Doxazosin Neo Aurovitas Spain 8 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Doxazosina Neo Aurovitas Spain 8 mg prolonged-release tablets EFG

Read all of this leaflet carefully before you start taking this medicine, as 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 pass it on 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 Aurovitas Spain is and what it is used for
2. What you need to know before taking Doxazosina Neo Aurovitas Spain
3. How to take Doxazosina Neo Aurovitas Spain
4. Possible side effects
5. How to store Doxazosina Neo Aurovitas Spain
6. Contents of the pack and other information

1. What Doxazosina Neo Aurovitas Spain is and what it is used for

Your doctor may have prescribed Doxazosina Neo Aurovitas Spain because you have high blood pressure, which can increase the risk of heart disease or heart attack if left uncontrolled. The active substance in the tablets, doxazosin, belongs to a group of medicines known as alpha-1 blockers. These medicines work by dilating your blood vessels, making it easier for the heart to pump blood through them. This helps lower blood pressure and reduces the risk of heart disease.

Doxazosina Neo Aurovitas Spain may also have been prescribed to treat the symptoms of benign prostatic enlargement (benign prostatic hyperplasia, BPH). This condition means that the prostate, located below the bladder in men, has increased in size. This makes it difficult to empty the bladder. Doxazosina Neo Aurovitas Spain works by relaxing the muscle around the outlet of the bladder and the prostate gland, thus making it easier to empty the bladder.

Doxazosin, contained in Doxazosina Neo Aurovitas Spain, may also be approved for the treatment of other conditions not listed in this leaflet. Consult your doctor, pharmacist, or other healthcare professional if you have any questions, and always follow their instructions.

2. What you need to know before taking Doxazosina Neo Aurovitas Spain

Do not take Doxazosina Neo Aurovitas Spain

• If you are allergic to doxazosin or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines of the same class as doxazosin, such as prazosin and terazosin.
• If you have low blood pressure or have ever experienced a drop in blood pressure causing dizziness or fainting when standing up from a lying or sitting position.
• If you have benign enlargement of the prostate and also have upper urinary tract obstruction, chronic urinary infection, or bladder stones.
• If you have or have had an obstruction of the gastrointestinal tract.
• If you are using this medicine for the treatment of Benign Prostatic Hyperplasia (BPH) and have low blood pressure.
• If you have overflow incontinence or lack of urine production with or without worsening of kidney function.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Doxazosina Neo Aurovitas Spain:

• At the beginning of treatment. You may experience a drop in blood pressure accompanied by dizziness, weakness, and in rare cases, fainting. Avoid situations that could lead to injury if these symptoms occur.
• If you suffer from an acute heart condition, such as heart failure.
• If you have liver disease. In cases of severe liver disease, the use of Doxazosina Neo Aurovitas Spain is not recommended.
• If you are also taking medicines for erectile dysfunction (PDE-5 inhibitors, e.g., sildenafil, tadalafil, vardenafil), as this may cause a significant drop in blood pressure. This is more likely to occur at the start of treatment with the PDE-5 inhibitor. This means that your treatment with doxazosin should be stabilized before starting treatment with PDE-5 inhibitors. Your doctor may consider using a lower starting dose of the PDE-5 inhibitor.
• If you are scheduled for eye surgery due to cataracts (lens opacity), inform your eye specialist before the operation that you are currently taking or have previously taken Doxazosina Neo Aurovitas Spain. This is because Doxazosina Neo Aurovitas Spain may cause complications during surgery, which can be avoided if your specialist is informed in advance.

Before starting treatment with doxazosin, your doctor may perform tests to rule out other conditions such as prostate cancer, which may cause symptoms similar to benign prostatic hyperplasia.

Occasionally, you may notice tablet remnants in your stools. This is normal. The active substance in the prolonged-release tablets is contained within a non-absorbable coating specifically designed to slowly release the substance into the body. Once this process is complete, the empty coating is eliminated from the body through the faeces.

Talk to your doctor or pharmacist before starting to take Doxazosina Neo Aurovitas Spain.

