Doxazosin Neo Sandoz 8 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Doxazosina Neo Sandoz 8 mg prolonged-release tablets EFG

doxazosin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Your doctor may have prescribed Doxazosina Neo Sandoz because you have high blood pressure, which can increase the risk of heart disease or stroke if left untreated. The active substance in the tablets, doxazosin, 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 lower high blood pressure and reduces the risk of heart disease.

Doxazosina Neo Sandoz may also have been prescribed to treat symptoms of benign enlargement of the prostate (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 outlet of the bladder and the prostate gland, making it easier to empty the bladder.

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

Do not take Doxazosina Neo Sandoz

• if you are allergic to doxazosin, to quinazolines such as prazosin or terazosin, or to any of the other ingredients of this medicine (listed in section 6),
• if you have low blood pressure or have ever experienced a drop in blood pressure causing dizziness or fainting when standing up from a sitting or lying position,
• if you have benign enlargement of the prostate and, at the same time, obstruction of the upper urinary tract, chronic urinary infection, or bladder stones,
• if you have or have had an obstruction of the gastrointestinal tract,
  • if you are taking this medicine to treat symptoms of benign prostatic hyperplasia (BPH) and have low blood pressure,
  • if you have bladder overflow or are unable to pass urine, with or without worsening of kidney function.

Warnings and precautions

Talk to your doctor or pharmacist before taking Doxazosina Neo Sandoz:

• if you have any acute heart disease, such as heart failure or pulmonary edema (fluid accumulation in the lungs),
• 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 erectile dysfunction (PDE-5 inhibitors, e.g., sildenafil, tadalafil, vardenafil) (see section "Other medicines and Doxazosina Neo Sandoz"),
• if you are scheduled for cataract surgery (clouding of the lens), inform your ophthalmologist before the procedure that you are currently taking or have previously taken doxazosin. This is because doxazosin may cause complications during surgery, which can be managed if your specialist is aware.

Take special care at the beginning of treatment. You may experience a drop in blood pressure accompanied by dizziness, weakness, and, rarely, fainting. Avoid situations where injury could occur if these symptoms arise. If you feel dizzy or faint, lie down; symptoms should resolve quickly.

Occasionally, you may notice in your stools something that looks like a tablet. This is normal. The active ingredient in the prolonged-release tablets is contained within a non-absorbable coating, specifically designed to slowly release the medicine into the body. Once the release process is complete, the empty coating is eliminated from the body in the faeces.

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

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

Talk to 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 need to take any other medicines, including those obtained without a prescription. In particular, inform your doctor if you are taking any of the following medicines:

• Medicines used to treat difficulties in achieving an erection (e.g., sildenafil, tadalafil, or vardenafil). Together with doxazosin, these may lower your blood pressure. Some patients may experience dizziness or lightheadedness due to low blood pressure when sitting or standing up quickly. To reduce the likelihood of these symptoms, you should take a regular daily dose of Doxazosina Neo Sandoz before starting treatment with erectile dysfunction medicines. You should also start treatment with erectile dysfunction medicines at the lowest dose and take it at least 6 hours after taking Doxazosina Neo Sandoz.
• Other alpha-blockers and other medicines used to treat high blood pressure.
• Medicines used to treat bacterial or fungal infections, e.g., clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used in the treatment of 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Doxazosina Neo Sandoz without first speaking to your doctor if you are pregnant or trying to become pregnant. The safety of this medicine during pregnancy has not been sufficiently established.

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

Driving and using machines

Be cautious if driving or operating 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 medicine contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet, i.e., essentially “sodium-free”.

3. How to take Doxazosina Neo Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Method of administration

Doxazosina Neo Sandoz has been specially manufactured to allow slow release of the active substance throughout the day. Choose a time of day that is convenient for you and take the tablets at that time every day. The tablets must be swallowed whole with a sufficient amount of liquid (preferably a glass of water). They must not be chewed, split, or crushed. You may take these tablets with or without food.

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

Adults

The usual dose of doxazosin is 4 mg of doxazosin 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 daily. The optimal effect may take up to four weeks to be achieved.

Elderly

The usual adult dose 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 lack of data on safety and efficacy.

Patients with kidney problems

Your doctor will prescribe the recommended adult dose.

Patients with liver problems

Your doctor may reduce your dose or monitor your condition closely. Doxazosin 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, for example, a child has accidentally taken the medicine, contact your doctor immediately. If you have taken too many tablets, you may experience dizziness or lightheadedness due to a drop in blood pressure. Lie down on your back with your feet elevated higher than your head.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 tablets at your usual time. Do not take a double dose to make up for forgotten 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Some of the adverse effects could be serious:

If you experience any of the following effects, stop taking this medicine immediately and contact your doctor or go to the nearest 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 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 whites of the eyes (jaundice), itching, loss of appetite, and pale-coloured urine due to 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),
• prolonged painful erection of the penis (priapism; may affect up to 1 in 10,000 people).

Other adverse effects:

Common (may affect up to 1 in 10 people)

• palpitations (strong heartbeat),
• dizziness, headache, drowsiness,
• sensation of 'spinning' (vertigo),
• inflammation of the airways (bronchitis), cough, difficulty breathing (dyspnea), rhinitis (nasal itching, runny nose 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 upon standing which may 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),
• nosebleeds,
• constipation, diarrhoea, flatulence, 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 (painful form of arthritis),
• pain and swelling, especially of the face (facial edema),
• abnormal liver function tests,
• inability to achieve an erection,
• anxiety, depression, difficulty sleeping.

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

• obstruction of the gastrointestinal 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 causing difficulty breathing or wheezing (bronchospasm),
• problems urinating, increased need to urinate, increased need to urinate at night, increased urine production and volume,
• hair loss, purple-coloured skin spots, skin rash,
• muscle cramps, muscle weakness,
• hot flushes,
• fatigue, general malaise,
• obstruction of bile excretion from the liver (cholestasis), inflammation of the liver (hepatitis),
• breast enlargement in men,
• restlessness, nervousness.

Frequency not known (cannot be estimated from 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, “dry orgasm”).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 outer packaging after EXP/CAD. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Doxazosina Neo Sandoz

The active substance is doxazosin (as mesilate).

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

The other components are:

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

Appearance of the product and contents of the pack

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

The tablets are packed in PVC/PVDC/aluminum blisters, contained in a cardboard box.

Pack sizes:

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

Calendar packs: 7, 14, 28, 56 and 98 prolonged-release tablets.

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

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised 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 the most recent review of this leaflet: 04/2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/