PRAZOSIN 1 MG TABLETS

Active substance: PRAZOSIN HYDROCHLORIDE

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Patient Information Leaflet
®

Hypovase 1 mg
Tablets
(prazosin)

Read all of this leaflet carefully before
you start taking this medicine.
 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.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
 If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
The name of your medicine is Hypovase® 1 mg
Tablets but it will be referred as Hypovase
throughout this leaflet. Your medicine is also
available in the following strength: 2 & 5 mg

In this leaflet:
1 What Hypovase is and what it is used for
2 Before you take Hypovase
3 How to take Hypovase
4 Possible side effects
5 How to store Hypovase

1. What Hypovase is and what it is
used for
Hypovase is one of a group of medicines
called alpha-blockers.
It is usually used to treat high blood pressure
(hypertension).
It may also be used to treat heart failure,
painful cold fingers (Raynaud’s Disease) or
mild enlargement of the prostate gland
(prostatic hyperplasia) in men.
In patients with high blood pressure
(hypertension) Hypovase works by relaxing
blood vessels so that blood passes through
them more easily. It can be used alone or in
combination with other drugs used to treat
hypertension.
In patients with heart failure, Hypovase works
by relaxing the main blood vessels of the
heart, allowing the heart to pump blood more
easily. Hypovase is usually used in heart
failure when other drugs are either no longer
working or have not worked at all.

In patients with Raynaud’s Disease the
treatment relaxes blood vessels in the hands,
so blood can reach the fingers more easily.
This helps to prevent coldness and stiffness.
In patients with enlargement of the prostate
gland the treatment is taken to treat poor
and/or frequent passing of urine. This is
common in patients with enlargement of the
prostate gland.
The treatment works by relaxing muscle
around the bladder and prostate gland so urine
is passed more easily.
You should ask your doctor if you are unsure
why you have been given Hypovase.

2. Before you take Hypovase
Do not take Hypovase if you:
 are allergic (hypersensitive) to prazosin, or to
any similar drugs (known as quinazoline
drugs) or any of the other ingredients listed
in section 6. This may have caused itching,
reddening of the skin or difficulty in
breathing.
 are under 12 years of age.

Take special care with Hypovase
Medicines are not always suitable for
everyone. Your doctor needs to know before
you take Hypovase if any of the following apply
to you:
 you have heart failure because of another
heart condition, e.g. heart valve disease, or a
recent heart attack. If you have heart failure,
Hypovase can gradually become less helpful
over several months. If this happens you
may notice swelling of your legs or ankles
due to retention of fluid. This is called
‘oedema’. If you develop oedema or weight
gain tell your doctor as your doctor may need
to change the dose of Hypovase or other
medicines you are taking.
 you have ever fainted after passing urine.
 you have liver or kidney disease.
 you are undergoing eye surgery because of
a cataract (cloudiness of the lens). This is
because Hypovase may cause complications
during the surgery which can be managed if
your specialist is prepared in advance.
Please inform your eye specialist before the
operation that you are using or have
previously used Hypovase.

Remember to tell your doctor that you are
taking Hypovase if you have any tests, such as
a urine test, as Hypovase may affect the result.

Taking other medicines
Some medicines can affect the way Hypovase
works. If you are taking any of the following
medicines tell your doctor before you start the
treatment:
 calcium antagonists, ACE inhibitors or betablockers which are usually given to treat
angina and/or high blood pressure.
 medicines for erectile dysfunction
(impotence).
Some patients who take Hypovase for the
treatment of high blood pressure or prostate
enlargement may experience dizziness or
light-headedness, 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 Hypovase. In
order to reduce the likelihood that these
symptoms occur, you should be on a regular
daily dose of Hypovase before you start drugs
for erectile dysfunction.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

Taking Hypovase with food and
drink
Hypovase can be taken before or after food
and drinks.

