DOXAZOSIN VIATRIS PHARMACEUTICALS 4 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Doxazosin Viatris Pharmaceuticals 4 mg 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

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

1. Contents of the pack and further information

1. What is Doxazosin Viatris Pharmaceuticals and what is it used for

Your medicine belongs to a group of medicines called alpha-blockers. Doxazosin Viatris Pharmaceuticals is used to treat high blood pressure (hypertension) by relaxing blood vessels and reducing blood pressure. Doxazosin Viatris Pharmaceuticals is also used in men to treat an enlarged prostate gland, as it relaxes the muscle around the bladder and prostate gland, making it easier for urine to flow.

2. What you need to know before you take Doxazosin Viatris Pharmaceuticals

Do not takeDoxazosinViatris Pharmaceuticalsif:

• You are allergic to doxazosin, other quinazolines (e.g. prazosin, terazosin), or any of the other ingredients of this medicine (listed in section 6).
• You have a history of 'orthostatic hypotension', a drop in blood pressure when standing up, which can lead to dizziness, fainting, or blackouts.
• You have an enlarged prostate gland (benign prostatic hyperplasia) and at the same time have problems with your bladder, chronic urinary tract infection, or difficulty urinating.
• You have low blood pressure.
• You suffer from overflow incontinence (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 doctor or pharmacist before taking Doxazosin Viatris Pharmaceuticals:

• 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-salt diet.
• If you are an elderly patient.
• If you are going to have a blood test, as doxazosin may affect the results of the tests.
• If you are going to have eye surgery for cataracts. Please inform your doctor before this operation if you are taking or have taken doxazosin in the past. This is because doxazosin may cause complications during the operation, which can be taken into account and controlled by your ophthalmologist if they have been informed beforehand.
• Before starting treatment with doxazosin, your doctor will perform tests to rule out the possibility that you have other conditions, such as prostate cancer, which may cause the same symptoms as benign prostatic hyperplasia.

When you start taking Doxazosin Viatris Pharmaceuticals or when your dose is increased, you may experience dizziness or fainting when standing up from a sitting or lying position due to low blood pressure. If you faint or feel dizzy, sit or lie down until you feel better and avoid situations where you could fall or hurt yourself. Your doctor may want to check your blood pressure regularly at the start of therapy or when your dose is increased to reduce the risk of these effects.

Children and adolescents

Doxazosin mesylate is not recommended for use in children or adolescents under 18 years of age, as the safety and efficacy have not been established.

Other medicines and Doxazosin Viatris Pharmaceuticals

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

• Other medicines to lower blood pressure, such as beta-blockers (e.g. atenolol) or vasodilators (e.g. hydralazine).
• Medicines for heart disease, such as nitrates (e.g. glyceryl trinitrate).
• Painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen.
• Medicines containing estrogens, such as HRT or oral contraceptives.
• Cimetidine, used to treat stomach ulcers.
• Diuretics or 'water tablets'.
• Medicines containing dopamine, metaraminol, methoxamine, adrenaline (epinephrine), cough and cold remedies, which may contain ephedrine, phenylephrine.
• Medicines for erection problems, such as sildenafil, vardenafil, or tadalafil. You should not take these types of medicines until your blood pressure is well controlled. You should take the lowest possible dose of the medicine for erection problems.
• Medicines for bacterial or fungal infections; e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, or voriconazole.
• Medicines used to treat HIV; e.g. indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Doxazosin should not be given to pregnant women unless the benefits to the mother outweigh the risks to the baby.

Do notbreastfeed your baby while taking this medicine, as small amounts of doxazosin may pass into breast milk.

Driving and using machines

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

Doxazosin Viatris Pharmaceuticals contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

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

3. How to take Doxazosin Viatris Pharmaceuticals

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Adults, including elderly patients

High blood pressure

The usual initial dose is 1 mg once daily. If necessary, your doctor may gradually increase the dose (e.g. 2 mg, 4 mg, and 8 mg) at 1-2 week intervals until the desired blood pressure is achieved. The maximum daily dose is 16 mg. Your doctor may prescribe another medicine to take with Doxazosin Viatris Pharmaceuticals.

Benign prostatic hyperplasia

The usual initial dose is 1 mg of doxazosin once daily. If necessary, your doctor may gradually increase the dose at 1-2 week intervals 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 Doxazosin Viatris Pharmaceuticals than you should

Consult your doctor immediatelyor go to the casualty department of your nearest hospital. Take the medicine pack with you. Symptoms of overdose include headache, dizziness, confusion, fainting, difficulty breathing, low blood pressure, palpitations (feeling your heart beats), fast or irregular heartbeats, slow heart rate, general malaise, vomiting, low blood sugar and potassium levels.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Doxazosin Viatris Pharmaceuticals

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

If you stop taking Doxazosin Viatris Pharmaceuticals

Do notstop taking your medicine suddenly, as this can cause serious changes in your blood pressure.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Stop takingdoxazosin and call an ambulance if you experience any of the following:

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

• Feeling of pressure, tightness, or pain in the chest or arms, which may spread to the neck, jaw, or back, these could be signs of a heart attack.
• Weakness in arms, legs, or speech problems, which can be symptoms of a stroke.
• Swelling of the face, tongue, or throat, which can be the result of an allergic reaction to this medicine.

