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HYDRALAZINE TABLETS 25MG

Active substance(s): HYDRALAZINE HYDROCHLORIDE

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Hydralazine
#25 mg
Film-coated
Tablets

5 055382 300298

Hydralazine
#25 mg
Film-coated
Tablets

Film-Coated

mg

56 Film-Coated Tablets

Oral use
Each film-coated tablet contains: 25 mg hydralazine hydrochloride.
Dosage: Oral use. Read the package leaflet before use.
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package in order to
protect from light.
PL 4569/0050 LL0435AF 585206 A0029a/4
MA Holder: Mylan, Potters Bar,
POM Hertfordshire, EN6 1TL, U.K.

TBC

or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

What is in this leaflet

1. What Hydralazine is and what it is used for
2. What you need to know before you take Hydralazine
3. How to take Hydralazine
4. Possible side effects
5. How to store Hydralazine
6. Contents of the pack and other information

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1. What Hydralazine is and what it is used for
Hydralazine belongs to a group of medicines called
antihypertensives.
Hydralazine can be used along with other medicines:
• to reduce high blood pressure (hypertension)
• to treat moderate and serious heart failure.

• an increase in blood pressure • inflammation of the
nerves, which may causes tingling or numbness
especially in the hands, arms, feet or legs • painful
swelling in the arms or legs • swollen (lymph)
glands in the armpits, neck or groins • feeling
depressed • seeing, feeling or hearing things that
are not there (hallucinations) • abnormal swelling
of the spleen (splenomegaly). You may notice
signs such as being unable to eat a large meal,
feeling discomfort, fullness, or pain on the upper
left side of the abdomen; this pain may spread to
your left shoulder
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
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Sunset
yellow (E110) which may cause allergic reactions in
some people.
3. How to take Hydralazine
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
If you are taking Hydralazine for a long time, your
doctor may wish to test your urine and blood every
six months.
Your doctor will start you on a low dose of Hydralazine
and gradually increase the dose depending on your
condition.
The recommended dose is:

Hydralazine Tablets 25
Film-Coated

TBC

1
20

Not all pack sizes may be marketed.
Marketing Authorisation Holder

56 Film-Coated Tablets

PL 4569/0050 LL0435AF 585206 A0029a/4
MA Holder: Mylan, Potters Bar,
POM Hertfordshire, EN6 1TL, U.K.

ethylcellulose, carnauba wax, red iron oxide (E172),
hypromellose, titanium dioxide (E171) and Quinoline
yellow (E104).

glass or plastic containers and blisters of 5, 7, 10, 14,
15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112,

mg

Oral use
Each film-coated tablet contains: 25 mg hydralazine hydrochloride.
Dosage: Oral use. Read the package leaflet before use.
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package in order to
protect from light.

away medicines you no longer use. These measures
will help to protect the environment.
6. Contents of the pack and other information
What Hydralazine contains
The active substance is hydralazine hydrochloride.

titanium dioxide (E171), lactose (see section 2
“Hydralazine contains lactose”), hypromellose,
macrogol, indigo carmine (E132), sunset yellow (E110)

hydrochloride.

(E110)”) iron oxide yellow (E172) and erythrosine
(E127).
What Hydralazine looks like and contents of
the pack

hydrochloride.
The other ingredients are microcrystalline cellulose,
pregelatinised maize starch, colloidal anhydrous silica,
disodium edetate, talc and magnesium stearate.

“HE 25” on one side and “G” on the reverse.

Manufacturer
Generics [UK] Limited, Potters Bar, Hertfordshire,

contains diethyl phthalate, hydroxypropylcellulose,

Grange Road, Dublin 13, Ireland.
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Anti-hypertensives work by lowering blood pressure.
High blood pressure increases the workload of the
heart and arteries (blood vessels) and if left untreated,
can lead to damage of the blood vessels of the brain,
heart and kidneys.

