OMNIC 0.4 mg MODIFIED-RELEASE CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omnic, 0.4 mg hard capsules of modified release

tamsulosin hydrochloride

Read the entire package leaflet carefully before starting to take the medicine.

• Keep this package 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 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

In this package 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

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 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. 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 frequent need to urinate both at night and during the day.

2. Before taking Omnic 0.4

Do not takeOmnic 0.4

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

Hypersensitivity may manifest as sudden local swelling of the body's soft tissues (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 up).

Be careful with Omnic 0.4

• Regular medical check-ups are necessary to monitor the development of the disease being treated.
• Rarely, fainting may occur during the use of Omnic 0.4, 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, consult your doctor.
• 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 Omnic 0.4 previously, are taking it, or are thinking of taking it. The specialist can then take the necessary 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

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

Taking other medicines

Taking Omnic 0.4 with other medications 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 being treated at the same time with medications that can decrease the elimination of Omnic from the body (e.g., ketoconazole, erythromycin).

Tell 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, breastfeeding, and fertility

Omnic is not indicated for use in women.

In men, abnormal ejaculation (altered ejaculation) has been reported. This means that the 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 0.4 affects the ability to drive or operate tools or machines. However, you should keep in mind that dizziness may occur, in which case you should not perform activities that require attention.

3. How to take Omnic 0.4

Follow the instructions for administration of Omnic 0.4 given by your doctor. Consult your doctor or pharmacist if you have any doubts. The dose is one capsule per day and should be taken after breakfast or the first meal of the day. The capsule should be swallowed whole and not broken or chewed. Normally, Omnic 0.4 is 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 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 0.4

If you have forgotten to take Omnic 0.4 as recommended, you can take your daily dose of Omnic 0.4 later that 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 make up for missed doses.

Effects that occur when treatment with Omnic 0.4 is interrupted

When treatment with Omnic 0.4 is abandoned prematurely, your original symptoms may return. Therefore, take Omnic 0.4 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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Omnic 0.4 can have side effects, although not everyone gets them.

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

Dizziness, especially when sitting or standing up.

Abnormal ejaculation (altered ejaculation). This means that the 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 patients):

Headache, palpitations (the heartbeat is faster than normal and also perceptible), reduction of blood pressure, for example, when standing up quickly after being in a seated or lying position, sometimes associated with dizziness, runny nose 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 patients):

Fainting and sudden local swelling of the body's soft tissues (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 patients):

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

Severe skin rash, inflammation, and blisters on 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
• Altered vision
• 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 0.4 previously, during the operation, the pupil may not dilate properly and the iris (the colored part of the eye) may become flaccid.
• Dry mouth

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side 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 sight and reach of children.

Do not use Omnic 0.4 after the expiration date stated on the blister pack after "EXP" and on the carton after "CAD" (month and year). The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

6. Further information

What Omnic 0.4 contains

• The active substance is tamsulosin hydrochloride
• The other ingredients are: in the capsule content: microcrystalline cellulose (E460), methacrylic acid - ethyl acrylate copolymer (1:1), polysorbate 80 (E433), sodium lauryl sulfate, triacetin (E1518), calcium stearate (E470a), and talc (E553b). In the capsule shell: hard 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 size

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

Not all pack sizes may be marketed.

Marketing authorization holder

Astellas Pharma, S.A.

Paseo de la Castellana, 259 D - 31st floor

28046 Madrid (Spain)

Phone 0034-914952700

Manufacturer

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

Netherlands

This package leaflet was approved in 12/2013

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