DOXAZOSIN NEO VIATRIS 4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Doxazosina 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. 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 and other information

1. What is Doxazosina NEO Viatris and what is it used for
2. What you need to know before you take Doxazosina NEO Viatris
3. How to take Doxazosina NEO Viatris
4. Possible side effects
   1. Storage of Doxazosina NEO Viatris

Contents of the pack and other information

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

Doxazosina NEO Viatris contains the active substance doxazosin, 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 reduction of urinary flow associated with BPH. Doxazosina NEO Viatris may be used in patients with hypertension and normal tension.

Doxazosin acts by relaxing the muscles around the bladder outlet and the prostate gland to help alleviate the difficulties in urinating, which are common in patients whose prostate has increased in size.

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

Do not take Doxazosina NEO Viatris

• If you are allergic to doxazosin, to other quinazolines (e.g. 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 fainting when standing up after sitting or lying down.
• If you have upper urinary tract congestion, chronic urinary tract infection, or bladder stones.
• If you have esophageal obstruction or narrowing or obstruction of the digestive tract.
• If you have low blood pressure.
• If you suffer from overflow incontinence (you feel that you cannot control the urge to urinate) or your body does not produce urine (anuria), with or without kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxazosina NEO Viatris:

• If you have liver problems.
• If you have changes in bowel habits or if you have undergone intestinal or digestive tract surgery, as it may affect how you absorb the medicine.
• If you have heart problems.

Before starting treatment with Doxazosina NEO Viatris, your doctor will perform tests to rule out the possibility that you have 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 feel like you are going to lose consciousness, due to low blood pressure, when standing up after sitting or lying down. If you feel dizzy or feel like you are going to faint, you should sit or lie down until you feel better and avoid situations where you may fall or get hurt. Your doctor may want to check your blood pressure regularly at the start of treatment to reduce the risk of these effects.

If you are going to undergo cataract surgery (clouding of the lens), you should inform your ophthalmologist before the operation that you are taking doxazosin or have taken it previously. This is because doxazosin may cause complications during surgery, which the specialist can treat if prepared in advance.

Very rarely, persistent and painful erections can occur. If this is the case, 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 its 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 take any other medicines, including those obtained without a prescription.

• Some patients who are given alpha-blockers for the treatment of hypertension or prostatic hyperplasia may feel dizzy or faint, which may be caused by a decrease in blood pressure when sitting or standing up quickly. Some patients have presented these symptoms when taking medications for erectile dysfunction (impotence) along with alpha-blockers. To reduce the likelihood of these symptoms, you should take a regular dose of the alpha-blocker before starting to use the medications for erectile dysfunction; you may be given a low dose at the start of treatment and you should wait at least 6 hours after taking doxazosin before starting to take the medication for impotence.

• Doxazosina NEO Viatris may further lower your blood pressure if you are using other medications to treat hypertension, such as terazosin or prazosin.

• Medicines to treat bacterial or fungal infections (e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, or voriconazole).
• Medicines to treat HIV (e.g. indinavir, nelfinavir, ritonavir, or saquinavir).
• Nefazodone, a medicine to treat depression.

Pregnancy and breastfeeding

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

No data suggest that doxazosin may affect fertility. If you plan to become pregnant, 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 use machines, especially at the start of treatment. If you feel dizzy or weak when taking this medicine, do not drive or use machines and inform your doctor or pharmacist.

Doxazosina NEO Viatris contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, so it is considered essentially "sodium-free".

3. How to take Doxazosina NEO Viatris

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The prolonged-release tablets of Doxazosina NEO Viatris contain the medicine inside a non-absorbable coating designed to release the drug slowly. After swallowing them, the tablets release the medicine as they pass through the digestive tract and the empty coating is eliminated from the body when you have a bowel movement. Therefore, you may occasionally notice something similar to a tablet in your stool. This is normal and should not worry you.

The recommended dose is:

• A single dose of 4 mg per day (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 a day.
• The maximum recommended dose is 8 mg once a day.
• Do not change the dose or stop taking the medicine unless your doctor tells you to.

Taking the medicine

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

The prolonged-release tablets should not be chewed, broken, or crushed. If you do, you risk the medicine being absorbed too quickly in the body and causing an overdose.

