Label: Information for the User

Doxazosina Teva-ratiopharm 4 mg Tablets

Doxazosina belongs to a group of medicines called alpha 1-adrenergic blockers.

Doxazosina is indicated for:

• Treatment of high blood pressure (hypertension).
• Treatment of urinary tract obstruction and associated symptoms with enlarged prostate (benign prostatic hyperplasia).

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

Patients with both conditions may be treated with doxazosina as a single therapy.

Do not take Doxazosina Teva-ratiopharm

• if you are allergic to doxazosina, to other quinazolines (for example, prazosina or terazosina) or to any of the other components of this medication (listed in section 6),
• if you have experienced hypotension (low blood pressure) 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 have low blood pressure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxazosina Teva-ratiopharm

• if you have liver problems, doxazosina should be used with caution,
• if you have benign prostatic hyperplasia and are hypotensive,

• if you suffer from acute heart disease (heart disease), such as pulmonary edema or heart failure,
• if you are about to undergo eye surgery for cataracts, please inform your doctor before the operation if you are taking or have taken Doxazosina Teva-ratiopharm previously. This is because doxazosina may cause complications during the operation, which can be taken into account and controlled by your ophthalmologist if you have been informed previously.

Prolonged and painful erectionsmay occur with very low frequency. If this happens, consult a doctor urgently.

Before starting treatment with this medication, your doctor may perform tests to rule out other diseases such as prostate cancer, which may cause the same symptoms as benign prostatic hyperplasia.

Children and adolescents

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

Use of Doxazosina Teva-ratiopharm with other medications

Inform your doctor or pharmacist if you are using, or have used recently or may need to use any other medication.

Doxazosina 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 medications to lower blood pressure (thiazide diuretics, furosemide, beta-blockers)

Consult your doctor or pharmacist before using this medication if you are taking any of the following medications, as they may change the effect of Doxazosina Teva-ratiopharm:

• Medications for erectile dysfunction (impotence) (for example, sildenafilo, tadalafilo, vardenafilo) with alpha-blockers such as doxazosina.
• Medications that reduce blood pressure.
• Medications used to treat bacterial or fungal infections (for example, claritromicina, itraconazol, ketoconazol, telitromicina, voriconazol).
• Medications used in the treatment of HIV (for example, indinavir, nelfinavir, ritonavir, saquinavir).
• Nefazodona, a medication used to treat depression.

Taking Doxazosina Teva-ratiopharm with food and drinks

Doxazosina can be taken with meals or without them.

Pregnancy, breastfeeding, and fertility

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

Doxazosina may appear in breast milk in small amounts. Do not take this medication while breastfeeding your baby unless your doctor recommends it.

Driving and operating machinery

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

Doxazosina Teva-ratiopharm contains yellow-orange S (azoic dye), lactose, and sodium

This medication may cause allergic reactions.

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

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

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.

This medication is administered orally.

The tablet can be divided into equal doses.

Hypertension

The usual dose is 2-4 mg once a day. It is recommended to start treatment with the administration of 1 mg of doxazosina once a day for 1 or 2 weeks.

According to the response of each patient, the doctor may increase the dose gradually 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.

This medication may be administered with other medications prescribed by your doctor for the treatment of high blood pressure.

Benign Prostatic Hyperplasia (BPH)

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 increase the dose gradually to 2 mg, 4 mg, or up to 8 mg per day as the maximum dose, at intervals of 1 or 2 weeks between each dose increase.

If you take more Doxazosina than you should

A overdose of this medication may cause a drop in blood pressure. In this case, sit with your head down.

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 forgot to take Doxazosina Teva-ratiopharm

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

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

Like all medicines, this medicine may 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, which are generally mild.

Frequent (may affect up to 1 in 10 people):

• Respiratory tract infection, urinary tract infection,
• Dizziness, headache, drowsiness (somnolence),
• Dizziness,
• Feeling of strong or rapid heartbeats (palpitations), increased heart rate (tachycardia),
• Low blood pressure and postural hypotension (sudden drop in blood pressure due to a change in body position)
• Inflammation of the bronchi (bronchitis), cough, difficulty breathing (dyspnea), inflammation of the nasal mucosa (rhinitis)
• Abdominal pain, indigestion (dyspepsia), dry mouth, nausea
• Itching (pruritus)
• Back pain, muscle pain (myalgia)
• Urinary tract inflammation (cystitis), urinary incontinence
• Fatigue (asthenia), chest pain, flu-like illness, swelling of hands, feet, or ankles (peripheral edema)

Less frequent (may affect up to 1 in 100 people):

• Allergic reaction,
• Abnormal loss of appetite (anorexia), gout, increased appetite,
• Anxiety, depression, difficulty initiating or maintaining sleep (insomnia), agitation, nervousness,
• Interruption of blood supply to the brain (stroke), decreased sensitivity (hypoesthesia), temporary loss of consciousness (syncope), tremor,
• Tinnitus (ringing in the ears)
• Chest pain or pressure (angina pectoris, myocardial infarction),
• Nosebleed (epistaxis),
• Constipation, diarrhea, flatulence, vomiting, gastroenteritis,
• Abnormal liver function tests,
• Dermatological eruption,
• Joint pain (arthralgia),
• Difficulty urinating (dysuria), blood in urine (hematuria), and frequent urination,
• Impotence,
• Pain, swelling of the face,
• Weight gain

Rare (may affect up to 1 in 1,000 people):

• Increased frequency of urination (polyuria).
• Obstruction of the digestive tract.

Very rare (may affect up to 1 in 10,000 people):

• Decreased white blood cell count (leucopenia), decreased platelet count in the blood (thrombocytopenia),

• Postural dizziness, paresthesia,
• Blurred vision,
• Decreased heart rate (bradycardia), cardiac arrhythmias,
• Seizures,
• Difficulty breathing (bronchospasm),
• Bile duct obstruction (cholestasis), liver inflammation (hepatitis), yellowing of the skin (jaundice),
• Hair loss (alopecia), purpura (purple skin discoloration of vascular origin), hives (urticaria),
• Muscle cramps, muscle weakness,
• Urination disorders, nocturia (need to urinate at night), or diuresis (amount of urine),
• Male breast enlargement (gynecomastia),
• Persistent and painful erection of the penis (priapism). Consult a doctor urgently,
• Fatigue, general malaise

Frequency unknown (cannot be estimated from available data)

• Flaccid Iris Syndrome, an eye disorder that may occur during cataract surgery,
• Semen entry into the bladder during ejaculation (retrograde ejaculation).

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, 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: 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.

Store in the original packaging.

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

Composition of Doxazosina Teva-ratiopharm 4 mg tablets

The active ingredient is doxazosina. Each tablet contains 4.85 mg of doxazosina mesilate equivalent to 4 mg of doxazosina.

The other components are: lactose monohydrate, carboxymethylcellulose sodium (type IA) from potato, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate, colloidal silicon dioxide, and yellow orange S (E110). See section 2 “Doxazosina Teva-ratiopharm contains yellow orange S (azoic dye), lactose, and sodium”.

Appearance of the product and content of the container

Tablets

Pink orange colored, biconvex, scored on both faces, and engraved with “DZS 4” on one face.

Each container contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing

SYNTHON HISPANIA, S.L.

Castelló, 1. Polígono Las Salinas.

08830 - Sant Boi de Llobregat (Spain)

or

Toll Manufacturing Services, S.L.

Aragoneses, 2.

28108 – Alcobendas (Spain)

Last review date of this leaflet:February 2024

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/”

You can access detailed and updated information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65123/P_65123.html