CARDURAN NEO 8 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

CARDURAN NEO 8 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. Storage of 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 and for the treatment of urinary outflow obstruction and associated symptoms in patients with benign prostatic hyperplasia (BPH).

Carduran Neo can be used in patients with BPH, whether hypertensive or normotensive. Those 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 regular 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 ever had a hypotensive reaction (dizziness) when taking other medicines to lower your 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 have any obstruction of the gastrointestinal tract,
• 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 impairment, use is not recommended in these patients
• you have a severe heart problem, such as heart failure or pulmonary oedema.

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 lead to injury if these symptoms occur should be avoided.

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

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

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 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 drink

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

Driving and using machines

Your ability to drive or operate machinery may be affected, 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; this is essentially “sodium-free”.

3. How to take Carduran Neo

Take Carduran Neo exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

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

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

Carduran Neo is taken by mouth.

The dose is one tablet (8 mg) once daily. The optimal effect is obtained after four weeks.

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 impairment.

Carduran Neo can be taken in the morning or at night.

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

Carduran Neo can be taken 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 medicine 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 in the faeces.

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 with or without food.

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

Remember to take your medicine.

Your doctor will tell you how long to take Carduran Neo. Do not stop treatment before then, as it may be harmful to your health.

If you think that the effect of Carduran Neo is too strong or too weak, consult your doctor or pharmacist. Do not take more tablets than your doctor has recommended.

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 Toxicology Information Service, telephone: 91 562 04 20 (indicating the medicine and the amount taken).

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 your next dose, do not take the missed tablet.

If you stop taking 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 usually 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 fast heartbeats (palpitations), increased heart rate (tachycardia)
• Low blood pressure, postural low blood pressure
• Bronchitis, cough, difficulty breathing (dyspnoea), nasal congestion (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 oedema)

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)
• Stroke, decreased sensitivity (hypoesthesia), temporary loss of consciousness (syncope), tremor
• Ringing in the ears (tinnitus)
• Chest pain (angina pectoris, myocardial infarction)
• Nosebleed (epistaxis)
• Constipation, diarrhoea, flatulence, vomiting, gastroenteritis
• Abnormal liver function tests
• Rash
• Joint pain (arthralgia)
• Painful urination (dysuria), blood in urine (haematuria) 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 white blood cell count (leucopenia), decreased platelet count (thrombocytopenia)
• Agitation, nervousness
• Postural dizziness, tingling (paraesthesia)
• 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 spots on the skin (purpura), red, itchy, raised patches on the skin (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 the male breast (gynaecomastia)
• Fatigue, general malaise
• Prolonged and painful erection of the penis. 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 via the Spanish Medicines Monitoring System for Human Use: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 8 mg modified-release tablets

• The active substance is doxazosin. Each tablet contains 8 mg of doxazosin as doxazosin mesylate.

• The other ingredients 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, ammonium hydroxide and propylene glycol).

Appearance and packaging of the product

Carduran Neo 8 mg modified-release tablets are white, round, biconvex, film-coated tablets with an orifice on one face printed with “CXL 8”.

Carduran Neo 8 mg modified-release tablets are available in packs containing 28 tablets.

Other presentations:

Carduran Neo 4 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 request more information about this medicine from 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/