Prospecto: information for the user

Doxazosina Neo STADA 4 mg prolonged-release tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

−Keep this prospect, as you may need to read it again.

−If you have any doubts, consult your doctor or pharmacist.

−This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

−If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Doxazosina Neo Stada

3.How to take Doxazosina Neo Stada

4.Adverse effects

5.Storage of Doxazosina Neo Stada

6. Contents of the package and additional information.

The active ingredient of the tablets, doxazosina, belongs to a group of medications known as alpha-1 antagonists. Doxazosina Neo Stada is used for the treatment of the following conditions:

• High blood pressure. If not controlled, high blood pressure can increase the risk of heart disease or stroke.

Doxazosina acts by dilating your blood vessels, which facilitates the heart's work of pumping blood through them. This helps to lower blood pressure and reduce the risk of heart disease.

• Symptoms of benign prostatic hyperplasia (BPH). This condition causes an enlargement of the prostate gland, which is located below the bladder in men. This makes it difficult to urinate.

Doxazosina acts by relaxing the muscle around the exit of the bladder and the prostate gland, which facilitates urination.

Do not take Doxazosina:

•if you are allergic to doxazosina, quinazolines (e.g. prazosina, terazosina) which are the chemical family to which doxazosina belongs or to any of the other components of this medication (listed in section 6). Allergic reactions may be, for example, itching, skin redness or difficulty breathing.

•if you have low blood pressure (hypotension) or have had a drop in blood pressure that has caused dizziness, fainting or dizziness when standing up (orthostatic hypotension).

•if you have any form of obstruction of the digestive tract.

•if you have benign prostatic hyperplasia (BPH) and at the same time have an upper urinary tract congestion, chronic urinary tract infection or bladder stones.

•if you have a bladder with excessive flow, produce little urine (anuria) or your kidneys do not function correctly (progressive renal insufficiency).

•if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxazosina Neo Stada.

•if you have liver disease.

•if you have had an acute heart disease, such as heart failure.

•lightheadedness, weakness and in rare cases fainting may occur, especially at the beginning of treatment with this medication. You should be careful at the beginning of treatment and avoid situations that may cause harm if these symptoms appear.

Your doctor will inform you on what to do if you experience symptoms of postural hypotension (a drop in blood pressure with symptoms when changing position, e.g. when standing up after lying down or sitting).

You should not worry if you occasionally observe remnants in the feces that resemble a tablet. This is due to the non-absorbable coating of Doxazosina Neo Stada, which has been designed to control the release of the medication for a prolonged period.

If you are to be operated on for cataracts (opacity of the crystalline lens), inform your eye specialist before the operation that you are taking or have previously taken Doxazosina Neo Stada. This is because Doxazosina Neo Stada may cause complications during the operation that can be avoided if your eye specialist is prepared in advance.

Children and adolescents

Do not recommend the use of Doxazosina Neo Stada in children and adolescents under 18 years of age because its safety and efficacy have not been established.

Taking Doxazosina Neo Stada with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication.

Inform your doctor if you take any of the following medications:

•non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen.

•other medications used in the treatment of high blood pressure.

•estrogens (female hormone).

•dopamine, ephedrine, adrenaline, metaraminol, methoxamine, phenylephrine (medications called sympathomimetics, used, for example, for the treatment of heart problems, low blood pressure, asthma or nasal congestion).

•doxazosina and the so-called phosphodiesterase-5 inhibitors (e.g. sildenafil, tadalafil or vardenafil). Some patients taking alpha-blockers for high blood pressure or prostate enlargement may experience dizziness or lightheadedness, which may be caused by a drop in blood pressure after sitting or standing up quickly. Some patients have experienced these symptoms when taking erectile dysfunction medications (impotence) with alpha-blockers. To reduce the likelihood of these symptoms occurring, you should take a regular daily dose of alpha-blockers before starting erectile dysfunction medications. In addition, it is recommended to respect a 6-hour interval since taking doxazosina and the phosphodiesterase-5 inhibitor.

Taking Doxazosina Neo Stada with food and drinks

Doxazosina Neo STADA can be taken with or without food.

Pregnancy and breastfeeding

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

Do not take Doxazosina Neo Stada if you are breastfeeding.

If you are pregnant, do not take this medication without consulting your doctor first. The safety of this medication in pregnancy has not been established.

Driving and operating machinery

Doxazosina Neo Stada may cause drowsiness or dizziness. If you feel drowsy, dizzy or vertigo, do not drive or operate machinery. Be especially careful when taking the first dose or if your dose is increased.

Doxazosina Neo Stada 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 for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dose

The dose of Doxazosina Neo Stada is the same whether you take it for hypertension or to treat the symptoms of benign prostatic hyperplasia. The usual dose is one tablet (4 mg) per day. Your doctor may increase your dose up to the maximum recommended dose of two tablets per day.

Choose any time of day that is convenient for you and take your tablets at that time every day. The tablets should be swallowed whole with a sufficient amount of water. Do not chew, break, or crush the tablets. Doxazosina Neo Stada releases the active ingredient slowly over the course of the day.

For the treatment of high blood pressure. Doxazosina Neo Stada may be used as monotherapy or in combination with other medications to lower blood pressure (e.g. diuretics, tablets to remove fluids).

