TERAZOSIN CINFA 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Terazosin Cinfa 5 mg Tablets EFG

Terazosin Hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Terazosin Cinfa and what is it used for
2. What you need to know before taking Terazosin Cinfa
3. How to take Terazosin Cinfa
4. Possible side effects
5. Storage of Terazosin Cinfa
6. Package contents and additional information

1. What is Terazosin Cinfa and what is it used for

Terazosin Cinfa contains terazosin, a substance that is a selective alpha-1 adrenergic blocker, blocking certain receptors in the prostate, bladder neck, and prostatic capsule, which improves the symptoms of benign prostatic hyperplasia. Additionally, it produces a decrease in blood pressure without a secondary increase in heart rate.

Terazosin Cinfa is used in the symptomatic treatment of benign prostatic hyperplasia. It is also indicated in the treatment of essential arterial hypertension, mild or moderate.

2. What you need to know before taking Terazosin Cinfa

Do not take Terazosin Cinfa:

• If you are allergic to terazosin 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 terazosin.

• After the first or first few doses, a significant drop in blood pressure may occur.
• Symptoms of dizziness, drowsiness, fainting, and palpitations may appear, so caution should be exercised and driving or performing hazardous tasks should be avoided.
• Syncope (fainting) may occur (in less than 1% of patients) after the initial intake 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 any other antihypertensive medication with caution.

• Cautious use is necessary in elderly patients due to the high incidence of orthostatic hypotension in this age group.

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

Children and adolescents

The safety and efficacy of terazosin in children have not been established.

Use of terazosin with other medications

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

The simultaneous administration with other antihypertensives may imply a reduction in the dose of the antihypertensive and/or an adjustment of the dose of terazosin.

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

Some patients who are receiving 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 medications for erectile dysfunction (impotence) with alpha-blockers like terazosin. To reduce the likelihood of these symptoms, you should be receiving your daily dose of alpha-blocker regularly before starting treatment for erectile dysfunction.

Taking terazosin with food, drinks, and alcohol

You can take Terazosin Cinfa with or without food. Do not consume alcohol while taking this medication.

Pregnancy and breastfeeding

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

Pregnancy:

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

Breastfeeding:

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

Driving and using machines

Do not drive or operate machines 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 an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Terazosin Cinfa

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

The recommended dose of Terazosin Cinfa should be determined by your doctor for each patient.

Benign prostatic hyperplasia:

For all patients, the initial dose is half a tablet of Terazosin Cinfa 2 mg (1 mg of terazosin), once a day, at bedtime. This initial treatment regimen should 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 one tablet of Terazosin Cinfa 2 mg per day (2 mg of terazosin), until the end of the package. Subsequently, the dose may be gradually increased until the desired clinical response is achieved.

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

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

Hypertension:

The initial dose for all patients is 1 mg (half a tablet of Terazosin Cinfa 2 mg) once a day, at bedtime. This initial treatment regimen should 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 terazosin 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 Terazosin Cinfa than you should

If you have taken more Terazosin 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Terazosin Cinfa

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

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

If you interrupt treatment with Terazosin Cinfa

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

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Benign prostatic hyperplasia:

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

Hypertension:

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

After marketing, cases of decreased platelets, atrial arrhythmia, and persistent abnormal erection of the penis have been reported.

Allergic reactions may rarely occur.

Reporting 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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Terazosin Cinfa

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 package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Terazosin Cinfa

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

Appearance of the product and package contents

Terazosin 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 manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Date of the last revision of this package leaflet:November 2024

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

You can access detailed and updated information about this medication by scanning the QR code included in the package 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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