TAMSULOSIN 0.4 mg Modified-release hard capsule

Зміст інструкції

1. TAMSULOSIN DOC Generici 0.4 mg modified-release hard capsules
   1. WHAT IS TAMSULOSIN DOC Generici AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING TAMSULOSIN DOC Generici
2. TAMSULOSIN DOC Generici with other medicines (for example, ketoconazole, erythromycin).
   1. HOW TO USE TAMSULOSIN DOC Generici
   2. POSSIBLE SIDE EFFECTS
   3. HOW TO STORE TAMSULOSIN DOC Generici
   4. PACKAGE CONTENTS AND OTHER INFORMATION

TAMSULOSIN DOC Generici 0.4 mg modified-release hard capsules

Generic medicine

Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1.What TAMSULOSIN DOC Genericiis and what it is used for
• 2.What you need to know before you use TAMSULOSIN DOC Generici
• 3.How to use TAMSULOSIN DOC Generici
• 4.Possible side effects
• 5.How to store TAMSULOSIN DOC Generici
• 6.Contents of the pack and other information

1. WHAT IS TAMSULOSIN DOC Generici AND WHAT IS IT USED FOR

The active ingredient of TAMSULOSIN DOC Generici is tamsulosin. Tamsulosin is
a drug with selective antagonist action on α /α adrenergic receptors which reduces
muscle contraction at the level of the prostate and urethra; this facilitates the flow
of urine through the urethra and eases urination (expulsion of urine - urinating). In
addition, it reduces the sensation of urgency to urinate.
TAMSULOSIN DOC Generici is used in men for the treatment of lower urinary tract symptoms associated with Benign Prostatic Hyperplasia (BPH, i.e. enlargement
of the prostate). These disorders may include difficulty urinating (reduced
stream), dripping, urgency and the need to urinate frequently both during the day and at
night.

2. WHAT YOU NEED TO KNOW BEFORE USING TAMSULOSIN DOC Generici

Do not use TAMSULOSIN DOC Generici:

• 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 can manifest as a sudden local swelling of the body's soft tissues (e.g. throat or tongue) and of hands or feet, difficulty breathing and/or itching and skin rashes (angioedema).
• if you have fainted due to a drop in blood pressure when changing position (sitting up from lying down or standing up).
• if you suffer from severe liver problems.

Warnings and precautions
Consult your doctor or pharmacist before using TAMSULOSIN DOC Generici.

• Periodic medical check-ups are necessary to monitor the development of the condition for which you are being treated.
• Rarely, with the use of TAMSULOSIN DOC Generici, fainting may occur, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until they disappear.
• If you suffer from severe kidney problems, tell your doctor.
• if during the use of tamsulosin you have experienced a sudden local swelling of the body's soft tissues (e.g. throat or tongue) and of the hands and/or feet, difficulty breathing and/or itching and skin rashes, caused by an allergic reaction (angioedema), inform your doctor.
• if you are to undergo or are on the waiting list for eye surgery for cataracts (clouding of the lens) or increased eye pressure (glaucoma), inform your ophthalmologist if you have previously taken, are taking or intend to take TAMSULOSIN DOC Generici because a condition of the eye called “intraoperative floppy iris syndrome” (IFIS) may occur. The specialist will then be able to take the most appropriate precautions regarding the pharmacological treatments and surgical technique to be used. Ask your doctor if you should postpone or temporarily suspend taking this medicine before undergoing eye surgery for cataracts (clouding of the lens) or increased eye pressure (glaucoma).

Consult your doctor if you are or have been in the past in any of the situations described above.

Children
Do not give this medicine to children and adolescents under 18 years of age
because the medicine is not effective in this population.

Other medicines and TAMSULOSIN DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Taking TAMSULOSIN DOC Generici 0.4 mg with other medicines of the same
class (alpha-adrenoceptor antagonists) may cause an unwanted drop in
blood pressure.
Diclofenac (a medicine used to treat various types of pain)
and warfarin (used to prevent blood clotting) may affect the
rate at which TAMSULOSIN DOC Generici is removed from the body.
It is particularly important to inform your doctor if you are taking
at the same time other medicines that can decrease the removal of

TAMSULOSIN DOC Generici with other medicines (for example, ketoconazole, erythromycin).

Please note that the above information may also be valid for products used
in the more or less recent past or to be used in the more or less near future.

TAMSULOSIN DOC Generici with food and drink
The intake of TAMSULOSIN DOC Generici should occur after breakfast or after
the first meal of the day, while taking it on an empty stomach may lead to an
increase in undesirable effects or the severity of one of these.

Pregnancy, breastfeeding and fertility
TAMSULOSIN DOC Generici is not indicated in women.
In men, abnormal ejaculation (ejaculation disorders) has been reported. This
means that the seminal fluid does not exit the body through the urethra but enters the
bladder (retrograde ejaculation) or that the volume of ejaculation is reduced or absent
(failure to ejaculate). This event is harmless.

Driving and using machines
So far, no evidence has been found that tamsulosin alters the ability to
drive or use machinery.
However, you must be aware that dizziness may occur; in this case
you should not undertake those activities that require attention.

