PATIENT INFORMATION LEAFLET

Omnic, 0.4 mg Modified Release Hard Capsules

tamsulosin hydrochloride

Read this leaflet carefully before you start taking 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 personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you notice any of the side effects listed below or any other side effects not listed in this leaflet, or if they become severe, tell your doctor or pharmacist.

Contents of the leaflet:

1. What Omnic 0.4 is and what it is used for
2. Before taking Omnic 0.4
3. How to take Omnic 0.4
4. Possible side effects
5. Storage of Omnic 0.4
6. Further information

The active ingredient in Omnic 0.4 is tamsulosin. It is a selective antagonist of alpha 1A/1D adrenergic receptors..It reduces the tension of the smooth muscles of the prostate and the urethra, allowing urine to pass more easily through the urethra and facilitating urination. Additionally, it decreases the sensation of urgency.

Omnic 0.4 is used in men for the treatment of lower urinary tract symptoms associated with an enlarged prostate gland (benign prostatic hyperplasia). These symptoms include: difficulty urinating (weak urine stream), dripping, urgent urination, and the need to urinate frequently both at night and during the day.

Do not takeOmnic 0.4

- if you are allergic (hypersensitive)to tamsulosin or any of the other components of Omnic 0.4.

Hypersensitivity may present as sudden swelling of soft body tissues (e.g. the throat or tongue), difficulty breathing and/or itching and skin rash (angioedema).

- if you have severe liver problems.

- if you experience dizziness due to a drop in blood pressure when changing position (sitting or standing up).

Be especially careful with Omnic 0.4

• Regular medical check-ups are necessary to monitor the progression of the disease you are being treated for.
• Rarely, dizziness may occur during the use of Omnic 0.4, as with other medications of this type. If you experience the first symptoms of dizziness or weakness, sit or lie down until they have disappeared.
• If you have severe kidney problems, consult your doctor.
• If you are scheduled to undergo or have scheduled eye surgery due to a cloudy lens (cataracts) or increased eye pressure (glaucoma). Please inform your ophthalmologist if you have taken Omnic 0.4 previously, are taking it now, or are thinking of taking it. The specialist will then take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should or should not postpone or temporarily discontinue taking this medication if you are scheduled to undergo eye surgery due to a cloudy lens (cataracts) or increased eye pressure (glaucoma).

Children

Do not administer this medication to children or adolescents under 18 years old because it does not work in this population.

Taking other medications

Taking Omnic 0.4 with other medications in the same group (alpha 1 adrenergic receptor antagonists)may cause an undesirable drop in blood pressure.

It is especially important to inform your doctor if you are being treated at the same time with medications that can reduce the elimination of Omnic from the body (e.g. ketoconazole, erythromycin).

Inform your doctor or pharmacist if you are taking or have taken recently any other medication, including those acquired without a prescription.

Taking Omnic 0.4 with food and drinks

Omnic 0.4 should be taken after breakfast or the first meal of the day.

Pregnancy, breastfeeding, and fertility

Omnic is not indicated for use in women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen does not release through the urethra, but goes to the bladder (retrograde ejaculation) or the volume of semen is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machines

There is no evidence that Omnic 0.4 affects the ability to drive or operate tools or machines. However, you should be aware that dizziness may occur, in which case, you should not perform activities that require attention.

Follow exactly the administration instructions for Omnic 0.4 provided by your doctor. Consult your doctor or pharmacist if you have any doubts. The dose is one capsule per day and it should be taken after breakfast or the first meal of the day. The capsule should be swallowed whole and not broken or chewed. Omnic 0.4 is usually prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with Omnic 0.4.

If you take more Omnic 0.4 than you should

Taking too much Omnic 0.4 may lead to an undesirable decrease in blood pressure and an increase in heart rate, with a feeling of dizziness. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested..

If you forget to take Omnic 0.4

If you have forgotten to take Omnic 0.4 as recommended, you can take your daily dose of Omnic 0.4 later in the same day. If you have missed a dose one day, you can simply continue taking your daily capsule as prescribed. Do not take a double dose to compensate for the missed doses.

Effects that occur when treatment with Omnic 0.4 is interrupted

When treatment with Omnic 0.4 is discontinued prematurely, your original discomforts may return. Therefore, take Omnic 0.4 for the entire time your doctor prescribes it, even if your discomforts have disappeared. Consult your doctor at all times if you decide to discontinue treatment.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, Omnic 0.4 may have side effects, although not everyone will experience them.

Frequent (may affect up to one in 10 patients):

Dizziness, especially when sitting or standing up.

Abnormal ejaculation (ejaculation alteration). This means that semen does not release through the urethra, but rather goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Less frequent (may affect up to one in 100 patients):

Headache, palpitations (the heart rate is faster than normal and also perceptible), reduction of blood pressure, for example, when standing up quickly after being seated or lying down, sometimes associated with dizziness, nasal dripping or obstruction (rhinitis), diarrhea, nausea and vomiting sensation, constipation, weakness (asthenia), skin rash, itching and hives (urticaria).

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

Fainting and sudden swelling of soft body tissues (such as the throat or tongue), breathing difficulty and/or itching and skin rash, often as an allergic reaction (angioedema).

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

Priapism (unwanted, prolonged, and painful erection that requires immediate medical treatment).

Skin rash, inflammation, and blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (Stevens-Johnson syndrome).

Unknown frequency (cannot be estimated from available data):

• Blurred vision
• Visual alteration
• Nosebleed (epistaxis)
• Severe skin eruptions (erythema multiforme, exfoliative dermatitis)
• Abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulty (dyspnea).
• If you are undergoing eye surgery due to a clouding of the lens (cataracts) or an increase in eye pressure (glaucoma), and you are taking or have taken Omnic 0.4 previously, during surgery, the pupil may dilate slightly and the iris (the colored part of the eye), may become flaccid.
• Dry mouth

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep in the original packaging.

Keep out of sight and reach of children.

Do not use Omnic 0.4 after the expiration date that appears on the blister after “EXP” and on the case after “CAD” (month and year). The expiration date is the last day of the month indicated.

Medicines should not be throwndown the drain orinto the trash.Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy.In case of doubtask your pharmacist how to dispose ofthe containers andthe medicines you no longer need. In this way, you will help protect the environment.

What Omnic 0.4 contains

• The active ingredient is tamsulosin hydrochloride
• The other components are: in the capsule content: microcrystalline cellulose (E460), copolymer of methacrylic acid and ethyl acrylate (1:1), polysorbate 80 (E433), sodium lauryl sulfate, triacetin (E1518), calcium stearate (E470a), and talc (E553b). In the capsule coating: hard gelatin, indigotin (E132), titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172). In the printing ink: Shellac (E904), propylene glycol (E1520), and black iron oxide (E172). (E172) .

Appearance of Omnic 0.4 and packaging size

Omnic 0.4 capsules are orange/green-olive colored, marked with the code “0.4”, logo, and “701”. Omnic 0.4 is packaged in aluminum blisters, which are then packaged in cardboard boxes. The packaging contains 10, 20, 30, 50, 60, 90, 100, or 200 capsules.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Astellas Pharma, S.A.

Paseo de la Castellana, 259 D - 31st Floor

28046 Madrid (Spain)

Phone: 0034-914952700

Responsible for Manufacturing:

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

Netherlands

This leaflet was approved in 12/2013

For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/