Package Insert: Information for the Patient

Doxazosina NEO Viatris 8 mg Extended-Release Tablets EFG

Read this package insert carefully before starting to take the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to 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 package insert. See section 4.

Your doctor may have prescribed Doxazosina NEO Viatris because you have high blood pressure and it may increase your risk of suffering from heart disease or a stroke if not treated. The active ingredient in the tablets, doxazosina, belongs to a group of medicines called alpha 1 blockers. These medicines work by widening blood vessels, making it easier for the heart to pump blood through them. This helps to lower high blood pressure and reduce the risk of heart disease.

It is also possible that you have been prescribed Doxazosina NEO Viatris to treat the symptoms of benign prostatic hyperplasia (BPH). This condition means that the prostate, which is located just below the bladder in men, is enlarged. This makes it difficult to empty the bladder. Doxazosina NEO Viatris works by relaxing the muscles around the exit of the bladder and the prostate gland, making it easier to empty the bladder.

Doxazosina may also be authorized to treat other conditions that are not listed in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any other questions and always follow their instructions.

Do not take Doxazosina NEO Viatris

-If you are allergic to doxazosina, to other quinazolines (for example, prazosina or terazosina)or to any of the other components of this medication (including in section 6).

-If you have low blood pressure or if you have ever had a drop in blood pressure that caused dizziness or fainting, when standing up after sitting or lying down.

-If you have benign prostatic hyperplasia and, at the same time, an obstruction of the upper urinary tract, chronic urinary tract infection or bladder stones.

-If you have or have had a blockage of the digestive tract, stomach or intestine (digestive tract).

-If you are taking this medication to treat high blood pressure and are breastfeeding.

-If you have low blood pressure.

-If you have incontinence by overflow (you do not detect or are unable to control the release of urine) or your body does not produce urine, with or without kidney problems.

Warnings and precautions

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

-If you have heart problems.

-If you haveliver problems.

-If you suffer from changes in bowel habits or if you have undergone a surgical intervention of the intestine or digestive apparatus, as this could affect how you absorb the medication.

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

During treatment

When you start taking Doxazosina NEOViatris, you may feel dizzy, weak or feel like you are going to pass out when standing up after sitting or lying down. If you feel dizzy or like you are going to pass out, sit or lie down until you feel better or avoid situations where you could fall or get hurt. Your doctor may want to measure your blood pressure regularly when you start taking this medication to reduce the possibility of these effects.

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

Very rarely, persistent and painful erections can occur. If this happens, you should contact your doctor immediately.

If you are going to undergo a urine or blood test, tell your doctor or nurse that you are taking Doxazosina NEO Viatris. This medication can affect the results of some tests.

On occasion, you may observe in the stool something that resembles a tablet. This is normal. The active ingredient of the prolonged-release tablets is contained in a non-absorbable coating, which is specially designed to slowly release the medication in the body. When the process is complete, the empty coating is eliminated from the body in the stool.

Consult your doctor or pharmacist if you have doubts.

Children and adolescents

The use of Doxazosina NEOViatris is not recommended in children or

adolescents under 18years, 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. Inform your doctor especially if you are taking:

-Other alpha blockers and other medications used to treat high blood pressure.

- Medications called phosphodiesterase inhibitors (PDE) (for example, sildenafilo, tadalafilo, vardenafilo), used to treat erectile dysfunction. You should take a daily dose of doxazosina before starting to use these medications; you may be given a low dose initially and you should wait for a period of about 6hours since the administration of doxazosina before starting to take a phosphodiesterase inhibitor.

-Non-steroidal anti-inflammatory drugs (NSAIDs), for example, ibuprofeno.

-Estrogens (female sex hormone).

-Dopamine, ephedrine, epinephrine (adrenaline), metaraminol, methoxamine, phenylephrine (medications known as sympathomimetics and used, for example, to treat heart problems, low blood pressure, asthma and nasal congestion).

• Medications for the treatment of bacterial or fungal infections (for example, claritromicina, itraconazol, ketoconazol, telitromicina or voriconazol).
• Medications for the treatment of HIV (for example, indinavir, nelfinavir, ritonavir or saquinavir).
• Nefazodone, a medication used to treat depression.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

This information is only applicable to patients taking Doxazosina NEO Viatristo treat high blood pressure.

Pregnancy

Do not take Doxazosina NEO Viatris without first talking to your doctor if you are pregnant or trying to become pregnant. The experience with the use of doxazosina during pregnancy is limited.

Lactation

Do not take Doxazosina NEO Viatris if you are breastfeeding.

Alternatively, you should interrupt breastfeeding when doxazosina treatment is necessary.

Driving and operating machinery

Doxazosina NEO Viatris may cause drowsiness. Be especially careful when taking the first dose, if your dose is increased or if you restart taking this medication. If you feel dizzy or disoriented, you should not drive or operate machinery.

It is your responsibility to evaluate whether you are in a condition to drive or perform tasks that require a high level of alertness. One of the factors that may affect your ability in this sense is the use of medications, by their effects and/or side effects. Therefore, read all the information in this prospectus to guide you.Consult your doctor or pharmacist if you have doubts.

Doxazosina NEO Viatris contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

Treatment of high blood pressure and symptoms of benign prostatic hyperplasia:

Use in adults (including elderly patients)

The recommended dose of doxazosina is 4 mg of doxazosina per day, although your doctor may increase your dose up to a maximum of 8 mg of doxazosina (one tablet) per day.

The maximum recommended dose is 8 mg of doxazosina once a day. The optimal effect may take up to four weeks to be achieved.

