Package Insert: Patient Information

Doxazosina Neo Teva 4 mg

Prolonged-Release Tablets EFG

Read this package insert carefully before starting to use 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 may 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 Neo Teva is a vasodilatory medication for the treatment of arterial hypertension and benign prostatic hyperplasia.

Doxazosina Neo Teva is indicated for the treatment of elevated blood pressure in the arteries (arterial hypertension) and for the treatment of urinary flow obstruction and irritative symptoms associated with benign prostatic hyperplasia (BPH).

Doxazosina Neo Teva may be used in patients with BPH, hypertensive or normotensive patients. Those patients with both pathologies may be treated with Doxazosina Neo Teva as monotherapy.

The treatment with Doxazosina Neo Teva requires periodic monitoring by your doctor.

Do not take Doxazosina Neo Teva

• If you are allergic to the active ingredient, to other quinazolones (for example, prazosin, terazosin), or to any of the other components of this medication (including in section 6).
• If you have experienced hypotension (dizziness) when taking other medications to lower blood pressure.
• If you have an enlarged prostate gland along with urinary tract congestion, chronic urinary tract infections, or bladder stones.
• If you suffer or have suffered any form of gastrointestinal obstruction.
• If you suffer from continuous urine loss (urinary incontinence), do not produce enough urine (anuria), or have kidney insufficiency (only for patients with benign prostatic hyperplasia taking doxazosina as monotherapy).
• If you are breastfeeding.
• If you have low blood pressure.

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Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxazosina Neo Teva

• If you have liver problems: since there is no clinical experience in patients with severe hepatic insufficiency, it is not recommended for use in these patients.
• If you suffer from acute heart disease, such as pulmonary edema or heart failure.
• If you are taking any medication to treat erectile dysfunction (see “Taking Doxazosina Neo Teva with other medications”).

Especially at the beginning of taking 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 appearing.

If you are to undergo eye surgery for cataracts, inform your doctor before the operation if you are taking or have taken Doxazosina Neo Teva previously. This is because Doxazosina Neo Teva may cause complications during the operation, which can be taken into account and controlled by your ophthalmologist if you have been informed in advance.

Children and adolescents

Doxazosina is not recommended for children or adolescents under 18 years old since its safety and efficacy have not been established.

Taking Doxazosina Neo Teva with other medications

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

Doxazosina Neo Teva has been administered with other anti-hypertensives, other medications such as non-steroidal anti-inflammatory drugs, antibiotics, oral antidiabetic drugs, uric acid-lowering drugs, anticoagulants, digoxin, warfarin, phenytoin, and indomethacin without any negative consequences. Doxazosina potentiates the action of other anti-hypertensives in lowering blood pressure.

Doxazosina should be used with caution in patients receiving medications for erectile dysfunction (for example, sildenafilo, tadalafilo, vardenafilo), since in some patients a symptomatic hypotension may occur.

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 quickly. Some patients have experienced these symptoms when taking medications for erectile dysfunction (impotence) with alpha-blockers like Doxazosina Neo Teva. 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.

Taking Doxazosina Neo Teva with food and drinks

Doxazosina Neo Teva can be taken with meals or without them.

Pregnancy and breastfeeding

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

Do not take Doxazosina Neo Teva if you are pregnant or breastfeeding your child.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Doxazosina Neo Teva contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

Your doctor will decide what dose of Doxazosina Neo Teva is most advisable for you. Do not take more tablets than those specified by your doctor.

Depending on the individual response, the doctor may modify the dose of Doxazosina Neo Teva.

Doxazosina Neo Teva is administered orally.

The initial dose is one tablet (4 mg) once a day. The optimal effect is achieved in four weeks. If necessary, after this period, it can be increased to a single daily dose of 8 mg, depending on the patient's response.

The maximum dose is 8 mg in a single daily dose.

No dose adjustment is necessary in elderly patients (over 65 years) and patients with renal insufficiency.

Doxazosina Neo Teva can be administered both in the morning and at night.

All dose modifications and monitoring will be performed under medical supervision.

Doxazosina Neo Teva can be administered with other medications used for the treatment of hypertension and benign prostatic hyperplasia (BPH) prescribed by your doctor.

Instructions for correct administration

Swallow the Doxazosina Neo Teva tablet whole, without chewing, breaking, or crushing. Swallow the tablets with a sufficient amount of liquid (e.g., a glass of water).

In Doxazosina Neo Teva, the medication is contained in a non-absorbable tablet, specifically designed to have a controlled release of the active ingredient. When this process is completed, the empty tablet is eliminated from the body through the feces.

Take Doxazosina Neo Teva once a day, every day, and approximately at the same time. Taking the tablets at the same time each day will have a better effect on your blood pressure. It will also help you remember when to take the tablets. Doxazosina Neo Teva can be taken during meals or outside of them.

Your doctor will indicate the duration of your treatment with Doxazosina Neo Teva.

