Package Leaflet: Information for the User

Omnic Ocas 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, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Omnic Ocas 0.4 is and what it is used for

2. What you need to know before taking Omnic Ocas 0.4

3. How to take Omnic Ocas 0.4

4. Possible side effects

5. Storage of Omnic Ocas 0.4

6. Contents of the pack and additional information

The active ingredient in Omnic Ocas 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 Ocas 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 Ocas

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omnic Ocas 0.4.

• because regular medical check-ups are necessary to monitor the progression of the disease you are being treated for.
• because, rarely, dizziness may occur during the use of Omnic Ocas, as with other medications of this type. Sit or lie down at the first symptoms of dizziness or weakness until they have disappeared.
• if you have severe kidney problems.
• if you are scheduled to undergo or have scheduled eye surgery due to a cloudy lens (cataracts) or increased pressure in the eye (glaucoma). Please inform your ophthalmologist if you have taken Omnic Ocas 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 (cataract) or increased pressure in the eye (glaucoma).

Children and adolescents

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

Taking Omnic Ocas 0.4 with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Taking Omnic Ocas with other medications in the same group (alpha 1 adrenergic receptor blockers)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 Ocas from the body (e.g. ketoconazole, erythromycin).

Taking Omnic Ocas 0.4 with food and drinks

You can take Omnic Ocas with or without food.

Pregnancy, breastfeeding, and fertility

Omnic Ocas 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 Ocas 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 Ocas indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet per day.You can take Omnic Ocas with or without food, preferably at the same time of day.

The tablet must be swallowed whole and should not be broken or chewed.

Omnic Ocas is a tablet designed to release the active ingredient gradually once ingested. It is possible that you may observe a remainder of the tablet in your stool. There is no risk of loss of efficacy since the active ingredient has already been released.

Omnic Ocas is usually prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with Omnic Ocas.

If you estimate that the action of Omnic Ocas is too strong or too weak, inform your doctor or pharmacist.

If you take more Omnic Ocas 0.4 than you should

Taking too many tablets of Omnic Ocas may lead to an undesirable decrease in blood pressure and an increase in heart rate, with a sensation 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 forgot to take Omnic Ocas 0.4

If you have forgotten to take Omnic Ocas as recommended, you can take your daily dose of Omnic Ocas later in the same day. In case you have missed a dose one day, you can simply continue taking your daily tablet as prescribed.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Omnic Ocas 0.4

When treatment with Omnic Ocas is discontinued prematurely, your original discomforts may return. Therefore, take Omnic Ocas for the entire time your doctor prescribes, 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 medication, ask your doctor or pharmacist.

Like all medicines, Omnic Ocas can cause side effects, although not everyone will experience them.

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

• 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

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

• headache, palpitations (the heart beats faster than normal and is 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 nasal obstruction (rhinitis), diarrhea, nausea and vomiting, constipation, weakness (asthenia), skin rash, itching and hives (urticaria)

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

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

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

• 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(the frequency cannot be estimated from available data):

• blurred vision
• vision alteration
• nosebleed (epistaxis)
• severe skin eruptions (erythema multiforme, exfoliative dermatitis)
• abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), breathing difficulty (dyspnea).
• if you are to undergo 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 Ocas previously, during the surgery, the pupil may dilate slightly and the iris (the colored part of the eye), may become flaccid.
• dry mouth

Reporting of adverse effects

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

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

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

Store this medication in its original packaging.

This medication does not require special storage conditions.

Medicines should not be throwndown the drains orinto the trash.Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy.Ask your pharmacist how to dispose of the packaging andmedicines you no longer need. In this way, you will help protect the environment.

Composition of Omnic Ocas 0.4

The active ingredient is hydrochloride of tamsulosin 0.4 mg.

The other components are: in the core of the tablet: macrogol 7,000,000, macrogol 8,000, magnesium stearate (E470b), butylhydroxytoluene (E321), colloidal silica (E551); in the coating of the tablet: hypromellose (E464) and the yellow iron oxide colorant (E172).

Appearance of the product and contents of the packaging

The Omnic Ocas tablets are round, yellow, coated with a film and marked with the code '04'.

The Omnic Ocas tablets are packaged in aluminum blisters which are in cartons of Omnic Ocas printed. The packaging contains 10, 14, 18, 20, 28, 30, 45, 50, 56, 60, 90, 100 or 200 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization

Astellas Pharma, S.A.

Paseo de la Castellana, 259 D - 31st Floor

28046 Madrid (Spain)

Responsible for manufacturing

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

Netherlands

This leaflet was approved in 12/2013

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ )