DOXAZOSIN NEO AUROVITAS SPAIN 4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Doxazosina Neo Aurovitas Spain 4 mg prolonged-release tablets EFG

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

1. What is Doxazosina Neo Aurovitas Spain and what is it used for
2. What you need to know before you take Doxazosina Neo Aurovitas Spain
3. How to take Doxazosina Neo Aurovitas Spain
4. Possible side effects
5. Storage of Doxazosina Neo Aurovitas Spain
6. Contents of the pack and other information

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

Doxazosina Neo Aurovitas Spain belongs to a group of medicines called alpha-blockers. They are used to treat high blood pressure or symptoms caused by an enlarged prostate in men.

Doxazosina Neo Aurovitas Spain may be used to treat high blood pressure (hypertension), by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure.

In patients with an enlarged prostate, Doxazosina Neo Aurovitas Spain is taken to treat the ability to urinate when it is scarce and/or frequent. This is common in patients who have an enlarged prostate. Doxazosina Neo Aurovitas Spain acts by relaxing the muscle that surrounds the exit of the bladder and prostate, making it easier to urinate.

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

Do not take Doxazosina Neo Aurovitas Spain

• If you are allergicto doxazosin, to other quinazolines (e.g. prazosin, terazosin) or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
• If you have benign prostatic hyperplasia(enlarged prostate) and also if you have bladder stonesor suffer from obstructions or infectionsin the urinary tract.
• If you have benign prostatic hyperplasia (enlarged prostate) and urinary incontinence, have urination problemsor worsen kidney problems.
• If you have any type of digestive tract obstruction.
• If you have a history of orthostatic hypotension (drop in blood pressure when standing up too quickly).
• If you have abnormally low blood pressure (only applicable if you are being treated for enlarged prostate).

Warnings and precautions

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

• If you have undergone surgery.
• At the start of treatment, you may experience fainting or dizziness caused by low blood pressure when standing up from a sitting or lying position. If you feel like you are going to faint or feel dizzy, you should sit or lie down until you feel better. Your doctor will monitor your blood pressure at the start of treatment.
• If you have acute heart disease, swelling and/or fluid accumulation in the lungs (pulmonary edema) and heart failure.
• If you have acute heart failure due to a blood clot or fluid accumulation around the heart.
• If you have severe liver problems.
• If you are a man and use medicines to treat impotence, such as sildenafil, tadalafil, and vardenafil, as taking these medicines at the same time as doxazosin may cause a decrease in blood pressure. Your doctor will advise you on the necessary interval between taking these medicines with doxazosin.
• If you are going to have cataract surgery on the eye (loss of transparency of the lens). Before the operation, inform the ophthalmologist that you are using or have previously used Doxazosina Neo Aurovitas Spain. Doxazosina Neo Aurovitas Spain may cause complications during the operation, which can be solved if your specialist is previously informed.
• If you have blood or urine tests; remember to inform the doctor or nurse that you are being treated with Doxazosina Neo Aurovitas Spain.

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

Doxazosina Neo Aurovitas Spain is a modified-release tablet. This medicine contains a non-absorbable coating that has been specially designed to release the medicine slowly. As the empty coating is eliminated from the body by intestinal movements, you may occasionally observe in your stool something that looks like an empty tablet. This is normal and you should not worry.

Children and adolescents

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

Other medicines and Doxazosina Neo Aurovitas Spain

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your treatment may be affected if Doxazosina Neo Aurovitas Spain is taken with other medicines.

It is especially important that your doctor knows if you have been treated with the following medicines:

• Medicines to treat impotence in men (sildenafil, tadalafil, and vardenafil); taken at the same time as doxazosin, may cause a decrease in blood pressure.
• Some patients who take alpha-blockers for the treatment of high blood pressure or for enlarged prostate may experience dizziness, which may be caused by low blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) with alpha-blockers. In order to reduce the likelihood of these symptoms occurring, you should be taking a regular daily dose of alpha-blockers before starting to take medicines for erectile dysfunction.
• Other medicines that lower blood pressure, as the blood pressure lowering effect of these medicines may be increased.
• Anti-inflammatory medicines of the NSAID type (non-steroidal anti-inflammatory medicines), as they may decrease the effects of Doxazosina Neo Aurovitas Spain.
• Cimetidine, a medicine used in the treatment of stomach ulcers; if taken at the same time as doxazosin, will increase the effect of doxazosin. Consult your doctor.
• Medicines 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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Doxazosin may appear in breast milk in small amounts. You should not take this medicine while breastfeeding your baby unless your doctor recommends it.

Driving and using machines

Be careful if you drive or use machines. The tablets may affect your ability to drive or use machines safely, especially when you first start taking them. If this happens, do not drive or use machines and contact your doctor immediately.

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 administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Oral use.

The tablets must be swallowed whole with a glass of water. Do not chew, break, or crush the tablets.

The tablets can be taken with or without food.

Doxazosina Neo Aurovitas Spain can be used if you have high blood pressure, as well as if you suffer from prostatic hyperplasia (enlarged prostate). Both diseases will be treated at the same time.

Adults, including the elderly:

• Treatment of high blood pressure in adult men and women

The recommended dose is 4 mg of doxazosin (1 prolonged-release tablet) once a day. If necessary, the dose may be increased to 8 mg of doxazosin (2 prolonged-release tablets) once a day. It may take up to 4 weeks to achieve the optimal effect.

• Treatment of symptoms of prostatic hyperplasia (enlarged prostate) in adult men

The recommended dose is 4 mg of doxazosin (1 prolonged-release tablet) once a day. If necessary, the dose may be increased to 8 mg of doxazosin (2 prolonged-release tablets) once a day.

