Tamsulosin Sandoz

Package leaflet: Information for the patient

Tamsulosin Sandoz

0.4 mg modified-release hard capsules
Generic medicine
tamsulosin hydrochloride

Read this entire 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 they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

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

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

Tamsulosin Sandoz modified-release capsules are used to treat urinary symptoms caused by benign prostatic hyperplasia (BPH – enlargement of the prostate). The active substance in the capsules is a so-called alpha receptor blocker, which reduces the muscle contraction ability of the prostate and urethra. This facilitates urine flow through the urethra and makes urination easier.

2. What you should know before taking Tamsulosina Sandoz

Do not take Tamsulosina Sandoz

• if you are allergic to tamsulosin hydrochloride or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity or allergy to Tamsulosina Sandoz may present as sudden swelling of hands or feet, swollen lips, tongue or throat causing difficulty in breathing and/or itching and skin rash (angioedema)
• if you have suffered from dizziness or fainting due to low blood pressure (for example, when sitting down or standing up suddenly)
• if you have been diagnosed with severe liver problems.

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

• if you have been diagnosed with severe kidney problems
• if you experience dizziness or fainting while using Tamsulosina Sandoz. Sit or lie down immediately until symptoms have passed
• if you experience sudden swelling of hands or feet, swollen lips, tongue or throat causing difficulty in breathing and/or itching and skin rash due to an allergic reaction (angioedema) while using Tamsulosina Sandoz.

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• if you are scheduled for or are on a waiting list for eye surgery due to cataract (clouding of the lens) or glaucoma (increased eye pressure).

Inform your ophthalmologist if you have previously used, are currently using, or plan to use Tamsulosina Sandoz. The specialist may then take appropriate precautions regarding medications and surgical techniques to be used. Ask your doctor whether you should postpone or temporarily discontinue the medication when undergoing eye surgery for cataract or increased eye pressure.
Before starting treatment with Tamsulosina Sandoz, your doctor should examine you to rule out other conditions that may cause similar symptoms, such as enlargement of the prostate (benign prostatic hyperplasia). A specific type of examination (digital rectal examination) should be performed. If necessary, measurement of prostate-specific antigen (PSA) should be carried out before treatment and subsequently at regular intervals.
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.
Other medicines and Tamsulosina Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking:

• medicines that lower blood pressure such as verapamil or diltiazem
• medicines for the treatment of HIV such as ritonavir or indinavir
• medicines used to treat fungal infections such as ketoconazole or itraconazole
• other alpha-blockers such as doxazosin, indoramin, prazosin or alfuzosin
• erythromycin or clarithromycin, antibiotics used to treat infections
• cyclosporine, an immunosuppressant used, for example, after organ transplantation.

When taken together with other alpha-receptor blockers, Tamsulosina Sandoz may reduce blood pressure.
In some patients receiving alpha-blockers for high blood pressure or enlarged prostate, dizziness or a sensation of "light-headedness" may occur, which can be caused by low blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) together with alpha-blockers.
To reduce the likelihood of these symptoms occurring, the daily dose of alpha-blockers should be adjusted before starting treatment with medicines for erectile dysfunction.
Diclofenac (a non-steroidal anti-inflammatory painkiller) and warfarin (used to prevent blood clotting) may affect how quickly Tamsulosina Sandoz is eliminated from the body.
Tamsulosina Sandoz with food and drink
Tamsulosina Sandoz should be taken after the first meal of the day. Taking Tamsulosina Sandoz on an empty stomach may increase the number of side effects or worsen the severity of a side effect.
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Pregnancy, breastfeeding and fertility
Tamsulosina Sandoz must not be used in women.
Fertility
In men, abnormal ejaculation (ejaculation disorders) has been reported. This means that semen does not exit the body through the urethra, but instead enters the bladder (retrograde ejaculation), or the volume of ejaculate is reduced or absent (anejaculation). This may affect male fertility.
Driving and using machines
There is currently no evidence that Tamsulosina Sandoz impairs the ability to drive or use machinery. However, patients should be warned that they may experience dizziness.
Tamsulosina Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per modified-release hard capsule, i.e. essentially 'sodium-free'.

