TAMSULOSIN ARISTO 0.4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tamsulosin Aristo 0.4 mg prolonged-release hard capsules EFG

tamsulosin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this 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 signs of illness 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 pack and other information

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

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

The active substance of this medicine is tamsulosin. It is a selective antagonist of alpha-1A/1D adrenergic receptors. It reduces the tension of the smooth muscles of the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. Additionally, it decreases the sensation of urgency.

Tamsulosin 0.4 is used in men for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (enlargement of the prostate gland). These symptoms include: difficulty urinating (weak urine flow), dribbling, urgent urination, and frequent need to urinate both at night and during the day.

2. What you need to know before you take Tamsulosin Aristo

Do not take tamsulosin

• If you are allergic (hypersensitive) to tamsulosin or any of the other ingredients of this medicine (listed in section 6).

Hypersensitivity may present as sudden local swelling of the soft tissues of the body (e.g., throat or tongue), difficulty breathing, and/or itching and skin rash (angioedema).

• If you have severe liver problems.
• If you have dizziness due to a decrease in blood pressure when changing position (sitting or standing up).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• Regular medical examinations are necessary to monitor the development of the disease being treated.
• Rarely, fainting may occur during the use of tamsulosin, as with other medications of this type. At the first symptoms of dizziness or weakness, you should sit or lie down until they have disappeared.
• If you have severe kidney problems, consult your doctor.
• If you are going to undergo or have scheduled eye surgery due to cataracts, inform your ophthalmologist if you have taken tamsulosin previously, are taking it, or are thinking of taking it. The specialist can then take the appropriate precautions regarding medication and surgical techniques to be used. Consult your doctor if you should or should not postpone or temporarily suspend taking this medicine if you are going to undergo such surgery due to a cataract.

Children and adolescents

This medicine is not suitable for children or adolescents under 18 years of age because it does not work in this population.

Other medicines and tamsulosin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking tamsulosin with other medicines of the same group (alpha-1 adrenergic receptor antagonists) may produce an undesired decrease in blood pressure.

It is especially important that you inform your doctor if you are being treated at the same time with medicines that can decrease the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Taking tamsulosin with food and drinks

Tamsulosin should be taken after breakfast or the first meal of the day.

Avoid consuming alcohol before or with tamsulosin.

Fertility, pregnancy, and breastfeeding

This medicine is not indicated for use in women, so 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 using machines

There is no evidence that tamsulosin affects the ability to drive or use tools or machines. However, you should keep in mind that dizziness may occur, in which case you should not perform activities that require attention.

3. How to take Tamsulosin Aristo

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The dose is one capsule per day and should be taken after breakfast or the first meal of the day. The capsule should be swallowed whole and not broken or chewed. Normally, tamsulosin 0.4 is prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with this medicine.

If you take more tamsulosin than you should

Taking too many tamsulosin capsules may lead to an undesired decrease in blood pressure and an increase in heart rate, with a feeling of fainting.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take tamsulosin

You can take your daily dose of tamsulosin 0.4 later the same day if you have forgotten to take it as recommended. In case you have missed the dose one day, you can simply continue taking your daily capsule as prescribed. Do not take a double dose to make up for forgotten doses.

If you stop taking tamsulosin

When treatment with tamsulosin 0.4 is abandoned prematurely, your original symptoms may return. Therefore, take this medicine for the entire time your doctor prescribes it, even if your symptoms have disappeared. Always consult your doctor if you decide to stop treatment.

If you have any other questions about 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(may affect up to 1 in 10 people):

Dizziness, especially when sitting or standing up.

Abnormal ejaculation. This means that semen is not released through the urethra but goes into the bladder. This phenomenon is harmless.

Uncommon(may affect up to 1 in 100 people):

Headache, palpitations (heartbeat is faster than normal and also perceptible), decreased blood pressure, for example, when getting up quickly from a sitting or lying position, sometimes associated with dizziness; runny or stuffy nose (rhinitis), diarrhea, feeling of nausea and vomiting, constipation, weakness (asthenia), skin rash, itching, and hives (urticaria). The latter means that semen does not come out of the body through the urethra but goes into the bladder. This phenomenon is harmless.

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

Fainting and sudden local swelling of the soft tissues of the body (such as the throat or tongue), difficulty breathing, and/or itching and skin rash, often as an allergic reaction (angioedema).

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

Priapism (undesired, prolonged, and painful erection that requires immediate medical treatment).

Rash, inflammation, and blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (Stevens-Johnson syndrome).

Frequency not known(cannot be estimated from the available data)

• Blurred vision.
• Alteration of vision.
• Nosebleeds.
• Severe skin rashes (erythema multiforme, exfoliative dermatitis).
• Abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea).
• If you are going to undergo eye surgery due to cataracts or due to increased eye pressure (glaucoma) and are already taking or have taken tamsulosin, the pupil may not dilate properly and the iris (the colored part of the eye) may become flaccid during the procedure.
• Dry mouth.

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

Reporting of side effects

If you experience 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 Spanish Medicines Agency's online platform (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Aristo

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

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

Composition of Tamsulosin Aristo

• The active substance is tamsulosin hydrochloride.

Each capsule contains 0.4 mg of tamsulosin hydrochloride.

• The other ingredients (excipients) are:

microcrystalline cellulose, talc, methacrylic acid - ethyl acrylate copolymer (1:1), triethyl citrate, polysorbate 80, glycerol monostearate, gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Appearance of the product and pack contents

The prolonged-release hard capsules are hard two-piece capsules, size 15.9 mm ± 0.3 mm with a yellow cap and white body containing white to off-white granules.

Tamsulosin Aristo is available in PVC/PVdC-Al blisters of 10, 20, 30, 50, 100 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany Tamsulosin Aristo 0.4 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Austria Tamsulosin Aristo Pharma 0.4 mg Hartkapseln mit veränderter Wirkstofffreisetzung

Czech Republic Tamsulosin Aristo 0.4 mg Tvrdé tobolky s rízeným uvolnováním

Spain Tamsulosina Aristo 0.4 mg cápsulas duras de liberación modificada EFG

Italy Tamsulosina Aristogen 0.4 mg Capsule rigide a rilascio modificato

Poland Tamsulosin Aristo

Date of last revision of this leaflet:May 2024

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/