Package Leaflet: Information for the User

Sutif 1 mg/ml Oral Solution

Terazosine (Hydrochloride)

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others, 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.

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. Storage of Sutif

6. Contents of the pack and additional information

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

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

Do not take Sutif

- If you are allergic to terazosin or any of the components of this medication (listed in section 6).

- If you have a history of syncope (fainting) during urination.

- In case of hereditary intolerance to fructose, as it contains 420 mg of sorbitol per ml

Warnings and precautions

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

- After taking the first two doses, it may cause a significant drop in blood pressure.

- If you experience dizziness, drowsiness, or palpitations, sit or lie down and call your doctor. Upon resuming treatment after its interruption, a similar effect may occur.

- Syncope (fainting) (less than 1% of patients) may occur after the initial intake of the medication, following a too rapid increase in dose or simultaneous use of another antihypertensive medication. Syncope can be controlled by limiting the initial dose to 1 mg and administering other hypertension medications with caution.

• If you are 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 determined.

Taking Sutif with other medications

- Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

- If you are taking an antihypertensive (to lower high blood pressure), consult your doctor as it may be necessary to adjust the dose.

- Some patients have experienced dizziness, fainting when taking erectile dysfunction medications (impotence) with alpha-blockers like this medication. 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 may be caused by a decrease in blood pressure when sitting or standing quickly.

Taking Sutif with food and drinks

This medication can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

The safety of terazosin during breastfeeding is unknown. Inform your doctor before breastfeeding your child if you are taking this medication.

Driving and operating machinery

Do not drive or operate machinery until you have checked how this medication 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 choking).

Sutif 1 mg/ml oral solution may cause a mild laxative effect due to the presence of 420 mg of sorbitol per ml.

If your doctor has indicated that you have intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

After 3 or 4 days, the dose can be increased to 2 ml (2 mg of terazosin) based on each patient's response, until the desired response is achieved. If necessary, the dose can be gradually increased to 5 mg once a day orally. Themaintenance dose: is 5 ml (5 mg of terazosin) once a day.

In cases where the clinical response justifies it, the dose can be gradually increased 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 only take your dose once a day.

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

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 medication and the amount ingested. You may experience acute hypotension (sudden drop in blood pressure). Wait for the doctor to lie down or sit, being careful not to get up suddenly.

If you forgot to take Sutif.

If you forgot to take a dose, take it as soon as you remember. Then continue taking this medication according to your doctor's instructions. Do not take a double dose to compensate for the missed doses.

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

If you interrupt treatment with Sutif 1 mg/ml oral solution

Unless your doctor tells you to stop treatment, it is essential to continue taking this medication according to their instructions.

If treatment is interrupted for several days, it is necessary to start again according to the initial administration regimen.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

After its commercialization, 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 produce an allergic reaction.

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

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

Reporting Adverse Effects

If you experience any of these adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, Website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date indicated on the label and the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition Sutif 1 mg/ml oral solution.

- The active ingredient is terazosin (in the form of hydrochloride). Each ml contains 1 mg of terazosin.

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

Appearance of the product and contents of the packaging

Sutif 1 mg/ml oral solution is presented in the form of a transparent solution.

Each package contains a 150 ml bottle accompanied by a dosing syringe. The syringe has a capacity of 5ml.

Holder of marketing authorization and responsible manufacturer

Holder of marketing authorizationBIOWISE PHARMACEUTICALS, S.L Industrial Park Can Robiols

07141 Marratxí

Balearic Islands

SPAIN

Responsible manufacturer:SALVAT, S.A. C/Gall 30-36

08950-Esplugues de Llobregat

Barcelona-SPAIN

Last review date of this leaflet:

October 2024

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

(www.aemps.gob.es/)