OMNIC OCAS 0.4 mg PROLONGED-RELEASE FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Omnic Ocas 0.4 mg

prolonged-release tablets, film-coated

tamsulosin hydrochloride

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Omnic Ocas 0.4 is and what it is used for
2. What you need to know before you take 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 other information

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

The active substance 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 urethra, allowing urine to pass more easily through the urethra and facilitating urination. It also 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 frequent need to urinate both at night and during the day.

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

Do not takeOmnic Ocas

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

Warnings and precautions

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

• because periodic medical examinations are necessary to monitor the progression of the disease being treated.
• because, rarely, fainting can occur during the use of Omnic Ocas, as with other medications of this type. At the first symptoms of dizziness or weakness, you should sit or lie down until they have disappeared.
• if you have severe kidney problems.
• if you are going to undergo or have scheduled eye surgery due to cataracts or increased pressure in the eye (glaucoma). Please inform your ophthalmologist if you have taken, are taking, or are thinking of taking Omnic Ocas. The specialist can then take the appropriate precautions regarding medication and surgical techniques to be used. Consult your doctor if you should or should not postpone or temporarily suspend taking this medication if you are going to undergo such surgery due to a cataract or increased pressure in the eye (glaucoma).

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age because it does not work in this population.

Taking Omnic Ocas 0.4 with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 that you inform your doctor if you are being treated at the same time with medications that can decrease 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 is not released through the urethra, but rather goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

There is no evidence that Omnic Ocas affects the ability to drive or use tools or machines. However, you should keep in mind that dizziness can occur, in which case you should not perform activities that require attention.

3. How to take Omnic Ocas 0.4

Follow exactly the administration instructions of 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 should be swallowed whole and not broken or chewed.

Omnic Ocas is a tablet designed to release the active substance gradually once the tablet is ingested. You may observe a remainder of the tablet in your stool. There is no risk of loss of efficacy since the active substance 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 think the action of Omnic Ocas is too strong or too weak, tell your doctor or pharmacist.

If you take more Omnic Ocas 0.4 than you should

Taking too many Omnic Ocas tablets can lead to an undesirable drop in blood pressure and an increase in heart rate, with a feeling of fainting. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget 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 that day. If you have missed the dose for a day, you can simply continue taking your daily tablet as prescribed.

Do not take a double dose to make up for forgotten doses.

If you stop taking Omnic Ocas 0.4

When treatment with Omnic Ocas is abandoned prematurely, your original symptoms may return. Therefore, take Omnic Ocas for the entire time your doctor prescribes it, even if your symptoms have disappeared. Always consult your doctor if you decide to stop treatment.

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

4. Possible side effects

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

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

• dizziness, especially when sitting or standing
• abnormal ejaculation (alteration of ejaculation). This means that semen is not released through the urethra, but rather goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory insufficiency). This phenomenon is harmless

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

• headache, palpitations (heartbeat is faster than normal and also perceptible), reduction of blood pressure, for example, when standing up quickly after sitting or lying down, sometimes associated with dizziness, nasal drip or nasal congestion (rhinitis), diarrhea, feeling of nausea and vomiting, constipation, weakness (asthenia), skin rash, itching, and hives (urticaria)

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

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

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

• priapism (undesired, 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)

Not known(frequency cannot be estimated from the available data):

• blurred vision
• vision changes
• nosebleeds (epistaxis)
• severe skin rashes (erythema multiforme, exfoliative dermatitis)
• abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea)
• if you are going to undergo eye surgery due to cataracts or increased pressure in the eye (glaucoma), and you are already taking or have taken Omnic Ocas, during the operation, the pupil may dilate poorly and the iris (colored part of the eye) may become flaccid.
• dry mouth

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omnic Ocas 0.4

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

Do not use Omnic Ocas after the expiry date which is stated on the blister after “EXP” and on the carton after “CAD” (month and year). The expiry date is the last day of the month stated.

Store this medicine in its original packaging.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omnic Ocas 0.4

The active substance is tamsulosin hydrochloride 0.4 mg.

The other ingredients 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 colorant yellow iron oxide (E172).

Appearance of the product and contents of the pack

Omnic Ocas tablets are round, yellow, film-coated, and marked with the code ‘04’.

Omnic Ocas tablets are packaged in aluminum blisters which are packaged in Omnic Ocas printed cardboard boxes. 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 authorization holder

Astellas Pharma, S.A.

Paseo de la Castellana, 259 D - Planta 31

28046 Madrid (Spain)

Manufacturer

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

Netherlands

This leaflet was approved in 12/2013

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)