• Patient with reduced liver function

A dose reduction may be necessary. Always follow the instructions of your doctor.

If you take more Doxazosina Neo Aurovitas Spain than you should

If you (or someone else) swallow (or someone else swallows) many tablets at the same time, or if you think a child has swallowed any tablets, go to the nearest hospital or contact your doctor immediately.

In case of overdose, signs such as headache, dizziness, fainting, loss of consciousness, difficulty breathing, low blood pressure, palpitations, rapid or irregular heartbeat, or discomfort may appear.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount administered.

If you forget to take Doxazosina Neo Aurovitas Spain

If you forget to take a dose, take it as soon as you remember, unless it is almost time to take the next dose. Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.

If you stop taking Doxazosina Neo Aurovitas Spain

Continue taking Doxazosina Neo Aurovitas Spain for as long as your doctor has recommended, and do not stop taking it or change the dose without consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately and stop taking the medicine if you experience an allergic reaction to the medicine. If a rash appears, swelling of the face, lips, tongue, throat, difficulty breathing or swallowing, stop taking Doxazosina Neo Aurovitas Spain and contact your doctor immediately, you may need urgent medical attention or hospitalization.

Contact your doctor immediately if you have a heart attack. It is a rare but very serious side effect.

Contact your doctor immediately if you develop hepatitis (liver disease with nausea, vomiting, loss of appetite, discomfort, fever, itching, yellowing of the skin and eyes, and darkening of the urine color) or jaundice (yellowing of the skin and the whites of the eyes) or experience a narrowing of the airways. It is a rare but very serious side effect.

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

• Respiratory infection.
• Urinary tract infection.
• Dizziness and weakness and rarely fainting.
• Headache.
• Drowsiness.
• Loss of balance when getting up quickly.
• Palpitations (abnormal heartbeat) or rapid heartbeat.
• Low blood pressure.
• Dizziness, especially when standing up suddenly.
• Bronchitis.
• Cough.
• Difficulty breathing.
• Runny nose or nasal congestion, sneezing, pain or facial pressure.
• Abdominal pain (stomach pain and discomfort).
• Indigestion and stomach acid.
• Dry mouth.
• Nausea.
• Itching.
• Back pain.
• Muscle pain.
• Inflammation of the urinary bladder (cystitis).
• Involuntary loss of urine.
• Chest pain.
• Weakness and loss of strength.
• Fluid retention in the legs.
• Flu-like symptoms.

Uncommon(may affect up to 1 in 100 people):

• Loss of appetite.
• Gout.
• Increased appetite.
• Generalized fear.
• Anxiety.
• Mental state characterized by extreme sadness (depression).
• Difficulty sleeping.
• Stroke (inability to move one or more limbs on one side of the body, inability to understand or speak, or inability to see one side of the visual field).
• Decreased sense of touch.
• Loss of consciousness.
• Fainting.
• Involuntary tremors.
• Ringing in the ears.
• Chest pain (angina pectoris).
• Constipation.
• Nosebleeds.
• Gas.
• Vomiting.
• Diarrhea.
• Abnormal liver function tests (detected by blood tests).
• Gastroenteritis.
• Rash.
• Joint pain.
• Blood in the urine.
• Pain when urinating.
• Urinating more frequently.
• Reduced sexual potency in men (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 white blood cells (may cause more infections, such as fever, chills, sore throat, or mouth ulcers) or platelets (may cause more bleeding or bruising) in the blood.
• Excitement or restlessness (agitation).
• Nervousness.
• Numbness.
• Dizziness related to posture.
• Blurred vision.
• Slow heartbeat.
• Irregular heartbeat.
• Narrowing of the airways, for example, asthma (may cause difficulty breathing, wheezing, or coughing).
• Alteration in bile passage.
• Sudden reddening.
• Hair loss, baldness (alopecia).
• Rash with itching.
• Red or purple discoloration of the skin (purpura).
• Muscle cramps.
• Tingling or cramps.
• Urinating frequently at night.
• Increased amount of urine.
• Urination problems.
• Persistent and painful erection of the penis. Consult a doctor urgently.
• Increased breast size in men.
• Fatigue.
• General feeling of discomfort.

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

• Intraoperative floppy iris syndrome (IFIS) that may develop during cataract surgery.
• Taste disturbances.
• Retrograde ejaculation - occurs when semen is redirected to the urinary bladder instead of being ejaculated through the urethra as normally occurs.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxazosina Neo Aurovitas Spain

No special storage conditions are required.

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

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

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Doxazosina Neo Aurovitas Spain

• The active ingredient is doxazosina (each tablet contains 4.85 mg of doxazosina mesylate corresponding to 4 mg of doxazosina).
• The other components are: polyethylene oxide, microcrystalline cellulose, povidone K29-32, butylhydroxytoluene (E321), all-rac-alpha-tocopherol, anhydrous colloidal silica, sodium stearyl fumarate, methacrylic acid-ethyl acrylate copolymer, hydrated colloidal silica, macrogol 1300-1600, and titanium dioxide (E171).

Appearance of the Product and Container Content

The prolonged-release tablets of Doxazosina Neo Aurovitas Spain are round, biconvex, white in color, and marked with "DL".

The containers hold 10, 28, 30, 50, 90, 98, or 100 prolonged-release tablets.

Only some package 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

Netherlands

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

Spain Doxazosina Neo Aurovitas Spain 4 mg prolonged-release tablets EFG

Netherlands Doxazosine Aurobindo Retard 4 mg, prolonged-release tablets

Portugal Doxazosina Ritisca

Date of the Last Revision of this Leaflet:July 2023

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