TAMSULOSIN KERN PHARMA 0.4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Tamsulosin KERN PHARMA 0.4 mg prolonged-release tablets EFG

Tamsulosin hydrochloride

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What Tamsulosin Kern Pharma is and what it is used for
2. Before taking Tamsulosin Kern Pharma
3. How to take Tamsulosin Kern Pharma
4. Possible side effects
5. Storage of Tamsulosin Kern Pharma
6. Additional information

1. What is TAMSULOSIN KERN PHARMA and what is it used for

The active ingredient is tamsulosin. It belongs to the group of medications called selective α1A/D adrenergic receptor antagonists. Tamsulosin acts by relaxing the muscles of the prostate and the urinary tract. By relaxing the muscles, it allows urine to pass more easily through the urinary tract and facilitates urination. Additionally, it reduces the sensation of urgency.

Tamsulosin is prescribed to men for the treatment of urinary symptoms associated with an enlarged prostate (benign prostatic hyperplasia). These symptoms may include difficulty urinating (poor flow), dripping, urgency, and having to urinate frequently both at night and during the day.

2. BEFORE TAKING TAMSULOSIN KERN PHARMA

Do not take Tamsulosin Kern Pharma

• if you are allergic (hypersensitive) to tamsulosin or to any of the other componentsof this medication. Hypersensitivity may cause sudden swelling of the soft tissues of the body (e.g., the throat or tongue), difficulty breathing, and/or itching and rashes (angioedema).
• if you have previously experienced low blood pressure when standing up, after sitting or lying down, which causes dizziness, weakness, or fainting.
• if you have severe liver problems.

Be careful with Tamsulosin Kern Pharma

• if you feel weak or dizzy, especially after standing up. Tamsulosin may cause a decrease in blood pressure. In this case, sit or lie down until the symptoms have disappeared.
• if you have severe kidney problems, inform your doctor.
• if you are going to undergo eye surgery due to cataracts. During the operation, a problem in the eye called "floppy iris syndrome" may occur (see section 4). Inform your ophthalmologist that you are taking or have recently taken tamsulosin hydrochloride, who can then take the necessary precautions regarding medication and surgical techniques.

Consult your doctor if you should postpone or temporarily suspend taking this medication if you are going to undergo such surgery.

It is necessary to undergo regular medical check-ups to monitor the evolution of the problem being treated.

You may notice residues of the tablet in your stool. The active ingredient of the tablet will have already been released, so there is no risk that the tablet will be less effective.

Taking other medications

The effects of other medications may be affected by taking tamsulosin. These medications, in turn, may affect the efficacy of tamsulosin. Tamsulosin may interact with:

• diclofenac, a pain-relieving and anti-inflammatory medication. This medication may accelerate the elimination of tamsulosin in the body, shortening the time during which it is effective.
• warfarin, an anticoagulant medication. This medication may accelerate the elimination of tamsulosin in the body, shortening the time during which it is effective.
• other alpha-adrenergic receptor blocking medications. The combination of tamsulosin with these medications may cause a decrease in blood pressure, which can cause dizziness and weakness.

Please inform your doctor or pharmacistif you are using or have recently used any medication from this list or other medications, including those purchased without a prescription.

Taking Tamsulosin Kern Pharma with food and drinks

Tamsulosin Kern Pharma can be taken with or without food.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive or operate tools or machines. However, you should keep in mind that tamsulosin can cause dizziness and weakness. Do not drive or operate machines if you experience any of these symptoms.

3. HOW TO TAKE TAMSULOSIN KERN PHARMA

Follow the instructions for taking Tamsulosin Kern Pharma exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any questions.

The normal doseis one tablet per day. You can take tamsulosin with or without food, preferably always at the same time each day.

The tablet should be swallowed wholeand should not be broken or chewed, as this may affect the efficacy of tamsulosin.

Tamsulosin is not indicated for use in children.

Normally, tamsulosin is prescribed for long periods of time. The effects on the bladder and urination are maintained during long-term treatment with tamsulosin.

If you think the effect of tamsulosin is too strong or too weak, inform your doctor or pharmacist.

If you take more Tamsulosin Kern Pharma than you should

Taking too many tamsulosin tablets may lead to a sudden decrease in blood pressure. In this case, you may experience dizziness, weakness, vomiting, diarrhea, and fainting. Lie down to minimize the effects of low blood pressure and contact your doctor.

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 Tamsulosin Kern Pharma

If you forget to take tamsulosin as recommended, take your daily tablet later the same day. If you forget to take it one day, simply take the next dose as prescribed. Do not take a double dose to make up for the missed dose.

If you stop taking Tamsulosin Kern Pharma

If treatment with tamsulosin is interrupted prematurely, the discomfort may reappear. Therefore, take tamsulosin for as long as your doctor indicates, even when the discomfort has disappeared. Always consult your doctor before stopping this treatment.

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

4. Possible side effects

Like all medications, Tamsulosin Kern Pharma can cause side effects, although not everyone experiences them.

Severe reactions to this medication are very rare. Contact your doctor immediatelyif you experience a severe allergic reaction that causes swelling in the face or throat(angioedema).

Frequent(may affect between 1 and 10 out of 100 patients treated) Dizziness, especially when sitting or standing; ejaculation disorders, abnormal ejaculation. The latter means that semen is not released through the urethra, but remains in the bladder. This phenomenon is harmless.

Uncommon(may affect between 1 and 10 out of 1,000 patients treated) Headache, palpitations (the heartbeat is faster than normal and also perceptible), reduced blood pressure, for example, when standing up quickly after sitting or lying down, 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 between 1 and 10 out of 10,000 patients treated) Fainting and sudden 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 less than 1 in 10,000 patients treated) Priapism (undesired, prolonged, and painful erection that requires immediate medical treatment); severe skin disease with blisters and burns on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

Frequency not known:Dry mouth.

If you are going to undergo eye surgery due to cataracts and are taking or have recently taken Tamsulosin Kern Pharma, during the operation, the pupil may not dilate properly, and the iris (the colored part of the eye) may become flaccid.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of TAMSULOSIN KERN PHARMA

Keep out of the reach and sight of children.

Do not use Tamsulosin Kern Pharma after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Tamsulosin Kern Pharma

• The active ingredient is tamsulosin hydrochloride. Each tablet contains 0.4 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
• The other components are: microcrystalline cellulose (E-460i), hypromellose (E-464), carbomer, colloidal anhydrous silica, red iron oxide (E-172), and magnesium stearate (E-470b).

Appearance of Tamsulosin Kern Pharma and packaging contents

Tamsulosin Kern Pharma tablets are round and white.

Tamsulosin Kern Pharma is available in blister packs of 30 tablets and clinical packaging of 100 tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

Manufacturer:

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

Manufacturer:

Synthon Hispania

Castelló 1

Polígono Las Salinas

08830 Sant Boi de Llobregat (Barcelona)

This package leaflet was approved in May 2011

Revision date of this package leaflet: November 2013

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