Omnic

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omnic 0.4 mg prolonged-release film-coated tablets

tamsulosin hydrochloride
Read this entire leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking Omnic
3. How to take Omnic
4. Possible side effects
5. How to store Omnic
6. Contents of the pack and other information

1. WHAT OMNIC IS AND WHAT IT IS USED FOR

The active substance of Omnic is tamsulosin, a selective antagonist of α₁ adrenoceptors, which reduces muscle tension in the prostate and urethra. This allows urine to pass more easily through the urethra, thus facilitating urination. In addition, it reduces the sensation of urinary urgency.
Omnic is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate (benign prostatic hyperplasia). These symptoms may include difficulty urinating (reduced urinary stream), dribbling, urgency, and increased frequency of urination both during the day and at night.

2. WHAT YOU SHOULD KNOW BEFORE TAKING OMNIC

Do not take Omnic

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

Warnings and precautions
Talk to your doctor or pharmacist before taking OMNIC

• because periodic medical checks are necessary to monitor the condition for which you are being treated.
• because fainting may rarely 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 symptoms disappear.
• if you have severe kidney problems.
• if you are scheduled for or on a waiting list for eye surgery due to cataract or increased eye pressure (glaucoma). Inform your ophthalmologist if you have previously taken, are currently taking, or plan to take Omnic. The specialist may then take appropriate precautions regarding the medicine and the surgical technique to be used. Ask your doctor whether you should postpone or temporarily discontinue treatment with this medicine before undergoing eye surgery for cataract or glaucoma.

Children and adolescents
Do not administer 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 medicines.
Taking Omnic together with other medicines belonging to the same class (α-adrenergic receptor 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 may reduce the elimination of Omnic from the body (e.g., ketoconazole, erythromycin).
Omnic with food and drink
You may take Omnic either during or apart from meals.
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 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 (anejaculation). This event is harmless.
Driving and using machines
Omnic has not been shown to impair the ability to drive or operate machinery or equipment. However, you should be aware of the possibility of dizziness occurring; in such a case, you should not engage in activities requiring attention.

3. HOW TO TAKE OMNIC

Always take Omnic exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet daily. You may take Omnic with or without food, preferably always at the same time each day.
The tablet must be swallowed whole, without crushing or chewing.
Omnic is a specially designed tablet that gradually releases the active substance after ingestion. You may notice tablet residues in your stools. Since the active substance has already been released, there is no risk of reduced tablet efficacy.
Omnic is usually prescribed for long-term use. The effects on the urinary bladder and urination are maintained during long-term treatment with Omnic.
If you take more Omnic than you should
Taking an excessive dose of Omnic may cause an unwanted drop in blood pressure and increased heart rate, associated with a feeling of weakness.
If you have taken too much Omnic, consult your doctor immediately.
If you forget to take Omnic
If you have forgotten to take a dose of Omnic, you may take it later the same day.
If you have missed a day, continue taking the tablet at your usual scheduled time.
Never take a double dose to make up for a forgotten dose.
If you stop taking Omnic
If treatment with Omnic is stopped prematurely, the initial symptoms may reappear. Therefore, continue taking Omnic 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 discontinued.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Omnic may cause adverse reactions, although not everyone experiences them.
Common (may affect up to 1 in 10 people):

• dizziness, particularly when sitting down or standing up
• abnormal ejaculation (ejaculation disorders). This symptom means that 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 (failure to ejaculate). This event is harmless

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

• headache, palpitations (heart beats faster than normal and is noticeable), reduction in blood pressure, for example when standing up quickly from sitting or lying down, often associated with dizziness, stuffy or runny nose (rhinitis), diarrhoea, nausea and vomiting, constipation, weakness (asthenia), skin rash, itching and urticaria

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

• fainting and cases of sudden localized swelling of soft tissues of the body (e.g. throat and tongue), difficulty breathing and/or itching and skin rash (rash), as often seen in an allergic reaction (angioedema)
  Very rare (may affect up to 1 in 10,000 people):
• priapism (painful, prolonged, involuntary erection requiring immediate medical treatment)
• skin rash, inflammation, blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome)

Frequency not known (frequency cannot be estimated from the available data):
blurred vision
visual disturbances
nosebleeds (epistaxis)
severe skin rashes (erythema multiforme, exfoliative dermatitis)
abnormal irregular 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 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 surgery
dry mouth

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, 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 stated on the blister and carton after "Exp" (month and year). The expiry date refers to the last day of the specified month.
Store in the original packaging.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Omnic contains
The active substance is tamsulosin hydrochloride 0.4 mg.
The excipients are: in the tablet core: macrogol 7,000,000, macrogol 8,000,
magnesium stearate (E470b), butylated hydroxytoluene (E321), anhydrous colloidal silica (E551); in the tablet coating: hypromellose (E464) and the yellow iron oxide colourant (E172).
Description of the appearance of Omnic and the contents of the pack
Omnic tablets are round, yellow, film-coated tablets marked with the code '04'.
Omnic tablets are packed in aluminium blisters contained in a cardboard carton which displays the printed name Omnic 0.4 mg prolonged-release film-coated tablets.
Pack sizes 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 Milan (MI)
Italy
Manufacturer
Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel
The Netherlands
This patient information leaflet was last approved on:

