ZAYASEL 5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Zayasel 5 mg Tablets EFG

Terazosin

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

• Keep this 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Zayasel and what is it used for

Zayasel contains terazosin, a substance that is a selective alpha-1 adrenergic blocker, blocks some receptors in the prostate, in the neck of the bladder and in the prostatic capsule, which improves the symptoms of benign prostatic hyperplasia (enlargement of the prostate). It also produces a decrease in blood pressure without being accompanied by an increase in secondary heart rate.

Zayasel is indicated for the symptomatic treatment of benign prostatic hyperplasia. It is also indicated for the treatment of essential arterial hypertension, mild or moderate.

2. What you need to know before you take Zayasel

Do not take Zayasel

• If you are allergic to terazosin or any of the other components of this medicine (listed in section 6).

• If you have ever suffered a fainting spell (loss of consciousness) during urination.

• If you have heart failure or inflammation of the heart lining.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zayasel.

Be especially careful with Zayasel:

When taking the first doses, as it may cause a significant drop in blood pressure. Symptoms of dizziness, drowsiness, dizziness, and palpitations may appear, so you should be careful when driving and performing hazardous tasks until you have checked how this medicine affects you.

• When resuming treatment after interruption, a similar effect to the previous one may occur.

• After the initial intake of the medicine, after a too rapid increase in the dose or due to the simultaneous use of another antihypertensive medicine (to lower blood pressure), fainting (loss of consciousness) may occur (observed in less than 1 in 100 patients). This can be avoided by limiting the initial dose of Zayasel to 1 mg and administering any other medicine for hypertension with caution.

• If you are going to undergo cataract surgery, please inform your doctor before the operation if you are taking or have previously taken Zayasel. This is because this medicine may cause complications during the operation, which must be taken into account and controlled by your ophthalmologist if you have been previously informed.

• Zayasel should be used with caution in patients with liver dysfunction.

• A decrease in hemoglobin, white blood cells, and some liver tests may occur in some patients.

Children and adolescents

The use of Zayasel is not indicated in children, as its safety and efficacy have not been determined in this age group, as this is a medicine intended for the treatment of adult diseases.

Elderly patients

Caution should be exercised when administering the first dose, when increasing the dose, or when starting the dose after treatment interruption, due to the high incidence of postural hypotension (low blood pressure when standing up) in this age group.

Other medicines and Zayasel

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

Angiotensin-converting enzyme inhibitors (ACE) and DIURETICS (medicines used to increase urine production).

Anti-inflammatory drugs (NSAIDs) (medicines used to treat hay fever, inflammation, and allergies).

Theophylline (a medicine used to treat asthma).

Nitrates (medicines used to treat chest pain and angina).

Metformin, acarbose (medicines used to lower blood sugar).

Sildenafil, tadalafil, vardenafil (medicines used to treat impotence).

General anesthetics (medicines used to induce anesthesia).

Warfarin (a medicine used to thin the blood).

Some patients who are taking an alpha-blocker for the treatment of high blood pressure or prostatic hyperplasia may experience dizziness or fainting that can be caused by a decrease in blood pressure when sitting or standing up quickly.

Some patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) with alpha-blockers like Zayasel. In order to reduce the likelihood of these symptoms occurring, you should be receiving your daily dose of alpha-blocker regularly before starting treatment for erectile dysfunction.

If you are taking other antihypertensives (to lower high blood pressure), consult your doctor. Concomitant administration with other antihypertensives may involve a reduction in the dose of the antihypertensive and/or an adjustment of the dose of Zayasel.

Hypotension (low blood pressure) has been observed when terazosin is used with medicines for treating erectile dysfunction (phosphodiesterase inhibitors) such as sildenafil and vardenafil.

Taking Zayasel with food, drinks, and alcohol

This medicine can be taken with or without food. Do not drink alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The safety of terazosin during pregnancy has not been established. Zayasel should not be used during pregnancy unless clearly necessary. Your doctor will assess the use of this medicine if you are pregnant.

If you are breastfeeding, it is not recommended to take Zayasel. There is no information on whether terazosin is excreted in breast milk. Inform your doctor before breastfeeding your child if you are taking Zayasel.

Driving and using machines

Do not drive or operate machinery until you have checked how this medicine affects you, as it may cause dizziness, especially at the beginning of treatment.

Zayasel tablets contain sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

3. How to take Zayasel

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose should be determined by the doctor for each patient:

Benign prostatic hyperplasia (enlargement of the prostate):

For all patients, the initial dose is 1 mg at bedtime. This initial treatment regimen must be strictly followed to avoid the possibility of acute hypotension. Zayasel 5 mg tablets are not indicated for initial treatment. For the initial dose, other presentations of this medicine should be used.

