DOXAZOSIN 2 mg Tabletki

Treść ulotki

1. Doxazosin Aurobindo 2 mg tablets, 4 mg tablets
   1. What is Doxazosin Aurobindo and what is it used for
   2. What you need to know before taking Doxazosin Aurobindo
   3. How to take Doxazosin Aurobindo
   4. Possible side effects
   5. How to store Doxazosin Aurobindo
   6. Contents of the pack and other information

Doxazosin Aurobindo 2 mg tablets, 4 mg tablets

Generic medicine

Read this leaflet carefully before you start to use this medicine as 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. Do not pass it on to others, even if their symptoms are the same as yours because it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Doxazosin Aurobindo is and what it is used for
• 2. What you need to know before you take Doxazosin Aurobindo
• 3. How to take Doxazosin Aurobindo
• 4. Possible side effects
• 5. How to store Doxazosin Aurobindo
• 6. Contents of the pack and other information

1. What is Doxazosin Aurobindo and what is it used for

Doxazosin belongs to a group of medicines known as vasodilators. These substances induce a
dilation of the blood vessels, which reduces blood pressure. Doxazosin can also reduce the
tension in the muscular tissues of the prostate and urinary tract.
Doxazosin is used for the treatment of:

• high blood pressure;
• treatment of the symptoms of an enlarged prostate.

2. What you need to know before taking Doxazosin Aurobindo

Do not use Doxazosin Aurobindo

• if you are allergic to doxazosin, to other types of quinazolines (such as prazosin and terazosin) or to any of the other ingredients of this medicine (listed in section 6). This may be recognised by the presence of itching, redness of the skin or difficulty breathing;
• if you are breastfeeding;
• if you are under 18 years of age;
• if you have an enlarged prostate (benign prostatic hyperplasia) andlow blood pressure;
• if you have previously had a condition known as “orthostatic hypotension”, a form of low blood pressure that makes you feel dizzy or lightheaded when you get up from sitting or lying down;
• if you have an enlarged prostate due to any of the following conditions: any type of congestion or blockage of the urinary tract, a long-lasting urinary tract infection or bladder stones;
• if you suffer from incontinence (you do not feel the urge to urinate) or anuria (your body is unable to produce urine) with or without kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Doxazosin Aurobindo if:

• you are pregnant or trying to become pregnant;
• you have a liver disease;
• you are taking other medicines;
• you have heart disease.

If you are to undergo cataract surgery (clouding of the lens) inform your
eye doctor about your current or previous treatment with Doxazosin Aurobindo. In fact, Doxazosin Aurobindo
may cause complications during the operation, which can be treated if the specialist has been
warned in advance.
Before starting treatment with Doxazosin Aurobindo, your doctor may perform tests to rule out other
conditions, such as prostate cancer, which can cause the same symptoms as benign prostatic hyperplasia
(enlargement of the prostate gland).
Very rarely, persistent painful erections may occur. If this should happen, contact
your doctor immediately.
When you start taking Doxazosin Aurobindo, you may feel weakness or dizziness caused by a
lowering of blood pressure when getting up from a sitting or lying position. If you feel
weak or dizzy, you should sit or lie down until you feel better, and avoid situations where
you could fall or injure yourself. Your doctor may decide to measure your blood pressure
regularly at the beginning of therapy, to reduce the possibility of these side effects.

Other medicines and Doxazosin Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. There are some medicines that can interact with Doxazosin Aurobindo.

• Some patients taking alpha-blockers for the treatment of high blood pressure or enlarged prostate may experience dizziness or lightheadedness, which may be caused by low blood pressure when sitting or rising quickly. Some patients have experienced these symptoms while taking medicines for erectile dysfunction (impotence) with alpha-blockers. To reduce the likelihood of these symptoms occurring, you should regularly continue therapy with alpha-blockers before starting therapy for erectile dysfunction.
• Doxazosin Aurobindo may further lower blood pressure if you are taking other medicines for the treatment of high blood pressure.

