one side and "0.4" on the other.

They are presented in PVC-PVDC/Aluminum, PVC/Aclar/Aluminum, or PA/Aluminum/PVC-Aluminum blisters.

Each package contains 10, 14, 18, 20, 28, 30, 45, 50, 56, 60, 90, 100, or 200 prolonged-release tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

or

Synthon Hispania S.L.

Castelló 1

Polígono Las Salinas

08830 Sant Boi de Llobregat Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen Netherlands

Date of the last revision of this package leaflet:November 2020

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74255/P_74255.html

QR code to: https://cima.aemps.es/cima/dochtml/p/74255/P_74255.html