Leaflet: information for the user

terazosina cinfa 5 mg tablets EFG

terazosina hydrochloride

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isterazosina cinfaand what it is used for

2. What you need to know before you start takingterazosina cinfa

3. How to taketerazosina cinfa

4. Possible side effects

5. Storage ofterazosina cinfa

6. Contents of the pack and additional information

terazosina cinfa 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. It also produces a decrease in blood pressure without being accompanied by an increase in heart rate.

terazosina cinfa is used for symptomatic treatment of benign prostatic hyperplasia. It is also indicated for the treatment of essential hypertension, mild or moderate.

Do not take terazosina cinfa:

• If you are allergic to terazosina or any of the other components of this medication (listed in section 6).
• If you have a history of syncope (fainting) during urination.

Warnings and precautions

Consult your doctor or pharmacist before starting to take terazosina.

• After the first or first two doses, a significant drop in blood pressure may occur.
• Symptoms of dizziness, drowsiness, drowsiness, and palpitations may appear, so caution is required and driving or hazardous work should be avoided.
• Syncope (fainting) (in less than 1% of patients) may occur after the initial dose of the medication, after a too rapid increase in dose or due to the simultaneous use of another antihypertensive medication. Syncope can be controlled by limiting the initial dose to 1 mg and administering other hypertension medications with caution.

• Caution is required in elderly patients due to the high incidence of hypotension when standing in this age group.

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

Children and adolescents

The safety and efficacy of terazosina in children have not been determined.

Use of terazosina with other medications

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

Simultaneous administration with other antihypertensives may involve a reduction in the antihypertensive dose and/or adjustment of the terazosina dose.

Hypotension has occurred when terazosina has been used with phosphodiesterase inhibitors (such as sildenafil and vardenafil).

Some patients receiving an alpha-blocker for the treatment of high blood pressure or benign prostatic hyperplasia may experience dizziness or fainting due to a decrease in blood pressure when sitting or standing quickly. Some patients have experienced these symptoms when taking erectile dysfunction medications (impotence) with alpha-blockers such as terazosina. 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.

Taking terazosina with food, drinks, and alcohol

You can take terazosina cinfa with or without food. Do not take alcohol while taking this medication.

Pregnancy and breastfeeding

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

Pregnancy:

The safety of terazosina during pregnancy has not been established. Terazosina should not be used during pregnancy unless clearly necessary.

Breastfeeding:

It is unknown whether terazosina passes into breast milk. Inform your doctor before breastfeeding your child if you are taking terazosina.

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.

This medication contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

The recommended dose of terazosina cinfa should be determined by your doctor for each patient.

Benign prostatic hyperplasia:

For all patients, the initial dose is half a tablet of terazosina cinfa 2 mg (1 mg of terazosina), once a day, at bedtime. This treatment regimen must be strictly followed to avoid the possibility of acute hypotension.

According to each patient's response and after 3 or 4 days, the dose may be increased to one tablet of terazosina cinfa 2 mg per day (2 mg of terazosina), until the package is finished. Subsequently, the dose may be gradually increased to achieve the desired clinical response.

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

If treatment is interrupted for several days, therapy should be reinstated according to the initial administration regimen.

Hypertension:

The initial dose for all patients is 1 mg (half a tablet of terazosina cinfa 2 mg) once a day, at bedtime. 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 of terazosina per day. However, some patients may improve with doses of up to 20 mg per day.

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

If you take more terazosina cinfa than you should

If you have taken more terazosina cinfa than you should, you may experience acute hypotension.

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 forget to take terazosina cinfa

If you forget to take a dose, take it as soon as you remember. Then continue using terazosina cinfa according to your doctor's instructions.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with terazosina cinfa

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

If treatment is interrupted for several days, it is necessary to restart 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 medications, this medication may produce adverse effects, although not all people may experience them.

Benign Prostatic Hyperplasia:

The adverse effects that appeared during the product study were the following: dizziness, weakness, headache, hypotension when standing, drowsiness, nasal obstruction/congestion, difficulty breathing, nausea, impotence, vertigo, blurred vision/reduced visual acuity, palpitations, edema in the extremities, decreased libido, hypotension, syncope, weight gain, tachycardia.

Hypertension:

The adverse effects that appeared during the product study were the following: dizziness, headache, weakness, nasal obstruction, edema in the extremities, drowsiness, nausea, palpitations, limb pain, difficulty breathing, sensation of burning or tingling (paresthesia), sinusitis, back pain, nervousness, tachycardia, blurred vision, hypotension when standing, impotence, syncope, edema, decreased libido, depression, weight gain.

After its commercialization, cases of decreased platelets, atrial arrhythmia, and persistent abnormal penile erection have been described.

Rarely, an allergic reaction may appear.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

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.

Terazosina cinfa composition

• The active ingredient is terazosina. Each tablet contains 5 mg of terazosina (as chlorhydrate).
• The other components are lactose monohydrate, cornstarch, microcrystalline cellulose, and magnesium stearate.

Product appearance and packaging contents

Terazosina cinfa is presented in the form of white, cylindrical, biconvex tablets marked with the code “T5”.

Each package contains 30 tablets.

Marketing authorization holder and responsible manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta.

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:November 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (www.aemps.gob.es/)

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/69087/P_69087.html

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