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HYDRALAZINE 25 MG TABLETS

Active substance(s): HYDRALAZINE HYDROCHLORIDE

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Patient Information Leaflet

Apresoline® 25 mg Tablets
(hydralazine hydrochloride)
This product is available as the above name but will be
referred to as Apresoline Tablets throughout this leaflet.
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 or are not sure about
anything please 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 Tablets are and what they are used for
2. Before you take Apresoline Tablets
3. How to take Apresoline Tablets
4. Possible side effects
5. How to store Apresoline Tablets
6. Further information
1. WHAT APRESOLINE TABLETS ARE AND WHAT
THEY ARE USED FOR
The name of your medicine is Apresoline® 25 mg Tablets.
The active ingredient is hydralazine hydrochloride.
Hydralazine hydrochloride belongs to a group of medicines
called antihypertensives.
Apresoline Tablets are used to treat high blood pressure
and heart failure.
It works by relaxing blood vessels and increasing the
supply of blood and oxygen to the heart.
2. BEFORE YOU TAKE APRESOLINE TABLETS
Do not take Apresoline Tablets 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 Tablets are not recommended for use in
children.
Take special care with Apresoline Tablets 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 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,
please tell your doctor before taking Apresoline
Tablets.

Taking 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 or diltiazem);
• medicines for water retention (e.g. diuretics);
• medicines for problems such as depression, including
monoamine oxidase inhibitors (MAOls) (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 Tablets.
Taking Apresoline Tablets with food and drink
It is advisable not to drink alcohol whilst taking Apresoline
Tablets as it may affect you more than usual.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breastfeeding, please tell your doctor before taking Apresoline
Tablets.
Driving and using machines
You can drive while taking Apresoline Tablets but do not
drive until you know how the tablets affect you.
They may make you feel dizzy. If they affect you in this
way, do not drive or operate any machinery.
Important information about some of the ingredients
of Apresoline Tablets
Apresoline Tablets contain sucrose. 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 APRESOLINE TABLETS
Always take Apresoline Tablets exactly as your doctor has
told you. You should check with your doctor or pharmacist
if you are not sure.
Adults
High blood pressure: The usual starting dose is one
tablet (25 mg) taken twice a day. This may be increased
up to 8 tablets a day (maximum of 200mg) by your doctor.
Heart failure: Treatment should be started in hospital, at a
dose of 25 mg three or four times a day. 50 mg to 75mg
four times a day is often given as a long-term dose. Your
doctor will adjust the dose to suit you.
Children
Apresoline Tablets are not recommended for use in
children.
The tablets should be taken with a drink of water. Ask your
doctor before stopping treatment with Apresoline Tablets,
as treatment should be stopped gradually over several
days.

If you take more Apresoline Tablets than you should
If you take more Apresoline Tablets than you should,
contact your doctor or go to your nearest hospital
emergency department immediately. Take the container
and any remaining tablets with you.
If you forget to take Apresoline Tablets
If you forget to take a dose, just take the next dose at the
usual time, DO NOT take a double dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines Apresoline Tablets 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;
• Iow blood pressure;
• feeling sick and being sick, particularly at the beginning
of the treatment or after an 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 susceptible 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 of 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 if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist immediately.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 or search for MHRA Yellow
Card in the Google Play or Apple App Store. By
reporting side effects, you can help provide more
information on the safety of this medicine.
5. HOW TO STORE APRESOLINE TABLETS
Do not store above 30°C. Protect from heat and moisture.
Do not use Apresoline Tablets after the expiry date shown
on the container. The expiry date refers to the last day of
that month.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
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.
If your medicine become discoloured or show signs of any
deterioration, consult your doctor or pharmacist who will
tell you what to do.
6. FURTHER INFORMATION
What Apresoline Tablets contain
The active substance is hydralazine hydrochloride.
Each tablet contains 25 mg of hydralazine hydrochloride.
The other ingredients are: colloidal anhydrous silica,
cellulose, magnesium stearate (E572), povidone, maize
starch, hypromellose, kollidon VA64, talc (E553b),
macrogol 8000, saccharose (sucrose). Colourants: iron
oxide (E172), titanium dioxide (E171).
What Apresoline Tablets look like and the contents of
the pack
Apresoline Tablets are pale yellow, round, sugar coated
tablets marked with “GF” on one side and plain on the
other side. Apresoline Tablets are available in a plastic
container with a tamper evident screw cap.
Apresoline Tablets are available in packs of 100 tablets.
PL: 15814/1325

POM

Manufactured by Rottendorf Pharma GmbH, Ostenfelder
Strasse 51-61, 59320 Ennigerloh, Germany.
Procured from within the EU and repackaged by the
Product Licence holder: O.P.D. Laboratories Ltd., Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 04.01.2018.
Apresoline is a registered trademark of Amdipharm Ltd.

To request a copy of this leaflet
in Braille, large print or audio
please call 01923 332 796.

