Package Insert: Information for the User

Doxazosina Neo Stada 8 mg Extended-Release Tablets EFG

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

− Keep this package insert, as you may need to refer to it again.

− If you have any questions, consult your doctor or pharmacist.

− This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

−If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this package insert. See section 4.

1. What is Doxazosina Neo Stada and how is it used

2. What you need to know before starting to take Doxazosina Neo Stada

3. How to take Doxazosina Neo Stada

4. Possible adverse effects

5. Storage of Doxazosina Neo Stada

6. Contents of the package and additional information.

Your doctor may have prescribed doxazosina because you have high blood pressure and it may increase your risk of suffering from heart disease or a stroke if not treated. The active ingredient in the tablets, doxazosina, belongs to a group of medicines known as alpha-1 blockers. These medicines work by widening blood vessels, making it easier for the heart to pump blood through them. This helps to lower high blood pressure and reduce the risk of heart disease.

You may also have been prescribed doxazosina to treat the symptoms of benign prostatic hyperplasia (BPH). This condition means that the prostate, which is located just below the bladder in men, is enlarged. This makes it difficult to empty the bladder. Doxazosina works by relaxing the muscles around the exit of the bladder and the prostate gland, making it easier to empty the bladder.

Doxazosina, 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.

Do not take Doxazosina Neo Stada:

• If you are allergic to doxazosina or any of the other ingredients of this medication (listed in section 6).
• If you have low blood pressure or if you have ever had a drop in blood pressure that caused dizziness or fainting when standing up from a sitting or lying position.
• If you have benign prostatic hyperplasia and, at the same time, an obstruction of the upper urinary tract, chronic urinary tract infection, or bladder stones.
• If you have or have had an obstruction of the digestive tract.
• If you are taking this medication to treat hypertension and are breastfeeding.
• If you are taking this medication to treat the symptoms of benign prostatic hyperplasia (BPH) and have low blood pressure.
• If you have urinary incontinence due to overflow or do not produce urine with or without a worsening of renal function.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxazosina Neo Stada.

• At the beginning of treatment, you may experience a drop in blood pressure accompanied by dizziness, weakness, and, in rare cases, fainting. Avoid any situation that may lead to injury if these symptoms occur.
• 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 doxazosina is not recommended.
• If, in addition, you are taking medications used to treat erectile dysfunction (PDE-5 inhibitors, e.g. sildenafilo, tadalafilo, vardenafilo), 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 doxazosina treatment should be stable before starting PDE-5 inhibitor treatment. Your doctor may consider using a lower initial dose of the PDE-5 inhibitor.
• Before starting doxazosina treatment, your doctor may perform tests to rule out other diseases such as prostate cancer, which may cause the same symptoms as benign prostatic hyperplasia.
• If you are to undergo eye surgery for cataracts (opacity of the crystalline lens), you should inform your ophthalmologist that you are taking or have taken doxazosina previously. This is because doxazosina may cause complications during surgery, which can be treated if this information is communicated to the specialist.

You may occasionally observe something in the stool that resembles a tablet. This is normal. The active ingredient of the prolonged-release tablets is contained in a non-absorbable coating, which is specially designed to slowly release the medication in 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

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

Other medications and Doxazosina Neo Stada

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication.

Some patients using alpha-blockers for the treatment of high blood pressure or benign prostatic hyperplasia may feel dizzy or disoriented, which may be due to a drop in blood pressure when standing up quickly. Some patients have experienced these symptoms when taking medications for erectile dysfunction (impotence) with alpha-blockers. To reduce the likelihood of these symptoms, you should take a regular daily dose of the alpha-blocker before starting the erectile dysfunction medication.

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

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

Taking Doxazosina Neo Stada with food and drinks

Doxazosina can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Only for the indication of hypertension:

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

The experience with the use of doxazosina during pregnancy is limited.

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

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

Driving and operating machinery

Doxazosina may cause drowsiness. Be especially careful when taking the first dose, if your dose is increased, or if you restart the medication after a break. If you feel dizzy or disoriented, do not drive or operate machinery.

