Tamsulosin Alter 0.4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tamsulosina Alter 0.4 mg prolonged-release tablets EFG

tamsulosin, hydrochloride

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The active substance of this medicine is tamsulosin. It is a selective antagonist of alpha1A/1D adrenergic receptors. It reduces the tone of the smooth muscles in the prostate and urethra, allowing urine to pass more easily through the urethra and facilitating urination. In addition, it reduces the sensation of urgency.

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

2. What you need to know before taking Tamsulosina Alter

Do not take Tamsulosina Alter

• if you are allergic to tamsulosin or to any of the other components of this medicine (listed in section 6). Hypersensitivity may present as sudden localized swelling of 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 suffer from dizziness due to a drop in blood pressure when changing position (sitting up or standing up).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

• Periodic medical examinations are necessary to monitor the progression of the condition being treated.
• Fainting may rarely occur during treatment with tamsulosin, as with other medicines of this type. At the first signs of dizziness or weakness, you should sit or lie down until symptoms have disappeared.
• If you have severe kidney problems.
• If you are scheduled for or will undergo eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma). Please inform your ophthalmologist if you have previously taken, are currently taking, or plan to take tamsulosin. The specialist can then take appropriate precautions regarding medication and surgical techniques. Consult your doctor about whether you should postpone or temporarily discontinue taking this medicine if you are undergoing surgery for a cloudy lens (cataract) or increased eye pressure (glaucoma).

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as it is not effective in this population.

Other medicines and Tamsulosina Alter

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

Taking tamsulosin together with other medicines of the same class (alpha1-adrenergic receptor blockers) may cause an undesirable drop in blood pressure.

It is especially important that you inform your doctor if you are also being treated with medicines that may reduce the elimination of tamsulosin from the body (e.g. ketoconazole, erythromycin).

Taking Tamsulosina Alter with food and drink

Tamsulosin may be taken with or without food.

Pregnancy, breastfeeding and fertility

Tamsulosin is not indicated for use in women.

In men, abnormal ejaculation (ejaculatory disorder) has been reported. This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or that the volume of ejaculate is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive, operate tools, or use machinery. However, you should bear in mind that dizziness may occur, and in such a case, you should not engage in activities requiring alertness.

3. How to take Tamsulosina Alter

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The tablet must be swallowed whole and must not be broken or chewed. The tablet has been designed so that the active substance is gradually released after ingestion. You may notice a residue of the tablet in your stools. There is no risk of loss of efficacy, as the active substance will have already been released.

Tamsulosina is usually prescribed for long periods. The effects on the bladder and urination are maintained during long-term treatment with tamsulosina.

If you feel that the effect 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 may lead to an unwanted drop in blood pressure and an increased heart rate, with a feeling of faintness. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Tamsulosina Alter

If you have forgotten to take your tablet as recommended, you may take your daily dose later on the same day. If you have missed the dose for one day, you may simply continue taking your daily tablet as prescribed.

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

If you stop taking Tamsulosina Alter

If treatment with tamsulosina is stopped prematurely, your original symptoms may return. Therefore, take tamsulosina for as long as your doctor prescribes, even if your symptoms have disappeared. Always consult your doctor if you decide to discontinue treatment.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• dizziness, especially when sitting down or standing up
• abnormal ejaculation (ejaculation disorder). This means that semen does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Uncommon (may affect up to 1 in 100 people):

• headache
• palpitations (heart beating faster than normal and noticeably)
• reduction in blood pressure, for example when standing up quickly after sitting or lying down, sometimes associated with dizziness
• runny or blocked nose (rhinitis)
• diarrhoea, 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 localized swelling of soft tissues of the body (such as the throat or tongue), breathing difficulty and/or itching and skin rash, often as an allergic reaction (angioedema)

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

• priapism (undesired, prolonged, and painful erection requiring immediate medical treatment)
• skin rash, inflammation, and blistering of 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 available data):

• dry mouth
• blurred vision, visual disturbance
• nosebleed (epistaxis)
• severe skin rashes (erythema multiforme, exfoliative dermatitis)
• abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnoea)

If you are undergoing eye surgery due to lens opacity (cataracts) or increased eye pressure (glaucoma), and you are currently taking or have previously taken tamsulosin, during surgery the pupil may dilate poorly and the iris (the circular colored part of the eye) may become floppy.

Reporting of adverse effects

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

5. Storage of Tamsulosin Alter

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tamsulosina Alter

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

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

Coating: Opadry Yellow (containing hypromellose, titanium dioxide (E-171), polyethylene glycol, and yellow iron oxide (E-172)).

Appearance of the product and contents of the pack

Film-coated tablets, round, biconvex, yellow in colour, with the mark “04” engraved on one side.

The tablets are packaged in blisters made of Polyamide/Aluminum/PVC-Aluminum, 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 most recent revision of this leaflet: December 2021

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