OMNIC OCAS 0.4 MG PROLONGED-RELEASE FILM-COATED TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omnic Ocas 0.4 mg

prolonged-release film-coated tablets

tamsulosin hydrochloride

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Omnic Ocas 0.4 mg is and what it is used for
2. What you need to know before taking Omnic Ocas 0.4 mg
3. How to take Omnic Ocas 0.4 mg
4. Possible side effects
5. How to store Omnic Ocas 0.4 mg
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 alpha1A/1D adrenergic receptors. It reduces the tone of the smooth muscles in the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. In addition, it reduces 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 are symptoms such as: difficulty urinating (weak urinary stream), dribbling, urgency, and frequent need to urinate both at night and during the day.

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

Do not take Omnic Ocas

• if you are allergic (hypersensitive) to tamsulosin or to any of the other components of Omnic Ocas. Hypersensitivity may manifest as sudden localized swelling of 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 suffer from 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 periodic medical examinations are necessary to monitor the progression of the condition being treated.
• because, rarely, fainting may occur during treatment with Omnic Ocas, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until symptoms have disappeared.
• if you have severe kidney problems.
• if you are scheduled for or are undergoing eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma). Please inform your ophthalmologist if you have previously taken, are currently taking, or are considering taking Omnic Ocas. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor whether you should postpone or temporarily discontinue taking this medicine if you are undergoing surgery due to a cloudy lens (cataract) or increased eye pressure (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.

Taking Omnic Ocas 0.4 with other medicines

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

Taking Omnic Ocas together with other medicines of the same group (alpha1-adrenergic receptor blockers) may cause an undesirable drop in blood pressure.

It is especially important that you inform your doctor if you are also being treated with medicines that may reduce the elimination of Omnic Ocas from the body (e.g. ketoconazole, erythromycin).

Taking Omnic Ocas 0.4 with food and drink

You may take Omnic Ocas with or without food.

Pregnancy, breastfeeding and fertility

Omnic Ocas is not indicated for use in women.

In men, abnormal ejaculation (ejaculatory disorder) has been reported. This means that semen is not released through the urethra but instead enters the bladder (retrograde ejaculation), or the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

There is no evidence that Omnic Ocas affects the ability to drive or operate tools or machinery. However, you should bear in mind that dizziness may occur, in which case you should not perform activities requiring attention.

3. How to take Omnic Ocas 0.4

Follow exactly the instructions for using Omnic Ocas provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

Omnic Ocas is a specially designed tablet that allows the active substance to be gradually released after the tablet has been swallowed. You may notice a residue of the tablet in your stools. There is no risk of loss of efficacy, as the active substance has already been released.

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

If you feel that the effect 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 may lead to an unwanted drop in blood pressure and an increased heart rate, accompanied by a feeling of faintness. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 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 directed, you may take your daily dose later on the same day. If you have missed the dose for a whole day, you may 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

If treatment with Omnic Ocas is stopped prematurely, your original symptoms may return. Therefore, take Omnic Ocas for as long as your doctor has prescribed, even if your symptoms have disappeared. Always consult your doctor if you decide to discontinue treatment.

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

4. Possible adverse effects

Like all medicines, Omnic Ocas may produce adverse effects, although not everyone will experience them.

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

• dizziness, especially when sitting down or standing up
• abnormal ejaculation (ejaculation disorder). This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or that the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless

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

• headache, palpitations (heart beating faster than normal and noticeably), reduction in blood pressure, for example when standing up quickly after sitting or lying down, sometimes associated with dizziness, nasal drip or nasal blockage (rhinitis), diarrhoea, 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 localized 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 1 in 10,000 people):

• priapism (unwanted, prolonged and painful erection requiring immediate medical treatment)
• skin rash, inflammation and blistering of 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 available data):

• blurred vision
• visual disturbance
• nosebleed (epistaxis)
• severe skin rashes (erythema multiforme, exfoliative dermatitis)
• abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea)
• if you are undergoing eye surgery due to cataracts (lens opacity) or increased eye pressure (glaucoma), and you are currently taking or have previously taken Omnic Ocas, the pupil may dilate poorly and the iris (the circular coloured part of the eye) may become floppy during surgery
• 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the blister after “EXP” and on the carton after “CAD” (month and year). The expiry date refers to the last day of the stated month.

Store this medicine in the original packaging.

This medicine requires no special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE point. Ask your pharmacist how to dispose of medicines and containers you no longer need. 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 components are: in the tablet core: macrogol 7,000,000, macrogol 8,000, magnesium stearate (E470b), butylhydroxytoluene (E321), colloidal silica (E551); in the tablet coating: hypromellose (E464) and the yellow colouring agent 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 packed in aluminium blisters, which are contained in printed cardboard cartons of Omnic Ocas. The packs contain 10, 14, 18, 20, 28, 30, 45, 50, 56, 60, 90, 100 or 200 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Astellas Pharma, S.A.

Paseo de la Castellana, 259 D - 31st Floor

28046 Madrid (Spain)

Manufacturer

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

The Netherlands

This leaflet was approved in 12/2013

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