Package Leaflet: Information for the User

Doxazosina Aurovitas 4 mg Tablets EFG

Read this 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 others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Doxazosina Aurovitas

3. How to take Doxazosina Aurovitas

4. Possible side effects

5. Storage of Doxazosina Aurovitas

6. Contents of the pack and additional information

Doxazosina Aurovitas belongs to a group of medicines called vasodilators. These substances cause blood vessels to dilate, which reduces blood pressure. Doxazosina can also reduce tension in the tissues of the prostate and urinary tract muscles.

Doxazosina is used to treat:

• High blood pressure.
• Symptoms of an enlarged prostate.

Do not take Doxazosina Aurovitas

• If you are allergic to doxazosina, to any other medicine in the same group (known as quinazolines to which medicines such as prazosina and terazosina belong) or to any of the other componentsofthis medicine (listed in section 6).
• If you have a history of a condition known as “orthostatic hypotension” which is a form of low blood pressure that can make you feel dizzy or lightheaded when you stand up from a sitting or lying position.
• If you have an enlarged prostate with one of the following symptoms: congestion or blockage of the urine flow, long-term infection of the urine flow or stones (stones) in the bladder.
• If you have an enlarged prostate (benign prostatic hyperplasia)andyou have low blood pressure.
• If you have incontinence due to overflow (you do not feel the urge to urinate) or anuria (your body does not produce urine) with or without kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxazosina Aurovitas if:

Inform your specialist doctor that you are using or have used Doxazosina Aurovitas if you are going to undergo cataract surgery (crystalline lens of the eye is opaque). Doxazosina Aurovitas may cause complications during the intervention that can be controlled by the specialist if you have been previously warned.

Important information about Doxazosina Aurovitas

The possibility of a sudden drop in blood pressure is higher at the beginning of treatment or when the dose is increased. This can manifest as dizziness or, less frequently, fainting when changing position. To reduce the risk of this occurring, the doctor should check blood pressure at the beginning of treatment and when the dose is increased. Avoid situations at the beginning of treatment where dizziness or fainting could cause injuries.

Doxazosina Aurovitas may also affect the results of some blood and urine tests. Inform your doctor that you are taking Doxazosina Aurovitas if you are going to have blood or urine tests.

Other medicines and Doxazosina Aurovitas

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

• Certain analgesics for rheumatism (known as non-steroidal anti-inflammatory drugs) such as naproxen, ibuprofen or any other analgesic anti-inflammatory as they may reduce the effect of blood pressure reduction.
• Medicines that may also affect the liver metabolism such as cimetidine (a stomach problem medicine).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant or think you may be, you should contact your doctor before taking Doxazosina Aurovitas. Doxazosina Aurovitas should only be used during pregnancy if the doctor decides that the benefit for the mother outweighs the possible risk to the fetus.

Small amounts of doxazosina may pass into breast milk. Do not use doxazosina during breastfeeding unless your doctor recommends it.

Driving and operating machinery

Doxazosina may cause dizziness or fainting. If this occurs, you should be careful during activities that require attention, such as driving, operating machinery and working at heights. Consult your doctor if you are unsure whether doxazosina will have a negative effect on your ability to drive.

Doxazosina Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Doxazosina Aurovitas contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

HIGH BLOOD PRESSURE

The initial dose is 1 mg per day (every 24 hours) as a single dose. After 1 to 2 weeks, the dose is generally increased to 2 mg taken as a single daily dose (every 24 hours). This dose is maintained for 1 to 2 weeks. If necessary, the dose may be increased further up to 4, 8, or 16 mg per day, until the desired reduction in blood pressure is achieved. The maximum daily dose is 16 mg.

The initial dose should preferably be taken before going to bed; since any dizziness that may occur would be a minor problem.

ENLARGEMENT OF THE PROSTATE

The initial dose is 1 mg per day (every 24 hours) as a single dose. After that, the usual dose is 2 mg or 4 mg per day. In some circumstances, the dose may be increased up to a maximum of 8 mg per day.

The tablets should be taken every day as a single dose (every 24 hours). The tablets should be taken with a lot of water.

If you take more Doxazosina Aurovitas than you should

Consult your doctor immediately or go to the nearest hospital emergency department, bringing this leaflet with you or call the Toxicological Information Service (phone 91-562.04.20), indicating the medication and the amount ingested. If you feel extremely dizzy or think you may faint, lie down with your head down.

