Leaflet: Information for the User

Tamsulosina Teva 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 should not give it to others even if they have the same symptoms of illness 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 Tamsulosina Teva is and what it is used for

2. What you need to know before you start taking Tamsulosina Teva

3. How to take Tamsulosina Teva

4. Possible side effects

5. Storage of Tamsulosina Teva

6. Contents of the pack and additional information

The active ingredient in Tamsulosina Teva 0.4 mg capsules is tamsulosin. It is a selective antagonist of alpha 1A/1D adrenergic receptors.It reduces the tension of the smooth muscles of the prostate and the urethra, allowing urine to pass more easily through the urethra and facilitating urination. It also decreases the sensation of urgency.

Tamsulosina Teva 0.4 mg capsules are used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate (benign prostatic hyperplasia). These symptoms include: difficulty urinating (weak urine flow), dribbling, urgent urination, and the need to urinate frequently both at night and during the day.

Do not take Tamsulosina Teva:

• if you are allergic to tamsulosina or any of the other ingredients of this medication (listed in section 6). Hypersensitivity may present as sudden swelling of the soft tissues of the body (e.g. the throat or tongue), difficulty breathing and/or itching and skin rash (angioedema).
• if you experience dizziness due to a drop in blood pressure when changing position (e.g. when sitting or standing up).
• if you have a severe liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosina Teva.

• because regular medical check-ups are necessary to monitor the development of the disease you are being treated for.
• because dizziness may occur during the use of Tamsulosina Teva, as with other medications of this type. If you experience the first symptoms of dizziness or weakness, sit or lie down until they 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 taken, are taking, or are planning to take Tamsulosina Teva. 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 surgery due to a cloudy lens (cataract) or increased eye pressure (glaucoma).

Children and adolescents

This medication should not be administered to children or adolescents under 18 years of age, as it is not indicated for this age group.

Tamsulosina Teva interactions with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor if you are taking any of the following medications:

• other medications of the same class, such as alfuzosin, doxazosin, or terazosin, because concurrent use with tamsulosina may cause an undesirable drop in blood pressure.
• diclofenac (an analgesic anti-inflammatory)
• warfarin (used to prevent blood coagulation)

• it is especially important to inform your doctor if you are being treated at the same time with medications that may reduce the elimination of tamsulosina from the body, such as ketoconazole (used to treat fungal infections) and erythromycin.

Taking Tamsulosina Teva with food and drinks

You can take tamsulosina after breakfast or the first meal of the day.Pregnancy, breastfeeding, and fertility

Tamsulosina Teva is not indicated for women.

In men, an abnormal ejaculation (ejaculatory disorder) has been reported. This means that semen does not come out through the urethra, but instead enters the bladder (retrograde ejaculation), or the volume of ejaculation is reduced or absent (ejaculatory failure). This phenomenon is not harmful.

Driving and operating machinery

There is no evidence that tamsulosina affects the ability to drive or operate machinery or equipment. However, you should be aware that dizziness may occur, in which case you should not perform activities that require attention.

Tamsulosina Teva contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule; it is essentially sodium-free.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist.

The recommended dose is one capsule per day. The capsule should be taken after breakfast or the first meal of the day.

The capsule should be swallowed whole and not broken or chewed.

Tamsulosina Teva is usually prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with Tamsulosina Teva.

If you take more Tamsulosina Teva than you should

Taking too many tamsulosina capsules can lead to an undesirable decrease in blood pressure and an increase in heart rate, with feelings of dizziness. Contact your doctor immediately if you have taken too much Tamsulosina Teva 0.4 mg modified-release capsules.

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 forget to take Tamsulosina Teva

If you forget to take Tamsulosina Teva as recommended, take your daily capsule later the same day. If you have missed a dose one day, simply continue taking your daily capsule as prescribed. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Tamsulosina Teva

When treatment with Tamsulosina Teva is discontinued prematurely, your original symptoms may return. Therefore, take tamsulosina for the entire time your doctor prescribes, even if your symptoms 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.

Stop treatment and consult your doctor immediatelyif you experience any of the following side effects:

• severe allergic reaction with sudden local swelling of the lips, face, tongue, or throat causing severe difficulty breathing and/or itching and skin rash (angioedema) (rare, may affect up to 1 in 1,000 people).
• serious disease withskin rash, inflammation, andblistering on the skinand/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals, known as Stevens-Johnson Syndrome (very rare, may affect up to 1 in 10,000 people).

These are very serious but rare side effects. You may need urgent medical attention or hospitalization.

The following side effects have been reported. If you experience any of these side effects, and they are concerning you, contact your doctor:

Common(may affect up to 1 in 10 people)

• dizziness, especially when sitting or standing up.
• abnormal ejaculation (ejaculation disorders). This means that semen does not release through the urethra, but rather goes to the bladder or the volume of ejaculation is reduced or there is none (ejaculatory failure). This phenomenon is harmless.

Uncommon(may affect up to 1 in 100 people)

• headache
• rapid or irregular heart rate (palpitations)
• reduced blood pressure, for example, when standing up quickly after being seated or lying down
• nasal discharge or obstruction (rhinitis)
• constipation, diarrhea, nausea, vomiting
• skin rash, itching, and hives (urticaria)
• sense of weakness (asthenia)

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

• syncope (sudden and transient loss of consciousness)

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

• persistent and painful erection of the penis that can last from several hours to days(priapism).

Frequency not known (cannot be estimated from available data)

• abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia).
• difficulty breathing (dyspnea)
• blurred vision
• altered vision
• nosebleed (epistaxis)
• severe skin rash (erythema multiforme, exfoliative dermatitis)
• dry mouth
• If you are about 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 previously during the surgery, the pupil may dilate slightly and the iris (the colored part of the eye), may become flaccid (see section 2 “Warnings and precautions”).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side 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.

Blister packs: Store in the original packaging.

Bottle packs: Store in the original packaging and keep the packaging perfectly closed. Do not transfer to another container.

Do not use this medication after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

Do not usethis medicationafter the expiration date that appears on the packaging and label of the bottle after the abbreviation CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Tamsulosina Teva 0.4 mg Modified-Release Hard Capsules Composition

• The active ingredient istamsulosin hydrochloride. Each capsule contains0.4 mg of tamsulosin hydrochloride.
• The other components are: microcrystalline cellulose, methacrylic acid copolymer and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc, gelatin, indigotin (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Appearance of the product and contents of the pack

• Tamsulosina Tevaare hard gelatin capsules formed by a orange-colored body and a green olive-colored cap. The capsules contain white or off-white pellets.

• The product is available in PVC/PE/PVDC/Aluminum blister packs containing10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 180 or 200 modified-release hard capsules, and in HDPE bottles with polypropylene child-resistant closures containing10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 2 x 100, 180 or 200 modified-release hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U

C/ Anabel Segura 11, Edificio Albatros B 1st floor

Alcobendas 28108 Madrid (Spain)

Responsible Manufacturer

Synthon Hispania S.L.

Castelló, 1 Polígono las Salinas

08830 Sant Boi de Llobregat

OR

Synthon BV

Microweg, 22, P.O.Box 7071

NL-6545 Nijmegen

Netherlands

OR

GALIEN LPS

98 Rue Bellocier, 89100 Sens,

France

OR

PHARMACHEMIE B.V.

Swensweg, 5. P.O. Box 552- Haarlem

Netherlands

OR

Laboratoria Qualiphar NV (Qualiphar NV)

Rijksweg 9, Bornem,

2880, Belgium

Last review date of this leaflet:July 2024

Detailed information about 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 about this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/67339/P_67339.html