TAMSULOSIN ALTER 0.4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Tamsulosin Alter 0.4 mg prolonged-release tablets EFG

tamsulosin, hydrochloride

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do 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.

Contents of the package leaflet

1. What is Tamsulosin Alter and what is it used for
2. What you need to know before you take Tamsulosin Alter
3. How to take Tamsulosin Alter
4. Possible side effects
5. Storage of Tamsulosin Alter
6. Contents of the pack and further information

1. What is Tamsulosin Alter and what is it used for

The active substance of this medicine 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.

Tamsulosin is used in men for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (enlargement of the prostate gland). These symptoms include: difficulty urinating (weak urine stream), dripping, urgent urination, and frequent need to urinate both at night and during the day.

2. What you need to know before you take Tamsulosin Alter

Do not take Tamsulosin Alter

• if you are allergicto tamsulosin or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may present as sudden local swelling of the soft tissues of the body (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).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

• Regular medical examinations are necessary to monitor the progression of the disease being treated.
• Rarely, fainting may occur during the use of tamsulosin, as with other medications of this type. At the first symptoms of dizziness or weakness, you should sit or lie down until they disappear.
• If you have severe kidney problems.
• 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, are taking, or plan to take tamsulosin. The specialist can then take the necessary precautions regarding medication and surgical techniques. Consult your doctor if you should postpone or temporarily suspend taking this medicine if you are going to undergo such surgery due to a cataract or increased pressure in the eye (glaucoma).

Children and adolescents

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

Other medicines and Tamsulosin Alter

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking tamsulosin with other medicines of the same group (alpha-1 adrenergic receptor blockers) 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 medicines that can decrease the elimination of tamsulosin from the body (e.g., ketoconazole, erythromycin).

Taking Tamsulosin Alter with food and drinks

Tamsulosin can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen is not released through the urethra but instead 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 tamsulosin affects the ability to drive, use tools, or operate machines. However, you should be aware that dizziness may occur, in which case you should not perform activities that require attention.

3. How to take Tamsulosin Alter

Follow exactly the administration instructions of this medicine 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 tamsulosin with or without food, preferably at the same time of day.

The tablet should be swallowed wholeand should not be broken or chewed. The tablet has been designed so that the active substance is gradually released after the tablet is swallowed. You may observe a remainder of the tablet in your stool. There is no risk of loss of efficacy since the active substance has already been released.

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, tell your doctor or pharmacist.

If you take more Tamsulosin Alter than you should

Taking too many tamsulosin tablets may 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 medicine and the amount taken.

If you forget to take Tamsulosin Alter

If you have forgotten to take your tablet as recommended, you can take your daily dose of tamsulosin later that day. If you have missed a dose one day, you can simply continue taking your daily tablet as prescribed.

Do not take a double dose to make up for forgotten doses.

If you stop taking Tamsulosin Alter

When treatment with tamsulosin is abandoned prematurely, your original symptoms may return. Therefore, take tamsulosin 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• dizziness, especially when sitting or standing up
• abnormal ejaculation (alteration of ejaculation). This means that semen is not released through the urethra but instead 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 people):

• headache
• palpitations (heartbeat is faster than normal and also perceptible)
• reduction of blood pressure, for example, when standing up quickly after sitting or lying down, sometimes associated with dizziness
• nasal dripping or obstruction (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 people):

• fainting
• sudden local 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 up to 1 in 10,000 people):

• priapism (undesirable, 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 not known(frequency cannot be estimated from the available data):

• dry mouth
• blurred vision, altered vision
• nasal bleeding (epistaxis)
• severe skin rashes (erythema multiforme, exfoliative dermatitis)
• irregular heartbeat (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 tamsulosin, during the operation, the pupil may not dilate properly, and the iris (the colored part of the eye) may become flaccid.

Reporting of 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamsulosin Alter

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the packaging after “EXP”. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Tamsulosin Alter

• The active substance is tamsulosin hydrochloride. Each tablet contains 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are:

Core of the tablet: macrogol, microcrystalline cellulose, anhydrous colloidal silica (E-551), magnesium stearate.

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

Appearance of the product and contents of the pack

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

The tablets are packaged in Poliamide/Aluminum/PVC-Aluminum blisters in packs of 30 tablets.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

Pabianice, 95-200

Poland

Date of the last revision of this package leaflet:December 2021

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