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DOXAZOSIN 8MG TABLETS

Active substance(s): DOXAZOSIN MESILATE

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Doxazosin 1 mg tablets
Doxazosin 2 mg tablets
Doxazosin 4 mg tablets
Doxazosin 8 mg tablets
Doxazosin
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.
What is in this leaflet:
1. What Doxazosin is and what it is used for
2. What you need to know before you take Doxazosin
3. How to take Doxazosin
4. Possible side effects
5. How to store Doxazosin
6. Contents of the pack and other information
1. What Doxazosin is and what it is used for
Doxazosin belongs to the group known as vasodilators. These substances
cause the blood vessel to widen, which reduces the blood pressure.
Doxazosin can also reduce tension in the muscle tissues of the prostate and
the urinary tract.
Doxazosin is used to treat:
• high blood pressure;
• symptoms of an enlarged prostate.
2. What you need to know before you take Doxazosin
Do not take Doxazosin
• if you are allergic to doxazosin, other medicines from the same group
(known as quinazolines, such as e.g. prazosin and terazosin) or any of the
other ingredients of of this medicine (listed in section 6.1); ;
• if you have a history of a condition known as ‘orthostatic hypotension’
which is a form of low blood pressure that causes you to feel dizzy or lightheaded when you stand up from sitting or lying down
• if you have an enlarged prostate gland with one of the following: any kind
of congestion or blockage in your urinary tract, a longstanding infection of
the urinary tract or you have bladder stones.
• if you are breast-feeding
• if you have an enlarged prostate gland (benign prostatic hyperplasia) and
have low blood pressure.
• if you have overflow incontinence (you do not feel the urge to urinate),
or anuria (your body is not producing any urine) with or without kidney
problems.
Warnings and precautions
Talk to your doctor or pharmacist before taking Doxazosin:
• suffer from serious heart problems such as e.g. severely reduced cardiac
function or a restrictive and painful sensation in the chest (angina
pectoris);
• are on a strict low-salt diet;
• are using diuretics;
• have kidney or liver problems.
If you are undergoing eye surgery because of cataract (cloudiness of the
lens) please inform your eye specialist before the operation that you are using
or have previously used Doxazosin. This is because Doxazosin may cause
complications during the surgery which can be managed if your specialist is
prepared in advance.
Important information about Doxazosin
The likelihood of your blood pressure dropping too fast is greatest at the
start of treatment or when the dosage is increased. You may observe this as
dizziness or more rarely fainting when changing position. To reduce the risk
of this happening, your doctor will check your blood pressure thoroughly at
the start of treatment and when the dosage is increased. You should therefore
avoid situations at the start of treatment in which dizziness or faintness could
cause injury.
Doxazosin may also affect the results of some blood and urine tests. If you
are due to have a blood or urine test make sure that you tell you are taking
Doxazosin.
Children and adolescents
Doxazosin is not recommended for use in children or adolescents below
18 years as safety and efficacy have not yet been established.

