TAMSULOSIN TEVA 0.4 mg MODIFIED-RELEASE CAPSULES

Introduction

Package Leaflet: Information for the User

Tamsulosin Teva 0.4 mg prolonged-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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Tamsulosin Teva and what is it used for
2. What you need to know before you take Tamsulosin Teva
3. How to take Tamsulosin Teva
4. Possible side effects
5. Storage of Tamsulosin Teva
6. Contents of the pack and other information

1. What is Tamsulosin Teva and what is it used for

The active substance in Tamsulosin Teva 0.4 mg prolonged-release hard capsules is tamsulosin. It is a selective alpha-1A/1D adrenergic receptor antagonist. It reduces the tension of the smooth muscles of the prostate and urethra, allowing urine to flow more easily through the urethra and facilitating urination. Additionally, it decreases the sensation of urgency.

Tamsulosin Teva 0.4 mg prolonged-release hard capsules are used in men for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (enlargement of the prostate gland). These symptoms include: difficulty urinating (weak urine flow), dripping, urgent urination, and frequent need to urinate both at night and during the day.

2. What you need to know before you take Tamsulosin Teva

Do not take Tamsulosin Teva:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosin Teva

• because regular medical examinations are necessary to monitor the development of the disease being treated.
• because fainting can rarely occur during the use of Tamsulosin Teva, as with other medications of this type. At the first symptoms of dizziness or weakness, you should sit or lie down until they have disappeared.
• if you have severe kidney problems.
• if you are going to undergo or have scheduled eye surgery due to cataracts or increased pressure in the eye (glaucoma). Please inform your ophthalmologist if you have taken, are taking, or are thinking of taking Tamsulosin Teva. The specialist can then take the necessary precautions regarding medication and surgical techniques to be used. Consult your doctor if you should or should not postpone or temporarily suspend taking this medication if you are going to undergo such surgery due to cataracts or increased pressure in the eye (glaucoma).

Children and adolescents

It should not be administered to children or adolescents under 18 years of age as it is not indicated for use in this population group.

Interaction of Tamsulosin Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are taking any of the following medicines:

• other medicines of the same class, such as alfuzosin, doxazosin, or terazosin, because concurrent use with tamsulosin may produce an undesirable drop in blood pressure.
• diclofenac (an anti-inflammatory pain reliever)
• warfarin (used to prevent blood clotting)

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

Taking Tamsulosin Teva with food and drinks

You can take tamsulosin after breakfast or the first meal of the day.Pregnancy, breast-feeding, and fertility

Tamsulosin Teva is not indicated in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen does not exit through the urethra, but rather enters the bladder (retrograde ejaculation), or the volume of ejaculation is reduced or absent (ejaculation failure). This phenomenon is harmless.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive or operate machinery or equipment. However, you should keep in mind that dizziness can occur, in which case you should not perform activities that require attention.

Tamsulosin Teva contains sodium

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

3. How to take Tamsulosin Teva

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of 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.

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

If you take more Tamsulosin Teva than you should

Taking too many tamsulosin capsules can lead to an undesirable drop in blood pressure and an increase in heart rate, with feelings of fainting. Contact your doctor immediately if you have taken too much Tamsulosin Teva 0.4 mg prolonged-release hard 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 medicine and the amount ingested.

If you forget to take Tamsulosin Teva

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

If you stop taking Tamsulosin Teva

When treatment with Tamsulosin Teva is abandoned prematurely, your original symptoms may return. Therefore, take tamsulosin for the entire time 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 medicine can cause side effects, although not everybody gets them.

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

• a 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).
• a severe disease with skin rash, inflammation, and blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals, called 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 effects and they worry 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 exit through the urethra, but rather enters the bladder or the volume of ejaculation is reduced or absent (ejaculation failure). This phenomenon is harmless.

Uncommon(may affect up to 1 in 100 people)

• headache
• rapid or irregular heartbeat (palpitations)
• reduced blood pressure, for example when standing up quickly after sitting or lying down
• runny or stuffy nose (rhinitis)
• constipation, diarrhea, nausea, vomiting
• skin rash, itching, and hives (urticaria)
• feeling of weakness (asthenia)

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

• fainting (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 the available data)

• abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia).
• difficulty breathing (dyspnea)
• blurred vision
• altered vision
• nosebleeds (epistaxis)
• severe skin rash (erythema multiforme, exfoliative dermatitis)
• dry mouth
• If you are going to undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma), and you are already taking or have taken tamsulosin previously, the pupil may not dilate properly 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 side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Teva

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

Blister packs: Store in the original package.

Bottle packs: Store in the original package and keep the bottle tightly closed. Do not transfer to another container.

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

Do not use this medicine after the expiry date which is stated on the packaging and label of the bottle after the abbreviation EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosin Teva 0.4 mg prolonged-release hard capsules

• The active substance is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are: microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc, gelatin, indigo carmine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Appearance of the product and packaging

• Tamsulosin Teva are hard gelatin capsules with an orange body and an olive green cap. The capsules contain white or off-white pellets.

• The product is available in PVC/PE/PVDC/Aluminum blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 180, or 200 prolonged-release hard capsules and in HDPE bottles with child-resistant polypropylene closures containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 2 x 100, 180, or 200 prolonged-release hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1ª planta

Alcobendas 28108 Madrid (Spain)

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

Or

Balkanpharma - Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa, 2600

Bulgaria

Date of last revision of this leaflet:July 2024

Detailed 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 packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67339/P_67339.html