DOXAZOSIN NEO VIATRIS 8 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Doxazosin NEO Viatris 8 mg prolonged-release 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 NEO Viatris and what is it used for
2. What you need to know before you take Doxazosin NEO Viatris
3. How to take Doxazosin NEO Viatris
4. Possible side effects
5. Storing Doxazosin NEO Viatris
6. Contents of the pack and other information

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

Your doctor may have prescribed Doxazosin NEO Viatris because you have high blood pressure and it may increase your risk of suffering from heart disease or stroke if left untreated. The active substance of 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 the blood that circulates through them. This helps to lower high blood pressure and reduce the risk of heart disease.

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

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

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

Do not take Doxazosin NEO Viatris

• If you are allergic to doxazosin, other quinazolines (e.g., prazosin or terazosin), or any of the other ingredients of this medicine (listed in section 6).
• If you have low blood pressure or if you have ever had a drop in blood pressure that has made you feel dizzy or faint when standing up from sitting or lying down.
• If you have benign prostatic hyperplasia and at the same time have an obstruction of the upper urinary tract, chronic urinary tract infection, or stones in the bladder.
• If you have or have had an obstruction of the digestive tract, stomach, or intestine (digestive 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 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 Doxazosin NEO Viatris

• If you have heart problems.
• If you have liver problems.
• If you have changes in bowel habits or if you have undergone intestinal or digestive tract surgery, as this may affect how you absorb the medicine.

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

During treatment

When you start taking Doxazosin NEO Viatris, you may feel dizzy, weak, or feel like you are going to lose consciousness when standing up after sitting or lying down. If you feel dizzy or like you are going to faint, sit or lie down until you feel better or avoid situations where you may fall or get hurt. Your doctor may want to check your blood pressure regularly when you start taking this medicine to reduce the possibility of these effects.

If you are going to undergo cataract surgery (clouding of the lens), you should inform your ophthalmologist that you are taking doxazosin or have taken it before. This is because doxazosin may cause complications during surgery that the specialist can treat if 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 have a urine or blood test, tell the doctor or nurse that you are taking Doxazosin NEO Viatris. This medicine may affect the results of some tests.

On occasion, you may notice something in your stool that looks like a tablet. This is normal. The active substance of the prolonged-release tablets is contained in a non-absorbable coating, which is specially designed to release the medicine slowly into 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 any doubts.

Children and adolescents

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

Other medicines and Doxazosin NEO Viatris

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

• Other alpha blockers and other medicines used to treat high blood pressure.
• Medicines called phosphodiesterase inhibitors (e.g., sildenafil, tadalafil, vardenafil), used to treat erection problems. You should take a daily dose of doxazosin before starting to use these medicines; you may be given a low dose at the beginning of treatment, and you should wait about 6 hours after taking doxazosin before starting to take a phosphodiesterase inhibitor.
• Non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen.
• Estrogens (female sex hormone).
• Dopamine, ephedrine, epinephrine (adrenaline), metaraminol, methoxamine, phenylephrine (medicines known as sympathomimetics and 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This information only applies to patients who are taking Doxazosin NEO Viatris to treat high blood pressure.

Pregnancy

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

Breastfeeding

Do not take Doxazosin NEO Viatris if you are breastfeeding.

Alternatively, you should stop breastfeeding when treatment with doxazosin is necessary.

Driving and using machines

Doxazosin NEO Viatris may cause drowsiness. Be especially careful when taking the first dose, if your dose is increased, or if you start taking this medicine again after a period of time. If you feel dizzy or drowsy, do not drive or use machines.

It is your responsibility to evaluate whether you are fit to drive or perform tasks that require a high level of alertness. One of the factors that can affect your ability to do so is the use of medicines, due to their effects and/or side effects. These effects and side effects are described in other sections. Therefore, read all the information in this leaflet to guide you. Consult your doctor or pharmacist if you have any doubts.

Doxazosin NEO Viatris contains sodium

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

3. How to take Doxazosin NEO Viatris

Follow exactly the instructions of administration of this medicine given by your doctor. If you are 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 per day, although your doctor may increase the 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 achieve.

Use in patients with liver problems

Your doctor may reduce the dose or monitor you more closely. Do not take doxazosin if you have severe liver problems.

