Tamsulosin Teva 0.4 mg modified-release capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Tamsulosin Teva 0.4 mg modified-release hard capsules 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

The active substance in Tamsulosin Teva 0.4 mg capsules is tamsulosin. It is a selective antagonist of alpha1A/1D adrenergic receptors. It reduces the tone 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.

Tamsulosin Teva 0.4 mg capsules is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate gland (benign prostatic hyperplasia). 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 taking Tamsulosin Teva

Do not take Tamsulosin Teva:

• 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), difficulty breathing and/or itching and skin rash (angioedema).
• if you suffer from dizziness due to a drop in blood pressure when changing posture (for example, when sitting down or standing up).
• if you have severe liver disease.

Warnings and precautions

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

• because periodic medical examinations are necessary to monitor the progression of the condition being treated.
• because fainting may rarely occur while using Tamsulosin Teva, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until symptoms have disappeared.
• if you have severe kidney problems.
• if you are undergoing or have scheduled eye surgery due to lens opacity (cataract) or increased eye pressure (glaucoma). Please inform your ophthalmologist if you have previously taken, are currently taking, or are considering taking Tamsulosin Teva. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor about whether you should delay or temporarily stop taking this medicine if you are undergoing surgery due to a cloudy lens (cataract) or increased eye pressure (glaucoma).

Children and adolescents

Tamsulosin Teva must not be given to children or adolescents under 18 years of age, as it is not indicated for this population group.

Interaction of Tamsulosin Teva with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tell your doctor if you are taking any of the following medicines:

• other medicines of the same class such as alfuzosin, doxazosin, or terazosin, because concomitant use with tamsulosin may cause an undesirable drop in blood pressure.

• diclofenac (a non-steroidal anti-inflammatory painkiller)

• warfarin (used to prevent blood clotting)

• it is especially important that you inform your doctor if you are being treated simultaneously with medicines that may reduce the elimination of tamsulosin from the body, such as ketoconazole (used to treat fungal infections) and erythromycin.

Taking Tamsulosin Teva with food and drinks

You may take tamsulosin after breakfast or the first meal of the day.

Pregnancy, breastfeeding and fertility

Tamsulosin Teva 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 enters the bladder (retrograde ejaculation), or the volume of ejaculation is reduced or absent (ejaculation failure). This phenomenon is not harmful.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive or operate machinery or equipment. However, you should bear in mind that dizziness may occur; in such a case, you should not perform activities requiring alertness.

Tamsulosin Teva contains sodium

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

3. How to take Tamsulosin Teva

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

The recommended dose is one capsule per day. The capsule should be taken after breakfast or the first meal of the day.

The capsule must be swallowed whole and must not be broken or chewed.

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

If you take more Tamsulosin Teva than you should

Taking too many tamsulosin capsules may lead to an unwanted decrease in blood pressure and an increased heart rate, with sensations of fainting. Contact your doctor immediately if you have taken too much Tamsulosin Teva 0.4 mg modified-release capsules.

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

If you forget to take Tamsulosin Teva as directed, take your daily capsule later the same day. If you have missed the dose for one day, you may simply continue taking your daily capsule as prescribed. Do not take a double dose to make up for the missed dose.

If you stop taking Tamsulosin Teva

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

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

4. Possible adverse effects

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

Stop taking this medicine and consult your doctor immediately if you experience any of the following adverse effects:

• a severe allergic reaction with sudden local swelling of the lips, face, tongue, or throat causing severe breathing difficulty and/or itching and skin rash (angioedema) (uncommon, may affect up to 1 in 1,000 people).
• a serious illness with skin rash, inflammation, and blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nose, or genitals, known as Stevens-Johnson syndrome (very rare, may affect up to 1 in 10,000 people).

These are very serious but rare adverse effects. You may require urgent medical attention or hospitalization.

The following adverse effects have been reported. If you experience any of these and they are concerning you, contact your doctor:

Common (may affect up to 1 in 10 people)

• dizziness, especially when sitting down or standing up.
• abnormal ejaculation (ejaculation disorders). This means that semen does not exit through the urethra but goes into the bladder, or the volume of ejaculate is reduced or absent (ejaculation failure). This phenomenon is harmless.

Uncommon (may affect up to 1 in 100 people)

• headache
• rapid or irregular heartbeat (palpitations)
• reduction in blood pressure, for example when standing up quickly after sitting or lying down
• nasal drip or nasal blockage (rhinitis)
• constipation, diarrhoea, nausea, vomiting
• skin rash, itching, and hives (urticaria)
• feeling of weakness (asthenia)

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

• syncope (sudden, temporary loss of consciousness)

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

• prolonged and painful erection of the penis lasting from several hours to days (priapism).

Frequency not known (cannot be estimated from available data)

• Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia).
• Difficulty breathing (dyspnoea)
• Blurred vision
• Altered vision
• Nosebleed (epistaxis)
• Severe skin rash (erythema multiforme, exfoliative dermatitis)
• Dry mouth
• If you are undergoing eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), and you are currently taking or have previously taken tamsulosin, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during surgery (see section 2 “Warnings and precautions”).

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse 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 adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Teva

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

Blister packs: Store in the original packaging.

Bottle packs: Store in the original container and keep the container tightly closed. Do not transfer to another container.

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

Do not use this medicine after the expiry date stated on the container and label of the bottle following the abbreviation EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosin Teva 0.4 mg modified-release hard capsules

• The active substance is tamsulosin hydrochloride. Each capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other components are: microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc, gelatin, indigotine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Appearance of the medicine and contents of the pack

• Tamsulosin Teva are modified-release hard gelatin capsules consisting of an orange body and an olive-green cap. The capsules contain white or almost white pellets.

• The medicine is available in cartons with PVC/PE/PVDC/Aluminum blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 180 or 200 modified-release hard capsules, and in HDPE bottles with child-resistant polypropylene caps containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 2 x 100, 180 or 200 modified-release hard capsules.

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
Alcobendas 28108 Madrid (Spain)

Manufacturer

Synthon Hispania S.L.
Castelló, 1 Polígono las Salinas
08830 Sant Boi de Llobregat
Spain

OR

Synthon BV
Microweg, 22, P.O. Box 7071
NL-6545 Nijmegen
The Netherlands

OR

GALIEN LPS
98 Rue Bellocier, 89100 Sens,
France

OR

PHARMACHEMIE B.V.
Swensweg, 5, P.O. Box 552 - Haarlem
The Netherlands

OR

Laboratoria Qualiphar NV (Qualiphar NV)
Rijksweg 9, Bornem,
2880, Belgium

OR

Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa, 2600
Bulgaria

Date of the most recent revision of this leaflet: July 2024

Detailed information on this medicine 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 up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67339/P_67339.html