Children and adolescents

Doxazosina Neo Aurovitas Spain is not recommended for use in children or adolescents under 18 years of age, as safety and efficacy have not been established.

Other medicines and Doxazosina Neo Aurovitas Spain

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

Some patients taking alpha-blockers for high blood pressure or prostate enlargement may experience dizziness or vertigo, caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medications for erectile dysfunction (impotence) together with alpha-blockers. To reduce the likelihood of these symptoms occurring, your daily dose of alpha-blocker should be stabilized before starting medications for erectile dysfunction.

Inform your doctor if you are taking any of the following medicines in particular:

• Other alpha-blockers and other medicines used to treat high blood pressure.
• Non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen.
• 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.

Pregnancy, breastfeeding, and fertility

For hypertension indication only:

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. Experience with the use of doxazosin during pregnancy is limited.

Doxazosin may appear in breast milk in small amounts. You should not take this medicine while breastfeeding unless your doctor advises you to do so.

Talk to your doctor or pharmacist before using any medicine.

There are no reports on the effects of doxazosin on male fertility.

Driving and using machines

Doxazosina Neo Aurovitas Spain may cause dizziness. Take special care when taking the first dose, when your dose is increased, or when restarting treatment after an interruption. If you feel dizzy or lightheaded, you should not drive or operate machinery.

It is your responsibility to assess whether you are fit to drive or perform work requiring special vigilance. One of the factors that may affect your ability to do so is the use of medicines, due to their effects and/or adverse reactions. A description of these effects and adverse reactions can be found in other sections. Therefore, please read all the information in this leaflet. Consult your doctor or pharmacist if you have any doubts.

Doxazosina Neo Aurovitas Spain contains sodium

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

3. How to take Doxazosina Neo Aurovitas Spain

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

Method of administration

Doxazosina Neo Aurovitas Spain has been specially formulated to release the active substance slowly throughout the day. Choose the time of day that is most convenient for you and take your tablets at that time each day.

The tablets must be swallowed whole with a sufficient amount of liquid. Do not chew, split, or crush the tablets.

Treatment of high blood pressure and symptoms of benign prostatic hyperplasia:

Adults (including elderly patients)

The usual dose of doxazosin is 4 mg once daily, although your doctor may increase your dose to 8 mg of doxazosin (one tablet) daily.

The maximum recommended dose is 8 mg of doxazosin per day. It may take up to 4 weeks to achieve the optimal effect.

Patients with liver problems

Your doctor may reduce your dose or monitor your progress carefully. The use of doxazosin is not recommended in patients with severe liver problems.

If you take more Doxazosina Neo Aurovitas Spain than you should

If you take too many tablets or, for example, a child accidentally takes the medicine, contact your doctor or go to a hospital emergency department immediately. If you have taken too many tablets, you may experience dizziness or vertigo due to a drop in blood pressure. Lie down on your back with your feet higher than your head.

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

If you forget to take Doxazosina Neo Aurovitas Spain

If you forget to take a dose, do not worry. Simply take the tablet the next day at your usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Doxazosina Neo Aurovitas Spain

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 experiences them.

Some adverse effects can be serious:

Stop taking this medicine and consult your doctor immediately or go to the nearest hospital if any of the following occur:

• Allergic reactions such as wheezing, difficulty breathing, severe dizziness or collapse, swelling of the face or throat, or severe skin rash with red spots or blisters (may affect up to 1 in 100 people).
• Chest pain (angina pectoris; may affect up to 1 in 100 people), rapid or irregular heartbeat (may affect up to 1 in 10,000 people), heart attack or myocardial infarction (may affect up to 1 in 100 people).
• Yellowing of the skin or whites of the eyes (jaundice), caused by liver problems (may affect up to 1 in 10,000 people).

