ZAYASEL 1 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Zayasel 1 mg/ml Oral Solution EFG

Terazosin

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

• Keep this package leaflet, as 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 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, blocking certain receptors in the prostate, bladder neck, and prostatic capsule, thus improving the symptoms of benign prostatic hyperplasia (enlargement of the prostate). Additionally, it 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 ingredients of this medicine (listed in section 6).

• If you have ever suffered a syncope (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 particularly careful with Zayasel:

When taking the first doses, as it may cause a significant drop in blood pressure. Symptoms of dizziness, drowsiness, fainting, and palpitations may appear, so caution is advised 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 dose, or when using another antihypertensive medicine (to lower blood pressure) at the same time, syncope (loss of consciousness) may occur (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 hypertension medicine with caution.

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

• 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 established in this age group, being a medicine intended for the treatment of adult diseases.

Elderly Patients

Caution is necessary 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

Inform 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 taking an alpha-blocker for the treatment of high blood pressure or prostatic hyperplasia may experience dizziness or fainting, which 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. To reduce the likelihood of these symptoms, you should be receiving your daily dose of alpha-blocker regularly before starting treatment for erectile dysfunction.

If you are taking other antihypertensive medicines (to lower high blood pressure), consult your doctor. The concomitant administration with other antihypertensive medicines may imply 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 available on whether terazosin passes into breast milk. Inform your doctor before breastfeeding your child if you are taking Zayasel.

Driving and Using Machines

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

Zayasel contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, and sorbitol

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

This medicine contains 132.48 mg of sorbitol (E-420) per ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medicine.

3. How to Take Zayasel

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

The recommended dose must 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, which is equivalent to 1 ml of Zayasel 1 mg/ml oral solution. This initial treatment regimen must be strictly followed to avoid the possibility of acute hypotension.

According to the response of each patient and after 3 or 4 days, the dose may be increased to 2 mg (2 ml of Zayasel 1 mg/ml oral solution). Subsequently, the dose may be gradually increased until the desired clinical response is achieved.

The recommended maintenance dose is 5 mg once a day, which is equivalent to 5 ml of Zayasel 1 mg/ml oral solution per day, orally. In cases where the clinical response justifies it, the dose may be increased up to a maximum of 10 mg per day, i.e., 10 ml of Zayasel 1 mg/ml oral solution taken once a day.

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, which is equivalent to 1 ml of Zayasel 1 mg/ml oral solution. This initial treatment regimen must be strictly followed to avoid the possibility of acute hypotension.

The daily dose may be doubled at approximately weekly intervals to achieve the desired result.

The recommended maintenance dose is 1 to 5 mg per day, which is equivalent to 1 or 5 ml of Zayasel 1 mg/ml oral solution 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.

Inform your doctor if you are taking or are going to start taking other medicines for treating arterial hypertension, 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.

Method of Administration: To adjust the dose to your needs, use the dosing syringe that comes with the medicine.

Open the bottle cap, then insert the dosing syringe into the perforated cap, turn the bottle upside down, pull the plunger until the liquid reaches the amount prescribed by the doctor, return the bottle to its original position, and remove the dosing syringe.

The syringe should be cleaned and dried after each use.

If You Take More Zayasel Than You Should

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 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 according to your doctor's instructions.

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

If You Interrupt Treatment with Zayasel

Unless your doctor tells you to interrupt your treatment, it is important to continue taking Zayasel according to their instructions.

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, this medicine 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 all over the body), 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 1,000 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 available data): Amblyopia (lazy eye), rhinitis (nasal congestion or secretion), nasal obstruction, constipation, diarrhea, pruritus (itching), rash, angioedema (skin swelling), 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.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet.

You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.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 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 SIGRE collection point at your pharmacy. If in doubt, 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 dihydrochloride dihydrate). Each ml of oral solution contains 1 mg of terazosin.

• The other ingredients (excipients) are: non-crystallizable liquid sorbitol (E-420), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), pineapple flavor (contains propylene glycol (E-1520) and glycerol triacetate (E-1518)), and purified water.

Appearance of the Product and Packaging Contents

Zayasel is a clear oral solution. It is presented in 150 ml bottles with a dosing syringe with a graduation ranging from 0.2 ml to 5 ml and a perforated cap.

Other Available Presentations:

Zayasel 5 mg EFG tablets

Marketing Authorization Holder and Manufacturer

Laboratorios Salvat, S.A.

C/ Gall, 30-36 -

08950-Esplugues de Llobregat

Barcelona – Spain

Date of Last Revision of this Package Leaflet:December 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS)

http://www.aemps.gob.es