Label: Information for the Patient

Doxazosina Viatris Pharmaceuticals 4 mg Tablets EFG

Read this label carefully before taking this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine 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 side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

6. Contents of the pack and additional information

Your medication belongs to a group of medications called alpha-blockers. Doxazosina Viatris Pharmaceuticals is used to treat high blood pressure (hypertension) by relaxing blood vessels and reducing blood pressure. Doxazosina Viatris Pharmaceuticals is also used in men to treat an enlarged prostate, as it acts by relaxing the muscle around the exit of the bladder and the prostate gland, allowing urine to flow more easily.

Do not takeDoxazosinaViatris Pharmaceuticals:

• If you are allergic to doxazosina, to other quinazolines (e.g. 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 drop in blood pressure when standing up that may cause dizziness, lightheadedness or fainting.
• If you have an enlarged prostate (benign prostatic hyperplasia) and, at the same time, urinary problems, chronic urinary tract infection or difficulty urinating.
• If you have low blood pressure.
• If you suffer from incontinence due to overflow (you do not feel the need to urinate) or anuria (your body does not produce urine) with or without kidney problems.

Warnings and precautions

Consult your doctoror pharmacistbefore starting to takeDoxazosina ViatrisPharmaceuticals:

• If you have any heart disease or heart problems.
• If you have any liver disease.
• If you have any kidney disease or kidney problems.
• If you have diabetes.
• If you are on a low-sodium diet.
• If you are an elderly patient.
• If you are going to have a blood test, as doxazosina may affect the results of the tests.
• If you are going to undergo eye surgery for cataracts. Please inform your doctor before the operation if you are taking or have taken previously any medication containing doxazosina. This is because doxazosina may cause complications during the operation, which can be taken into account and controlled by your ophthalmologist if you have been informed in advance.
• Before starting treatment with doxazosina, your doctor will perform tests to rule out the possibility of having other conditions, such as prostate cancer, which may cause the same symptoms as benign prostatic hyperplasia.

When you start taking Doxazosina Viatris Pharmaceuticals or when your doctor increases your dose, you may experience dizziness or lightheadedness when standing up from a seated or lying position due to low blood pressure. If you faint or feel dizzy, you should sit or lie down until you feel better and avoid situations where you could fall or get hurt. Your doctor may want to measure your blood pressure regularly at the start of treatment or when your dose is increased to reduce the likelihood of these effects.

Children and adolescents

The use of doxazosina mesylate is not recommended in children or adolescents under 18 years of age, as its safety and efficacy have not been established.

Other medications and Doxazosina Viatris Pharmaceuticals

Inform your doctor or pharmacist if you are taking, have taken recently ormay need to take anyother medication. This includes medicationsobtained without a prescription or the following:

• Other medications to lower blood pressure, such as beta-blockers (e.g. atenolol) or vasodilators (e.g. hydralazine).
• Medications to treat heart disease, such as nitrates (e.g. glyceryl trinitrate).
• Analgesics called non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen.
• Medications containing estrogenssuch as HRT or oral contraceptives.
• Cimetidine, used to treat stomach ulcers.
• Diuretics or ‘water pills’.
• Medications containing dopamine, metaraminol, methoxamine, adrenaline (epinephrine), cold and flu remedies, as they may contain ephedrine, phenylephrine.
• Medications for erectile dysfunction, such as sildenafil, vardenafil or tadalafil. Do not take this type of medication until your blood pressure is well controlled. Take the lowest possible dose of the erectile dysfunction medication.
• Medications for the treatment of bacterial or fungal infections; e.g. clarithromycin, itraconazole, ketoconazole, telithromycin or voriconazole.
• Medications used in the treatment of HIV; e.g., indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medication used to treat depression.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication. Doxazosina should not be administered to pregnant women, unless the benefits to the mother outweigh the risks to the baby.

Do notbreastfeed your baby, as small amounts of doxazosina may pass into breast milk.

Driving and operating machinery

Do not drive or operate machinery if you feel less alert while taking this medication. This makes you feel weak or dizzy. This is more likely at the start of treatment or if your doctor increases your dose.

Doxazosina Viatris Pharmaceuticalscontains lactose and sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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

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

Adults including elderly patients

Hypertension

The usual initial dose is 1 mg once a day. If necessary, your doctor may gradually increase the dose (e.g. 2 mg, 4 mg, and 8 mg) at intervals of 1-2 weeks until the desired blood pressure is reached. The maximum daily dose is 16 mg. Your doctor may prescribe any other medication to be taken with Doxazosina Viatris Pharmaceuticals.

Benign Prostatic Hyperplasia

The usual initial dose is 1 mg of doxazosina once a day. If necessary, your doctor may gradually increase the dose at intervals of 1-2 weeks until symptoms are controlled. The maximum daily dose is 8 mg.

Take your tablets with water, approximately at the same time each day.

If you take more Doxazosina Viatris Pharmaceuticals than you should

Consult immediately with your doctor or the nearest hospital emergency service. Bring with you the packaging and remaining tablets. Symptoms of overdose include headache, dizziness, confusion, fainting, difficulty breathing, low blood pressure, palpitations (feeling your heartbeats), rapid heartbeat, irregular heartbeat, slow heart rate, general discomfort, vomiting, low blood sugar, and low potassium levels.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20.