3. How to take Tamsulosin Sandoz

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one capsule daily after the first meal of the day.
The capsule should be taken while standing or sitting (not lying down) and must be swallowed whole with
a glass of water.
Do not chew the capsule.
Your doctor has prescribed a dosage suitable for you and your condition and has specified the duration of
treatment.
Do not change the dose on your own.
If you feel that the effects of Tamsulosin Sandoz are too strong or too weak, consult your
doctor or pharmacist.
If you take more Tamsulosin Sandoz than you should
If you have taken more Tamsulosin Sandoz than you should, contact your doctor or pharmacist immediately.
If you forget to take Tamsulosin Sandoz
If you have forgotten to take Tamsulosin Sandoz after the first meal of the day, you may take it later on the same day after another meal. If you have forgotten to take the dose for a whole day, simply continue taking your daily capsule as prescribed.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Tamsulosin Sandoz
Do not stop taking Tamsulosin Sandoz unless your doctor tells you to, as this may cause symptoms to return or worsen.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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Stop taking Tamsulosin Sandoz and contact your doctor immediately if you experience any of the
following symptoms:

• sudden swelling of the hands, feet, lips, tongue or throat causing breathing difficulties and/or itching and skin rash due to an allergic reaction (angioedema).
• severe ulcers and lesions of the mucous membranes (Stevens-Johnson syndrome)
• a serious inflammation and blistering of the skin known as erythema multiforme

Common (may affect up to 1 in 10 people):
dizziness, ejaculation disorders, including reduced or absent ejaculate.
Uncommon (may affect up to 1 in 100 people):
headache, irregular heartbeat, dizziness, especially when sitting down or standing up, common cold, constipation, diarrhoea, nausea and vomiting, skin rash, itching, hives, feeling of weakness.
Rare (may affect up to 1 in 1,000 people):
fainting, swelling of hands or feet, swelling of lips, tongue or throat causing breathing difficulties and/or itching and rash (angioedema).
Very rare (may affect up to 1 in 10,000 people):
severe ulcers and lesions of the mucous membranes (Stevens-Johnson syndrome), persistent, involuntary and painful erection (priapism).
Not known (frequency cannot be estimated from the available data):
blurred vision, visual disturbance, nosebleed, severe inflammation and peeling of the skin (erythema multiforme), scaly skin rash (exfoliative dermatitis), irregular heartbeat (sometimes life-threatening), rapid heartbeat, breathing difficulties, dry mouth. If you are undergoing eye surgery due to clouding of the lens (cataract) or increased intraocular pressure (glaucoma) and you are currently taking or have recently stopped taking Tamsulosin Sandoz, the pupil may have difficulty dilating and the iris (the coloured part of the eye) may become floppy during the procedure.
Reporting of side effects
If you experience any side effect, 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tamsulosina Sandoz

Keep this medicine out of the sight and reach of children.
Blister: Store in the original packaging.
Bottle: Keep the bottle tightly closed.
Do not use this medicine after the expiry date stated on the blister, bottle and outer carton box marked "Exp.". The expiry date refers to the last day of the month indicated.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
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6. Package contents and other information

What Tamsulosina Sandoz contains

• The active substance is tamsulosin hydrochloride.
• Each modified-release capsule contains 0.4 mg of tamsulosin hydrochloride.
• The excipients are: microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc, inside the capsule;
• gelatin, indigo carmine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) in the capsule shell.

Description of the appearance of Tamsulosina Sandoz and contents of the pack
Modified-release hard capsules, orange/olive green in colour, containing white to off-white granules.
The modified-release hard capsules are packed in PVC/PE/PVDC/Al blisters or in HDPE bottles with child-resistant closures made of polypropylene, and placed in a cardboard carton, or packed in HDPE bottles with child-resistant closures.
Pack sizes:
Blister: 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 200 modified-release hard capsules.
Bottle: 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 200 modified-release hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturers responsible for batch release

• Synthon BV - Microweg 22 - 6545 CM Nijmegen - Netherlands
• Synthon Hispania S.L. - Castello 1, Polígono Las Salinas - Sant Boi de Llobregat - Spain
• Salutas Pharma GmbH - Otto-von-Guericke-Allee 1 - 39179 Barleben - Germany
• Lek Pharmaceuticals d.d. - Trimlini 2 D - 9220 Lendava - Slovenia
• Lek Pharmaceuticals d.d. - Verovškova 57 - 1526 Ljubljana - Slovenia

This medicinal product is authorized in the European Economic Area countries under the following
names:
Austria Tamsulosin Sandoz retard 0.4 mg – Kapseln
Belgium Tamsulosine Sandoz 0.4 mg capsules met gereguleerde afgifte, hard
Finland Tamsulosiinihydrokloridi Sandoz 0.4 mg depotkapseli, kova
France TAMSULOSINE SANDOZ LP 0.4 mg, gélule à libération prolongée
Italy Tamsulosina Sandoz 0.4 mg
Portugal Tamsulosina Sandoz 0.4 mg cápsulas de libertação prolongada
Spain Tamsulosina Sandoz 0.4 mg capsulas duras de liberacion modificada EFG
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