Doxazosin Neo Cinfia 8 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

doxazosina neo cinfa 8 mg prolonged-release tablets EFG

doxazosin

Read the entire 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 other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

doxazosina neo cinfa is a vasodilating medicine used for the treatment of high blood pressure (hypertension) and benign prostatic hyperplasia.

doxazosina neo cinfa is indicated for the treatment of elevated blood pressure in the arteries (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 BPH patients, whether they are hypertensive or normotensive. Patients with both conditions may be treated with doxazosin as monotherapy.

2. What you need to know before starting doxazosin neo cinfa

Treatment with doxazosin requires periodic monitoring by your doctor.

Do not take doxazosin neo cinfa

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

Warnings and precautions

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

• If you have liver problems. Since there is no clinical experience in patients with severe hepatic impairment, use in these patients is not recommended.
• If you suffer from a serious heart condition, such as heart failure or pulmonary edema.

Especially at the beginning of treatment with this medicine, dizziness, weakness, and, rarely, fainting may occur. Therefore, caution should be exercised at the start of treatment, and situations that could lead to injury if these symptoms occur should be avoided.

Before starting treatment with doxazosin, 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 scheduled for cataract eye surgery, please inform your doctor before the procedure if you are currently taking or have previously taken doxazosin. This is because doxazosin may cause complications during surgery, which can be anticipated and managed by your ophthalmologist if they are informed in advance.

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

Other medicines and doxazosin neo cinfa

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

Doxazosin has been administered together with other antihypertensives and other medicines such as non-steroidal anti-inflammatory drugs, antibiotics, oral antidiabetics, gout medications, anticoagulants, digoxin, warfarin, phenytoin, and indomethacin without negative consequences. Doxazosin enhances the blood pressure-lowering effect of other antihypertensive medicines.

Consult your doctor or pharmacist before using doxazosin if you are taking any of the following medicines, as they may alter the effect of doxazosin:

• Medicines for treating erectile dysfunction (e.g., sildenafil, tadalafil, vardenafil).
• Medicines that lower blood pressure.
• Medicines used to treat bacterial or fungal infections, for example, clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used in the treatment of HIV, for example, indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.

Taking doxazosin neo cinfa with food and drinks

You may take doxazosin with or without food.

Children and adolescents

The use of doxazosin is not recommended in children and adolescents under 18 years of age, as 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 medicine.

Doxazosin, the active substance in doxazosin neo cinfa, may appear in breast milk in small amounts. You should not take doxazosin while breastfeeding unless your doctor recommends it.

Driving and using machines

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

doxazosin neo cinfa contains sodium

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

3. How to take Doxazosin Neo Cinfa

Follow exactly the administration instructions for this medicine as indicated by your physician. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the most appropriate dose of doxazosin for you. Do not take more tablets than indicated by your physician.

Depending on your individual response, your doctor may adjust the dose of doxazosin.

This medicine is taken orally.

The dose is one tablet (8 mg) once daily. The optimal effect is achieved after four weeks.

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

Dose adjustment is not required in elderly patients (over 65 years of age) or in patients with renal impairment.

This medicine may be taken either in the morning or at night.

All dose modifications and monitoring must be carried out under medical supervision.

This medicine may be administered together with other medicines prescribed by your doctor for the treatment of high blood pressure and benign prostatic hyperplasia (BPH).

Instructions for correct administration

Swallow the doxazosin tablet whole, without chewing, dividing, or crushing.

Swallow the tablets with sufficient liquid (for example, a glass of water).

In Doxazosin Neo Cinfa, the medicine is contained within a non-absorbable tablet specially designed to provide controlled release of the active substance. When this process is complete, the empty tablet shell is eliminated from the body through the feces.

Take this medicine once daily, every day, at approximately the same time each day. Taking the tablets at the same time daily will provide a better effect on your blood pressure and will help you remember when to take them. Doxazosin may be taken with or without food.

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

Remember to take your medicine.

Your doctor will determine how long your treatment with doxazosin should last. Do not stop treatment prematurely, as this may be harmful to your health.

If you feel the effect of this medicine 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 Doxazosin Neo Cinfa than you should

If you take more doxazosin than prescribed by your doctor, seek immediate advice from your doctor, pharmacist, or hospital emergency service. Remember to bring the packaging and any remaining tablets with you.

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

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

If you forget to take Doxazosin Neo Cinfa

Do not take a double dose to make up for missed doses. It is important to take this medicine regularly at the same time each day. If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed tablet.

If you stop taking Doxazosin Neo Cinfa

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Reactions to doxazosin vary in intensity from person to person and should be especially considered at the beginning of treatment or when changing medication; they are generally mild.

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

• Respiratory tract infection, urinary tract infection.
• Dizziness, headache, tendency to sleepiness (somnolence).
• Vertigo.
• Sensation of strong or rapid heartbeat (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).
• Inflammation of the bladder (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 in falling or staying asleep (insomnia).
• Interruption of blood supply to the brain (stroke), decreased sensation (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).
• Discomfort when 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 gastrointestinal 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), disturbances in heart rhythm (cardiac arrhythmias).
• Hot flushes.
• Breathing difficulty (bronchospasm).
• Blockage or suppression of bile flow (cholestasis), inflammation of the liver (hepatitis), yellowing of the skin (jaundice).
• Hair loss (alopecia), confluent purplish skin spots (purpura), raised red itchy welts appearing on the skin surface (urticaria).
• Muscle cramps, muscle weakness.
• Urination disorders, need to urinate at night (nocturia), increased frequency of urination (polyuria) or urine volume (diuresis).
• Enlargement of male breast glands (gynecomastia).
• Fatigue, general malaise.
• Persistent and painful penile erection. Consult a doctor urgently.

Frequency not known (cannot be estimated from available data):

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

No differences were observed regarding adverse events between young 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Doxazosin neo cinfa storage instructions

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

Do not use this medicine after the expiry date stated on the packaging after 'EXP'. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of doxazosina neo cinfa

• The active substance is doxazosin (as doxazosin mesylate). Each prolonged-release tablet contains 8 mg of doxazosin, equivalent to 9.70 mg of doxazosin mesylate.

• The other components are:

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

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

Appearance of the medicine and contents of the container

The tablets are white, round and biconvex, with the inscription “DH” on one side.

The medicine is available in PVC/PVDC/aluminum blisters.

Pack sizes:

7, 10, 14, 15, 28, 30, 50, 56, 60, 98 or 100 tablets.

Calendar packs: 7, 14, 28, 56 or 98 tablets.

Unit dose pack: 50 x 1 tablet.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Spain: doxazosina neo cinfa 8 mg prolonged-release tablets EFG

Date of the most recent revision of this leaflet: November 2021

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74986/P_74986.html

QR code links to: https://cima.aemps.es/cima/dochtml/p/74986/P_74986.html