TAMSULOSIN KRKA 0.4 MG MODIFIED-RELEASE HARD CAPSULES EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tamsulosina Krka 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 you must 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 adverse effects 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 adverse effects
5. How to store Tamsulosina Krka
6. Contents of the pack and other information

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

The active substance in this medicine is tamsulosin hydrochloride. 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.

Tamsulosin is used in men for the treatment of lower urinary tract symptoms associated with enlargement of the 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 night and during the day.

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 tamsulosine hydrochloride may present as sudden swelling of the hands or feet, swollen lips, tongue or throat, causing breathing difficulties 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 starting to take 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 scheduled for, or undergoing, eye surgery due to cataracts or increased eye pressure (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 this medicine prior to undergoing surgery for cataracts or glaucoma.

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 also taking medicines that may reduce the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Taking Tamsulosin Krka with food and drinks

Tamsulosin should be taken after breakfast or the first meal of the day.

Pregnancy, breastfeeding and fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (ejaculatory 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 using machines

There is no evidence that tamsulosin affects the ability to drive or operate machinery or tools.

However, you should bear in mind that dizziness may occur, in which case you should not perform activities requiring attention.

Tamsulosin Krka 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 Tamsulosina Krka

Follow exactly the dosing instructions for tamsulosin as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

The dose is one capsule daily for adults and elderly patients. It should be taken after breakfast or the first meal of the day. The capsule must be swallowed whole. It must not be broken or chewed.

Your doctor may want to examine you periodically while you are taking this medicine.

If you take more Tamsulosina Krka than you should

Taking too much tamsulosin may lead to an unwanted drop 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 Tamsulosina Krka

If you forget to take your dose, you may take it later the same day. If you have missed a day's dose, simply continue with your next daily dose the following day. Do not take a double dose to make up for forgotten doses.

If you stop taking Tamsulosina Krka

If treatment with tamsulosin is stopped prematurely, your original symptoms may return. Therefore, continue taking 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 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).

Frequent (may affect up to 1 in 10 people)

• dizziness, especially when sitting down or standing up,
• abnormal ejaculation (ejaculatory 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 (heartbeats that are faster than normal and noticeable),
• 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 tissues of the body (such as 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 disturbances,
• 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 clouding of the lens (cataracts) or increased pressure in the eye (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 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: 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 out of 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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosina Krka

• The active substance is tamsulosin hydrochloride. Each modified-release hard capsule contains 0.4 mg of tamsulosin hydrochloride.
• The other components are: microcrystalline cellulose (E460), methylacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 percent, polysorbate 80 (E433), sodium lauryl sulfate, triethyl citrate (E1505) and talc (E553b) in the capsule core; and gelatin, indigo carmine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172) in the capsule coating.

See section 2 “Tamsulosina Krka contains sodium”.

Nature of the product and contents of the pack

Tamsulosina Krka 0.4 mg modified-release hard capsules are orange/olive green in colour. The capsules contain white to off-white pellets. The capsule size is 19.3 mm x 6.4 mm.

Tamsulosina Krka is available in packs containing 20, 30, 90 and 100 modified-release hard capsules in blisters.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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/ Castello 1 Poligono Las Salinas

08830 Sant Boi de Llobregat, Barcelona

Spain

Tad Pharma GmbH

Heinz-Lohmann-Strabe 5

Groden Cuxhaven 27472, Germany

For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

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

This medicinal product is authorised 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 medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/