TAMSULOSIN KRKA

Package leaflet: Information for the patient

Tamsulosina Krka 0.4 mg 400 micrograms modified-release hard capsules

Generic medicine
tamsulosin hydrochloride
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 Tamsulosina Krka is and what it is used for

What Tamsulosina Krka is
The active substance in Tamsulosina Krka is tamsulosin hydrochloride. This is a selective
antagonist of α-adrenoceptors. It reduces muscle tension in the prostate and urethra, allowing
urine to pass more easily through the urethra and facilitating urination. In addition, it reduces
the urgency to urinate.
Tamsulosina Krka is used in men for the treatment of lower urinary tract symptoms associated
with benign prostatic enlargement (benign prostatic hyperplasia). These symptoms may include
difficulty urinating (reduced flow), dribbling, urgency, and increased frequency of urination
both during the day and at night.

2. What you need to know before taking Tamsulosina Krka

Do not take Tamsulosina Krka

• if you are allergic to tamsulosin or to any of the excipients of this medicine (listed in section 6). Hypersensitivity or allergy to tamsulosin hydrochloride may present as sudden swelling of the hands and feet, lips, tongue or throat causing difficulty in breathing and/or itching and skin rash (angioedema);
• if you have severe liver problems;
• if you suffer from fainting caused by a drop in blood pressure when changing position (sitting down or standing up).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tamsulosina Krka.

• Periodic medical examinations are necessary to monitor the condition for which you are being treated.
• Fainting may rarely occur during treatment with Tamsulosina Krka, 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 kidney problems, inform your doctor.
• If you are undergoing or have scheduled eye surgery due to cataract (lens opacity) or increased intraocular pressure (glaucoma), you must inform your ophthalmologist that you have used, are currently using, or are planning to use Tamsulosina Krka. The specialist can then take appropriate precautions regarding medications and surgical techniques to be used. Ask your doctor whether you should delay or temporarily discontinue taking this medicine during eye surgery for cataract or increased intraocular pressure (glaucoma).

Children
Do not give this medicine to children or adolescents under 18 years of age, as it has no effect in
this population.
Other medicines and Tamsulosina Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Taking Tamsulosina Krka together with other medicines of the same class (α1-adrenoceptor antagonists) may cause an unintended drop in blood pressure.
It is particularly important to inform your doctor if you are being treated simultaneously with medicines that may reduce the elimination of Tamsulosina Krka from the body (e.g. ketoconazole,
erythromycin).
Tamsulosina Krka with food and drink
Tamsulosina Krka should be taken after breakfast or after the first meal of the day.
Pregnancy and breastfeeding
Tamsulosina Krka is not indicated for use in women.
In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen does not leave the body through the urethra, but enters the bladder (retrograde ejaculation), or the volume of ejaculation is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.
Driving and using machines
There is no evidence that Tamsulosina Krka affects the ability to drive or operate machinery.
However, you should bear in mind the possibility that dizziness may occur; in such case,
you should not undertake activities requiring alertness.
Tamsulosina Krka contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take Tamsulosina Krka

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
For adults and elderly patients, the dose is one capsule per day. It should be taken after breakfast or after the first meal of the day. Swallow the capsule whole. Do not crush or chew.
Your doctor may decide to monitor you periodically while you are taking this medicine.
If you take more Tamsulosina Krka than you should
Taking too much Tamsulosina Krka may cause an unwanted drop in blood pressure and an increased heart rate, with a feeling of fainting. Contact your doctor immediately if you have taken too much Tamsulosina Krka.
If you forget to take Tamsulosina Krka
If you forget to take a dose of Tamsulosina Krka, you may take it later on the same day. If you have missed a day, continue taking the daily capsule as prescribed. Do not take a double dose to make up for the missed dose.
If you stop taking Tamsulosina Krka
If treatment with Tamsulosina Krka is stopped prematurely, the initial symptoms may reappear. Therefore, continue taking Tamsulosina Krka for the full duration prescribed by your doctor, even if your symptoms have already disappeared. Always consult your doctor if you are considering stopping this therapy.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may have side effects, although not everyone experiences them.
Serious adverse events are rare. Contact your doctor immediately if a serious allergic reaction occurs causing swelling of the face or throat (angio-oedema).

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• headache
• palpitations (heart beats faster than normal and is noticeable)
• low blood pressure, for example when standing up quickly from a sitting or lying position, sometimes associated with dizziness
• stuffy or runny nose (rhinitis)
• diarrhoea, nausea and vomiting, constipation
• weakness (asthenia)
• skin rash, itching and urticaria.

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

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

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

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

Not known (frequency cannot be estimated from available data)

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

If you are undergoing eye surgery for clouding of the lens (cataract) or for increased eye pressure (glaucoma), and you are currently taking or have recently taken Tamsulosin Krka, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during surgery.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 packaging after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tamsulosina Krka contains

• The active substance is tamsulosin hydrochloride. Each modified-release hard capsule contains 0.4 mg (400 micrograms) of tamsulosin hydrochloride.
• The other ingredients are: microcrystalline cellulose (E460), methacrylic acid-ethyl acrylate copolymer (1:1) 30 percent dispersion, polysorbate 80 (E433), sodium lauryl sulfate, triethyl citrate (E1505), talc (E553b) in the capsule core; and gelatin (E441), indigotine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) in the capsule shell. See Section 2 “Tamsulosina Krka contains sodium”.

Description of the appearance of Tamsulosina Krka and package contents
Tamsulosina Krka 0.4 mg (400 micrograms) modified-release hard capsules are orange/olive green capsules. The capsules contain white to off-white pellets. Capsule size: 19.3 mm x 6.4 mm.
Tamsulosina Krka is available in boxes containing 20, 30, 90 and 100 modified-release hard capsules in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
Synthon Hispania S.L., Castelló, 1, Polígono las Salinas, 08830 Sant Boi de Llobregat, Spain
Synthon BV, Microweg 22, 6545 CM Nijmegen, The Netherlands
TAD Pharma GmbH, Heinz-Lohman Straße 5, 27472 Cuxhaven, Germany
KRKA d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative in Italy
KRKA Farmaceutici Milano S.r.l. - Italy

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