Alfaproston 5 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
ALFAPROST 5 mg tablets
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, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What ALFAPROST is and what it is used for
- What you need to know before taking ALFAPROST
- How to take ALFAPROST
- Possible side effects
- How to store ALFAPROST
- Contents of the pack and other information
1. What ALFAPROST is and what it is used for
ALFAPROST contains terazosin as the active substance, 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 starting to take ALFAPROST
Do not take ALFAPROST
- If you are allergic to terazosin or to any of the other ingredients of this medicine (listed in section 6).
- If you have ever experienced syncope (loss of consciousness) during urination.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to take ALFAPROST
- When taking the first doses, as they may cause a marked drop in blood pressure. If you experience dizziness, lightheadedness, or palpitations, remain seated or lie down and contact your doctor.
- When resuming treatment after interruption, a similar effect to the initial dose may occur.
If you are scheduled for cataract eye surgery, please inform your doctor before the procedure if you are currently taking or have previously taken ALFAPROST. This is because ALFAPROST may cause complications during surgery, which can be anticipated and managed by your ophthalmologist if they are informed in advance.
Children and adolescents
The use of ALFAPROST is not indicated in children, as the safety and efficacy of this medicine in pediatric patients have not been established.
Elderly people
Caution is necessary when administering the first dose, increasing the dose, or restarting treatment after interruption, due to the higher incidence of postural hypotension (low blood pressure upon standing) in this age group.
Taking ALFAPROST with other medicines
If you are taking antihypertensive medicines (to lower high blood pressure), consult your doctor so they can adjust your dosage.
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.
Some patients receiving an alpha-blocker for the treatment of high blood pressure or benign prostatic hyperplasia may experience dizziness or fainting, which may be 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) together with alpha-blockers such as ALFAPROST. To reduce the likelihood of these symptoms occurring, you should already be on a stable daily dose of the alpha-blocker before starting treatment for erectile dysfunction.
Taking ALFAPROST with food, drinks, and alcohol
This medicine can be taken with or without food.
Pregnancy, breastfeeding, and fertility
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.
The safety of ALFAPROST during pregnancy has not been established. ALFAPROST should be used during pregnancy only if your 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 human milk.
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.
3. How to take ALFAPROST
- Follow exactly the dosing 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 restarted according to the initial dosing regimen.
- Take your dose with a glass of water.
- The tablet may be divided into equal doses.
- If you feel that 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 tablets once daily (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 daily of ALFAPROST 5 mg tablets (10 mg of terazosin), taken once daily. If a different maintenance dose is prescribed, the number of tablets you take will differ. Check your doctor's instructions to confirm how many tablets you should take. You must take your tablets only once daily.
If you take more ALFAPROST than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.
If you have taken more than the prescribed amount of ALFAPROST 5 mg tablets, seek immediate medical help. Symptoms will be those of 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 ALFAPROST
Do not take a double dose to make up for missed doses.
If you have forgotten to take several doses, consult your doctor so they can advise you on the dosing schedule to follow to reach your maintenance dose again.
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.
- Systemic effects: asthenia (weakness or lack of energy) 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, dizziness, decreased libido, and somnolence.
- Respiratory system: dyspnea (shortness of breath), rhinitis (nasal congestion), nasal obstruction (frequency not known).
- Urogenital system: impotence and retrograde ejaculation. In postmenopausal women: urinary incontinence.
- Sense organs: blurred vision.
- Among these, the most common symptoms are asthenia (weakness or lack of energy), blurred vision, dizziness, postural hypotension (dizziness upon standing), nasal congestion, nausea, peripheral edema (swelling of the extremities), impotence, and somnolence, generally of mild to moderate intensity.
Thrombocytopenia (reduced platelet count), atrial fibrillation (heart arrhythmia), and priapism (persistent and painful penile erection) have also been reported.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system of the Spanish Pharmacovigilance System for Human Medicinal Products at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of ALFAPROST
Keep this medicine out of the sight and reach of children.
This medicine does not require special storage conditions.
Store in the original container.
Do not use this medicine after the expiry date stated on the blister and the outer box, 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 collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of ALFAPROST
- The active substance is terazosin (as terazosin hydrochloride) in an amount of 5 mg per tablet.
- The other components are: microcrystalline cellulose, mannitol, talc, sodium croscarmellose, colloidal silicon dioxide, and magnesium stearate.
Nature of the product and pack size
ALFAPROST 5 mg tablets are presented as oral tablets, in packs 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 most recent revision of this leaflet: October 2024.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.