Common adverse effects: may affect up to 1 in 10 people

• Palpitations (strong heartbeat), increased heart rate,
• Dizziness, headache, drowsiness,
• Sensation of vertigo or spinning,
• Inflammation of the airways (bronchitis), cough, difficulty breathing (dyspnea), rhinitis (nasal itching, runny nose, and nasal congestion),
• Abdominal discomfort, stomach discomfort (dyspepsia), dry mouth, nausea,
• Inflammation of the bladder (cystitis), loss of bladder control,
• Itching of the skin,
• Back pain, muscle pain,
• Lung infection (respiratory tract infection), kidney or bladder infection (urinary tract infection),
• Low blood pressure, sudden drop in blood pressure upon standing,
• Weakness, flu-like symptoms, swelling, particularly of the feet and lower limbs (edema).

Uncommon adverse effects: may affect up to 1 in 100 people

• Weight gain,
• Reduced sensation, fainting, tremors,
• Tinnitus (ringing in the ears),
• Nosebleeds,
• Constipation, diarrhea, flatulence, vomiting, inflammation of the stomach and intestines,
• Pain during urination, blood in the urine, increased frequency of urination,
• Skin rashes,
• Pain and stiffness in the joints (arthralgia),
• Increased or decreased appetite, gout (a painful form of arthritis),
• Pain and swelling of the face (facial edema),
• Increased levels of liver enzymes,
• Inability to achieve an erection,
• Anxiety, depression, insomnia.

Rare adverse effects: may affect up to 1 in 1,000 people

• Obstruction of the gastrointestinal tract.

Very rare adverse effects: may affect up to 1 in 10,000 people

• Reduced heart rate,
• Reduction in levels of certain blood cells (leukopenia, thrombocytopenia),
• Dizziness upon standing, tingling with loss of sensation,
• Blurred vision,
• Narrowing of the airways causing difficulty breathing or wheezing (bronchospasm),
• Problems urinating, increased need to urinate at night, increased production and volume of urine,
• Hair loss, unusual bleeding or bruising, rash,
• Muscle cramps, muscle weakness,
• Hot flushes,
• Fatigue, usually accompanied by malaise,
• Blockage of bile excretion from the liver (cholestasis), inflammation of the liver (hepatitis),
• Breast enlargement in men,
• Persistent and painful penile erection. Seek urgent medical attention,
• Restlessness, nervousness.

Frequency not known: frequency cannot be estimated from available data

• Intraoperative complications (“Intraoperative Floppy Iris Syndrome”) during cataract surgery (see section 2 “Warnings and precautions”),
• Retrograde ejaculation – occurs when semen is redirected into the urinary bladder instead of being normally ejaculated through the urethra.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Doxazosin Neo Aurovitas Spain

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Doxazosina Neo Aurovitas Spain

• The active substance is doxazosin (as mesilate). Each prolonged-release tablet contains 8 mg of doxazosin (as mesilate).

• The other components are:

Tablet core: polyethylene oxide (MW 900,000), polyethylene oxide (MW 200,000); microcrystalline cellulose, povidone (K29-32), butylhydroxytoluene (E321), all-rac-?-tocopherol, colloidal anhydrous silica, sodium stearyl fumarate.

Tablet coating: 30% dispersion of methacrylic acid – ethyl acrylate copolymer (1:1), hydrated colloidal silica, macrogol 1300-1600, titanium dioxide (E171).

Description of the product and contents of the pack

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

The medicine is packaged in:

• PVC/PVDC/aluminum blisters containing 7, 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, or 100 tablets.
• Calendar blister packs: 7, 14, 28, 56, and 98 tablets.
• Unit-dose packaging: 50 x 1 tablet.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

Aurobindo Pharma B.V.

Baarnsche Dijk 1

LN Baarn, 3741

The Netherlands

Or

Arrow Generiques

26 Avenue Tony Garnier

69007 Lyon

France

This medicine is authorized in the European Economic Area member states under the following names:

Spain: Doxazosina Neo Aurovitas Spain 8 mg prolonged-release tablets EFG

France: Doxazosine Arrow LP 8 mg, comprimé à libération prolongée

Ireland: Raporsin 8 mg Prolonged Release Tablets

The Netherlands: Doxazosine Aurobindo Retard 8 mg, tabletten met verlengde afgifte

Portugal: Doxazosina Ritisca

Date of the most recent revision of this leaflet: July 2023

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)