Pregnancy and Breast-feeding
If you are pregnant, planning to get pregnant
or are breastfeeding, tell your doctor before
you take Hypovase.
Ask your doctor or pharmacist for advice
before taking any medicine.

Driving and using machines
Hypovase may cause dizziness, drowsiness or
weakness. If you experience these symptoms,
do not drive or use any tools or machinery.

3. How to take Hypovase
Always take Hypovase exactly as you doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
Hypovase tablets are to be taken by mouth.
Sometimes Hypovase can make you feel lightheaded or weak particularly when you first take
it. This can happen when standing up and can
occasionally cause fainting. If the treatment
makes you feel light-headed or weak; lie down
until you feel better. Get up slowly when you
feel better. If you are concerned, tell your
doctor.
Hypovase is usually started at the lowest
possible dose and gradually increased,
depending on how you respond to treatment.
Do not change the dose or stop taking the
tablets without first checking with your doctor.
Make sure you get a new prescription before
your tablets run out.

High blood pressure (hypertension)
The recommended starting dose is one 0.5 mg
tablet, two or three times a day for 3 to 7 days
with the starting dose taken in the evening.
The dose is usually then increased to a 1 mg
tablet taken two or three times a day for a
further 3 to 7 days. Your doctor may then
advise you to gradually increase the dose
further (up to a maximum of 20 mg daily)
depending on how your blood pressure has
responded to treatment.

Heart failure
The recommended starting dose is one 0.5 mg
tablet taken two, three or four times a day.
Your doctor may then advise you to increase
the dose further (up to a maximum of 20 mg
daily) depending on how you have responded
to treatment.

Raynaud’s disease
The recommended starting dose is one 0.5 mg
tablet, twice a day for 3 to 7 days.
Your doctor may then advise you to increase
the dose further (up to 2 mg twice a day)
depending on how you have responded to
treatment.

Enlarged prostate
The recommended starting dose is one 0.5 mg
tablet, twice a day for 3 to 7 days, with the
initial dose taken in the evening.
Your doctor may then advise you to increase
the dose further (up to 2 mg twice a day)
depending on how you have responded to
treatment.

If you take more Hypovase than you
should
If you accidentally take too much Hypovase,
contact your doctor immediately or go to your
nearest hospital casualty department.
Always take the labelled medicine package
with you, whether there is any Hypovase left or
not.

If you forget to take Hypovase
If you forget to take a dose, take it as soon as
you remember unless it is time for your next
dose. Do not take a double dose to make up
for a missed dose.

If you stop taking Hypovase
Do not stop taking Hypovase unless your
doctor tells you to.
Your condition may return if you stop using
Hypovase.
If you have any further questions on how to
take this product, ask your doctor or
pharmacist.

4. Possible side effects
Hypovase, like most medicines may cause
side effects, but not everybody gets them.
Tell your doctor immediately if you experience
any of the following symptoms after taking this
medicine. Although they are very rare, the
symptoms can be severe:
 Sudden wheeziness, difficulty in breathing,
swelling of eyelids, face or lips, rash or
itching (especially affecting the whole body).
The following side effects have been reported
with Hypovase:
Common side effects (occurring in less
than 1 in 10 patients):
 feeling faint, fainting or feeling dizzy,
particularly on standing-up (see section 3
‘How to take Hypovase’
 headache, drowsiness or weakness

