Tamsulosin pharmalab

Patient Information Leaflet

Tamsulosin Pharmalab, 0.4 mg, prolonged-release tablets
Tamsulosini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine 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 Pharmalab is and what it is used for
2. What you need to know before taking Tamsulosin Pharmalab
3. How to take Tamsulosin Pharmalab
4. Possible side effects
5. How to store Tamsulosin Pharmalab
6. Contents of the pack and other information

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

The active substance in Tamsulosin Pharmalab is tamsulosin hydrochloride. It belongs to a group of medicines called α-adrenolytics (or α-1A-adrenergic antagonists).
Tamsulosin reduces the tone of smooth muscles in the prostate gland and urethra, thus facilitating urine flow through the urethra and urination. Additionally, tamsulosin reduces the sensation of urinary urgency.
Tamsulosin Pharmalab is used in the treatment of lower urinary tract symptoms associated with an enlarged prostate gland (benign prostatic hyperplasia). These symptoms may include difficulty in urinating (weak stream), dribbling after urination, urinary urgency, and increased frequency of urination both during the day and at night.

2. Important information before taking Tamsulosin Pharmalab

When not to take Tamsulosin Pharmalab:

• If the patient is allergic (hypersensitive) to tamsulosin or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may manifest as sudden swelling of soft tissues (e.g. throat or tongue), difficulty in breathing and/or itching and rash (angioedema).
• If the patient has severe liver impairment.
• If the patient experiences fainting associated with low blood pressure upon changing position (from lying down to sitting or standing).

Do not take Tamsulosin Pharmalab without first consulting a doctor
if any of the above symptoms apply to the patient.
If in doubt, consult a doctor or pharmacist before taking this medicine.
Warnings and precautions
Before starting treatment with Tamsulosin Pharmalab, discuss it with your doctor.
Regular medical check-ups are necessary to monitor the progression of the disease being treated.
Rarely, as with other medicines in this class, a drop in blood pressure and fainting may occur. If symptoms such as dizziness or feeling weak occur, sit or lie down until symptoms subside.
If the patient has severe kidney disease, inform the doctor.
If the patient is scheduled for eye surgery due to cataract (clouding of the eye lens) or increased intraocular pressure (glaucoma), inform the ophthalmologist that the patient is currently taking, has previously taken, or plans to take Tamsulosin Pharmalab. The specialist can then take appropriate precautions regarding suitable treatment and surgical techniques. Ask the doctor whether the patient should refrain from starting or temporarily discontinue taking Tamsulosin Pharmalab prior to cataract removal or surgical treatment of increased intraocular pressure (glaucoma).
Children and adolescents
Tamsulosin Pharmalab should not be used in children and adolescents under 18 years of age, as safety and efficacy have not been established in this population.
Tamsulosin Pharmalab with other medicines
Concomitant use of Tamsulosin Pharmalab with other medicines of the same class (alpha-1 adrenergic receptor antagonists) may lead to unintended lowering of blood pressure.
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
It is particularly important to inform the doctor if the patient is taking medicines that may reduce the elimination of Tamsulosin Pharmalab from the body (e.g. ketoconazole, erythromycin).
Tamsulosin Pharmalab with food and drink
Tamsulosin Pharmalab can be taken independently of meals.
Pregnancy, breastfeeding and fertility
Tamsulosin Pharmalab is not indicated for use in women.
Cases of ejaculation disorders in men have been reported. This means that semen does not exit through the urethra but flows backward into the bladder (retrograde ejaculation), or the volume of ejaculate (semen) is reduced or ejaculation does not occur. This phenomenon is not dangerous.
Driving and operating machinery
The effect of Tamsulosin Pharmalab on the ability to drive and operate machinery has not been established. However, one should remain aware of the possibility of dizziness occurring; in such a case, activities requiring alertness should not be performed.

