Package Leaflet: Information for the Patient

Doxazosina Neo Sandoz 4 mg prolonged-release tablets EFG

Doxazosina

Read this 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 only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Doxazosina Neo Sandoz 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. Storage of Doxazosina Neo Sandoz

6. Contents of the pack and additional information

Doxazosina Neo Sandozbelongs 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 acts by relaxing blood vessels, allowing blood to pass 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 urination, common in patients with an enlarged prostate (benign prostatic hyperplasia). This medicine acts by relaxing the muscle around the bladder outlet and prostate gland, allowing urine to flow more easily.

Do not takeDoxtazosin Neo Sandoz:

• if you are allergic to doxazosin, quinazolines related such as prazosin or terazosin, or any of the other ingredients ofthis medication (listed in section 6),
• if you have had any form of obstruction of the digestive tract,
• if you have an enlarged prostate gland along with urinary tract congestion, chronic urinary tract infections, or bladder stones,
• if you have loss of bladder control (urinary incontinence), inability to urinate, or kidney failure,
• if you are being treated for an enlarged prostate and have low blood pressure,
• if you have or have had any time a drop in blood pressure that may lead to dizziness, lightheadedness, or fainting.

Warnings and precautions

Consult your doctor before starting to take this medication:

• if you have liver disease,
• if you have heart disease, particularly heart failure or pulmonary edema (fluid buildup in the lungs),
• if you are about to undergo cataract surgery (clouding of the eye lens),
• if you are pregnant or trying to become pregnant,
• if you are also taking medications used to treat erectile dysfunction (PDE-5 inhibitors, for example, such as sildenafil, tadalafil, or vardenafil) (see section "Taking Doxtazosin Neo Sandoz with other medications").

Especially at the beginning of taking this medication, dizziness, weakness, and in rare cases, fainting may occur. Therefore, proceed with caution at the start of treatment, and avoid situations that could cause injuries if these symptoms appear. If you feel dizzy or faint, lie down and the symptoms will disappear quickly.

Rarely, prolonged and sometimes painful erections may occur. If this happens, inform your doctor immediately.

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

Taking Doxtazosin Neo Sandoz with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.. Before taking this medication, it is especially important to note:

• medications used with Doxtazosin Neo Sandoz to treat erectile dysfunction (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 quickly. To reduce the likelihood of these symptoms, take a normal daily dose of Doxtazosin Neo Sandoz before starting erectile dysfunction medications. Your doctor may start with the lowest possible dose of erectile dysfunction medication, and it is recommended to take it at least 6 hours after taking Doxtazosin Neo Sandoz,
• blood pressure medications (anti-hypertensives),
• medications to treat bacterial or fungal infections, e.g., clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole,
• medications used in the treatment of HIV, e.g., indinavir, nelfinavir, ritonavir, saquinavir,
• nefazodone, a medication used to treat depression.

Pregnancy and breastfeeding

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

• if you are pregnant, do not take this medication without consulting your doctor first. The safety of this medication during pregnancy is not well known.
• small amounts of doxazosin, the active ingredient in this medication, may pass into breast milk. You should not take this medication while breastfeeding unless your doctor advises you to.

Driving and operating machinery

be cautious if you drive or operate machinery. This medication 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.

Doxtazosin Neo Sandoz contains sodium

this medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults (including elderly)

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

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

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

Administration form

• 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 "Warnings and precautions").

Use in children and adolescents

This medication is not recommended for patients under 18 years old.

If you take more Doxazosina Neo Sandoz than you should

Too many tablets at once may make you feel unwell. Taking multiple tablets can be hazardous.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 forgot to takeDoxazosina Neo Sandoz

Do not worry. If you have forgotten to take a tablet, forget about this dose. Then return to your usual dose. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withDoxazosina Neo Sandoz

It is essential that you continue taking your medication. Do not change the dose or interrupt treatment without consulting your doctor first.

Do not wait until the tablets are finished to visit your doctor.

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

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

Some side effects can be serious:

If any of the following side effects occur, stop taking this medicine and immediately call your doctor or go to the nearest hospital emergency room:

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

These side effects are rare (may affect up to 1 in 100 people) or very 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 that may cause dizziness, lightheadedness or fainting,
• dizziness,
• 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,
• painful urination, frequent urination, inability to control urination (urinary incontinence),
• weakness, chest pain, flu-like symptoms, swelling of hands, feet or ankles.

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

• loss of appetite, increased appetite,
• gout (joint pain and swelling),
• anxiety, depression, difficulty sleeping,
• numbness, fainting (syncope), tremors,
• ringing or noise in the ears,
• nosebleeds,
• constipation, diarrhea, flatulence, vomiting, inflammation of the stomach and intestines (gastroenteritis),
• abnormal liver function tests,
• skin rash,
• joint pain,
• blood in urine, painful or difficult urination, frequent urination,
• difficulty achieving or maintaining an erection,
• pain,swelling of the face (facial edema),
• weight gain.

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

• decrease in the number of white blood cells,
• agitation, nervousness,
• sensation of tingling or altered sensitivity of feet and hands,
• blurred vision,
• decrease in heart rate,
• feeling of heat,
• difficulty breathing or wheezing,
• hair loss, confluent purpuric skin discoloration, urticaria,
• muscle cramps, muscle weakness,
• urination difficulties, need to urinate, increased number of times that needs to urinate at night (nocturia),
• increased male breast tissue,
• fatigue, general feeling of illness.

Frequency not known(cannot be estimated from available data)

• entry of semen into the bladder during ejaculation through the urethra (retrograde ejaculation, dry orgasm),
• some complications may arise during cataract surgery (iridocyclitis intraoperatoria, see also "Warnings and precautions").

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: 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 usethis medicationafter the expiration date that appears on the blister and box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Doxazosin Neo Sandoz Composition4 mg prolonged-release tablets

• The active ingredient 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 stearate fumarate,copolymers of methacrylic acid and ethyl acrylate (1:1), 30% dispersion,hydrated colloidal silica,macrogol (1300-1600),and titanium dioxide (E 171).

Product appearance and packaging contents

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

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

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

Only some packaging sizes may be commercially available.

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 member states of the European Economic Community with 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

Last review date of this prospectus:August 2019

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/