Doxazosin Aurobindo with food and drink
See section 3.

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
The safety of using doxazosin during pregnancy has not been established. If you are pregnant,
planning a pregnancy, or if you are breastfeeding with breast milk, ask your doctor for advice before
taking this medicine.
Do not take Doxazosin Aurobindo if you are breastfeeding.

Driving and operating machinery
Be careful if you drive or operate machinery. These tablets may impair your ability
to drive or operate machinery safely, especially at the beginning of treatment. They may
cause you to feel weak or dizzy. If you experience these symptoms, do not drive or operate machinery
and contact your doctor immediately.

Doxazosin Aurobindo containslactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.

Doxazosin Aurobindo containssodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

3. How to take Doxazosin Aurobindo

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

• The recommended dose of Doxazosin Aurobindo is one tablet taken once a day.
• If you are taking Doxazosin Aurobindo for the first time, the usual dose is 1 mg per day. After one or two weeks, your doctor may increase the dose to 2 mg or 4 mg per day. In some circumstances the dose may be increased up to a maximum of 8 mg per day, if you are being treated for an enlarged prostate, or up to 16 mg per day, if you are being treated for high blood pressure.
• Doxazosin Aurobindo can be taken either in the morning or in the evening.
• It is best to take the tablets at approximately the same time each day, with a glass of water.
• Doxazosin Aurobindo can be taken with or without food.
• Take the tablets as directed by your doctor, or following the days and arrows shown on the blister.
• It is important that you continue to take the tablets. They help to control your blood pressure.
• Do not change the dose and do not stop taking the tablets without first consulting your doctor. Do not wait for the tablets to run out before consulting your doctor.

Use in children
The safety and efficacy of Doxazosin Aurobindo in children have not been established.

If you take more Doxazosin Aurobindo than you should
Taking too many tablets together can make you feel unwell. This can be dangerous. Inform your
doctor immediately or go to the emergency room of the nearest hospital.

If you forget to take Doxazosin Aurobindo
Do not worry. If you forget to take a tablet, completely skip the dose. Then continue
as before. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP treatment with Doxazosin Aurobindo and call an ambulance immediatelyif you
experience any of these symptoms:

• Heart attack.
• Weakness in the arms or legs, or problems with speech, which may be symptoms of a stroke.
• Swelling of the face, tongue or throat, which can be a result of an allergic reaction to this medicine.

Inform your doctor immediatelyif you experience any of the
following symptoms after taking Doxazosin Aurobindo:

• Shortness of breath, difficulty breathing (common: may affect up to 1 in 10 people).
• Increased or decreased heartbeat (common: may affect up to 1 in 10 people).
• Awareness of your heartbeat (palpitations) (common: may affect up to 1 in 10 people).
• Chest pain, angina (uncommon: may affect up to 1 in 100 people).
• Irregular heartbeat (very rare: may affect up to 1 in 10,000 people).
• Yellowing of the skin or eyes (jaundice) (very rare: may affect up to 1 in 10,000 people).
• Low number of white blood cells or platelets in the blood, which can lead to increased bruising or a tendency to bleed (very rare: may affect up to 1 in 10,000 people).
• Persistent, painful erection of the penis. In this case, seek urgent medical advice.

The following adverse events have been reported in patients treated with Doxazosin Aurobindo. If any of
these side effects worsen, or if you notice any side effect not listed
in this leaflet, tell your doctor.

Common: may affect up to 1 in 10 people

• Dizziness, feeling of spinning or whirling around (vertigo), headache.
• Low blood pressure.
• Swelling of the feet, ankles or fingers.
• Cold chest, cough, respiratory tract infections (nose, throat, lungs).
• Blocked nose, sneezing and/or runny nose due to inflammation of the nasal mucosa (rhinitis).
• Stomach/abdominal pain, feeling/being sick.
• Urinary tract infection, urinary incontinence (inability to control and retain urine), bladder inflammation (cystitis).
• Sleepiness, general weakness.
• Indigestion, heartburn, dry mouth.
• Itching.
• Back pain, muscle pain.
• Flu-like symptoms.

