Doxazosin Neo Viatris 8 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Doxazosina NEO Viatris 8 mg prolonged-release tablets EFG

Read the entire leaflet carefully before starting to take this medicine, as 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, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Doxazosina NEO Viatris is and what it is used for
2. What you need to know before taking Doxazosina NEO Viatris
3. How to take Doxazosina NEO Viatris
4. Possible side effects
5. How to store Doxazosina NEO Viatris
6. Contents of the pack and other information

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

Your doctor may have prescribed Doxazosina NEO Viatris because you have high blood pressure, which could increase your risk of heart disease or stroke if left untreated. The active substance in the tablets, doxazosin, belongs to a group of medicines called alpha-1 blockers. These medicines work by widening the blood vessels, making it easier for the heart to pump blood through them. This helps lower high blood pressure and reduces the risk of heart disease.

Additionally, your doctor may have prescribed Doxazosina NEO Viatris to treat the symptoms of benign enlargement of the prostate gland (benign prostatic hyperplasia, BPH). This condition means that the prostate, a gland 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 outlet of the bladder and the prostate gland, thus making it easier to empty the bladder.

Doxazosin may also be approved for the treatment of other conditions not listed in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

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

Do not take Doxazosina NEO Viatris

• If you are allergic to doxazosin, to other quinazolines (for example, prazosin or terazosin), or to any of the other ingredients of this medicine (listed in section 6).
• If you have low blood pressure or have ever experienced a drop in blood pressure causing dizziness or fainting upon standing up from a sitting or lying position.
• If you have benign prostatic enlargement and, at the same time, an obstruction of the upper urinary tract, chronic urinary infection, or bladder stones.
• If you have or have had an obstruction of the digestive tract, stomach, or intestine (gastrointestinal tract).
• If you are taking this medicine to treat hypertension and are breastfeeding.
• If you have low blood pressure.
• If you have overflow incontinence (you do not sense or are unable to control urine release) or your body does not produce urine, regardless of whether you have kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before starting Doxazosina NEO Viatris

• If you have heart problems.
• If you have liver problems.
• If you have changes in bowel habits or have undergone intestinal or gastrointestinal surgery, as this may affect how your body absorbs the medicine.

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

During treatment

When you start taking Doxazosina NEO Viatris, you may feel dizzy, weak, or feel like you might lose consciousness when standing up after sitting or lying down. If you feel dizzy or like you might faint, sit or lie down until you feel better, and avoid situations where you could fall or get injured. Your doctor may want to monitor your blood pressure regularly when you start taking this medicine to reduce the likelihood of these effects.

If you are scheduled for cataract surgery (clouding of the lens), you must inform your ophthalmologist that you are currently taking or have previously taken doxazosin. This is because doxazosin could cause complications during surgery, which the specialist can manage if prepared in advance.

Very rarely, prolonged and painful erections may occur. If this happens, you must contact your doctor immediately.

If you are undergoing a blood or urine test, tell your doctor or nurse that you are taking Doxazosina NEO Viatris. This medicine may affect the results of certain tests.

Occasionally, you may notice something in your stool that looks like a tablet. This is normal. The active ingredient in the prolonged-release tablets is contained within a non-absorbable shell, specifically designed to slowly release the medicine into the body. Once the process is complete, the empty shell is eliminated from the body in the stool.

Talk to your doctor or pharmacist if you have any doubts.

Children and adolescents

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

Other medicines and Doxazosina NEO Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Specifically inform your doctor if you are taking:

• Other alpha-blockers and other medicines used to treat high blood pressure.
• Medicines called phosphodiesterase inhibitors (PDE) (e.g., sildenafil, tadalafil, vardenafil), used to treat erectile dysfunction. You should have taken a daily dose of doxazosin before starting these medicines; you may be started on a low dose, and you should wait approximately 6 hours after taking doxazosin before taking a phosphodiesterase inhibitor.
• Non-steroidal anti-inflammatory drugs (NSAIDs), for example, ibuprofen.
• Estrogens (female sex hormone).
• Dopamine, ephedrine, epinephrine (adrenaline), metaraminol, methoxamine, phenylephrine (medicines known as sympathomimetics, used, for example, to treat heart disorders, low blood pressure, asthma, and nasal congestion).
  • Medicines for the treatment of bacterial or fungal infections (e.g., clarithromycin, itraconazole, ketoconazole, telithromycin, or voriconazole).
  • Medicines for the treatment of HIV (e.g., indinavir, nelfinavir, ritonavir, or 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 using this medicine.

This information applies only to patients taking Doxazosina NEO Viatris for the treatment of high blood pressure.

Pregnancy

Do not take Doxazosina NEO Viatris without first speaking to your doctor if you are pregnant or trying to become pregnant. Experience with the use of doxazosin during pregnancy is limited.

Breastfeeding

Do not take Doxazosina NEO Viatris if you are breastfeeding.

Alternatively, you must stop breastfeeding if treatment with doxazosin is necessary.

Driving and using machines

Doxazosina NEO Viatris may cause drowsiness. Exercise particular caution when taking the first dose, when your dose is increased, or when restarting this medicine after a break. If you feel dizzy or lightheaded, you must not drive or operate machinery.

It is your responsibility to assess whether you are fit to drive or perform tasks requiring a high level of alertness. One factor that may affect your ability to do so is the use of medicines, due to their effects and/or side effects. These effects and adverse reactions are described in other sections. Therefore, read all the information in this leaflet carefully for guidance. Consult your doctor or pharmacist if you have any doubts.

