DOXAZOSIN NEO STADA 8 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Doxazosina Neo Stada 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 package leaflet:

1. What is Doxazosina Neo Stada and what is it used for
2. What you need to know before you take Doxazosina Neo Stada
3. How to take Doxazosina Neo Stada
4. Possible side effects
5. Storage of Doxazosina Neo Stada
6. Contents of the pack and further information

1. What is Doxazosina Neo Stada and what is it used for

Your doctor may have prescribed doxazosin for you 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 known as 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.

Also, you may have been prescribed doxazosin 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 works by relaxing the muscles around the bladder outlet and the prostate gland, making it easier to empty the bladder.

Doxazosin, which is in Doxazosina Neo Stada, may be authorized to treat other conditions that are 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 Doxazosina Neo Stada

Do not take Doxazosina Neo Stada:

• If you are allergic to doxazosin 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 infection, or stones in the bladder.
• If you have a blockage of the digestive tract.
• If you are taking this medicine to treat high blood pressure and you are breastfeeding.
• If you are taking this medicine to treat the symptoms of BPH and you have low blood pressure.
• If you have urinary incontinence due to overflow or do not produce urine with or without an increase in kidney function deterioration.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Doxazosina Neo Stada.

• At the start of treatment, you may feel a drop in blood pressure accompanied by dizziness, weakness, and, in rare cases, fainting. Avoid any situation that may lead to injury if you experience these symptoms.
• If you have any acute heart disease, such as heart failure.
• If you have any liver disease. In cases of severe liver disease, the use of doxazosin is not recommended.
• If you are also taking medicines used to treat erection problems (PDE-5 inhibitors, e.g., sildenafil, tadalafil, vardenafil), as they may cause a significant decrease in blood pressure. This is likely to occur shortly after taking the PDE-5 inhibitor. This means that treatment with doxazosin should be established before starting treatment with PDE-5 inhibitors. Your doctor may consider using a lower initial dose of the PDE-5 inhibitor.
• Before starting treatment with doxazosin, your doctor may perform tests to rule out other diseases such as prostate cancer that may cause the same symptoms as BPH.
• If you are going to undergo eye surgery for cataracts (clouding of the lens), you should inform your ophthalmologist that you are taking or have taken doxazosin before. This is because doxazosin may cause complications during surgery, which can be treated if this information is communicated to the specialist.

Sometimes 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.

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

Children and adolescents

Doxazosin is not recommended for use in children and/or adolescents under 18 years of age as its safety and efficacy have not been established yet.

Other medicines and Doxazosina Neo Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some patients who use alpha-blockers for the treatment of high blood pressure or prostate enlargement may feel dizzy or lightheaded, which may be due to a drop in blood pressure when standing up or getting up quickly. Some patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) with alpha-blockers. In order to reduce the likelihood of experiencing these symptoms, you should take a regular daily dose of the alpha-blocker before starting the medication for erectile dysfunction.

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription. Tell your doctor in particular if you are taking any of the following medicines:

• Other alpha-blockers and other medicines used to treat high blood pressure.
• Non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen.
• Estrogens (female sex hormone).
• Dopamine, ephedrine, adrenaline, metaraminol, methoxamine, phenylephrine (medicines known as sympathomimetics and used, for example, to treat heart disorders, low blood pressure, asthma, and nasal congestion).
• Medicines used to treat bacterial or fungal infections, for example, clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used to treat HIV, for example, indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.

Taking Doxazosina Neo Stada with food and drinks

Doxazosin can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Only for the indication of hypertension:

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.

Do not take doxazosin without talking to your doctor first if you are pregnant or trying to become pregnant.

Experience with the use of doxazosin during pregnancy is limited.

Do not take doxazosin if you are breastfeeding. Alternatively, you should stop breastfeeding when treatment with doxazosin is necessary.

No effects of doxazosin on reproduction in males have been described.

Driving and using machines

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

It is your responsibility to evaluate whether you are in a fit state to drive or perform work that requires a high level of alertness. One of the factors that can affect your ability in this respect is the use of medicines, due to their effects and/or side effects. These effects and side effects are described in other sections of this leaflet. Therefore, read all of this leaflet carefully to inform yourself. Talk to your doctor or pharmacist if you have any doubts.

Doxazosina Neo Stada contains sodium

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

3. How to take Doxazosina Neo Stada

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

Method of administration

Doxazosin 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 a sufficient amount of liquid. They should not be chewed, broken, or crushed.