Seek medical advice immediatelyif you experience any of the following symptoms after taking doxazosin:

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

• Angina.
• Fainting.
• Shortness of breath, difficulty breathing.

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

• Abnormal or irregular heartbeats.
• Liver disease (hepatitis) or a disorder 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 whites of the eyes (jaundice).
• An increase in the number of infections you get, such as sore throat, mouth ulcers, with chills and fever, which may be due to a low white blood cell count.
• Prolonged 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.
• Feeling of dizziness or spinning (vertigo).
• Drowsiness.
• Weakness.
• Feeling of dizziness.
• Feeling of indifference or lack of interest.
• Swelling of the ankles.
• Low blood pressure or a drop in blood pressure when standing up from a sitting or lying position.
• Chest pain.
• Fast heart rate.
• Palpitations (feeling your heart beats).
• Stupor.
• Back pain.
• Muscle pain.
• Abdominal pain (stomach).
• Dry mouth.
• Indigestion.
• Bronchitis.
• Cough.
• Itching.
• Difficulty breathing.
• Nasal congestion.
• Runny nose.
• Delayed ejaculation.
• Urinary incontinence (inability to control the flow of urine).
• Difficulty focusing.
• Flu-like symptoms.

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

• Tremor.
• Feeling of anxiety.
• Loss or increased appetite.
• Difficulty sleeping.
• Feeling of nervousness.
• Diarrhea.
• Swelling of the face and body.
• Pallor or flushing of the face.
• Fever or chills.
• Cold fingers and toes.
• Muscle pain.
• Constipation.
• Gas.
• Feeling of discomfort.
• Inflammation of the stomach and intestines (gastroenteritis).
• Abnormal liver function tests.
• Muscle stiffness.
• Painful inflammation of the joints (gout).
• Joint pain (arthralgia).
• Rash.
• Nosebleeds.
• Painful throat inflammation.
• Low potassium levels in the blood.
• Feeling of thirst.
• Altered taste.
• Agitation.
• Depression.
• Nightmares.
• Memory loss.
• Reduced or altered sense of touch or sensitivity.
• Mood changes.
• Changes in urination frequency.
• Blood in urine (hematuria).
• Failure to achieve or maintain an erection.
• General pain.
• Pain when urinating.
• Sensitivity of the eyes to light.
• Changes in tear flow.
• Ringing in the ears.
• Weight gain.

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

• Decreased body temperature in elderly people.
• Changes in blood flow to the brain.
• Swelling of the throat.
• Sweating.
• Swollen, watery eyes (conjunctivitis).
• Increased levels of urea and creatinine in the blood.
• Decrease in red blood cells, which can cause paleness of the skin and weakness or difficulty breathing.
• Low blood sugar levels.
• Changes in urine volume (polyuria).
• Muscle cramps.
• Muscle weakness.

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

• Decrease in the number of white blood cells or blood platelets, which can increase the risk of bleeding or bruising.
• Blurred vision.
• Worsening of asthma.
• Redness of the skin with itching.
• Increased urine volume, disorder of urination, with a need to urinate at night.
• Increased breast size in men.
• Feeling of tingling, pricking, or numbness of the skin (paresthesia).
• Feeling of dizziness when standing up. This is more likely to happen at the start of treatment.
• Hair loss.
• Bleeding into the skin (purpura).
• Hot flushes.
• Feeling of tiredness and discomfort (feeling unwell).

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

• Intraoperative floppy iris syndrome (IFIS).
• Altered taste.
• Retrograde ejaculation (little or no semen released during orgasm, cloudy urine after orgasm).

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 via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Doxazosin Viatris Pharmaceuticals

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month stated.

This medicine does not require any 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. Container Content and Additional Information

Composition ofDoxazosinViatris 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 starch glycolate, magnesium stearate (E-470b), and sodium lauryl sulfate.

Appearance of theproductand container content

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

Doxazosin Viatris Pharmaceuticals is available in plastic bottles with a screw cap and a seal of 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 pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

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 under the following names:

Germany Doxazosin dura 4 mg Tablets

Austria Doxazosin "Arcana" 4 mg Tablets

Spain Doxazosina Viatris Pharmaceuticals 4 mg EFG tablets

Date of the last revision of this leaflet:May 2021

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