According to the response of each patient and after 3 or 4 days, the dose may be increased to 2 mg. Subsequently, the dose may be gradually increased to achieve the desired clinical response.

The recommended maintenance dose is 5 mg once a day. In cases where the clinical response justifies it, the dose may be increased up to a maximum of 10 mg per day (two Zayasel 5 mg tablets).

If treatment is interrupted for several days, it is necessary to restart it according to the initial administration regimen.

Hypertension:

For all patients, the initial dose is 1 mg at bedtime. This initial treatment regimen must be strictly followed to avoid the possibility of acute hypotension. Zayasel 5 mg tablets are not indicated for initial treatment; for the initial dose, other presentations of this medicine should be used.

The daily dose may be doubled at intervals of approximately one week to achieve the desired result.

The recommended maintenance dose is 1 to 5 mg per day. However, some patients may improve with doses as high as 20 mg per day.

If treatment is interrupted for several days, it is necessary to restart it according to the initial administration regimen.

Elderly patients

The dose should be kept as low as possible and increased under close supervision.

Liver dysfunction

The dose of patients with liver dysfunction should be carefully adjusted.

Tell your doctor if you are taking or are going to start taking other medicines to treat high blood pressure, as you may need to reduce your dose of Zayasel.

Use in children and adolescents

This medicine should not be administered to children and adolescents, as the efficacy and safety of terazosin have not been studied in this population.

If you take more Zayasel than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested. If you take more Zayasel than you should, you may suffer from acute hypotension.

If you forget to take Zayasel

If you forget to take a dose, take it as soon as you remember. Then continue using Zayasel as instructed by your doctor.

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

If you stop taking Zayasel

Unless your doctor tells you to stop treatment, it is important to continue taking Zayasel as instructed.

If treatment is interrupted for several days, it is necessary to restart it according to the initial administration regimen.

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

4. Possible side effects

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

All medicines can cause allergic reactions, although serious allergic reactions are very rare. If you experience sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching (especially if it is all over the body), you should inform your doctor immediately.

Side effects include:

Very common (may affect more than 1 in 10 patients treated):

Dizziness, headache, drowsiness.

Common (may affect up to 1 in 10 patients treated):

Swelling of the limbs (peripheral edema), nervousness, drowsiness, tingling or numbness of the hands or feet (paresthesia), blurred vision, decreased vision, increased heart rate, fainting, increased heart rate, low blood pressure when standing up (orthostatic hypotension), shortness of breath (dyspnea), nasal congestion/inflammation and irritation inside the nose, dizziness, pain in the limbs (orthostatic hypotension), swelling of the limbs, back pain, impotence, drowsiness, nausea.

Uncommon (may affect up to 1 in 100 patients treated):

Swelling of hands and feet (edema), decreased sexual desire (libido), sadness (depression), hypotension, weight gain.

Rare (may affect up to 1 in 1000 patients treated):

Weight gain, cases of low platelet count, and as with other medicines in this group, priapism (persistent and painful erection of the penis) have been reported. Allergic reactions can also occur.

Frequency not known (frequency cannot be estimated from the available data):

Amblyopia (lazy eye), rhinitis (nasal congestion or secretion), nasal obstruction, constipation, diarrhea, pruritus (itching), rash, angioedema (swelling of the skin), urinary tract infection, atrial fibrillation (heart arrhythmia), thrombocytopenia (decrease in platelet count in blood), persistent erection of the penis despite the absence of desire, and urinary incontinence (inability to control urine).

Other side effects reported in clinical trials or during market experience, but not clearly associated with the use of terazosin, include the following: vasodilation (increase in blood vessel caliber), arrhythmia (irregular heartbeat), dry mouth, flatulence, arthralgia (joint pain), arthritis, increased cough, increased urination frequency.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: ww.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zayasel

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

No special storage conditions are required.

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 indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zayasel

• The active substance is terazosin (in the form of dihydrate hydrochloride). Each tablet contains 5 mg of terazosin.
• The other ingredients (excipients) are: microcrystalline cellulose, mannitol, talc, sodium croscarmellose, colloidal silica, and magnesium stearate.

Appearance of the product and pack contents

Zayasel is presented in the form of tablets for oral administration in calendar packs.

Each pack contains 28 tablets.

Other available presentations:

Zayasel 1 mg/ml oral solution EFG

Marketing authorization holder and manufacturer

LABORATORIOS SALVAT, S.A.

C/ Gall 30-36

08950-Esplugues de Llobregat

Barcelona - SPAIN

Date of the last revision of this leaflet: December 2024

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/