Leaflet: information for the user

tamsulosin cinfa 0.4 mg prolonged-release EFG tablets

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, and you must 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.

The active ingredient is tamsulosina. It is a selective antagonist of alpha 1A/1D adrenergic receptors.

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), dribbling, urgent urination, and frequent urination both at night and during the day.

Do not take tamsulosina cinfa

• if you are allergic to tamsulosina hydrochloride or any of the other ingredients of this medication (listed in section 6). Hypersensitivity may present as sudden swelling of soft body tissues (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 tamsulosina cinfa

• because regular medical check-ups are necessary to monitor the progression of the disease you are being treated for.
• because, rarely, dizziness may occur during the use of tamsulosina, as with other medications of this type. Sit or lie down until the symptoms have disappeared.
• if you have severe kidney problems.
• if you are about to undergo or have scheduled eye surgery due to a cloudy lens (cataract) or increased eye pressure (glaucoma). Please inform your ophthalmologist if you have recently taken, are taking, or are thinking of taking tamsulosina cinfa. 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 about to undergo eye surgery due to a cloudy lens (cataract) or increased eye pressure (glaucoma).

Children and adolescents

Do not administer this medication to children or adolescents under 18 years old because 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.

The use of tamsulosina with other medications of the same group (alpha 1-adrenergic receptor blockers) 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 (e.g., ketoconazole, erythromycin).

Taking tamsulosina cinfa with food and drinks

You can take tamsulosina with or without food.

Pregnancy, breastfeeding, 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 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 machines

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 or pharmacist. In case of doubt, 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 must be swallowed whole and should not be broken or chewed.

Tamsulosin is a tablet designed specifically so that the active ingredient, once the tablet is ingested, is released gradually. It is possible that you may observe a remainder of the tablet in your feces. There is no risk of loss of efficacy since the active ingredient has already been released.

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 estimate that the action of tamsulosin is too strong or too weak, inform your doctor or pharmacist.

If you take more tamsulosin cinfa than you should

Taking too many tablets of tamsulosin may lead to an undesirable decrease in blood pressure and an increase in heart rate, with a sensation 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 tamsulosin cinfa

If you have forgotten to take tamsulosin as recommended, you can take your daily dose of tamsulosin later in the same day. In case you have missed a dose one day, you can simply continue taking your daily tablet as prescribed.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with tamsulosin cinfa

When treatment with tamsulosin is discontinued prematurely, your original discomforts may return. Therefore, take tamsulosin for the entire time your doctor prescribes, even if your discomforts have disappeared. Always consult your doctor 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 1 in 10 patients):

• dizziness, especially when sitting or standing up
• abnormal ejaculation (alteration of ejaculation). 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

Less frequent (may affect up to 1 in 100 patients):

• headache, palpitations (the heart rate is faster than normal and also perceptible), reduction of blood pressure, for example, when standing up quickly after being seated or lying down, sometimes associated with dizziness, nasal dripping or obstruction (rhinitis), diarrhea, nausea and vomiting, constipation, weakness (asthenia), skin rash, itching and hives (urticaria)

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

• syncope and sudden swelling of soft body tissues (such as the throat or tongue), respiratory 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 (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
• vision alteration
• nosebleed (epistaxis)
• severe skin eruptions (erythema multiforme, exfoliative dermatitis)
• abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulty (dyspnea).
• if you are 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, 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 of 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 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.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Deposit 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.

Tamsulosin Hydrochloride Composition

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

The other components are:

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

Appearance of the product and contents of the package

Tamsulosin hydrochloride tablets are cylindrical, unnotched, 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.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

or

Synthon Hispania S.L.

Castelló 1

Las Salinas Industrial Estate

08830 Sant Boi de Llobregat Spain

or

Synthon BV

Microweg 22

6545 CMNijmegen Netherlands

Last review date of this leaflet:November 2020

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

You can access detailed and updated information on this medicine by scanning the QR code included in the 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