 unpleasant sensation of forceful beating of
the heart (palpitations)
 feeling or being sick
 lack of energy, depression or nervousness
 constipation or diarrhoea
 dry mouth, nasal stuffiness or blurred vision
 shortness of breath or rash
 swelling of the feet, ankles or legs
 increase in frequency of passing urine
If any of these cause you problems or if they
last for more than one week, you should
contact your doctor.
Other side effects that have been reported are
listed below:
Uncommon side-effects (occurring in less
than
1 in 100 patients)
 stomach discomfort and/or pain
 chest pain or abnormally fast heart beat
 tingling sensation or numbness
 buzzing or ringing in the ear
 nose bleeds, eye pain or red eyes
 difficulty sleeping
 sweating, itching or itchy skin rash
 painful joints
 inability or difficulty in achieving erection of
the penis
Rare side effects (occurring in less than 1
in 1000 patients)
 abnormal blood tests that check for liver
function
 pain or infection in the pancreas
 abnormally slow heartbeat
 hallucinations (imagining things which are
not really there)
 hair loss
 low blood pressure
 flushing (redness)
 positive ANA (a blood test that checks
function of the immune system)
 abnormal breast tissue development,
especially in men
 persistent erection of the penis
 an increased tendency to fall asleep if you
have a sleep disorder (narcolepsy)
 leaking of urine (incontinence)
 fever or pain
 inflammation of blood vessels

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.

5. How to store Hypovase
Keep out of the sight and reach of children.
Do not use Hypovase after the expiry date
which is stamped on the pack after EXP. The
expiry date refers to the last day of that month.
Do not store above 30°C.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Further Information
What Hypovase contains
Hypovase tablets are white and oblong shaped
scored on both sides and engraved “M6” on
one side.
The active ingredient in Hypovase is prazosin
hydrochloride.
Each tablet contains 1mg of prazosin (as
hydrochloride).
Also contains: microcrystalline cellulose,
calcium phosphate dibasic anhydrous,
magnesium stearate, maize starch and sodium
lauryl sulphate.
Hypovase tablets are available in blister packs
of 60 tablets.
Manufactured by: Farmasierra Manufacturing,
S.L. Ctra. N-I, Km 26,200, 28700 San
Sebastian de los Reyes, Madrid, Spain.
Procured from within the EU & repackaged
by Product Licence holder:
Kosei Pharma UK Ltd., 956 Buckingham
Avenue, Slough, SL1 4NL.
Hypovase® 1mg Tablets
PL No: 39352/0227

POM

Hypovase is a registered trademark of Pfizer
Products Inc.
Leaflet date: 06.03.2014

Patient Information Leaflet

Prazosin 1 mg Tablets
Read all of this leaflet carefully before
you start taking this medicine.
 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.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
 If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
The name of your medicine is Prazosin 1 mg
Tablets but it will be referred as Prazosin
throughout this leaflet. Your medicine is also
available in the following strength: 2 & 5 mg.

In this leaflet:
1 What Prazosin is and what it is used for
2 Before you take Prazosin
3 How to take Prazosin
4 Possible side effects
5 How to store Prazosin

2. What Prazosin is and what it is
used for
Prazosin is one of a group of medicines called
alpha-blockers.
It is usually used to treat high blood pressure
(hypertension).
It may also be used to treat heart failure,
painful cold fingers (Raynaud’s Disease) or
mild enlargement of the prostate gland
(prostatic hyperplasia) in men.
In patients with high blood pressure
(hypertension) Prazosin works by relaxing
blood vessels so that blood passes through
them more easily. It can be used alone or in
combination with other drugs used to treat
hypertension.
In patients with heart failure, Prazosin works
by relaxing the main blood vessels of the
heart, allowing the heart to pump blood more
easily. Prazosin is usually used in heart failure
when other drugs are either no longer working
or have not worked at all.

In patients with Raynaud’s Disease the
treatment relaxes blood vessels in the hands,
so blood can reach the fingers more easily.
This helps to prevent coldness and stiffness.
In patients with enlargement of the prostate
gland the treatment is taken to treat poor
and/or frequent passing of urine. This is
common in patients with enlargement of the
prostate gland.
The treatment works by relaxing muscle
around the bladder and prostate gland so urine
is passed more easily.
You should ask your doctor if you are unsure
why you have been given Prazosin.

