Tamsulosin Aurovitas

Package Leaflet: Information for the User

Tamsulosin Aurovitas, 400 micrograms, prolonged-release hard capsules

Tamsulosin hydrochloride

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 experience any side effects, or if any of the side effects get serious, tell your doctor or pharmacist. See section 4.

Contents of the package leaflet:

• 1. What is Tamsulosin Aurovitas and what is it used for
• 2. Before you take Tamsulosin Aurovitas
• 3. How to take Tamsulosin Aurovitas
• 4. Possible side effects
• 5. How to store Tamsulosin Aurovitas
• 6. Contents of the pack and other information

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

The active substance of Tamsulosin Aurovitas is tamsulosin. It is a selective alpha-1 adrenergic receptor antagonist. It reduces the tension of the prostate and urethra (urethral sphincter), allowing urine to flow through the urethra and making it easier to urinate. Additionally, it reduces the feeling of pressure on the bladder. Tamsulosin Aurovitas is used in men to treat the symptoms of benign prostatic hyperplasia (BPH), which include: difficulty urinating (weak urine flow), urinating in drops or interrupted streams, sudden urge to urinate, and frequent urination both at night and during the day.

2. Before you take Tamsulosin Aurovitas

When not to take Tamsulosin Aurovitas:

if you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Symptoms of hypersensitivity include sudden local swelling of soft tissues (throat or tongue), difficulty breathing, and (or) itching and rash (angioedema), if you have severe liver disease, if you have experienced fainting when changing body position (sitting or standing) due to decreased blood pressure.

Warnings and precautions

Before taking Tamsulosin Aurovitas, consult your doctor or pharmacist. Regular medical check-ups are necessary to monitor changes in your condition and the disease being treated. Rarely, as with other medicines of this type, when taking Tamsulosin Aurovitas, fainting may occur. If you experience the first symptoms such as dizziness or weakness, you should sit or lie down until these symptoms pass. If you have severe kidney disease, you should tell your doctor. If you are going to have cataract surgery (clouding of the lens) or increased eye pressure (glaucoma), you should inform your ophthalmologist that you have taken or plan to take Tamsulosin Aurovitas. The ophthalmologist may take necessary precautions regarding the treatment and surgical technique. You should ask your doctor if you should stop or temporarily discontinue taking this medicine if you are planning to have cataract surgery or increased eye pressure. Children and adolescentsDo not take this medicine if you are under 18 years old, as it does not work in this population.

Tamsulosin Aurovitas with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Taking Tamsulosin Aurovitas with other medicines in the same group (alpha-1 adrenergic receptor antagonists) may lead to undesirable blood pressure lowering. It is especially important to inform your doctor if you are being treated with medicines that may reduce the elimination of Tamsulosin Aurovitas from your body (e.g., ketoconazole, erythromycin).

Tamsulosin Aurovitas with food and drink

Tamsulosin Aurovitas should be taken after the first meal of the day.

Pregnancy and breast-feeding

Tamsulosin Aurovitas is not indicated for use in women. In men, ejaculation disorders (ejaculation failure) have been reported. This means that semen does not leave the body through the urethra but instead enters the bladder (retrograde ejaculation) or the volume of ejaculation is reduced, or ejaculation does not occur (ejaculation failure). This phenomenon is harmless.

Driving and using machines

There is no evidence that tamsulosin impairs the ability to drive or operate machinery. However, you should be aware of the possibility of dizziness, so if this applies to you, you should not engage in activities that require attention. The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Tamsulosin Aurovitas

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is one capsule per day after breakfast or after the first meal of the day. The capsule should be swallowed whole, do not chew or crush it. Tamsulosin Aurovitas is usually prescribed for long-term use. The effect on the bladder and urination is maintained during long-term treatment with Tamsulosin Aurovitas.

If you take more Tamsulosin Aurovitas than you should

If you take more Tamsulosin Aurovitas than you should, you may experience a sudden drop in blood pressure and an increase in heart rate, with a feeling of fainting. If you take more Tamsulosin Aurovitas than you should, contact your doctor immediately.

If you forget to take Tamsulosin Aurovitas

If you forget to take your daily dose of Tamsulosin Aurovitas, you can take it later that day. If you forget to take a dose, skip the missed dose and continue with your regular dosing schedule the next day. Do not take a double dose to make up for the missed dose.

