Tamsulosin Aristo

Package Leaflet: Information for the User

Tamsulosin Aristo, 0.4 mg, prolonged-release hard capsules
Tamsulosini hydrochloridum

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

• 1. What Tamsulosin Aristo is and what it is used for
• 2. Before you take 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 of Tamsulosin Aristo is tamsulosin. It is a selective alpha-1 adrenergic receptor antagonist. Tamsulosin reduces the tension of the smooth muscles of the prostate gland (prostate) and the urethra, thus facilitating the flow of urine through the urethra. Additionally, it reduces the feeling of urgency to urinate. Tamsulosin Aristo is used in men for the treatment of symptoms of benign prostatic hyperplasia (BPH). These symptoms may include difficulty urinating (weak stream), urinating in drops, feeling of sudden urgency to urinate, and frequent urination both at night and during the day.

2. Before you take Tamsulosin Aristo

When not to take Tamsulosin Aristo

• if you are allergic (hypersensitive) to tamsulosin or 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 disorders,
• if you have experienced fainting due to low blood pressure when changing positions (e.g., sitting or standing up).

Warnings and precautions

Before starting treatment with Tamsulosin Aristo, you should discuss it with your doctor.

• Regular medical check-ups are necessary to determine the progression of the disease being treated.
• Rarely, as with other medicines in the same group, fainting may occur. If symptoms such as dizziness or weakness occur, you should sit or lie down until the symptoms pass.
• If you have severe kidney disease, you should inform your doctor.
• If you are scheduled to undergo eye surgery for cataracts, you should inform your ophthalmologist that you have taken, are taking, or plan to take Tamsulosin Aristo. The specialist will be able to take appropriate precautions regarding treatment and surgical techniques. You should ask your doctor if you should stop taking Tamsulosin Aristo or temporarily discontinue it if you are scheduled to undergo eye surgery for cataracts.

Children and adolescents

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

Tamsulosin Aristo with other medicines

Taking Tamsulosin Aristo with other medicines in the same group (alpha-1 adrenergic receptor antagonists) may cause unintended lowering of blood pressure. It is especially 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). You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription.

Tamsulosin Aristo with food, drink, and alcohol

Tamsulosin Aristo should be taken after breakfast or the first meal of the day. You should avoid consuming alcohol before or during treatment with Tamsulosin Aristo.

Pregnancy, breastfeeding, and fertility

Tamsulosin Aristo is not indicated for use in women, so information on pregnancy and breastfeeding is not relevant.

Fertility

There have been reports of ejaculation disorders associated with tamsulosin use (see section 4).

Driving and using machines

There is no evidence of the effect of tamsulosin on the ability to drive and use machines or equipment. However, you should be aware that tamsulosin may cause dizziness, and in such cases, you should not engage in activities that require concentration.

3. How to take Tamsulosin Aristo

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, ask your doctor or pharmacist. The recommended dose is one capsule per day, taken after breakfast or the first meal of the day. The capsule should be swallowed whole, without crushing or chewing. Tamsulosin Aristo is usually prescribed for long-term use. The effect on the bladder and urination is maintained during long-term treatment with Tamsulosin Aristo.

If you take more Tamsulosin Aristo than you should

Taking too much Tamsulosin Aristo may lead to unintended lowering of blood pressure and increased heart rate with a feeling of fainting. If you have taken too much Tamsulosin Aristo, you should contact your doctor immediately.

If you forget to take Tamsulosin Aristo

If you forget to take your daily dose of Tamsulosin Aristo as prescribed, you can take it later that day. If you miss a dose on a given day, simply continue taking the capsule as scheduled. Do not take a double dose to make up for the missed dose.

If you stop taking Tamsulosin Aristo

If you stop taking Tamsulosin Aristo prematurely, the symptoms of the disease may return. Therefore, you should take Tamsulosin Aristo for as long as your doctor has prescribed, even if the symptoms of the disease have disappeared. If you plan to stop treatment, you should always consult your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Common(less than 1 in 10, but more than 1 in 100 people (1-10%)):
Dizziness, especially when sitting or standing up. Ejaculation disorders. This means that semen does not flow 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 (heartbeat felt and faster than usual), low blood pressure, e.g., when standing up quickly from a sitting or lying position, sometimes with accompanying dizziness; runny nose or feeling of a blocked nose (rhinitis); diarrhea; nausea and vomiting, constipation; feeling of weakness (asthenia), rash, itching, and localized 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 localized swelling of soft tissues (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 genitals (Stevens-Johnson syndrome).
Frequency not known(frequency cannot be estimated from the available data):

• blurred vision;
• vision disorders;
• nasal bleeding;
• severe skin reactions (erythema multiforme, exfoliative dermatitis);
• abnormal, irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea).
• If you are scheduled to undergo eye surgery for cataracts or increased eye pressure (glaucoma) and have taken or are taking Tamsulosin Aristo, the pupil may not dilate properly, and the iris may become floppy.

dry mouth.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please 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 to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tamsulosin Aristo

Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 and ethyl acrylate copolymer, 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, prolonged-release hard capsules, are hard capsules with a size of 15.9 mm ± 0.3 mm, consisting of two parts: a yellow cap and a white body, containing white or almost white pellets.
Tamsulosin Aristo, 0.4 mg, prolonged-release hard capsules, are packaged in PVC/PVDC/Aluminum blisters containing 10, 20, 30, 50, or 100 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw
phone: +48 22 855 40 93
Manufacturer
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 medicine is authorized in the Member States of the European Economic Area 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

Date of last revision of the package leaflet: