Package Insert: Information for the Patient

Doxazosina Neo Sandoz 8 mg Extended-Release Tablets EFG

doxazosina

Read this package insert carefully before you start taking this medicine, because it contains important information for you..

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Your doctor may have prescribed Doxazosina Neo Sandoz because you have high blood pressure, which can increase your risk of suffering from heart disease or a stroke if left untreated. The active ingredient in the tablets, doxazosina, belongs to a group of medicines called 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.

It is also possible that you have been prescribed Doxazosina Neo Sandoz for the treatment of 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 Neo Sandoz works by relaxing the muscles around the exit of the bladder and the prostate gland, making it easier to empty the bladder.

Do not take Doxazosina Neo Sandoz

• if you are allergic to doxazosina, quinazolines (e.g., prazosina or terazosina), or any of the other ingredients of this medication (listed in section 6).
• if you have low blood pressure or have 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 for the treatment of the symptoms of benign prostatic hyperplasia (BPH) and have low blood pressure.
• if you have urinary retention or are unable to urinate with or without an increase in renal function deterioration.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxazosina Neo Sandoz:

• if you have any acute heart disease, such as heart failure or pulmonary edema (fluid buildup in the lungs).
• if you have any liver disease. In cases of severe liver disease, the use of doxazosina is not recommended.
• if you are also taking medications used to treat erectile dysfunction (PDE-5 inhibitors, e.g., sildenafilo, tadalafilo, vardenafilo) (see section "Other medications and Doxazosina Neo Sandoz").
• if you are to undergo eye surgery due to cataracts (clouding of the lens), inform your ophthalmologist before the operation that you are taking or have taken doxazosina previously. This is because doxazosina may cause complications during surgery, which can be managed if your specialist has been informed.

Be especially careful 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 cause injury if these symptoms occur. If you feel dizzy or faint, lie down and the symptoms should disappear quickly.

In some cases, you may observe something that resembles a tablet in your stool. This is normal.The active ingredientof the prolonged-release tabletsis contained in anon-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.

Rarely, prolonged and sometimes painful erections may occur. If you have an erection that lasts more than 4 hours, contact your doctor immediately.

Before starting treatment with doxazosina for the treatment of benign prostatic hyperplasia, your doctor may perform tests to rule out other conditions, such as prostate cancer, which may cause the same symptoms as benign prostatic hyperplasia.

Consult your doctor or pharmacist if you have any doubts.

Other medications and Doxazosina Neo Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to takeany other medication, including those purchased without a prescription.Inform your doctor particularly if you are taking any of the following medications:

• Medications used to treat erectile dysfunction (e.g., sildenafilo, tadalafilo, or vardenafilo). Together with doxazosina, they may lower your blood pressure. Certain patients may experience dizziness or lightheadedness caused by low blood pressure when standing up or sitting quickly. To reduce the likelihood of these symptoms, take a daily regular dose of Doxazosina Neo Sandoz before starting treatment with medications for erectile dysfunction (impotence). Also, start your treatment with erectile dysfunction medications at the lowest dose, and take it at least 6 hours after taking Doxazosina Neo Sandoz.
• Other alpha-blockers and other medications used to treat high blood pressure.
• Medications used to treat bacterial or fungal infections, e.g., claritromicina, itraconazol, ketoconazol, telitromicina, voriconazol.
• Medications used to treat HIV, e.g., indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodona, a medication used to treat depression.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Do not take Doxazosina Neo Sandoz without first speaking with your doctor if you are pregnant or trying to become pregnant. The safety of this medication in pregnancy is not sufficiently established.

Small amounts of doxazosina, the active ingredient of this medication, may pass into breast milk. Do not use this medication during breastfeeding unless your doctor advises you to do so.

Driving and operating machinery

Be careful if you drive or operate machinery. Your ability to perform activities such as operating machinery or driving may be impaired, especially at the beginning of treatment with Doxazosina Neo Sandoz.You may feel weak or dizzy. If affected, do not drive or operate machinery and inform your doctor immediately.

Doxazosina Neo Sandoz contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet, which is essentially "sodium-free".

Follow exactly the administration instructionsof this medicationindicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Administration Form

Doxazosina Neo Sandoz has been manufactured in a special form to ensure 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 (preferably a glass of water). Do not chew, break, or crush them. You can take these tablets with or without food.

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

Adults

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

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

Advanced age

The usual adult dose is recommended for elderly patients.

Use in childrenand adolescents

Doxazosina Neo Sandoz is not recommended for use in patients under 18 years of age due to the absence of data on safety and efficacy.

Patients with kidney problems

Your doctor will prescribe the recommended dose for adults.

Patients with liver problems

Your doctor may reduce your dose or monitor your condition closely. Doxazosina is not recommended for use in patients with severe liver problems (see section “Warnings and precautions).

