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HYDRALAZINE 50 MG TABLETS

Active substance(s): HYDRALAZINE HYDROCHLORIDE

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Package leaflet: Information for the patient

Hydralazine 25mg and 50mg tablets
Read all of this leaflet carefully
before you start taking your 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 pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet
1 What Hydralazine tablets are
and what they are used for
2 What you need to know
before you take Hydralazine
tablets
3 How to take Hydralazine
tablets
4 Possible side effects
5 How to store Hydralazine
tablets
6 Contents of the pack and
other information
1 What Hydralazine tablets are and what
they are used for

Hydralazine belongs to a group of medicines called
vasodilators. These medicines relax the muscles of
artery walls and cause blood vessels to expand.
Hydralazine tablets are used to:
• treat moderate to severe high blood pressure (with or
without a beta-blocker or diuretic medicine)
• manage moderate to severe congestive heart failure
(where use of other medicines alone are not enough)

2 What you need to know before you
take Hydralazine tablets

Do not take Hydralazine tablets if you have:
• an allergy to hydralazine, dihydralazine or any of the
other ingredients in this medicine (listed in section 6)
• a racing heart beat (tachycardia)
• heart failure caused by narrowing of blood vessels
or heart valves (aortic or mitral stenosis), high
blood pressure in blood vessels supplying the lungs
(pulmonary hypertension) or inflammation of the
heart (constrictive pericarditis)
• heart failure with a normal or increased output of
blood from the heart (e.g. in thyrotoxicosis)
• systemic lupus erythematosus (SLE) or any related
disease
• swelling in a blood vessel wall (aortic aneurism)
• (or a relative has) an inherited disorder of the red
blood pigment haemoglobin (porphyria)

Warnings and precautions

Talk to your doctor or pharmacist before taking
Hydralazine tablets if you:
• have had a heart attack in the past three months
• have coronary heart disease
• 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
that other people)
• suffer from any serious liver or kidney problems.

Tests

If you are taking long-term Hydralazine treatment,
your doctor may want to carry out blood and urine
tests every 6 months.

Other medicines and Hydralazine tablets

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
It is especially important to 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 antiinflammatory drugs (NSAIDs)
• medicines to control psychoses
• a specific group of medicines know as nitrates, used
to control blood pressure
• oestrogens (a group of female sex hormones used in
contraception and in treating the menopause.)
• muscle relaxants (e.g baclofen, tizonidine)
• medicines that stimulate the nervous system (e.g.
adrenaline, norepinephrine)
• steroids
If you are going to have general anaesthetic, you
should tell the doctor or dentist in charge that you
are taking Hydralazine tablets.

Hydralazine tablets with alcohol

It is advisable not to drink alcohol whilst taking
Hydralazine tablets 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 you doctor before taking
Hydralazine Tablets.

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.

Hydralazine tablets and lactose

If you have been told you have an intolerance to
some sugars, contact your doctor before taking this
medicine, as the 25mg tablets contain lactose.

Hydralazine tablets and E122

The 50mg tablets contain the colour E122 which may
cause allergic reactions.

3 How to take Hydralazine tablets

Always take Hydralazine tablets exactly as your doctor
has told you. If you are not sure, check with your
doctor or pharmacist.

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130x210 Leaflet Reel Fed Profile (BST)

Hydralazine All strengths Tablets PIL UK
item no:
print proof no:

AAAJ1080

dimensions: 130 x 210

3

pharmacode:

origination date: 17.6.16
approved for print/date

originated by:

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db

JDE No.:

2.

Dimensions: 130x210 (Reel Fed)
Component: Leaflet for Bottles

3.
5.
6.

revision date:

23.6.16

Technical Approval

revised by:

db

date sent:

n/a

supplier:

Actavis UK

approved:

n/a

50902985

1. black

4.

min pt size: 6.4 pt

Hydralazine Tablets BP
25 & 50mg x 56’s (UK)

Non Printing Colours
1. profile
2.
3.

*P
 lease note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

Pharmacode: 3362
Date Sent:
14/06/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
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Speak to your doctor before drinking alcohol with this
medicine.
Swallow these tablets with water.
The recommended dose is:
Adults (including the elderly):
Hypertension: Initially 25mg twice a day or 50mg once
a day. Your doctor may gradually increase this, up to a
maximum of 200mg a day. Your doctor will decide on the
best dose for you.
Chronic congestive heart failure: Treatment should be
started in hospital and dosages can vary. The maintenance
dose is 50mg - 75mg four times a day.
Use in children: Not recommended
If you take more Hydralazine tablets than you should
If you (or someone else) swallow a lot of the tablets at the
same time or if you think a child may have swallowed any,
contact your nearest hospital casualty department or tell
your doctor immediately.
Symptoms of an overdose include low blood pressure,
racing heart beat, decreased blood flow to the heart,
irregular heart beat, coma.

If you forget to take Hydralazine tablets

Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose take it as soon as you remember
it and then take the next dose at the right time.

If you stop taking Hydralazine tablets

Do not stop treatment early because an increase in blood
pressure may occur. Talk to your doctor before you stop
taking the tablets and follow their advice.
If you have any further questions on the use of this
medicine, ask your doctor, or pharmacist.

4 Possible side effects

Like all medicines, this medicine 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:
Very common (may affect more than 1 in 10 people)
• Abnormal heart beat (palpitations)
• An unusually fast heart beat
• Headaches
Common (may affect up to 1 in 10 people)
• 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
•D
 iarrhoea
• Flushing
Uncommon (may affect up to 1 in 100 people)
• Heart failure, swelling
• Increased levels of substances 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 brushing or rashes
• 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
Rare (may affect up to 1 in 1,000 people)
• 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
•D
 epression
• 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.

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 tablets

Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original container.
Do not use Hydralazine tablets after the expiry date stated
on the label/carton. The expiry date refers to the last day of
that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6 Contents of the pack and other
information
What Hydralazine tablets contain

• The active substance is hydralazine
hydrochloride.
- Each film-coated tablet contains 25mg of the
active substance.
- Each film-coated tablet contains 50mg of the
active substance.
• The other ingredients are polyvidone,
disodium edetate, microcrystalline cellulose
(E460), magnesium stearate
• Tablet coating: hypromellose (E464), titanium
dioxide (E171)
25mg also contains: lactose monohydrate,
macrogol, glycerol triacetate (E1518), iron oxide
(E172)
50mg also contains: polyethylene glycol,
carmoisine aluminium lake azorubine (E122)

What Hydralazine tablets look like and
contents of the pack
25mg tablets are ivory, circular, biconvex,
film-coated tablets.
50mg tablets are pink, circular, biconvex,
film-coated tablets.
Pack size: 56

Marketing Authorisation Holder and
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in June 2016

Continued top of next column
50902985
AAAJ1080

Actavis, Barnstaple, EX32 8NS, UK.

130x210 Leaflet Reel Fed Profile (BST)

Hydralazine All strengths Tablets PIL UK
item no:
print proof no:

AAAJ1080

dimensions: 130 x 210

3

pharmacode:

origination date: 17.6.16
approved for print/date

originated by:

colours/plates:

db

JDE No.:

2.

Dimensions: 130x210 (Reel Fed)
Component: Leaflet for Bottles

3.
5.
6.

revision date:

23.6.16

Technical Approval

revised by:

db

date sent:

n/a

supplier:

Actavis UK

approved:

n/a

50902985

1. black

4.

min pt size: 6.4 pt

Hydralazine Tablets BP
25 & 50mg x 56’s (UK)

Non Printing Colours
1. profile
2.
3.

*P
 lease note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

Pharmacode: 3362
Date Sent:
14/06/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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