Do not discontinue treatment as it may be detrimental to your health.

If you feel that the effect of Doxazosina Neo Teva is too strong or too weak, consult your doctor or pharmacist. Do not take more tablets than those recommended by your doctor.

If you take more Doxazosina Neo Teva 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.

A Doxazosina Neo Teva overdose may cause a drop in blood pressure. In this case, sit down with your head down.

If you forgot to take Doxazosina Neo Teva

Do not take a double dose to compensate for the missed doses. It is essential to take Doxazosina Neo Teva regularly at the same time each day. If you forget to take a dose, take it as soon as you can. However, if it is almost time for the next dose, do not take the missed tablet.

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

Like all medications, this medication may cause side effects, although not everyone will experience them. Doxazosina side effects vary in intensity from one individual to another and should be taken into account especially at the beginning of treatment or when changing medication, which are generally mild.

Frequent side effects: may affect up to 1 in 10 people

• Respiratory tract infection, urinary tract infection;
• Dizziness, headache, drowsiness tendency;
• Dizziness;
• Strong or rapid heartbeat sensation (palpitations), increased heart rate (tachycardia);
• Low blood pressure, postural hypotension;
• Bronchitis, cough, difficulty breathing (dyspnea), nasal mucosa inflammation (rhinitis);
• Abdominal pain, indigestion (dyspepsia), dry mouth, nausea;
• Itching (pruritus);
• Back pain, muscle pain (myalgia);
• Bladder inflammation (cystitis), urinary incontinence;
• Fatigue (asthenia), chest pain, flu-like illness, peripheral edema;

Rare side effects: may affect up to 1 in 100 people

• Allergic reaction;
• Abnormal loss of appetite (anorexia);
• Anxiety, depression, difficulty initiating or maintaining sleep (insomnia);
• Cerebral blood supply interruption (stroke), decreased sensitivity (hypoesthesia), temporary loss of consciousness (syncope), tremor;
• Tinnitus;
• Chest pain or pressure (angina pectoris, myocardial infarction);
• Nasal bleeding (epistaxis);
• Constipation, diarrhea, flatulence, vomiting, gastroenteritis;
• Dermatological eruption;
• Joint pain (arthralgia);
• Urination discomfort (dysuria), blood in urine (hematuria), and frequent urination;
• Impotence;
• Chest pain, facial swelling;
• Weight gain.

Very rare side effects: may affect up to 1 in 10,000 people

• Decreased white blood cell count (leucopenia), decreased platelet count (thrombocytopenia);
• Agitation, nervousness;
• Postural dizziness, paresthesia;
• Blurred vision;
• Decreased heart rate (bradycardia), cardiac arrhythmias;
• Heat sensation;
• Difficulty breathing (worsening bronchospasm);
• Bile flow interruption (cholestasis), liver inflammation (hepatitis), yellow skin discoloration (jaundice);
• Hair loss (alopecia), confluent purpuric skin discoloration (purpura), elevated, pruritic, and reddish skin rashes (urticaria);
• Muscle cramps, muscle weakness;
• Urination disorders, nocturia, increased urination frequency (polyuria), or volume (diuresis);
• Enlarged breast tissue (gynecomastia),
• Persistent and painful penile erection (priapism). Consult a doctor urgently;
• Fatigue, general malaise.

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

• IFIS (Intraoperative Floppy Iris Syndrome), a certain eye disorder that can be experienced during cataract surgery;
• Semen entry into the bladder during ejaculation (retrograde ejaculation).

No differences were observed regarding adverse events between young and elderly patients.

Reporting of side effects

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

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging. 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 the packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofDoxazosina Neo Teva 4 mg prolonged-release tablets

• The active ingredient is Doxazosina. Each tablet contains 4 mg of doxazosina as doxazosina mesilate.
• The other components (excipients) are:

Tablet core: polyethylene oxide, microcrystalline cellulose, povidone, α-tocopherol, anhydrous colloidal silica, and sodium stearate fumarate.

Tablet coating: titanium dioxide (E171), copolymer of methacrylic acid and ethyl acrylate (1:1), anhydrous colloidal silica, and macrogol 1300-1600.

Appearance of the product and content of the container

Doxazosina Neo Teva 4 mg prolonged-release tablets are presented as prolonged-release tablets. Each container contains 28 tablets.

Other presentations:

Doxazosina Neo Teva 8 mg prolonged-release tablets EFG.

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid Spain

Responsible for manufacturing

Teva Pharma B.V.

Swensweg 5,

2031 GA Haarlem

Netherlands

or

Teva Czech Industries, s.r.o.

Ostravska 29, c.p. 305,

74770 Opava-Komarov

Czech Republic

or

Merckle GmbH

Ludwig Merckle Strasse 3

89143 Blaubeuren

Last revision date of thisleaflet:February 2025

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS) http: //www.aemps.gob.es/