Doxazosin Aurobindo

Package leaflet: Information for the user

Doxazosin Aurobindo 2 mg tablets, 4 mg tablets

Equivalent medicine
Please read all of this leaflet carefully before you start using 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. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 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

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

Doxazosin belongs to a group of medicines known as vasodilators. These substances cause dilation of blood vessels, thereby reducing blood pressure. Doxazosin can also reduce tension in the muscle tissue of the prostate and urinary tract.
Doxazosin is used for the treatment of:

• high blood pressure;
• treatment of 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 recognized by itching, skin redness or difficulty breathing;
• if you are breastfeeding;
• if you are under 18 years of age;
• if you have an enlarged prostate (benign prostatic hyperplasia) and low blood pressure;
• if you have previously had a condition known as "orthostatic hypotension", a form of low blood pressure causing dizziness or lightheadedness when standing up from sitting or lying down;
• if your enlarged prostate is due to any of the following conditions: urinary tract congestion or obstruction, long-standing urinary tract infection, or bladder stones;
• if you suffer from incontinence (inability to sense 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 liver disease;
• you are taking other medicines;
• you have heart disease.

If you are scheduled for cataract surgery (clouding of the lens), inform your ophthalmologist that you are currently or have previously been treated with Doxazosin Aurobindo. Indeed, Doxazosin Aurobindo may cause complications during surgery, which can be managed if the specialist is informed in advance.
Before starting treatment with Doxazosin Aurobindo, your doctor may perform tests to rule out other conditions, such as prostate cancer, which may cause the same symptoms as benign prostatic hyperplasia (enlargement of the prostate gland).
Very rarely, prolonged painful erections may occur. If this happens, contact your doctor immediately.
When you start taking Doxazosin Aurobindo, you may experience weakness or dizziness caused by a drop in blood pressure upon standing from a sitting or lying position. If you feel weak or dizzy, sit or lie down until you feel better, and avoid situations where you might fall or get injured. Your doctor may decide to monitor your blood pressure regularly at the beginning of treatment to reduce the likelihood of these side effects.

Other medicines and Doxazosin Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines may interact with Doxazosin Aurobindo.

• Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or lightheadedness, caused by low blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms while taking medications for erectile dysfunction (impotence) together with alpha-blockers. To reduce the likelihood of these symptoms, you should already be on a stable regimen of alpha-blockers before starting treatment for erectile dysfunction.
• Doxazosin Aurobindo may further lower your blood pressure if you are taking other medicines for high blood pressure.

Doxazosin Aurobindo with food and drink
Refer to 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 breastfeeding, consult your doctor before taking this medicine.
Do not take Doxazosin Aurobindo if you are breastfeeding.

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

Doxazosin Aurobindo contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

Doxazosin Aurobindo contains sodium
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 exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

• The recommended dose of Doxazosin Aurobindo is one tablet taken once daily.
• If you are taking Doxazosin Aurobindo for the first time, the usual starting 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 certain 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 may be taken with or without food.
• Take the tablets as directed by your doctor, or follow the days and arrows indicated on the blister pack.
• It is important that you continue to take the tablets. They help you control your blood pressure.
• Do not change the dose or stop taking the tablets without first consulting your doctor. Do not wait until the tablets are finished before contacting 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 at once may make you feel unwell. This could be dangerous. Contact your doctor immediately or go to the nearest hospital emergency department.
If you forget to take Doxazosin Aurobindo
Do not worry. If you forget to take a tablet, simply skip the missed dose and take the next tablet at your usual time. Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
STOP treatment with Doxazosin Aurobindo and call an ambulance immediately if you experience any of the following symptoms:

• Heart attack.
• Weakness in the arms, legs, or difficulty speaking, which could be signs of a stroke.
• Swelling of the face, tongue, or throat, which may result from an allergic reaction to this medicine.

Inform your doctor immediately if 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 heart rate (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 may lead to increased bruising or tendency to bleed (very rare: may affect up to 1 in 10,000 people).
• Prolonged painful erection of the penis. In such case, seek urgent medical advice.

The following adverse events have been reported in patients treated with Doxazosin Aurobindo. If any of these side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor.
Common: may affect up to 1 in 10 people

• Dizziness, sensation of spinning or rotation of the surrounding environment (vertigo), headache.
• Low blood pressure.
• Swelling of the feet, ankles, or fingers.
• Cold chest, cough, respiratory tract infections (nose, throat, lungs).
• Nasal congestion, sneezing and/or runny nose due to inflammation of the nasal mucosa (rhinitis).
• Stomach/abdominal pain, feeling unwell.
• Urinary tract infection, urinary incontinence (inability to control and retain urine), bladder inflammation (cystitis).
• Drowsiness, generalized weakness.
• Indigestion, heartburn, dry mouth.
• Itching.
• Back pain, muscle pain.
• Influenza-like symptoms.

Uncommon: may affect up to 1 in 100 people

• Constipation, flatulence, inflammation of the stomach and intestine (gastroenteritis) which may cause diarrhoea and vomiting.
• Pain or discomfort when urinating, need to urinate more frequently than usual, blood in the urine.
• Joint inflammation (gout), joint pain, generalized pain.
• Swelling of the face.
• Insomnia, restlessness, anxiety, depression, or nervousness.
• Reduced or altered sensitivity to touch in hands and feet.
• Increased or decreased appetite, weight gain.
• Nosebleeds.
• Skin rash.
• Ringing or buzzing in the ears, tremor.
• Inability to maintain penile erection.
• Increased liver enzymes, which may alter certain medical tests.
• Stroke.

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

• Increased frequency of needing 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 standing up from a sitting or lying position.
• Hepatitis (liver inflammation) or biliary disorder.
• Hives, hair loss, red or purple spots on the skin, bleeding under the skin.
• Tingling or numbness in the hands and feet.
• Fatigue, feeling of general malaise.
• Worsening of breathlessness.
• Blurred vision.
• Hot flushes.
• Urination disorders, need to urinate at night, increased urine volume.
• Discomfort or enlargement of the breast in men.

Not known: frequency cannot be estimated from the available data

• Low volume or absence of semen during ejaculation, cloudy urine after sexual intercourse.
• Eye problems that may occur during cataract surgery (cloudy lens). See section “Warnings and precautions”.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the blister, label, bottle or carton after “EXP”. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Doxazosin Aurobindo contains

• The active substance is doxazosin. Each tablet contains 2 mg or 4 mg of doxazosin (as doxazosin mesylate).
• 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, capsule-shaped tablets, white to off-white, marked with "H02" 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, diamond-shaped tablets, white to off-white, marked with "H03" on one side and a score line on the other side.
The tablet can be divided into two equal parts.
Aluminum PVC-PVDC blisters:
Pack sizes of 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 140 tablets.
HDPE bottle:
Pack size of 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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
Poland

This medicinal product is authorised in the European Economic Area countries 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 on