If you take more Doxazosina Neo Sandoz 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.If you have taken too many tablets, you may experience dizziness or drowsiness due to decreased blood pressure. Lie down with your feet higher than your head.

In case 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 Sandoz

If you forget to take a dose, do not worry. Skip the missed dose and continue taking your dose at the usual time.Do not take a double dose to make up for the missed dose..

If you interrupt treatment with Doxazosina Neo Sandoz

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

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

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

Some side effects could be serious:

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

• allergic reactions such as sneezing, difficulty breathing, extreme dizziness or fainting, swelling of the face or throat, or a severe skin rash with red patches or blisters (may affect up to 1 in 100 people),
• chest pain (angina; may affect up to 1 in 100 people), increased heart rate or irregular heartbeat (may affect up to 1 in 10 people), heart attack or myocardial infarction (may affect up to 1 in 100 people),
• yellowing of the skin or white of the eyes (jaundice), itching, loss of appetite, and pale-colored urine, caused by liver problems (may affect up to 1 in 10,000 people),
• unusual bleeding or bruising caused by low platelet count (may affect up to 1 in 10,000 people).
• persistent painful erection of the penis (may affect up to 1 in 10,000 people).

Other side effects:

Frequent(may affect up to 1 in 10 people)

• palpitations (strong heartbeat),
• dizziness, headache, drowsiness,
• sensation of spinning,
• inflammation of the respiratory tract (bronchitis), cough, difficulty breathing (dyspnea), rhinitis (itching, nasal discharge, and nasal congestion),
• abdominal pain, indigestion (dyspepsia), dry mouth, nausea,
• painful and frequent urination,
• itching,
• back pain, muscle pain,
• lung infection (respiratory tract infection), kidney or bladder infection (urinary tract infection),
• low blood pressure, sudden drop in blood pressure when standing that may cause dizziness, fainting, or fainting,
• weakness, flu-like symptoms, chest pain, swelling, especially of the feet and lower extremities (edema).

Infrequent(may affect up to 1 in 100 people)

• weight gain,
• reduced senses, fainting, tremors,
• ringing in the ears (tinnitus),
• nosebleeds,
• constipation, diarrhea, gas, vomiting, inflammation of the stomach and intestines (gastroenteritis),
• difficulty and pain urinating, blood in the urine, increased frequency of urination,
• skin rash,
• joint pain and stiffness (arthralgia),
• increased or decreased appetite,
• gout (painful form of arthritis),
• swelling, especially of the face (facial edema),
• altered liver function tests,
• difficulty achieving an erection,
• anxiety, depression, difficulty sleeping.

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

• obstruction of the digestive tract.

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

• slowing of the heartbeat,
• decrease in the number of certain blood cells (leucopenia),
• sensation of tingling with numbness,
• blurred vision,
• narrowing of the respiratory tract with difficulty breathing or wheezing (bronchospasm),
• problems urinating, increased need to urinate, increased need to urinate at night, increased production and volume of urine,
• hair loss, purple-colored patches on the skin, skin rash,
• muscle cramps, muscle weakness,
• seizures,
• fatigue, general malaise,
• obstruction of bile excretion from the liver (cholestasis), inflammation of the liver (hepatitis),
• enlargement of the breasts in men,,
• agitation, nervousness.

Frequency unknown(cannot be estimated from available data):

• complications during cataract surgery (intraoperative floppy iris syndrome) (see "Warnings and precautions"),
• entry of semen into the bladder during ejaculation (retrograde ejaculation, "orgasm without ejaculation").

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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://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 blister pack and on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does notrequire special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Doxazosina Neo Sandoz Composition

The active ingredient is doxazosin (as mesilate).

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

The other components are:

polyethylene oxide (PM 900,000), polyethylene oxide (PM 200,000), microcrystalline cellulose, povidone (K29-32), butylhydroxytoluene (E321), all-rac-α-tocopherol, anhydrous colloidal silica, fumarate of stearic acid and sodium, copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, hydrated colloidal silica, macrogol 1300-1600, titanium dioxide (E171).

Product appearance and packaging contents

White, round, biconvex tablets with the inscription “DH” on one face.

The tablets are packaged in PVC/PVDC/aluminum blisters within a cardboard box.

Packaging sizes:

7, 10, 14, 15, 28, 30, 50, 56, 60, 98, 100 prolonged-release tablets.

Calendarized packaging: 7, 14, 28, 56, and 98 prolonged-release tablets.

Single-dose packaging: 50 x 1 prolonged-release tablets.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

NetherlandsDoxazosine Sandoz retard 8 mg tablets with prolonged release

PortugalDosazosina Sandoz

Last review date of this leaflet::04/2024

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.gob.es/