Leaflet: information for the user

Terazosina Normon 5 mg tablets EFG

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, pharmacist or nurse.
• This medicine has been prescribed for you, 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 any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Terazosina Normon 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 pressurewithout being accompanied by an increase in heart rate.

Terazosin 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 Normon

• 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.
• If you have heart failure or inflammation of the heart lining.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take terazosina.

• A significant drop in blood pressure may occur after the first or first two doses.

Symptoms of dizziness, drowsiness, drowsiness, and palpitations may appear, so be cautious with driving and performing hazardous tasks until you have checked how this medication affects you.

• Syncope (fainting) may occur (in less than 1% of patients) after the initial dose of the medication, after a too rapid increase in dose, or when used simultaneously with another antihypertensive medication. Syncope can be controlled by limiting the initial dose to 1 mg and administering other hypertension medications with caution.
• Care should be taken in elderly patients due to the high incidence of blood pressure drop when standing up in this age group.
• If you are to undergo eye surgery for cataracts, 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.

• Terazosina should be used with caution in patients with liver dysfunction.

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

•Some patients have experienced dizziness or dizziness that may be caused by hypotension when sitting or standing up quickly when taking medications for erectile dysfunction (impotence) with alpha blockers. To reduce the likelihood of these symptoms, take a daily dose of alpha blockers before starting treatment for erectile dysfunction.

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

Children and adolescents

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

Other medications and Terazosina Normon

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

Inhibitors of the angiotensin-converting enzyme (ACE) and diuretics (medications used to increase urine production).

Anti-inflammatory agents (AINE) (medications used to treat hay fever, inflammation, and allergies).

Theophylline (medication used to treat asthma).

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

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

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

General anesthetics (medications used to induce anesthesia).

Warfarin (medication used to thin the blood).

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

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

Terazosina Normon with food, drinks, and alcohol

Terazosina can be taken with or without food. Do not take alcohol while taking this medication.

Pregnancy, breastfeeding, and fertility

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

The safety of terazosina during pregnancy has not been established. Terazosina should not be used during pregnancy unless clearly necessary.Terazosina may delay absorption, and precautions should be taken if terazosina is taken before administration.

The passage of terazosina into breast milk is unknown. 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.

Important information about some of the components of Terazosina Normon

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

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

This medication may cause allergic reactions because it contains red cochineal A (Ponceau 4R) (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

The recommended dose must be determined by your doctor for each patient.

Benign prostatic hyperplasia (prostate enlargement)

Initial treatment

This medication is not indicated for initial treatment. There are other appropriate medications for starting treatment.

For all patients, the initial dose is 1 mg 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 can be increased to 2 mg. Subsequently, the dose can be gradually increased to achieve the desired clinical response.

Maintenance treatment

The recommended maintenance dose is 5 mg once a day. In cases where the clinical response justifies it, the dose can 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 start again according to the initial administration treatment regimen.

Hypertension

Initial treatment

This medication is not indicated for initial treatment. There are other appropriate medications for starting treatment.

For all patients, the initial dose is 1 mg at bedtime.

This initial treatment must be strictly followed to avoid the possibility of acute hypotension.

The daily dose can be doubled at approximately weekly intervals to achieve the desired result.

Maintenance treatment

The recommended maintenance dose is 1 to 5 mg per day. However, some patients may improve with doses as high as 20 mg per day.

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

Older patients

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

Liver insufficiency

The dose of patients with liver insufficiency should be carefully adjusted.

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

Use in children and adolescents

This medication should 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, 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 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 according to your doctor's instructions.

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

If you interrupt treatment with Terazosina Normon

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

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

All medicines can cause allergic reactions, although severe allergic reactions are very rare. If you experience sudden shortness of breath or difficulty breathing, swelling of the eyelids, face, or lips, hives, or itching (especially if it is all over the body), you should inform your doctor immediately.

The side effects include:

Very common (may affect more than 1 in 10 people):

Dizziness, headache, drowsiness.

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

Swelling of the limbs (peripheral edema), nervousness, drowsiness, tingling or numbness of the hands or feet (paresthesia), blurred vision, decreased vision, increased heart rate, fainting, increased heart rate, low blood pressure when standing (orthostatic hypotension), shortness of breath (dyspnea), nasal congestion/inflammation and irritation inside the nose, dizziness, pain in the extremities (orthostatic hypotension), swelling of the extremities, back pain, impotence, drowsiness, nausea.

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

Swelling of the hands and feet (edema), decreased sexual desire (libido), sadness (depression), low blood pressure, weight gain

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

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

Unknown frequency: the frequency cannot be estimated from the available data

Amblyopia (wandering eye), rhinitis (nasal congestion or secretion), constipation, diarrhea, pruritus (itching), urticaria, angioedema (skin swelling), urinary tract infection, thrombocytopenia (decreased number of a type of blood cell that causes coagulation disorders), persistent erection of the penis despite the absence of desire and urinary incontinence (inability to control urination).

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

Unknown frequency: the frequency cannot be estimated from the available data

Nasal obstruction.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use (www.notificaram.es).By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This product does not require special conditions for conservation.

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

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.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Terazosina Normon

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

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

Appearance of the product and contents of the container

Terazosina Normon 5 mg is presented in greyish-colored, elongated, biconvex, and scored tablets.

Each container contains 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid

Spain

Date of the last review of this leaflet:February 2025