3. How to use Tamsulosin Pharmalab

Tamsulosin Pharmalab should always be taken exactly as directed by your doctor. If you are unsure,
you should consult your doctor or pharmacist.
The recommended dose is 1 tablet once daily.
Tamsulosin Pharmalab should be taken independently of meals, preferably at the same time each day.
The tablet should be swallowed whole and must not be chewed or crushed.
Tamsulosin Pharmalab is a modified-release tablet designed to release the active substance gradually
and evenly after swallowing. Remnants of the tablet may appear in the stool. This does not indicate
that the tablet has been ineffective, as the active substance has already been released from the tablet.
Tamsulosin Pharmalab is usually prescribed for long-term use.
Its effect on the bladder and urination is maintained during prolonged treatment with Tamsulosin Pharmalab.
Taking more Tamsulosin Pharmalab than recommended
Taking too many Tamsulosin Pharmalab tablets may lead to unwanted lowering of blood pressure and
increased heart rate accompanied by a feeling of weakness.
If you take more tablets than recommended, you should consult your doctor or go to a hospital immediately.
If you forget to take a dose of Tamsulosin Pharmalab
If you miss a dose, you may take the tablet later on the same day.
If a dose has been missed on any given day, continue treatment according to your previous dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping Tamsulosin Pharmalab treatment prematurely
If treatment is stopped early, symptoms of the disease may return. Therefore, you should continue taking
Tamsulosin Pharmalab for as long as your doctor has instructed, even if symptoms have improved.
Any decision to discontinue treatment should always be discussed with your doctor.
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 will experience them.
The following adverse reactions have been reported during treatment with Tamsulosin Pharmalab:
Common (may affect up to 1 in 10 patients):

• dizziness, particularly when changing position from lying to sitting or standing,
• ejaculation disorders (retrograde ejaculation, absence of ejaculation). Ejaculation disorders mean that semen does not exit through the urethra but instead flows backward into the bladder (retrograde ejaculation), or the volume of ejaculate (semen) is reduced or ejaculation does not occur. This phenomenon is not dangerous.

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

• headache,
• sensation of heart palpitations (palpitations, i.e. noticeable and faster than usual heartbeat),
• low blood pressure felt, for example, when sitting down or standing up from a lying position, associated with dizziness,
• nasal mucosal inflammation,
• gastrointestinal reactions (constipation, diarrhoea, nausea, vomiting),
• allergic reactions (rash, itching, urticaria),
• weakness.

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

• fainting,
• sudden localized swelling of soft tissues, e.g. throat, tongue, breathing difficulties and (or) itching and rash, often occurring as a result of an allergic reaction (angioedema).

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

• prolonged and painful penile erection (priapism), usually not during sexual activity, which requires immediate treatment,
• Stevens-Johnson syndrome (severe skin reactions which may manifest as rash, inflammation, and formation of blisters on the skin and (or) mucous membranes of the lips, eyes, mouth, nostrils or genital organs).

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

• blurred vision,
• visual disturbances,
• nosebleeds,
• severe skin reactions (erythema multiforme, exfoliative dermatitis),
• irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulties (dyspnoea),
• if a patient is scheduled for a surgical procedure due to cataract or elevated intraocular pressure (glaucoma), and the patient is currently taking or has previously taken tamsulosin, it should be considered that the patient's pupil may not dilate properly and the iris (the coloured, round part of the eyeball) may become flaccid during the procedure,
• dryness of the mouth.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, treatment with the medicine should be discontinued and a doctor or pharmacist should be notified.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Medical Devices and Biocidal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
ul. Al. Jerozolimskie 181C
PL - 02 222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather further information on the safety of this medicine.

5. How to store Tamsulosin Pharmalab

Keep this medicine out of sight and reach of children.
The blisters should be stored in the original packaging to protect them from light.
Do not use this medicine after the expiry date stated on the cardboard box and
on the immediate packaging (month / year). Blister labelling: EXP – expiry date, Lot – batch number.
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 packaging and other information

What Tamsulosin Pharmalab contains:

• The active substance is tamsulosin hydrochloride. Each prolonged-release tablet contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are: hypromellose, microcrystalline cellulose, carbomer (Carbopol 71G), colloidal anhydrous silica, iron oxide red (E 172), magnesium stearate.

What Tamsulosin Pharmalab looks like and contents of the pack
White, round tablets without a break line, 9 mm in diameter, with "T9SL" engraved on one side and "0.4" on the other.
The medicine is available in blister packs containing 14 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Pharmalab Poland Sp. z o.o.
ul. Siemianowicka 84
41-902 Bytom
[email protected]

Manufacturer:
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania SL
Castelló 1, Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain