Terazosin Alter, 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Terazosin Alter 5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms, as it could harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Terazosin Alter 5 mg tablets are and what they are used for
2. Before taking Terazosin Alter 5 mg tablets
3. How to take Terazosin Alter 5 mg tablets
4. Possible side effects
5. How to store Terazosin Alter 5 mg tablets
6. Further information

1. What Terazosina Alter 5 mg tablets are and what they are used for

Terazosin is a medicine that improves urinary symptoms in patients with difficulty urinating due to an enlarged prostate, while at the same time lowering blood pressure.

Terazosina Alter is used for the treatment of symptoms of benign prostatic hyperplasia and for the treatment of high blood pressure (hypertension).

2. BEFORE TAKING Terazosin Alter 5 mg tablets

Do not take Terazosin Alter:

• If you are allergic (hypersensitive) to terazosin or to any of the other components of this medicine.
• If you have a history of dizziness or fainting during urination.

Take special care with Terazosin Alter

• If you have orthostatic hypotension or syncope, inform your doctor.
• If dizziness, drowsiness, lightheadedness, or palpitations occur, remain seated or lying down, take care when getting up, and inform your doctor.
• If you are scheduled for cataract eye surgery, please inform your doctor before the procedure 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 they have been informed in advance.

Use of other medicines

Inform your doctor if you are currently using, or have recently used, any other medicines, including those obtained without a prescription.

Certain medicines may interact with Terazosin Alter; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

Terazosin may interact with antihypertensives (medicines used to lower blood pressure).

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 upon sitting or standing up quickly. Some patients have experienced these symptoms when taking medications for erectile dysfunction (impotence) together with alpha-blockers such as Terazosin Alter. To reduce the likelihood of these symptoms occurring, you should already be on a regular daily dose of the alpha-blocker before starting treatment for erectile dysfunction.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Terazosin should be used during pregnancy only if your doctor considers that the potential benefits justify the risk to the fetus. It is not known whether terazosin is excreted in breast milk.

Use in children

The safety and efficacy of this medicine in children have not been established, and therefore its use is not recommended in this patient group.

Use in elderly patients

If you are elderly, you may be more sensitive to the effects mentioned above. If any of these effects occur, inform your doctor.

Driving and use of machines

Terazosin may cause a drop in blood pressure. Patients whose work involves activities where such effects could pose a potential risk should be aware of the possibility of these symptoms, especially at the beginning of treatment. Avoid driving or performing hazardous tasks during the first 12 hours after taking the initial dose, when the dose is increased, or when restarting treatment after interruption. If symptoms of low blood pressure occur, the patient should sit or lie down, taking care when getting up.

Important information about some of the components of Terazosin Alter

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

This medicine can cause allergic reactions as it contains Sunset Yellow FCF (E-110).

It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

3. How to TAKE Terazosina Alter 5 mg Tablets

Follow exactly the dosing instructions for Terazosina Alter provided by your physician. Consult your doctor or pharmacist if you have any questions.

Terazosina Alter is administered orally. You may use a glass of water to help swallow the tablets. Terazosin may be taken with or without food.

Benign prostatic hyperplasia:

Initial dose: The initial dose for all patients is 1 mg taken at bedtime. This initial treatment regimen must be strictly followed to avoid the possibility of acute hypotension.

Subsequent doses: Depending on the individual patient's response and after 3 or 4 days, the dose may be increased to 2 mg daily. Subsequently, the dose may be gradually increased until the desired clinical response is achieved.

The recommended maintenance dose is 5 mg (one Terazosina Alter 5 mg tablet) once daily. In cases where clinical response justifies it, the dose may be increased up to a maximum of 10 mg daily (two Terazosina Alter 5 mg tablets).

Hypertension:

Initial dose: The initial dose for all patients is 1 mg taken at bedtime. This initial treatment regimen must be strictly followed to avoid the possibility of acute hypotension.

Subsequent doses: The daily dose may be doubled at approximately weekly intervals to achieve the desired effect.

The recommended maintenance dose is 1 to 5 mg daily. However, some patients may require doses as high as 20 mg daily.

If you feel that the effect of Terazosina Alter 5 mg is too strong or too weak, consult your doctor or pharmacist.

If you take more Terazosina Alter than you should

Contact your doctor or pharmacist immediately. A sudden drop in blood pressure may occur.

In case of overdose or accidental ingestion, contact the Toxicology Information Service (Telephone 91 562 04 20), stating the product and the amount ingested.

If you forget to take Terazosina Alter

Do not take a double dose to make up for missed doses.

If you stop taking Terazosina Alter

Treatment should be restarted following the initial dosing regimen. If you have any further questions about the use of this product, ask your doctor or pharmacist.

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

4. Possible adverse effects

Like all medicines, Terazosin Alter may cause adverse effects, although not everyone experiences them.

The most common adverse effects were:

Cardiac and vascular disorders: palpitations, postural hypotension, syncope, and tachycardia.
Gastrointestinal disorders: nausea.

Metabolism and nutrition disorders: peripheral edema (swelling due to fluid retention) and weight gain.

Nervous system disorders: headache, fainting, dizziness, decreased libido, and somnolence.

Respiratory, thoracic and mediastinal disorders: dyspnea (difficulty breathing), nasal congestion, rhinitis.

Renal and urinary disorders: impotence and retrograde ejaculation caused by relaxation of the bladder neck. Urinary incontinence in postmenopausal women.

Eye disorders: blurred vision.

General disorders: asthenia (weakness).

Among these symptoms, the most frequent were: asthenia, blurred vision, dizziness, postural hypotension, nasal congestion, nausea, peripheral edema, impotence, palpitations, and somnolence, generally of mild or moderate intensity. Cases of thrombocytopenia (reduced platelet count) and atrial fibrillation (abnormal heart rhythm) have been reported.

Priapism (abnormal and prolonged penile erection) has been described.

Not known (frequency cannot be estimated from the available data):

Nasal obstruction.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Terazosin Alter 5 mg Tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

Expiry:

Do not use Terazosin Alter after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

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

6. ADDITIONAL INFORMATION

Composition of Terazosin Alter 5 mg tablets

• The active substance is terazosin. Each tablet contains 5 mg of terazosin (as dihydrate hydrochloride).
• The other components are: monohydrate lactose, corn starch (gluten-free), talc, magnesium stearate, sunset yellow S (E110), quinoline yellow (E104), and patent blue V (E131).

Appearance of the product and contents of the pack

Terazosin Alter 5 mg is presented as round, smooth, brown tablets. Each pack contains 30 tablets.

Marketing Authorization Holder:

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Manufacturer:

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

or

LACER, S.A.

Boters, 5.

Parc Tecnologic del Vallés.

Cerdanyola del Vallés 08290 Spain

This leaflet was approved in October 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/