If you forget to take Doxazosina Aurovitas

If you forget to take a dose, take your regular dose when it is due again. Consult your doctor or pharmacist if you are unsure. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Doxazosina Aurovitas

In case of abrupt interruption of treatment with doxazosina, the previous problems may return at the beginning of treatment. Therefore, it is recommended not to interrupt this treatment abruptly. Your doctor will gradually reduce the dose. Consult your doctor or pharmacist if you are unsure.

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

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

Some side effects can be serious:

Stop taking this medicine and seek immediate medical attention if you notice any of the following side effects:

• Allergic reactions such as hives, difficulty breathing, severe dizziness or fainting, swelling of the face or throat, or severe skin rash with red patches or blisters.
• Chest pain (angina), increased heart palpitations or irregular heartbeats, heart attack or stroke (symptoms may include fainting, numbness or weakness in the arms or legs, headache, dizziness, and confusion, visual disturbances, difficulty swallowing, slurred speech, or loss of speech).
• Yellowing of the skin or white of the eyes, caused by liver problems (jaundice).
• Unusual bruises or bleeding caused by low platelet count.
• Blood in the urine.
• Hepatitis (liver disease with nausea, vomiting, loss of appetite, general discomfort, fever).
• Bile duct blockage (cholestasis) - may cause itchy skin, light-colored stools, and dark urine.

These side effects are rare (affect fewer than 1 in 1,000 patients) or very rare (affect fewer than 1 in 10,000 patients).

Other side effects:

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

• Respiratory infection (nose, throat, lungs).
• Urinary tract infection (symptoms may include: pain or burning when urinating or a frequent need to urinate), urinary incontinence (inability to control urine flow).
• Dizziness, somnolence, headache.
• Sensation of spinning or dizziness (vertigo).
• Sensation of irregular heartbeats, increased heart rate.
• Low blood pressure and low blood pressure due to changes in position from sitting or lying down (postural hypotension).
• Inflammation of the airways, cough, difficulty breathing, nasal congestion, and/or nasal discharge.
• Abdominal pain, indigestion, dry mouth, sensation of dizziness (nausea).
• Itching (pruritus).
• Back pain, muscle pain (myalgia).
• Inflammation of the bladder (cystitis), increased urine production.
• Sensation of weakness (asthenia), chest pain, flu-like symptoms.
• Inflammation of the ankles, feet, or toes (peripheral edema), generalized edema.
• Accommodation disorders.

Rare (may affect up to 1 in 1,000 patients):

• Gout, increased appetite, anorexia (loss of appetite), thirst.
• Agitation, depression, anxiety, difficulty sleeping (insomnia), emotional instability, nervousness, tremor, apathy.
• Abnormal tear flow, photophobia.
• Stroke, reduced sense of touch, fainting.
• Tinnitus or ringing in the ears.
• Pharyngitis, nasal bleeding.
• Constipation, flatulence, vomiting (sensation of dizziness), inflammation of the gastrointestinal tract, diarrhea.
• Anomalous liver function tests, increased liver enzymes.
• Skin rash.
• Joint pain.
• Difficulty urinating, paleness.
• Difficulty achieving an erection (impotence).
• Pain, swelling of the face.
• Weight gain, hypopotasemia, hypoglycemia.

Very rare (may affect up to 1 in 10,000 patients):

• Cerebrovascular alterations.
• Laryngeal edema.

Frequency unknown (cannot be estimated from available data):

• Eye problems that may occur during cataract surgery (opaque lens of the eye). See "Be careful with Doxazosina Aurovitas" section.
• Scant or no ejaculation during orgasm, cloudy urine after orgasm (retrograde ejaculation).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister and the box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment..

Composition of Doxazosina Aurovitas

- The active ingredient is doxazosin. Each tablet contains 4 mg of doxazosin (as doxazosin mesylate).

- The other components (excipients) are: microcrystalline cellulose, lactose, carboxymethylstarch sodium (type A) (derived from potato starch) and magnesium stearate

Appearance of the product and contents of the packaging

Uncoated tablets of white to off-white color, of rhomboidal shape, engraved with “D O” on one face separated by a groove and a “4” on the other.

The tablet can be divided into equal doses.

Doxazosina Aurovitas 4 mg tablets are available in blister packaging.

Packaging sizes: 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 140 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Malta:Doxazosin Aurobindo 4 mg tablets

Poland:Doxazosin Aurovitas

Portugal:Doxazosina Aurovitas

Spain:Doxazosina Aurovitas 4 mg tablets EFG

Date of the last review of this leaflet:September 2023

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