Doxazosin Viatris Pharmaceuticals 4 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Doxazosina Viatris Pharmaceuticals 4 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Doxazosina Viatris Pharmaceuticals

3. How to take Doxazosina Viatris Pharmaceuticals

4. Possible side effects

5. How to store Doxazosina Viatris Pharmaceuticals

6. Contents of the container and other information

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

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

2. What you need to know before taking Doxazosina Viatris Pharmaceuticals

Do not take Doxazosina Viatris Pharmaceuticals:

• 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 drop in blood pressure upon standing that may cause dizziness, lightheadedness, or fainting.
• If you have an enlarged prostate gland (benign prostatic hyperplasia) and, at the same time, bladder problems, chronic urinary infection, or difficulty urinating.
• If you have low blood pressure.
• If you suffer from overflow incontinence (you do not feel the urge to urinate) or anuria (your body does not produce urine), with or without kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Doxazosina 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 laboratory tests.
• If you are scheduled for cataract eye surgery. Please inform your doctor before the surgery if you are currently taking or have previously taken any medicine containing doxazosin. This is because doxazosin may cause complications during surgery, which can be anticipated and managed by your ophthalmologist if they are informed in advance.
• Before starting treatment with doxazosin, your doctor will perform tests to rule out 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 dose is increased, you may experience fainting or dizziness upon standing from a sitting 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 injure yourself. Your doctor may want to monitor your blood pressure regularly at the beginning of treatment or when your dose is increased to reduce the likelihood of these effects.

Children and adolescents

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

Other medicines and Doxazosina Viatris Pharmaceuticals

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription or the following:

• Other medicines to lower blood pressure such as beta-blockers (e.g. atenolol) or vasodilators (e.g. hydralazine).
• Medicines to treat heart conditions such as nitrates (e.g. glyceryl trinitrate).
• Painkillers known as 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 or phenylephrine.
• Medicines for erectile dysfunction such as sildenafil, vardenafil, or tadalafil. You should not take these medicines until your blood pressure is well controlled. You should take the lowest possible dose of the erectile dysfunction medicine.
• Medicines used to treat bacterial or fungal infections; e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, or voriconazole.
• Medicines used in the treatment of 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 plan to become pregnant, consult your doctor or pharmacist before taking this medicine. Doxazosin should not be given to pregnant women unless the benefits to the mother outweigh the risks to the baby.

You must not breastfeed 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 medicine may make you feel weak or dizzy. This is more likely at the beginning of treatment or if your doctor increases your dose.

Doxazosina Viatris Pharmaceuticals contains lactose and sodium

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

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

3. How to take Doxazosina Viatris Pharmaceuticals

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults including elderly patients

High blood pressure

The usual starting 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 intervals of 1–2 weeks until the desired blood pressure is achieved. The maximum daily dose is 16 mg. Your doctor may prescribe other medications to be taken together with Doxazosina Viatris Pharmaceuticals.

Benign prostatic hyperplasia

The usual starting dose is 1 mg of doxazosin once daily. 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, at approximately the same time each day.

If you take more Doxazosina Viatris Pharmaceuticals than you should

Contact your doctor or the nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose include headache, dizziness, confusion, fainting, difficulty breathing, low blood pressure, palpitations (feeling your heartbeat), rapid heartbeat, irregular heartbeat, 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 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 forgotten doses.

If you stop taking Doxazosina Viatris Pharmaceuticals

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

STOP taking doxazosin and call an ambulance immediately 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 the arms or legs, or speech problems, which could be symptoms of a stroke.
• Swelling of the face, tongue, or throat, which may be due to an allergic reaction to this medicine.

Seek medical advice immediately if 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.

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

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

Other possible adverse effects:

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

• Dizziness.
• Headache.
• Respiratory tract infection (nose, throat, lungs).
• Urinary tract infection.
• Feeling dizzy or of spinning (vertigo).
• Drowsiness.
• Weakness.
• Dizzy feeling.
• Feeling of indifference or lack of interest.
• Swelling of the ankles.
• Low blood pressure or drop in blood pressure when standing up after sitting or lying down.
• Chest pain.
• Increased heart rate.
• Awareness of heartbeat (palpitations).
• Lightheadedness.
• Back pain.
• Muscle pain.
• Abdominal (stomach) pain.
• Dry mouth.
• Indigestion.
• Bronchitis.
• Cough.
• Itching.
• Difficulty breathing.
• Nasal congestion.
• Runny nose.
• Delayed ejaculation.
• Bladder infection.
• Urinary incontinence (inability to control urine passage).
• Difficulty focusing.
• Flu-like symptoms.

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

• Tremor.
• Feeling of anxiety.
• Loss or increase in appetite.
• Difficulty sleeping.
• Feeling nervous.
• Diarrhea.
• Swelling of the face and body.
• Paleness or redness of the face.
• Fever or chills.
• Cold hands and feet.
• Muscle pain.
• Constipation.
• Gas (flatulence).
• Feeling unwell.
• Inflammation of the stomach and intestines (gastroenteritis).
• Abnormal liver function tests.
• Muscle stiffness.
• Painful joint inflammation (gout).
• Joint pain (arthralgia).
• Skin rash.
• Nosebleed.
• Pain due to throat inflammation.
• Low potassium levels in the blood.
• Feeling thirsty.
• Taste disturbances.
• Restlessness.
• Depression.
• Nightmares.
• Memory loss.
• Reduced or altered sense of touch or sensitivity.
• Mood changes.
• Changes in frequency of urination.
• Blood in urine (haematuria).
• Failure/inability to achieve penile erection.
• General pain.
• Pain when urinating.
• Sensitivity of the eyes to light.
• Changes in tear production.
• Ringing in the ears (tinnitus).
• 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.
• Watery, swollen eyes (conjunctivitis).
• Increased levels of urea and creatinine in the blood.
• Reduction in red blood cells, which may cause paleness of the skin and lead to 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):

• Decreased number of white blood cells or blood platelets, increasing the risk of bleeding or bruising.
• Blurred vision.
• Worsened wheezing.
• Red, itchy skin rash.
• Increased urine volume, urinary disorder, with need to urinate during the night.
• Enlargement of male breast glands.
• Tingling, prickling, or numbness of the skin (paraesthesia).
• Dizzy feeling when standing up. This is more likely to occur at the beginning of treatment.
• Hair loss.
• Bruising due to bleeding under the skin (purpura).
• Hot flushes.
• Tiredness and malaise (feeling unwell).

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

• Intraoperative floppy iris syndrome (IFIS).
• Taste disturbances.
• Retrograde ejaculation (little or no semen release during sexual climax, cloudy urine after sexual climax).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxazosina Viatris Pharmaceuticals

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

Do not use this medicine after the expiry date stated on the packaging after EXP or CAD. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Doxazosina Viatris Pharmaceuticals

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

What Doxazosina Viatris Pharmaceuticals looks like and contents of the pack

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

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

Only some pack sizes may be commercially available.

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

Further information on this medicinal product is available upon request to 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 European Economic Area member states under the following names:

Germany: Doxazosin dura 4 mg Tabletten
Austria: Doxazosin “Arcana” 4 mg Tabletten
Spain: Doxazosina Viatris Pharmaceuticals 4 mg tablets EFG

Date of the most recent review of this leaflet: May 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) at: https://www.aemps.gob.es/