DOXAZOSIN NEO CINFA 4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

doxazosina neo cinfa 4 mg prolonged-release tablets EFG

doxazosina

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 and other information

1. What is doxazosina neo cinfa and what is it used for
2. What you need to know before you take doxazosina neo cinfa
3. How to take doxazosina neo cinfa
4. Possible side effects
5. Storing doxazosina neo cinfa
6. Contents of the pack and further information

1. What is doxazosina neo cinfa and what is it used for

Doxazosina neo cinfa is a medication with vasodilatory action 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 can be used in patients with BPH, whether they are hypertensive or normotensive. Those patients with both pathologies can be treated with doxazosina as monotherapy.

2. What you need to know before you take doxazosina neo cinfa

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. prazosin, terazosin) 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 congestion of the upper urinary tract, chronic urinary tract infections, or stones in the bladder.
• If you have 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 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 a serious heart problem, such as heart failure or pulmonary edema.

Especially at the beginning of taking this medication, dizziness, weaknessand, 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 appear.

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

If you are going 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 informed beforehand.

Prolonged and painful erectionscan occur very rarely. If this happens, consult your doctor immediately.

Other medications and doxazosina neo cinfa

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

Doxazosina has been administered along with other antihypertensives, other medications such as non-steroidal anti-inflammatory drugs, antibiotics, oral antidiabetics, gout medications, anticoagulants, digoxin, warfarin, phenytoin, and indomethacin without any negative consequences. Doxazosina enhances the action of other antihypertensives in reducing 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 for treating erection disorders (e.g. sildenafil, tadalafil, vardenafil).
• Medications that lower blood pressure.
• Medications for treating bacterial or fungal infections, e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medications used in the treatment of HIV, e.g. indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, 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

The use of doxazosina is not recommended 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, think you may be pregnant, or plan to become pregnant, 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. You should not take doxazosina while breastfeeding your baby unless your doctor recommends it.

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.

doxazosina neo cinfa contains sodium

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

3. How to take doxazosina neo cinfa

Follow exactly the administration instructions of this medication 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 achieved after four weeks. If necessary, after this period, the dose 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 administered both in the morning and at night.

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

This medication can be administered along 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 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 cinfa, the medication is inside a non-absorbable tablet, specially designed for the active ingredient to have a controlled release. When this process is completed, 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 you should take the tablets. Doxazosina can be taken with or without food.

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 the 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 prescribed by your doctor, seek advice immediately from your doctor, pharmacist, or hospital emergency department. Remember to take the package 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).

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

If you forget to take doxazosina neo cinfa

Do not take a double dose to make up for forgotten doses. It is important that you take this medication 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 stop taking doxazosina neo cinfa

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication 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, being generally mild.

Common (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 accelerated 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 (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 (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.
• Abnormal liver function tests.
• Skin rash.
• Joint pain (arthralgia).
• Difficulty urinating (dysuria), blood in the urine (hematuria), and frequent urination.
• Impotence.
• Pain, swelling of the face.
• 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):

• 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).
• Hot flashes.
• Breathing difficulties (bronchospasm).
• Stop or suppression of bile flow (cholestasis), liver inflammation (hepatitis), yellowing of the skin (jaundice).
• Hair loss (alopecia), confluent purple-colored skin spots (purpura), red, itchy, and raised skin rashes (urticaria).
• Muscle cramps, muscle weakness.
• Urination disorders, need to urinate at night (nocturia), increased number of times urinating (polyuria) or amount of urine (diuresis).
• Increased male breast tissue (gynecomastia).
• Fatigue, general malaise.
• Prolonged and painful erection. Consult a doctor urgently.

Frequency not known (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 patients and elderly patients.

Reporting of side effects

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

5. Storing doxazosina neo cinfa

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

Do not use this medication after the expiry date which is stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to a pharmacy for proper disposal. If in doubt, ask your pharmacist how to dispose of the packaging and unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of doxazosina neo cinfa

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

Core of the tablet: polyethylene oxide (PM 200,000), polyethylene oxide (PM 900,000), microcrystalline cellulose, povidone (K29-32), all-rac-α-tocopherol, anhydrous colloidal silica, and sodium stearyl fumarate.

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

Appearance of the product and packaging contents

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

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

Package sizes:

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

ACINO AG

Leopoldstraße 115

80804 Múnich

Germany

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany Doxazosin-Acino 4 mg Retardtabletten

Spain Doxazosina Neo Cinfa 4 mg prolonged-release tablets EFG

Portugal Doxazosin Acino 4 mg Comprimidos MG

Date of the last revision of this leaflet: September 2022.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about 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 to: https://cima.aemps.es/cima/dochtml/p/75009/P_75009.html