Package Insert: Information for the User

CARDURAN NEO 4 mg Modified-Release Tablets

Doxazosina

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist,eveniftheyare not listed in this package insert. See section 4.

Carduran Neo is a medication with vasodilatory action for the treatment of high blood pressure and benign prostatic hyperplasia.

Carduran Neo 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).

CarduranNeomay be used in patients with BPH, hypertensive or normotensive patients. Those patients with both pathologies may be treated withCarduranNeoas monotherapy.

The treatment with Carduran Neo requires periodic monitoring by your doctor.

Do not take Carduran Neo

• if you are allergic to doxazosina, other quinazolines (for example, prazosina, terazosina) or to any of the componentsof this medication(listed in section 6),
• if you have experienced hypotension (dizziness) when taking other medications to lower blood pressure,
• if you have an enlarged prostate gland along with urinary tract congestion, chronic urinary tract infections, or bladder stones,
• if you have any form of gastrointestinal obstruction,
• if you have low blood pressure.

Warnings and precautions

Consult your doctor before starting to use Carduran Neoif:

• you haveliver problems.Since there is no clinical experience in patients with severe liver insufficiency, it is not recommended for use in these patients
• you suffer from aserious heart problem, such as heart failure or pulmonary edema.

At the beginning of taking this medication, dizziness, weakness, and, in rare cases, fainting may occur. Therefore, proceed with caution at the start of treatment, and avoid situations that could cause injuries in the event of these symptoms appearing.

Before starting treatment with Carduran Neo, 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 to undergo eye surgery for cataracts, please inform your doctor before the operation if you are taking or have taken Carduran Neo previously. This is because Carduran Neo may cause complications during the operation, which can be taken into account and controlled by your ophthalmologist if you have been informed in advance.

Prolonged and painful erectionsmay occur with very low frequency. If this happens, consult a doctor urgently.

Use of Carduran Neo with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Carduran Neo has been administered with other anti-hypertensives, other medications such as non-steroidal anti-inflammatory drugs, antibiotics, oral antidiabetic drugs, uric acid-lowering drugs, anticoagulants, digoxin, warfarin, phenytoin, and indomethacin without any negative consequences. Doxazosina potentiates the action of other anti-hypertensives in lowering blood pressure.

Consult your doctor or pharmacist before using Carduran Neo if you are taking any of the following medications, as they may change the effect of Carduran Neo:

• Medications to treat erectile dysfunction (for example, sildenafilo, tadalafilo, vardenafilo).
• Medications that lower blood pressure.
• Medications used to treat bacterial or fungal infections, for example, claritromicina, itraconazol, ketoconazol, telitromicina, voriconazol.
• Medications used in the treatment of HIV, for example, indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodona, a medication used to treat depression.

Taking Carduran Neo with food and drinks

Carduran Neo can be taken with meals or without them.

Children and adolescents

Carduran Neo is not recommended for use in children and adolescents under 18 years old as its safety and efficacy have not been established.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consultyour doctor or pharmacist before using this medication.

Doxazosina, the active ingredient in Carduran Neo, may appear in breast milk in small amounts. Do not take Carduran Neo while breastfeeding your baby unless your doctor recommends it.

Driving and operating machines

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

Carduran Neo contains sodium

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

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

Your doctor will decide on the most suitable dose of Carduran Neo for you. Do not take more tablets than specified by your doctor.

Depending on the individual response, your doctor may modify the dose of Carduran Neo.

Carduran Neo is administered orally.

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

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

No dose adjustment is necessary in elderly patients (over 65 years) and patients with renal insufficiency.

Carduran Neo can be administered both in the morning and at night.

All dose modifications and monitoring will be performed under medical supervision.

Carduran Neo can be administered with other medications used for the treatment of hypertension and benign prostatic hyperplasia (BPH) prescribed by your doctor.

Instructions for correct administration

Swallow the Carduran Neo tablet whole, without chewing, breaking, or crushing.

Swallow the tablets with a sufficient amount of liquid (e.g., a glass of water).

Carduran Neo contains medication inside a non-absorbable tablet, specifically designed for controlled release. When this process is complete, the empty tablet is eliminated from the body through the feces.

Take Carduran Neo once a day, every day, and approximately at the same time. Taking the tablets at the same time each day will have a better effect on your blood pressure. It will also help you remember when to take the tablets. Carduran Neo can be taken during meals or outside of them.

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Carduran Neo. Do not discontinue treatment prematurely, as it may be harmful to your health.

