Tamsulosin Teva-Ratiopharm 0.4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tamsulosina Teva-ratiopharm 0.4 mg prolonged-release tablets EFG

Tamsulosin hydrochloride

Read the entire 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Tamsulosina Teva-ratiopharm is and what it is used for
2. What you need to know before taking Tamsulosina Teva-ratiopharm
3. How to use Tamsulosina Teva-ratiopharm
4. Possible side effects
5. How to store Tamsulosina Teva-ratiopharm
6. Contents of the pack and other information

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

The active substance of Tamsulosina Teva-ratiopharm is tamsulosin. It is a selective antagonist of alpha 1A/1D adrenergic receptors that reduces the tone of the smooth muscles in the prostate and urethra (the tube through which urine passes to the outside). As a result, the urethra, which runs through the prostate, becomes less constricted, facilitating urination. In addition, it reduces 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 a non-cancerous enlargement of the prostate gland. These symptoms include: difficulty urinating (weak urine stream), dribbling, urgent need to urinate, and frequent need to urinate both during the night and during the day.

2. What you need to know before starting to take Tamsulosin Teva-ratiopharm

Do not take Tamsulosin Teva-ratiopharm

• if you are allergic (hypersensitive) to tamsulosin or to any of the other ingredients of this medicine. Hypersensitivity may present as sudden localized swelling of soft tissues in 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 down 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.
• Fainting may rarely occur while using Tamsulosin Teva-ratiopharm when sitting or standing up. If you feel weak or dizzy, you should sit or lie down until symptoms resolve.
• Before starting Tamsulosin Teva-ratiopharm, your doctor will examine you to ensure that you do not have another condition that could cause symptoms similar to those of non-cancerous prostate enlargement. Your doctor will perform a manual examination of the prostate to check for possible abnormalities and will order tests to detect a chemical substance produced by the prostate (prostate-specific antigen, PSA) in the blood before starting treatment, and then 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 Tamsulosin Teva-ratiopharm immediately and consult your doctor.
• If you are undergoing eye surgery due to lens opacity (cataract) or increased pressure in the eye (glaucoma), please inform your ophthalmologist if you are currently taking or have previously taken Tamsulosin Teva-ratiopharm. The specialist can then take appropriate precautions regarding medication and surgical techniques to be used. Consult your doctor whether you should delay or temporarily discontinue taking this medicine if you are scheduled for surgery due to lens opacity (cataract) or increased intraocular pressure (glaucoma).

Talk to your doctor if you have experienced or have previously experienced 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 any other medicines.

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

• Other alpha1-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 used to treat pain)
• Warfarin (used to prevent blood clotting)
• Ketoconazole (used to treat fungal infections)

Taking Tamsulosin Teva-ratiopharm with food and drinks

Tamsulosin may be taken regardless of meals.

Pregnancy, breastfeeding and fertility

Tamsulosin is not indicated for use in women.

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

Driving and use of machines

There is no evidence that tamsulosin affects the ability to drive or operate tools or machinery. However, you should be aware that dizziness may occur; in such a case, you should not perform activities requiring attention.

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

3. How to take Tamsulosin Teva-ratiopharm

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day. You may 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 it.

Dose adjustment is not necessary if you have renal impairment or mild to moderate hepatic disease (see section 2 "Do not take Tamsulosin Teva-ratiopharm").

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

Do not forget to take your medication. 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 unwanted drop in blood pressure and an increased heart rate, accompanied by a feeling of faintness.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medication and the amount ingested.

If you forget to take Tamsulosin Teva-ratiopharm

If you have forgotten to take tamsulosin as directed, you may take your daily dose later on the same day. If you have missed a day's dose, you may simply continue taking your daily tablet as prescribed. Do not take a double dose to make up for forgotten doses.

If you stop taking Tamsulosin Teva-ratiopharm

If you stop treatment with Tamsulosin Teva-ratiopharm prematurely, your original symptoms may return. Therefore, take Tamsulosin Teva-ratiopharm for as long as your doctor has prescribed, even if your symptoms have disappeared. Always consult your doctor if you decide to stop treatment.

If you have any further 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 everyone will experience them.

Stop taking the tablets and consult your doctor or go to a hospital immediately if you experience any of the following side effects:

• An allergic reaction (rash or hives all over the 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 serious illness 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 require 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 disorders). This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or that the ejaculated volume is reduced or absent (failure to ejaculate). This phenomenon is harmless.

Uncommon (may affect up to 1 in 100 people)

• Headache
• Faster than normal heartbeat (palpitations)
• Postural hypotension (dizziness due to a drop in blood pressure, especially when standing up quickly after sitting or lying down)
• Nasal swelling and irritation (rhinitis)
• Feeling unwell or being unwell (nausea and vomiting), diarrhoea, constipation
• Rash, itching and hives
• Weakness (asthenia)

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

• Fainting
• Rash or hives 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 rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals, developing 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 available data)

• Blurred vision
• Visual impairment
• Nosebleeds (epistaxis)
• Dry mouth
• Itching, pinkish spots on the limbs (erythema multiforme)
• Redness and peeling of the skin (exfoliative dermatitis)
• Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia)
• Difficulty breathing (dyspnoea)

If you undergo eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma) and have taken or are currently taking Tamsulosina Teva-ratiopharm, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during surgery (see also section 2 "Warnings and precautions").

Reporting of side effects:

If you experience any type of side effect, talk to your doctor, pharmacist or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human 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-ratiopharm

Keep out of sight and reach of children.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This way, you will help protect the environment.

6. Contents of the pack and other information

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

Appearance of the medicinal product and contents of the pack

• 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 (hospital pack) prolonged-release tablets.

Only certain 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, 1st floor
28108 Alcobendas, Madrid
Spain

Manufacturer(s)

Pharmachemie B.V.
Swensweg 5, Postbus 552, 2003 RN Haarlem
The Netherlands

or

TEVA OPERATIONS POLAND SP.Z.O.O.
Ul. Mogilska 80
Krakow-Polonia
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 European Economic Area member states 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, comprimé à libération prolongée
Hungary: Tamsulosin-Teva 0.4 mg retard filmtabletta
Poland: Bazetham Retard 0.4 mg, tabletki o przedłużonym uwalnianiu

Date of the most recent revision of this leaflet: August 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74908/P_74908.html