SUTIF 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Sutif 5 mg Tablets

Terazosin (hydrochloride)

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

Contents of the pack

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

1. What Sutif is and what it is used for

Sutif contains terazosin as the active substance, a drug that acts as a selective alpha-1 adrenergic blocker, blocking receptors in the prostate, bladder neck, and prostatic capsule, thus improving the symptoms of benign prostatic hyperplasia.

Sutif is indicated for the symptomatic treatment of benign prostatic hyperplasia (enlargement of the prostate).

2. What you need to know before you take Sutif

Do not take Sutif

-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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• After taking the first doses, it may cause a marked decrease in blood pressure.
• If you notice dizziness, drowsiness, or palpitations, stay seated or lie down and call your doctor. When resuming treatment after interruption, a similar effect to the previous one may occur.
• Syncope (fainting) may occur (in less than 1% of patients) after the initial intake of the medicine, after a too rapid increase in dose, or due to the simultaneous use of another antihypertensive medicine. Syncope can be controlled by limiting

the initial dose to 1 mg and administering any other antihypertensive medication with caution.

Caution is necessary 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 the operation if you are taking or have taken terazosin previously. This is because terazosin may cause complications during the operation, which can be taken into account and controlled by your ophthalmologist if informed beforehand.

Children and adolescents:

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

Taking Sutif with other medicines

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

• If you are taking an antihypertensive (to lower high blood pressure), consult your doctor, as a dose adjustment may be necessary.
• Some patients have experienced dizziness or fainting when taking erectile dysfunction medications (impotence) with alpha-blockers like this medicine. To reduce the likelihood of these symptoms, they should be receiving their daily dose of alpha-blocker regularly before starting erectile dysfunction treatment.
• Some patients may experience dizziness or fainting that can be caused by a decrease in blood pressure when sitting or standing up quickly.

Taking Sutif with food and drinks

This medicine can be taken with or without food. Take the tablet with a glass of water.

Pregnancy and breastfeeding

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.

Sutif should be used during pregnancy only when the doctor considers that the potential benefits justify the risk to the fetus.

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

Driving and using machines

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

3. How to take Sutif

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

The recommended initial dose for all patients is 1 mg of terazosin at bedtime. This initial treatment regimen must be strictly followed to avoid the possibility of acute hypotension. The 5 mg dose is not suitable for starting treatment, although there are medications under other brand names suitable for starting treatment.

According to the response of each patient and after 3 or 4 days, the dose may be increased to 2 mg of terazosin until the desired clinical response is achieved. If necessary, the dose can be gradually increased up to 5 mg once a day orally. The maintenance dose is 5 mg of terazosin once a day.

In cases where the clinical response justifies it, the dose may be gradually increased up to a maximum of 2 tablets a day of Sutif 5 mg tablets (10 mg of terazosin) once a day.

Check your doctor's instructions to remember how many tablets you need to take. You should take your tablets only once a day.

Your doctor will indicate the duration of treatment with this medicine.

If you take more Sutif than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 915630420, indicating the medicine and the amount ingested. You may suffer from acute hypotension (abrupt decrease in blood pressure). Wait for the doctor lying down or sitting, being careful not to get up abruptly.

If you forget to take Sutif

If you forget to take a dose, take it as soon as you remember. Then continue taking this medicine according to your doctor's instructions. Do not take a double dose to make up for forgotten doses.

If you have forgotten to take several doses, consult your doctor to indicate the dosage regimen to follow until you reach your maintenance dose.

If you stop taking Sutif

Unless your doctor tells you to stop treatment, it is important to continue taking this medicine according to the instructions.

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 on 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.

The most common side effects are dizziness, headache, vertigo, asthenia (weakness), blurred vision, vertigo, postural hypotension (feeling of dizziness when getting up), nasal congestion, nausea, peripheral edema (swelling of the limbs), impotence, somnolence, palpitations, syncope, and tachycardia.

After marketing, the appearance of thrombocytopenia (decrease in platelet count), atrial fibrillation (heart arrhythmia), and priapism (persistent and painful erection of the penis) has been described.

Rarely, it may cause an allergic reaction.

Side effects with unknown frequency (frequency cannot be estimated from the available data): nasal obstruction.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet.

Reporting of side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Sutif

Keep this medicine out of the 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 blister and carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, 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 other information

Sutif 5 mg Tablets Composition

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

• The other ingredients (excipients) are: sodium croscarmellose, talc, mannitol (E-421), magnesium stearate, and microcrystalline cellulose.

Appearance and packaging of the product

Sutif 5 mg Tablets are presented as white, flat, and round tablets. Each pack contains 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Laboratorios BIOWISE PHARMACEUTICALS, S.L. Polígono industrial Can Robiols

07141 Marratxí

Islas Baleares

SPAIN

Manufacturer: Laboratorios S.A.L.V.A.T., S.A. C/Gall 30-36

08950-Esplugues de Llobregat

Barcelona-SPAIN

Date of last revision of this leaflet:

November 2024.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (www.aemps.gob.es/)