It may take up to four weeks to achieve the optimal effect of blood pressure reduction with Doxazosina Neo Stada. Since the treatment of high blood pressure is done to prevent problems that may occur, you may not notice any symptoms while taking Doxazosina Neo Stada. Although you may feel better, do not stop taking your medication until your doctor tells you to. Do not change the dose or stop taking your medication without consulting your doctor first.

If you take more Doxazosina Neo Stada than you should

If you take too many tablets, lie down with your feet higher than your head. The most likely symptoms of an overdose would be a feeling of dizziness or vertigo due to a drop in blood pressure. If you notice these symptoms, you should consult your doctor or pharmacist immediately or visit a hospital as soon as possible.

If you forgot to take Doxazosina Neo Stada

If you forget to take a dose, do not worry. Simply take the tablet the next day when it is due. Do not take a double dose to make up for the missed doses.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

STOP taking Doxazosina Neo Stada and call an ambulance immediately if you experience any of the following:

•Heart attack (rare)

•Weakness in arms, legs, or speech difficulties that may be symptoms of a stroke (rare)

•Swelling of the face, tongue, or throat that may be the result of an allergic reaction to this medication (rare)

Consult your doctor immediately if you experience any of the following symptoms after taking Doxazosina Neo Stada:

•Chest pain (frequent), angina pectoris (rare)

•Respiratory insufficiency, difficulty breathing, wheezing (very rare)

•Increased (frequent), decreased, or irregular heartbeats (very rare)

•Palpitations (frequent)

•Rash or itching (especially on the entire body) (frequent)

•Fainting (rare)

• Yellowing of the skin or eyes (jaundice) (very rare)

•Decreased number of white blood cells or platelets in the blood, which may lead to bruises or easy bleeding (very rare)

Other side effects

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

•Respiratory tract infections

•Dizziness, headache, drowsiness

•Loss of balance

•Low blood pressure and low blood pressure as a result of standing up from a seated or lying position (postural hypotension)

•Inflammation of the airways of the lungs, cough, respiratory insufficiency, nasal congestion, and/or nasal discharge

•Abdominal pain, indigestion, dry mouth, feeling unwell (nausea)

•Back pain, muscle pain

•Bladder inflammation (cystitis), urinary incontinence

•General feeling of illness, flu-like symptoms

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

•Loss of appetite, gout, increased appetite

•Anxiety, emotional instability (depression), lack of sleep (insomnia)

•Reduced sensation or sense of touch, tremors, ringing or noise in the ears (tinnitus)

•Nasal bleeding

•Constipation, diarrhea, flatulence, feeling sick (vomiting), inflammation of the gastrointestinal tract

•Abnormal liver function tests

•Joint pain

•Pain or difficulty urinating, presence of red blood cells in the urine (hematuria), frequent urination

•Abnormal accumulation of fluid under the skin causing facial swelling (facial edema)

•Difficulty achieving an erection (impotence)

•Pain

•Weight gain

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

•Decreased number of red blood cells

•Postural dizziness

•Anxiety, nervousness

•Tickling

•Blurred vision

•Redness

•Bile duct obstruction (cholestasis), liver inflammation (hepatitis)

•Loss of hair (alopecia), rash caused by bleeding under the skin (purpura), urticaria

•Muscle cramps, muscle weakness

•Urinary tract problems, frequent urination at night, increased urine volume

•Temporary breast growth (gynecomastia)

• Persistent and painful erection of the penis. Consult a doctor urgently.

•Feeling tired (fatigue), feeling unwell

Unknown (frequency cannot be estimated from available data):

•Intraoperative iris flaccidity syndrome

•Alteration of taste

•Retrograde ejaculation

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 medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the carton, label, and blister pack, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition of Doxazosina Neo Stada

-The active ingredient is doxazosina. A prolonged-release tablet contains 4 mg of doxazosina (as mesilato).

-The other components are: polyethylene oxide, microcrystalline cellulose, povidone, butylhydroxytoluene (E321), all racemic forms of α-tocopherol, anhydrous colloidal silica, sodium stearate fumarate, copolymer of methacrylic acid – ethyl acrylate (1:1) in a 30% dispersion, hydrated colloidal silica, macrogol, and titanium dioxide (E171).

Appearance of the product and contents of the package

The tablets are white, round, biconvex, with the letters “DL” engraved on one face.

Your medicine is presented in:

PVC/PVDC/aluminum blister packs:

Packs of 10, 20, 28, 30, 50, 56, 60, 90, 98, 100, 140 (10x14) prolonged-release tablets

Calendar packs of 28 and 98 prolonged-release tablets

Single-dose packs of 50 x 1 prolonged-release tablets

or in plastic bottles (PP container with an LDPE closure and a filling space (LDPE)) with 500 tablets

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona) Spain

info@stada.es

Responsible manufacturer:

STADA Arzneimittel AG

Stadastrasse. 2 – 18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E4814 NE Breda

Netherlands

or

Genus Pharmaceuticals Ltd.

Linthwaite,

Huddersfield

HD7 5QH

United Kingdom

This medicine has been authorized in the Member States of the EEA with the following names:

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

Estonia:Doxalfa

Netherlands:Doxazosine retard CF

Latvia:Doxalfa 4 mg prolonged-release tablets

Lithuania:Doxalfa

United Kingdom:Doxadura XL

Sweden:Doxastad

Last review date of this leaflet:December 2019

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/