ALFAPROST 5 mg TABLETS

Introduction

Leaflet:information for theuser

ALFAPROST 5 mg tablets

Terazosin Hydrochloride

Read the entire leaflet carefully before startingto takethis medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is ALFAPROST and what is it used for
2. What you need to know before taking ALFAPROST
3. How to take ALFAPROST
4. Possible side effects
5. Storage of ALFAPROST
6. Package contents and additional information

1. What is ALFAPROST and what is it used for

ALFAPROST contains terazosin as the active ingredient, which acts by improving symptoms in patients with benign prostatic hyperplasia.

ALFAPROST is indicated for the symptomatic treatment of benign prostatic hyperplasia.

2. What you need to know before taking ALFAPROST

Do not take ALFAPROST

• If you are allergic to terazosin or any of the other components of this medication (listed in section 6).
• If you have ever experienced syncope (loss of consciousness) during urination.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take ALFAPROST

• When taking the first doses, as it may cause a significant drop 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 may occur.

If you are going to undergo cataract surgery, please inform your doctor before the operation if you are taking or have taken ALFAPROST previously. This is because ALFAPROST may cause complications during the operation, which can be taken into account and controlled by your ophthalmologist if they have been informed beforehand.

Children and adolescents

The use of ALFAPROST is not indicated in children, as the safety and efficacy of this medication in children have not been determined.

Elderly people

Caution is necessary when administering the first dose, increasing the dose, or starting the dose after treatment interruption, due to the high incidence of postural hypotension (low blood pressure when standing up) in this age group.

Taking ALFAPROST with other medications

If you are taking an antihypertensive (to lower high blood pressure), consult your doctor to adjust the dose.

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Some patients who are receiving an alpha-blocker for the treatment of high blood pressure or prostatic hyperplasia may experience dizziness or fainting, which can be caused by a decrease in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medications for erectile dysfunction (impotence) with alpha-blockers like ALFAPROST. To reduce the likelihood of these symptoms, you should be receiving your daily dose of alpha-blocker regularly before starting treatment for erectile dysfunction.

Taking ALFAPROST with food, drinks, and alcohol

This medication can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

The safety of ALFAPROST during pregnancy has not been established. ALFAPROST should only be used during pregnancy when the doctor considers that the potential benefits justify the risk to the fetus.

If you are breastfeeding, it is not recommended to take ALFAPROST. It is not known whether terazosin is excreted in breast milk.

Driving and using machines

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

3. How to take ALFAPROST

• Follow the administration instructions of the medication indicated by your doctor or pharmacist exactly. If in doubt, consult your doctor or pharmacist again.
• Do not stop treatment without consulting your doctor.
• If treatment is interrupted for several days, therapy should be initiated according to the initial administration regimen.
• Take your dose with a glass of water.
• The tablet can be divided into equal doses.
• If you think ALFAPROST is not having the expected effect, inform your doctor or pharmacist.

The recommended dose is:

The normal maintenance dose is 1 tablet of ALFAPROST 5 mg tabletsonce a day (meaning a single daily dose of 5 mg of terazosin). In cases where the clinical response justifies it, the dose may be gradually increased up to a maximum of 2 tablets a day of ALFAPROST 5 mg tablets(10 mg of terazosin), once a day. If a different maintenance dose is prescribed, the number of tablets you take will be different. Check your doctor's instructions to remember how many tablets you need to take. You should take your tablets only once a day.

If you take more ALFAPROST than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have taken ALFAPROST 5 mg tabletsin a larger quantity than recommended, seek immediate medical attention. The symptoms are those of acute hypotension (sudden drop in blood pressure). Wait for the doctor while lying down or sitting, being careful not to get up suddenly.

If you forget to take ALFAPROST

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 schedule to follow until you reach your maintenance dose.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

• Systemic effects: asthenia (weakness or fatigue) and headache.
• Cardiovascular system: palpitations, postural hypotension (dizziness when standing up), syncope, and tachycardia.
• Metabolic disorders: peripheral edema (swelling of the extremities) and weight gain.
• Nervous system: fainting, dizziness, decreased libido, and somnolence.
• Respiratory system: dyspnea (shortness of breath), rhinitis (nasal congestion), and nasal obstruction (frequency not known).
• Urogenital system: impotence and retrograde ejaculation. In postmenopausal women: urinary incontinence.
• Senses: blurred vision.
• Of these, the most common symptoms are asthenia (weakness or fatigue), blurred vision, dizziness, postural hypotension (dizziness when standing up), nasal congestion, nausea, peripheral edema (swelling of the extremities), impotence, and somnolence, usually of moderate or moderate intensity.

Thrombocytopenia (decrease in platelet count), atrial fibrillation (heart arrhythmia), and priapism (persistent and painful erection of the penis) have also been reported.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system in the Spanish Medicines and Healthcare Products Agency (AEMPS) www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of ALFAPROST

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Store in the original package.

Do not use this medication after the expiration date shown on the blister pack and carton after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and information

Composition of ALFAPROST

• The active ingredient is terazosin (as terazosin hydrochloride) in an amount of 5 mg per tablet.
• The other components are: microcrystalline cellulose, mannitol, talc, sodium croscarmellose, colloidal silica, and magnesium stearate.

Appearance of the product and package contents

ALFAPROST 5 mg tablets are presented in the form of oral tablets, in packages of 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Biowise Pharmaceuticals, S.L.

C/Teixidors 22,

Polígono Can Rubiol

07141-Marratxí

Illes Balears

Manufacturer:

Laboratorios S.A.L.V.A.T., S.A.

C/ Gall 30-36

08950-Esplugues de Llobregat

Barcelona

Date of the last revision of this leaflet:October 2024.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.