Package Insert: Information for the Patient

Zayasel 1 mg/ml Oral Solution EFG

terazosina

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 read 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 even if they 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.

1. What is Zayasel and how is it used

2. What you need to know before starting to take Zayasel

3. How to take Zayasel

4. Possible adverse effects

5. Storage of Zayasel

6. Contents of the package and additional information

Zayasel contains terazosin, a substance that is a selective alpha-1 adrenergic blocker, blocking some receptors in the prostate, at the neck of the bladder and in the prostatic capsule, thereby improving symptoms of benign prostatic hyperplasia (enlargement). Additionally, it produces a decrease in blood pressure without being accompanied by an increase in heart rate secondary to it.

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

Do not take Zayasel

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

• If you have ever experienced 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 especially careful with Zayasel:

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

• When resuming treatment after its interruption, a similar effect may occur.

• After the initial intake of the medication, following a too rapid increase in dose or simultaneous use of another antihypertensive medication (to lower blood pressure), 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 other antihypertensive medications with caution.

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

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

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

Children and adolescents

The use of Zayasel is not indicated in children, as its safety and effectiveness have not been determined in this age group, as this is a medication directed at treating adult diseases.

Older patients

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

Other medications and Zayasel

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

Angiotensin-converting enzyme inhibitors (ACE inhibitors) and diuretics (medications used to increase urine production).

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

Theophylline (medication used to treat asthma).

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

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

Sildenafil, tadalafil, vardenafil (medications used to treat erectile dysfunction).

General anesthetics (medications used to induce anesthesia).

Warfarin (medication used to thin the blood).

Some patients taking an alpha-blocker for the treatment of high blood pressure or benign prostatic hyperplasia may experience dizziness or fainting caused by a decrease in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medications 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.

Consult your doctor if you are taking other antihypertensive medications (to lower high blood pressure). Concomitant administration with other antihypertensive medications may involve reducing the dose of the antihypertensive medication and/or adjusting the dose of Zayasel.

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

Taking Zayasel with food, drinks, and alcohol

This medication can be taken with or without food. Do not take alcohol while taking this medication.

Pregnancy, breastfeeding, and fertility

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

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

Do not breastfeed while taking 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 operating machinery

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

Zayasel contains parahydroxybenzoic acid methyl ester, parahydroxybenzoic acid propyl ester, and sorbitol

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

This medication contains 132.48 mg of sorbitol (E-420) per ml. Sorbitol is a source of fructose. If your doctor has indicated 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 (or your child) before taking this medication.

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

The recommended dose must be determined by the doctor for each patient.

Benign prostatic hyperplasia (prostate enlargement):

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 treatment regimen must be strictly followed to avoid the possibility of acute hypotension.

After 3 or 4 days, the dose may be increased to 2 mg (2 ml of Zayasel 1 mg/ml oral solution). The dose may then be increased gradually to achieve the desired clinical response.

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, taken orally. In cases where 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 start again 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 treatment regimen must be strictly followed to avoid the possibility of acute hypotension.

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, 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 start again according to the initial administration regimen.

Patients with advanced age

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

Liver insufficiency

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

Inform your doctor if you are taking or are about to start taking other medications to treat high blood pressure, as you may need to reduce your Zayasel dose.

Use in children and adolescents

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

Administration form: to adjust the dose to your needs, use the dosing syringe provided with the medication.

Open the bottle cap, then insert the dosing syringe into the perforated cap, invert the bottle, pull the plunger until the liquid reaches the prescribed amount by the doctor, return the bottle to its initial 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 Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested. If you take more Zayasel than you should, you may experience 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 compensate for the missed doses.

If you interrupt treatment with Zayasel

Unless your doctor tells you to stop treatment, it is essential to continue taking Zayasel according to your doctor's instructions.

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

If you have any other doubts 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.

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

The 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, drop in blood pressure when standing (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 the hands and feet (edema), decreased sexual desire (libido), sadness (depression), low blood pressure, weight gain.

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

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

Frequency not known (the frequency cannot be estimated from the available data):Amblyopia (lazy eye), rhinitis (nasal congestion or secretion), nasal obstruction, constipation, diarrhea, pruritus (itching), hives, angioedema (skin swelling), urinary tract infection, atrial fibrillation (heart arrhythmia), thrombocytopenia (decreased platelet count in blood), persistent erection of the penis despite the absence of desire and urinary incontinence (inability to control urination).

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

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 Pharmacovigilance of Medicines for Human Use http://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.

No special storage conditions are required.

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 of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Zayasel

• The active principle is terazosin (in the form of dihydrochloride hydrate). Each ml of oral solution contains 1 mg of terazosin.

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

Appearance of the product and contents of the packaging

Zayasel is a transparent oral solution. It is presented in 150 ml bottles accompanied by 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

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Salvat, S.A.

C/ Gall, 30-36 -

08950-Esplugues de Llobregat

Barcelona – Spain

Last review date of this leaflet:December 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob/.es