TAMSULOSIN CINFA 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Leaflet: information for the user

tamsulosina cinfa 0.4 mg modified-release hard capsules EFG

tamsulosina hydrochloride

Read this leaflet carefully before starting to take this medicine, as 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 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 leaflet. See section 4.

Contents of the 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. Contents of the pack and further information

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

Tamsulosina is an alpha-1A adrenergic receptor blocker. It relaxes the muscles of the prostate and the urinary tract.

Tamsulosina is prescribed to relieve urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). By relaxing the muscles, it allows urine to pass more easily and facilitates urination.

2. What you need to know before taking tamsulosina cinfa

Do not take tamsulosina cinfa:

• If you are allergic to tamsulosina or any of the other componentsof this medicine (listed in section 6), (symptoms may include swelling of the face and throat(angioedema)).
• If you have a history of decreased blood pressure when standing up, which causes dizziness, mild fainting or fainting.
• If you have severe liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take tamsulosina cinfa

• If you suffer from dizziness or mild fainting, especially when standing up. Tamsulosina may lower your blood pressure and cause these symptoms. You should sit or lie down until the symptoms have disappeared.
• If you have severe kidney problems. The normal dose of tamsulosina may not have the expected effect if your kidneys are not working properly.
• If you are going to undergo eye surgerydue to cataracts or increased pressure in the eye (glaucoma). A condition called "Intraoperative Floppy Iris Syndrome" (IFIS) may occur (see section 4, "Possible side effects"). Inform your ophthalmologist that you are taking or have previously taken tamsulosina hydrochloride. The ophthalmologist will take the necessary precautions regarding medication and surgical techniques. Ask your doctor if you should postpone or temporarily stop taking this medicine if you are going to undergo surgery due to cataracts or increased pressure in the eye (glaucoma).

Before starting treatment with tamsulosina, your doctor should examine you to confirm that the symptoms are actually caused by an enlarged prostate.

Children and adolescents

It is not recommended for use in children and adolescents under 18 years of age, as it is not effective in this age group.

Other medicines and tamsulosina cinfa

Other medicines may be affected by tamsulosina. On the other hand, other medicines may affect the action of tamsulosina. Tamsulosina may interact with:

• Medicines that lower blood pressure (such as verapamil and diltiazem)
• Medicines used to treat HIV (such as ritonavir or saquinavir)
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, voriconazole, or fluconazole).
• Medicines to prevent blood clotting (such as warfarin).
• Anti-inflammatory medicines (such as diclofenac).
• Medicines used to treat infections (such as erythromycin and clarithromycin).
• Immunosuppressants (such as cyclosporine).

Tell your doctor or pharmacistif you are taking, have recently taken, or may take any other medicine, even if it is without a prescription.

Taking tamsulosina cinfa with food and drinks

Tamsulosina should be taken after breakfast or the first meal of the day with the help of a glass of water.

Pregnancy, breastfeeding, and fertility

Tamsulosina is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means

that the semen is not released through the urethra, but rather goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory failure).

Driving and using machines

There is no information available on the effects of tamsulosina on the ability to drive and use machinery. You should keep in mind that tamsulosina may cause dizziness and mild fainting. Drive or use machinery only if you feel well.

tamsulosina cinfa contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is, essentially "sodium-free".

3. How to take tamsulosina cinfa

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

The recommended doseis one capsule per day and should be taken after breakfastor the first meal of the day.

You should swallow the capsule wholewith a glass of water, standing or sitting (not lying down). It is important that you do not break or crush the capsule, as this may interfere with the action of tamsulosina.

If you have mild to moderate kidney or liver failure, you can take the usual dose of tamsulosina.

If you take more tamsulosina cinfa than you should

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 medicine and the amount taken.

If you take more tamsulosina than you should, your blood pressure may drop suddenly. In this case, you may experience dizziness, weakness, and fainting, as well as vomiting and diarrhea. Lie down to minimize the effect of the drop in blood pressure and then contact your doctor. Your doctor may give you medicine to recover your blood pressure and fluid levels and monitor your body functions. If necessary, you may have a stomach wash and a laxative to eliminate tamsulosina that has not yet entered the bloodstream.

If you forget to take tamsulosina cinfa

Do not take a double dose to make up for forgotten doses. Simply take the next dose when it is due.

If you stop taking tamsulosina cinfa

When treatment with tamsulosina is stopped prematurely, your original symptoms may return. Therefore, take tamsulosina for as long as 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicinecan cause side effects, although not everyone gets them.

Stop taking tamsulosina and contact your doctor immediately if you experience any of the following symptoms:

• Rare(may affect up to 1 in 1,000 people): sudden swelling of: hands, feet, lips, tongue, or throat causing difficulty breathing and/or itching and skin rash, caused by an allergic reaction (angioedema).

• Very rare(may affect up to 1 in 10,000 people): widespread 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): a severe and blistering skin condition known as erythema multiforme.

Common(may affect up to 1 in 10 people)

Dizziness, abnormal ejaculation, retrograde ejaculation, and ejaculation failure.

Uncommon(may affect up to 1 in 100 people)

Headache, palpitations, decreased blood pressure when standing up, which causes dizziness, mild fainting, or fainting (orthostatic hypotension), swelling and irritation inside the nose (rhinitis), constipation, diarrhea, nausea, vomiting, rash, urticaria, feeling of weakness (asthenia), itching.

Rare(may affect up to 1 in 1,000 people)

Fainting (syncope)

Very rare(may affect up to 1 in 10,000 people)

Painful erection (priapism).

Frequency not known(cannot be estimated from available data)

Blurred vision, loss of vision, nosebleeds, dry mouth.

During eye surgery due to cataracts or increased pressure in the eye (glaucoma), a condition called "Intraoperative Floppy Iris Syndrome" (IFIS) may occur: the pupil dilates little and the iris (the colored part of the eye) may become flaccid during the procedure. For more information, see section 2, "Warnings and precautions".

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of tamsulosina cinfa

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

Store in the original package and keep the package tightly closed.

Do not use this medicine after the expiration date stated on the package, after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the package and any unused medicine in the pharmacy's SIGRE collection point. If you are in doubt, ask your pharmacist how to dispose of the package and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of tamsulosina cinfa

The active ingredient is tamsulosina hydrochloride.

The other ingredients are:

Contents of the capsule:microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, polysorbate 80, sodium lauryl sulfate, triethyl citrate, and talc.

Body of the capsule: gelatin, carmine (E-132), titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), and black iron oxide (E-172).

Appearance of the product and contents of the pack

tamsulosina cinfa is presented in the form of modified-release hard capsules, orange/greenish in color.

Each pack contains 30 capsules.

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 BV

Microweg, 22, P.O.Box 7071

Nijmegen-Netherlands

or

SYNTHON HISPANIA, S.L.

Castello 1, Poligono Las Salinas.

Sant Boi de Llobregat (Barcelona)-Spain

Date of the last revision of this leaflet:February 2021

Detailed and updated information on this medicine 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 medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67308/P_67308.html

QR code to: https://cima.aemps.es/cima/dochtml/p/67308/P_67308.html