Package Leaflet: Information for the User

doxazosina neo cinfa 4 mg prolonged-release tablets EFG

doxazosina

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

• 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 for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Doxazosina neo cinfa is a vasodilatory medication for the treatment of arterial hypertension and benign prostatic hyperplasia.

Doxazosina neo cinfa 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 cinfa may be used in patients with BPH, hypertensives, or normotensives.Patients with both conditions may be treated with doxazosina as monotherapy.

The treatment with doxazosina requires periodic monitoring by your doctor.

Do not take doxazosina neo cinfa

• If you are allergic to doxazosina, to other quinazolines (e.g.: prazosina, terazosina) or to any of the other components of this medication (listed in section 6).
• If you have had hypotension (dizziness) when taking other medications to lower blood pressure.
• If you have an enlarged prostate along with upper urinary tract congestion, chronic urinary tract infections or bladder stones.
• If you have or have had any form of gastrointestinal tract obstruction.
• If you have low blood pressure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• If you haveliver 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 aserious heart problem, such as heart failure or pulmonary edema.

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.

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

If you are to undergo eye surgeryfor cataracts, please inform your doctor before the operation if you are taking or have taken doxazosina 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 in advance.

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

Other medications and doxazosina neo cinfa

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 antihypertensives, other medications such as nonsteroidal 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 antihypertensives in lowering blood pressure.

Consult your doctor or pharmacist before using doxazosina if you are taking any of the following medications, as they may change the effect of doxazosina:

• Medications to treat erectile dysfunction (e.g.: sildenafilo, tadalafilo, vardenafilo).
• Medications to lower blood pressure.
• Medications 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 Neo Cinfa with food and drinks

You can take doxazosina with or without food.

Children and adolescents

Do not recommend the use of doxazosina in children and adolescents under 18 years old since the safety and efficacy have not been established.

Pregnancy and breastfeeding

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

Doxazosina, the active ingredient of doxazosina neo cinfa, may appear in breast milk in small amounts. Do not take doxazosina while breastfeeding your baby unless your doctor recommends it.

Driving and operating machines

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

doxazosina neo cinfa 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 is most suitable for you. Do not take more tablets than indicated by your doctor.

Depending on your individual response, your doctor may modify the dose of doxazosina.

This medication is taken orally.

The dose is one tablet (4 mg) once a day. The optimal effect is obtained after 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 as a single daily dose.

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

This medication can be taken both in the morning and at night.

All dose modifications and control should be performed under medical supervision.

This medication can be taken with other medications used for the treatment of hypertension and benign prostatic hyperplasia (BPH) that your doctor has prescribed.

Instructions for correct administration

Swallow the doxazosina 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 cinfa, the medication is contained within a non-absorbable tablet, specifically designed to provide controlled release. When this process is complete, the empty tablet is eliminated from the body through the feces.

Take this medication once a day, every day, 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 can be taken with or without meals.

Follow these instructions unless your doctor has given you different instructions.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with doxazosina. Do not interrupt treatment prematurely, as it may be harmful to your health.

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

If you take more doxazosina neo cinfa than you should

If you take more doxazosina than your doctor has prescribed, seek advice immediately from your doctor, pharmacist, or hospital emergency service. Remember to bring the packaging and remaining tablets with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

A doxazosina overdose can cause a drop in your blood pressure.In this case, sit down with your head down.

If you forgot to take doxazosina neo cinfa

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

If you interrupt treatment with doxazosina neo cinfa

Continue taking the tablets until your doctor tells you to stop.

If you have any other doubts 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 of doxazosina 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 (may affect up to 1 in 10 people):

• Respiratory tract infection, urinary tract infection.
• Dizziness, headache, tendency to sleep (somnolence).
• Dizziness.
• Feeling of strong or rapid heartbeats (palpitations), increased heart rate (tachycardia).
• Hypotension, postural hypotension.
• 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).
• Interruption of blood supply to the brain (cerebrovascular accident), decreased sensitivity (hypoesthesia), temporary loss of consciousness (syncope), tremor.
• Ringing in the ears (tinnitus).
• Chest pain or pressure (angina pectoris, myocardial infarction).
• Nasal bleeding (epistaxis).
• Constipation, diarrhea, flatulence, vomiting, gastroenteritis.
• Abnormal liver function tests.
• Skin rash.
• Joint pain (arthralgia).
• Difficulty urinating (dysuria), blood in the urine (hematuria), and frequent urination.
• Impotence.
• Chest pain, facial swelling.
• Weight gain.

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

• 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 (thrombocytopenia).
• Restlessness, nervousness.
• Postural dizziness, paresthesia.
• Blurred vision.
• Decreased heart rate (bradycardia), cardiac arrhythmias.
• Hot flashes.
• Difficulty breathing (bronchospasm).
• Bile duct obstruction (cholestasis), liver inflammation (hepatitis), yellow skin discoloration (jaundice).
• Hair loss (alopecia), confluent purpuric skin discoloration (purpura), itchy, raised, and red skin rashes (urticaria).
• Muscle cramps, muscle weakness.
• Urination disorders, nocturia, polyuria, or diuresis.
• Male breast enlargement (gynecomastia).
• Fatigue, general malaise.
• Persistent and painful penile erection. Consult a doctor urgently.

Frequency unknown (cannot be estimated from available data):

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. Throughthe reporting of adverse 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 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.

This medication does not require special storage conditions.

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

Doxazosin Neo Cinfa Composition

• The active ingredient is doxazosin (as mesylate of doxazosin). Each prolonged-release tablet contains 4 mg of doxazosin, equivalent to 4.85 mg of mesylate of doxazosin.
• The other components are:

Tablet core: polyethylene oxide (PM 200,000), polyethylene oxide (PM 900,000), microcrystalline cellulose, povidone (K29-32), all-rac-?-tocopherol, anhydrous colloidal silica, and sodium stearate fumarate.

Tablet coating: copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion of 30%, hydrated colloidal silica, macrogol 1300-1600, and titanium dioxide (E-171).

Product Appearance and Packaging Contents

The tablets are white, round, and biconvex, with the inscription “DL”.

The medication is presented in PVC/PVDC/Aluminum blisters.

Packaging sizes:

14, 15, 28, 30, 50 x 1, 60, 90, 100 tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible Manufacturer

ACINO AG

Leopoldstraße 115

80804 Munich

Germany

or

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

This Medication is Authorized in the Member States of the European Economic Area with the Following Names:

GermanyDoxazosin-Acino 4 mg Retardtabletten

SpainDoxazosina Neo Cinfa 4 mg prolonged-release tablets EFG

PortugalDoxazosin Acino 4 mg Comprimidos MG

Last Review Date of this Leaflet: September 2022.

For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75009/P_75009.html

QR Code Link:https://cima.aemps.es/cima/dochtml/p/75009/P_75009.html