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PRAZOSIN 1MG TABLETS

Active substance(s): PRAZOSIN HYDROCHLORIDE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

HYPOVASE® 1mg TABLETS/PRAZOSIN 1mg TABLETS
(prazosin hydrochloride)
Patient Information Leaflet
Throughout this leaflet this product will be collectively referred to as 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.

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 beta-blockers which are usually given to treat angina
and/or high blood pressure.
• medicines for erectile dysfunction (impotence).

UK PIL DATED MAY 2010
REPORTING OF SIDE EFFECTS

CODE:

PRODUCT:

CUSTOMER:

WARNING!

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.

TVT CHECKED

DATE:
20/02/14

DATE:

DT

DATE OF PROOF:

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.

Hypovase 1mg tabs

ARTWORKER:

CUSTOMER
APPROVED:
04-1957
PRE-PRESS NO.:

Q.A.
APPROVED:

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.

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 breast-feeding, 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 light-headed 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.
You will find more about HYPOVASE on the back of this leaflet

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WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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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
6. Further information

PROOF HISTORY:
v.1
- 20/02/14

Leaflet Flat Size = 148 x 432

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.

WARNING!

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

Leaflet Flat Size = 148 x 432

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FONT SIZE 8
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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:

By reporting side effects you can help provide more information on the safety of this medicine.








5. How to store Hypovase
Do not store Hypovase tablets/Prazosin tablets above 30°C. Store in the original package in a
dry place. The expiry date refers to the last day of that month.
Do not use after the expiry date printed on the carton label or blister strip.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
The tablets should be whole to work effectively, however if you notice any defects (such as broken
tablets) consult your doctor or pharmacist immediately.
If the tablets become discoloured or show any other signs of deterioration, you should seek the
advice of your pharmacist.
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
Each Hypovase 1mg tablet/Prazosin 1mg tablet contains 1mg of the active ingredient, prazosin (as the
hydrochloride) in a white, oblong tablet which is marked ‘M’ breakline ‘6’ on one side and a breakline on the
reverse.
Hypovase 1mg tablets/Prazosin 1mg tablets also contain the following:
maize starch, microcrystalline cellulose, calcium phosphate dibasic anhydrous, magnesium stearate, and
sodium lauryl sulphate.
Hypovase 1mg tablets/Prazosin 1mg tablets are available in blister packs of 30 and 60 tablets.
POM

PL No: 18799/2720 Hypovase 1mg tablets/Prazosin 1mg tablets

This product is manufactured by Farmasierra Manufacturing, S.L., Ctra. N-1, km 26,200-28700 San
Sebastian de los Reyes (Madrid), Spain and procured from within the EU and repackaged by the Product
Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Leaflet revision and issue date (Ref.)
Hypovase® is a registered trademark of Pfizer limited.

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Ž>iAfW

ËSifT

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

UK PIL DATED MAY 2010
REPORTING OF SIDE EFFECTS

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.

WARNING!

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
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.

TVT CHECKED
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20/02/14
DATE OF PROOF:

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

CODE:

DATE:

DT
ARTWORKER:
Hypovase 1mg tabs
PRODUCT:

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:

DATE:

Q.A.
APPROVED:
PRE-PRESS NO.:
CUSTOMER:

WARNING!

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

04-1957

CUSTOMER
APPROVED:

PROOF HISTORY:
v.1
- 20/02/14

«PAdBì

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.

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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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