3. HOW TO USE TAMSULOSIN DOC Generici

Take this medicine following exactly the instructions of your doctor. If you have
doubts, consult your doctor or pharmacist.
The medicine is for oral use.
The recommended dose is one capsule a day after breakfast or after the first
meal of the day.
The capsule must be taken standing or sitting (not lying down) and must be swallowed
whole with a glass of water. The capsule must not be crushed or chewed
because this interferes with the modified release of the active substance.
Normally TAMSULOSIN DOC Generici is prescribed for long
periods of time. The effects on the urinary bladder and urination are maintained following
long-term treatment with tamsulosin.
The doctor who is treating you has prescribed a dose suitable for you and the disease you
suffer from, specifying the duration of treatment. Do not change this dose on your own initiative.
If you have the impression that the effect of tamsulosin is too strong or too weak,
talk to your doctor or pharmacist.

If you take more TAMSULOSIN DOC Generici than you should
If you take more TAMSULOSIN DOC Generici than you should, contact your doctor or
pharmacist immediately.
Taking an excessive dose of tamsulosin may induce an unwanted drop in
blood pressure and an increase in heart rate, associated with a feeling of
weakness. Dizziness, weakness, vomiting, diarrhea and
fainting may occur in such cases. Lie down to minimize the effects of lowering
blood pressure.

If you forget to take TAMSULOSIN DOC Generici
If you have forgotten to take a dose of TAMSULOSIN DOC Generici after
breakfast or after the first meal of the day, you can do so when you remember after
having eaten food. If you have missed a day, simply continue to take the daily
dose as prescribed.
Do not take a double dose to compensate for forgetting the dose.

If you stop taking TAMSULOSIN DOC Generici
When treatment with TAMSULOSIN DOC Generici is stopped
prematurely, the initial symptoms may reappear. Therefore, continue to take
TAMSULOSIN DOC Generici for the entire period of time prescribed by your doctor, even
if your symptoms have already disappeared. Always consult your doctor if you believe that this
therapy should be stopped.
If you have any doubts 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 will experience them.
Side effects classified according to the probability with which they may occur:

Common effects(occur in more than 1 in 100 patients, but less than 1 in 10):
dizziness (particularly when sitting up or standing up).
Abnormal ejaculation (ejaculation disorders). This symptom means that the
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
(anejaculation). This event is harmless.

Uncommon effects(occur in more than 1 in 1000 patients, but less than 1 in

100):
headache, palpitations (feeling your heartbeat faster than normal),
irregular decrease in blood pressure, for example when getting up quickly from
sitting or lying down, often associated with dizziness, stuffy or
runny nose (rhinitis), constipation, diarrhea, nausea, vomiting, skin redness (rash),
itching, skin redness (urticaria), feeling of weakness (asthenia).

Rare effects(occur in more than 1 in 10,000 patients, but less than 1 in 1000):
feeling faint (syncope); sudden localized swelling of soft tissues of the
body (e.g. throat and tongue) and hands and/or feet, difficulty
breathing with or without itching and skin redness (rash), as often occurs in an
allergic reaction (angioedema).

Very rare effects(occur in less than 1 in 10,000 patients):
severe skin rash, inflammation, blistering on the skin and/or
mucous membranes of lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome); involuntary, prolonged and painful erection requiring immediate medical
treatment (priapism).

Effects with unknown frequency(frequency cannot be estimated based on available
data):
blurred vision, impaired vision, nosebleeds (epistaxis),
severe skin rashes (erythema multiforme, exfoliative dermatitis), dry mouth,
abnormal irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), difficulty
breathing (dyspnea).
If you are about to undergo eye surgery for cataracts
or increased eye pressure (glaucoma) and if you are already taking or have
recently taken TAMSULOSIN DOC Generici, the pupil may dilate poorly
and the iris (the colored circular part of the eye) may become floppy during
surgery.

Reporting of side effects
If you experience any side effects, including those not listed in this
leaflet, please inform your doctor or pharmacist. You can also report side
effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information
on the safety of this medicine.

5. HOW TO STORE TAMSULOSIN DOC Generici

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

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

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

6. PACKAGE CONTENTS AND OTHER INFORMATION

What TAMSULOSIN DOC Generici contains
The active ingredient is tamsulosin hydrochloride 0.4 mg.
The other ingredients 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), iron oxide
yellow (E172), iron oxide red (E172), iron oxide black (E172).

Ink: shellac, iron oxide black (E172), propylene glycol.

Description of the appearance of TAMSULOSIN DOC Generici and package contents
The capsules of TAMSULOSIN DOC Generici are orange/olive green in colour with a
black band on both ends and the inscription ”TSL 0.4” in black on the capsule.
Available pack sizes are blisters or tablet containers with 10, 14, 20, 28, 30,
50, 56, 60, 90, 100 or 200 capsules.
Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER
DOC Generici Srl - Via Turati 40, 20121 Milan (Italy).

MANUFACTURER
SYNTHON BV - Microweg 22 - 6545 CM Nijmegen (Netherlands).
SYNTHON Hispania S.L. - Castello 1 Poligono las Salinas - 08830 Sant Boi de
Llobregat (Spain).

………..