PACKAGE LEAFLET: INFORMATION FOR THE USER

TAMSULOSIN PENSA 0.4 mg modified-release hard capsules

Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What TAMSULOSIN PENSA is and what it is used for
What you need to know before taking TAMSULOSIN PENSA
How to take TAMSULOSIN PENSA
Possible side effects
How to store TAMSULOSIN PENSA
Contents of the pack and other information

1. WHAT TAMSULOSIN PENSA IS AND WHAT IT IS USED FOR

The active substance in TAMSULOSIN PENSA is tamsulosin. Tamsulosin is a selective antagonist of α /α adrenoceptors, which reduces muscular contraction at the level of the prostate and urethra; this facilitates the flow of urine through the urethra and improves urination (urine expulsion). In addition, it reduces the sensation of urinary urgency.
TAMSULOSIN PENSA is used in men for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH, i.e. enlargement of the prostate gland). These symptoms may include difficulty urinating (reduced urinary stream), dribbling, urgency, and the need to urinate frequently both during the day and at night.

2. WHAT YOU SHOULD KNOW BEFORE USING TAMSULOSIN PENSA

Do not use TAMSULOSIN PENSA:

if you are allergic to tamsulosin hydrochloride or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity or allergy to tamsulosin hydrochloride may manifest as sudden local swelling of soft body tissues (e.g. throat or tongue) and of hands or feet, difficulty in breathing and/or itching and skin rashes (angioedema).
if you experience fainting due to a drop in blood pressure when changing position (e.g. sitting up from lying down or standing up).
if you have severe liver problems.

Warnings and precautions
Talk to your doctor or pharmacist before using TAMSULOSIN PENSA.

Regular medical check-ups are necessary to monitor the condition for which you are being treated.
Fainting may rarely occur during treatment with TAMSULOSIN PENSA, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until symptoms disappear.
If you have severe kidney problems, inform your doctor.
If you experienced sudden local swelling of soft body tissues (e.g. throat or tongue) and of hands and/or feet, breathing difficulties and/or itching and skin rashes caused by an allergic reaction (angioedema) while taking tamsulosin, inform your doctor.
If you are scheduled for, or are on a waiting list for, eye surgery due to cataract (lens opacity) or increased eye pressure (glaucoma), inform your ophthalmologist if you have previously taken, are currently taking, or plan to take TAMSULOSIN PENSA, as a condition called “intraoperative floppy iris syndrome” (IFIS) may occur. The specialist may therefore adopt appropriate precautions regarding pharmacological treatments and surgical technique. Ask your doctor whether you should delay or temporarily discontinue this medicine before undergoing eye surgery for cataract or glaucoma.

Consult your doctor if you are or have previously been in any of the situations described above.
Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age, as the medicine is not effective in this population.
Other medicines and TAMSULOSIN PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking TAMSULOSIN PENSA together with other medicines of the same class (α-adrenergic receptor antagonists) may cause an unintended drop in blood pressure.
Diclofenac (an anti-inflammatory medicine used to treat various types of pain) and warfarin (used to prevent blood clotting) may affect the rate at which TAMSULOSIN PENSA is eliminated from the body.
It is particularly important to inform your doctor if you are simultaneously taking other medicines that may reduce the elimination of TAMSULOSIN PENSA from the body (e.g., ketoconazole, erythromycin).
Please bear in mind that the above may also apply to products used in the recent or more distant past, or those to be used in the near or more distant future.
TAMSULOSIN PENSA with food and drink
TAMSULOSIN PENSA should be taken after breakfast or after the first meal of the day. Taking it on an empty stomach may increase the occurrence or severity of adverse effects.
Pregnancy, breastfeeding and fertility
TAMSULOSIN PENSA is not indicated for use in women.
In men, abnormal ejaculation (ejaculation disorders) has been reported. This means that seminal fluid does not exit the body through the urethra but enters the bladder (retrograde ejaculation), or that the volume of ejaculate is reduced or absent (anejaculation). This event is harmless.
Driving and using machines
To date, there is no evidence that tamsulosin impairs the ability to drive or operate machinery.
However, you should be aware that dizziness may occur; in such a case, you should avoid activities requiring alertness.
TAMSULOSIN PENSA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.

