DOXAZOSIN NEO STADA 4 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Doxazosina Neo STADA 4 mg prolonged-release tablets EFG

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 and other information

1. What is Doxazosina Neo Stada and what is it used for
2. What you need to know before you take Doxazosina Neo Stada
3. How to take Doxazosina Neo Stada
4. Possible side effects
5. Storage of Doxazosina Neo Stada
6. Pack contents and further information.

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

The active substance of the tablets, doxazosin, belongs to a group of medicines known as alpha-1 blockers. Doxazosina Neo Stada is used to treat the following conditions:

• High blood pressure. If left uncontrolled, high blood pressure can increase the risk of heart disease or stroke.

Doxazosin works by widening your blood vessels, making it easier for your heart to pump blood through them. This helps to lower your blood pressure and reduce the risk of heart disease.

• Symptoms of benign prostatic hyperplasia (BPH). This condition causes an enlarged prostate gland, which is located below the bladder in men. This can make it difficult to pass urine.

Doxazosin works by relaxing the muscle around the bladder outlet and prostate gland, making it easier to pass urine.

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

Do not take Doxazosina:

• if you are allergic to doxazosin, to quinazolines (e.g. prazosin, terazosin) which are the chemical family to which doxazosin belongs or to any of the other ingredients of this medicine (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 when standing up that has made you feel dizzy, faint or lightheaded (orthostatic hypotension).
• if you suffer from any form of obstruction of the digestive tract.
• if you have benign prostatic hyperplasia (BPH) and at the same time have congestion of the upper urinary tract, chronic urinary infection or bladder stones.
• if you have an overactive bladder, produce little urine (anuria) or your kidneys do not work properly (progressive renal failure).
• if you are breast-feeding.

Warnings and precautions

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

• if you suffer from liver disease.
• if you have had acute heart disease, such as heart failure.
• dizziness, weakness and in rare cases fainting, especially at the start of treatment with this medicine, may occur. You should therefore be careful when starting treatment and avoid situations that could cause you harm if these symptoms appear.

Your doctor will inform you about what to do in case you experience symptoms of postural hypotension (a drop in blood pressure with symptoms when changing position, e.g. when standing up after being stretched out or sitting).

Do not worry if you occasionally notice remains in the stool that look like a tablet. This is because Doxazosina Neo Stada has a non-absorbable coating that has been designed to control the release of the medicine over a prolonged period.

If you are going to have cataract surgery (clouding of the 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 specialist is prepared beforehand.

Children and adolescents

Doxazosina Neo Stada is not recommended for use in children and adolescents under 18 years of age because its safety and efficacy have not been established.

Taking Doxazosina Neo Stada with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking any of the following medicines:

• non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen.
• other medicines used to treat high blood pressure.
• estrogens (female hormone).
• dopamine, ephedrine, adrenaline, metaraminol, methoxamine, phenylephrine (medicines called sympathomimetics, used, for example, to treat heart problems, low blood pressure, asthma or nasal congestion).
• doxazosin and the so-called phosphodiesterase-5 inhibitors (e.g. sildenafil, tadalafil or vardenafil). Some patients being treated with alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or lightheadedness, which can be caused by a drop in blood pressure after sitting or standing up quickly. Some patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) with alpha-blockers. To reduce the possibility of these symptoms, you should take a regular daily dose of alpha-blockers before starting the medicines for erectile dysfunction. Additionally, it is recommended to respect an interval of 6 hours between taking doxazosin 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 breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Doxazosina Neo Stada if you are breast-feeding.

If you are pregnant, do not take this medicine without consulting your doctor first. The safety of this medicine in pregnancy is not well established.

Driving and using machines

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

Doxazosina Neo Stada 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 Stada

Follow exactly the administration instructions of this medicine given 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 substance slowly throughout the day.

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

It may take up to four weeks to achieve the optimal effect of blood pressure reduction with Doxazosina Neo Stada. Because the treatment of high blood pressure is carried out to prevent problems that may appear, you may not notice any symptoms while taking Doxazosina Neo Stada. Although you may feel better, do not stop taking your medicine without your doctor's advice. Do not change the dose or stop taking your medicine 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 up, and your head down. The most likely symptoms of 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 forget to take Doxazosina Neo Stada

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

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.

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

• Heart attack (uncommon)
• Weakness of arms, legs or speech problems that can be symptoms of a stroke (uncommon)
• Swelling of the face, tongue or throat which can be the result of an allergic reaction to this medicine (uncommon)

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

• Chest pain (common), angina pectoris (uncommon)
• Respiratory failure, difficulty breathing, wheezing (very rare)
• Increased (common), decreased or irregular heart rate (very rare)
• Palpitations (common)
• Rash or itching (especially all over the body) (common)
• Fainting (uncommon)
  • Yellowing of the skin or eyes (jaundice) (very rare)

• Decreased number of white blood cells or platelets in the blood, which can lead to bruising or bleeding easily (very rare)

Other side effects

Common (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 sitting or lying position (postural hypotension)
• inflammation of the airways of the lungs, cough, respiratory failure, nasal congestion and/or runny nose
• abdominal pain, indigestion, dry mouth, feeling of discomfort (nausea)
• back pain, muscle pain
• inflammation of the bladder (cystitis), urinary incontinence
• general malaise, flu-like symptoms

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

• loss of appetite, gout, increased appetite
• anxiety, emotional instability (depression), insomnia
• reduced sense of touch, tremors, ringing or noises in the ears (tinnitus)
• nosebleeds
• constipation, diarrhea, flatulence, feeling sick (vomiting), inflammation of the gastrointestinal tract
• abnormal liver function tests
• joint pain
• difficulty or pain when urinating, presence of red blood cells in the urine (hematuria), frequent need to urinate
• abnormal accumulation of fluid under the skin causing swelling of the face (facial edema)
• difficulty having 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
• restlessness, nervousness
• tingling
• blurred vision
• redness
• blockage of bile flow (cholestasis), liver inflammation (hepatitis)
• hair loss (alopecia), rash caused by bleeding under the skin (purpura), hives
• muscle cramps, muscle weakness
• urinary disorders, frequent urination at night, increased urine volume
• temporary breast growth (gynecomastia)
  • painful and prolonged erection of the penis. Consult a doctor urgently.

• feeling of tiredness (fatigue), malaise

Not known (frequency cannot be estimated from the available data):

• intraoperative floppy iris syndrome
• altered taste
• retrograde ejaculation

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 via the Spanish Medicines Monitoring 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 Stada

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 carton, label and blister 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 any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and further information

Composition of Doxazosina Neo Stada

• The active substance is doxazosin. One prolonged-release tablet contains 4 mg of doxazosin (as mesylate).

• The other ingredients are: polyethylene oxide, microcrystalline cellulose, povidone, butylhydroxytoluene (E321), all-rac-α-tocopherol, colloidal anhydrous silica, sodium stearyl fumarate, methacrylic acid - ethyl acrylate copolymer (1:1) in 30% dispersion, hydrated colloidal silica, macrogol and titanium dioxide (E171).

Appearance of the product and pack contents

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

Your medicine is available 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

Unit dose packs of 50 x 1 prolonged-release tablets

or in plastic bottles (PP container with LDPE screw cap and fill space (LDPE)) with 500 prolonged-release tablets

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona) Spain

[email protected]

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 EEA Member States with the following names:

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

Estonia: Doxalfa

Netherlands: Doxazosine retard CF

Latvia: Doxalfa 4 mg ilgstošas darbibas tabletes

Lithuania: Doxalfa

United Kingdom: Doxadura XL

Sweden: Doxastad

Date of last revision of this leaflet:December 2019

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