Package Insert: Information for the Patient

Doxazosina Alter 4 mg Tablets EFG

Doxazosina, mesylate

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Doxazosina belongs to a group of medications called alpha-adrenergic blockers and is used:

• For the treatment of high blood pressure (high blood pressure).
• For the obstruction of urinary tracts and symptoms associated with an increase in the size of the prostate (benign prostatic hyperplasia).

Doxazosina Alter may be used in patients with benign prostatic hyperplasia, with high or normal blood pressure.

Patients with both diseases may be treated with Doxazosina as a single therapy.

Do not take Doxazosina Alter

• if you are allergic to doxazosina or other quinazolines (such as prazosina or terazosina), or to any of the other components of this medication (listed in section 6),
• if you have experienced dizziness (dizziness) when taking other medications to treat high blood pressure,
• if you have an enlarged prostate along with urinary tract obstruction, chronic infection, or bladder stones,
• if you are breastfeeding,
• if you have low blood pressure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxazosina Alter:

• if you have liver problems. Since there is no clinical experience in patients with severe liver insufficiency, it is not recommended for use in these patients,
• if you have benign prostatic hyperplasia and are hypotensive,
• if you have acute heart disease (heart disease), such as pulmonary edema or heart failure.

At the beginning of treatment with this medication, dizziness, weakness, and in rare cases, fainting may occur. Therefore, proceed with caution at the beginning of treatment and avoid situations that could cause injuries in the event of these symptoms.

If you are to undergo cataract surgery, inform your doctor if you are taking or have taken doxazosina. This medication may cause complications during the operation that your ophthalmologist can control if informed in advance.

Taking Doxazosina Alter with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Doxazosina has been administered with other antihypertensive medications, other medications such as nonsteroidal anti-inflammatory drugs, antibiotics, oral antidiabetic drugs, urate-lowering drugs, anticoagulants, digoxin, warfarin, phenytoin, and indomethacin without negative consequences. Doxazosina potentiates the action of other medications to lower blood pressure (thiazide diuretics, furosemide, beta-blockers).

Doxazosina should be used with caution in patients receiving medications for erectile dysfunction (such as sildenafilo, tadalafilo, vardenafilo) as some patients may experience hypotension with symptoms such as paleness, dizziness, or fainting.

Taking Doxazosina Alter with food and drinks

Doxazosina can be taken with meals or without them.

Children and adolescents

Doxazosina is not recommended for use in children and adolescents under 18 years of age as its safety and efficacy have not been established.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take doxazosina if you are pregnant or breastfeeding your child.

Driving and operating machinery

Your ability to perform activities such as driving or operating machinery may be impaired, especially at the beginning of treatment.

Doxazosina Alter contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Do not take more tablets than specified by your doctor. Doxazosina is administered orally.

Hypertension

The usual dose is 2-4 mg once a day. It is recommended to start treatment with the administration of 1 mg once a day, for 1 or 2 weeks. According to the response of each patient, the doctor may gradually increase the dose to 2 mg, 4 mg, 8 mg, or up to 16 mg per day as the maximum dose, at intervals of 1 or 2 weeks between each dose increase, until blood pressure is reduced.

Doxazosina may be administered with other medications prescribed by your doctor for the treatment of hypertension.

Benign Prostatic Hyperplasia

The usual dose is 2-4 mg once a day. It is recommended to start treatment with the administration of 1 mg once a day. Depending on the response of each patient, the doctor may gradually increase the dose to 2 mg, 4 mg, or up to 8 mg per day as the maximum dose.

If you take more Doxazosina Alter 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 forget to take Doxazosina Alter

It is essential to take this medication at the same time every day. If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, do not take the missed dose. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Doxazosina Alter

Your doctor will indicate the duration of your treatment with Doxazosina Alter. Do not discontinue treatment prematurely.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects vary in intensity from one person to another and should be taken into account especially at the beginning of treatment or when changing medication, being generally mild.

Frequent side effects (can affect up to 1 in 10 people):

Less frequent side effects (can affect up to 1 in 100 people):

Rare side effects (can affect more than 1 in 10,000 patients):

• Increased frequency of urination (polyuria).

Very rare side effects (can affect fewer than 1 in 10,000 patients):

Side effects of unknown frequency (frequency cannot be estimated from available data):

No differences were observed regarding side effects between young and elderly patients.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above30°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Doxazosina Alter Composition

• The active ingredient is doxazosina. Each tablet contains 4 mg of doxazosina (as mesilato).
• The other components are: microcrystalline cellulose (E460i), lactose, carboxymethylstarch sodium type A (from potato), sodium lauryl sulfate, anhydrous colloidal silica (E551), and magnesium stearate (E572).

Product appearance and packaging contents

White, oblong tablets with a groove on one face and the mark D4 on the other face, packaged in PVC/PVDC/Al blisters.

Each package contains 28 tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

or

Siegfried Malta Ltd

HHF070 Hal Far Industrial Estate

Hal Far BBG3000

Malta

Last review date of this leaflet: June 2017.

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