OMNIC 0.4 MG Kapsułki o przedłużonym uwalnianiu

Treść ulotki

1. Omnic 0.4 mg prolonged-release film-coated tablets
   1. WHAT OMNIC IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING OMNIC
   3. HOW TO TAKE OMNIC
2. Omnic is a tablet specially designed to gradually release the
   1. POSSIBLE SIDE EFFECTS
   2. HOW TO STORE OMNIC
   3. PACKAGE CONTENTS AND OTHER INFORMATION
   4. WHAT OMNIC IS AND WHAT IT IS USED FOR
   5. BEFORE USING OMNIC
   6. HOW TO USE OMNIC
   7. POSSIBLE SIDE EFFECTS
   8. HOW TO STORE OMNIC
   9. OTHER INFORMATION

Omnic 0.4 mg prolonged-release film-coated tablets

tamsulosin hydrochloride

Read this leaflet carefully before you start taking 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 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 Omnic is and what it is used for
• 2. What you need to know before you take Omnic
• 3. How to take Omnic
• 4. Possible side effects
• 5. How to store Omnic Contents of the pack and other information

1. WHAT OMNIC IS AND WHAT IT IS USED FOR

The active ingredient of Omnic is tamsulosin, a drug with selective antagonist action on α / α adrenoreceptors which reduces muscle tension in the prostate and urethra. This allows urine to pass more quickly through the urethra, facilitating urination. In addition, it decreases the sensation of urgency to urinate.
Omnic is used in male subjects for the treatment of lower urinary tract symptoms associated with an enlarged prostate (benign prostatic hyperplasia).
These disorders can include difficulty urinating (reduced stream), dripping, urgency, and increased frequency of urination both during the day and at night.

2. WHAT YOU NEED TO KNOW BEFORE TAKING OMNIC

Do not take Omnic

• if you are allergic (hypersensitive) to tamsulosin or any of the other ingredients of Omnic. Hypersensitivity may manifest as sudden local swelling of soft tissues (e.g. throat or tongue), difficulty breathing and/or itching and rash (angioedema),
• if you suffer from severe liver problems,
• if you have fainting due to a drop in blood pressure when changing body position (sitting up or standing up). Warnings and precautions

Consult your doctor or pharmacist before taking OMNIC

• because periodic medical check-ups are necessary to monitor the development of the condition for which you are being treated.
• because, rarely, fainting may occur with the use of Omnic, 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.
• if you are to undergo or are on the waiting list for eye surgery for cataracts or increased eye pressure (glaucoma). Inform the ophthalmologist if you have previously taken, are taking or intend to take Omnic. The specialist may consequently adopt appropriate precautions regarding the medicine and the surgical technique to be used. Ask your doctor if you should postpone or temporarily suspend treatment with this medicine before undergoing eye surgery for cataracts or increased eye pressure (glaucoma). Children and adolescentsDo not give this medicine to children or adolescents under 18 years of age as it is not effective in this population. Other medicines and Omnic

Inform your doctor or pharmacist if you are taking, have recently taken or might
take any other medicine.
Taking Omnic with other medicines belonging to the same class (alpha-adrenoceptor antagonists)
may cause an unwanted drop in blood pressure.
It is particularly important to inform your doctor if you are simultaneously being treated
with medicines that can decrease the elimination of Omnic from the body (e.g.,
ketoconazole, erythromycin).

Omnic with food and drink
You can take Omnic with or without food.

Pregnancy, breastfeeding and fertility
The use of OMNIC 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 ejaculate is reduced or absent
(anejaculation). This event is harmless.

Driving and operating machinery
It has not been demonstrated that Omnic alters the ability to drive vehicles or operate
machinery or equipment. However, you should be aware of the possibility that
dizziness may occur, in which case you should not engage in activities that require
attention.

3. HOW TO TAKE OMNIC

Always take Omnic exactly as your doctor or pharmacist has instructed. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is 1 tablet daily. You can take Omnic with or without food, preferably at the same time each day.
The tablet should be swallowed whole, without breaking or chewing it.

Omnic is a tablet specially designed to gradually release the

active substance after ingestion. You may notice residues of the tablet in your stools. Since the active substance has already been released, there is no risk of reduced
tablet efficacy.
Normally Omnic is prescribed for long periods of time. The effects on the urinary bladder
and urination are maintained following long-term treatment with
Omnic.

If you take more Omnic than you should
Taking an excessive dose of Omnic may induce an unwanted drop in blood
pressure and an increase in heart rate, associated with a feeling of weakness.
If you have taken too many doses of Omnic, consult your doctor immediately.

If you forget to take Omnic
If you have forgotten to take a dose of Omnic, you can take it later in the same
day. If you have missed a day, continue taking the tablet for the day at the usual
time. Never take a double dose to make up for a forgotten one.