2. Before you take Prazosin
Do not take Prazosin if you:
 are allergic (hypersensitive) to prazosin, or to
any similar drugs (known as quinazoline
drugs) or any of the other ingredients listed
in section 6. This may have caused itching,
reddening of the skin or difficulty in
breathing.
 are under 12 years of age.

Take special care with Prazosin
Medicines are not always suitable for
everyone. Your doctor needs to know before
you take Prazosin if any of the following apply
to you:
 you have heart failure because of another
heart condition, e.g. heart valve disease, or a
recent heart attack. If you have heart failure,
Prazosin can gradually become less helpful
over several months. If this happens you
may notice swelling of your legs or ankles
due to retention of fluid. This is called
‘oedema’. If you develop oedema or weight
gain tell your doctor as your doctor may need
to change the dose of Prazosin or other
medicines you are taking.
 you have ever fainted after passing urine.
 you have liver or kidney disease.
 you are undergoing eye surgery because of
a cataract (cloudiness of the lens). This is
because Prazosin may cause complications
during the surgery which can be managed if
your specialist is prepared in advance.
Please inform your eye specialist before the
operation that you are using or have
previously used Prazosin.

Remember to tell your doctor that you are
taking Prazosin if you have any tests, such as
a urine test, as Prazosin may affect the result.

Taking other medicines
Some medicines can affect the way Prazosin
works. If you are taking any of the following
medicines tell your doctor before you start the
treatment:
 calcium antagonists, ACE inhibitors or betablockers which are usually given to treat
angina and/or high blood pressure.
 medicines for erectile dysfunction
(impotence).
Some patients who take Prazosin for the
treatment of high blood pressure or prostate
enlargement may experience dizziness or
light-headedness, 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 Prazosin. In order
to reduce the likelihood that these symptoms
occur, you should be on a regular daily dose of
Prazosin before you start drugs for erectile
dysfunction.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

Taking Prazosin with food and drink
Prazosin can be taken before or after food and
drinks.

Pregnancy and Breast-feeding
If you are pregnant, planning to get pregnant
or are breastfeeding, tell your doctor before
you take Prazosin.
Ask your doctor or pharmacist for advice
before taking any medicine.

Driving and using machines
Prazosin may cause dizziness, drowsiness or
weakness. If you experience these symptoms,
do not drive or use any tools or machinery.

3. How to take Prazosin
Always take Prazosin exactly as you doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
Prazosin tablets are to be taken by mouth.
Sometimes Prazosin can make you feel lightheaded or weak particularly when you first take
it. This can happen when standing up and can
occasionally cause fainting. If the treatment
makes you feel light-headed or weak; lie down
until you feel better. Get up slowly when you
feel better. If you are concerned, tell your
doctor.
Prazosin is usually started at the lowest
possible dose and gradually increased,
depending on how you respond to treatment.
Do not change the dose or stop taking the
tablets without first checking with your doctor.
Make sure you get a new prescription before
your tablets run out.

High blood pressure (hypertension)
The recommended starting dose is one 0.5 mg
tablet, two or three times a day for 3 to 7 days
with the starting dose taken in the evening.
The dose is usually then increased to a 1 mg
tablet taken two or three times a day for a
further 3 to 7 days. Your doctor may then
advise you to gradually increase the dose
further (up to a maximum of 20 mg daily)
depending on how your blood pressure has
responded to treatment.

Heart failure
The recommended starting dose is one 0.5 mg
tablet taken two, three or four times a day.
Your doctor may then advise you to increase
the dose further (up to a maximum of 20 mg
daily) depending on how you have responded
to treatment.

Raynaud’s disease
The recommended starting dose is one 0.5 mg
tablet, twice a day for 3 to 7 days.
Your doctor may then advise you to increase
the dose further (up to 2 mg twice a day)
depending on how you have responded to
treatment.

Enlarged prostate
The recommended starting dose is one 0.5 mg
tablet, twice a day for 3 to 7 days, with the
initial dose taken in the evening.
Your doctor may then advise you to increase
the dose further (up to 2 mg twice a day)
depending on how you have responded to
treatment.