Taking the medicine

Doxazosin NEO Viatris has been formulated in a special way so that the release of the active substance is slow throughout the day. Choose a time of day that is convenient for you and always take the tablets at that time. 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 Doxazosin NEO Viatris than you should

If you ingest too many tablets or if, for example, a child takes the medicine 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 very fast heartbeat, nausea, vomiting, or low blood sugar or potassium levels.

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

If you forget to take Doxazosin 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 forgotten doses.

If you stop taking Doxazosin NEO Viatris

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

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

4. Possible side effects

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

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

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, lumps, or blisters.
• Sudden numbness or weakness of the arms, legs, or face, severe headache, dizziness, or confusion, vision or speech problems. These are signs of a reduction in blood flow to the brain caused by a clot or bleeding (stroke).
• A feeling of pressure or heaviness in the chest with chest pain and increasingly difficult breathing when exercising (these signs could be indicative of heart problems, such as angina pectoris).

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

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

• Swelling, pain, or cramps in the stomach, gas, bad breath, constipation, diarrhea, vomiting, or feeling full. These signs could be indicative of obstruction of the digestive tract.

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

• Yellowing of the skin or the whites of the eyes (jaundice), nausea, loss of appetite, itching, dark urine. These symptoms could be indicative of severe liver problems.
• An increased number of infections, which can cause fever, chills, mouth ulcers, sore throat, or lower respiratory tract infections. These signs could be indicative of low white blood cell counts.
• Persistent and painful erections. Contact your doctor urgently.

Other possible side effects could be:

Common(may affect up to 1 in 10 people)

• Palpitations (strong heartbeat), fast heartbeat (tachycardia).
• Dizziness, headache, drowsiness.
• Feeling of dizziness or that the head is spinning (vertigo).
• Inflammation of the respiratory tract (bronchitis), cough, difficulty breathing (dyspnea), itching, nasal discharge and congestion, sneezing, facial pain or pressure (rhinitis).
• Abdominal discomfort, indigestion (dyspepsia), dry mouth, feeling of nausea.
• Inflammation of the bladder (cystitis), uncontrolled urination.
• Itching of the skin.
• Impotence.
• Back pain, muscle pain.
• Respiratory tract infection (infection of the nose, throat, and lungs), urinary tract infection (infection of the kidneys or bladder).
• Low blood pressure, sudden drop in blood pressure when standing up.
• Weakness, flu-like symptoms, swelling, especially of the feet and lower limbs (edema).

Uncommon(may affect up to 1 in 100 people)

• Weight gain.
• Decreased sensation or sensitivity, especially of the skin, fainting, tremors.
• 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 (disease with swollen and painful joints).

• Pain, swelling especially of the face (facial edema).
• Abnormal liver function tests.
• Anxiety (nervousness), depression, difficulty sleeping (insomnia).

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

• Slow heartbeat (bradycardia), irregular heartbeat (arrhythmia).
• Appearance of bruises without cause and bleeding more easily or for longer than usual. These could be signs of a low platelet count (thrombocytopenia).
• Dizziness when standing up, feeling of tingling with numbness.
• Blurred vision.
• Narrowing of the airways with difficulty breathing or wheezing (bronchospasm).
• Urination problems, 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 flashes.
• Fatigue, general malaise.
• Enlargement of the breasts in men.
• Agitation, nervousness.

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

• Complications (intraoperative floppy iris syndrome) during cataract surgery (see section 2: "Warnings and precautions").
• Production of little or no semen when ejaculating (retrograde ejaculation).

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

5. Storing Doxazosin NEO Viatris

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 and blister after CAD or EXP. The expiry date is the last day of the month shown.

This medicine doesnot 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 of Doxazosina NEO Viatris

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

The other components are:

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

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

Product Appearance and Container Content

Doxazosina NEO Viatris tablets are white, round, biconvex, and engraved with "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 pack 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

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 under the following names:

Spain Doxazosina NEO Viatris 8 mg prolonged-release tablets EFG

France DOXAZOSINE MYLAN LP 8 mg, prolonged-release tablet

Netherlands Doxazosine Retard Mylan 8 mg, prolonged-release tablets

Portugal Doxazosina Mylan

Date of the last revision of this leaflet:January 2020

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