Package Insert: Information for the Patient

Tamsulosin Alter 0.4 mg Extended-Release Tablets EFG

tamsulosin hydrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

The active ingredient of this medication is tamsulosina. It is a selective antagonist of alpha 1A/1D adrenergic receptors.It reduces the tension of the smooth muscles of the prostate and the urethra, allowing urine to pass more easily through the urethra and facilitating urination. Additionally, it decreases the sensation of urgency.

Tamsulosina 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 urination both at night and during the day.

Do not takeTamsulosina Alter

• if you areallergicto tamsulosina or any of the other componentsof this medication (listed in section 6). Hypersensitivity may 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).
• if you have severe liver problems.
• if you experience dizziness due to a drop in blood pressure when changing position (sitting or standing up).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• Regular medical check-ups are necessary to monitor the progression of the disease you are being treated for.
• Rarely, dizziness may occur during the use of tamsulosina, as with other medications of this type. Sit or lie down at the first symptoms of dizziness or weakness until they have passed.
• if you have severe kidney problems.
• if you are scheduled to undergo or have scheduled eye surgery due to a cloudy lens (cataracts) or increased pressure in the eye (glaucoma). Please inform your ophthalmologist if you have taken, are taking, or intend to take tamsulosina. 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 scheduled to undergo eye surgery due to a cloudy lens (cataracts) or increased pressure in the eye (glaucoma).

Children and adolescents

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

Other medications and Tamsulosina Alter

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The use of tamsulosina with other medications of the same group (alpha 1 adrenergic receptor blockers)may produce an undesirable drop in blood pressure.

It is especially important to inform your doctor if you are being treated at the same time with medications that can reduce the elimination of tamsulosina from the body (e.g. ketoconazole, erythromycin).

Taking Tamsulosina Alter with food and drinks

Tamsulosina can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Tamsulosina is not indicated for use in women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen does not release through the urethra, but goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machines

There is no evidence that tamsulosina affects the ability to drive, operate tools, or use machines. However, you should be aware that dizziness may occur, in which case, you should not perform activities that require attention.

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

The recommended dose is 1 tablet per day.You can take tamsulosina with or without food, preferably at the same time of day.

The tablet must be takenwholeandshould not be broken or chewed. The tablet has been designed so that the active ingredient, once the tablet is ingested, is released gradually. It is possible that you may observe a remainder of the tablet in your stool. There is no risk of loss of efficacy since the active ingredient has already been released.

Tamsulosina is usually 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 Alter than you should

Taking too many tamsulosina tablets can lead to an undesirable decrease in blood pressure and an increase in heart rate, with a sensation of dizziness. 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 Alter

If you have forgotten to take your tablet as recommended, you can take your daily dose of tamsulosina later in the same day. In case you have missed a dose one day, you can simply continue taking your daily tablet as prescribed.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Tamsulosina Alter

When treatment with tamsulosina is discontinued prematurely, your original discomforts may return. Therefore, take tamsulosina for the entire time your doctor prescribes it, even if your discomforts have disappeared. Consult your doctor at all times 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, this medicine may cause side effects, although not everyone will experience them.

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

• dizziness, especially when sitting or standing up
• abnormal ejaculation (ejaculation alteration). This means that semen does not release through the urethra, but rather goes to the bladder (retrograde ejaculation) or the volume ejaculated is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Possibly frequent(may affect up to 1 in 100 people):

• headache
• palpitations (the heart rate is faster than normal and is perceivable)
• reduction in blood pressure, for example, when standing up quickly after sitting or lying down, sometimes associated with dizziness
• nasal discharge or obstruction (rhinitis)
• diarrhea, nausea, and vomiting, constipation
• weakness (asthenia)
• skin rash, itching, and hives (urticaria).

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

• syncope (fainting)
• sudden swelling of soft body 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 people):

• priapism (unwanted, prolonged, and painful erection that requires immediate medical treatment)
• 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 unknown(the frequency cannot be estimated from available data):

• dry mouth
• blurred vision, altered vision
• nasal bleeding (epistaxis)
• severe skin eruptions (erythema multiforme, exfoliative dermatitis)
• irregular and abnormal heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnea).

If you are undergoing eye surgery due to a clouding of the lens (cataracts) or an increase in eye pressure (glaucoma), and you are taking or have taken tamsulosin, during the surgery, the pupil may dilate slightly and the iris (the colored part of the eye), may become flaccid.

Reporting of 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 the 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.

This medication does not require special storage conditions.

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

Medications should not be disposed ofthrough drains orin the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.Ask your pharmacist how to dispose of the packaging andmedications you no longer need. In this way, you will help protect the environment.

Tamsulosina Alter Composition

• The active ingredient is hydrochloride of tamsulosina. Each tablet contains 0.4 mg of hydrochloride of tamsulosina.
• The other components are:

Tablet core: macrogol, microcrystalline cellulose, anhydrous colloidal silica (E-551), magnesium stearate.

Covering: Opadry yellow (contains hypromellose, titanium dioxide (E-171), macrogol, and yellow iron oxide (E-172)).

Product appearance and packaging contents

Coated tablets, round, biconvex, yellow in color, with the mark “04” engraved on one face.

The tablets are packaged in Poliamida/Aluminio/PVC-Aluminio blisters in containers of 30 tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

Pabianice, 95-200

Poland

Last review date of this leaflet:December 2021

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