3. HOW TO TAKE TAMSULOSIN PENSA

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
This medicine is for oral use.
The recommended dose is one capsule daily, taken after breakfast or after the first meal of the day.
The capsule should be taken while standing or sitting (not lying down) and must be swallowed whole with a glass of water. The capsule must not be crushed or chewed, as this would interfere with the modified release of the active substance.
TAMSULOSIN PENSA is usually prescribed for long-term use. The effects on the urinary bladder and urination are maintained with long-term treatment with tamsulosin.
Your doctor has prescribed a dose appropriate for you and your condition, specifying the duration of treatment. Do not change this dose on your own initiative.
If you feel that the effect of tamsulosin is too strong or too weak, speak to your doctor or pharmacist.

If you take more TAMSULOSIN PENSA than you should
If you take more TAMSULOSIN PENSA than prescribed, contact your doctor or pharmacist immediately.
Taking an excessive dose of tamsulosin may cause an unwanted drop in blood pressure and an increased heart rate, associated with a feeling of weakness. Dizziness, weakness, vomiting, diarrhoea, and fainting may then occur. Lie down to minimize the effects of low blood pressure. Contact your doctor immediately if you have taken too much TAMSULOSIN PENSA.

If you forget to take TAMSULOSIN PENSA
If you forget to take a dose of TAMSULOSIN PENSA after breakfast or after the first meal of the day, you may take it as soon as you remember, provided you have already eaten. If you have missed a day, simply continue taking your daily dose as prescribed.
Do not take a double dose to make up for a forgotten dose.

If you stop taking TAMSULOSIN PENSA
If treatment with TAMSULOSIN PENSA is stopped prematurely, the initial symptoms may return. Therefore, continue taking TAMSULOSIN PENSA for the full duration prescribed by your doctor, even if your symptoms have already improved. Always consult your doctor if you think this treatment should be stopped.

If you have any 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 everyone experiences them.
Side effects categorized by how commonly they may occur:

Common side effects (may affect up to 1 in 10 people):
Dizziness (particularly when sitting down or standing up).
Ejaculation disorders (problems with ejaculation). This symptom means that semen does not exit the body through the urethra but enters the urinary bladder (retrograde ejaculation), or that the volume of semen is reduced or absent (failure to ejaculate). This event is harmless.

Uncommon side effects (may affect up to 1 in 100 people):
Headache, palpitations (feeling the heartbeat faster than normal), irregular drop in blood pressure, for example when standing up quickly from sitting or lying down, often associated with dizziness, stuffy or runny nose (rhinitis), constipation, diarrhoea, nausea, vomiting, skin rash, itching, skin redness (urticaria), feeling of weakness (asthenia).

Rare side effects (may affect up to 1 in 1,000 people):
Feeling faint (fainting); sudden localized swelling of soft tissues of the body (e.g. throat and tongue) and of the hands and/or feet, difficult breathing with or without itching and skin rash, as often seen in an allergic reaction (angioedema).

Very rare side effects (may affect up to 1 in 10,000 people):
Severe skin rash, inflammation, blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome); involuntary, prolonged and painful erection requiring immediate medical treatment (priapism).

Side effects with unknown frequency (frequency cannot be estimated from the available data):
Blurred vision, visual impairment, nosebleeds (epistaxis), severe skin rashes (erythema multiforme, exfoliative dermatitis), dry mouth, irregular or abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulty (dyspnoea).

If you are about to undergo eye surgery for clouding of the lens (cataract) or increased eye pressure (glaucoma), and you are currently taking or have recently taken TAMSULOSIN PENSA, your pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during surgery.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TAMSULOSIN PENSA

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

Blister pack: store in the original packaging.
Tablet container: keep the bottle tightly closed. Do not use this medicine after the expiry date which is stated on the blister, on the bottle, and on the carton after “Exp.”. The expiry date refers to the last day of that month.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What TAMSULOSIN PENSA contains
The active substance is tamsulosin hydrochloride 0.4 mg.
The other components are:
Capsule contents: microcrystalline cellulose, methacrylic acid – ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.
Capsule shell: gelatin, indigotine (E132), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Description of the appearance of TAMSULOSIN PENSA and contents of the pack
TAMSULOSIN PENSA capsules are orange/olive green in colour.
Pack sizes available are blisters or tablet containers containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 capsules. Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER
AND MANUFACTURER

MARKETING AUTHORISATION HOLDER
Pensa Pharma S.p.A. – Via Ippolito Rosellini, 12 – 20124 Milano, Italy

MANUFACTURER
SYNTHON BV - Microweg 22 - 6545 CM Nijmegen (The Netherlands).
SYNTHON Hispania S.L. - Castello 1, Poligono las Salinas - 088830 Sant Boi de Llobregat (Spain).
Quinta-Analytica s.r.o. – Pražská 1486/18c - 10200 Prague 10 – Czech Republic