Terazosin Normon 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Terazosin Normon 5 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if the adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Terazosin Normon is and what it is used for
2. What you need to know before taking Terazosin Normon
3. How to take Terazosin Normon
4. Possible side effects
5. How to store Terazosin Normon
6. Contents of the pack and other information

1. What Terazosina Normon is and what it is used for

Terazosina Normon 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 the symptoms of benign prostatic hyperplasia. Additionally, it produces a reduction in blood pressure without a secondary increase in heart rate.

Terazosin is used 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 Terazosina Normon

Do not take Terazosina Normon

• 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.
• If you suffer from heart failure or inflammation of the heart lining.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse 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 required when driving or performing hazardous tasks until you have determined how this medicine affects you.

• 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 administering any other antihypertensive medication.

• Caution is necessary in elderly patients due to the higher incidence of orthostatic hypotension (low blood pressure upon standing) in this age group.

• If you are scheduled for cataract eye 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.

• Terazosin should be used with caution in patients with hepatic impairment.

• Inform your doctor or pharmacist if you are taking any of the following medicines:

• Some patients have experienced dizziness or lightheadedness, which may be caused by hypotension when standing up or sitting up quickly, while taking erectile dysfunction medications (impotence) together with alpha-blockers. To reduce the likelihood of these symptoms, a stable daily dose of alpha-blocker should be established before initiating treatment for erectile dysfunction.

• A decrease in hemoglobin levels, white blood cells, and certain liver function tests may occur in some patients.

Children and adolescents

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

Other medicines and Terazosina Normon

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

Angiotensin-converting enzyme (ACE) inhibitors and diuretics (medicines used to increase urine production).

Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to treat hay fever, inflammation, and allergies).

Theophylline (a medicine used to treat asthma).

Nitrates (medicines used to treat chest pain and angina).

Metformin, acarbose (medicines used to lower blood sugar).

Sildenafil, tadalafil, vardenafil (medicines used to treat impotence).

General anesthetics (medicines used to induce anesthesia).

Warfarin (a medicine used to thin the blood).

Concomitant administration with other antihypertensives may require a reduction in the dose of the antihypertensive and/or adjustment of the dose of Terazosina Normon.

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

Taking Terazosina Normon with food, drinks, and alcohol

Terazosin may 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. Terazosin should not be used during pregnancy unless clearly necessary. It has been observed that terazosin delays absorption, and therefore, precautions should be taken if terazosin is taken prior to administration.

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

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.

Important information about some of the ingredients of Terazosina Normon

Terazosina Normon contains lactose and cochineal red A (Ponceau 4R) (E-124).

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.

This medicine may cause allergic reactions as it contains cochineal red A (Ponceau 4R) (E-124). It may trigger asthma, particularly in patients allergic to acetylsalicylic acid.

3. How to take Terazosina Normon

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose must be determined by the physician for each individual patient.

Benign prostatic hyperplasia (enlarged prostate)

Initial treatment

This medicine is not indicated for initial treatment. There are other appropriate medicines available for initiating treatment.

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.

Depending on each 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.

Maintenance treatment

The recommended maintenance dose is 5 mg once daily. In cases where clinical response justifies it, the dose may be increased up to a maximum of 10 mg per day (2 tablets per day).

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

Hypertension

Initial treatment

This medicine is not indicated for initial treatment. There are other appropriate medicines available for initiating treatment.

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.

The daily dose may be doubled at approximately one-week intervals to achieve the desired effect.

Maintenance treatment

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 according to the initial dosing regimen.

Elderly patients

The dose should be kept as low as possible and increased under close supervision.

Liver impairment

The dose for patients with liver impairment must be carefully adjusted.

Inform your doctor if you are taking or are about to start taking other medicines for high blood pressure, as you may need to reduce your dose of terazosin.

Use in children and adolescents

This medicine must not be administered to children and adolescents, as the efficacy and safety of terazosin have not been studied in this population.

If you take more Terazosina Normon than you should

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 take more terazosin than you should, you may experience acute hypotension.

If you forget to take Terazosina Normon

If you forget to take a dose, take it as soon as you remember. Then continue taking terazosin as instructed by your doctor.

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

If you stop taking Terazosina Normon

Unless your doctor tells you otherwise, it is important to continue taking terazosin as directed.

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

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 people):

Dizziness, headache, somnolence.

Common (may affect up to 1 in 10 people):

Swelling of limbs (peripheral edema), nervousness, somnolence, tingling or numbness of 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, pain in extremities (orthostatic hypotension), swelling of extremities, back pain, impotence, somnolence, nausea.

Uncommon (may affect up to 1 in 100 people):

Swelling of hands and feet (edema), decreased sexual desire (libido), sadness (depression), hypotension, weight gain.

Rare (may affect up to 1 in 1,000 people):

Weight gain has been reported, cases of low platelet count, and abnormal prolonged penile erection. Allergic reactions may also occur.

Frequency not known: frequency cannot be estimated from the available data

Amblyopia (lazy eye), rhinitis (nasal congestion or discharge), constipation, diarrhea, pruritus (itching), rash, angioedema (skin swelling), urinary tract infection, thrombocytopenia (decrease in the number of a type of blood cell causing coagulation disorders), prolonged penile erection despite absence of desire, and urinary incontinence (inability to control urine).

Other adverse effects reported in clinical trials or from post-marketing experience, but not clearly associated with terazosin use, include: vasodilation (widening of blood vessels), arrhythmia (irregular heartbeat), dry mouth, flatulence, arthralgia (joint pain), arthritis, increased cough, increased frequency of urination.

Frequency not known: frequency cannot be estimated from the available data

Nasal obstruction.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, 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 Terazosin Normon

No special storage conditions are required.

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

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 unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Terazosin Normon

The active substance is terazosin hydrochloride dihydrate. Each tablet contains 5 mg of terazosin (as dihydrate hydrochloride).

The other components are: monohydrate lactose, corn starch, magnesium stearate, colloidal silica, indigo carmine (E-132), and carmine red A (Ponceau 4R) (E-124).

Appearance of the medicinal product and contents of the pack

Terazosin Normon 5 mg is presented as greyish, elongated, biconvex, scored tablets.

Each pack contains 30 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid
Spain

Date of the latest revision of this leaflet: February 2025

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 leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68278/P_68278.html