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HYDRALAZINE 25 MG TABLETS

Active substance(s): HYDRALAZINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Hydralazine
25mg and 50mg Tablets

Hydralazine Hydrochloride

1. What Hydralazine Tablets are and what
they are used for
Hydralazine Tablets contain the active
substance hydralazine hydrochloride.
Hydralazine hydrochloride belongs to a group
of medicines called antihypertensives. These
medicines relax the muscles of artery walls
and cause blood vessels to expand and help
to reduce high blood pressure.
2. What you need to know before you
take Hydralazine Tablets
You have been prescribed Hydralazine Tablets
by your doctor. The following information will
help you get the best results with Hydralazine
Tablets. If you have any further questions
please ask your doctor or pharmacist.
Do not take Hydralazine Tablets
Tell your doctor if any of the following are
true for you as patients with these
conditions should not take Hydralazine
Tablets
• if you are allergic to hydralazine,
dihydralazine or any of the other ingredients
of this medicine (listed in section 6),
• if you have lupus (also called systemic lupus
erythematosus or SLE) or a related disease,
• if you suffer from severe tachycardia or
right-sided heart failure due to increased
pressure in the blood vessels of the lungs
(cor pulmonale),
• if you suffer from 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),
• if you 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),
• if you have 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 liver or kidney problems,

• if you are at risk of having a stroke,
• if you are recovering from a heart attack,
• if you need surgery.
If you are taking long-term Hydralazine
treatment, your doctor may want to carry out
blood and urine tests every 6 months.
Children
Do not give this medicine to children.
Other medicines and Hydralazine Tablets
Some medicines can affect the way other
medicines work.
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines especially:
• other antihypertensives including Diazoxide,
beta-blockers (e.g. Propranolol), an ACE
inhibitor (e.g. Captopril), ‘water’ tablets
(diuretics),
• medicine to treat depression e.g. Dosulepin,
• monoamine oxidase inhibitors (MAOIs)
such as Phenelzine; or medicines to
treat mental illness (e.g. Chlorpromazine);
or tranquilisers (e.g. Diazepam),
• non-steroidal anti-inflammatory drugs
(NSAIDs) e.g. Indometacin,
• a specific group of medicines called nitrates
such as isosorbide mononitrate tablets,
• medicines containing oestrogens e.g. HRT,
the combined oral contraceptive pill.
Hydralazine Tablets with food and alcohol
Hydralazine Tablets may be taken without food.
Alcohol may increase the effects of Hydralazine
Tablets causing side effects such as dizziness.
Pregnancy, breast-feeding and fertility
Hydralazine Tablets should only be used in the
last few months of pregnancy and only when
the benefits to mother outweigh the risk to the
baby.
Hydralazine can pass into breast milk.
Breast-fed babies of mothers taking
Hydralazine Tablets should be monitored
closely by the doctor.
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
You should be aware of how you react
to Hydralazine Tablets before you drive
or operate machinery. If you feel dizzy or
drowsy or unable to concentrate after taking
Hydralazine Tablets, do not drive or operate
machinery until these effects wear off.
3. How to take Hydralazine Tablets
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
Your doctor will start you on a low dose of
the tablets and gradually increase the dose
depending on your condition. The usual doses
are:
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.
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: Hydralazine Tablets is for
adults only, it is not for use in children.

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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 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

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
If any of the following happen, stop taking
Hydralazine Tablets and tell your doctor
immediately:
If you have:
• an allergic reaction such as skin rash,
swelling of the face, wheezing or difficulty in
breathing,
• SLE-type syndrome, which can cause
symptoms such as joint pains, fever and
anaemia,
• a skin reaction such as rash, blistering or
peeling of the skin,
• inflammation of the liver or jaundice (your
skin or the whites of your eyes look yellow).
Very common: may affect more than 1 in
10 people
• increase in heart beats,
• feeling of fast or irregular heart beat
(pounding, racing, skipping beats),
• headaches.
Common: may affect up to 1 in 10 people
• flushing,
• low blood pressure,
• suffocating pain in the chest (angina),
• pain or swelling of joints, muscles or nerves,
• nausea (feeling sick) or vomiting,
• diarrhoea.
Uncommon: may affect up to 1 in 100 people
• heart failure, swelling,
• dizziness,
• increased levels of a substance called
creatinine in your blood,
• presence of protein or blood in your urine
which may be associated with diseases of
the kidney,
• liver damage or enlargement causing a
hepatitis like syndrome (yellowing of the skin
or eyes),
• anaemia (changes in red blood cells that
can cause fatigue and breathlessness),
• reduced number of white blood cells
(which help protect the body from infection)
and blood platelets (increased chance of
bleeding or bruising),
• feeling anxious or agitated,
• feeling generally unwell, loss of appetite or
weight loss,
• blocked or stuffy nose,
• red, swollen or teary eyes,
• shortness of breath or breathing difficulties
or pain on breathing.

Rare: may affect up to 1 in 1,000 people
• increase in blood pressure,
• kidney failure,
• difficulty passing urine,
• nerve problems. Tell your doctor if you
notice any pins and needles, tingling or
numb sensations while you are taking this
medicine,
• depression,
• hallucinations,
• enlarged eye ball,
• a restriction or reduction in movement of
part of the intestine,
• enlarged spleen,
• changes in number of red or white blood
cells with possible increased risk of
infection,
• disease of the lymph nodes.
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.
By reporting side effects you can help
provide more information on the safety of this
medicine.
5. How to store Hydralazine Tablets
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 blister and carton after
‘EXP’. The expiry date refers to the last day of
that month.
Do not store above 25°C.
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 tablet contains 25 mg
or 50 mg hydralazine.
• The other ingredients (excipients) are:
microcrystalline cellulose, dicalcium
phosphate anhydrous, polyvinyl pyrrolidone,
sodium starch glycolate, stearic acid,
colloidal anhydrous silica and quinoline
yellow aluminium lake.
What Hydralazine Tablets look like and
contents of the pack
The 25mg tablets are round, flat, yellow to light
yellow in colour, with ‘C’ and ‘1’ de-bossed on
either side of break-line on one side and plain
on the other side with diameter of 6.5 mm.
The 50mg tablets are round, flat, yellow to light
yellow in colour, with ‘C’ and ‘2’ de-bossed on
either side of break-line on one side and plain
on the other side with diameter of 8.0 mm.
Hydralazine Tablets are available in blisters of
7, 10, 14, 28, 30, 56, 60, 84, 90, 100 and 112.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester, UK
Manufacturer
Morningside Pharmaceuticals Ltd
5 Pavilion Way
Loughborough, UK
This leaflet was last revised in October 2015.
M0258LAMUKNAS-001

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If you take more Hydralazine Tablets than
you should
You should not take more tablets than your
doctor tells you to. If you take too many tablets
contact your doctor, pharmacist or hospital
and take your medicine with you. Symptoms
of an overdose include low blood pressure,
racing heartbeat, decreased blood flow to the
heart, irregular heart-beat and coma.
If you forget to take Hydralazine Tablets
If you forget to take a tablet, take it as soon as
you remember. Do not take a double dose to
make up for forgotten doses.
If you stop taking Hydralazine Tablets
Suddenly stopping your treatment with
Hydralazine Tablets may lead to an increase in
your blood pressure. 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.

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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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