Zayasel 5 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Zayasel 5 mg tablets EFG
terazosin
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 could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Zayasel is and what it is used for
- What you need to know before taking Zayasel
- How to take Zayasel
- Possible side effects
- How to store Zayasel
- Contents of the pack and other information
1. What Zayasel is and what it is used for
Zayasel contains terazosin, a substance that is a selective alpha-1 adrenergic blocker. It blocks receptors in the prostate, the bladder neck, and the prostatic capsule, thereby improving symptoms of benign prostatic hyperplasia (enlargement of the prostate). Additionally, it reduces blood pressure without causing a secondary increase in heart rate.
Zayasel is indicated for the symptomatic treatment of benign prostatic hyperplasia. It is also indicated for the treatment of mild to moderate essential arterial hypertension.
2. What you need to know before taking Zayasel
Do not take Zayasel
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If you are allergic to terazosin or to any of the other ingredients of this medicine (listed in section 6).
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If you have ever experienced syncope (loss of consciousness) during urination.
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If you have heart failure or inflammation of the heart lining.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Zayasel.
Take special care with Zayasel:
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When taking the first doses, as it may cause a significant drop in blood pressure. Symptoms such as dizziness, drowsiness, lightheadedness, and palpitations may occur; therefore, caution should be exercised when driving or performing hazardous tasks until you have determined how this medicine affects you.
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When restarting treatment after interruption, a similar effect as described above may occur.
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After the initial dose, a rapid increase in dose, or concomitant use of another antihypertensive medicine (to lower blood pressure), syncope (loss of consciousness) may occur (observed in fewer than 1 in 100 patients). This can be avoided by limiting the initial dose of Zayasel to 1 mg and carefully managing any other antihypertensive medications.
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If you are scheduled for cataract eye surgery, please inform your doctor before the procedure if you are currently taking or have previously taken Zayasel. This is because this medicine may cause complications during surgery, which must be anticipated and managed by your ophthalmologist if previously informed.
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Zayasel should be used with caution in patients with hepatic impairment.
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A decrease in hemoglobin levels, white blood cells, and certain liver function 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, since this medicine is intended for the treatment of conditions specific to adults.
Elderly patients
Caution is necessary when administering the first dose, increasing the dose, or restarting treatment after interruption, due to the high incidence of postural hypotension (low blood pressure upon standing) in this age group.
Other medicines and Zayasel
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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Angiotensin-converting enzyme (ACE) inhibitors and diuretics (medicines used to increase urine production).
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Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to treat hay fever, inflammation, and allergies).
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Theophylline (a medicine used to treat asthma).
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Nitrates (medicines used to treat chest pain and angina).
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Metformin, acarbose (medicines used to lower blood sugar).
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Sildenafil, tadalafil, vardenafil (medicines used to treat erectile dysfunction).
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General anesthetics (medicines used to induce anesthesia).
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Warfarin (a medicine used to thin the blood).
Some patients taking an alpha-blocker for high blood pressure or benign prostatic hyperplasia may experience dizziness or fainting caused by a drop in blood pressure when sitting or standing up quickly.
Some patients have experienced these symptoms when taking medications for erectile dysfunction (impotence) together with alpha-blockers such as Zayasel. To reduce the likelihood of these symptoms, you should already be on a stable daily dose of the alpha-blocker before starting treatment for erectile dysfunction.
If you are taking other antihypertensives (to lower high blood pressure), consult your doctor. Concomitant use with other antihypertensives may require a reduction in the dose of the antihypertensive and/or adjustment of the Zayasel dose.
Hypotension (low blood pressure) has been observed when terazosin is used together with medications for 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 consume alcohol while taking this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 whether this medicine should be used if you are pregnant.
If you are breastfeeding, it is not advisable to take Zayasel. There is no information available on whether terazosin is excreted in breast milk. Inform your doctor before breastfeeding your child if you are taking Zayasel.