Use in patients with liver problems

Your doctor may reduce your dose or monitor your condition more closely.Do not take doxazosina if you have severe liver problems.

Medication intake

Doxazosina NEO Viatris has been specially formulated to provide slow release of the active ingredient throughout the day. Choose a time of day that is convenient for you and take the tablets at the same time every day. The tablets should be swallowed whole with sufficient liquid, with or without food. They should not be chewed, broken, or crushed.

If you take more Doxazosina NEO Viatris than you should

If you take too many tablets or if, for example, a child takes the medication by mistake, contact your doctor or the hospital emergency department immediately and lie down. You may experience headaches, dizziness, fainting, drowsiness, loss of consciousness, breathing difficulties, low blood pressure, palpitations, irregular or rapid heartbeat, nausea, vomiting, or low levels of blood or potassium in the blood.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used.

If you forget to take Doxazosina NEO Viatris

If you forget to take a dose, do not worry. Simply take the dose the next day at the usual time.Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Doxazosina NEO Viatris

Continue taking the tablets until your doctor tells you to stop.

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

Like all medicines,this medicinecan 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 visit the nearest hospital emergency department:

Rare(may affect up to 1 in 100 people)

• Severe allergic reactions, such as wheezing, shortness of breath, difficulty breathing or swallowing, collapse or extreme dizziness, facial swelling, mouth, lip, tongue, or throat swelling, or severe skin rash with itching, blisters, or pimples.
• Sudden numbness or weakness in the arms, legs, or face, severe headache, dizziness, or confusion, vision or speech problems. 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 spread to the neck or arm, along with difficult breathing and a feeling of suffocation (these signs may indicate a heart attack or other heart problems).

Rare(may affect up to1 in 1,000people)

• 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)

• Yellowing of the skin or white of the eyes (jaundice), discomfort (nausea), loss of appetite, itching, dark urine. These symptoms may indicate severe 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:

Frequent(may affect up to 1 in 10 people)

• Palpitations(strong heart rhythm), rapid heart rhythm (tachycardia).
• Dizziness, headache, drowsiness.
• Sensation of dizziness or feeling like 'the head is spinning' (vertigo).
• Inflammation of the respiratory tract (bronchitis), cough, difficulty breathing (dyspnea), itching, secretion, and nasal congestion, sneezing, facial pain (rhinitis).
• Abdominal discomfort, indigestion (dyspepsia), dry mouth, sensation of dizziness (nausea).
• Inflammation of the bladder (cystitis), uncontrolled urination.
• Itching skin.
• Inability to achieve an erection.
• Back pain, muscle pain.
• Nasal, throat, and lung infections (respiratory tract infections), kidney or bladder infections (urinary tract infections).
• Low blood pressure, sudden drop in blood pressure when standing up.
• Weakness, flu-like symptoms, swelling, especially of the feet and lower extremities (edema).

Rare(may affect up to 1 in 100 people)

• Weight gain.
• Reduced sensitivity or sensation, especially of the skin, fainting, trembling.
• Tinnitus in the ears (acufenos).
• Nasal bleeding (epistaxis).
• Constipation, diarrhea, gas, vomiting, inflammation of the stomach and intestines.
• Painful urination, blood in the urine, increased frequency of urination.
• Skin rash.
• Pain and stiffness in the joints (artralgia).
• Increased appetite, loss of appetite, gout (disease with swollen and painful joints).

especially of the face (edema facial).

• Abnormal liver function tests.
• Nervousness (anxiety), depression, difficulty sleeping (insomnia).

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

• Slow heart rate (bradycardia), irregular heart rhythm (arrhythmia).
• Appearance of petechiae without cause and hemorrages with more ease or for a longer time than normal. They may be signs of low platelet count (thrombocytopenia).
• Dizziness when standing up, sensation of pins and needles with numbness.
• Blurred vision.
• Narrowing of the airways with difficulty breathing or wheezing (bronchospasm).
• Difficulty urinating, increased need to urinate at night, increased production and volume of urine.
• Hair loss, unusual bleeding or hematomas under the skin, urticaria.
• Muscle cramps, muscle weakness.
• Hot flashes.
• Fatigue, general discomfort.
• Enlargement of the breasts in men.
• Agitation, nervousness.

Unknown frequency(cannot be estimated from available data)

• Complications (intraoperative floppy iris syndrome) during cataract surgery (see section 2: "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 Vigilance 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 this medication 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 after CAD or EXP. The expiration date is the last day of the month indicated.

This medication does notrequire special storage conditions.

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

Doxazosina NEO Viatris Composition

The active ingredient is doxazosina. Each prolonged-release tablet contains 8 mg of doxazosina (as doxazosina mesilate).

The other components are:

Tablet core: polyethylene oxide, microcrystalline cellulose, povidone, butylhydroxytoluene, all-rac-α-tocopherol, anhydrous colloidal silica, sodium stearate fumarate.

Tablet coating: methacrylic acid copolymer and ethyl acrylate copolymer, anhydrous colloidal silica, macrogol, titanium dioxide (E-171).

Product appearance and packaging contents

Doxazosina NEO Viatris tablets are white, round, biconvex, and have the inscription “DH” on one side.

They are available in blister packs of 7, 10, 14, 15, 28, 30, 50 x 1, 56, 60, 98, and 100 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan Hungary Kft.

H-2900 Komarom

Mylan utca 1

Hungary

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 8 mg prolonged-release tablets EFG

FranceDOXAZOSINE MYLAN LP 8 mg, prolonged-release tablet

NetherlandsDoxazosine Retard Mylan 8 mg, tablets with prolonged release

PortugalDoxazosina Mylan

Last review date of this leaflet:January 2020

Further detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/