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APRESOLINE AMPOULES 20MG

Active substance(s): HYDRALAZINE HYDROCHLORIDE

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The usual dosage is 5 to 10 mg by intravenous
injection, and will be repeated if necessary
after 20 to 30 minutes.

Patient Information Leaflet
GBR 726-6836-APIL

Apresoline® Ampoules 20 mg
Hydralazine hydrochloride
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 becomes severe,
or if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Apresoline Ampoules 20 mg are and
what they are used for
2. Before you are given Apresoline
Ampoules 20 mg
3. How Apresoline Ampoules 20 mg
are given
4. Possible side effects
5. How to store Apresoline Ampoules 20 mg
6. Further information
1. WHAT APRESOLINE AMPOULES 20 MG
ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Apresoline
Ampoules 20 mg.
The active ingredient is hydralazine
hydrochloride in the form of a powder.
Hydralazine hydrochloride belongs to a
group of medicines called antihypertensives.
Apresoline is used to treat very high blood
pressure, particularly when this condition occurs
in pregnancy or in people with kidney disease.
It works by relaxing blood vessels which
increases the supply of blood and oxygen
to the heart.
2. BEFORE YOU ARE GIVEN APRESOLINE
AMPOULES 20 MG
You should not be given this medicine if you:
• are allergic to hydralazine, dihydralazine
or any of the other ingredients in this
medicine (allergic reactions include mild
symptoms such as itching and/or rash.
More severe symptoms include swelling of
the face, lips, tongue and/or throat with
difficulty in swallowing or breathing);
• have or have ever had a condition called
Systemic Lupus Erythematosus (SLE),
an autoimmune condition which causes
joint pain, skin rashes and fever;
• suffer from severe tachycardia or right
sided heart failure due to increased
pressure in the blood vessels of the lungs
(cor pulmonale);
• suffer from thyrotoxicosis (an excess of
thyroid hormones in the blood that can
cause a fast heartbeat, sweating, trembling,
anxiety, increased appetite, loss of weight
and intolerance of heat);
• have a condition known as porphyria.
Apresoline Ampoules 20 mg are not
recommended for use in children.
Take special care with Apresoline if you:
• have had a heart attack in the past three
months;







have angina pectoris, which causes pain in
the chest with exercise;
have cerebrovascular disease (narrowing
of the blood vessels in the brain);
have been told that you are a slow
acetylator (this means that your body
handles some medicines more slowly than
other people);
suffer from any serious liver or kidney
problems.

If any of the above apply to you, or if you are
not sure, tell your doctor before receiving
Apresoline Ampoules 20 mg.
Taking with other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
It is especially important that you tell your doctor if you are taking:
• medicines for high blood pressure, such
as vasodilators (e.g. minoxidil, diazoxide);
• ACE inhibitors (e.g. enalapril, lisinopril,
captopril);
• beta-blockers (e.g. propranolol);
• calcium antagonists (e.g. nifedipine,
diltiazem);
• medicines for water retention
(e.g. diuretics);
• medicines for problems such as
depression, including monoamine
oxidase inhibitors (MAOIs)
(e.g. moclobemide, phenelzine,
isocarboxazid, tranylcypromine), tricyclic
antidepressants
(e.g. amitriptyline, clomipramine) or
tranquillisers (e.g. diazepam);
• medicines to control pain and inflammation
(a group of medicines known as
Non-steroidal anti-inflammatory drugs
(NSAIDs));
• medicines to control psychoses;
• a specific group of medicines known as
nitrates, used to control blood pressure;
• oestrogens (a group of female sex
hormones used in contraception and in
treating the menopause).
If you are going to have a general anaesthetic,
you should tell the doctor or dentist in charge
that you are taking Apresoline Ampoules 20 mg.
Taking Apresoline with food and drink
It is advisable not to drink alcohol whilst taking Apresoline as it may affect you more than
usual.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or
breast-feeding, please tell your doctor before
being treated with Apresoline.
Driving and operating machinery
You can drive while being treated with Apresoline
but do not drive until you know how it affects
you. It may make you feel dizzy. If it affects you
in this way, do not drive or operate any machinery.
3. HOW APRESOLINE AMPOULES 20 MG
ARE GIVEN
This medicine will be given to you in hospital.
Your doctor will decide when and how to treat
you with this medicine. It can be given to you
in one of 2 ways:
- usually it is injected slowly into your vein
using a syringe, this is called an
intravenous injection or;
- it may be diluted further and injected very
slowly into your vein through a drip
(intravenous infusion).

