Sutif 5 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sutif 5 mg tablets

Terazosin (hydrochloride)

Read all of this leaflet carefully before you start taking this medicine, as 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 other people, 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 such effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Sutif is and what it is used for
2. What you need to know before taking Sutif
3. How to take Sutif
4. Possible side effects
5. How to store 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 compound that acts as a selective alpha-1-adrenergic blocker. It blocks receptors in the prostate, bladder neck, and prostatic capsule, thereby improving symptoms of benign prostatic hyperplasia.

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

2. What you need to know before taking Sutif

Do not take Sutif

• If you are allergic to terazosin or to any of the components 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, a marked drop in blood pressure may occur.
• If you experience dizziness, lightheadedness, or palpitations, remain seated or lie down and contact your doctor. Similar effects may occur when restarting treatment after interruption.
• Syncope (fainting) (in less than 1% of patients) may occur after the initial dose, following too rapid an increase in dose, or due to concomitant use of another antihypertensive medicine. Syncope can be minimized by starting with a 1 mg dose and carefully adjusting any other antihypertensive medications.

Caution is required in elderly patients due to the higher incidence of orthostatic hypotension in this age group.

• If you are scheduled for cataract surgery, please inform your doctor 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 have not been established.

Taking Sutif with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 medications for erectile dysfunction (impotence) are taken together with alpha-blockers such as this medicine. To reduce the likelihood of these symptoms occurring, patients should already be on a stable daily dose of the alpha-blocker before starting treatment for erectile dysfunction.
• Some patients may experience dizziness or fainting, which may be pronounced due to a drop in blood pressure when sitting or standing up quickly.

Taking Sutif with food and drinks

This medicine may 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 become pregnant, consult your doctor or pharmacist before using this medicine.

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

It is unknown 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 know 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 for this medicine as indicated 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, even though medicines under other brand names may be appropriate for initiating therapy.

Depending on each patient's response and after 3 or 4 days, the dose may be increased to 2 mg of terazosin, gradually increasing as needed until the desired clinical response is achieved. If necessary, the dose may be gradually increased up to 5 mg once daily orally. The maintenance dose is 5 mg of terazosin once daily.

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

Check your doctor's instructions to remind yourself how many tablets you need to take. You must take your tablets only once daily.

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, contact your doctor, pharmacist, or call the Toxicology Information Service, telephone: 915630420, indicating the medicine and the amount ingested. You may experience acute hypotension (sudden drop in blood pressure). Wait for the doctor lying down or sitting, taking care not to stand up suddenly.

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 missed doses.

If you have forgotten to take several doses, consult your doctor so that they can advise you on the dosing schedule to follow until reaching your maintenance dose.

If you stop taking Sutif

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

If treatment is interrupted for several days, it is necessary to restart treatment 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 can cause adverse effects, although not everyone will experience them.

The most common adverse effects are dizziness, headache, vertigo, asthenia (weakness or fatigue), blurred vision, postural hypotension (dizzy sensation when standing up), nasal congestion, nausea, peripheral edema (swelling of the extremities), impotence, somnolence, palpitations, syncope, and tachycardia.

After marketing, cases of thrombocytopenia (reduced platelet count), atrial fibrillation (heart arrhythmia), and priapism (persistent and painful penile erection) have been reported.

Rarely, it may cause an allergic reaction.

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

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

Reporting of adverse effects

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

5. Storage of Sutif

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 blister and carton, following EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of Sutif 5 mg tablets

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

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

Appearance of the medicine and contents of the pack

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: Laboratorios BIOWISE PHARMACEUTICALS, S.L
Polígono industrial Can Robiols
07141 Marratxí
Balearic Islands
SPAIN

Manufacturer: Laboratorios S.A.L.V.A.T., S.A.
C/Gall 30-36
08950 Esplugues de Llobregat
Barcelona, SPAIN

Date of the most recent 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/)