DOXAZOSIN NEO TEVA 4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Doxazosina Neo Teva 4 mg

prolonged-release tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Doxazosina Neo Teva and what is it used for
2. What you need to know before you take Doxazosina Neo Teva
3. How to take Doxazosina Neo Teva
4. Possible side effects
5. Storage of Doxazosina Neo Teva
6. Pack contents and further information

1. What is Doxazosina Neo Teva and what is it used for

Doxazosina Neo Teva is a vasodilator for the treatment of arterial hypertension and benign prostatic hyperplasia.

Doxazosina Neo Teva is indicated for the treatment of high 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 can be used in patients with BPH, whether hypertensive or normotensive. Patients with both conditions can be treated with Doxazosina Neo Teva as monotherapy.

2. What you need to know before you take Doxazosina Neo Teva

Treatment with Doxazosina Neo Teva requires periodic monitoring by your doctor.

Do not take Doxazosina Neo Teva

• If you are allergic to the active substance, to other quinazolines (e.g. prazosin, terazosin) or to any of the other components of this medicine (listed in section 6).
• If you have suffered from hypotension (dizziness) when taking other medications to lower blood pressure.
• If you have an enlarged prostate gland along with congestion of the upper urinary tract, chronic urinary tract infections, or bladder stones.
• If you suffer from any form of gastrointestinal obstruction.
• If you suffer from continuous urine loss (urinary incontinence), do not produce enough urine (anuria), or have kidney failure (only for patients with benign prostatic hyperplasia taking doxazosin as monotherapy).
• If you are breast-feeding.
• 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: as there is no clinical experience in patients with severe hepatic insufficiency, its use is not recommended in these patients.
• If you suffer from acute heart disease, such as pulmonary edema or heart failure.
• If you take any medication to treat erection problems (see "Taking Doxazosina Neo Teva with other medicines").

Especially at the start of taking this medicine, dizziness, weakness, and, in rare cases, fainting may occur. Therefore, you should proceed with caution when starting treatment and avoid situations that could cause injury if such symptoms occur.

If you are going to undergo cataract surgery, inform your doctor before surgery if you are taking or have previously taken Doxazosina Neo Teva. This is because Doxazosina Neo Teva may cause complications during surgery, which can be taken into account and controlled by your ophthalmologist if they have been previously informed.

Children and adolescents

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

Taking Doxazosina Neo Teva with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Doxazosina Neo Teva has been administered with other antihypertensives, other medications such as non-steroidal anti-inflammatory drugs, antibiotics, oral antidiabetics, gout medications, anticoagulants, digoxin, warfarin, phenytoin, and indomethacin without negative consequences. Doxazosina enhances the action of other antihypertensives in reducing blood pressure.

Doxazosina should be used with caution in patients receiving medications for treating erectile dysfunction (e.g., sildenafil, tadalafil, vardenafil), as symptomatic hypotension may occur in some patients.

Some patients who are receiving an alpha-blocker for the treatment of high blood pressure or prostatic hyperplasia may experience dizziness or fainting that can be 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 Doxazosina Neo Teva. In order to reduce the likelihood of these symptoms, 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 or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Doxazosina Neo Teva if you are pregnant or breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

Doxazosina Neo Teva contains sodium

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

3. How to take Doxazosina Neo Teva

Follow exactly the administration instructions of this medicine 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 suitable for you. Do not take more tablets than prescribed 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 at four weeks. If necessary, after this period, it may 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 in the morning or 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 arterial hypertension and benign prostatic hyperplasia (BPH) that your doctor has prescribed.

Instructions for correct administration

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

In Doxazosina Neo Teva, the medication is inside a non-absorbable tablet, specially designed for controlled release of the active ingredient. When this process is complete, 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 with or without food.

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

Do not stop treatment before consulting your doctor, as it may be harmful to your health.

If you think that the effect of Doxazosina Neo Teva is too strong or too weak, consult your doctor or pharmacist. Do not take more tablets than recommended by the 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, telephone 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Doxazosina Neo Teva

Do not take a double dose to make up for forgotten doses. It is important that you 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 further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Doxazosina reactions vary in intensity from one individual to another and should be taken into account, especially at the start of treatment or when changing medication, and are generally mild.

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

• Respiratory tract infection, urinary tract infection;
• Dizziness, headache, tendency to sleep (somnolence);
• Vertigo;
• Feeling of strong or rapid heartbeats (palpitations), increased heart rate (tachycardia);
• Hypotension, 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, swelling of hands, feet, or ankles (peripheral edema).

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

• Allergic reaction;
• Abnormal loss of appetite (anorexia);
• Anxiety, depression, difficulty starting or maintaining sleep (insomnia);
• Disruption of blood supply to the brain (stroke), decreased sensitivity (hypoesthesia), temporary loss of consciousness (syncope), tremor;
• Ringing in the ears (tinnitus);
• Chest pain or tightness (angina pectoris, myocardial infarction);
• Nosebleed (epistaxis);
• Constipation, diarrhea, flatulence, vomiting, gastroenteritis;
• Skin rash;
• Joint pain (arthralgia);
• Difficulty urinating (dysuria), blood in urine (hematuria), and frequent urination;
• Impotence;
• Pain, swelling of the face;
• Weight gain.

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

• Decrease in the number of white blood cells (leukopenia), decrease in the number of blood platelets (thrombocytopenia);
• Agitation, nervousness;
• Postural dizziness, tingling (paresthesia);
• Blurred vision;
• Decreased heart rate (bradycardia), heart rhythm disorders (cardiac arrhythmias);
• Heat sensation;
• Difficulty breathing (worsening of bronchospasm);
• Stop or suppression of bile flow (cholestasis), liver inflammation (hepatitis), yellowing of the skin (jaundice);
• Hair loss (alopecia), confluent purple spots on the skin (purpura), red, itchy, raised patches on the skin (urticaria);
• Muscle cramps, muscle weakness;
• Urination disorders, need to urinate at night (nocturia), increased number of times you need to urinate (polyuria), or amount of urine (diuresis);
• Enlargement of breast tissue in men (gynecomastia),
• Prolonged and painful erection of the penis (priapism). Consult a doctor urgently;
• Fatigue, general malaise.

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

• IFIS (Intraoperative Floppy Iris Syndrome), a certain eye disorder that can occur during cataract surgery;
• Entry of semen into the bladder during ejaculation (retrograde ejaculation).

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxazosina Neo Teva

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Pack contents and further information

Composition of Doxazosina Neo Teva 4 mg prolonged-release tablets

• The active substance is Doxazosina. Each tablet contains 4 mg of doxazosina as doxazosina mesylate.
• The other ingredients (excipients) are:

Core of the tablet: polyethylene oxide, microcrystalline cellulose, povidone, α-tocopherol, colloidal anhydrous silica, and sodium stearyl fumarate.

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

Appearance and pack contents

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

Other presentations:

Doxazosina Neo Teva 8 mg prolonged-release tablets EFG.

Marketing Authorisation Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108, Madrid Spain

Manufacturer

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

Date of last revision of this leaflet:February 2025

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/