TAMSULOSIN TEVA-RATIOPHARM 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Tamsulosin Teva-ratiopharm 0.4 mg Modified Release Hard Capsules EFG

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-ratiopharm and what is it 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. Storing Tamsulosin Teva-ratiopharm.
6. Contents of the pack and other information.

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

The active substance in Tamsulosin Teva-ratiopharm is tamsulosin. It is a selective antagonist of α1A/1D adrenergic receptors. 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-ratiopharm is 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), dribbling, 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 to tamsulosin or any other component 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), sudden swelling of hands or feet, difficulty breathing and/or itching and skin rash (angioedema). if you have a history of decreased blood pressure when standing up, which causes dizziness, mild fainting, or fainting.
• if you have severe liver problems.

Before starting treatment with your medicine, your doctor may want to perform tests to check that you do not have any other disease that is causing your symptoms.

Warnings and precautions

Tell your doctor or pharmacist before taking Tamsulosin Teva-ratiopharm

• if you have severe kidney problems,

Tell your doctor or pharmacist while taking Tamsulosin Teva-ratiopharm

• if you experience dizziness or mild fainting. You should sit or lie down until the symptoms have disappeared. If you do not feel better, contact your doctor.
• if you experience sudden swelling of hands or feet, swelling of lips, tongue, or throat, difficulty breathing, and/or itching and skin rash, caused by an allergic reaction (angioedema) during the use of tamsulosin.
• if you are going to undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma). Please inform your ophthalmologist if you have taken tamsulosin before, are taking it, or are thinking of taking it. 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 medicine if you are going to undergo such surgery due to cataracts or increased pressure in the eye (glaucoma).

Children and adolescents

Do not give this medicine to children or adolescents under 18 years old because it does not work in this population.

Using Tamsulosin Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is especially important in the case of:

• • Terazosin, doxazosin, and/or any other α1A receptor antagonist (used to treat benign prostatic hyperplasia and high blood pressure). The combination with these medicines may produce an undesired decrease in blood pressure.
• Diclofenac (an anti-inflammatory pain reliever) and warfarin (used to prevent blood clotting). These medicines may speed up the elimination of tamsulosin from the body, thus shortening the time of action of tamsulosin.
• Ketoconazole (used to treat fungal infections). These medicines may slow down the elimination of tamsulosin from the body.

Taking Tamsulosin Teva-ratiopharm with food and drinks

Tamsulosin should be taken after breakfast or the first meal of the day. If you take tamsulosin on an empty stomach, you may increase the risk of side effects or increase their severity.

Fertility, pregnancy, and breastfeeding

This medicine is not indicated in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen does not exit the body through the urethra but instead passes into the bladder (retrograde ejaculation) or that 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 use tools or machines. However, dizziness may occur, in which case you should not perform activities that require concentration.

Tamsulosin Teva-ratiopharm contains sodium

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

3. How to take Tamsulosin Teva-ratiopharm

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is one capsule (0.4 mg of tamsulosin hydrochloride) per day, after breakfast or the first meal of the day.
• The capsule should be taken while standing or sitting in a vertical position (you should not be lying down) and should be swallowed whole with a glass of water.
• The capsule should not be crushed or chewed.

Your doctor has prescribed the appropriate dose for you and your disease, and has specified the duration of treatment. The effects on the bladder and urination are maintained during long-term treatment with tamsulosin.

You should not change the dosage without talking to your doctor first.

If you think the action of this medicine is too strong or too weak, consult your doctor or pharmacist.

If you take more Tamsulosin Teva-ratiopharm than you should

Taking too much Tamsulosin Teva-ratiopharm may lead to an undesired decrease in blood pressure and an increase in heart rate, with a feeling of fainting. In case of overdose or accidental ingestion, consult 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

Do not take a double dose to make up for the forgotten dose. If you forgot to take your daily capsule after the first meal of the day, you can take it during the same day after a meal.

In case you have missed the dose for a day, you can simply continue taking your daily capsule as prescribed.

If you stop taking Tamsulosin Teva-ratiopharm

When treatment with tamsulosin is abandoned prematurely, your original symptoms may return. Therefore, take tamsulosin for as long as your doctor prescribes it, even if your symptoms have disappeared. Always consult your doctor if you decide to stop treatment.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you have any of the following allergic reactions, stop taking this medicine and tell your doctor immediately or go to the nearest hospital:

• Difficulty breathing
• Swelling of the face, tongue, or throat (angioedema)
• Itching and skin rash

Common (may affect up to 1 in 10 people)

• Dizziness, especially when sitting or standing up.
• Ejaculation disorders, including delayed ejaculation (ejaculation in the bladder) and ejaculation failure.

Uncommon (may affect up to 1 in 100 people)

• Headache.
• Fast or irregular heartbeat (palpitations)
• Decreased blood pressure, runny or stuffy nose (rhinitis)
• Constipation,
• Diarrhea,
• Nausea,
• Vomiting,
• Skin rash,
• Itching,
• Redness, itching, or inflamed skin rash (urticaria)
• Feeling of weakness (asthenia).

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

• Fainting
• Swelling of hands or feet and soft tissues of the body (e.g. throat or tongue)
• Difficulty breathing and/or itching and skin rash (angioedema)

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

• Painful and persistent erection of the penis in the absence of sexual excitement (priapism).
• Severe inflammatory skin and mucous membrane rash due to an allergic reaction to medicines and other substances (Stevens-Johnson syndrome).

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

• Nosebleeds
• Blurred vision, eye problems.
• Dry mouth
• Severe skin rashes (erythema multiforme, exfoliative dermatitis)

If you are going to undergo eye surgery due to cataracts and are already taking or have taken tamsulosin before, the pupil may not dilate properly and the iris (the colored part of the eye) may become flaccid (see section 2).

In addition to the side effects mentioned above, the following adverse reactions have been reported in association with the use of tamsulosin:

• Irregular heartbeat
• Abnormal heart rhythm
• Fast heartbeat
• Difficulty breathing

Because these reactions have been reported spontaneously from post-marketing experience worldwide, the frequency of these events and the role of tamsulosin in their causality cannot be reliably determined.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Tamsulosin Teva-ratiopharm

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

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

Blister: Store in the original package.

Keep the container tightly closed.

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 modified release hard capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are: microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, and talc.

The capsule body contains: gelatin, indigo carmine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Appearance and packaging

Tamsulosin Teva-ratiopharm 0.4 mg Modified Release Hard Capsules are orange/olive green capsules.

They are available in blister packs or bottles of 10, 20, 28, 30, 50, 60, 90, 98, and 100 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva Pharma, S.L.U.

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

Alcobendas 28108 Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig Merckle Strasse, 3

89143 - Blaubeuren (Germany)

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

Austria: Tamsulsoin “ratiopharm” retard 0.4 mg-Kapsel

Denmark: Cepalux

Finland: Tamsumin 0,4 mg depotkapseli, kova

Germany: Tamsulosin-ratiopharm 0.4 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Luxembourg: Tamsulosin-ratiopharm 0.4 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Norway: Cepalux

Spain: Tamsulosina Teva-ratiopharm 0.4 mg cápsulas duras de liberación modificada EFG

Date of last revision of this leaflet: May 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/