Tamsulosin aristo

Package leaflet: Information for the user

Tamsulosin Aristo, 0.4 mg, modified-release hard capsules
Tamsulosini hydrochloridum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Tamsulosin Aristo is and what it is used for
2. Important information before taking Tamsulosin Aristo
3. How to take Tamsulosin Aristo
4. Possible side effects
5. How to store Tamsulosin Aristo
6. Contents of the pack and other information

1. What Tamsulosin Aristo is and what it is used for
The active substance in Tamsulosin Aristo is tamsulosin. It is a selective alpha-adrenergic receptor antagonist. Tamsulosin reduces the tone of smooth muscles in the prostate gland and urethra, thus facilitating urine flow through the urethra. Additionally, it reduces the sensation of urinary urgency.
Tamsulosin Aristo is used in men to treat lower urinary tract symptoms associated with an enlarged prostate gland (benign prostatic hyperplasia).
These symptoms may include difficulty urinating (weak stream), dribbling after urination, a sudden urge to urinate, and the need to urinate frequently both during the day and at night.

2. Important information before taking Tamsulosin Aristo

When not to take Tamsulosin Aristo

• if you are allergic (hypersensitive) to tamsulosin or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may manifest as sudden localized swelling of soft tissues (e.g. throat or tongue), difficulty breathing and/or itching and rash (angioedema).
• if you have severe liver function impairment,
• if you experience fainting caused by low blood pressure upon changing position (sitting or standing up).

Warnings and precautions
Before starting treatment with Tamsulosin Aristo, discuss this with your doctor.

• Regular medical check-ups are necessary to monitor the progression of the condition being treated.
• Rarely, as with other medicines in this class, fainting may occur. If symptoms such as dizziness or weakness occur, sit or lie down until symptoms subside.
• If you have severe kidney disease, inform your doctor.
• If you are scheduled for eye surgery due to cataract, inform your ophthalmologist that you are currently taking, have previously taken, or plan to take Tamsulosin Aristo. The specialist may take appropriate precautions regarding treatment and surgical techniques. Ask your doctor whether you should delay starting Tamsulosin Aristo or temporarily discontinue it if cataract surgery is planned.

Children and adolescents
Tamsulosin Aristo must not be used in children and adolescents under 18 years of age, as it is not effective in this patient population.

Tamsulosin Aristo with other medicines
Concomitant use of Tamsulosin Aristo with other medicines from the same class (alpha-adrenergic receptor antagonists) may lead to unintended lowering of blood pressure.
It is particularly important to inform your doctor if you are taking medicines that may reduce the elimination of Tamsulosin Aristo from the body (e.g. ketoconazole, erythromycin).
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any you plan to take, including those obtained without a prescription.

Tamsulosin Aristo with food, drink and alcohol
Tamsulosin Aristo should be taken after breakfast or after the first meal of the day.
Avoid consuming alcohol before or during treatment with Tamsulosin Aristo.

Pregnancy, breastfeeding and fertility
Tamsulosin Aristo is not indicated for use in women; therefore, information regarding pregnancy and breastfeeding is not relevant.

Fertility
Cases of ejaculation disorders have been reported with the use of tamsulosin (see section 4).

Driving and operating machinery
There is no evidence regarding the effect of tamsulosin on the ability to drive or operate machinery or equipment. However, bear in mind that tamsulosin may cause dizziness, and in such cases, activities requiring mental concentration should be avoided.

3. How to use Tamsulosin Aristo

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. The recommended dose is one capsule per day, taken after breakfast or after the first meal of the day. The capsule must be swallowed whole and should not be crushed or chewed. Tamsulosin Aristo is usually prescribed for long-term use. Its effect on the bladder and urination is maintained during prolonged treatment with Tamsulosin Aristo.

Taking more Tamsulosin Aristo than recommended
Taking too high a dose of Tamsulosin Aristo may lead to unwanted lowering of blood pressure and increased heart rate accompanied by a feeling of faintness. If an overdose of Tamsulosin Aristo has been taken, contact your doctor immediately.

