Doxazosin Neo Cinfa 4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

doxazosina neo cinfa 4 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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 adverse 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 to treat 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 relieving urinary flow obstruction and irritative symptoms associated with benign prostatic hyperplasia (BPH).

Doxazosina neo cinfa can be used in patients with BPH, whether they have high blood pressure or normal blood pressure. 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 ingredients of this medicine (listed in section 6).
• If you have experienced hypotension (dizziness) when taking other medicines 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

Talk to 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 beforehand.

Prolonged and painful erections may occur very rarely. If this occurs, 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 concomitantly 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 effect of other antihypertensive drugs in lowering blood pressure.

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 used to treat erectile dysfunction (e.g., sildenafil, tadalafil, vardenafil).
• Medicines that reduce 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 drink

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 are planning 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 advises you to do so.

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 instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

This medicine is taken orally.

The usual dose is one tablet (4 mg) once daily. The optimal effect is achieved after four weeks. If necessary, after this period, the dose may be increased to a once-daily dose of 8 mg, depending on the patient's response.

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 medications used for the treatment of hypertension and benign prostatic hyperplasia (BPH) that your doctor has prescribed for you.

Instructions for correct administration

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

Swallow the tablets with a sufficient amount of 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 ingredient. When this process is complete, the empty tablet shell is eliminated from the body in the faeces.

Take this medicine once daily, every day, at approximately the same time. Taking the tablets at the same time each day will provide better control of your blood pressure and 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 advice.

Remember to take your medicine.

Your doctor will advise you on 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 your doctor has prescribed, seek immediate advice from your doctor, pharmacist, or hospital emergency department. 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 the 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 may cause adverse effects, although not everyone experiences them.

Reactions to doxazosin vary in intensity from one individual to another and should be especially considered at the beginning of treatment or when changing medication, being generally mild.

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

• Respiratory tract infection, urinary tract infection.
• Dizziness, headache, drowsiness (somnolence).
• Vertigo.
• Awareness 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).
• 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 during urination (dysuria), blood in the urine (hematuria), 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 (leucopenia), decrease in the number of blood platelets (thrombocytopenia).
• Restlessness, 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 purple-colored skin spots (purpura), raised red itchy rashes appearing on the skin surface (urticaria).
• Muscle cramps, muscle weakness.
• Urination disorders, need to urinate at night (nocturia), increased frequency of urination (polyuria) or increased 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 eye disorder that may occur during cataract surgery).
• Backward flow of semen into the bladder during ejaculation (retrograde ejaculation).

No differences in adverse events were observed between younger 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. Storage of doxazosina neo cinfa

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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines 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 mesilate). Each prolonged-release tablet contains 4 mg of doxazosin, equivalent to 4.85 mg of doxazosin mesilate.
• 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: copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, hydrated colloidal silica, macrogol 1300-1600, and titanium dioxide (E-171).

Appearance of the product and contents of the pack

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

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

Pack sizes:

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

Only some pack sizes may be commercially available.

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 Munich

Germany

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

This medicinal product 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 most recent review of this leaflet: September 2022.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (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 leaflet and packaging. You can also access this information at the following web 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