Your blood pressure will be taken whilst you
are receiving treatment and the dose adjusted
to make sure that you have gradual fall in your
blood pressure to normal levels.
If you are given more medicine than you
should
As this medicine is given to you in hospital it
is very unlikely that an overdose will happen.
Should an overdose occur, the doctor will treat
any symptoms that follow.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Apresoline Ampoules
20 mg can cause side effects, although not
everybody gets them.
Stop taking the medicine and seek immediate
medical advice if you notice the following:
• SLE-type syndrome, which can cause
symptoms such as joint pain, fever, change
in blood count and skin rash.
• Allergic reactions including itching, skin
rash, inflammation of the walls of small
blood vessels and difficulty in breathing.
• Yellowing of the skin and whites of the eyes,
which may indicate problems with the liver
such as jaundice and hepatitis.
Other side effects may include:
Frequent effects
• Abnormal heart beat (palpitations);
• An unusually fast heart beat;
• Headaches;
Occasional side effects
• Chest pains;
• Swelling and/or pain in joints, muscle pain;
• Low blood pressure;
• Feeling sick and being sick, particularly at
the beginning of the treatment or after and
increase in dose;
• Diarrhoea;
• Flushing;
Rare side effects
• Heart failure, swelling;
• Increased levels of a substance called
creatinine in the blood;
• Breathlessness, breathing difficulties or pain
when breathing;
• Skin rash;
• Blood in the urine which may be associated
with a disease of the kidneys;
• Presence of protein in the urine;
• Inflammation or the abnormal functioning of
the liver;
• Watering or sore itchy eyes;
• A reduction in the number of platelets in the
blood which can cause unexplained bruising
or rashes;
• A reduction in red blood cells, which can
make you feel tired or breathless with
physical exertion;
• A reduction in certain white blood cells
which may make you more suscetible to
infections;
• An increase in other kinds of white blood cells;
• Fever;
• Anxiety;
• Restlessness;
• Blocked or stuffy nose;
• Loss of appetite;
• Weight loss;
• Dizziness;
• Generally feeling unwell.
Very rare side effects
• Kidney failure;
• A change in the amount of urine
produced;
• A restriction of movement in part of the
intestine;
• Episodes of high blood pressure;












A deficiency of certain white blood cells
which can result in fever and ulceration of
the mouth and throat;
An increased number of white blood cells;
Enlargement if the spleen;
A reduction in the number of red and white
blood cells and platelets in the blood;
Depression;
Seeing or hearing things which are not
really there (hallucinations);
Inflammation of the nerves which may
cause weakness or numbness especially in
your fingers and toes;
Tingling (pins and needles) in your hands or
feet;
Disease of the lymph nodes;
Enlarged eye balls.

If you feel very tired, experience unexpected
bruising or bleeding, or more infections (e.g.
colds and sore throats) than usual please tell
your doctor. Your doctor may decide to conduct
tests on your blood periodically as a result of
these symptoms.
If any of the side effects becomes severe, or
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist
immediately.
5. HOW TO STORE APRESOLINE
AMPOULES 20 MG
The ampoules will be stored in the hospital
and they will follow the instructions below.
The ampoules should be protected from light
and stored below 30˚C.
The doctor or nurse will check that the expiry
date on the label has not passed before you
are given the injection. The solution will be
used as soon as it has been made up.
KEEP OUT OF THE REACH AND SIGHT OF
CHILDREN
6. FURTHER INFORMATION
What Apresoline Ampoules 20 mg contain
Each ampoule contains 20 mg of the active
ingredient, hydralazine hydrochloride as a
powder. They also contain hydrochloric acid
(as an inactive ingredient).
What Apresoline Ampoules 20 mg look like
and the contents of the pack
Apresoline is provided as a powder in 2 ml
clear glass ampoules.
Each pack contains 5 ampoules.
Marketing Authorisation Holder and
Manufacturer
Waymade Plc, T/A Sovereign Medical,
Sovereign House,
Miles Gray Road,
Basildon,
Essex SS14 3FR.
Apresoline is a registered trademark.

Date of leaflet October 2010

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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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