If you stop taking Omnic
When treatment with Omnic is stopped prematurely, your initial symptoms may reappear.
Therefore, continue taking Omnic for the entire period of time prescribed
by your doctor, even if your symptoms have already disappeared. Always consult your doctor if
you believe this therapy should be stopped.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Common (may affect up to 1 in 10 people):

• dizziness, particularly when getting up from sitting or lying down
• abnormal ejaculation (ejaculation disorders). This symptom means that the seminal fluid does not exit externally through the urethra but enters the urinary bladder (retrograde ejaculation) or that the volume of seminal fluid is reduced or absent (anejaculation). This event is harmless Uncommon (may affect up to 1 in 100 people):
• headache, palpitations (the heart beats faster than normal and is also noticeable), reduced blood pressure for example when getting up quickly from sitting or lying down often associated with dizziness, blocked or runny nose (rhinitis), diarrhoea, nausea and vomiting, constipation, weakness (asthenia), skin rash, itching and hives

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

• fainting and cases of sudden localised swelling of soft tissues of the body (for example of the throat and tongue), difficulty breathing and/or itching and

skin rash (rash), as often occurs in an allergic reaction
(angioedema)

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

• priapism (involuntary, painful and prolonged erection that requires immediate medical treatment)
• skin rash, inflammation, blistering on the skin and/or mucous membranes of lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome) Frequency not known(the frequency cannot be estimated on the basis of the available data): blurred vision impaired vision nosebleeds (epistaxis) severe skin rashes (erythema multiforme, exfoliative dermatitis) abnormal irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnoea) if you are about to undergo eye surgery for cataracts or increased pressure in the eye (glaucoma) and are already taking or have recently taken Omnic, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the operation dry mouth

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through 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 OMNIC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the outer packaging
after “Exp” (month and year). The expiry date refers to the last day of the month.
Store in the original package.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household . Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Omnic contains
The active ingredient is tamsulosin hydrochloride 0.4 mg.
The excipients are: in the tablet core: macrogol 7,000,000, macrogol 8,000,
magnesium stearate (E470b), butylhydroxytoluene (E321), anhydrous colloidal silica (E551); in the
tablet coating: hypromellose (E464) and the colorant yellow iron oxide (E172).

Description of the appearance of Omnic and contents of the pack
Omnic tablets are round, yellow, film-coated and marked with the code
‘04’.
Omnic tablets are packaged in aluminum blisters contained in a cardboard box that is printed with the name Omnic 0.4 mg prolonged-release film-coated tablets.
The packs contain 10, 14, 18, 20, 28, 30, 45, 50, 56, 60, 90, 100 or 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Astellas Pharma S.p.A.
Viale Don Luigi Sturzo, 43
20154 Milano (MI)
Italy

Manufacturer
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
Netherlands
Omnic 0.4 mg modified-release hard capsules
tamsulosin hydrochloride
_________________________________________________________________________

Read this leaflet carefully before you start using this medicine.

• 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. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Omnic is and what it is used for
• 2. Before you use Omnic
• 3. How to use Omnic
• 4. Possible side effects
• 5. How to store Omnic
• 6. Further information

1. WHAT OMNIC IS AND WHAT IT IS USED FOR

The active ingredient of Omnic is tamsulosin, a drug with selective antagonist action on α 1A/ α 1D adrenergic receptors which reduces muscle tension in the prostate and urethra. This allows urine to pass more quickly through the urethra, facilitating urination. In addition, it decreases the sensation of urgency to urinate.
Omnic is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate (benign prostatic hyperplasia). These disorders may include difficulty urinating (reduced stream), dripping, urgency, and increased frequency of urination both during the day and at night.

2. BEFORE USING OMNIC

Do not use Omnic

• if you are allergic (hypersensitive) to tamsulosin or any of the excipients of Omnic. Hypersensitivity may manifest as sudden local swelling of soft body tissues (e.g. throat or tongue), difficulty breathing and/or itching and rash (angioedema),
• if you suffer from severe liver problems,
• if you experience fainting due to a drop in blood pressure when changing position (sitting up from lying down or standing up).

Take special care with Omnic

• Periodic medical check-ups are necessary to monitor the development of the condition for which you are being treated.
• Rarely, with the use of Omnic, 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, inform your doctor.
• If you are to undergo or are on the waiting list for eye surgery for cataract (clouding of the lens) or increased eye pressure (glaucoma). Inform the ophthalmologist if you have previously taken, are taking or intend to take Omnic. The specialist may consequently adopt the most appropriate precautions regarding the medicine and the surgical technique to be used. Ask your doctor if you should postpone or temporarily suspend treatment with this medicine before undergoing eye surgery for cataract (clouding of the lens) or increased eye pressure (glaucoma).

Children
Do not administer this medicine to children or adolescents under 18 years of age as it is not
effective in this population.

