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APRESOLINE 25 MG TABLETS

Active substance(s): HYDRALAZINE HYDROCHLORIDE / HYDRALAZINE HYDROCHLORIDE / HYDRALAZINE HYDROCHLORIDE

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Patient Information Leaflet

Apresoline® 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 Apresoline 25 mg Tablets are
and what they are used for
2. Before you take Apresoline 25 mg Tablets
3. How to take Apresoline 25 mg Tablets
4. Possible side effects
5. How to store Apresoline 25 mg Tablets
6. Further Information
1. WHAT APRESOLINE 25 MG 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 is 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 25 MG
TABLETS
Do not take Apresoline 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.
Apresoline 25 mg Tablets are not
recommended for use in children.
Take special care with Apresoline 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
Apresoline 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
(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 25 mg Tablets.
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
taking Apresoline.
Driving and using machines
You can drive while taking Apresoline 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.
3. HOW TO TAKE APRESOLINE 25 MG
TABLETS
Always take Apresoline 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 75 mg four times a day is often given
as a long-term dose. Your doctor will adjust the
dose to suit you.
Children
Apresoline is not recommended for use in
children. The tablets should be taken with a drink
of water. Ask your doctor before stopping
treatment with Apresoline, as treatment should be
stopped gradually over several days.
Ref: 772

VERSION

If you take more Apresoline 25 mg Tablets than
you should
If you take more Apresoline 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 Apresoline 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 Apresoline 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;
• low 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,
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 APRESOLINE 25 MG
TABLETS
Protect from heat and moisture.
Do not store above 30°C.
Do not use Apresoline 25 mg Tablets after the expiry
date shown on the container, after ‘EXP’. The expiry
date refers to the last day of that month.
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
If your tablets become discoloured, or if you notice
any other signs of deterioration, please contact
your pharmacist who will advise you what to do.
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 Apresoline 25 mg Tablets contain
Each sugar coated tablet contains 25 mg
hydralazine hydrochloride.
The other ingredients are: colloidal anhydrous silica,
cellulose, magnesium stearate (E572), povidone,
maize starch, hypromellose, crospovidone, talc
(E553b), macrogol 8000, sucrose. Colourants: iron
oxide (E172), titanium dioxide (E171).
What Apresoline 25 mg Tablets look like and
the contents of the pack
Apresoline Tablets are pale yellow, round, sugar
coated tablets. The tablet is marked in brown with
GF on one side and plain on the other.
Apresoline 25 mg Tablets are available in bottles
containing: 100 Tablets.
Manufactured by: Rottendorf Pharma GmbH,
Ostenfelder Strasse 51-61, 59320 Ennigerloh,
Germany.
Procured from within the EU by the Product
Licence Holder: Expono Ltd, Cornwall Road,
Smethwick, B66 2JT, UK.
Repackaged by: N.G. Ltd, West Midlands, B66
2JT, UK.
PL 22961/0170 – Apresoline® 25 mg Tablets
Revision Date: 10.10.2016
POM
Apresoline® is a registered trademark of
Ref: 772
Amdipharm Ltd.

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 is 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
recommended for use in children.

are

not

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
(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 Hydralazine 25 mg Tablets.
Taking hydralazine with food and drink
It is advisable not to drink alcohol whilst taking
hydralazine 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
taking hydralazine.
Driving and using machines
You can drive while taking hydralazine 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.
3. HOW TO TAKE HYDRALAZINE 25 MG
TABLETS
Always take hydralazine 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 75 mg four times a day is often given
as a long-term dose. Your doctor will adjust the
dose to suit you.
Children
Hydralazine is not recommended for use in
children. The tablets should be taken with a drink
of water. Ask your doctor before stopping
treatment with hydralazine, as treatment should
be stopped gradually over several days.
Ref: 771

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;
• low 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,
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 HYDRALAZINE 25 MG
TABLETS
Protect from heat and moisture.
Do not store above 30°C.
Do not use Hydralazine 25 mg Tablets after the
expiry date shown on the container, after ‘EXP’. The
expiry date refers to the last day of that month.
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
If your tablets become discoloured, or if you notice
any other signs of deterioration, please contact
your pharmacist who will advise you what to do.
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 Hydralazine 25 mg Tablets contain
Each sugar coated tablet contains 25 mg
hydralazine hydrochloride.
The other ingredients are: colloidal anhydrous silica,
cellulose, magnesium stearate (E572), povidone,
maize starch, hypromellose, crospovidone, talc
(E553b), macrogol 8000, sucrose. Colourants: iron
oxide (E172), titanium dioxide (E171).
What Hydralazine 25 mg Tablets look like and
the contents of the pack
Hydralazine Tablets are pale yellow, round, sugar
coated tablets. The tablet is marked in brown with
GF on one side and plain on the other.
Hydralazine 25 mg Tablets are available in bottles
containing: 100 Tablets.
Manufactured by: Rottendorf Pharma GmbH,
Ostenfelder Strasse 51-61, 59320 Ennigerloh,
Germany.
Procured from within the EU by the Product
Licence Holder: Expono Ltd, Cornwall Road,
Smethwick, B66 2JT, UK.
Repackaged by: N.G. Ltd, West Midlands, B66
2JT, UK.
PL 22961/0170 – Hydralazine 25 mg Tablets
Revision Date: 10.10.2016
POM
Ref: 771

Expand Transcript

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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