Omnic 0.4 mg modified-release capsules

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omnic, 0.4 mg modified-release hard capsules

tamsulosin hydrochloride

Read the entire 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 other people. It may harm them, even if their symptoms are the same as yours.

• If you notice any adverse effects not listed in this leaflet, or if you experience any of the described adverse effects severely, inform your doctor or pharmacist.

In this leaflet:

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

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

The active substance in Omnic 0.4 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 0.4 is used in men for the treatment of lower urinary tract symptoms associated with enlargement of the prostate gland (benign prostatic hyperplasia). These are symptoms such as: difficulty urinating (weak urine stream), dribbling, urgency, and frequent need to urinate both during the night and during the day.

2. Before taking Omnic 0.4

Do not take Omnic 0.4

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

Hypersensitivity may manifest as sudden localized swelling of soft tissues in 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).

Take special care with Omnic 0.4

• Periodic medical examinations are necessary to monitor the progression of the condition being treated.
• Fainting episodes may rarely occur during treatment with Omnic 0.4, 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, consult your doctor.
• If you are undergoing or have scheduled 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 0.4. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor whether you should delay or temporarily discontinue this medicine prior to undergoing surgery for a cloudy lens (cataract) or increased eye pressure (glaucoma).

Children

Do not give this medicine to children or adolescents under 18 years of age, as it is not effective in this population.

Taking other medicines

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

It is especially important that you 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 obtained 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, breast-feeding and fertility

Omnic is not indicated for use in women.

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

Driving and using machines

There is no evidence that Omnic 0.4 affects the ability to drive or operate tools or machinery. However, you should bear in mind that dizziness may occur, and in such a case, you should not perform activities requiring alertness.

3. How to take Omnic 0.4

Follow exactly your doctor's instructions for taking Omnic 0.4. If you have any doubts, consult your doctor or pharmacist. The dose is one capsule per day, to be taken after breakfast or the first meal of the day. The capsule must be swallowed whole and must not be broken or chewed. Omnic 0.4 is usually prescribed for long-term use. 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 unwanted drop in blood pressure and an increased heart rate, accompanied by a feeling of fainting. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 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 directed, you may take your daily dose later on the same day. If you have missed the dose for one day, you may simply continue taking your daily capsule as prescribed. Do not take a double dose to make up for missed doses.

Effects when treatment with Omnic 0.4 is stopped

When treatment with Omnic 0.4 is discontinued prematurely, your original symptoms may return. Therefore, take Omnic 0.4 for as long as your doctor has prescribed, even if your symptoms have disappeared. Always consult your doctor if you decide to stop treatment.

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

4. Possible adverse effects

Like all medicines, Omnic 0.4 may have adverse effects, although not everyone experiences them.

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

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 patients):

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 congestion (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 patients):

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 patients):

Priapism (undesired, 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).

Frequency not known (cannot be estimated from available data):

• Blurred vision
• Vision disturbances
• Nosebleeds (epistaxis)
• Severe skin rashes (erythema multiforme, exfoliative dermatitis)
• Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnoea).
• If you are undergoing eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), and you are currently taking or have previously taken Omnic 0.4, your pupil may dilate poorly and the iris (the coloured circular 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Omnic 0.4

Keep in the original packaging.

Keep out of the sight and reach of children.

Do not use Omnic 0.4 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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Additional Information

What Omnic 0.4 contains

• The active substance 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 shell: gelatin, indigo carmine (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).

Appearance of Omnic 0.4 and pack sizes

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Astellas Pharma, S.A.

Paseo de la Castellana, 259 D - 31st Floor

28046 Madrid (Spain)

Tel 0034-914952700

Manufacturer:

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

The Netherlands

This leaflet was approved in 12/2013

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/