Driving and use of machines
Do not drive or operate machinery until you have determined 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 exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose should be determined by the doctor for each individual patient:
Benign prostatic hyperplasia (enlargement of the prostate gland):
For all patients, the initial dose is 1 mg taken 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 must be used.
Depending on the patient's response and after 3 or 4 days, the dose may be increased to 2 mg. Subsequently, the dose may be gradually increased until the desired clinical response is achieved.
The recommended maintenance dose is 5 mg once daily. 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 treatment following the initial administration regimen.
Hypertension:
For all patients, the initial dose is 1 mg taken 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 must be used.
The daily dose may be doubled at approximately weekly intervals to achieve the desired effect.
The recommended maintenance dose is 1 to 5 mg per day. However, some patients may require doses as high as 20 mg per day.
If treatment is interrupted for several days, it is necessary to restart treatment following the initial administration regimen.
Elderly patients
The dose should be kept as low as possible and increased under close supervision.
Hepatic impairment
The dose for patients with hepatic dysfunction must be carefully adjusted.
Inform your doctor if you are taking or plan to start taking other medicines for the treatment of high blood pressure, as your dose of Zayasel may need to be reduced.
Use in children and adolescents
This medicine must not be administered to children or 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, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 as directed by your doctor.
Do not take a double dose to make up for missed doses.
If you stop taking Zayasel
Unless your doctor tells you otherwise, it is important to continue taking Zayasel as directed.
If treatment is interrupted for several days, it is necessary to restart treatment following the initial administration regimen.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Zayasel may cause adverse effects, although not everyone experiences them.
All medicines can cause allergic reactions, although severe allergic reactions are very rare. If you experience sudden wheezing or difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially if widespread), you should inform your doctor immediately.
Adverse effects include:
Very common (may affect more than 1 in 10 treated patients):
Dizziness, headache, somnolence.
Common (may affect up to 1 in 10 treated patients):
Swelling of limbs (peripheral edema), nervousness, somnolence, tingling or numbness in hands or feet (paresthesia), blurred vision, decreased vision, increased heart rate, fainting, increased heart rate, drop in blood pressure upon standing (orthostatic hypotension), shortness of breath (dyspnea), nasal congestion/inflammation and nasal irritation, dizziness, limb pain (orthostatic hypotension), swelling of extremities, back pain, impotence, somnolence, nausea.
Uncommon (may affect up to 1 in 100 treated patients):
Swelling of hands and feet (edema), decreased sexual desire (libido), sadness (depression), hypotension, weight gain.
Rare (may affect up to 1 in 1,000 treated patients):
Weight gain has been reported, cases of low platelet count, and as with other medicines in this class, priapism (persistent and painful penile erection) has been described. Allergic reactions may also occur.
Frequency not known (frequency cannot be estimated from available data):
Amblyopia (lazy eye), rhinitis (nasal congestion or discharge), nasal obstruction, constipation, diarrhea, pruritus (itching), rash, angioedema (skin swelling), urinary tract infection, atrial fibrillation (heart arrhythmia), thrombocytopenia (reduced number of platelets in blood), persistent penile erection despite absence of desire, and urinary incontinence (inability to control urine).
Other adverse effects reported in clinical trials or during post-marketing experience, but not clearly associated with the use of terazosin include: vasodilation (widening of blood vessels), arrhythmia (irregular heartbeat), dry mouth, flatulence, arthralgia (joint pain), arthritis, increased cough, increased frequency of urination.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
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 via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Zayasel
Keep this medicine out of 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 refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Zayasel
- The active substance is terazosin (as dihydrate hydrochloride). Each tablet contains 5 mg of terazosin.
- The other components (excipients) are: microcrystalline cellulose, mannitol, talc, sodium croscarmellose, colloidal silicon dioxide, and magnesium stearate.
Appearance of the medicinal product and contents of the pack
Zayasel is presented as 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 most recent review of this leaflet: December 2024
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)
http://www.aemps.gob.es/.es/