Taking Omnic with other medicines
Taking Omnic with other medicines belonging to the same class (alpha 1-adrenoceptor antagonists)
may cause an unwanted drop in blood pressure.
It is particularly important to inform your doctor if you are simultaneously undergoing treatment
with medicines that may decrease the elimination of Omnic from the body (e.g.,
ketoconazole, erythromycin). Inform your doctor or pharmacist if you are taking or have
recently taken any other medicines, including those without a prescription.

Taking Omnic with food and drink
Omnic should be taken after breakfast or after the first meal of the day.

Pregnancy, breastfeeding and fertility
The use of OMNIC 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 ejaculate is reduced or absent (lack of
ejaculation). This event is harmless.

Driving and operating machinery
It has not been demonstrated that Omnic alters the ability to drive vehicles or operate
machinery or equipment. However, you should be aware of the possibility that
dizziness may occur, in which case you should not engage in activities that require
attention.

3. HOW TO USE OMNIC

Always take Omnic exactly as your doctor has instructed. If you have any doubts
you should consult your doctor or pharmacist. The usual dose is 1 capsule daily, to be
taken after breakfast or after the first meal of the day, every day.
The capsule should be swallowed whole, without crushing or chewing it.
Normally Omnic is prescribed for long periods of time. The effects on the urinary
bladder and urination are maintained following long-term treatment with
Omnic.

If you take more Omnic than you should
Taking an excessive dose of Omnic may induce an unwanted drop in blood
pressure and an increase in heart rate, associated with a feeling of weakness.
If you have taken too many doses of Omnic, consult your doctor immediately.

If you forget to take Omnic
If you have forgotten to take a dose of Omnic, you can take it later in the same day.
If you have skipped a day, continue to take the capsule for the day at the usual scheduled time.
Never take a double dose to make up for a forgotten one.

If you stop taking Omnic
When treatment with Omnic is stopped prematurely, the initial
symptoms may reappear. Therefore, continue to take Omnic 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 discontinued.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Omnic can cause side effects, although not everybody gets them.
Common side effects (less than 1 in 10 people, more than 1 in 100 people (1-10%)):
dizziness, particularly when getting up from sitting or lying down.
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 side effects (more than 1 in 1000 people, less than 1 in 100 people (0.1-1%)):
headache, palpitations (the heart beats faster than normal and is also noticeable),
low blood pressure, for example when getting up quickly from sitting or lying down, often
associated with dizziness, stuffy or runny nose (rhinitis), diarrhoea, nausea and
vomiting, constipation, weakness (asthenia), skin redness (rash), itching and hives.
Rare side effects (more than 1 in 10,000 people, less than 1 in 1000 people (0.01-0.1%)):
fainting and cases of sudden localised swelling of the soft tissues of the body (for example
of the throat and tongue), difficulty breathing with or without itching and skin redness
(rash), as often occurs in an allergic reaction (angioedema).
Very rare side effects (less than 1 in 10,000 people (<0.01%)):
priapism (involuntary, painful and prolonged erection that requires immediate medical
treatment). Skin rash, inflammation, blistering on the skin and/or on the
mucous membranes of the lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome).
Side effects with unknown frequency (frequency cannot be estimated based on available data):

• blurred vision
• impaired vision
• nosebleed (epistaxis)
• severe skin rashes (erythema multiforme, exfoliative dermatitis)
• abnormal irregular heartbeat (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnoea).
• if you are about to undergo eye surgery for cataracts or increased pressure in the eye (glaucoma) and are already taking or have recently taken Omnic, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the operation.
• dry mouth.

If any of these side effects get serious, or if you notice any side effects not listed in this leaflet,
tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 OMNIC

Store in the original package.
Keep Omnic out of the reach and sight of children.
Do not use Omnic after the expiry date which is reported on the blister and on the package after “Scad”
(month and year). The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. OTHER INFORMATION

What Omnic contains
The active ingredient is tamsulosin hydrochloride.
The excipients are: capsule content: microcrystalline cellulose (E460); methacrylic acid-ethyl acrylate copolymer (1:1); polysorbate 80 (E433); sodium lauryl sulfate; triacetin (E1518); calcium stearate (E470a); talc (E553b). Capsule shell: hard gelatin; indigotin (E132); titanium dioxide (E171); yellow iron oxide (E172); red iron oxide (E172). Printing ink: shellac (E904), propylene glycol (E1520), black iron oxide (E172).

Description of the appearance of Omnic and the contents of the pack
The Omnic capsules are orange/olive green in colour, marked with the codes ‘0.4’, ‘701’ and logo.
The Omnic capsules are packaged in polypropylene-aluminium blisters contained in a cardboard box. The pack contains 10, 20, 30, 50, 60, 90, 100 or 200 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Astellas Pharma S.p.A.
Viale Don Luigi Sturzo, 43
20154 Milan (MI)
Italy

Manufacturer
Astellas Pharma Europe B.V.
Sylviusweg 622333 BE Leiden
Netherlands