Stopping treatment with Tamsulosin Aurovitas

If you stop treatment with Tamsulosin Aurovitas too early, the original symptoms of the disease may return. Therefore, the medicine should be taken for as long as your doctor has prescribed, even if the symptoms of the disease have disappeared. Consult your doctor if you are considering stopping treatment. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tamsulosin Aurovitas can cause side effects, although not everybody gets them.

Stop taking Tamsulosin Aurovitas and contact your doctor immediately if you experience any of the following allergic reactions:

difficulty breathing, swelling of the face or throat (angioedema), itching and rash. Frequent(may affect up to 1 in 10 people): dizziness, especially when sitting or standing, abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body through the urethra but instead enters the bladder (retrograde ejaculation) or the volume of ejaculation is reduced, or ejaculation does not occur (ejaculation failure). This phenomenon is harmless. Uncommon(may affect up to 1 in 100 people): headache, palpitations (heart rate is faster than usual and is noticeable), low blood pressure, for example when standing up quickly from a sitting or lying position, sometimes with dizziness, runny nose or stuffy nose (rhinitis), constipation, diarrhea, nausea and vomiting, weakness (asthenia), rash, itching and hives. Rare(may affect up to 1 in 1,000 people): fainting and sudden local swelling of soft tissues (e.g., throat or tongue), difficulty breathing and (or) itching and rash, often as an allergic reaction (angioedema). Very rare(may affect up to 1 in 10,000 people): painful, prolonged, and unwanted erection (priapism), which requires immediate treatment, severe disease characterized by blistering of the skin, around the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome).

Not known (frequency cannot be estimated from the available data):

vision disorders, blurred vision, nosebleeds, severe skin rash (erythema multiforme, exfoliative dermatitis), irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea), if you are undergoing eye surgery for cataracts or increased eye pressure and you are taking or have taken Tamsulosin Aurovitas, during the procedure the pupil may not dilate properly and the iris (the colored round part of the eye) may become floppy. dry mouth.

Reporting of side effects

If you experience any side effects, including any not listed in this package leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported 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 Aurovitas

Keep this medicine out of the sight and reach of children. There are no special precautions for storage temperature. Store in the original package to protect from moisture. Do not use this medicine after the expiry date stated on the carton or bottle after: Expiry date (EXP). The expiry date refers to 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. This will help protect the environment.

6. Contents of the pack and other information

What Tamsulosin Aurovitas contains

The active substance is tamsulosin hydrochloride. One prolonged-release hard capsule contains 0.4 mg of tamsulosin hydrochloride.

• Other ingredients are: Capsule content: microcrystalline cellulose, talc, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, polysorbate 80, sodium lauryl sulfate, triacetin, and calcium stearate.

Capsule shell: indigo carmine (E 132), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), gelatin, sodium lauryl sulfate. Ink: shellac, propylene glycol, iron oxide black (E 172), potassium hydroxide.

What Tamsulosin Aurovitas looks like and contents of the pack

Prolonged-release hard capsules. Olive-green and orange, non-transparent, hard gelatin capsules, size "1EL", with black edible ink prints "D" on the cap and "53" on the body. The capsules contain white or almost white pellets. Tamsulosin Aurovitas prolonged-release hard capsules are available in the following packs: PVC/PE/PVDC/Aluminum blister pack in a cardboard box: Pack sizes: 1, 2, 4, 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100, and 200 hard capsules. HDPE bottle with PP cap in a cardboard box: Pack sizes: 10 and 250 hard capsules. Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warsaw e-mail: [email protected] Manufacturer:APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta Generis Farmacêutica, S.A. Rua João de Deus 19, Venda Nova 2700-487 Amadora Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France:

TAMSULOSINE ARROW LP 0,4 mg, gélule à libération prolongée Germany: Tamsulosin Aurobindo 0,4 mg Retardkapseln Italy: Tamsulosina Aurobindo 400 microgrammi capsule rigide a rilascio prolungato Malta: Tamsulosin Aurobindo 0.4 mg prolonged-release capsules Netherlands: Tamsulosine HCl Aurobindo 0,4 mg, capsules met gereguleerde afgifte, hard Poland: Tamsulosin Aurovitas Portugal: Tansulosina Aurobindo Romania: Tamsulosin Aurobindo, 400 micrograme capsule cu eliberare prelungită Spain: Tamsulosina Aurobindo 0,4 mg capsulas duras de liberacion prolongada EFG

Date of last revision of the package leaflet: 07/2023