Tamsulosin aurovitas

Package leaflet: Information for the user

Tamsulosin Aurovitas, 400 micrograms, prolonged-release capsules, hard
Tamsulosini hydrochloridum
Read the entire leaflet before taking this medicine, as it contains important information
for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any further questions.
• 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 any of the side effects worsens or if any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Tamsulosin Aurovitas is and what it is used for
2. Important information before taking 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 Tamsulosin Aurovitas is and what it is used for

The active ingredient in Tamsulosin Aurovitas is tamsulosin. It is a selective antagonist of
α-adrenergic receptors. It reduces the tone of the muscles in the prostate gland and the urinary
tract (urethra), allowing urine to flow through the urethra and facilitating urination. Additionally,
it reduces the sensation of bladder pressure.
Tamsulosin Aurovitas is used in men to treat symptoms of the lower urinary tract associated
with benign prostatic hyperplasia (BPH). These symptoms include: difficulty urinating (weakened
urine stream), urination in drops or interrupted stream, sudden urge to urinate, and frequent
urination both during the night and during the day.

2. Important information before using Tamsulosin Aurovitas

When not to use Tamsulosin Aurovitas:
if the patient is allergic to tamsulosin or to any of the other ingredients of this medicine
(listed in section 6). Symptoms of hypersensitivity include sudden localised swelling
of soft tissues of the body (throat or tongue), difficulty in breathing and (or) itching and rash
(angioedema),
if the patient has severe liver disease,
if the patient has experienced fainting upon changing body position (sitting or standing up)
due to low blood pressure.

Warnings and precautions
Before starting treatment with Tamsulosin Aurovitas, consult a doctor or pharmacist.
Regular medical check-ups are necessary to monitor changes in the patient's condition and the disease being treated.
Rarely, as with other medicines of this type, fainting may occur during treatment with Tamsulosin Aurovitas. If first symptoms such as dizziness or weakness occur, the patient should sit or lie down until these symptoms subside.
If the patient has severe kidney disease, he should inform his doctor.
If the patient is to undergo cataract surgery (clouding of the eye lens) or surgery for increased eye pressure (glaucoma), he should inform his ophthalmologist before the procedure that he has previously taken or plans to take Tamsulosin Aurovitas. The ophthalmologist may take necessary precautions regarding treatment and surgical technique. Please consult your doctor whether discontinuation or temporary interruption of this medicine is advisable if cataract surgery (cataract) or surgery for increased eye pressure (glaucoma) is planned.

Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age, as it is not effective in this population.

Tamsulosin Aurovitas with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Concomitant use of Tamsulosin Aurovitas with other medicines belonging to the same group (α-adrenergic receptor antagonists) may lead to an undesirable decrease in blood pressure.
It is particularly important to inform the doctor if the patient is being treated simultaneously with medicines that may reduce the elimination of Tamsulosin Aurovitas from the patient's 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 breastfeeding
Tamsulosin Aurovitas is not indicated for use in women.
In men, ejaculation disorders 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 ejaculate is reduced, or ejaculation does not occur at all (anejaculation). This phenomenon is harmless.

Driving and operating machinery
There are no data indicating that tamsulosin impairs the ability to drive or operate machinery.
However, one should bear in mind the possibility of dizziness; therefore, if this affects the patient, he should not engage in activities requiring attention.

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to use Tamsulosin Aurovitas

This medicine should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.
The recommended dose is one capsule daily, taken 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 urinary bladder and urination is maintained during prolonged treatment with Tamsulosin Aurovitas.

Taking more Tamsulosin Aurovitas than recommended
If more than the recommended dose of Tamsulosin Aurovitas is taken, a sudden drop in blood pressure and increased heart rate may occur, accompanied by a feeling of faintness.
If an overdose is taken, contact a doctor immediately.

Missing a dose of Tamsulosin Aurovitas
If a patient forgets to take the daily dose of Tamsulosin Aurovitas as prescribed, the dose can be taken later the same day. If a patient forgets to take the medicine for one day, the missed dose should be skipped and the patient should continue taking the prescribed dose at the usual time the next day. Do not take a double dose to make up for the missed dose.

Stopping Tamsulosin Aurovitas treatment
If treatment with Tamsulosin Aurovitas is stopped too early, the original symptoms of the disease may return. Therefore, the medicine should be taken for as long as prescribed by the doctor, even if symptoms have improved. Consult your doctor before considering discontinuation of treatment.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should 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.

Common (may occur in up to 1 in 10 patients):
dizziness, especially when sitting down or standing up
abnormal ejaculation (ejaculation disorder). This means that semen does not exit the body through the urethra but enters the urinary bladder (retrograde ejaculation), or the volume of ejaculate is reduced, or ejaculation does not occur (ejaculation failure). This phenomenon is harmless.

Uncommon (may occur in up to 1 in 100 patients):
headache
palpitations (heart beating faster than normal and felt by the patient)
lowering of blood pressure, for example when standing up quickly from a sitting or lying position, sometimes associated with dizziness
nasal congestion or runny nose (rhinitis)
constipation
diarrhea
nausea and vomiting
weakness (asthenia)
rash
itching and urticaria.

Rare (may occur in up to 1 in 1,000 patients):
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 (may occur in up to 1 in 10,000 patients):
painful, prolonged and unwanted erection (priapism), which requires immediate treatment
severe illness characterized by blister formation on the skin, around the mouth, eyes, nasal passages, and genital organs (Stevens-Johnson syndrome).

Unknown frequency (cannot be estimated from available data):
vision disturbances
blurred vision
nosebleeds
severe skin rashes (erythema multiforme, exfoliative dermatitis)
irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia)
breathing difficulties (dyspnea)
if the patient undergoes eye surgery due to cataract or increased intraocular pressure (glaucoma) and is currently taking or has previously taken Tamsulosin Aurovitas, the pupil may dilate poorly and the iris (the colored circular part of the eye) may become floppy during the procedure.
dry mouth.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Tamsulosin Aurovitas

Keep this medicine out of the sight and reach of children.
No special precautions regarding the storage temperature of the medicinal product are required.
Store in the original packaging 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 stated month.
Medicines must not be disposed of via the sewage system or in 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 Aurovitas contains
The active substance is tamsulosin hydrochloride. One prolonged-release hard capsule contains 0.4 mg of tamsulosin hydrochloride.

• Other components are:
  Capsule contents: 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.
Printing 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 opaque/orange opaque hard gelatin capsules, size "1EL", printed with black edible ink markings "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 pack sizes:
PVC/PE/PVDC/Aluminium blister packs in cardboard packaging:
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 closure in cardboard packaging:
Pack sizes: 10 and 250 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer / Importer:
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 authorised in the European Economic Area under the following names:
France: TAMSULOSINE ARROW LP 0.4 mg, prolonged-release capsules
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