Package Leaflet: Information for the Patient

Tamsulosina Teva-ratiopharm 0.4 mg prolonged-release tablets 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What Tamsulosina Teva-ratiopharm is and what it is used for

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

3. How to use Tamsulosina Teva-ratiopharm

4. Possible side effects

5. Storage of Tamsulosina Teva-ratiopharm

6. Contents of the pack and additional information

The active ingredient of Tamsulosina Teva-ratiopharm is tamsulosin. It is a selective antagonist of alpha 1A/1D adrenergic receptorsthat reduces the tension of the smooth muscles of the prostate and the urethra (the tube that carries urine out of the body). As a result of this, the urethra, which passes through the prostate, is less constricted and facilitates urination. Additionally, it decreases the sensation of urgency.

Tamsulosina Teva-ratiopharm is used in men for the treatment of lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH), which is an enlargement of the prostate gland. This includes symptoms such as: difficulty urinating (weak urine stream), dripping, urgent urination, and the need to urinate frequently both at night and during the day.

Do not take Tamsulosina Teva-ratiopharm

- If you are allergic (hypersensitive) to tamsulosina or to any of the other components of this medication. 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 have severe liver problems.

- If you have orthostatic hypotension (you feel dizzy due to a drop in blood pressure when sitting or standing up).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamsulosina Teva-ratiopharm:

- If you have severe kidney problems.

- Rarely, dizziness may occur during the use of Tamsulosina Teva-ratiopharm when sitting or standing up. If you feel weak or dizzy, sit or lie down until the symptoms disappear.

- Before starting to take Tamsulosina Teva-ratiopharm, your doctor will examine you to ensure that you do not have another disease that may cause symptoms similar to those of an enlarged non-cancerous prostate. Your doctor will manually examine your prostate for possible abnormalities and order tests to detect a chemical substance produced by the prostate (prostate-specific antigen, PSA) in the blood before starting treatment, and at regular intervals.

- In rare cases, a severe allergic reaction may occur with swelling of the face, lips, tongue, and throat, which may make it difficult to breathe, speak, or swallow (angioedema). If this occurs, stop taking Tamsulosina Teva-ratiopharm immediately and consult your doctor.

- If you undergo eye surgery due to opacity of the lens (cataract) or increased pressure in the eye (glaucoma), please inform your ophthalmologist if you are taking or have taken Tamsulosina Teva-ratiopharm previously. 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 to undergo such an operation due to a cloudy lens (cataract) or increased pressure in the eye (glaucoma).

Consult your doctor if you present or have presented in the past any of these warnings.

Children and adolescents

Do not administer this medication to children or adolescents under 18 years old as it is not effective in this population.

Taking Tamsulosina Teva-ratiopharm with other medications

Inform your doctor or pharmacist if you are taking/using, have taken/used recently, or may take/use other medications.

Consult your doctor if you are taking any of the following:

• Other alpha1-adrenergic receptor antagonists (medications used to treat prostate disease) such as Alfuzosin, Doxazosin, or Terazosin, as they may cause an undesirable drop in blood pressure.
• Diclofenac (an anti-inflammatory medication for pain relief)
• Warfarin (used to prevent blood coagulation)
• Ketoconazole (used to treat fungal infections)

Taking Tamsulosina Teva-ratiopharm with food and beverages

Tamsulosina can be taken regardless of meals.

Pregnancy, breastfeeding, and fertility

Tamsulosina is not indicated for women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen does not release through the urethra, but rather goes to the bladder (retrograde ejaculation) or the volume of semen is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machinery

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

Tamsulosina Teva-ratiopharm may cause dizziness. If you experience this symptom, do not drive or operate tools or machinery that require concentration.

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

The recommended dose is one tablet per day. You can take Tamsulosina Teva-ratiopharm with or without food, preferably at the same time of day.

Swallow the tablet whole with a glass of water, do not break or chew.

No adjustment of the dose is necessary if you have mild to moderate renal insufficiency or liver disease (see section 2 "Do not take Tamsulosina Teva-ratiopharm").

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

Do not forget to take your medication. Your doctor will tell you how long you should continue taking Tamsulosina.

If you take more Tamsulosina Teva-ratiopharm than you should

Taking too many tablets of Tamsulosina Teva-ratiopharm can lead to an undesirable drop in blood pressure and an increase in heart rate, with a feeling of dizziness.