Uncommon: may affect up to 1 in 100 people

• Constipation, flatulence, inflammation of the stomach and intestines (gastroenteritis) which can cause diarrhoea and vomiting.
• Pain or discomfort when urinating, needing to urinate more often than usual, blood in the urine.
• Inflammation of the joints (gout), joint pain, generalized pain.
• Swelling of the face.
• Insomnia, agitation, anxiety, depression or nervousness.
• Reduced or altered sensitivity to touch in hands and feet.
• Increased or decreased appetite, weight gain.
• Nosebleeds.
• Skin rash.
• Tinnitus (ringing or buzzing in the ears), tremor.
• Inability/difficulty in maintaining a penile erection.
• Increased liver enzymes which may alter some medical tests.
• Stroke.

Rare: may affect up to 1 in 1,000 people

• Increased number of times you need to urinate.
• Muscle cramps, muscle weakness.

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

• Weakness or dizziness caused by low blood pressure when getting up from a sitting or lying position.
• Hepatitis (inflammation of the liver) or bile disorder.
• Urticaria, hair loss, red or purple patches on the skin, bleeding under the skin.
• Tingling or numbness in the hands and feet.
• Fatigue, general feeling of being unwell.
• Worsening of breathlessness.
• Blurred vision.
• Hot flushes.
• Problems with urination, needing to urinate at night, increased urine volume.
• Discomfort or enlargement of the breasts in men.

Not known: frequency cannot be estimated from the available data

• Scarcity or absence of sperm during ejaculation, cloudy urine after sexual intercourse.
• Eye problems that can occur during cataract surgery (clouded lens). See section “Warnings and precautions”.

Reporting of side effects
If you get 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 through the national reporting system at http://www.aifa.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Doxazosin Aurobindo

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, the label, the bottle or
the carton after “EXP”. The expiry date refers to the last day of the month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Doxazosin Aurobindo contains

• The active ingredient is doxazosin. Each tablet contains 2 mg or 4 mg of doxazosin (as doxazosin mesilate).
• The excipients are: microcrystalline cellulose, anhydrous lactose, sodium starch glycolate, magnesium stearate.

Description of the appearance of Doxazosin Aurobindo and contents of the pack
Doxazosin Aurobindo 2 mg tablets:
Uncoated tablets, capsule-shaped, from white to off-white, with H02 inscribed on one side and a score line on the other side.
The tablet can be divided into two equal parts.
Doxazosin Aurobindo 4 mg tablets:
Uncoated tablets, lozenge-shaped, from white to off-white, with H03 inscribed on one side and a score line on the other side.
The tablet can be divided into two equal parts.
Aluminum PVC-PVDC blister packs:
Packs of 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 140 tablets.
HDPE bottle:
Pack of 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102

• 21047 - Saronno (VA) Italy

Manufacturer responsible for batch release
Milpharm Limited
Ares, Odyssey Business Park, West End Road,
South Ruislip HA4 6QD
United Kingdom
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Bulgaria: Doxazosin Aurobindo 1mg/ 2mg/ 4mg тaблетки
Czech Republic: Doxazosin Aurovitas
Germany: Doxazosin Aurobindo 1mg/ 2mg/ 4mg/ 8mg Tabletten
Italy: Doxazosin Aurobindo
Poland: Adadox, 2 mg/4 mg
Doxazosin Aurobindo, 1 mg
Spain: Doxazosina Aurobindo 2mg/ 4mg comprimidos EFG
United Kingdom: Doxazosin 1mg/ 2mg/ 4mg/ 8mg tablets

This leaflet was last updated in