DOXAZOSIN NEO SANDOZ 8 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Doxazosina Neo Sandoz

Do not take Doxazosina Neo Sandoz

• if you are allergic to doxazosina, 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 a sitting or lying position.
• 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 a blockage of the digestive tract.
  • if you are taking this medicine for the treatment of symptoms of benign prostatic hyperplasia (BPH) and you have low blood pressure.
  • if you have urinary retention or do not produce urine with or without an increase in kidney 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 deposits 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 medicines used to treat erection problems (PDE-5 inhibitors, e.g. sildenafil, tadalafil, vardenafil) (see section "Other medicines and Doxazosina Neo Sandoz").
• if you are going to undergo eye surgery due to a cataract (clouding of the lens), inform your ophthalmologist before the operation that you are taking or have previously taken doxazosina. This is because doxazosina can cause complications during surgery, which can be managed if your specialist has been informed.

Be careful when starting 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.

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.

Rarely, prolonged and sometimes painful erections may occur. If you have an erection that lasts more than 4 hours, you should 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 can cause the same symptoms as benign prostatic hyperplasia.

Consult your doctor or pharmacist if you have any doubts.

Other medicines and Doxazosina Neo Sandoz

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

• Medicines used to treat erection problems (e.g. sildenafil, tadalafil or vardenafil). Together with doxazosina, they can lower your blood pressure. Certain patients may experience dizziness or lightheadedness caused by low blood pressure when sitting or standing up quickly. In order to reduce the likelihood of these symptoms, you should take a regular daily dose of Doxazosina Neo Sandoz before starting to take medicines for erectile dysfunction (impotence). You should also start your treatment with medicines for erectile dysfunction at the lowest dose, and you should take it at least 6 hours after taking Doxazosina Neo Sandoz.
• Other alpha-blockers and other medicines used to treat high blood pressure.
• Medicines to treat bacterial or fungal infections, e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used to treat HIV, e.g. indinavir, nelfinavir, ritonavir, 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.

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

Small amounts of doxazosina, the active substance of this medicine, may pass into breast milk. You should not use this medicine during breastfeeding unless your doctor advises you to.

Driving and using machines

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

Doxazosina Neo Sandoz contains sodium

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

3. How to take Doxazosina Neo Sandoz

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Method of administration

Doxazosina Neo Sandoz has been specially formulated to release the active substance slowly throughout the day. Choose a time of day that suits you and always take the tablets at that time. The tablets should be swallowed whole with a sufficient amount of liquid (preferably a glass of water). They should not be chewed, broken, or crushed. 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 4 mg of doxazosina per day, although your doctor may increase the dose to a maximum of 8 mg of doxazosina (one tablet) per day.

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

Elderly

The usual dose in adults is recommended for elderly patients.

Use in children and adolescents

Doxazosina Neo Sandoz is not recommended for use in patients under 18 years of age due to the lack 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 the dose or monitor you 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 medicine by mistake, call your doctor immediately. If you have taken too many tablets, you may experience dizziness or fainting due to a drop in blood pressure. Lie down with your feet up, higher than your head.

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 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 missed doses.

If you stop taking Doxazosina Neo Sandoz

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

If you have any further questions on the use of this product, 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 and inform your doctor immediately or go to the casualty department of the nearest hospital:

• 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 up to 1 in 100 people).
• chest pain (angina pectoris; 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 the whites of the eyes (jaundice), itching, loss of appetite, and pale 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).
• painful and prolonged erection of the penis (may affect up to 1 in 10,000 people).

Other side effects:

Common(may affect up to 1 in 10 people)

• palpitations (strong heartbeat),
• dizziness, headache, drowsiness.
• feeling that 'the head is spinning',
• inflammation of the respiratory tract (bronchitis), cough, difficulty breathing (dyspnoea), 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 (infection of the respiratory tract), kidney or bladder infection (urinary tract infection),
• low blood pressure, sudden drop in blood pressure when standing up, which can cause dizziness, lightheadedness, or fainting.
• weakness, flu-like symptoms, chest pain, swelling especially of the feet and lower limbs (edema).

Uncommon(may affect up to 1 in 100 people)

• weight gain.
• reduced senses, fainting, tremors.
• ringing in the ears (tinnitus),
• nasal bleeding.
• constipation, diarrhea, gas, vomiting, inflammation of the stomach and intestine (gastroenteritis),
• difficulty and pain when urinating, blood in the urine, increased frequency of urination.
• skin rash.
• joint pain and stiffness (arthralgia),
• increased or decreased appetite.
• gout (a painful form of arthritis),
• pain, swelling especially of the face (facial edema),
• abnormal liver function tests.
• impotence.
• 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 10,000 people):

• slow heart rate.
• decrease in the number of certain blood cells (leucopenia),
• tingling sensation with numbness.
• blurred vision.
• narrowing of the airways with difficulty breathing or wheezing (bronchospasm),
• urination problems, increased need to urinate, increased need to urinate at night, increased urine production and volume.
• hair loss, purple spots on the skin, skin rash.
• muscle cramps, muscle weakness.
• hot flashes.
• fatigue, general malaise.
• obstruction of bile flow from the liver (cholestasis), liver inflammation (hepatitis),
• breast enlargement in men.
• agitation, nervousness.

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

• complications during cataract surgery (intraoperative floppy iris syndrome) (see section "Warnings and precautions").
• entry of semen into the bladder during ejaculation (retrograde ejaculation, "orgasm without 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 via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxazosina Neo Sandoz

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 blister and on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does notrequire any special storage conditions.

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

6. Contents of the pack and further information

Composition of Doxazosina Neo Sandoz

The active substance is doxazosina (as mesylate).

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

The other ingredients are:

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

Appearance and packaging

White, round, and biconvex tablets with the inscription "DH" on one side.

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

Package sizes:

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

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

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

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 under the following names:

Netherlands Doxazosine Sandoz retard 8 mg tabletten met verlengde afgifte

Portugal Dosazosina Sandoz

Date of last revision of this leaflet: 04/2024

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.gob.es/