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APRESOLINE TABLETS 25MG

Active substance(s): HYDRALAZINE HYDROCHLORIDE

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LF-103498-01

AMS Component No.:
Proof Number:
Revision Date:
Product Description:

Apresoline® Tablets 25 mg

Component:
Product Code:
Country:
Vendor Name:

Patient Information Leaflet

Hydralazine hydrochloride

In this leaflet:
1. What Apresoline Tablets 25 mg are
and what they are used for
2. Before you take Apresoline Tablets 25 mg
3. How to take Apresoline Tablets 25 mg
4. Possible side effects
5. How to store Apresoline Tablets 25 mg
6. Further Information
1. WHAT APRESOLINE TABLETS 25 MG
ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Apresoline
Tablets 25 mg.
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
TABLETS 25 MG
Do not take Apresoline 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 25 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 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 25 mg.

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.
mocIobemide,
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 (NSAlDs));
• 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 25 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 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
TABLETS 25 MG
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 75mg
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.

CRF(s):
Revised by:
Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref.:
Print Colours:
Non-Print Colours:

120 x 320 mm
307840
766
N/A
Black
Cutter

Min. Font Size:

9 pt

PAGE 1 OF 2

766

766

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.

LF-103498-01

1
29-Sep-2017
Apresoline 25mg
Tablets - 84s
Leaflet
102349
UK
Rottendorf Pharma
GMBH
PR 15411
PAT

If you forget to take Apresoline
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 25
mg can cause side effects, although not
everybody gets them.

766

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.

• 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.

5. HOW TO STORE APRESOLINE 25 MG
TABLETS
Store in the original package in order to
protect from moisture. Store below 30°C.
Do not use Apresoline after the expiry date
shown on the container. The expiry date
refers to the last day of that month.
KEEP OUT OF THE REACH AND SIGHT 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.
6. FURTHER INFORMATION
What Apresoline Tablets 25 mg contain
The active substance is hydralazine
hydrochloride. The other ingredients are:
silicon dioxide, microcrystalline cellulose,
magnesium stearate, polyvinylpyrrolidone,
maize starch, hydroxypropylmethylcellulose,
povidone, talc, titanium dioxide (E171),
polyethylene glycol, sucrose, yellow iron
oxide, shellac glaze, Black iron oxide (E172),
Red iron oxide (E172), Ammonium hydroxide
(E527), propylene glycol (E1520) and water.
What Apresoline Tablets 25 mg look
like and the contents of the pack
Apresoline Tablets 25 mg are pale yellow,
round, sugar coated tablets. The tablet is
marked with GF on one side.
Apresoline is available in packs of 56, 84
or 100 tablets.
Not all pack sizes may be marketed.

Manufacturer and Batch Release Site:
Rottendorf Pharma GmbH,
Ostenfelder Straße 51-61,
59320 Ennigerloh, Germany

Very rare side effects
Apresoline® is a registered trademark.
• kidney failure;
• a change in the amount of urine This leaflet was last revised in October
produced;
2017.
• a restriction of movement in part of
the intestine;
• episodes of high blood pressure;

307840

CRF(s):
Revised by:
Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref.:
Print Colours:
Non-Print Colours:

120 x 320 mm
307840
766
N/A
Black
Cutter

Min. Font Size:

9 pt

PAGE 2 OF 2

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.

Marketing Authorisation Holder and
Manufacturer responsible for batch
release:
Amdipharm UK Limited,
Regency House,
Miles Gray Road, Basildon
Essex, SS14 3AF, UK

LF-103498-01

1
29-Sep-2017
Apresoline 25mg
Tablets - 84s
Leaflet
102349
UK
Rottendorf Pharma
GMBH
PR 15411
PAT

Component:
Product Code:
Country:
Vendor Name:

766

If you take more Apresoline than you
should
If you take more Apresoline than you
should, contact your doctor or go to your
nearest hospital emergency department
immediately. Take the container and any
remaining tablets with you.

AMS Component No.:
Proof Number:
Revision Date:
Product Description:

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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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