Leaflet: information for the user

Tamsulosina KERN PHARMA 0.4 mg prolonged-release tablets EFG

Tamsulosina hydrochloride

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for 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 experiencing are serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

1. What Tamsulosina Kern Pharma is and what it is used for

2. Before taking Tamsulosina Kern Pharma

3. How to take Tamsulosina Kern Pharma

4. Possible side effects

5. Storage of Tamsulosina Kern Pharma

6. Additional information

The active ingredient is tamsulosin. It belongs to a group of medicines 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 poor urine flow (dysuria), dribbling, urgency, and having to urinate frequently both at night and during the day.

Do not take Tamsulosina Kern Pharma

• if you areallergic (hypersensitive) to tamsulosina or any of the other componentsof this medication. Hypersensitivity can 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 causesdizziness, weakness or fainting.
• if you havesevere liver problems.

Be especially careful with Tamsulosina Kern Pharma

• if you feelweakness or dizziness, especially after standing up. Tamsulosina can cause a decrease in blood pressure. In this case, sit or lie down until the symptoms have disappeared.
• if you haveserious kidney problems, inform your doctor.
• if you are about to undergo eye surgery due to a cataract opacity. During the surgery, a problem in the eye called "floppy iris syndrome" (see section 4) may occur. Inform your ophthalmologist that you are taking or have taken tamsulosina hydrochloride in the past, who will 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 discontinue taking this medication if you are about to undergo such surgery.

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

You may observe 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 tamsulosina. These medications, in turn, may affect the efficacy of tamsulosina. Tamsulosina may interact with:

• diclofenac, a pain-relieving and anti-inflammatory medication. This medication may accelerate the elimination of tamsulosina from the body, shortening the time during which it is effective.
• warfarin, an anticoagulant medication. This medication may accelerate the elimination of tamsulosina from the body, shortening the time during which it is effective.
• other alpha-adrenergic receptor blockers. The combination of tamsulosina with these medications may cause a decrease in blood pressure, which may 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, even those purchased without a prescription.

Taking Tamsulosina Kern Pharma with food and drinks

Tamsulosina Kern Pharma can be taken with or without food.

Driving and operating machinery

There is no evidence that tamsulosina affects the ability to drive or operate tools or machines. However, you should be aware that tamsulosina may cause dizziness and weakness. Do not drive or operate machinery if you experience any of these symptoms.

Follow exactly the administration instructions for Tamsulosina Kern Pharma as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Theusual doseis one tablet a day. You can take tamsulosina with or without food, preferably at the same time every day.

The tablet must be swallowedwholeandshould not be broken or chewed, as this may affect the efficacy of tamsulosina.

Tamsulosina is not indicated for use in children.

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

If you estimate that the action of tamsulosina is too strong or too weak, inform your doctor or pharmacist.

If you take more Tamsulosina Kern Pharma than you should

Taking too many tamsulosina tablets may lead to a sudden drop in blood pressure. In this case, you may experience dizziness, feeling of 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Tamsulosina Kern Pharma

If you forgot to take tamsulosina as recommended, take your daily tablet later the same day. If you forgot to take it one day, simply take the next dose as prescribed. Do not take a double dose to compensate for the missed dose.

If you stop taking Tamsulosina Kern Pharma

If tamsulosina treatment is interrupted prematurely, symptoms may reappear. Therefore, take tamsulosina for as long as your doctor indicates, even when symptoms have disappeared. Always consult your doctor before stopping this treatment.

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

Like all medications, Tamsulosina Kern Pharma may produce adverse effects, although not all people will experience them.

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

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

Infrequent(may affect between 1 and 10 out of 1,000 treated patients) Headache, palpitations (the heart beats faster than normal and is more noticeable), reduction in blood pressure, for example, when standing up quickly after being seated or lying down, sometimes associated with dizziness, nasal dripping or obstruction (rhinitis), diarrhea, nausea and vomiting sensation, constipation, weakness (asthenia), skin rash, itching and hives (urticaria).

Rare(may affect between 1 and 10 out of 10,000 treated patients) Fainting and sudden swelling of soft body tissues (such as the throat or tongue), respiratory difficulty and/or itching and skin rash, often as an allergic reaction (angioedema).

Very Rare(may affect fewer than 1 out of 10,000 treated patients) Priapism, (unwanted, prolonged, and painful erection that requires immediate medical treatment; severe disease with blisters and burns on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

Unknown frequency:Dry mouth.

If you are to undergo eye surgery due to a cataract opacity, and you are already taking or have recently taken Tamsulosina Kern Pharma, during the surgery, the pupil may dilate slightly and the iris (the colored circular part of the eye), may become flaccid.

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Tamsulosina Kern Pharma after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Tamsulosina 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, anhydrous colloidal silica, red iron oxide (E-172), and magnesium stearate (E-470b).

Appearance of Tamsulosina Kern Pharma and contents of the package

Tamsulosina Kern Pharma tablets are round and white.

Tamsulosina Kern Pharma is presented in blister packaging in a package of 30 tablets and a clinical package of 100 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Colón II Industrial Estate

Venus, 72

08228 Terrassa (Barcelona)

Responsible for manufacturing:

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

Responsible for manufacturing:

Synthon Hispania

Castelló 1

Las Salinas Industrial Estate

08830 Sant Boi de Llobregat (Barcelona)

This leaflet was approved in May 2011

Review date of this leaflet: November 2013

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/