If you take too much Tamsulosina Teva-ratiopharm, consult your doctor or pharmacist or go to the nearest emergency service immediately. Bring this leaflet with you and the remaining tablets.

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-ratiopharm

If you have forgotten to take tamsulosina as recommended, you can take your daily dose later in the same day. If you have missed a day's dose, simply continue taking your daily tablet as prescribed. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Tamsulosina Teva-ratiopharm

If you interrupt treatment with Tamsulosina Teva-ratiopharm prematurely, your original symptoms may return. Therefore, take Tamsulosina Teva-ratiopharm for the entire time your doctor prescribes it, 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 taking the tablets and consult your doctor or go to the hospital immediately if you experience any of the following side effects:

• An allergic reaction (skin rash or urticaria all over your body with swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema) (may affect up to 1 in 1,000 people).

• A severe disease with blisters on the skin, mouth, eyes, and genitals called Stevens-Johnson syndrome (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 with tamsulosin hydrochloride:

Frequent(may affect up to 1 in 10 people)

-Dizziness

-Abnormal ejaculation (alterations in ejaculation). 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 failure). This phenomenon is harmless.

Rare(may affect up to 1 in 100 people)

-Headache

-Abnormal heart rate (palpitations)

-Postural hypotension (dizziness due to a drop in blood pressure, especiallywhen standing up quickly after being in a seated or lying position)

-Nasal congestion and irritation (rhinitis)

-Feeling or being sick (nausea and vomiting) diarrhea, constipation

-Rash, itching, and urticaria

-Weakness (asthenia)

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

-Fainting

-Rash or urticaria all over the body with swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema)

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

-Severe skin rash, inflammation, and blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals that develops with symptoms similar to the flu (Stevens-Johnson syndrome)

-Priapism (persistent painful erection in the absence of sexual stimulation, this side effect requires immediate treatment)

Frequency not known(cannot be estimated from the available data)

• Blurred vision,
• Worsening of vision
• Nosebleeds (epistaxis)
• Dry mouth
• Itching, red spots on the extremities (erythema multiforme)
• Redness and peeling of the skin (dermatitis exfoliativa)
• Abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia)
• Difficulty breathing (dyspnea)

If you undergo eye surgery due to opacity of the lens (cataracts) or increased pressure in the eye (glaucoma) and have taken or are taking Tamsulosin Teva-ratiopharm, the pupil may dilate slightly and the iris (the colored part of the eye), may become flaccid during the operation (see also section 2 "Warnings and precautions").

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist or nurse, 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 Vigilance 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 out of the sight and reach of children.

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

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Tamsulosina Teva-ratiopharm Composition

-The active ingredient is hydrochloride of tamsulosin. Each prolonged-release tablet contains 0.40 mg of hydrochloride of tamsulosin equivalent to 0.367 mg of tamsulosin.

-The other components are: microcrystalline cellulose, polyethylene oxide, anhydrous colloidal silica, and magnesium stearate in the core and hypromellose 6cP, titanium dioxide (E171), macrogol 8000, and iron oxide red and yellow (E172) in the coating.

Product Appearance and Packaging Content

• Prolonged-release tablet
• Coated tablets with yellow film, biconvex, oval, marked with "T04" on one side and smooth on the other.

• Available in packaging of 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 200, and 50x1 (clinical packaging) prolonged-release tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer:

Marketing Authorization Holder

Teva Pharma, S.L.U

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

28108 Alcobendas. Madrid

Spain

Responsible Manufacturer(s)

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Netherlands

or

TEVA OPERATIONS POLAND SP.Z.O.O.

Ul. Mogilska 80

Krakow-Poland

or

Teva Pharma S.L.U.

Polígono Malpica, Calle C nº 4.

50016 Zaragoza.

Spain

or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Teva Czech Industries, s.r.o.

Ostravská 29, c.p. 305, 747 70 Opava –Komárov

Czech Republic

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Republic of Czech: TAMSULOSIN HCL TEVA

Spain: Tamsulosina Teva-ratiopharm 0.4 mg prolonged-release tablets EFG

France: TAMSULOSINE TEVA LP 0.4 mg, prolonged-release tablet

Hungary: Tamsulosin-Teva 0.4 mg retard filmtabletta

PolandBazetham Retard 0.4 mg, prolonged-release tablets

Last review date of this leaflet: August 2022

Detailed information about 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 updated information about this medicinal product by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74908/P_74908.html