Doxazosina NEO Viatris contains sodium

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

3. How to take Doxazosina NEO Viatris

Always follow exactly the instructions for use of this medicine as given by your doctor. If in 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 doxazosin is 4 mg of doxazosin daily, although your doctor may increase your dose up to a maximum of 8 mg of doxazosin (one tablet) per day.

The maximum recommended dose is 8 mg of doxazosin once daily. 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 doxazosin if you have severe liver problems.

How to take the medicine

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

If you take more Doxazosina NEO Viatris than you should

If you take too many tablets or, for example, a child accidentally takes the medicine, contact your doctor or the hospital emergency department immediately and lie down on your back. You may experience headaches, dizziness, fainting, lightheadedness, loss of consciousness, difficulty breathing, low blood pressure, pounding heartbeat (palpitations), irregular or rapid heartbeat, feeling unwell (nausea), discomfort (vomiting), or low levels of blood or potassium in the blood.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Doxazosina NEO Viatris

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

If you stop taking Doxazosina NEO Viatris

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

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 will experience them.

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

Uncommon (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, swelling of the face, mouth, lips, tongue or throat, or a severe skin rash with itching, spots or blisters.

• Sudden numbness or weakness in the arms, legs or face, sudden severe headache, dizziness or confusion, vision or speech problems. These are signs of reduced blood flow to the brain caused by a blood clot or hemorrhage (stroke).

• Feeling of heaviness or pressure in the chest with chest pain and increasingly difficult breathing during exercise (these signs could indicate heart problems, such as angina pectoris).

• Sudden chest pain that may spread to the neck or arm, along with difficulty breathing and a sensation of warmth (these signs could indicate a heart attack or other heart problems).

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

• Swelling, pain or stomach cramps, gas, bad breath, constipation, diarrhea, vomiting or feeling full. These signs could indicate gastrointestinal obstruction.

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

• Yellowing of the skin or whites of the eyes (jaundice), feeling unwell (nausea), loss of appetite, itching, darkening of the urine. These symptoms could indicate serious liver problems.
• Increased number of infections, causing fever, severe chills, mouth ulcers, sore throat or lower respiratory tract infections. These signs could indicate low levels of white blood cells.
• Persistent and painful erection of the penis. Consult a doctor urgently.

Other possible adverse effects may include:

Frequent (may affect up to 1 in 10 people)

• Palpitations (strong heartbeat), rapid heartbeat (tachycardia).
• Dizziness, headache, drowsiness.
• Feeling dizzy or that ‘the head is spinning’ (vertigo).
• Inflammation of the respiratory tract (bronchitis), cough, difficulty breathing (dyspnea), itching, runny and congested nose, sneezing, facial pain or pressure (rhinitis).
• Abdominal discomfort, indigestion (dyspepsia), dry mouth, feeling dizzy (nausea).
• Inflammation of the bladder (cystitis), uncontrolled urination.
• Itching of the skin.
• Inability to achieve an erection.
• Back pain, muscle pain.
• Infection of the nose, throat and lungs (respiratory tract infection), infection of the kidneys or bladder (urinary tract infection).
• Low blood pressure, sudden drop in blood pressure upon standing.
• Weakness, flu-like symptoms, swelling, especially of the feet and lower limbs (edema).

Uncommon (may affect up to 1 in 100 people)

• Weight gain.

• Reduced sensation or sensitivity, especially of the skin, fainting, tremor.

• Ringing in the ears (tinnitus).

• Nosebleeds (epistaxis).

• Constipation, diarrhea, gas, vomiting, inflammation of the stomach and intestine.

• Pain when urinating, blood in the urine, increased frequency of urination.

• Skin rash.

• Pain and stiffness in the joints (arthralgia).

• Increased appetite, loss of appetite, gout (joint disease with swollen and painful joints).

• Pain, swelling, especially of the face (facial edema).

• Abnormal liver function tests.

• Nervousness (anxiety), depression, difficulty sleeping (insomnia).

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

• Slowing of the heartbeat (bradycardia), irregular heartbeat (arrhythmia).
• Appearance of bruises without reason and bleeding more easily or for longer than normal. These could be signs of low platelet count (thrombocytopenia).
• Dizziness upon standing, tingling sensation with numbness.
• Blurred vision.
• Narrowing of the airways with difficulty breathing or wheezing (bronchospasm).
• Problems urinating, increased need to urinate at night, increased production and volume of urine.
• Hair loss, unusual bleeding or bruising under the skin, hives.
• Muscle cramps, muscle weakness.
• Hot flushes.
• Fatigue, general malaise.
• Breast enlargement in men.
• Restlessness, nervousness.

Frequency not known (cannot be estimated from available data)

• Complications (intraoperative floppy iris syndrome) during cataract surgery (see section 2: "Warnings and precautions").
• Little or no semen produced during ejaculation (retrograde ejaculation).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet.

You can also report them directly via the Spanish System of Pharmacovigilance 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 Doxazosin NEO Viatris

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Doxazosina NEO Viatris

The active substance is doxazosin. Each prolonged-release tablet contains 8 mg of doxazosin (as doxazosin mesylate).

The other components are:

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

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

Appearance of the product and contents of the pack

Doxazosina NEO Viatris tablets are white, round, biconvex tablets with the imprint “DH” on one side.

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

Only certain 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

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

For further information about this medicinal product, please contact 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 (EEA) under the following names:

Spain: Doxazosina NEO Viatris 8 mg prolonged-release tablets EFG
France: DOXAZOSINE MYLAN LP 8 mg, comprimé à libération prolongée
Netherlands: Doxazosine Retard Mylan 8 mg, tabletten met verlengde afgifte
Portugal: Doxazosina Mylan

Date of the most recent review of this leaflet: January 2020

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