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Doxazosin

Package leaflet: Information for the user

Doxazosin

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Other medicines and Doxazosin
Tell your doctor or pharmacist if you are taking or have recently taken or might
take any other medicines.
• Some patients who take alpha-blocker therapy for the treatment of high
blood pressure or prostate enlargement may experience dizziness or lightheadedness, which may be caused by low blood pressure upon sitting or
standing up quickly. Certain patients have experienced these symptoms
when taking drugs for erectile dysfunction (impotence) with alpha-blockers.
In order to reduce the likelihood that these symptoms occur, you should
be on a regular daily dose of your alpha-blocker before you start drugs for
erectile dysfunction.
• Doxazosin may lower your blood pressure even more if you are already
taking other medicines to treat high blood pressure such as terazosin and
prazosin;
• nitrates (medicines for heart problems) such as nitroglycerine and
isosorbide nitrate: these can exacerbate the hypotensive effect;
• certain painkillers for rheumatism (known as non-steroidal antiinflammatory drugs) such as naproxen, ibuprofen or any other antiinflamatory painkiller: these can reduce the hypotensive effect;
• medications that could also possibly affect the liver metabolism, e.g.
cimetidine (a medicine for stomach problems);
Pregnancy, breast-feeding 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 or think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Doxazosin should only be used during pregnancy if your doctor decides that
the benefits for the mother outweigh the possible risk for the foetus.
Do not breast feed while taking Doxazosin.
Driving and using machines
Doxazosin can sometimes cause dizziness or fainting. In such an event,
you should exercise care during activities that require attentiveness, such
as driving, operating machinery and working at heights. If you are unsure
whether Doxazosin is having a negative effect on your ability to drive, discuss
this with your doctor.
Doxazosin contains lactose. If you have been told by your doctor that you
have an intolerance to some sugars contact your doctor before taking this
medicinal product.
3. How to take Doxazosin
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
The recommended dose is:
HIGH BLOOD PRESSURE
The initial dose is 1mg daily (= 24 hours) in a single dose. After 1 to 2 weeks,
the dose is generally increased to 2mg in a single daily dose (= 24 hours).
This dose is also retained for 1 to 2 weeks. If necessary, the dosage can be
further increased to 4, 8 or 16mg per day, until the desired reduction in blood
pressure is achieved. The maximum daily dose is 16mg.
An initial dose should preferably be taken before going to bed; this means that
any dizziness you may experience is less of a problem.
ENLARGED PROSTATE
The initial dose is 1mg daily (= 24 hours) in a single dose. After this the usual
dose is 2mg or 4mg daily. In some circumstances this may be increased to a
maximum of 8mg daily.
The tablets should be taken as a single dose each day (= 24 hours). The
tablets must be taken with plenty of water.
If you take more Doxazosin than you should
If you have taken more than the prescribed dose, you should consult your
doctor and/or pharmacist immediately. If you feel extremely dizzy or think you
might faint, you should lie down immediately with your head down.
If you forget to take Doxazosin
If you have forgotten to take a tablet, then skip it and take the next tablet at
the usual time. You should check with your doctor or pharmacist if you are
unsure. Do not take a double dose to make up for a forgotten dose.
If you stop taking Doxazosin
If you suddenly stop taking doxazosin, the complaints you suffered prior to
the start of treatment may recur. It is therefore better not to stop taking this
medication suddenly. Your doctor will decrease the dosage gradually. You
should always check with your doctor or pharmacist if you are unsure.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

Some side effects could be serious:
If any of the following happens, stop taking this medicine and tell your doctor
immediately or go to the casualty department at your nearest hospital:
• Allergic reactions such as wheezing, shortness of breath, extreme
dizziness or collapse, swelling of the face or throat, or a serious skin rash
with red spots or blisters (especially affecting the whole body).
• Chest pain (angina pectoris), increased or irregular heartbeat,
heart attack or stroke(symptoms may include collapse, numbness or
weakness of the arms or legs, headache, dizziness and confusion, visual
disturbance, difficulty swallowing, slurred speech, and loss of speech).
• Yellowing of the skin or whites of the eyes, caused by liver problems
(jaundice).
• Unusual bruising or bleeding caused by low blood platelets.
• Presence of blood in the urine
• Hepatitis (liver disease with nausea, vomiting, loss of appetite, generally
feeling unwell, fever)
• Cholestasis (blocked flow of bile - can cause itchy skin, pale stool, and
dark urine)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.By reporting side effects you can help provide
more information on the safety of this medicine.

These side effects are uncommon (affects 1 to 10 users in 1,000) or rare
(affects 1 to 10 users in 10,000)