Other medicines and Hydralazine
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines
including medicines obtained without a prescription,
herbal medicines or any of the following:
• other antihypertensives including medicines
used to widen the blood vessels such as diazoxide
or nitrates, beta-blockers (e.g. propranolol), ACE
inhibitors (e.g. captopril), “water” tablets (diuretics
e.g. furosemide ) and medicines known as “calcium
channel blockers” (e.g. verapamil) • medicines used
to treat depression e.g. tricyclic antidepressants
such as dosulepin, monoamine oxidase inhibitors
(MAOIs) such as phenelzine or to treat a mental
illness (eg. Chlorpromazine) • medicines used to
treat anxiety such as tranquillisers (e.g. diazepam)

bruising or bleeding of the skin (reduced number
of platelets), frequent infections, fever, chills, sore
throat or mouth ulcers (reduced number of white
blood cells) • liver problems, which can cause
yellowing of the skin or whites of the eyes, dark
urine and pale stools • blood in the urine (the
urine may look red or pink)
Very rare
• illness resulting from the destruction of red blood
cells with signs such as looking pale, feeling tired,
breathlessness, yellowing of the skin and/or eyes
• a reduction in all types of blood cells, which
may cause frequent infections, unusual bruising
or bleeding of the skin or you to feel tired and
breathless • changes in how much you urinate,

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2. What you need to know before you take
Hydralazine
Do not take Hydralazine:
• if you are allergic to hydralazine hydrochloride or
dihydralazine, or any of the other ingredients of this
medicine (listed in section 6) • if you suffer from
the condition systemic lupus erythematosus
(SLE) or a related disease • if you suffer from an
unusually fast heart beat • if you have heart failure,
heart valve problems (aortic or mitral stenosis)

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• anti-inflammatory painkillers (NSAIDs) e.g.
indometacin • corticosteroids e.g. prednisolone •
medicines which slow down the nervous system
(CNS depressants) • carbenoxolone, used to
treat stomach ulcers • anaesthetics • medicines
containing oestrogens e.g. HRT, or the combined
oral contraceptive pill.
Ask your doctor or pharmacist for advice before taking
any medicine.
Hydralazine with alcohol
Alcohol may increase the effects of hydralazine
causing side effects such as dizziness.
Pregnancy and breast-feeding
Hydralazine should only be used in the last few
months of pregnancy

test • increased levels of creatinine in the blood
which would be seen in a blood test • loss of
appetite, weight loss • feeling generally unwell •
feeling anxious or agitated • itchy, red, infected
eyes (conjunctivitis), watery or swollen eyes. •
abdominal swelling caused by enlarged liver or
fluid retention in the body • swelling of blood
vessels. Signs include fever, general aches and
pain, loss of appetite, weight loss and tiredness
• pinkish, itchy swellings on the skin, also called
hives or nettle rash • increase in some white blood
cells which may be seen in a blood test • decrease
in some red blood cells which may be seen in a
blood test
Very rare

REVISED ARTWORK FOR MHRA APPROVAL

DRAFT ISSUE: 4
REASON FOR CHANGE: SAFETY TEXT UPDATE
SUPPLIER ISSUE DATE: 12.10.2015

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This leaflet was last revised in 09/2015.

Package leaflet: Information for the patient

HYDRALAZINE 25 mg FILM-COATED TABLETS
HYDRALAZINE 50 mg FILM-COATED TABLETS
(hydralazine hydrochloride)

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.

• 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 only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as
yours. • If you get any side effects, talk to your doctor

or inflammation of the heart (constrictive
pericarditis) • if you have an aortic aneurysm
(swelling in the wall of the aorta which can cause
sweating, a fast heartbeat, and abdominal or back
pain) • if you have an enlarged heart often caused
by lung disease (cor pulmonale) • if there is a
family history of the rare condition porphyria.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Hydralazine:
• if you have liver or kidney problems. • if you suffer
from hardened arteries (coronary artery disease),
chest pain (angina) or are at risk of having a
stroke. • if you are recovering from a heart attack. •
if you need surgery.