If you take more Prazosin than you
should
If you accidentally take too much Prazosin,
contact your doctor immediately or go to your
nearest hospital casualty department.
Always take the labelled medicine package
with you, whether there is any Prazosin left or
not.

If you forget to take Prazosin
If you forget to take a dose, take it as soon as
you remember unless it is time for your next
dose. Do not take a double dose to make up
for a missed dose.

If you stop taking Prazosin
Do not stop taking Prazosin unless your doctor
tells you to.
Your condition may return if you stop using
Prazosin.
If you have any further questions on how to
take this product, ask your doctor or
pharmacist.

4. Possible side effects
Prazosin, like most medicines may cause side
effects, but not everybody gets them.
Tell your doctor immediately if you experience
any of the following symptoms after taking this
medicine. Although they are very rare, the
symptoms can be severe:
 Sudden wheeziness, difficulty in breathing,
swelling of eyelids, face or lips, rash or
itching (especially affecting the whole body).
The following side effects have been reported
with Prazosin:
Common side effects (occurring in less
than 1 in 10 patients):
 feeling faint, fainting or feeling dizzy,
particularly on standing-up (see section 3
‘How to take Prazosin’
 headache, drowsiness or weakness

 unpleasant sensation of forceful beating of
the heart (palpitations)
 feeling or being sick
 lack of energy, depression or nervousness
 constipation or diarrhoea
 dry mouth, nasal stuffiness or blurred vision
 shortness of breath or rash
 swelling of the feet, ankles or legs
 increase in frequency of passing urine
If any of these cause you problems or if they
last for more than one week, you should
contact your doctor.
Other side effects that have been reported are
listed below:
Uncommon side-effects (occurring in less
than
1 in 100 patients)
 stomach discomfort and/or pain
 chest pain or abnormally fast heart beat
 tingling sensation or numbness
 buzzing or ringing in the ear
 nose bleeds, eye pain or red eyes
 difficulty sleeping
 sweating, itching or itchy skin rash
 painful joints
 inability or difficulty in achieving erection of
the penis
Rare side effects (occurring in less than 1
in 1000 patients)
 abnormal blood tests that check for liver
function
 pain or infection in the pancreas
 abnormally slow heartbeat
 hallucinations (imagining things which are
not really there)
 hair loss
 low blood pressure
 flushing (redness)
 positive ANA (a blood test that checks
function of the immune system)
 abnormal breast tissue development,
especially in men
 persistent erection of the penis
 an increased tendency to fall asleep if you
have a sleep disorder (narcolepsy)
 leaking of urine (incontinence)
 fever or pain
 inflammation of blood vessels

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.

5. How to store Prazosin
Keep out of the sight and reach of children.
Do not use Prazosin after the expiry date
which is stamped on the pack after EXP. The
expiry date refers to the last day of that month.
Do not store above 30°C.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Further Information
What Prazosin contains
Prazosin tablets are white and oblong shaped
scored on both sides and engraved “M6” on
one side.
The active ingredient in Prazosin is prazosin
hydrochloride.
Each tablet contains 1mg of prazosin (as
hydrochloride).
Also contains: microcrystalline cellulose,
calcium phosphate dibasic anhydrous,
magnesium stearate, maize starch and sodium
lauryl sulphate.
Prazosin tablets are available in blister packs
of 60 tablets.
Manufactured by: Farmasierra Manufacturing,
S.L. Ctra. N-I, Km 26,200, 28700 San
Sebastian de los Reyes, Madrid, Spain.
Procured from within the EU & repackaged
by Product Licence holder:
Kosei Pharma UK Ltd., 956 Buckingham
Avenue, Slough, SL1 4NL.
Prazosin 1 mg Tablets
PL No: 39352/0227
Leaflet date: 06.03.2014

POM

Expand view ⇕

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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