6. Contents of the pack and other information

Common: (may affect up to 1 in 10 people):
• respiratory tract infection(nose, throat, lung)
• urinary tract infection(symptoms may include: pain or a burning sensation
when you urinate or a
• frequent need to urinate), urinary incontinence (inability to control passing
urine)
• dizziness, sleepiness (somnolence), headache
• feeling of dizziness or “spinning” (vertigo)
• feeling or sensation of irregular heartbeat (palpitation), increased heart
rate
• low blood pressure and low blood pressure as a result of getting up from a
sitting or lying position (postural hypotension)
• inflammation of the air passages within the lungs, cough, shortage of
breath, nasal stuffiness and/or runny nose
• abdominal pain, indigestion, dry mouth, feeling sick (nausea)
• itching (pruritus)
• back pain, muscle pain (myalgia)
• inflammation of the bladder (cystitis)
• feeling of weakness (asthenia), chest pain, influenza like symptoms
• swelling of the ankles, feet or fingers (peripheral oedema)
Uncommon: (may affect 1 in 100 people):
• gout, increased appetite, anorexia (loss of appetite)
• agitation, depression, anxiety, sleeplessness (insomnia), nervousness,
tremor
• stroke, reduced sense of touch or sensation, fainting
• ringing or noise in the ears (tinnitus)
• flushing
• nosebleed
• constipation, flatulence, vomiting (being sick), inflammation of the
gastrointestinal tract, diarrhoea
• abnormal liver function test
• skin rash
• joint pain
• painful or difficult urination
• difficulty to develop an erection (impotence)
• pain, swelling of the face
• weight increase.
Very Rare (may affect up to 1 in 10000 people):
• dizziness postural (dizziness as a result of getting up from a sitting or lying
position),tingling or numbness of the hands and feet (paraesthesia)
• reduced number of white blood cells(symptoms may include frequent
infections such as fever, severe chills, sore throat or mouth ulcers)
• blurred vision
• reduced heart rate
• hot flushes
• bronchial spasm (difficulty in breathing, wheezing or coughing)
• muscle cramps, muscle weakness
• polyuria (passing large volumes of urine)
• increased blood levels of urea and creatin
• hives (urticaria) , hair loss (alopecia), rash caused by bleeding under the
skin (purpura)
• disorder in passing urine, needing to pass urine at night, increased volume
of urine passed
• temporary enlargement of the breasts in men (gynaecomastia), painful
persistent erection
• feeling tired (fatigue), malaise (general feeling of being unwell)
Not known (frequency cannot be estimated from available data):
• eye problems may occur during eye surgery for cataract (cloudiness of the
lens of the eye). See section “Take special care with Doxazosin”.
• little or no semen ejaculated at sexual climax, cloudy urine following
sexual climax (retrograde ejaculation)

Do not use this medicine after the expiry date which is stated on the blister, ,
label, bottle and carton after EXP. The expiry date refers to the last day of that
month.
This medicinal product does not require any special storage condition.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment
What Doxazosin contains
- The active substance is doxazosin. Each tablet contains 1/2/4/8 mg
doxazosin (as doxazosin mesilate).
- The other ingredients are: Cellulose microcrystalline, lactose anhydrous,
sodium starch glycollate, magnesium stearate
What Doxazosin looks like and contents of the pack
Doxazosin 1mg tablets:
White to off-white coloured, circular biconvex shaped uncoated tablet
debossed with H on one side and 01 on other side.
Doxazosin 2mg tablets:
White to off-white coloured, caplet shaped uncoated tablet debossed with H02
on one side and breakline on other side.
The tablet can be divided into equal halves.
Doxazosin 4mg tablets:
White to off-white coloured, diamond shaped uncoated tablet debossed with
H03 on one side and breakline on other side.
The tablet can be divided into equal halves.
Doxazosin 8mg Tablets:
White to off-white coloured, caplet shaped uncoated tablet debossed with H04
on one side and breakline on other side.
The tablet can be divided into equal halves.
PVC-PVDC Aluminium blisters:
Pack size: 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 140 tablets
HDPE bottle:
Pack size: 100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurobindo Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913
Malta
Manufacturer
Milpharm Limited
Ares, Odyssey Business Park, West End Road,
South Ruislip HA4 6QD.
United Kingdom
or
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the Member States of the EEA
under the following names:
Bulgaria:
Doxazosin Aurobindo 1mg/ 2mg/ 4mg тaблетки
Czech Republic: Doxazosin Aurobindo 4mg tablety
Germany:
Doxazosin Aurobindo 1mg/ 2mg/ 4mg/ 8mg Tabletten
Hungary:
Doxazosin Aurobindo 2mg/ 4mg tabletta
Ireland: Doxazosin Aurobindo 1mg/ 2mg/ 4mg tablets
Italy:
Doxazosin Aurobindo 2mg/ 4mg compresse
Poland:
Doxazosin Aurobindo
Spain: DOXAZOSINA AUROBINDO 2mg/ 4mg comprimidos
United Kingdom: Doxazosin 1mg/ 2mg/ 4mg/ 8mg tablets
This leaflet was last revised in 07/2016.

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Other side effects:

5. How to store Doxazosin
Keep this medicine out of the sight and reach of children.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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