Doxazosin Neo Sandoz 4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Doxazosina Neo Sandoz 4 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. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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

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

It is used to treat:

• High blood pressure.
• Symptoms caused by enlargement of the prostate gland in men.

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

In patients with an enlarged prostate gland, this medicine is used to treat poor and/or frequent urination, commonly seen in patients with prostate enlargement (benign prostatic hyperplasia). This medicine works by relaxing the muscle around the outlet of the bladder and the prostate gland, allowing urine to flow more easily.

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

Do not take Doxazosina Neo Sandoz:

• if you are allergic to doxazosin, related quinazolines such as prazosin or terazosin, or any of the other ingredients of this medicine (listed in section 6),
• if you have any form of intestinal obstruction,
• if you have an enlarged prostate gland together with upper urinary tract congestion, chronic urinary tract infections, or bladder stones,
• if you suffer from loss of bladder control (overflow incontinence), 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 upon standing, which may cause dizziness, lightheadedness, 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 accumulation in the lungs),
• if you are scheduled for cataract surgery (clouding of the eye's lens),
• if you are pregnant or trying to become pregnant,
• if you are also taking medicines used to treat erectile problems (PDE-5 inhibitors, for example, sildenafil, tadalafil, vardenafil) (see section "Taking Doxazosina Neo Sandoz with other medicines").

Dizziness, weakness, and, rarely, fainting may occur especially at the beginning of treatment. Therefore, caution should be exercised at the start of treatment, and situations that could lead to injury if these symptoms occur should be avoided. If you feel dizzy or faint, lie down; symptoms will quickly subside.

Rarely, prolonged and sometimes painful erections may occur. If this happens, you must inform 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, which can cause the same symptoms as benign prostatic hyperplasia.

Taking Doxazosina Neo Sandoz with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is especially important to consider the following before taking this medicine:

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

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

Driving and using machines

Be cautious if driving or operating machinery. This medicine may affect your ability to drive or operate machinery safely, especially at the beginning of treatment. It may cause dizziness or weakness. If you experience these effects, do not drive or operate machinery and contact your doctor immediately.

Doxazosina Neo Sandoz contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is 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.

Adults (including 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 contained within a non-absorbable coating specifically designed to slowly release the drug. After ingestion, doxazosin is slowly released until the tablet is emptied.

Since the empty tablet shell is eliminated from the body through bowel movements, you may occasionally notice something resembling a tablet in your faeces. This is expected and should not cause concern.

Method of administration

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

Patients with hepatic impairment

If you have hepatic impairment, your doctor will monitor you closely 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 may make you feel unwell. It can be dangerous to take several tablets. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Doxazosina Neo Sandoz

Do not worry. If you forget to take a tablet, simply forget about this dose and take your next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Doxazosina Neo Sandoz

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

Do not wait until you run out of tablets before visiting your doctor.

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 adverse effects may be serious:

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

• 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 patches or blisters,
• chest pain, increased or irregular heart rate, heart attack or stroke,
• yellowing of the skin or whites of the eyes, loss of appetite, dark urine, caused by liver problems,
• unusual bruising or bleeding due to low platelet levels in the blood,
• painful and prolonged erection.

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

Other adverse effects:

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

• respiratory and urinary tract infections,
• dizziness, headache, drowsiness,
• awareness of heartbeats (palpitations),
• low blood pressure,
• drop in blood pressure upon standing, which may cause dizziness, lightheadedness 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 (joint pain and swelling),
• anxiety, depression, difficulty sleeping,
• reduced sensation, fainting (syncope), tremor,
• ringing or noises in the ears (tinnitus),
• nosebleeds,
• constipation, diarrhea, flatulence, vomiting, inflammation of the stomach and intestines (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 gastrointestinal tract.

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

• decrease in white blood cell count,
• restlessness, nervousness,
• tingling sensation or altered sensation in feet and hands,
• blurred vision,
• decreased heart rate,
• flushing,
• difficulty breathing or shortness of breath,
• hair loss, confluent purplish skin spots, hives,
• muscle cramps, muscle weakness,
• urinary disturbances, need to urinate, increased frequency of nighttime urination (nocturia),
• enlargement of male breast glands,
• fatigue, general malaise.

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

• entry of semen into the bladder during ejaculation through the urethra (retrograde ejaculation, dry orgasm),
• certain complications may occur during cataract surgery (intraoperative floppy iris syndrome; see also section "Warnings and precautions").

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 stated on the blister and packaging following EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your usual pharmacy. Ask your pharmacist how to properly 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 4 mg prolonged-release tablets

• The active substance is doxazosin (as mesilate).

Each tablet contains 4 mg of doxazosin (as mesilate).

• The other components are: macrogol 200, macrogol 900, butylhydroxytoluene (E321), microcrystalline cellulose, povidone K 30, rac-α-tocopherol (E307), anhydrous colloidal 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).

Nature of the product and contents of the container

Doxazosina Neo Sandoz are white, round, biconvex tablets marked with "DL".

The tablets are packed in PVC/PVDC/ALU blisters and placed in a carton.

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

Only certain pack 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

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 medicinal product is authorized in the European Economic Area member states 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 the most recent review of this leaflet: August 2019

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/