DOXAZOSIN NEO SANDOZ 4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Doxazosina Neo Sandoz 4 mg prolonged-release tablets EFG

Doxazosina

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 pack

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

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

Doxazosina Neo Sandoz belongs to a group of medicines called alpha-blockers.

It is used to treat:

• High blood pressure.
• Symptoms caused by an enlarged prostate gland in men.

In patients taking this medicine to treat high blood pressure (hypertension), it works by relaxing blood vessels, so that blood passes through them more easily. This helps to lower blood pressure.

In patients with an enlarged prostate gland, this medicine is taken to treat poor and/or frequent passage of urine, common in patients with an enlarged prostate gland (benign prostatic hyperplasia). This medicine works by relaxing the muscle around the bladder outlet and the prostate gland, so that urine can flow more easily.

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

Do not takeDoxazosina Neo Sandoz:

• if you are allergic to doxazosina, related quinazolines such as prazosina or terazosina or any of the other ingredients of this medicine (listed in section 6),
• if you have had any form of obstruction of the digestive tract,
• if you have an enlarged prostate gland at the same time as congestion of the upper urinary tract, chronic urinary tract infections or stones in the bladder,
• if you suffer from loss of bladder control (bladder overflow), inability to urinate or kidney failure,
• if you are being treated for an enlarged prostate gland and have low blood pressure,
• if you have or have ever had a drop in blood pressure when standing up that can lead to dizziness, dizziness or fainting.

Warnings and precautions

Talk to your doctor before starting to take this medicine:

• if you have liver disease,
• if you have heart disease, particularly heart failure or pulmonary edema (fluid deposits in the lungs),
• if you are going to undergo cataract surgery (clouding of the eye lens),
• if you are pregnant or trying to become pregnant,
• if you are also taking medicines used to treat erection problems (PDE-5 inhibitors, e.g. sildenafil, tadalafil, vardenafil) (see section "Taking Doxazosina Neo Sandoz with other medicines”).

Especially at the start of taking this medicine, dizziness, weakness and, in rare cases, fainting may occur. Therefore, you should proceed with caution when starting treatment and avoid situations that could cause injury if such symptoms occur. If you feel dizzy or faint, lie down and the symptoms will disappear quickly.

Rarely, prolonged and sometimes painful erectionsmay occur. If this happens, you should contact a doctor immediately.

Before starting treatment with Doxazosina Neo Sandoz for an enlarged prostate gland, your doctor may perform tests to rule out other conditions, such as prostate cancer, that may cause the same symptoms as benign prostatic hyperplasia.

Taking Doxazosina Neo Sandozwith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Before taking this medicine, it is especially important to consider:

• medicines used together with Doxazosina Neo Sandoz to treat difficulties in achieving an erection (e.g. sildenafil, tadalafil or vardenafil) may lower blood pressure. Some patients may experience dizziness or dizziness, which may be caused by low blood pressure when sitting or standing up quickly. To reduce the likelihood of these symptoms, you should take a normal daily dose of Doxazosina Neo Sandoz before starting to take medicines for erectile dysfunction (impotence). Your doctor may start with the lowest possible dose of the medicine for erectile dysfunction, and it is recommended to take it at least 6 hours after taking Doxazosina Neo Sandoz,
• medicines for high blood pressure (called antihypertensives),
• medicines for treating 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• If you are pregnant, do not take this medicine without consulting your doctor first. The safety of this medicine during pregnancy is not well known.
• Small amounts of doxazosina, the active substance of this medicine, may pass into breast milk. You should not take this medicine if you are breastfeeding unless your doctor advises you to.

Driving and using machines

Be careful if you drive or use machines. This medicine may affect your ability to drive or use machines safely, especially at the start of treatment. It can make you feel dizzy or weak. If you experience these effects, do not drive or use machines and contact your doctor immediately.

Doxazosina Neo Sandoz contains sodium

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

3. How to take Doxazosina Neo Sandoz

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

Adults (including the elderly)

The recommended dose of Doxazosina Neo Sandoz is 4 mg taken as a single daily dose. Your doctor may decide to increase your dose to 8 mg once daily. This is the maximum dose of Doxazosina Neo Sandoz.

Doxazosina Neo Sandoz is a prolonged-release tablet. The medicine is inside a non-absorbable coating that has been specially designed to release the medicine slowly. Once swallowed, doxazosina is released slowly, until the tablet is empty.

Since the empty tablet is eliminated from the body with bowel movements, from time to time you may observe in the stool something that looks like a tablet. This is to be expected and should not worry you.

Method of administration

• Do not chew, divide or break the tablets.
• Swallow the tablets whole with a glass of water.
• You can take these tablets with or without food.

Patients with liver disorders.

If you have liver disorders, your doctor will closely monitor you during treatment. Doxazosina Neo Sandoz is not recommended for use in patients with severe liver problems (see section "Warnings and precautions").

