Doxazosin Neo Viatris 4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Doxazosin NEO Viatris 4 mg prolonged-release tablets EFG

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 and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you get any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What this leaflet contains

1. What Doxazosin NEO Viatris is and what it is used for
2. What you need to know before taking Doxazosin NEO Viatris
3. How to take Doxazosin NEO Viatris
4. Possible side effects
5. How to store Doxazosin NEO Viatris

Contents of the pack and other information

1. What Doxazosina NEO Viatris is and what it is used for

Doxazosina NEO Viatris contains the active substance doxazosina, which belongs to a group of medicines called alpha-adrenergic receptor antagonists or alpha-blockers. This medicine is used to treat the clinical symptoms of benign prostatic hyperplasia (BPH) and the reduced urinary flow associated with BPH. Doxazosina NEO Viatris can be used in patients with hypertension and with normal blood pressure.

Doxazosina works by relaxing the muscles around the bladder outlet and the prostate gland to help relieve difficulties in urination, which are common in patients whose prostate has enlarged.

2. What you need to know before taking Doxazosina NEO Viatris

Do not take Doxazosina NEO Viatris

• If you are allergic to doxazosin, to other quinazolines (for example: prazosin, terazosin), or to any of the other ingredients of this medicine (listed in section 6).
• If you have a history of orthostatic hypotension, a type of low blood pressure that causes dizziness or lightheadedness when standing up from a sitting or lying position.
• If you have upper urinary tract obstruction, chronic urinary infection, or bladder stones.
• If you have or have had esophageal obstruction or narrowing or obstruction of the gastrointestinal tract.
• If you have low blood pressure.
• If you suffer from overflow incontinence (feeling that you cannot control the urge to urinate) or your body does not produce urine (anuria), regardless of whether or not you have kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before starting Doxazosina NEO Viatris:

• If you have liver problems.
• If you have changes in bowel habits or have undergone intestinal or gastrointestinal surgery, as this may affect how your body absorbs the medicine.
• If you have heart problems.

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

During treatment

When you start taking Doxazosina NEO Viatris, you may feel dizzy or faint due to low blood pressure when standing up from a sitting or lying position. If you feel dizzy or feel like fainting, you should sit or lie down until you feel better and avoid situations where you could fall or get injured. Your doctor may want to monitor your blood pressure regularly at the beginning of treatment to reduce the likelihood of these effects.

If you are scheduled for cataract surgery (clouding of the lens), you must inform your ophthalmologist before the procedure that you are currently taking or have previously taken doxazosin. This is because doxazosin could cause complications during surgery, which the specialist can manage if prepared in advance.

Very rarely, prolonged and painful erections may occur. If this happens, contact a doctor immediately.

Children and adolescents

The use of Doxazosina NEO Viatris is not recommended in children or adolescents under 18 years of age, as safety and efficacy have not been established.

Other medicines and Doxazosina NEO Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

• Some patients who are prescribed alpha-blockers for the treatment of hypertension or benign prostatic hyperplasia may experience dizziness or lightheadedness, caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medications for erectile dysfunction (impotence) together with alpha-blockers. To reduce the likelihood of such symptoms, you should be taking a regular dose of the alpha-blocker before starting erectile dysfunction medication; you may be started on a low dose, and you should wait at least 6 hours after taking doxazosin before taking the impotence medication.

• Doxazosina NEO Viatris may further lower your blood pressure if you are taking other medicines for hypertension, such as terazosin or prazosin.

• Medicines used to treat bacterial or fungal infections (for example, clarithromycin, itraconazole, ketoconazole, telithromycin, or voriconazole).

• Medicines used to treat HIV (for example, indinavir, nelfinavir, ritonavir, or saquinavir).

• Nefazodone, a medicine used to treat depression.

Pregnancy and breastfeeding

Doxazosina NEO Viatris is indicated for men with benign prostatic hyperplasia and should not be used by women.

There are no data suggesting that doxazosin may affect fertility. If you are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Doxazosina NEO Viatris may affect your ability to drive (cars, motorcycles, etc.) or operate machinery, especially at the beginning of treatment. If you feel dizzy or weak while taking this medicine, do not drive or use machinery and inform your doctor or pharmacist.

Doxazosina NEO Viatris contains sodium

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

3. How to take Doxazosina NEO Viatris

Follow exactly the instructions for the use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The modified-release tablets of Doxazosina NEO Viatris contain the medicine within a non-absorbable coating designed to release the drug slowly. After swallowing, the tablets release the medicine gradually as they pass through the digestive tract, and the empty coating is eliminated from the body during bowel movements. Therefore, you may occasionally notice something resembling a tablet in your stools. This is normal and should not be a cause for concern.

The recommended dose is:

• A single dose of 4 mg once daily (one 4 mg tablet). It may take up to 4 weeks to achieve the full effect of Doxazosina NEO Viatris. If necessary, your doctor may increase the dose to 8 mg once daily.
• The maximum recommended dose is 8 mg once daily.
• Do not change the dose or stop taking the medicine unless instructed by your doctor.

How to take the medicine

Doxazosina NEO Viatris should be swallowed whole with a sufficient amount of liquid, with or without food.

Prolonged-release tablets must not be chewed, broken, or crushed. If they are, there is a risk that the medicine will be absorbed too quickly into the body, potentially causing an overdose.

If you take more Doxazosina NEO Viatris than you should

If you or someone else (e.g., a child) accidentally take more tablets than prescribed at one time, you should contact a doctor, call the Toxicology Information Service at telephone 91 562 04 20, or go to the nearest hospital emergency department. Some signs of overdose with this medicine include headache, dizziness, nausea, difficulty breathing, sweating, trembling, fainting, low blood pressure, or fast, strong, or irregular heartbeat.

