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HYDRALAZINE TABLETS BP 25MG

Active substance(s): HYDRALAZINE HYDROCHLORIDE

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Hydralazine 25mg and 50mg tablets
Read all of this leaflet carefully before
you start to take 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.

Index
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 C ontents 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:
• t reat moderate to severe high blood pressure (with or without a
beta-blocker or diuretic medicine)
•m
 anage 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 and tell your doctor if
you have:

• an allergy (hypersensitivity) to hydralazine, dihydralazine
or any of the other ingredients in Hydralazine tablets (see
section 6)
• a racing heart beat (tachycardia)
• h eart 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)
• h eart failure with a normal or increased output of blood from
the heart (e.g. in thyrotoxicosis)
• s ystemic lupus erythematosus (SLE) or any related disease
• s welling in a blood vessel wall (aortic aneurism)
• ( or a relative has) an inherited disorder of the red blood
pigment haemoglobin (porphyria)

Check with your doctor or pharmacist before taking
Hydralazine tablets if you:
• h ave had a heart attack in the past three months
• have angina pectoris, which causes pain in the chest with
exercise

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• have cerebrovascular disease (narrowing of the blood vessels
in the brain
• h ave been told you are a slow acetylator (this means that your
body handles some medicines more slowly that other people)
• s uffer from any serious liver or kidney problems.
If any of the above apply to your or if you are not sure,
please tell you doctor you are taking Hydralazine 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 to tell your doctor if you are taking:
•m
 edicines for high blood pressure, such as vasodilators (e.g.
minoxidil diazoxide)
• A CE inhibitors (e.g. enalapril, lisinopril, captopril)
• B eta-blockers (e.g. propranolol)
• c alcium antagonists (e.g. nifedipine or diltiazem)
•m
 edicines for water retention (e.g. diuretics)
•m
 edicines for problems such as depression, including
monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide,
phenelzine, isocarboxazid, tranylcypromine)
• t ricyclic antidepressants (e.g. amitriptyline, clomipramine) or
tranquillisers (e.g. diazepam)
•m
 edicines to control pain and inflammation (a group of
medicines known as non-steroidal anti-inflammatory drugs
(NSAIDs)
•m
 edicines to control psychoses
• a specific group of medicines know as nitrates, used to control
blood pressure
• o estrogens (a group of female sex hormones used in
contraception and in treating the menopause.)
If you are going to have general anaesthetic, you should tell
the doctor or dentist in charge that you are taking Hydralazine
tablets.

Taking Hydralazine with food and drink

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 breastfeeding, please tell you doctor before taking Hydralazine Tablets.

Important information about some of the
ingredients in this medicine

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

Tests

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

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 tablets

Always take Hydralazine tablets exactly as your doctor has told
you. If you are not sure, check with your doctor or pharmacist.
Speak to your doctor before drinking alcohol with this medicine.
Swallow these tablets with water.

Doses:
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.
Children: Not recommended

If you take more 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 the 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 the 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.

4 Possible side effects

Like all medicines, Hydralazine tablets can cause side effects, although
not everybody gets them.
Stop taking the medicine and seek immediate medical advice if you
notice the following:
• S LE-type syndrome, which can cause symptoms such as joint pain,
fever, chaning in blood count and skin rash.
• A llergic reactions including itching, skin rash, inflammation of the
walls of small blood vessels and difficulty in breathing.
• Y ellowing 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
• A bnormal heart beat (palpitations)
• A n unusually fast heart beat
•H
 eadaches
Occasional side effects
• C hest pains
• S welling and/or pain in joints, muscle pain
• L ow blood pressure
• F eeling sick and being sick, particularly at the beginning of the
treatment or after an increase in dose
•D
 iarrhoea
• F lushing
Rare side effects
•H
 eart failure, swelling
• Increased levels of substances called creatinine in the blood
• B reathlessness, breathing difficulties or pain when breathing
• S kin rash
• B lood in the urine which may be associated with a disease of the
kidneys
• P resence of protein in the urine
• Inflammation or the abnormal functioning of the liver
•W
 atering 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
• A n increase in other kinds of white blood cells
• F ever
• A nxiety
• R estlessness
• B locked or stuffy nose
• L oss of appetite
•W
 eight loss
•D
 izziness
•G
 enerally feeling unwell
50837976 AAAH5014

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Very rare side effects
• K idney failure
• A change in the amount of urine produced
• A restricition of movement in part of the intestine
• E pisodes of high blood pressure
• A deficiency of certain white blood cells which can result in fever and
ulceration of the mouth and throat
• A n increased number of white blood cells
• E nlargement of the spleen
• A reduction in the number of red and white blood cells and platelets
in the blood
•D
 epression
• S eeing 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
• T ingling (pins and needles) in your hands or feet
•D
 isease of the lymph nodes
• E nlarged 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 reach and sight 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/bottle. The expiry date refers to the last day of that month.
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 Contents of the pack anf other information
What Hydralazine tablets contain

• T he active substance (the ingredient that makes the tablet work) is
hydralazine hydrochloride.
- E ach film-coated tablet contains 25mg of the active
substance.
- E ach film-coated tablet contains 50mg of the active
substance.
• T he other ingredients are polyvidone, disodium
edetate, microcrystalline cellulose (E460), magnesium
stearate
• T ablet coating: hypromellose (E464), titanium dioxide
(E171)
- 2 5mg also contains: lactose monohydrate, macrogol,
glycerol triacetate (E1518), iron oxide (E172)
- 5 0mg 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 December 2014.

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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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