TAMSULOSIN TEVA-RATIOPHARM 0.4 mg PROLONGED-RELEASE TABLETS

Introduction

Patient Information Leaflet: Information for the Patient

Tamsulosin Teva-ratiopharm 0.4 mg prolonged-release tablets EFG

Tamsulosin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 experience 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 Tamsulosin Teva-ratiopharm is and what it is used for
2. What you need to know before you take Tamsulosin Teva-ratiopharm
3. How to take Tamsulosin Teva-ratiopharm
4. Possible side effects
5. Storage of Tamsulosin Teva-ratiopharm
6. Contents of the pack and other information

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

The active substance of Tamsulosin Teva-ratiopharm is tamsulosin. It is a selective alpha-1A/1D adrenergic receptor antagonist that reduces the tension of the smooth muscles of the prostate and urethra (the tube that carries urine to the outside). As a result, the urethra, which passes through the prostate, is less constricted, and urination is facilitated. Additionally, it decreases the sensation of urgency.

Tamsulosin 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. These symptoms include difficulty urinating (weak urine stream), 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-ratiopharm

Do not take Tamsulosin Teva-ratiopharm

• if you are allergic (hypersensitive) to tamsulosin or any of the other ingredients of this medicine. 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 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

Talk to your doctor or pharmacist before starting to take Tamsulosin Teva-ratiopharm:

• If you have severe kidney problems.
• Rarely, fainting may occur during the use of Tamsulosin Teva-ratiopharm when sitting or standing up. If you feel weak or dizzy, you should sit or lie down until the symptoms disappear.
• Before starting to take Tamsulosin Teva-ratiopharm, your doctor will examine you to ensure that you do not have another illness that may cause similar symptoms to those of non-cancerous prostate enlargement. 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 thereafter.
• In rare cases, a severe allergic reaction may occur with swelling of the face, lips, tongue, and throat, which can make it difficult to breathe, speak, or swallow (angioedema). If this happens, stop taking Tamsulosin Teva-ratiopharm immediately and talk to your doctor.
• If you are undergoing eye surgery due to cataracts or increased pressure in the eye (glaucoma), please inform your ophthalmologist if you are taking or have previously taken Tamsulosin Teva-ratiopharm. The specialist can then take the necessary precautions regarding medication and surgical techniques to be used. Talk to your doctor if you should or should not postpone or temporarily discontinue taking this medicine if you are going to undergo such an operation due to cataracts or increased pressure in the eye (glaucoma).

Talk to your doctor if you have or have had any of these warnings.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as it is not effective in this population.

Taking Tamsulosin Teva-ratiopharm with other medicines

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

Talk to your doctor if you are taking any of the following:

• Other alpha-1 adrenergic receptor antagonists (medicines used to treat prostate disease), e.g., Alfuzosin, Doxazosin, or Terazosin, as they may cause an undesirable drop in blood pressure.
• Diclofenac (an anti-inflammatory medicine for pain relief)
• Warfarin (used to prevent blood clotting)
• Ketoconazole (used to treat fungal infections)

Taking Tamsulosin Teva-ratiopharm with food and drinks

Tamsulosin can be taken independently of meals.

Pregnancy, breastfeeding, and fertility

Tamsulosin is not indicated in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen is not released through the urethra but instead goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory failure). This phenomenon is harmless.

Driving and using machines

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

Tamsulosin Teva-ratiopharm may cause dizziness. If you experience this symptom, do not drive or use tools or machines that require concentration.

3. How to take Tamsulosin Teva-ratiopharm

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

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

Swallow the tablet whole with a glass of water, without breaking or chewing.

No dose adjustment is necessary if you have mild to moderate kidney or liver impairment (see section 2 "Do not take Tamsulosin Teva-ratiopharm").

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

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

If you take more Tamsulosin Teva-ratiopharm than you should

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

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

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tamsulosin Teva-ratiopharm

If you have forgotten to take tamsulosin as recommended, you can take your daily dose later that day. If you have missed a dose for one day, you can simply continue taking your daily tablet as prescribed. Do not take a double dose to make up for the forgotten doses.

If you stop taking Tamsulosin Teva-ratiopharm

If you stop taking Tamsulosin Teva-ratiopharm prematurely, your original symptoms may return. Therefore, take Tamsulosin Teva-ratiopharm for the entire time your doctor prescribes it, even if your symptoms have disappeared. Always talk to your doctor if you decide to stop treatment.

If you have any further questions on 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 taking the tablets and talk to your doctor or go to a hospital immediately if you have any of the following side effects:

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

• A serious 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:

Common(may affect up to 1 in 10 people)

• Dizziness
• Abnormal ejaculation (ejaculation disorder). This means that semen is not released through the urethra but instead goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory failure). This phenomenon is harmless.

Uncommon(may affect up to 1 in 100 people)

• Headache
• Fast heart rate (palpitations)
• Orthostatic hypotension (feeling dizzy due to a drop in blood pressure, especially when standing up quickly after sitting or lying down)
• Nasal congestion and irritation (rhinitis)
• Feeling or being sick (nausea and vomiting), diarrhea, constipation
• Rash, itching, and hives
• Weakness (asthenia)

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

• Fainting
• Skin rash or hives all over your body with swelling of the face, lips, tongue, or throat, which can 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, nasal passages, or genitals, which develops with flu-like symptoms (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
• Impaired vision
• Nosebleeds (epistaxis)
• Dry mouth
• Itching, pink spots on the limbs (erythema multiforme)
• Redness and peeling of the skin (exfoliative dermatitis)
• Abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia)
• Breathing difficulties (dyspnea)

If you undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma) and have taken or are taking Tamsulosin Teva-ratiopharm, the pupil may dilate poorly, 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 side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: 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-ratiopharm

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosin Teva-ratiopharm

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

• The other ingredients are: microcrystalline cellulose, polyethylene oxide, colloidal anhydrous 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.

Appearance of the product and pack contents

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

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

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

28108 Alcobendas, Madrid

Spain

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: 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

Poland: Bazetham Retard 0.4 mg, tablets with prolonged release

Date of the last revision of this leaflet: August 2022

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 smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74908/P_74908.html