It is your responsibility to evaluate whether you are capable of driving or performing tasks that require a high level of alertness. One of the factors that may affect your ability in this regard is the use of medications, due to their effects and/or adverse effects. In other sections, these effects and adverse effects are described. Therefore, read the entire information in this leaflet to guide you. Consult your doctor or pharmacist if you have any doubts.

Doxazosina Neo Stada contains sodium

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

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

Administration Form

Doxazosina has been formulated in a special way to allow for slow release of the active ingredient throughout the day. Choose a time of day that is convenient for you and take the tablets at the same time every day. The tablets should be swallowed whole with sufficient liquid. They should not be chewed, broken, or crushed.

Treatment of High Blood Pressure and Benign Prostatic Hyperplasia Symptoms:

Adults (including elderly patients)

The recommended dose of doxazosina is 4 mg per day, although your doctor may increase your dose up to a maximum of 8 mg of doxazosina (one tablet) per day.

The maximum recommended dose is 8 mg of doxazosina once a day. Optimal effect may take up to four weeks to achieve.

Patients with Liver Problems

Your doctor may reduce your dose or monitor your condition more closely. Doxazosina 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 medication by mistake, call your doctor immediately or go to the hospital emergency department immediately. If you have taken too many tablets, you may experience dizziness or drowsiness due to decreased blood pressure. Lie down on your back with your feet higher than your head.

In cases of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication 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 the missed dose.

If You Interrupt Treatment with Doxazosina Neo Stada

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

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some of the side effects could be serious:

If any of the following side effects appear, stop taking this medicine, inform your doctor immediately or go to the nearest hospital emergency service:

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

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

• Palpitations (strong heartbeat), increased heart rate.
• Dizziness, headache, drowsiness.
• Sensation of dizziness or feeling like "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 skin.
• Back pain, muscle pain.
• Pulmonary infection (respiratory tract infection), 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 extremities (edema).

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

• Weight gain.
• Reduced senses, fainting, trembling.
• Tinnitus (ringing in the ears).
• Nasal bleeding.
• Constipation, diarrhea, gas, vomiting, inflammation of the stomach and intestines.
• Painful urination, blood in the urine, increased frequency of urination.
• Skin rash.
• Joint pain and stiffness (arthralgia).
• Increased or decreased appetite, gout (painful form of arthritis).
• Pain, swelling, especially of the face (facial edema).
• Increased concentration of liver enzymes.
• Impotence.
• Anxiety, depression, insomnia.

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

• Decreased heart rate.
• Decreased concentration of certain blood cells (leucopenia, thrombocytopenia).
• Dizziness when standing up, sensation of numbness with tingling.
• Blurred vision.
• Narrowing of the respiratory tract with difficulty breathing or wheezing (bronchospasm).
• Difficulty urinating, increased need to urinate at night, increased production and volume of urine.
• Hair loss, unusual bleeding or hematomas under the skin, rashes.
• Muscle cramps, muscle weakness.
• Hot flashes.
• Fatigue, general malaise.
• Obstruction of bile excretion from the liver (cholestasis), inflammation of the liver (hepatitis).
• Enlargement of the breasts in men.
• Persistent and painful erection of the penis. Consult a doctor urgently.
• Agitation, nervousness.

Frequency unknown(cannot be estimated from available data):

• Complications (Intraoperative Flaccid Iris Syndrome) during cataract surgery (see section 2 "Warnings and precautions").
• Delayed ejaculation – occurs when semen is redirected to the urinary bladder instead of the normal ejaculation through the urethra.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Doxazosina Neo Stada

• The active ingredient is doxazosina (as mesilato).

Each prolonged-release tablet contains 8 mg of doxazosina (as mesilato).

• The other components are:

Tablet core : polyethylene oxide (MW 900.000), polyethylene oxide (MW 200.000); microcrystalline cellulose, povidone (K29-32), butylhydroxytoluene (E321), all-rac-α-tocopherol, anhydrous colloidal silica, sodium stearate fumarate.

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

Appearance of the product and content of the container

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

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 packaging: 50x1 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing:

STADA ARZNEIMITTEL AG

Stadastrasse 2- 18

D-61118 Bad Vilbel

Germany

Last review date of this leaflet: December 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es