Leaflet:information for theuser

ALFAPROST 5 mg tablets

Terazosine Hydrochloride

Read this leaflet carefully before startingto takethis medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must 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, pharmacist or nurse, even if they are not listed in this leaflet.See section 4.

1. What is ALFAPROSTand for what it is used

2. What you need to know before starting to take ALFAPROST

3. How to take ALFAPROST

4. Possible side effects

5. Storage of ALFAPROST

6. Contents of the pack and additional information

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.

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 experience dizziness, faintness, or palpitations, stay seated or lying down and call your doctor.
• When resuming treatment after its interruption, a similar effect may occur.

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

Children and adolescents

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

Older adults

Care should be taken when administering the first dose, when increasing the dose, or when initiating the dose after a treatment interruption, due to the high incidence of postural hypotension (low blood pressure when standing up) in this age group.

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 used recently, or may need to use any other medication.

Some patients receiving an alpha-blocker for the treatment of high blood pressure or prostate hypertrophy may experience dizziness or fainting caused by a drop 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.

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 be used during pregnancy only 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 if terazosin is excreted in breast milk.

Driving and operating 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.

• Follow exactly the medication administration instructions provided by your doctor or pharmacist. 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 reinstated according to the initial administration regimen.
• Take your dose with a glass of water.
• The tablet can be divided into equal doses.
• If you consider that ALFAPROST does not have the expected action, inform your doctor or pharmacist.

The recommended dose is:

The maintenance dose is 1 tablet ofALFAPROST 5 mg tabletsonce a day (which means a single daily dose of 5 mg of terazosin). In cases where the clinical response justifies it, the dose can be increased gradually up to a maximum of 2 tablets a day ofALFAPROST 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 only take your tablets 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have taken ALFAPROST 5 mg tablets in excess of the prescribed amount, seek immediate medical assistance. The symptoms are those of acute hypotension (sudden drop in blood pressure). Wait for the doctor lying down or sitting, being careful not to get up suddenly.

If you forgot to take ALFAPROST

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 dosing 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.

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

• Systemic effects: asthenia (fatigue or weakness) and headache.
• Cardiovascular system: palpitations, postural hypotension (dizziness upon standing), syncope, and tachycardia.
• Metabolic disorders: peripheral edema (swelling of the extremities) and weight gain.
• Nervous system: fainting, vertigo, decreased libido, and somnolence.
• Respiratory system: dyspnea (sensation of lack of air), rhinitis (nasal congestion), nasal obstruction (unknown frequency).
• Urinary and genital system: impotence and retrograde ejaculation. In postmenopausal women: urinary incontinence.
• Sensory organs: blurred vision.
• Of these, the most common symptoms are asthenia (fatigue or weakness), blurred vision, vertigo, postural hypotension (dizziness upon standing), nasal congestion, nausea, peripheral edema (swelling of the extremities), impotence, and somnolence, generally of medium or moderate intensity.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system in the Spanish System of Pharmacovigilance of Medicines for Human Use www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

Store in the original packaging.

Do not use this medication after the expiration date that appears on the blister 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 the 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 the packaging and medications you no longer need.This will help protect the environment.

Composition of ALFAPROST

• The active ingredient is terazosin (as hydrochloride of terazosin) 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 content of packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Biowise Pharmaceuticals, S.L.

C/Teixidors 22,

Polígono Can Rubiol

07141-Marratxí

Illes Balears

Responsible for manufacturing:

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

C/ Gall 30-36

08950-Esplugues de Llobregat

Barcelona

Last review date of this leaflet:October 2024.

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.