Terazosin CINFA 5 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
terazosin cinfa 5 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 may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What terazosin cinfa is and what it is used for
- What you need to know before taking terazosin cinfa
- How to take terazosin cinfa
- Possible adverse effects
- How to store terazosin 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, bladder neck, and prostatic capsule, thereby improving symptoms of benign prostatic hyperplasia. Additionally, it lowers blood pressure without causing 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 taking 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.
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After the first dose or initial doses, a marked drop in blood pressure may occur.
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Symptoms such as dizziness, drowsiness, lightheadedness, and palpitations may appear; therefore, caution is required, and you should avoid driving or performing hazardous tasks.
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Syncope (fainting) may occur (in less than 1% of patients) after the initial dose, following too rapid an increase in dose, or due to concomitant use of another antihypertensive medicine. Syncope can be managed by limiting the initial dose to 1 mg and carefully adjusting the dose of any other antihypertensive medication.
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Caution is necessary in elderly patients due to the higher incidence of orthostatic hypotension in this age group.
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If you are scheduled for cataract surgery, please inform your doctor before the procedure if you are currently taking or have previously taken terazosin. This is because terazosin may cause complications during surgery, which can be anticipated and managed by your ophthalmologist if they are informed in advance.
Children and adolescents
The safety and efficacy of terazosin in children has not been established.
Taking 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 been reported when terazosin is 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 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 regular daily dose of the alpha-blocker before starting treatment for erectile dysfunction.
Taking terazosin 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 your child 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 them before taking this medicine.
3. How to take terazosin cinfa
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist.
The recommended dose of terazosin cinfa must be determined by the doctor for each individual patient.
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 risk of acute hypotension.
Depending on the 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. Afterwards, 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 following 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 risk 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 require 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, contact 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 according to your doctor's instructions.
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, it is necessary to restart therapy 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, this medicine may cause adverse effects, although not everyone experiences 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 persistent 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 Medicinal Products: 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 refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of terazosin cinfa
- The active substance is terazosin. Each tablet contains 5 mg of terazosin (as hydrochloride).
- The other components are monohydrate lactose, corn starch, microcrystalline cellulose, and magnesium stearate.
Appearance of the product and contents of the pack
Terazosin cinfa is presented as white, cylindrical, biconvex tablets marked with the code "T5".
Each pack 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 most recent review of this leaflet: November 2024
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (www.aemps.gob.es/)
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. 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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