If you forget to take Doxazosina NEO Viatris

If you forget to take a dose, take it as soon as you remember and continue taking the medicine as scheduled. However, if it is almost time for your next dose, skip the missed dose and continue taking the tablets as usual. Do not take a double dose to make up for a missed one.

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 can cause adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects, stop taking this medicine immediately and contact your doctor or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people):

• Severe allergic reactions, which may cause skin rashes, swelling of the face, lips, tongue or throat, difficulty breathing, wheezing or difficulty breathing or swallowing.
• Sudden numbness or weakness in the arms, legs or face, sudden severe headache, dizziness or confusion, vision or speech problems. These are signs indicating reduced blood flow to the brain caused by a blood clot or bleeding (stroke).
• Feeling of heaviness or pressure in the chest with chest pain and increasing shortness of breath during exercise (these signs could indicate heart problems, such as angina).
• Sudden chest pain that may spread to the neck or arm, together with difficulty breathing and hot flushes (these signs could indicate a heart attack or other heart problems).

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

• Swelling, stomach pain or cramps, gas, bad breath, constipation, diarrhoea, vomiting or feeling full. These signs could indicate obstruction of the digestive tract.

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

• Yellowing of the skin and eyes, feeling unwell, loss of appetite, itching, darkening of the urine (signs indicating liver problems).
• Increased number of infections, causing fever, severe chills, mouth ulcers, sore throat or lower respiratory tract infections. These signs could indicate low levels of white blood cells.
• Persistent and painful erection of the penis. Consult a doctor urgently.

Other possible adverse effects may include:

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

• Throat or urinary tract infections.
• Dizziness, headache, numbness.
• Dizziness (vertigo).
• Rapid or strong heartbeat (palpitations, tachycardia).
• Low blood pressure (hypotension), dizziness when standing up (orthostatic hypotension).
• Bronchitis, cough, difficulty breathing (dyspnoea), runny or stuffy nose (rhinitis).
• Abdominal pain, indigestion (dyspepsia), dry mouth, nausea.
• Itching (pruritus).
• Back pain, muscle pain (myalgia).
• Cystitis (bladder inflammation), urinary incontinence.
• Inability to achieve or maintain an erection (impotence).
• Weakness (asthenia), chest pain, flu-like symptoms, swelling of arms or legs (peripheral oedema).

Uncommon (may affect up to 1 in 100 people):

• Loss of appetite (anorexia), increased appetite.
• Pain or swelling in the joints caused by uric acid crystals (gout).
• Feeling of worry (anxiety), low mood (depression), difficulty sleeping (insomnia).
• Reduced sense of touch (hypoesthesia), fainting (syncope), restlessness (tremor).
• Ringing or buzzing in the ears (tinnitus).
• Nosebleeds (epistaxis).
• Constipation, diarrhoea, flatulence (gas), vomiting, gastroenteritis.
• Abnormal results in liver function tests.
• Skin rash.
• Joint pain (arthralgia).
• Burning or pain when urinating (dysuria), blood in the urine (haematuria), change in frequency of urination (frequent micturition).
• Pain, swelling of the face (facial oedema).
• Weight gain.

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

• Appearance of bruises without reason and bleeding more easily or for longer than normal. These could be signs indicating a low platelet count (thrombocytopenia).
• Restlessness (agitation), nervousness.
• Dizziness when standing up (tingling and numbness in hands or feet).
• Blurred vision.
• Slow or irregular heartbeat (bradycardia, arrhythmia).
• Flushing (reddening).
• Difficulty breathing, wheezing or cough (bronchospasm).
• Partial, temporary or general hair loss (alopecia), visible purple spots on the skin (purpura), itchy rash, blisters (urticaria).
• Muscle cramps, muscle weakness.
• Difficulty urinating (urinary disorder), urgency to urinate at night (nocturia), increased volume of urine passed (polyuria, increased diuresis).
• Enlargement of the breasts (gynaecomastia).

Frequency not known (cannot be estimated from available data):

• Complications during cataract surgery ("Intraoperative floppy iris syndrome", see section 2 "Warnings and precautions").
• Producing little or no semen when ejaculating (retrograde ejaculation).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxazosina NEO Viatris

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, 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 Doxazosina NEO Viatris

• The active substance is doxazosin. Each prolonged-release tablet contains 4.85 mg of doxazosin mesylate equivalent to 4 mg of doxazosin.
• The other components of the tablet core are: polyethylene oxide, microcrystalline cellulose, povidone, butylhydroxytoluene, ?-tocopherol, colloidal anhydrous silica, sodium stearyl fumarate.
• The other components of the film coating are: copolymer of methacrylic acid and ethyl acrylate, colloidal anhydrous silica, macrogol, titanium dioxide (E-171).

Nature of the product and contents of the container

Doxazosina NEO Viatris are prolonged-release, film-coated, biconvex, round, white tablets marked with "DL" on one side.

They are supplied in blisters containing 14, 15, 28, 30, 60, 90, 100 tablets and in perforated single-dose blisters of 50 tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Mylan Hungary Kft.
H-2900 Komarom,
Mylan utca 1,
Hungary

Or

McDermott Laboratories Limited T/A Gerard Laboratories
Unit 35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Doxazosina NEO Viatris 4 mg prolonged-release tablets EFG
France: DOXAZOSINE MYLAN LP 4 mg, prolonged-release tablet
Portugal: Doxazosina Mylan

Date of the most recent review of this leaflet: January 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.es/