Treatment of high blood pressure and symptoms of benign prostatic hyperplasia:

Adults (including elderly patients)

The recommended dose of doxazosin is 4 mg per day, 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 per day. The optimal effect may take up to four weeks to achieve.

Patient with liver problems

Your doctor may reduce your dose or monitor your progress more closely. Doxazosin is not recommended for use in patients with severe liver problems.

If you take more Doxazosina Neo Stada than you should

If you take too many tablets or if, for example, a child has taken the medicine by mistake, call your doctor or go to the hospital emergency department immediately. If you have taken too many tablets, you may feel dizzy or lightheaded due to a drop in blood pressure. Lie down on your back with your feet raised higher than your head.

In cases 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 ingested.

If you forget to take Doxazosina Neo Stada

If you forget to take a dose, do not worry. Simply take the dose the next day at the usual time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Doxazosina Neo Stada

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

If you have any doubts 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.

Some of the side effects could be serious:

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

• Allergic reactions such as wheezing, difficulty breathing, extreme dizziness, or fainting, swelling of the face or throat, or a severe skin rash with red spots or blisters (may affect between 1 and 10 in 1,000 people).
• Chest pain (angina pectoris; may affect between 1 and 10 in 1,000 people), increased heart rate or irregular heartbeat (may affect less than 1 in 10,000 people), heart attack or myocardial infarction (may affect between 1 and 10 in 1,000 people).
• Yellowing of the skin or the whites of the eyes (jaundice), caused by liver problems (may affect less than 1 in 10,000 people).

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

• Palpitations (strong heartbeat), increased heart rate.
• Dizziness, headache, drowsiness.
• Feeling of dizziness or that “the head is spinning”.
• Inflammation of the respiratory tract (bronchitis), cough, difficulty breathing (dyspnea), rhinitis (itching, nasal discharge, and nasal congestion).
• Abdominal discomfort, stomach discomfort (dyspepsia), dry mouth, nausea.
• Inflammation of the bladder (cystitis), uncontrolled urination.
• Itching of the skin.
• Back pain, muscle pain.
• Lung infection (infection of the respiratory tract), kidney or bladder infection (urinary tract infection).
• 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.
• Reduced senses, fainting, tremors.
• Tinnitus (ringing in the ears).
• Nosebleeds.
• Constipation, diarrhea, gas, vomiting, inflammation of the stomach and intestine.
• Painful urination, blood in the urine, increased frequency of urination.
• Skin rash.
• Pain and stiffness in the joints (arthralgia).
• Increased or decreased appetite, gout (a painful form of arthritis).
• Pain, swelling especially of the face (facial edema).
• Increased liver enzyme levels.
• Impotence.
• Anxiety, depression, insomnia.

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

• Decreased heart rate.
• Decreased levels of certain blood cells (leukopenia, thrombocytopenia).
• Dizziness when standing up, tingling sensation 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, rashes.
• Muscle cramps, muscle weakness.
• Hot flashes.
• Fatigue, general malaise.
• Obstruction of bile excretion from the liver (cholestasis), liver inflammation (hepatitis).
• Enlargement of the breasts in men.
• Prolonged and painful erection of the penis. Consult a doctor urgently.
• 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”).
• Delayed ejaculation – occurs when semen is redirected to the urinary bladder instead of being ejaculated normally through the urethra.

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 national reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxazosina Neo Stada

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 EXP. The expiry date is 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. Contents of the pack and further information

Composition of Doxazosina Neo Stada

• The active substance is doxazosin (as mesylate).

Each prolonged-release tablet contains 8 mg of doxazosin (as mesylate).

• The other ingredients are:

Core of the tablet: polyethylene oxide (MW 900,000), polyethylene oxide (MW 200,000); microcrystalline cellulose, povidone (K29-32), butylhydroxytoluene (E321), all-rac-α-tocopherol, colloidal anhydrous silica, sodium stearyl fumarate.

Coating of the tablet: methacrylic acid – ethyl acrylate copolymer (1:1), 30% dispersion of hydrated colloidal silica, macrogol 1300-1600, titanium dioxide (E171).

Appearance of the product and contents of the pack

Doxazosina Neo Stada are prolonged-release tablets, white, round, biconvex, with the letters “DH” engraved on one side.

The medicine is packaged in:

PVC/PVDC/aluminum blisters of 7, 10, 14, 15, 28, 30, 50, 56, 60, 98, 100 tablets.

Calendar blisters: 7, 14, 28, 56, and 98 tablets.

Unit dose packs: 50x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

STADA ARZNEIMITTEL AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

Date of last revision of this leaflet:December 2021

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