Tamsulosin CINFA 0.4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

tamsulosina cinfa 0.4 mg prolonged-release tablets EFG

tamsulosine hydrochloride

Read the entire 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 you should not give it to others, even if they have the same symptoms as you, because it may 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 cinfa is and what it is used for
2. What you need to know before taking tamsulosina cinfa
3. How to take tamsulosina cinfa
4. Possible adverse effects
5. How to store tamsulosina cinfa
6. Contents of the pack and other information

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

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

tamsulosin cinfa 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 urinary stream), dribbling, urgency, and frequent need to urinate both during the night and during the day.

2. What you need to know before taking tamsulosin cinfa

Do not take tamsulosin cinfa

• if you are allergic to tamsulosin hydrochloride or to any of the other ingredients of this medicine (listed in section 6). 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

Talk to your doctor or pharmacist before starting tamsulosin cinfa

• because periodic medical examinations are necessary to monitor the progression of the condition being treated.
• because fainting may rarely occur during treatment with 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.
• if you are scheduled for or are undergoing eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma). Please inform your ophthalmologist if you have recently taken, are currently taking, or are considering taking tamsulosin cinfa. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor about whether you should delay or temporarily stop taking this medicine if you are undergoing surgery due to a cloudy lens (cataract) or increased eye pressure (glaucoma).

Children and adolescents

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

Other medicines and tamsulosin cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Taking tamsulosin together with other medicines of the same class (alpha-1 adrenergic receptor blockers) may cause an undesirable drop in blood pressure.

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

Taking tamsulosin cinfa with food and drink

You may take tamsulosin with or without food.

Pregnancy, breastfeeding and fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen is not expelled 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 using 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, in which case you should not perform activities requiring alertness.

3. How to take tamsulosina cinfa

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

Tamsulosina is a specially designed tablet that releases the active substance gradually after the tablet has been swallowed. You may notice a residue of the tablet in your stools. There is no risk of loss of efficacy, as the active substance will have 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 feel that the effect of tamsulosina is too strong or too weak, inform your doctor or pharmacist.

If you take more tamsulosina cinfa than you should

Taking too many tamsulosina tablets may lead to an undesirable drop in blood pressure and an increased heart rate, accompanied by a feeling of faintness.

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 cinfa

If you have forgotten to take tamsulosina as recommended, you may take your daily dose later on the same day. If you have missed the dose for a day, you may 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

If treatment with tamsulosina is stopped prematurely, your original symptoms may return. Therefore, take tamsulosina for as long as your doctor has prescribed, 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 (ejaculation disorder). This means that semen is not released 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 (heart beats faster than normal and are noticeable), reduction in blood pressure, for example when standing up quickly after sitting or lying down, sometimes associated with dizziness, nasal drip or nasal congestion (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 tissues of the body (such as the throat or tongue), breathing difficulty 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 requiring immediate medical treatment)
• skin rash, inflammation and blistering of 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
• visual 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 clouding of the lens (cataracts) or increased eye pressure (glaucoma), and you are currently taking or have previously taken tamsulosin, during surgery the pupil may show poor dilation 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 they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of tamsulosin cinfa

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 is the last day of the month indicated.

Store in the original packaging to protect from light.

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

6. Contents of the container and other information

Composition of tamsulosina cinfa

The active substance 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 contents of the container

Tamsulosina cinfa tablets are cylindrical, uncoated, white in colour, with the imprint “T9SL” on one side and “0.4” on the other.

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

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

Only certain pack 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 latest revision of this leaflet: November 2020

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. 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