Use in children and adolescents

This medicine is not recommended for patients under 18 years of age.

If you take more Doxazosina Neo Sandoz than you should

Taking too many tablets at once can make you feel unwell. It can be dangerous if several tablets are taken. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeDoxazosina Neo Sandoz

Do not worry. If you have forgotten to take a tablet, forget about this dose completely. Then go back to your usual dose. Do not take a double dose to make up for forgotten doses.

If you stop takingDoxazosina Neo Sandoz

It is important that you keep taking your medicine. Do not change the dose or stop treatment without consulting your doctor first.

Do not wait until you run out of tablets to visit your doctor.

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 side effects may be serious:

If you get any of the following side effects, stop taking this medicine and contact your doctor immediately or go to the emergency department of the nearest hospital:

• allergic reactions such as shortness of breath, wheezing, extreme dizziness or collapse, swelling of the face or throat, or a severe skin rash with red spots or blisters,
• chest pain, increased heart rate or irregular, heart attack or stroke,
• yellowing of the skin or the whites of the eyes, loss of appetite, dark-colored urine, caused by liver problems,
• unusual bruising or bleeding due to a low platelet count in the blood,
• painful and persistent erection.

These side effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 10,000 people).

Other side effects:

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

• respiratory and urinary tract infections,
• dizziness, headache, drowsiness,
• feeling of strong heartbeats,
• low blood pressure,
• drop in blood pressure when standing up that can lead to dizziness, dizziness or fainting,
• vertigo,
• itching (pruritus),
• shortness of breath, nasal congestion or runny nose (rhinitis),
• inflammation of the bronchi (bronchitis), cough,
• abdominal pain, indigestion, dry mouth, nausea,
• back pain, muscle pain,
• pain and frequent urination, inability to control urine (urinary incontinence),
• weakness, chest pain, flu-like symptoms, swelling of hands, feet or ankles.

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

• loss of appetite, increased appetite,
• gout (pain and swelling of joints),
• anxiety, depression, difficulty sleeping,
• decreased sensitivity, fainting (syncope), tremor,
• ringing or noise in the ears,
• nasal bleeding,
• constipation, diarrhea, flatulence, vomiting, inflammation of the stomach and intestine (gastroenteritis),
• abnormal liver function tests,
• skin rash,
• joint pain,
• blood in urine, discomfort or difficulty urinating, frequent urination,
• difficulty achieving or maintaining an erection,
• pain, swelling of the face (facial edema),
• weight gain.

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):

• decrease in the number of white blood cells,
• agitation, nervousness,
• tingling or altered sensitivity of feet and hands,
• blurred vision,
• decrease in heart rate,
• hot flushes,
• difficulty breathing or shortness of breath,
• hair loss, confluent purple-colored spots on the skin, hives,
• muscle cramps, muscle weakness,
• urination disorders, need to urinate, increased number of times you need to urinate at night (nocturia),
• enlargement of male breast tissue,
• fatigue, general malaise.

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

• semen entering the bladder during ejaculation through the urethra (retrograde ejaculation, dry orgasm),
• some complications may arise during cataract surgery (intraoperative floppy iris syndrome, see also section "Warnings and precautions").

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 to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: 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 carton 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. Return the containers and any unused medicine to your usual pharmacy. Ask your pharmacist how to dispose of containers and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Doxazosina Neo Sandoz4 mg prolonged-release tablets

• The active substance is doxazosina (as mesylate).

Each tablet contains 4 mg of doxazosina (as mesylate).

• The other ingredients are: macrogol 200, macrogol 900, butylhydroxytoluene (E321), microcrystalline cellulose, povidone K 30, rac-α-tocopherol (E307), colloidal anhydrous silica, sodium stearyl fumarate, copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, hydrated colloidal silica, macrogol (1300-1600), titanium dioxide (E 171).

Appearance of the productand pack contents

Doxazosina Neo Sandoz are white, round, biconvex tablets with the mark “DL”.

The tablets are packaged in PVC/PVDC/ALU blisters and inserted into a carton.

Package sizes: 14, 28, 30, 56, 98, 100 and 500 tablets.

Not all pack sizes may be marketed.

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

or

Hexal Polska SP.Z.O.O

ul. Domanieewska 50C

(Warsaw)-PL 02-672

Poland

or

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15

62-020 Swarzedz

Poland

This medicine is authorised in the Member States of the European Economic Community under the following names:

Denmark: Doxazosin “Sandoz”

Netherlands: DOXAZOSINE SANDOZ RETARD 4 MG, TABLETTEN MET VERLENGDE AFGIFTE

Poland: Doxazosin XR Genoptim

Spain: Doxazosina Neo Sandoz 4 mg prolonged-release tablets EFG

Sweden: Doxazosin Sandoz

United Kingdom: Colixil XL 4 mg Prolonged-release Tablets

Date of last revision of thisleaflet:August 2019

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/