Leaflet: information for the user

tamsulosin cinfa 0.4 mg modified-release hard capsules EFG

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.

1. What istamsulosin cinfaand what it is used for

2. What you need to know before you start takingtamsulosin cinfa

3. How to taketamsulosin cinfa

4. Possible side effects

5. Storage oftamsulosin cinfa

6. Contents of the pack and additional information

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.

Do not take tamsulosin cinfa:

• If you areallergic to tamsulosin or any of the other ingredientsof this medicine (including those listed in section 6), (the symptoms may includeswelling of the face and throat(angioedema)).
• If you have a history oflow blood pressure when standing up, which causesdizziness, mild fainting, or fainting.
• If you have severeliver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take tamsulosin cinfa

• If you suffer fromdizziness or mild fainting, especially when standing up. Tamsulosin may lower your blood pressure and cause these symptoms. You should sit or lie down until the symptoms have disappeared.
• If you havesevere kidney problems. It is possible that the usual dose of tamsulosin may not have the expected effect if your kidneys do not work properly.
• If you are about to undergoeye surgerydue to opacity of the lens (cataract) or increased pressure in the eye (glaucoma). A condition called "Intraoperative Flaccid Iris Syndrome" (see section 4, "Possible side effects") may occur. Inform your ophthalmologist that you are taking or have previously taken hydrochloride tamsulosin. The ophthalmologist will take the necessary precautions regarding medication and surgical techniques used. Ask your doctor if you should postpone or temporarily stop taking this medicine if you are about to undergo surgery due to an opaque lens (cataract) or increased pressure in the eye (glaucoma).

Before starting treatment with tamsulosin, 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 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 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 to treat infections (such as erythromycin and clarithromycin).
• Immunosuppressants (such as cyclosporin).

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

Taking tamsulosin cinfa with food and drinks

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 (alteration of ejaculation) has been reported. This means

that semen does not release through the urethra, but goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency).

Driving and operating machinery

No information is available regarding the effects of tamsulosin on the ability to drive and operate machinery. You should be aware that tamsulosin may cause dizziness and mild fainting. 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; it is essentially "sodium-free".

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.

Therecommended doseis one capsule per day and it should be takenafter breakfastor the first meal of the day.

The capsule should be swallowedwholewith a glass of water, standing or sitting (not lying down). It is essential thatyou do not break or crush the capsule, as this can interfere with the action of tamsulosin.

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

If you take more tamsulosin cinfa than you should

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 take more tamsulosin 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, afterwards, contact your doctor. Your doctor may administer medications to recover your blood pressure and fluid levels and monitor your bodily functions. If necessary, they may perform a gastric lavage and give you a laxative to eliminate tamsulosin from your body that has not yet been absorbed into the blood.

If you forgot to take tamsulosin cinfa

Do not take a double dose to compensate for the missed doses. Simply take the next dose when it is due.

If you interrupt 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 it, 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 medications,this medicationmay cause side effects, although not everyone will experience 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): generalized rash, inflammation, and blisters on 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): a severe inflammation and blisters on the skin known as erythema multiforme.

Frequent(mayaffect up to1 in 10 people)

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

Occasional(may affect up to 1 in 100 people)

Headache, perception of the heartbeats (palpitations), decrease in blood pressure upon standing,which causes dizziness, mild fainting, or falls (orthostatic hypotension), nasal congestion and irritation (rhinitis), constipation, diarrhea, nausea, vomiting, rash, urticaria, feeling of weakness (asthenia), itching.

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

Loss of consciousness (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, nosebleed, dry mouth.

During eye surgery due to opacity of the lens (cataracts) or increased pressure in the eye (glaucoma) may causea condition known as the "Irish Flap Intraoperative Syndrome" (IFI): the pupilsdo not dilate welland the iris(the colored part of the eye) may becomeflaccid during the procedure.To obtain more information, consult section 2, "Warnings and precautions".

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication

Keepyourmedicationout of thereach ofchildren.

Storein theoriginalpackagingandkeep thepackagingperfectlyclosed.

Do not usethismedicationafter theexpiration datethat appears on thepackaging,afterCAD. Theexpiration dateis thelast day of themonththat itindicates.

Do notdispose ofthemedicationby flushing itdown thetoiletorpouring itinto thesink. Dispose of thepackagingandthemedicationthat is no longer needed at thePharmacyReturnPoint. If you are unsure, ask yourpharmacisthow todispose of thepackagingandthemedicationthat is no longer needed.

Composition of tamsulosin cinfa

The active ingredient is tamsulosin hydrochloride.

The other components are:

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

Capsule body: 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 packaging

tamsulosin cinfa is presented in the form of modified-release hard capsules, orange/yellow-green in color.

Each package contains 30 capsules.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Responsible 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

Last review date of this leaflet:February 2021

Detailed and updated information on this medicine is available on 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/67308/P_67308.html

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