Sutif 1 mg/ml oral solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sutif 1 mg/ml oral solution

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they 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.
• In case of hereditary fructose intolerance, because 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 drop in blood pressure may occur.

• If you feel dizziness, lightheadedness, or palpitations, remain sitting or lying down and contact your doctor. Resuming treatment after interruption may produce a similar effect.

• Syncope (fainting) (in less than 1% of patients) may occur after the initial dose, following too rapid an increase in dose, or when used concomitantly with another antihypertensive medicine. Syncope can be managed by limiting the initial dose to 1 mg and administering any other antihypertensive medicine with caution.

• If you are scheduled for cataract eye 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 previously informed.

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 regular 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.

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 only be used during pregnancy 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.

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 sensation of suffocation).

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

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

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

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 ml (1 mg of terazosin) taken at bedtime. This initial treatment regimen must be strictly followed to avoid the possibility of acute hypotension. The 5 mg dose is not appropriate for starting treatment, even though there are other commercially available medicines suitable for initiating therapy.

Depending on each patient's response and after 3 or 4 days, the dose may be increased to 2 ml (2 mg of terazosin) to achieve the desired response. If necessary, the dose may be gradually increased up to 5 mg once daily orally. The maintenance dose is 5 ml (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 10 ml (10 mg of terazosin) once daily.

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 advise you on how long to continue 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 immediately at telephone number: 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 as directed by your doctor. Do not take a double dose to make up for missed doses.

If you have missed several doses, consult your doctor, who will advise you on the dosing schedule to follow until reaching your maintenance dose.

If you stop taking Sutif 1 mg/ml oral solution

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 may cause adverse effects, although not everyone will experience them.

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

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

Rarely, it may cause allergic reactions.

Adverse effects with unknown frequency (frequency cannot be estimated from 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, talk to your doctor or pharmacist, even if it is an effect not mentioned in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines at 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 the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the label and the carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition Sutif 1 mg/ml oral solution.

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

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

Appearance of the medicinal product and contents of the pack

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

Each pack contains a 150 ml bottle accompanied by 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 latest revision of this leaflet:

October 2024

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