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HYPOVASE TABLETS 0.5MG

Active substance(s): PRAZOSIN HYDROCHLORIDE

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Text only is subject to market approval.
PACKAGE LEAFLET: INFORMATION FOR THE USER
UNITED KINGDOM

Hypovase™ Tablets
0.5mg, 1mg
prazosin

Read all of this leaflet carefully before you start
taking this medicine.

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

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.

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 beta-blockers 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 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.

Heart failure



• 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.

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.

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.

You will find more about HYPOVASE on the back of this leaflet

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
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.

6. Further information
What Hypovase contains

The active substance in Hypovase is prazosin hydrochloride. Hypovase
tablets come in two strengths: 500 microgram (0.5 mg) and 1mg.
The other ingredients in each tablet are: microcrystalline cellulose,
calcium phosphate dibasic anhydrous, magnesium stearate, maize
starch and sodium lauryl sulphate.

What Hypovase looks like and contents of the pack

The 0.5 mg tablets are white and round marked “Pfizer” on one side.
The 1 mg tablets are white and oblong shaped scored on both sides
and engraved “M6” on one side.
Each pack of 0.5 mg tablets contains 4 blister strips of 15 tablets (60
tablets in total).
Each pack of 1 mg tablets contains 4 blister strips of 15 tablets (60
tablets in total).

Marketing Authorisation Holder

Pfizer Limited, Ramsgate Road, Sandwich,
Kent, CT13 9NJ, United Kingdom.

Manufacturer

Fareva Amboise, Zone Industrielle,
29 route des Industries, 37530 Pocé-sur-Cisse, France.
For further information on this medicine please contact
Pfizer Medical Information on 01304 616161.
This leaflet was last revised in 10/2014.
©Pfizer Limited

Ref: HY 11_0 UK

5. How to store Hypovase
Keep out of the reach and sight 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.
Store in a cool, dry, place below 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.

8811986

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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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