If you forgot to take Doxazosina Viatris Pharmaceuticals

Take the next dose as soon as you remember. Unless it is almost time for your next dose, do not take a double dose to make up for the missed doses.

If you interrupt treatment with Doxazosina Viatris Pharmaceuticals

Do not stop taking your medication suddenly, as this may cause severe changes in your blood pressure.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

STOP taking doxazosina and call an ambulance if you experience any of the following:

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

• Sensation of pressure, oppression, or pain in the chest or arms, which may extend to the neck, jaw, or back, these could be indicative of a heart attack.
• Weakness in arms, legs, or speech problems, which may be symptoms of a stroke.
• Swelling of the face, tongue, or throat, which may be the result of an allergic reaction to this medication.

Seek medical adviceimmediatelyif you experience any of the following symptoms after taking doxazosina:

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

• Angina.
• Blackout.
• Lack of air, difficulty breathing.

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

• Decreased or irregular heartbeats.
• Liver disease (hepatitis) or a condition in which the flow of bile from the liver is blocked (cholestasis), causing dark urine, pale stools, nausea, fever, and yellowing of the skin or the white of the eyes (jaundice).
• Increased number of infections, such as sore throat, mouth ulcers, chills, and fever, which may be due to low white blood cell count.
• Persistent and painful erection of the penis.

Other possible side effects:

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

• Dizziness.
• Headache.
• Respiratory tract infection (nose, throat, lungs).
• Urinary tract infection.
• Sensation of dizziness or spinning (vertigo).
• Drowsiness.
• Weakness.
• Sensation of dizziness.
• Sensation of indifference or lack of interest.
• Swelling of the ankles.
• Low blood pressureor decrease in blood pressure when standing up after being in a seated or lying position.
• Chest pain.
• Increased heartbeats.
• Feeling the heartbeats (palpitations).
• Drowsiness.
• Back pain.
• Muscle pain.
• Abdominal pain(stomach).
• Dry mouth.
• Indigestion.
• Bronchitis.
• Cough.
• Itching.
• Difficulty breathing.
• Stuffy nose.
• Runny nose.
• Delayed ejaculation.
• Urinary infection.
• Urinary incontinence (inability to control urine flow).
• Difficulty focusing.
• Symptoms similar to the flu.

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

• Trembling.
• Sensation of anxiety.
• Loss or increase of appetite.
• Difficulty sleeping.
• Sensation of nervousness.
• Diarrhea.
• Swelling of the face and body.
• Pale or flushed face.
• Fever or chills.
• Cold hands and feet.
• Muscle pain.
• Constipation.
• Gas.
• Sensation of discomfort.
• Gastroenteritis (inflammation of the stomach and intestines).
• Alteration in liver function tests.
• Muscle stiffness.
• Joint pain (arthralgia).
• Joint inflammation (gout).
• Rash.
• Nosebleed.
• Throat pain.
• Low potassium levels in the blood.
• Sensation of thirst.
• Alteration in taste.
• Restlessness.
• Depression.
• Nightmares.
• Memory loss.
• Reduction or alteration of touch or sensitivity.
• Changes in mood.
• Change in urination frequency.
• Blood in urine (hematuria).
• Failure to achieve erection of the penis.
• General pain.
• Pain while urinating.
• Sensitivity of the eyes to light.
• Changes in tear flow.
• Ringing in the ears
• Weight gain.

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

• Decreased body temperature in elderly people.
• Changes in cerebral blood flow.
• Swelling of the throat.
• Sweating.
• Conjunctivitis (inflamed, watery eyes).
• Increased levels of urea and creatinine in the blood.
• Reduction in red blood cells, which may cause pale skin and cause weakness or difficulty breathing.
• Low blood sugar levels.
• Changes in urine volume (polyuria).
• Muscle cramps.
• Muscle weakness.

Unknown frequency(cannot be estimated from available data):

• Iris flaccida intraoperative syndrome (IFIS).
• Alteration in taste.
• Retrograde ejaculation (little or no semen release during orgasm, cloudy urine after orgasm).

Reporting of side effects

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

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition ofDoxazosinaViatris Pharmaceuticals

• The active ingredient is doxazosin. Each tablet contains 4 mg of doxazosin (as doxazosin mesylate).
• The excipients are: microcrystalline cellulose (E-460), anhydrous lactose, sodium carboxymethyl starch, magnesium stearate (E-470b), and sodium lauryl sulfate.

Appearance of theproductand contents of the package

Doxazosina Viatris Pharmaceuticals are white, oblong-shaped tablets marked with DX/4 on one side.

Doxazosina Viatris Pharmaceuticals is available in plastic bottles with a cap and a tamper-evident seal containing 10, 20, 28, 30, 50, 60, 90, 100, 250, 500, and 1,000 tablets, and in blisters of 10, 20, 28, 30, 50, 60, 90, and 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

or

Mylan Germany GmbH

Benzstrasse 1

Bad Homburg v. d. Hoehe

Hessen, 61352

Germany

or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

GermanyDoxazosin dura 4 mg Tabletten

AustriaDoxazosin “Arcana” 4 mg Tabletten

SpainDoxazosina Viatris Pharmaceuticals 4 mg tablets EFG

Last review date of this leaflet:May 2021

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