Tamsulosin CINFA 0.4 mg modified-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

tamsulosina cinfa 0.4 mg modified-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; 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 other people, 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 these are 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

Tamsulosin is an alpha1A-adrenergic receptor blocker. It relaxes the muscles in the prostate and urinary tract.

Tamsulosin 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 tamsulosin cinfa

Do not take tamsulosin cinfa:

• If you are allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6) (symptoms may include swelling of the face and throat (angioedema)).
• If you have a history of low blood pressure upon standing, causing dizziness, lightheadedness, or fainting.
• If you have severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking tamsulosin cinfa

• If you experience dizziness or lightheadedness, especially when standing up. Tamsulosin can lower blood pressure and cause these symptoms. You should sit or lie down until symptoms resolve.
• If you have severe kidney problems. The normal dose of tamsulosin may not have the desired effect if your kidneys are not functioning properly.
• If you are scheduled to undergo eye surgery due to cataract (clouding of the lens) or increased eye pressure (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 tamsulosin hydrochloride. Your ophthalmologist will take appropriate precautions regarding medication and surgical techniques. Ask your doctor whether you should delay or temporarily stop taking this medicine before undergoing surgery for cataract or glaucoma.

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

Children and adolescents

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 tamsulosin cinfa

Other medicines may be affected by tamsulosin. Conversely, other medicines may affect the action of tamsulosin. Tamsulosin 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 used 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 pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Taking tamsulosin cinfa with food and drink

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

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 does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or that the volume of ejaculated semen is reduced or absent (ejaculatory insufficiency).

Driving and using machines

There is no information available regarding the effects of tamsulosin on the ability to drive or operate machinery. You should bear in mind that tamsulosin may cause dizziness and lightheadedness. Drive or operate machinery only if you feel well.

tamsulosin cinfa contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take tamsulosina cinfa

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

The recommended dose is one capsule daily, to be taken after breakfast or the first meal of the day.

The capsule must be swallowed whole with a glass of water, while standing or sitting (not lying down). It is important not to break or crush the capsule, as this may interfere with the action of tamsulosin.

If you have mild to moderate renal or hepatic impairment, you may take the usual dose of tamsulosin.

If you take more tamsulosina cinfa than you should

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

If you take more tamsulosin than prescribed, your blood pressure may suddenly decrease. In such a case, you may experience dizziness, weakness, fainting, vomiting, and diarrhea. Lie down to minimize the effect of low blood pressure, and then contact your doctor. Your doctor may administer medications to restore your blood pressure and fluid levels and will monitor your bodily functions. If necessary, gastric lavage and a laxative may be given to eliminate tamsulosin not yet absorbed into the bloodstream.

If you forget to take tamsulosina cinfa

Do not take a double dose to make up for missed doses. Simply take the next dose at the scheduled time.

If you stop taking tamsulosina cinfa

If treatment with tamsulosin is stopped prematurely, your original symptoms may return. Therefore, take tamsulosin 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.

Stop taking tamsulosin 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 due to an allergic reaction (angioedema).

• Very rare (may affect up to 1 in 10,000 people): widespread rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome).

• Frequency not known (cannot be estimated from available data): severe inflammation and blistering of the skin known as erythema multiforme.

Frequent (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, awareness of heartbeat (palpitations), drop in blood pressure upon standing, causing dizziness, brief fainting or fainting (orthostatic hypotension), swelling and irritation inside the nose (rhinitis), constipation, diarrhoea, feeling unwell (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, vision loss, nosebleed, dry mouth.

During eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), a disorder called "Intraoperative Floppy Iris Syndrome" (IFIS) may occur: the pupil dilates poorly and the iris (the coloured circular part of the eye) may become floppy during surgery. For further information, see section 2, "Warnings and precautions".

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: 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.

Store in the original packaging and keep the container tightly closed.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of tamsulosina cinfa

The active substance is tamsulosin hydrochloride.

The other components are:

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

Capsule shell: gelatin, indigo 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 container

tamsulosina cinfa is available as modified-release hard capsules, orange/olive green in colour.

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 – The Netherlands

or

SYNTHON HISPANIA, S.L.

Castello 1, Poligono Las Salinas

Sant Boi de Llobregat (Barcelona) – Spain

Date of the most recent revision of this leaflet: February 2021

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/67308/P_67308.html

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