Patient Information Leaflet

Hydralazine 25 mg Tablets
(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 or are not sure about
anything please 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 Hydralazine 25 mg Tablets are and what they are
used for
2. Before you take Hydralazine 25 mg Tablets
3. How to take Hydralazine 25 mg Tablets
4. Possible side effects
5. How to store Hydralazine 25 mg Tablets
6. Further information
1. WHAT HYDRALAZINE 25 mg TABLETS ARE AND
WHAT THEY ARE USED FOR
The name of your medicine is Hydralazine 25 mg Tablets.
The active ingredient is hydralazine hydrochloride.
Hydralazine hydrochloride belongs to a group of medicines
called antihypertensives.
Hydralazine 25 mg Tablets are used to treat high blood
pressure and heart failure.
It works by relaxing blood vessels and increasing the
supply of blood and oxygen to the heart.
2. BEFORE YOU TAKE HYDRALAZINE 25 mg TABLETS
Do not take Hydralazine 25 mg Tablets 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
Hydralazine 25 mg Tablets are not recommended for
use in children.
Take special care with Hydralazine 25 mg Tablets 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 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,
please tell your doctor before taking Hydralazine
25 mg Tablets.

Taking 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 or diltiazem);
• medicines for water retention (e.g. diuretics);
• medicines for problems such as depression, including
monoamine oxidase inhibitors (MAOls) (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 Hydralazine 25 mg Tablets.
Taking Hydralazine 25 mg Tablets with food and drink
It is advisable not to drink alcohol whilst taking
Hydralazine 25 mg Tablets as it may affect you more than
usual.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breastfeeding, please tell your doctor before taking Hydralazine
25 mg Tablets.
Driving and using machines
You can drive while taking Hydralazine 25 mg Tablets but
do not drive until you know how the tablets affect you.
They may make you feel dizzy. If they affect you in this
way, do not drive or operate any machinery.
Important information about some of the ingredients
of Hydralazine 25 mg Tablets
Hydralazine 25 mg Tablets contain sucrose. 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 HYDRALAZINE 25 mg TABLETS
Always take Hydralazine 25 mg Tablets exactly as your
doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Adults
High blood pressure: The usual starting dose is one
tablet (25 mg) taken twice a day. This may be increased
up to 8 tablets a day (maximum of 200mg) by your doctor.
Heart failure: Treatment should be started in hospital, at a
dose of 25 mg three or four times a day. 50 mg to 75mg
four times a day is often given as a long-term dose. Your
doctor will adjust the dose to suit you.
Children
Hydralazine 25 mg Tablets are not recommended for use
in children.
The tablets should be taken with a drink of water. Ask your
doctor before stopping treatment with Hydralazine 25 mg
Tablets, as treatment should be stopped gradually over
several days.

If you take more Hydralazine 25 mg Tablets than you
should
If you take more Hydralazine 25 mg Tablets than you
should, contact your doctor or go to your nearest hospital
emergency department immediately. Take the container
and any remaining tablets with you.
If you forget to take Hydralazine 25 mg Tablets
If you forget to take a dose, just take the next dose at the
usual time, DO NOT take a double dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines Hydralazine 25 mg Tablets 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;
• Iow blood pressure;
• feeling sick and being sick, particularly at the beginning
of the treatment or after an 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 susceptible 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 of 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 if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist immediately.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 or search for MHRA Yellow
Card in the Google Play or Apple App Store. By
reporting side effects, you can help provide more
information on the safety of this medicine.
5. HOW TO STORE HYDRALAZINE 25 mg TABLETS
Do not store above 30°C. Protect from heat and moisture.
Do not use Hydralazine 25 mg Tablets after the expiry
date shown on the container. The expiry date refers to the
last day of that month.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
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.
If your medicine become discoloured or show signs of any
deterioration, consult your doctor or pharmacist who will
tell you what to do.
6. FURTHER INFORMATION
What Hydralazine 25 mg Tablets contain
The active substance is hydralazine hydrochloride.
Each tablet contains 25 mg of hydralazine hydrochloride.
The other ingredients are: colloidal anhydrous silica,
cellulose, magnesium stearate (E572), povidone, maize
starch, hypromellose, kollidon VA64, talc (E553b),
macrogol 8000, saccharose (sucrose). Colourants: iron
oxide (E172), titanium dioxide (E171).
What Hydralazine 25 mg Tablets look like and the
contents of the pack
Hydralazine 25 mg Tablets are pale yellow, round, sugar
coated tablets marked with “GF” on one side and plain on
the other side. Hydralazine 25 mg Tablets are available in
a plastic container with a tamper evident screw cap.
Hydralazine 25 mg Tablets are available in packs of 100
tablets.
PL: 15814/1325

POM

Manufactured by Rottendorf Pharma GmbH, Ostenfelder
Strasse 51-61, 59320 Ennigerloh, Germany.
Procured from within the EU and repackaged by the
Product Licence holder: O.P.D. Laboratories Ltd., Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 04.01.2018.

To request a copy of this leaflet
in Braille, large print or audio
please call 01923 332 796.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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