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.

difficulty or pain when passing urine, lower back
pain, fever, nausea and vomiting – these may
be signs of kidney problems • severe pain in the
stomach with bloating, cramps, constipation and
vomiting • protruding eyes
Other possible side effects
Very common
• fast or irregular heart beat • headache
Common
• low blood pressure • muscle or joint pain • swelling
of the joints • feeling or being sick • diarrhoea,
upset stomach • chest pain • flushing • dizziness •
blocked nose
Rare
• protein in the urine which would be seen in a urine

If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Driving and using machines
Do not drive or use machines if you suffer from
headaches or have difficulty concentrating while
taking this medicine. Speak to your doctor or
pharmacist for advice.
Hydralazine contains lactose
lactose. If you
have been told by your doctor that you have an
intolerance to some sugars, such as lactose, contact
your doctor before taking this medicine.
Hydralazine contains Sunset yellow (E110)

should carry on taking your medicine as long as your
doctor or pharmacist tells you to, even if you feel
better.
Use in children and adolescents
Hydralazine should not be given to children or
adolescents.
Method of administration
Swallow the tablets with a glass of water.
If you take more Hydralazine than you should
The signs and symptoms of hydralazine overdose
include low blood pressure, a racing heart beat,
headache and generalised skin flushing. If you
take more Hydralazine than you should contact
your doctor or hospital emergency department
immediately.

If you forget to take Hydralazine
If you forget to take a dose of Hydralazine take it as
soon as you remember unless it is nearly time for your
next dose. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Hydralazine
Do not stop taking Hydralazine without talking to
your doctor, even if you feel better, because it may
make your illness worse.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

5

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5. How to store Hydralazine
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which is
stated on the label or container after “EXP”. The expiry
date refers to the last day of that month.
Do not store above 25°C. Store in the original package
in order to protect from light.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw

8

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see your doctor straight away or go to the nearest
hospital immediately.
Common
people)
• systemic lupus erythematosus (SLE) or a related
disease with signs such as joint pain (similar to
rheumatoid arthritis), fever, change in blood count
and skin rash
Rare
• swelling of the hands and lower legs, breathlessness,
tightness of the chest, sharp chest pain which is worse
when breathing in, feeling dizzy • allergic reactions
such as itchy red and swollen skin, red skin rash
on cheeks and other parts of the body, skin rashes
which may be severe • signs of reduced numbers
of different blood cells, which may cause unusual

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Adults
Hypertension
Hydralazine twice a day, increasing to a maximum
Heart failure
of Hydralazine three or four times a day; if necessary,
day.
A small group of patients can break down hydralazine
in their body at a different rate to the majority of
patients. This can lead to unwanted effects. Your
doctor will check for this possibility, and if this occurs,
will change your dose of Hydralazine as needed. You

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VERSION: 4 (MYLAN)

4

19

2

“HE 50” on one side and “G” on the reverse.

Almus ® is a registered trademark

PEEL HERE BUT DO NOT REMOVE

Hydralazine Tablets 25

Almus ® is a registered trademark

PEEL HERE BUT DO NOT REMOVE

22

DIMENSIONS 52 x 101mm
BARCODE 5055382300298
PHARMA CODE TBC
ALMUS CODE A0029a/4
SUPPLIER CODE LL0435AF
SUPPLIER CODE 585206

4. Possible side effects
Like all medicines, Hydralazine can cause side effects,
although not everybody gets them. If any of the
following happen, stop taking this medicine and

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Client:

Almus UK

Project:

10021 / UK
Hydralazine Tablets
25mg x 56

Item(s):

Colours used:

BLACK

PMS
349

PMS
1788

PMS
142

Label Leaflet

Checked by: Paul Adams

KEYLINE
This scale measures 100mm when artwork is 100%
0
10
20
30

Queries regarding this artwork,
please contact: Steve Hobbs or
Paul Adams

BRAILLE

Date: 12.10.2015
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pmdc design llp
Lower Test Studios
Sheardley Lane, Droxford
Hampshire SO32 3QY
+44 (0)1489 878780
www.pmdc.co.uk

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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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