TERAZOSIN ALTER 5 mg TABLETS

Introduction

Leaflet: information for the user

Terazosina Alter 5 mg tablets EFG

Read the entire leaflet carefully before starting to take the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

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

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

Terazosina is a medicine that improves urinary symptoms in patients with difficulty urinating due to an enlarged prostate, while also lowering blood pressure.

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

2. BEFORE TAKING Terazosina Alter 5 mg tablets

Do not take Terazosina Alter:

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

Be careful with Terazosina Alter

• If you have postural hypotension and syncope, inform your doctor.
• If you experience dizziness, drowsiness, fainting, and palpitations, remain seated or lying down, being careful when getting up and inform your doctor.
• If you are going to undergo cataract surgery, please inform your doctor before the operation if you are taking or have taken Terazosina previously. This is because Terazosina may cause complications during the operation, which can be taken into account and controlled by your ophthalmologist if informed beforehand.

Use of other medicines

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

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

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

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 medicines 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 medicine.

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 if terazosina is excreted in breast milk.

Use in children

The safety and efficacy of this medicine in children have not been determined, so its use is not recommended 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 appear, inform your doctor.

Driving and using machines

Terazosina may cause a decrease in blood pressure. Patients with jobs where these effects may pose a potential problem should be aware of the possibility of these symptoms, especially at the start of therapy, and avoid driving or performing hazardous tasks during the first 12 hours after taking the initial dose, when the dose is increased, and when treatment is resumed after an interruption. If symptoms of low blood pressure appear, the patient should sit or lie down, being careful when getting up.

Important information about some of the components of Terazosina Alter

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

This medicine may cause allergic reactions because it contains Orange Yellow S (E-110).

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

3. HOW TO TAKE Terazosina Alter 5 mg tablets

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

Terazosina Alter is administered orally. For 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 initial 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 can be increased to 2 mg per day. Subsequently, the dose can be gradually increased until the desired clinical response is achieved.

The maintenance doserecommended is 5 mg (one Terazosina Alter 5 mg tablet) once a day. In cases where the clinical response justifies it, the dose can 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 initial treatment regimen must be strictly followed to avoid the possibility of acute hypotension.

Subsequent doses: The daily dose can be doubled at intervals of approximately one week to achieve the desired result.

The maintenance doserecommended is 1 to 5 mg per day. However, some patients may improve with doses as high as 20 mg per day.

If you think 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

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

In case of overdose or accidental ingestion, consult the Toxicology 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 make up for forgotten doses.

If you interrupt treatment with Terazosina Alter

Therapy should be started according to the initial administration regimen. If you have any other questions about the use of this product, ask your doctor or pharmacist.

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

4. Possible side effects

Like all medicines, Terazosina Alter can have side effects, although not everyone gets them.

The most common side effects were:

Cardiovascular 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, fainting, dizziness, decreased libido, and drowsiness.

Respiratory, thoracic, and mediastinal disorders: 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.

Ocular disorders: blurred vision.

General disorders: asthenia (weakness).

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

Priapism (abnormal and persistent erection of the penis) has been described.

Unknown (frequency cannot be estimated from available data):

Nasal obstruction.

If you think any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Terazosina Alter 5 mg tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

Expiry date:

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. By doing so, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Terazosina Alter 5 mg tablets

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

Appearance of the product and packaging content

Terazosina Alter 5 mg is presented in the form of round, smooth, brown tablets. Each package 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 updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/