Leaflet: information for the user

Terazosina Alter 5 mg tablets EFG

Read this leaflet carefully before you start taking the 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 and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

1. What is Terazosina Alter 5 mg tablets and what it is used for

2. Before taking Terazosina Alter 5 mg tablets

3. How to take Terazosina Alter 5 mg tablets

4. Possible side effects

5. Storage of Terazosina Alter 5 mg tablets

6. Additional information

Terazosina is a medication that improves urinary symptoms in patients with difficulty urinating due to an enlarged prostate, while also 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).

Do not take Terazosina Alter:

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

Be especially careful with Terazosina Alter

• If you experience postural hypotension and syncope, inform your doctor.
• If you experience vertigo, drowsiness, dizziness, and palpitations, remain seated or lying down, taking care when getting up, and inform your doctor.
• If you are undergoing eye surgery for cataracts, please inform your doctor before the surgery if you are taking or have taken Terazosina previously. This is because Terazosina may cause complications during the surgery, which can be taken into account and controlled by your ophthalmologist if you have been informed beforehand.

Use of other medications

Inform your doctor if you are using, or have used recently, other medications, including those purchased without a prescription..

Certain medications may interact with Terazosina Alter; in these cases, it may be necessary to change the dose or discontinue treatment with one of them.

Terazosina may interact with antihypertensives (medications to lower blood pressure).

Some patients receiving an alpha-blocker for the treatment of high blood pressure or prostate hypertrophy may experience dizziness or fainting 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 Terazosina Alter. In order to reduce the likelihood of these symptoms occurring, you should be receiving your daily dose of alpha-blocker regularly before starting treatment for erectile dysfunction.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Terazosina should be used during pregnancy only when the doctor considers that the potential benefits justify the risk to the fetus. It is not known whether terazosina is excreted in breast milk.

Use in children

The safety and efficacy of this medication in children have not been determined, so it is not recommended for use in this type of patient.

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 operating machinery

Terazosina may cause a decrease in blood pressure. Patients with jobs where these effects represent a potential problem should be aware of the possibility of these symptoms, especially at the beginning of therapy and avoid driving or performing hazardous work during the first 12 hours after the initial dose, when the dose is increased, and when resuming treatment after interruption. If symptoms of decreased blood pressure occur, the patient should sit or lie down, taking care when getting up.

Important information about one of the components of Terazosina Alter

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication may cause allergic reactions because it contains Yellow 5 (E-110).

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

Follow exactly the administration instructions for Terazosina Alter indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Terazosina Alter is administered orally. For the ingestion of the tablets, you can use a glass of water. Terazosina can be taken with or without food.

Benign prostatic hyperplasia:

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

Subsequent doses: According to the response of each patient and after 3 or 4 days, the dose may be increased to 2 mg per day. Subsequently, the dose may be increased gradually to achieve the desired clinical response.

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

Hypertension:

Initial dose: The initial dose for all patients is 1 mg at bedtime. This 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 result.

Therecommended maintenance doseis 1 to 5 mg per day. However, some patients may improve with doses as high as 20 mg per day.

If you estimate that the action 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

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service (Telephone 91 562 04 20), indicating the product and the amount ingested.

If you forget to take Terazosina Alter

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Terazosina Alter

The therapy should be reinstated according to the initial administration regimen. If you have any other doubts about the use of this product, ask your doctor or pharmacist.

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

Like all medications, Terazosina Alter may have adverse effects, although not all people may experience them.

The most common adverse effects were:

Cardiovascular and Vascular Disorders: palpitations, postural hypotension, syncope, and tachycardia.Gastrointestinal Disorders: nausea.

Metabolic and Nutritional Disorders: peripheral edema (swelling due to fluid retention) and weight gain.

Nervous System Disorders: headache, dizziness, vertigo, decreased libido, and somnolence.

Respiratory, Thoracic, and Mediastinal Disorders: dyspnea, 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).

Of all these symptoms, the most common were: asthenia, blurred vision, vertigo, postural hypotension, nasal congestion, nausea, peripheral edema, impotence, palpitations, and somnolence, generally of medium or moderate intensity. Cases of thrombocytopenia (decreased platelet count) and atrial fibrillation (altered heart rhythm) have been reported.

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

Unknown (frequency cannot be estimated from available data):

Nasal obstruction.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

No special storage conditions are required.

Expiration:

Do not use Terazosina Alter after the expiration date appearing on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Terazosina Alter 5 mg tablets

• The active ingredient is terazosin. Each tablet contains 5 mg of terazosin (as dihydrochloride hydrate).
• The other components are: lactose monohydrate, cornstarch (gluten-free), talc, magnesium stearate, yellow orange S (E110), quinoline yellow (E104), and patent blue V (E131).

Appearance of the product and contents of the package

Terazosina Alter 5 mg is presented in the form of round, smooth tablets with a brown color. Each package contains 30 tablets.

Holder of the marketing authorization:

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Responsible for manufacturing:

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

or

LACER, S.A

Boters, 5.

Parc Tecnologic del Vallés.

Cerdanyola del Vallés 08290 España

This prospectus was approved in October 2024

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