SUTIF 1 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Sutif 1 mg/ml Oral Solution

Terazosin (hydrochloride)

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

• Keep this package 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Sutif and what is it used for

Sutif contains terazosin as the active substance, a selective alpha-1 adrenergic blocker that blocks receptors in the prostate, bladder neck, and prostatic capsule, thereby 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 taking 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.
• In case of hereditary fructose intolerance, since it contains 420 mg of sorbitol per ml.

Warnings and precautions

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

• After taking the first doses, a marked decrease in blood pressure may occur.
• If you feel dizzy, lightheaded, or experience palpitations, stay seated or lie down and call your doctor. When resuming treatment after interruption, a similar effect 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.

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

• 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 medicines for erectile dysfunction (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 treatment for erectile dysfunction.
• Some patients may experience dizziness or fainting that can be exacerbated by a decrease in blood pressure when standing up or sitting down quickly.

Taking Sutif with food and drinks

This medicine can be taken with or without food.

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 only be used during pregnancy if your doctor considers that the potential benefits outweigh the risks 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 start of treatment.

Warnings about excipients

Sutif 1 mg/ml oral solution contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216), which may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden feeling of suffocation).

Sutif 1 mg/ml oral solution may have a mild laxative effect because it contains 420 mg of sorbitol per ml.

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

Sutif 1 mg/ml oral solution contains 18.85 mg of propylene glycol in each ml, equivalent to 18.85 mg/ml.

3. How to take Sutif

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended initial dose for all patients is 1 ml (1 mg of terazosin) at bedtime. This initial treatment regimen must be strictly followed to avoid the possibility of acute hypotension. The dose of 5 mg is not suitable for starting treatment, although there are medicines 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 ml (2 mg of terazosin) until the desired response is achieved. If necessary, the dose can be gradually increased up to 5 mg once a day orally. The maintenance dose is 5 ml (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 10 ml (10 mg of terazosin) once a day.

Check your doctor's instructions to remember how much (ml) you need to take. You should take your dose 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 Toxicological Information Service, phone: 915630420, indicating the medicine and the amount ingested. You may experience acute hypotension (abrupt decrease in blood pressure). Wait for the doctor lying down or sitting, being careful not to get 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 forgotten doses.

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

If you stop taking Sutif 1 mg/ml oral solution

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

The most common side effects are dizziness, headache, vertigo, asthenia (weakness or fatigue), blurred vision, vertigo, postural hypotension (feeling of dizziness when standing 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.

It may rarely cause an allergic reaction.

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

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

Reporting of side effects

If you experience any of the side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this package 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. Storage of 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 label 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Sutif 1 mg/ml oral solution composition.

• The active substance is terazosin (as hydrochloride). Each ml contains 1 mg of terazosin.

• The other ingredients (excipients) are: sorbitol (E-420), sodium cyclamate, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), propylene glycol (E-1520), pineapple flavor, and purified water.

Appearance of the product and pack contents

Sutif 1 mg/ml oral solution is a clear solution.

Each pack contains a 150 ml bottle with a dosing syringe. The syringe has a capacity of 5 ml.

Marketing authorization holder and manufacturer

Marketing authorization 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 package leaflet:

October 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/)