Carduran Neo 8 mg modified-release tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

CARDURAN NEO 8 mg modified-release tablets

Doxazosin

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Carduran Neo is a vasodilating drug used for the treatment of arterial hypertension and benign prostatic hyperplasia.

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

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

2. What you need to know before starting to 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 (for example, prazosin, terazosin), or any of the 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 together with upper urinary tract obstruction, chronic urinary tract infections, or bladder stones,
• if you suffer or have suffered from 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. Since there is no clinical experience in patients with severe hepatic impairment, use in these patients is not recommended.
• you suffer from a serious heart condition, such as heart failure or pulmonary edema.

Especially at the beginning of treatment with this medicine, dizziness, weakness, and, in rare cases, fainting may occur. Therefore, caution should be exercised at the start of treatment, and you should avoid situations that could lead to injury if these symptoms occur.

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 scheduled for eye surgery for cataracts, please inform your doctor before the procedure if you are currently taking or have previously taken Carduran Neo. This is because Carduran Neo may cause complications during surgery, which can be anticipated and managed by your ophthalmologist if they are informed in advance.

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

Use of Carduran Neo with other medicines

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

Carduran Neo has been administered together with other antihypertensives and other medicines such as non-steroidal anti-inflammatory drugs, antibiotics, oral antidiabetics, gout medications, anticoagulants, digoxin, warfarin, phenytoin, and indomethacin without negative consequences. Doxazosin enhances the effect of other antihypertensive medicines 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 alter the effect of Carduran Neo:

• Medicines to treat erectile dysfunction (for example, sildenafil, tadalafil, vardenafil).
• Medicines that reduce blood pressure.
• Medicines used 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.

Taking Carduran Neo with food and drink

Carduran Neo may be taken with or without food.

Children and adolescents

The use of Carduran Neo is not recommended 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 become pregnant, consult your doctor or pharmacist before using 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 advises you to do so.

Driving and using machines

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

Carduran Neo contains sodium

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

3. How to take Carduran Neo

Follow exactly the administration instructions for Carduran Neo given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide which dose of Carduran Neo is most appropriate for you. Do not take more tablets than specified by your doctor.

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

Carduran Neo is administered orally.

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

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

Dose adjustment is not required in elderly patients (over 65 years of age) or in patients with renal impairment.

Carduran Neo may be taken either in the morning or at night.

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

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

Instructions for correct administration

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

Take the tablets with sufficient liquid (for example, a glass of water).

In Carduran Neo, the medication is contained within a non-absorbable tablet specially designed to provide controlled release of the active substance. Once this process is complete, the empty tablet shell is eliminated from the body through the feces.

Take Carduran Neo once daily, every day, and at approximately the same time each day. Taking the tablets at the same time each day will provide the best effect on your blood pressure and will also help you remember when to take them. Carduran Neo may be taken during meals or independently of meals.

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

Remember to take your medication.

Your doctor will advise you on how long your treatment with Carduran Neo should last. Do not discontinue treatment prematurely, as this could 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 your doctor.

If you take more Carduran Neo than you should:

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

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

If you forget to take Carduran Neo:

Do not take a double dose to make up for missed doses. It is important to take Carduran Neo regularly at the same time each day. If you forget to take a dose, take it as soon as possible. However, if it is almost time for the next dose, do not take the missed tablet.

If you stop taking Carduran Neo

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. Reactions to doxazosin vary in intensity from one individual to another and should be particularly considered at the beginning of treatment or when changing medication, generally being mild.

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

• Respiratory tract infection, urinary tract infection
• Dizziness, headache, drowsiness (somnolence)
• Vertigo
• Sensation of strong or rapid heartbeat (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)
• Inflammation of the bladder (cystitis), urinary incontinence
• Fatigue (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
• Abnormal loss of appetite (anorexia), gout, increased appetite
• Anxiety, depression, difficulty in falling or staying asleep (insomnia)
• Interruption 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
• Skin rash
• Joint pain (arthralgia)
• Discomfort when 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):

• Decrease in white blood cell count (leukopenia), decrease in blood platelet count (thrombocytopenia)
• Agitation, restlessness
• Postural dizziness, tingling (paresthesia)
• Blurred vision
• Decreased heart rate (bradycardia), disturbances in heart rhythm (cardiac arrhythmias)
• Hot flushes
• Difficulty breathing (bronchospasm)
• Blockage or suppression of bile flow (cholestasis), inflammation of the liver (hepatitis), yellowing of the skin (jaundice)
• Hair loss (alopecia), confluent purplish skin spots (purpura), raised red itchy skin lesions (urticaria)
• Muscle cramps, muscle weakness
• Urinary disorders, need to urinate at night (nocturia), increased frequency of urination (polyuria) or increased urine volume (diuresis)
• Enlargement of male breast glands (gynecomastia)
• Fatigue, general malaise
• Persistent and painful erection of the penis. Seek medical advice urgently.

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

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

Retrograde ejaculation (semen entering the bladder during ejaculation)

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse 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.

Protect from moisture.

Store below 30°C.

Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This 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 doxazosina mesylate.

• The other components (excipients) are:

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

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

Appearance of the medicine and contents of the pack

Carduran Neo 8 mg tablets are modified-release, film-coated, white, round, biconvex tablets, with a hole on one side 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 Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Klocke Verpackungs-Service GmbH

Max-Becker-Strasse 6

76356 Weingarten (Baden)

Germany

or

Pfizer Manufacturing Deutschland GmbH,

Mooswaldallee 1

79108 Freiburg im Breisgau

Germany

For further information on this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatis Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of the most recent review of this leaflet: December 2018

Other sources of information

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