CARDURAN NEO 4 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

CARDURAN NEO 4 mg modified-release tablets

Doxazosin

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

1. What is Carduran Neo and what is it used for

Carduran Neo is a vasodilator medicine used to treat high blood pressure and benign prostatic hyperplasia.

Carduran Neo is indicated for the treatment of high blood pressure in the arteries (hypertension) and for the treatment of urinary flow obstruction and irritative symptoms associated with benign prostatic hyperplasia (BPH).

Carduran Neo can be used in patients with BPH, whether they are hypertensive or normotensive. Patients with both conditions can be treated with Carduran Neo as monotherapy.

2. What you need to know before you take Carduran Neo

Treatment with Carduran Neo requires periodic monitoring by your doctor.

Do not take Carduran Neo

• if you are allergic to doxazosin, 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 gland with congestion of the upper urinary tract, chronic urinary tract infections, or bladder stones,
• if you suffer from or have suffered any form of gastrointestinal obstruction,
• if you have low blood pressure.

Warnings and precautions

Consult your doctor before starting to use Carduran Neo if:

• you have liver problems. As there is no clinical experience in patients with severe hepatic insufficiency, its use is not recommended in these patients
• you suffer from a serious heart problem, such as heart failure or pulmonary edema.

Especially at the start of treatment with this medicine, dizziness, weaknessand, in rare cases, fainting can occur. Therefore, caution should be exercised when starting treatment, and situations that could cause injury if such symptoms occur should be avoided.

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

If you are going to undergo eye surgeryfor cataracts, please inform your doctor before the operation if you are taking or have taken Carduran Neo. This is because Carduran Neo can cause complications during surgery, which can be taken into account and controlled by your ophthalmologist if they have been previously informed.

Prolonged and painful erectionscan occur very rarely. If this happens, consult a doctor urgently.

Using Carduran Neo with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Carduran Neo has been given with other antihypertensives, other medicines such as non-steroidal anti-inflammatory drugs, antibiotics, oral antidiabetics, gout medicines, anticoagulants, digoxin, warfarin, phenytoin, and indomethacin without any negative consequences. Doxazosin enhances the action of other antihypertensives in lowering blood pressure.

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

• Medicines for treating erection disorders (e.g. sildenafil, tadalafil, vardenafil).
• Medicines that lower blood pressure.
• Medicines for treating bacterial or fungal infections, e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used in the treatment of HIV, e.g. indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.

Taking Carduran Neo with food and drinks

Carduran Neo can be taken with or without food.

Children and adolescents

Carduran Neo is not recommended for use 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Doxazosin, the active substance of Carduran Neo, may appear in breast milk in small amounts. You should not take Carduran Neo while breastfeeding your baby unless your doctor recommends it.

Driving and using machines

Your ability to drive or operate machinery may be impaired, especially at the start of treatment with Carduran Neo.

Carduran Neo contains sodium

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

3. How to take Carduran Neo

Follow exactly the instructions of administration of Carduran Neo given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Your doctor will decide what dose of Carduran Neo is most suitable for you. Do not take more tablets than prescribed by your doctor.

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

Carduran Neo is given orally.

The initial dose is one tablet (4 mg) once daily. The optimal effect is achieved at four weeks. If necessary, after this period, the dose can 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 in the morning or at night.

All dose modifications and monitoring will be carried out under medical supervision.

Carduran Neo can be administered with other medicines used to treat high blood pressure and benign prostatic hyperplasia (BPH) that your doctor has prescribed.

Instructions for correct administration

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

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

In Carduran Neo, the medication is inside a non-absorbable tablet, specially designed for controlled release of the active substance. When this process is complete, the empty tablet is eliminated from the body through the feces.

Take Carduran Neo once daily, 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 meals.

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

Remember to take your medicine.

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

If you feel that the effect of Carduran Neo is too strong or too weak, consult your doctor or pharmacist. Do not take more tablets than recommended by the 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, telephone: 91 562 04 20 (indicating the medicine and the amount ingested).

An overdose of Carduran Neo can cause a drop in blood pressure. In this case, sit with your head down.

If you forget to take Carduran Neo:

Do not take a double dose to make up for forgotten doses. It is important that you take Carduran Neo regularly 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 stop treatment with Carduran Neo

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Doxazosin reactions vary in intensity from one individual to another and should be taken into account, especially at the start of treatment or when changing medication, and are generally mild.

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

• Respiratory tract infection, urinary tract infection
• Dizziness, headache, tendency to sleep (somnolence)
• Vertigo
• Feeling of strong or rapid heartbeats (palpitations), increased heart rate (tachycardia)
• Hypotension, postural hypotension
• Bronchitis, cough, difficulty breathing (dyspnea), nasal mucosa inflammation (rhinitis)
• Abdominal pain, indigestion (dyspepsia), dry mouth, nausea
• Itching (pruritus)
• Back pain, muscle pain (myalgia)
• Bladder inflammation (cystitis), urinary incontinence
• Weakness (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
• Loss of appetite (anorexia), gout, increased appetite
• Anxiety, depression, difficulty initiating or maintaining sleep (insomnia)
• Disruption of blood supply to the brain (stroke), decreased sensitivity (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
• Rash
• Joint pain (arthralgia)
• Difficulty urinating (dysuria), blood in urine (hematuria), and frequent urination
• 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):

• Decreased number of white blood cells (leukopenia), decreased number of blood platelets (thrombocytopenia)
• Agitation, nervousness
• Postural dizziness, tingling (paresthesia)
• Blurred vision
• Decreased heart rate (bradycardia), heart rhythm disorders (cardiac arrhythmias)
• Hot flushes
• Breathing difficulties (bronchospasm)
• Stop or suppression of bile flow (cholestasis), liver inflammation (hepatitis), yellowing of the skin (jaundice)
• Hair loss (alopecia), purple-colored skin spots (purpura), red, itchy, raised skin rashes (urticaria)
• Muscle cramps, muscle weakness
• Urination disorders, need to urinate at night (nocturia), increased frequency of urination (pollakiuria) or amount of urine (diuresis)
• Enlargement of male breast tissue (gynecomastia)
• Fatigue, general malaise
• Prolonged and painful erections. Consult a doctor urgently.

Side effects of unknown frequency (frequency cannot be estimated from the available data):

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

Entry of semen into the bladder during ejaculation (retrograde ejaculation)

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

Reporting of side effects

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

5. Storing Carduran Neo

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

Store in a dry place.

Do not store above 30°C.

Store in the original package.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Carduran Neo 4 mg modified-release tablets

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

• The other ingredients (excipients) are:

Core of the tablet: polyethylene oxide, sodium chloride, hypromellose, red iron oxide (E172), and magnesium stearate

Coating of the tablet: cellulose acetate, macrogol 3350, hypromellose, titanium dioxide (E171), printing ink (shellac, black iron oxide (E172), isopropyl alcohol, ammonia, and propylene glycol).

Appearance and packaging

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

Carduran Neo 4 mg modified-release tablets are available in packs of 28 tablets.

Other presentations:

Carduran Neo 8 mg modified-release tablets

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Pfizer Manufacturing Deutschland GmbH,

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of last revision of this leaflet: December 2018

Other sources of information

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