PATIENT LEAFLET: INFORMATION FOR THE USER

Omnic 0.4 mg modified-release hard capsules

tamsulosin hydrochloride
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What Omnic is and what it is used for
2. Before you take Omnic
3. How to take 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 substance in Omnic is tamsulosin, a selective antagonist of α₁ adrenoceptors, which reduces muscular tension in the prostate and urethra. This allows urine to pass more easily through the urethra, thus facilitating urination. Additionally, it reduces the sensation of urinary urgency.
Omnic is used in men for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). These symptoms may include difficulty urinating (reduced urinary stream), dribbling, 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 to any of the excipients of Omnic. Hypersensitivity may present as sudden local swelling of soft body tissues (e.g. throat or tongue), breathing difficulties and/or itching and skin rash (angioedema),
• if you have 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 condition for which you are being treated.
• Fainting is rare but may occur with Omnic, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until symptoms subside.
• If you have severe kidney problems, inform your doctor.
• If you are scheduled for, or are on a waiting list for, eye surgery due to cataract or increased eye pressure (glaucoma). Inform your ophthalmologist if you have previously taken, are currently taking, or plan to take Omnic. The specialist may then adopt the most appropriate precautions regarding the choice of medication and surgical technique. Ask your doctor whether you should postpone or temporarily discontinue treatment with this medicine before undergoing eye surgery for cataract or 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 together with other medicines of the same class (α-adrenergic receptor 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 may reduce 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 not requiring a prescription.
Taking Omnic with food and drinks
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 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
It has not been shown that Omnic impairs the ability to drive vehicles or operate machinery or equipment. However, you should be aware of the possibility of dizziness occurring; in such a case, you should not undertake activities requiring attention.

3. HOW TO USE OMNIC

Always take Omnic exactly as directed by your doctor. If you have any doubts, you must consult your doctor or pharmacist. The usual dose is 1 capsule per day, taken after breakfast or after the first meal of the day, every day.
The capsule should be swallowed whole, without crushing or chewing it.
Omnic is normally prescribed for long-term use. The effects on the urinary bladder and urination are maintained with long-term treatment with Omnic.
If you take more Omnic than you should
Taking an excessive dose of Omnic may cause an unwanted drop in blood pressure and an increased heart rate, associated with a feeling of weakness.
If you have taken too much Omnic, consult your doctor immediately.
If you forget to take Omnic
If you forget to take a dose of Omnic, you may take it later on the same day. If you miss a day, continue taking the capsule at your usual scheduled time. Never take a double dose to make up for a missed dose.
If you stop taking Omnic
If treatment with Omnic is stopped prematurely, the initial symptoms may reappear. Therefore, continue taking Omnic for the entire duration prescribed by your doctor, even if your symptoms have already disappeared. Always consult your doctor if you think this treatment should be stopped.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Omnic may cause adverse reactions, although not everyone experiences them.
Common adverse reactions (less than 1 in 10, more than 1 in 100 (1-10%)):
dizziness, particularly when sitting down or standing up.
Abnormal ejaculation (ejaculation disorders). This symptom means that seminal fluid does not exit the body through the urethra but enters the urinary bladder (retrograde ejaculation), or that the volume of seminal fluid is reduced or absent (failure to ejaculate). This event is harmless.
Uncommon adverse reactions (more than 1 in 1,000, less than 1 in 100 (0.1-1%)):
headache, palpitations (heart beating faster than normal and perceptible), reduction in blood pressure, for example when standing up quickly from sitting or lying down, often associated with dizziness, nasal congestion or runny nose (rhinitis), diarrhoea, nausea and vomiting, constipation, weakness (asthenia), skin redness (rash), itching and urticaria.
Rare adverse reactions (more than 1 in 10,000, less than 1 in 1,000 (0.01-0.1%)):
fainting and cases of sudden localized swelling of soft tissues of the body (e.g. throat and tongue), difficulty breathing with or without itching and skin redness (rash), as often seen in an allergic reaction (angioedema).
Very rare adverse reactions (less than 1 in 10,000 (<0.01%)):
priapism (painful, prolonged involuntary erection requiring immediate medical treatment).
Skin rash, inflammation, blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils or genitals (Stevens-Johnson syndrome).
Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):
blurred vision
visual disturbances
nosebleeds (epistaxis)
severe skin rashes (erythema multiforme, exfoliative dermatitis)
abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulties (dyspnoea).
if you are about to undergo eye surgery for lens opacity (cataract) or increased eye pressure (glaucoma) and you are already taking or have recently taken Omnic, your pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during surgery.
dry mouth.
If any of the adverse reactions worsen, or if you notice a new adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

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

5. HOW TO STORE OMNIC

Store in the original packaging.
Keep Omnic out of the reach and sight of children.
Do not use Omnic after the expiry date stated on the blister pack and carton after "Exp" (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 substance is tamsulosin hydrochloride.
The excipients are: capsule contents: 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: gelatin; indigo carmine (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 contents of the pack
Omnic capsules are orange/olive green in colour, marked with the codes '0.4', '701' and the logo.
Omnic capsules are packed in polypropylene-aluminum blisters contained in a cardboard carton. Packs contain 10, 20, 30, 50, 60, 90, 100 or 200 capsules. Not all pack sizes may be marketed.

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

Manufacturer
Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel
The Netherlands

This leaflet was last approved on: