TERAZOSIN NORMON 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Terazosina 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Terazosina Normon contains terazosin, a substance that is a selective alpha-1 adrenergic blocker, blocking certain receptors in the prostate, bladder neck, and prostatic capsule, thereby improving the symptoms of benign prostatic hyperplasia. Additionally, it produces a decrease in blood pressure without being accompanied by an increase in secondary heart rate.

Terazosin 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 you take Terazosina Normon

Do not take Terazosina Normon

• If you are allergic to terazosin or 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

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

• After the first or first few doses, a marked decrease in blood pressure may occur.

Symptoms of dizziness, drowsiness, fainting, and palpitations may appear, so caution should be exercised when driving and performing hazardous tasks until it has been determined how this medicine affects you.

• Syncope (fainting) may occur (in less than 1% of patients) after initial administration of the medicine, after too rapid an increase in dose, or with concomitant use of another antihypertensive medicine. Syncope can be controlled by limiting the initial dose to 1 mg and administering any other antihypertensive medicine with caution.
• Caution should be exercised 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 surgery 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 beforehand.

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

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

• Some patients have felt dizzy or lightheaded, which may be caused by hypotension when sitting or standing up quickly when taking medicines for erectile dysfunction (impotence) with alpha-blockers. To reduce the likelihood of these symptoms, you should take a constant daily dose of an alpha-blocker before starting treatment for erectile dysfunction.
• A decrease in hemoglobin, white blood cells, and some liver 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

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

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

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 antihypertensive medicines may involve a reduction in the dose of the antihypertensive and/or an adjustment of the dose of Terazosina.

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

Taking Terazosina Normon with food, drinks, and alcohol

Terazosin can be taken with or without food. Do not drink alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 before administration.

It is not known whether terazosin passes into breast milk. Inform your doctor before breastfeeding your child if you are taking Terazosina.

Driving and using machines

Do not drive or operate machinery until you have determined how this medicine affects you, as it may cause dizziness, especially at the start of treatment.

Important information about some of the ingredients of Terazosina Normon

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

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Terazosina Normon

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

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

Benign prostatic hyperplasia(enlargement of the prostate)

Initial treatment

This medicine is not indicated for initial treatment. There are other medicines suitable for initial treatment.

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

This initial treatment regimen must 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 can be increased to 2 mg. Subsequently, the dose can be gradually increased until the desired clinical response is achieved.

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 restart it according to the initial administration regimen.

Hypertension

Initial treatment

This medicine is not indicated for initial treatment. There are other medicines suitable for initial 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 intervals of approximately one week 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 restart it according to the initial administration regimen.

Elderly patients

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

Hepatic impairment

The dose in patients with hepatic impairment should be carefully adjusted.

Tell your doctor if you are taking or are going to start taking other medicines to treat high blood pressure, as you may need to reduce your dose of terazosin.

Use in children and adolescents

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

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, telephone: 91 562 04 20, indicating the medicine and the amount ingested. If you take more terazosin than you should, you may suffer from 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 using 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 to stop treatment, it is important to continue taking terazosin as instructed.

If treatment is interrupted for several days, it is necessary to restart it 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although severe allergic reactions are very rare. If you experience sudden wheezing, swelling of the eyelids, face, or lips, rash, or itching (especially all over the body), you should inform your doctor immediately.

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, orthostatic hypotension, shortness of breath (dyspnea), nasal congestion/inflammation and irritation inside the nose, dizziness, pain in the limbs (orthostatic hypotension), swelling of the limbs, back pain, impotence, drowsiness, 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, low platelet count, and persistent abnormal erection of the penis have been reported. Allergic reactions can also occur.

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

Amblyopia (lazy eye), rhinitis (nasal congestion or secretion), constipation, diarrhea, pruritus (itching), rash, angioedema (skin swelling), urinary tract infection, thrombocytopenia (decrease in the 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 urine).

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

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

Nasal obstruction.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Terazosina 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 which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Terazosina Normon

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

The other ingredients are: