TAMSULOSINA 0.4 MG Kapsułki o przedłużonym uwalnianiu

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1. Tamsulosina Aristogen 0.4 mg modified-release hard capsules
   1. What is Tamsulosina Aristogen and what is it used for
   2. What you need to know before taking Tamsulosina Aristogen
   3. How to take Tamsulosina Aristogen
   4. Possible side effects
   5. How to store Tamsulosina Aristogen
   6. Package contents and other information

Tamsulosina Aristogen 0.4 mg modified-release hard capsules

tamsulosin hydrochloride

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

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

The active substance of Tamsulosina Aristogen 0.4 mg is tamsulosin, a drug with selective action
antagonist of alpha-adrenergic receptors which reduces muscle tension in the prostate and urethra.
This allows urine to pass more quickly through the urethra, facilitating urination. In
addition, it decreases the sensation of urgency to urinate.
Tamsulosina Aristogen is used in men for the treatment of lower urinary tract symptoms
associated with an enlargement of the prostate (benign prostatic hyperplasia). These disorders can
include difficulty urinating (reduced stream), dripping, urgency and the need to urinate
frequently at night as well as during the day.

2. What you need to know before taking Tamsulosina Aristogen

Do not take Tamsulosina Aristogen

• if you are allergic (hypersensitive) to tamsulosin or any of the excipients of Tamsulosina Aristogen. Hypersensitivity may manifest as sudden local swelling of soft body tissues (e.g. throat or tongue), difficulty breathing and/or itching and rash (angioedema)
• if you suffer from severe liver problems.
• if you experience fainting due to a drop in blood pressure when changing position (sitting up from lying down or standing up).

Warnings and precautions

• Periodic medical check-ups are necessary to monitor the development of the condition for which you are being treated.
• Rarely, with the use of Tamsulosina Aristogen, fainting may occur, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until they disappear.
• If you suffer from severe kidney problems, inform your doctor.
• If you are to undergo or are on the waiting list for eye surgery for cataracts. Inform the ophthalmologist if you have previously taken, are taking or intend to take Tamsulosina Aristogen. The specialist may consequently adopt the most appropriate precautions regarding the medicine and the surgical technique to be used. Ask your doctor if you should postpone or temporarily suspend treatment with this medicine before undergoing eye surgery for cataracts.

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

Other medicines and Tamsulosina AristogenTaking Tamsulosina Aristogen with other
medicines belonging to the same class (α1 adrenoreceptor antagonists) may cause an unwanted drop in
blood pressure.
It is particularly important to inform your doctor if you are simultaneously being treated with
medicines that may decrease the elimination of Tamsulosina Aristogen from the body (e.g.,
ketoconazole, erythromycin).
Inform your doctor or pharmacist if you are taking or have recently taken any other
medicine, including those without a prescription.

Tamsulosina Aristogen with food and drink
Tamsulosina Aristogen should be taken after breakfast or after the first meal of the day.
Avoid consuming alcohol before or concurrently with Tamsulosina Aristogen.

Pregnancy, breastfeeding and fertility
The use of Tamsulosina Aristogen is not indicated in women, therefore information on pregnancy and
breastfeeding is not relevant.

Fertility
Difficulty with ejaculation has been reported in association with the use of tamsulosin (see section
4).

Driving and operating machinery
It has not been demonstrated that Tamsulosina Aristogen alters the ability to drive vehicles or operate
machinery or equipment. However, you should be aware of the possibility of dizziness occurring, in which
case you should not engage in activities that require attention.

3. How to take Tamsulosina Aristogen

Always take Tamsulosina Aristogen exactly as your doctor has instructed. If you have any
doubts, consult your doctor or pharmacist. The usual dose is 1 capsule a day, to be
taken after breakfast or after the first meal of the day, every day. The capsule should be
swallowed whole, without crushing or chewing it. Normally, Tamsulosina Aristogen is prescribed for
long periods of time. The effects on the bladder and urination are maintained following long-term
treatment with Tamsulosina Aristogen.

