Terazosin Cinfac 2 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
terazosina cinfa 2 mg tablets EFG
terazosin hydrochloride
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 others, 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.
Contents of the leaflet
- What terazosina cinfa is and what it is used for
- What you need to know before taking terazosina cinfa
- How to take terazosina cinfa
- Possible side effects
- How to store terazosina cinfa
- Contents of the pack and other information
1. What terazosin cinfa is and what it is used for
terazosin cinfa 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. Additionally, it produces a reduction in blood pressure without a secondary increase in heart rate.
terazosin cinfa is used for the symptomatic treatment of benign prostatic hyperplasia. It is also indicated for the treatment of mild to moderate essential hypertension.
2. What you need to know before starting terazosin cinfa
Do not take terazosin cinfa:
- If you are allergic to terazosin or to any of the other ingredients of this medicine (listed in section 6).
- If you have a history of syncope (fainting) during urination (micturition).
Warnings and precautions
Consult your doctor or pharmacist before starting terazosin.
- After the first dose or initial doses, a marked drop in blood pressure may occur.
- Symptoms such as dizziness, drowsiness, lightheadedness, and palpitations may appear; therefore, caution is advised and you should avoid driving or performing hazardous tasks.
- Syncope (fainting) may occur (in less than 1% of patients) after the initial dose, following too rapid an increase in dose, or when used concomitantly with another antihypertensive medicine. Syncope can be managed by limiting the initial dose to 1 mg and carefully adjusting concomitant antihypertensive therapy.
- Caution is necessary in elderly patients due to the higher incidence of orthostatic hypotension in this age group.
- If you are scheduled for cataract surgery, please inform your doctor before the procedure if you are currently taking or have previously taken terazosin cinfa. This is because terazosin may cause complications during surgery, which can be anticipated and managed by your ophthalmologist if previously informed.
Children and adolescents
The safety and efficacy of terazosin in children have not been established.
Using terazosin with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Concomitant administration with other antihypertensives may require a reduction in the dose of the antihypertensive and/or adjustment of the terazosin dose.
Hypotension has occurred when terazosin was used with phosphodiesterase inhibitors (such as sildenafil and vardenafil).
Some patients receiving an alpha-blocker for treatment of 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 terazosin. To reduce the likelihood of these symptoms occurring, you should already be on a stable daily dose of the alpha-blocker before starting treatment for erectile dysfunction.
Taking terazosin cinfa with food, drinks, and alcohol
You may take terazosin cinfa with or without food. Do not consume alcohol while taking this medicine.
Pregnancy and breastfeeding
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.
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 if you are taking terazosin.
Driving and using machines
Do not drive or operate machinery until you know how this medicine affects you, as it may cause dizziness, especially at the beginning of treatment.
This medicine contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take terazosin cinfa
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose of terazosin cinfa should be determined by the doctor for each individual patient.
The tablet may be divided into equal doses.
Benign prostatic hyperplasia:
For all patients, the initial dose is half a terazosin cinfa 2 mg tablet (1 mg of terazosin) once daily at bedtime. This initial treatment regimen must be strictly followed to avoid the possibility of acute hypotension.
Depending on each patient's response and after 3 or 4 days, the dose may be increased to one terazosin cinfa 2 mg tablet daily (2 mg of terazosin), until the pack is finished.
Subsequently, the dose may be gradually increased until the desired clinical response is achieved.
The recommended maintenance dose is one terazosin cinfa 5 mg tablet (5 mg of terazosin) once daily. In cases where clinical response justifies it, the dose may be increased up to a maximum of two terazosin cinfa 5 mg tablets daily (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 terazosin cinfa 2 mg tablet), once daily at bedtime. This initial treatment regimen must be strictly followed to avoid the possibility of acute hypotension.
The daily dose may be doubled at approximately one-week intervals to achieve the desired effect.
The recommended maintenance dose is 1 to 5 mg of terazosin daily. However, some patients may benefit from doses up to 20 mg daily.
If treatment is interrupted for several days, it is necessary to restart therapy 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 at telephone number 91 562 04 20, indicating the medicine 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 taking terazosin cinfa as instructed by your doctor.
Do not take a double dose to make up for forgotten doses.
If you stop taking terazosin cinfa
Unless your doctor tells you otherwise, it is important to continue taking terazosin cinfa as instructed.
If treatment is interrupted for several days, therapy must be restarted according to 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, this medicine may produce adverse effects, although not everyone will experience them.
Benign prostatic hyperplasia:
The adverse effects observed during the product's study were the following: dizziness, weakness, headache, orthostatic hypotension, somnolence, nasal congestion/rhinitis, difficulty breathing, nausea, impotence, vertigo, blurred vision/decreased visual acuity, palpitations, peripheral edema, decreased libido, hypotension, syncope, weight gain, tachycardia.
Hypertension:
The adverse effects observed during the product's study were the following: dizziness, headache, weakness, nasal congestion, peripheral edema, somnolence, nausea, palpitations, limb pain, difficulty breathing, burning or tingling sensation (paresthesia), sinusitis, back pain, nervousness, tachycardia, blurred vision, orthostatic hypotension, impotence, syncope, edema, decreased libido, depression, weight gain.
After marketing, cases of thrombocytopenia, atrial arrhythmia, and prolonged abnormal penile erection have been reported.
Allergic reactions may rarely occur.
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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of terazosin cinfa
Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of terazosin cinfa
- The active substance is terazosine. Each tablet contains 2 mg of terazosine (as hydrochloride).
- The other components are monohydrate lactose, corn starch, microcrystalline cellulose and magnesium stearate.
Appearance of the medicinal product and contents of the pack
Terazosin cinfa is presented as white, scored, biconvex, cylindrical tablets marked with the code "T2".
Each pack contains 15 tablets.
Marketing Authorization Holder and Manufacturer:
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta.
31620 Huarte (Navarra) - Spain
Date of the most recent review of this leaflet: November 2024
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (www.aemps.gob.es/)
You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69086/P_69086.html
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