Product Information for the User

Doxazosina NEO Viatris 4 mg Extended-Release Tablets EFG

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1.What is Doxazosina NEO Viatris and how is it used

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

3.How to take Doxazosina NEO Viatris

4.Possible adverse effects

1. Storage of Doxazosina NEO Viatris

Contents of the package and additional information

Doxazosina NEO Viatris contains the active ingredient 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 ofbenign prostatic hyperplasia(BPH) and the reduction of urine flow associated with BPH. Doxazosina NEO Viatris may be used in patients with hypertension and normal blood pressure.

Doxazosina works by relaxing the muscles around the exit of the bladder and the prostate gland to help alleviate the difficulties in urinating, which are common in patients whose prostate has enlarged.

Do not take Doxazosina NEO Viatris

• If you are allergic to doxazosina, to other quinazolines (for example: prazosina, terazosina) or to any of the other components of this medication (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 after sitting or lying down.
• If you have aurinary tractobstruction, chronic urinary tract infection or bladder stones.
• If you have or have had an esophageal obstruction or a narrowing or obstruction of the digestive tract.
• If you have low blood pressure.
• If you suffer from urinary incontinence (you feel 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 this may affect how you absorb the medication.
• If you have heart problems.

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

During treatment

When you start taking Doxazosina NEO Viatris, you may feel dizzy or lightheaded due to low blood pressure when standing up after sitting or lying down. If you feel dizzy or lightheaded, 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 measure your blood pressure regularly at the beginning of treatment to reduce the likelihood of these effects.

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

Persistent and painful erections may occur very rarely. 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, as its safety and efficacy have not been determined.

Other medications and Doxazosina NEO Viatris

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication, including those purchased without a prescription.

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

• Doxazosina NEO Viatris may further lower your blood pressure if you are taking other medications to treat hypertension, such as terazosina or prazosina.

• Medications to treat bacterial or fungal infections (for example, claritromycin, itraconazole, ketoconazole, telithromycin or voriconazole).
• Medications to treat HIV (for example, indinavir, nelfinavir, ritonavir or saquinavir).
• Nefazodone, a medication 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 doxazosina could affect fertility. If you intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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 when taking this medication, do not drive or operate machinery and inform your doctor or pharmacist.

Doxazosina NEO Viatris contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet, making it essentially "sodium-free".

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

The modified-release tablets of Doxazosina NEO Viatris contain the medication within a non-absorbable coating designed to release the drug slowly. After swallowing them, the tablets release the medication as they pass through the digestive tract, and the empty coating is eliminated from the body with a bowel movement. Therefore, it is possible to occasionally feel something similar to a tablet in the stool. This is normal and should not cause concern.

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 per day.
• Do not change the dose or stop taking the medication unless your doctor tells you to.

Medication intake

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 this is done, there is a risk that the medication will be absorbed too quickly into the body and cause an overdose.

If you take more Doxazosina NEO Viatris than you should

If you or another person (for example, a child) accidentally take more tablets than you should at the same time, you should contact a doctor, call the Toxicology Information Service at 91 562 04 20, or go to the nearest hospital emergency department. Some signs of an overdose of this medication include headache, dizziness, nausea, difficulty breathing, sweating, tremors, fainting, low blood pressure, or rapid 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 medication as planned. However, if it is almost time to take the next dose, skip the missed dose and continue taking the tablets as usual.Do not take a double dose to make up for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

• Severe allergic reactions, which can cause skin rashes, facial swelling, lip, tongue, or throat swelling, difficulty breathing, wheezing, or difficulty breathing or swallowing.
• Sudden numbness or weakness in the arms, legs, or face, severe headache, dizziness, confusion, vision problems, and speech difficulties. These are signs of reduced blood flow to the brain caused by a clot or hemorrhage (stroke).
• Feeling of heaviness or pressure in the chest with chest pain and increasingly difficult breathing while exercising (these signs may indicate heart problems, such as angina).
• Sudden chest pain that may radiate to the neck or arm along with difficulty breathing and shortness of breath (these signs may indicate 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 may indicate obstruction of the digestive tract.

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

• Yellow skin and eyes, feeling unwell, loss of appetite, itching, dark urine (signs indicating liver problems).
• Increased number of infections, causing fever, intense chills, mouth ulcers, sore throat, or lower respiratory tract infections. These signs may indicate low white blood cell counts.
• Persistent and painful erection of the penis. Consult 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.
• Dizziness (vertigo).
• Fast 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 (inflammation of the bladder), urinary incontinence.
• Inability to achieve or maintain an erection (impotence).
• Weakness (asthenia), chest pain, flu-like symptoms, swelling of the arms or legs (peripheral edema).

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

• Loss of appetite (anorexia), increased appetite.
• Pain or swelling of the joints caused by uric acid crystals (gout).
• Feeling of concern (anxiety), feeling down (depression), difficulty sleeping (insomnia).
• Decreased tactile sensitivity (hypoesthesia), fainting (syncope), agitation (tremor).
• Ringling or buzzing in the ears (tinnitus).
• Nosebleeds (epistaxis).
• Constipation, diarrhea, gas, vomiting, gastroenteritis.
• Abnormal results in liver function tests.
• Skin rash.
• Joint pain (arthralgia).
• Burning or pain when urinating (dysuria), blood in the urine (hematuria), change in 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 petechiae without cause and bleeding with increased ease or for a longer period than normal. This may indicate low platelet counts (thrombocytopenia).
• Restlessness (agitation), nervousness.
• Dizziness when standing up (tingling and numbness in the hands or feet).
• Blurred vision.
• Slow or irregular heartbeats (bradycardia, arrhythmia).
• Redness (rubefaction).
• Difficulty breathing, wheezing, or cough (bronchospasm).
• Partial, temporary, or general hair loss (alopecia), visible purple spots on the skin (purpura), itchy rashes, blisters (urticaria).
• Muscle cramps, muscle weakness.
• Urination problems (urinary tract disorder), nocturia (urination at night), increased urine volume (polyuria, increased diuresis).
• Enlargement of the breasts (gynecomastia).

Unknown frequency(cannot be estimated from available data):

• Complications during cataract surgery (“Intraoperative Flaccid Iris Syndrome”, see section2 “Warnings and Precautions”).
• Producing little or no semen during ejaculation (retrograde ejaculation).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does notrequire special conditions for conservation.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofDoxazosina NEO Viatris

• The active ingredient isdoxazosina. Each prolonged-release tablet contains 4.85mg of mesilato de doxazosina equivalent to 4mg of doxazosina.
• The other components of the tablet core are: polyethylene oxide, microcrystalline cellulose, povidone, butylhydroxytoluene,?-tocopherol, hydrated colloidal silica , sodium stearate fumarate.
• The other components of the tablet coating are: methacrylic acid copolymer and ethyl acrylate copolymer, anhydrous colloidal silica, macrogol, titanium dioxide (E-171).

Appearance of the product and contents of the package

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

They are presented in blisters containing 14, 15, 28, 30, 60, 90, 100 tablets and a perforated single-dose blister of 50 tablets.Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

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 about this medicinal product can be obtained 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 with the following names:

SpainDoxazosina NEO Viatris 4 mg prolonged-release tablets EFG

FranceDOXAZOSINE MYLAN LP4 mg, prolonged-release tablet

PortugalDoxazosina Mylan

Last review date of this leaflet: January 2020

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