If you think the effect of Carduran Neo 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 Carduran Neo than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

A Carduran Neo overdose may cause a drop in blood pressure. In this case, sit down with your head down.

If you forgot to take Carduran Neo:

Do not take a double dose to compensate for the missed doses.It is essential to takeCarduran Neoregularly at the same time each day. If you forget to take a dose, take it as soon as you can. However, if it is almost time for the next dose, do not take the missed tablet.

If you interrupt treatment with Carduran Neo

If you have any other doubtsabout the use of thismedication, ask your doctororpharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them. Doxazosina side effects vary in intensity from one individual to another and should be taken into account, especially at the beginning of treatment or when changing medications, which are generally mild.

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

• Respiratory tract infection, urinary tract infection
• Dizziness, headache, drowsiness
• Dizziness
• Feeling 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)
• Bladder inflammation (cystitis), urinary incontinence
• Fatigue (asthenia), chest pain, flu-like illness, peripheral edema

Less frequent (may affect up to 1 in 100 people):

• Allergic reaction
• Abnormal loss of appetite (anorexia), gout, increased appetite
• Anxiety, depression, difficulty initiating or maintaining sleep (insomnia)
• Cerebral ischemia, decreased sensitivity (hypoesthesia), temporary loss of consciousness (syncope), tremor
• Tinnitus
• Chest pain or pressure (angina pectoris, myocardial infarction)
• Nasal bleeding (epistaxis)
• Constipation, diarrhea, flatulence, vomiting, gastroenteritis
• Abnormal liver function tests
• Dermatological eruption
• Joint pain (arthralgia)
• Difficulty urinating (dysuria), blood in urine (hematuria), and frequent urination
• Impotence
• Chest pain, facial swelling
• 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):

• Decreased white blood cell count (leucopenia), decreased platelet count (thrombocytopenia)
• Restlessness, nervousness
• Postural dizziness, paresthesia
• Blurred vision
• Decreased heart rate (bradycardia), cardiac arrhythmias
• Hot flashes
• Difficulty breathing (bronchospasm)
• Bile duct obstruction (cholestasis), liver inflammation (hepatitis), yellow skin discoloration (jaundice)
• Hair loss (alopecia), confluent purpuric skin lesions (purpura), itchy, raised, and confluent skin lesions (urticaria)
• Muscle cramps, muscle weakness
• Urination disorders, nocturia, polyuria, or increased urine volume (diuresis)
• Male breast enlargement (gynecomastia)
• Fatigue, general malaise
• Persistent and painful penile erection. Consult a doctor urgently.

Side effects of unknown frequency (frequency cannot be established with available data):

Intraoperative Flaccid Iris Syndrome (IFIS, a certain eye disorder that can occur during cataract surgery)

Semen entry into the bladder during ejaculation (retrograde ejaculation)

No differences were observed regarding adverse events between young and elderly patients.

Reporting of side effects

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

Keepthis medicationout of sightandout of reach of children.

Store protected from humidity.

Store below30°C.

Store in the original packaging.

Do not usethis medicationafter the expiration datethat appearson the packaging after”CAD”. The expiration dateis thelast day ofthemonthindicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines that you no longer need at the SIGRE collection pointof the pharmacy.Please ask your pharmacist how to dispose of the packaging and medicines thatyouno longer need. This will help to protect the environment.

Composition of Carduran Neo 4 mg modified-release tablets

• The active ingredient is doxazosin. Each tablet contains 4 mg of doxazosin as doxazosin mesylate.

• The other components (excipients) are:

Tablet core: polyethylene oxide, sodium chloride, hydroxypropylmethylcellulose, iron oxide red (E172) and magnesium stearate

Tablet coating: cellulose acetate, polyethylene glycol (Macrogol) 3350, hydroxypropylmethylcellulose, titanium dioxide (E171), printing ink (Shellac lacquer, iron oxide black (E172), isopropyl alcohol, ammonium hydroxide and propylene glycol).

Appearance of the product and content of the container

Carduran Neo 4 mg tablets are modified-release, coated, white, round, biconvex tablets with a hole on one face printed with “CXL 4”.

Carduran Neo 4 mg modified-release tablets are available in containers containing 28 tablets.

Other presentations:

Carduran Neo 8 mg modified-release tablets

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

Pfizer Manufacturing Deutschland GmbH,

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 Madrid

Spain

Last review date of this leaflet: December 2018

Other sources of information

The 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/