If you take more Doxazosina NEO Viatris than you should

If you or another person (e.g. a child) accidentally take more tablets than you should at the same time, you should contact a doctor, call the Toxicology Information Service, phone 91 562 04 20, or go to the emergency department of the nearest hospital. Some signs of overdose of this medicine include headache, dizziness, nausea, difficulty breathing, sweating, tremors, fainting, low blood pressure, or rapid, strong, or irregular heartbeats.

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 missed doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

• Severe allergic reactions, which can cause skin rash, swelling of the face, lips, tongue, or throat, difficulty breathing, wheezing, or difficulty swallowing.
• Numbness or sudden weakness of the arms, legs, or face, severe headache, dizziness, or confusion, vision problems, and speech problems. These are signs of reduced blood flow to the brain caused by a clot or bleeding (stroke).
• A feeling of heaviness or pressure in the chest with chest pain and increasingly difficult breathing when exercising (these signs could be indicative of heart problems, such as angina pectoris).
• Sudden chest pain that can spread to the neck or arm along with difficult breathing and shortness of breath (these signs could be indicative of a heart attack or other heart problems).

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

• Swelling, pain, or cramps in the stomach, gas, bad breath, constipation, diarrhea, vomiting, or feeling full. These signs could be indicative of 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 indicative of liver problems).
• An increase in the number of infections, which can cause fever, chills, mouth ulcers, sore throat, or lower respiratory tract infections. These signs could be indicative of low white blood cell counts.
• Persistent and painful erections. Contact a doctor urgently.

Other possible side effects may be:

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

• Throat or urinary tract infections.
• Dizziness, headache, numbness.
• Feeling dizzy (vertigo).
• Rapid or strong heartbeats (palpitations, tachycardia).
• Low blood pressure (hypotension), dizziness when standing up (orthostatic hypotension).
• Bronchitis, cough, difficulty breathing (dyspnea), runny nose or stuffy nose (rhinitis).
• Abdominal pain, indigestion (dyspepsia), dry mouth, nausea.
• Itching (pruritus).
• Back pain, muscle pain (myalgia).
• Cystitis (bladder inflammation), urinary incontinence.
• Impotence.
• Weakness (asthenia), chest pain, flu-like symptoms, swelling of the arms or legs (peripheral edema).

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

• Lack of appetite (anorexia), increased appetite.
• Pain or swelling of the joints caused by uric acid crystals (gout).
• Feeling anxious (anxiety), depressed, difficulty sleeping (insomnia).
• Decreased sensitivity to touch (hypoesthesia), fainting (syncope), agitation (tremor).
• Ringing or buzzing in the ears (tinnitus).
• Nosebleeds (epistaxis).
• Constipation, diarrhea, flatulence (gas), vomiting, gastroenteritis.
• Abnormal results in liver function tests.
• Skin rash.
• Joint pain (arthralgia).
• Pain or burning when urinating (dysuria), blood in the urine (hematuria), change in the frequency of urination (frequent urination).
• Pain, swelling of the face (facial edema).
• Weight gain.

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

• Appearance of bruises without cause and bleeding more easily or for longer than usual. This could be a sign of low platelet count (thrombocytopenia).
• Restlessness (agitation), nervousness.
• Dizziness when standing up (tingling and numbness of the hands or feet).
• Blurred vision.
• Slow or irregular heartbeats (bradycardia, arrhythmia).
• Redness (flushing).
• Difficulty breathing, wheezing, or coughing (bronchospasm).
• Partial, temporary, or total hair loss (alopecia), purple spots visible on the skin (purpura), itchy rashes, hives (urticaria).
• Muscle cramps, muscle weakness.
• Urination problems (urination disorder), urgent need to urinate at night (nocturia), increased volume of urine excreted (polyuria, increased diuresis).
• Increased breast size (gynecomastia).

Frequency not known(cannot be estimated from the 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 side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

This medicine does notrequire special storage conditions.

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 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 ingredients of the tablet core are: polyethylene oxide, microcrystalline cellulose, povidone, butylhydroxytoluene, ?-tocopherol, hydrated colloidal silica, sodium stearyl fumarate.
• The other ingredients of the tablet coating are: methacrylic acid and ethyl acrylate copolymer, anhydrous colloidal silica, macrogol, titanium dioxide (E-171).

Appearance of the product and pack contents

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

They are available in blisters containing 14, 15, 28, 30, 60, 90, 100 tablets, and a perforated unit-dose blister of 50 tablets. Not all pack sizes may be marketed.

Marketing authorisation 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

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised 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 last revision of this leaflet: January 2020

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