If you take more Tamsulosina Aristogen than you should
Taking an excessive dose of Tamsulosina Aristogen may induce an unwanted drop in
blood pressure and an increase in heart rate, associated with a feeling of weakness. If you have
taken too many doses of Tamsulosina Aristogen, consult your doctor immediately.

If you forget to take Tamsulosina Aristogen
If you have forgotten to take a dose of Tamsulosina Aristogen, you can take it later in the same
day. If you have missed a day, continue to take the capsule of the day as prescribed. Do not
ever take a double dose to make up for a forgotten one.

If you stop taking Tamsulosina Aristogen
When treatment with Tamsulosina Aristogen is stopped prematurely, your initial symptoms may
reappear. Therefore, continue to take Tamsulosina Aristogen for the entire
period of time prescribed by your doctor, even if your symptoms have already disappeared. Always consult
your doctor if you believe that this therapy should be stopped.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tamsulosina Aristogen can cause side effects, although not everybody gets them.

Common(less than 1 in 10 people, more than 1 in 100 people (1-10%)):
Dizziness, particularly when sitting up or standing up. Abnormal ejaculation. This
symptom means that the seminal fluid does not exit the body through the urethra but enters
the bladder. This event is harmless.

Uncommon(more than 1 in 1000 people, less than 1 in 100 people (0.1-1%)):
Headache, palpitations (the heart beats faster than normal and is also noticeable),
low blood pressure, for example when getting up quickly from sitting or lying down
often associated with dizziness; blocked or runny nose (rhinitis), diarrhoea, nausea and vomiting, constipation,
weakness (asthenia), skin redness (rash), itching and hives.

Rare(more than 1 in 10,000 people, less than 1 in 1000 people (0.01-0.1%)):
Fainting and cases of sudden localised swelling of the soft tissues of the body (for example
of the throat and tongue), difficulty breathing with or without itching and skin redness
(rash), as often occurs in an allergic reaction (angioedema).

Very rare(less than 1 in 10,000 (<0.01%)):
Priapism (involuntary, painful and prolonged erection that requires immediate
medical treatment). Skin rash, inflammation, blistering of the skin and/or
mucous membranes of the lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome).

Not known:

• Blurred vision
• Impaired vision
• Nosebleed
• Severe skin rashes (erythema multiforme, exfoliative dermatitis)
• Abnormal irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), difficulty
• breathing (dyspnoea).
• If you are about to undergo eye surgery for cataracts or increased eye pressure (glaucoma) and are already taking or have recently taken Tamsulosina Aristogen, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the operation.
• Dry mouth.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 Aristogen

Do not store at a temperature above 30 °C.
Keep this medicine out of the sight and reach of children.
Do not use Tamsulosina Aristogen after the expiry date which is stated on the blister and the package after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 Aristogen contains

• The active ingredient is tamsulosin hydrochloride.
• The other ingredients are microcrystalline cellulose, talc, methacrylic acid-ethyl acrylate copolymer, triethyl citrate, polysorbate 80, glycerol monostearate, gelatin, titanium dioxide (E171); yellow iron oxide (E172).

Description of the appearance of Tamsulosina Aristogen and package contents
Tamsulosina Aristogen 0.4 mg modified-release capsules are hard-shell capsules
consisting of two pieces, size 15.9 mm ± 0.3 mm, with a yellow cap and a white body
containing granules from white to off-white in color.
Tamsulosin 0.4 mg modified-release capsules are packaged in PVC/PVdC-Al blisters
of 10, 20, 30, 50, 100 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany Tamsulosin Aristo 0.4 mg prolonged-release hard capsules
Austria Tamsulosin Aristo Pharma 0.4 mg hard capsules with modified
release
Czech Republic Tamsulosin Aristo 0.4 mg Hard capsules with controlled release
Spain Tamsulosina Aristo 0.4 mg Modified-release hard capsules
Italy Tamsulosina Aristogen
Poland Tamsulosin Aristo