Missing a dose of Tamsulosin Aristo
If the patient forgets to take the daily dose of Tamsulosin Aristo as recommended, it may be taken later on the same day. If a dose is missed on any given day, simply continue taking the capsule according to the prescribed dosing schedule.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Tamsulosin Aristo
If treatment with Tamsulosin Aristo is stopped prematurely, symptoms of the disease may return. Therefore, Tamsulosin Aristo should be taken for as long as your doctor has advised, even if symptoms have improved. If the patient plans to discontinue treatment, they should always consult their doctor first.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Common (less than 1 in 10 but more than 1 in 100 people (1-10%)):
Dizziness, particularly when sitting down or standing up. Ejaculation disorders. This means that
semen does not pass through the urethra but instead flows back into the bladder. This phenomenon is
harmless.
Uncommon (more than 1 in 1,000 but less than 1 in 100 people (0.1-1%)):
Headache, palpitations (awareness of heartbeat and faster than usual heart rate), low blood pressure,
e.g. when standing up quickly from a sitting or lying position, sometimes accompanied by
dizziness; nasal congestion or a stuffy nose (inflammation of nasal mucosa); diarrhoea;
nausea and vomiting, constipation; feeling of weakness (asthenia), rash, itching and local skin
inflammation (urticaria).
Rare (more than 1 in 10,000 but less than 1 in 1,000 people (0.01-0.1%)):
Fainting and sudden local swelling of soft tissues of the body (e.g. throat or tongue), difficulty
breathing and (or) itching and rash, often as an allergic reaction (angioedema).
Very rare (less than 1 in 10,000 people (<0.1%)):
Priapism (painful, prolonged, unwanted erection, which requires immediate treatment). Rash,
inflammation and blistering of the skin and (or) mucous membranes of the lips, eyes, mouth, nostrils or genital organs (Stevens-Johnson syndrome).
Frequency not known (frequency cannot be estimated from the available data):

• Blurred vision;

• Visual disturbances;

• Nosebleeds;

• Severe skin reactions (erythema multiforme, exfoliative dermatitis);

• Irregular, abnormal heartbeat (atrial fibrillation, arrhythmia, tachycardia), breathing difficulties (dyspnoea).

• If a patient is scheduled for eye surgery due to lens opacity (cataract) or increased intraocular pressure (glaucoma), and the patient is currently or has previously been treated with Tamsulosin Aristo, the pupil may dilate poorly and the iris (the coloured, circular part of the eyeball) may become floppy.

• Dry mouth.

If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform a doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Tamsulosin Aristo

Do not store above 30°C.
Keep the medicine in a place invisible and out of reach of children.
Do not use this medicine after the expiry date stated on the blister and cardboard
package after: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help
protect the environment.

6. Contents of the pack and other information

What Tamsulosin Aristo contains

• The active substance is tamsulosin hydrochloride.
• The other ingredients are: microcrystalline cellulose, talc, methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, polysorbate 80, glycerol monostearate, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172).

What Tamsulosin Aristo looks like and contents of the pack
Tamsulosin Aristo 0.4 mg modified-release hard capsules are hard capsules, 15.9 mm ± 0.3 mm in size, consisting of two parts: a yellow cap and a white body, containing white or almost white pellets.
Tamsulosin Aristo 0.4 mg modified-release hard capsules are packed in PVC/PVDC/aluminium blisters containing 10, 20, 30, 50 or 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warsaw
tel: +48 22 855 40 93

Manufacturers
Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany

Laboratorios Medicamentos Internacionales S.A.
Calle De La Solana 26
28850 Torrejón de Ardoz (Madrid)
Spain

This medicinal product is authorised in the European Economic Area member countries under the following names:
Germany Tamsulosin Aristo
Austria Tamsulosin Aristo
Czech Republic Tamsulosin Aristo
Spain Tamsulosina Aristo
Italy Tamsulosina Aristogen
Netherlands Tamsulosine Aristo 0.4 mg harde capsules met gereguleerde afgifte
Poland Tamsulosin Aristo