Tamsulosin Krka 0.4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tamsulosina Krka 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 could harm them.

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

Leaflet contents

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

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

The active substance of this medicine is tamsulosin. It is a selective α1A/1D-adrenergic receptor antagonist. 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.

Tamsulosin is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate gland (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak urine stream), dribbling, urgency, and the need to urinate frequently both during the day and at night.

2. What you need to know before taking Tamsulosin Krka

Do not take Tamsulosin Krka

• if you are allergic to tamsulosin or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity or allergy to tamsulosin hydrochloride 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 have severe liver problems.
• if you suffer from dizziness due to a drop in blood pressure when changing position (sitting or standing up).

Warnings and precautions

Talk to your doctor or pharmacist before taking tamsulosin.

• Periodic medical examinations are necessary to monitor the progression of the condition for which you are being treated.
• Fainting may rarely occur during treatment with tamsulosin, 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, consult your doctor.
• If you are undergoing or have scheduled eye surgery due to clouding of the lens (cataracts) or increased pressure in the eye (glaucoma). Please inform your ophthalmologist if you have previously taken, are currently taking, or plan to take tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor about whether you should delay or temporarily discontinue taking this medicine if you are undergoing surgery due to a cloudy lens (cataract) or increased eye pressure (glaucoma).

It is possible that remnants of the tablet may be observed in the stool. Since the active ingredient of the tablet has already been released, there is no risk of reduced effectiveness of the tablet.

Children

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

Other medicines and Tamsulosin Krka

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

Taking tamsulosin together with other medicines of the same class (α1-adrenergic receptor antagonists) may cause an undesirable drop in blood pressure.

It is especially important that you inform your doctor if you are simultaneously being treated with medicines that may reduce the elimination of tamsulosin from the body (e.g. ketoconazole, erythromycin).

Taking Tamsulosin Krka with food and drinks

Tamsulosin may be taken with or without food.

Pregnancy, breast-feeding and fertility

This section is not relevant, as tamsulosin is intended only for male patients.

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 ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive or operate machinery. However, you should bear in mind that tamsulosin may cause dizziness and drowsiness. Only drive or operate machinery if you feel well.

3. How to take Tamsulosina Krka

Follow exactly the administration instructions for tamsulosine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet daily. You may take tamsulosine with or without food, preferably at the same time each day.

The tablet must be swallowed whole. It is important not to break or chew the tablet, as this may affect the proper functioning of tamsulosine.

Tamsulosine is usually prescribed for long periods. The effects on the bladder and urination are maintained during long-term treatment with tamsulosine.

If you take more Tamsulosina Krka than you should

Taking too much tamsulosine may lead to an unwanted drop in blood pressure and an increased heart rate, accompanied by a feeling of fainting. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Tamsulosina Krka

You may take your daily tablet later on the same day if you forgot to take it as recommended. If you have missed a dose one day, you may simply take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Tamsulosina Krka

When treatment with tamsulosine is stopped prematurely, your original symptoms may return. Therefore, take Tamsulosina Krka 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

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

Serious reactions are rare. Contact your doctor immediately if you experience a severe allergic reaction causing swelling of the face and throat (angioedema).

Common (may affect up to 1 in 10 people)

• dizziness, especially when sitting down or standing up,
• abnormal ejaculation (ejaculation disorder). This means that semen does not exit through the urethra but goes into the bladder (retrograde ejaculation), or that the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Uncommon (may affect up to 1 in 100 people)

• headache,
• palpitations (heart beating faster than normal and noticeably),
• reduction in blood pressure, for example when standing up quickly after sitting or lying down, sometimes associated with dizziness,
• runny or blocked nose (rhinitis),
• diarrhoea, feeling nauseous and vomiting, constipation,
• weakness (asthenia),
• skin rash, itching, and hives (urticaria).

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

• fainting,
• sudden localized swelling of soft body tissues (such as the throat or tongue), difficulty breathing and/or itching and skin rash, often as an allergic reaction (angioedema).

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

• priapism (undesired, prolonged and painful erection requiring immediate medical treatment),
• skin rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).

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

• dry mouth,
• blurred vision, visual disturbance,
• nosebleeds,
• severe skin rashes (erythema multiforme, exfoliative dermatitis),
• abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnoea).

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.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Krka

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

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

Store in the original packaging to protect from light.

This medicine does not require any special storage temperature.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosin Krka

• The active substance is tamsulosin hydrochloride. Each prolonged-release tablet contains 0.4 mg of tamsulosin hydrochloride.
• The other components are:

Tablet core: hypromellose (E464), microcrystalline cellulose (E460), carbomer, anhydrous colloidal silica (E551), red iron oxide (E172), magnesium stearate (E470b).

Tablet coating: hypromellose (E464), microcrystalline cellulose (E460), carbomer, anhydrous colloidal silica (E551), magnesium stearate (E470b).

Appearance of the product and contents of the pack

Tamsulosin Krka 0.4 mg prolonged-release tablets are white, unmarked, rounded with a diameter of 9 mm, printed on one side with “T9SL” and “0.4” on the other.

Tamsulosin Krka is available in packs containing 30 and 90 prolonged-release tablets in blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.

Synthon Hispania, S.L.

C/ Castelló 1, Poligono Las Salinas

08830 Sant Boi de Llobregat, Barcelona

Spain

TAD Pharma GmbH

Heinz-Lohmann-Strabe 5

27472 Groden Cuxhaven

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

This patient information leaflet was approved in: June 2019

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