Package Leaflet: Information for the User

Tamsulosin Almus 0.4 mg prolonged-release tablets EFG

Tamsulosin hydrochloride

Read this 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. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

Tamsulosina relaxes the muscles in the prostate and urinary tract. By relaxing the muscles, tamsulosina allows urine to pass more easily and facilitatesurination. Additionally, it reduces the sensation of urgency.

Tamsulosina is used in men to relieve urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). These symptoms may include difficulty urinating (weak stream), dripping, urgency and the need to urinate frequently both at night and during the day

Do not take Tamsulosina Almus if:

- you areallergic (hypersensitive) to tamsulosina or to any of the other componentsof Tamsulosina Almus. Hypersensitivitymay present as sudden swelling of the soft tissues of the body (e.g. the throat or tongue), difficulty breathing and/or itching and skin rash (angioedema);

• you have a drop in blood pressure when standing up, which causesdizziness or fainting;
• you havesevere liver problems.

Warnings and precautions

Be especially careful withTamsulosina Almus if:

- you experiencedizziness or fainting, especially after getting up. Tamsulosina may lower your blood pressure, causing this. You should lie down or sit until the symptoms have disappeared;

- you havesevere kidney problems, consult your doctor;

- you are about to undergo eye surgery due to a cataract opacity. You may develop a condition called Intraoperative Flaccid Iris Syndrome (see section 4, Possible side effects). Please inform your ophthalmologist if you are taking or have taken tamsulosina previously. The specialist will then take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should or should not postpone or temporarily discontinue taking this medication if you are about to undergo such an operation.

Regular medical check-ups are necessary to monitor the development of the disease you are being treated for.

You may observe remnants of tablets in your stool. Since the active ingredient of the tablet has already been released, there is no risk that the tablet will be less effective.

Use of Tamsulosina Almus with other medications

Inform your doctor or pharmacistif you are using or have recently used other medications, including those purchased without a prescription.

Other medications may be affected by tamsulosina. These medications, in turn, may affect the proper functioning 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 of effectiveness of tamsulosina.
• Warfarin, a medication to prevent blood coagulation. This medication may accelerate the elimination of tamsulosina from the body, shortening the time of effectiveness of tamsulosina.
• Otheralpha-1A adrenergic receptor blockers. The combination may produce a drop in blood pressure, causing dizziness.

TakingTamsulosina Almus with food and drinks

Tamsulosina can be taken regardless of meals.

Driving and operating machinery

There is no evidence that tamsulosina affects the ability to drive and operate machinery. However, tamsulosina may cause dizziness. Only drive or operate machinery if you feel well.

Follow exactly the administration instructions for Tamsulosina Almus as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Theusual doseis 1 tablet per day. You can take tamsulosina with or without food, preferably at the same time every day.

The tablet must be swallowedwhole. It is essentialnot to break or chew the tabletas this may affect the proper functioning of tamsulosina.

Tamsulosina is not indicated for children.

If you take moreTamsulosina Almusthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you take more tamsulosina than you should, your blood pressure may drop suddenly. You may experience dizziness, weakness, vomiting, diarrhea, and fainting. Lie down to minimize the effects of low blood pressure and consult your doctor.

If you forgot to takeTamsulosina Almus

If you have forgotten to take Tamsulosina Almus as recommended, you can take your dose later in the same day. If you have missed a day's dose, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withTamsulosina Almus

When tamsulosina treatment is discontinued prematurely, your original symptoms may return. Therefore, take Tamsulosina Almus for the entire time your doctor prescribes, even if your symptoms have disappeared. Always consult your doctor if you decide to discontinue treatment.

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

Like all medicines, Tamsulosina Almus can cause side effects, although not everyone will experience them.

It is rare for severe adverse reactions to occur.Contact your doctor immediatelyif you experience asevere allergic reaction that causes swelling of the face or throat(angioedema).

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

Dizziness•Abnormal ejaculation.

Occasional(may affect up to 1 in 100 patients):

Headache•Perceptible heartbeat (palpitations)•Reduced blood pressure when standing, which causes dizziness or fainting (orthostatic hypotension)•Swelling and irritation in the nose (rhinitis)•Constipation•Diarrhea•Nausea•Vomiting•Rash•Itching (urticaria)•Feeling of weakness (asthenia).

Rare(may affect up to 1 in 1,000 patients):

Fainting (syncope).

Very rare(may affect up to 1 in 10,000 patients):

Pain during erection (priapism)•Severe disease with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

Frequency unknown(cannot be estimated from available data):

Abnormal heart rhythm•Irregular heartbeat•Fast heartbeat•Difficulty breathing•Dry mouth.

During eye surgery, a condition called Flaccid Iris Syndrome (IFIS) may occur: the pupil may dilate poorly and the iris (the colored part of the eye) may become flaccid during the surgery. For more information, see section 2, Be especially careful.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store in the original packaging to protect from light.

Do not use Tamsulosina Almus after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

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 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 Almus 0.4 mg

• The active ingredient is 0.400 mg of tamsulosin hydrochloride, equivalent to 0.367 mg of tamsulosin.
• The other components are: Internal tablet : microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, red iron oxide (E172), magnesium stearate. External tablet : microcrystalline cellulose, hypromellose, carbomer, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and content of the container

Tamsulosina Almus is presented in the form of round, white tablets, with the inscription “T9SL” on one face and “0.4” on the other.

They are presented in containers of 10, 18, 20, 28, 30, 50, 60, 90, 98, and 100 tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization :

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible for manufacturing:

Synthon Hispania, S.L.

Castello, 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

Synthon BV

Microweg 22,

6545 CM Nijmegen

Netherlands

Last review date of this leaflet : December 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/.