Tamsulosin Teva-Ratiopharm 0.4 mg modified-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Tamsulosin Teva-ratiopharm 0.4 mg modified-release hard capsules EFG

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 could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Tamsulosin Teva-ratiopharm is and what it is used for
2. What you need to know before taking Tamsulosin Teva-ratiopharm
3. How to take Tamsulosin Teva-ratiopharm
4. Possible adverse effects
5. How to store Tamsulosin 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 in Tamsulosina Teva-ratiopharm is tamsulosin. It is a selective antagonist of α1A/1D-adrenergic receptors. It reduces the tension of the smooth muscles in the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. In addition, it decreases the sensation of urgency.

Tamsulosina Teva-ratiopharm is used in men for the treatment of lower urinary tract symptoms associated with enlargement of the prostate gland (benign prostatic hyperplasia). These are symptoms such as: difficulty urinating (weak urinary stream), dribbling, urgency, and the need to urinate frequently both during the night and during the day.

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

Do not take Tamsulosin Teva-ratiopharm:

• if you are allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may present as sudden localized swelling of 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 low blood pressure upon standing up, which causes dizziness, mild fainting, or fainting spells.
• if you have severe liver problems.

Before starting treatment with this medicine, your doctor may want to carry out tests to ensure you do not have any other illness causing your symptoms.

Warnings and precautions

Tell your doctor or pharmacist before taking Tamsulosin ratiopharm:

• if you have severe kidney problems.

Tell your doctor or pharmacist while you are taking Tamsulosin Teva-ratiopharm:

• if you experience dizziness or mild fainting. You should sit or lie down until symptoms resolve. If there is no improvement, contact your doctor.
• if you develop sudden swelling of the hands or feet, swelling of the lips, tongue or throat, difficulty breathing and/or itching and skin rash due to an allergic reaction (angioedema) during treatment with tamsulosin.
• if you are scheduled for eye surgery due to cataracts (clouding of the lens) or increased eye pressure (glaucoma). Please inform your ophthalmologist if you have previously taken, are currently taking, or are considering taking tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor whether you should delay or temporarily discontinue this medicine if you are undergoing surgery for a cloudy lens (cataract) or increased eye pressure (glaucoma).

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.

Use of Tamsulosin Teva-ratiopharm with other medicines

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

• • Terazosin, doxazosin and/or any other α1A-adrenergic receptor antagonists (used to treat benign prostatic hyperplasia and high blood pressure). Combination with these medicines may cause an undesirable drop in blood pressure.
• Diclofenac (an anti-inflammatory painkiller) and warfarin (used to prevent blood clotting). These medicines may accelerate the elimination of tamsulosin from the body, thereby shortening the duration of tamsulosin’s effectiveness.
• Ketoconazole (used to treat fungal infections). This medicine may slow down the elimination of tamsulosin from the body.

Taking Tamsulosin Teva-ratiopharm with food and drink

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

Fertility, pregnancy and breastfeeding

This medicine is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen does not exit the body through the urethra but enters the bladder (retrograde ejaculation), or that the volume of ejaculate 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 tools or machinery. However, dizziness may occur, in which case you should not perform activities requiring concentration.

Tamsulosin Teva-ratiopharm contains sodium

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

3. How to take Tamsulosin Teva-ratiopharm

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

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

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

You must not change the dosage without first speaking to your doctor.

If you think that the effect 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 unwanted decrease in blood pressure and an increased heart rate, accompanied by a feeling of faintness. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 missed dose. If you forgot to take your daily capsule after the first meal of the day, you may take it later the same day after a meal.

If you have missed a dose for one day, you may simply continue taking your daily capsule as prescribed.

If you stop taking Tamsulosin Teva-ratiopharm

When treatment with tamsulosin is stopped prematurely, your original symptoms may return. Therefore, take tamsulosin for as long as your doctor has prescribed, even if your symptoms have disappeared. Always consult your doctor if you decide to discontinue treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience any of the following allergic reactions, stop taking this medicine immediately and contact your doctor 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 down or standing up
• Ejaculation disorders including delayed ejaculation (ejaculation into the bladder) and failure to ejaculate

Uncommon (may affect up to 1 in 100 people)

• Headache
• Fast or irregular heartbeat (palpitations)
• Reduction in blood pressure
• Runny or blocked nose (rhinitis)
• Constipation
• Diarrhea
• Nausea
• Vomiting
• Skin rash
• Itching
• Redness, itching, or inflamed rash (urticaria)
• Feeling of weakness (asthenia)

Common (may affect up to 1 in 10 people)

• Dizziness, especially when sitting down or standing up
• Ejaculation disorders including delayed ejaculation (ejaculation into the bladder) and failure to ejaculate

Uncommon (may affect up to 1 in 100 people)

• Headache
• Fast or irregular heartbeat (palpitations)
• Reduction in blood pressure
• Runny or blocked nose (rhinitis)
• Constipation
• Diarrhea
• Nausea
• Vomiting
• Skin rash
• Itching
• Redness, itching, or inflamed rash (urticaria)
• Feeling of weakness (asthenia)

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

• Fainting (syncope)
• Swelling of hands, 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)

• Persistent, painful erection of the penis in the absence of sexual stimulation (priapism)
• Severe inflammatory rash of the skin and mucous membranes due to an allergic reaction to medicines and other substances (Stevens-Johnson Syndrome)

Frequency not known (cannot be estimated from available data)

• Nosebleed (epistaxis)
• Blurred vision, vision problems
• Dry mouth
• Severe skin rashes (erythema multiforme, exfoliative dermatitis)

If you are undergoing eye surgery due to clouding of the lens (cataracts) and you are currently taking or have previously taken tamsulosin, the pupil may dilate poorly and the iris (the colored circular part of the eye) may become floppy (see section 2).

In addition to the adverse effects listed above, the following adverse reactions have been reported with the use of tamsulosin:

• Irregular heartbeat
• Abnormal heart rhythm
• Rapid 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 adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Teva-ratiopharm

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

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

Blister: Store in the original container.

Keep the container tightly closed.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This 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 modified-release hard capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other components are: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate and talc.

The capsule shell contains: gelatin, indigotine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Appearance of the product and contents of the pack

Tamsulosina Teva-ratiopharm 0.4 mg modified-release hard capsules are orange/olive green in colour.

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

Only certain 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, 1st Floor

Alcobendas 28108 Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig Merckle Strasse, 3

89143 - Blaubeuren (Germany)

This medicinal product is authorised in the European Economic Area member states 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 capsulas duras de liberación modificada EFG

Date of the most recent review of this leaflet: May 2024

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