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APRESOLINE TABLETS 25MG

Active substance(s): HYDRALAZINE HYDROCHLORIDE / HYDRALAZINE HYDROCHLORIDE / HYDRALAZINE HYDROCHLORIDE

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Patient Information Leaflet
GB 727-0317-APIL

Hydralazine 25 mg Tablets
Hydralazine hydrochloride
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.
In this leaflet:
1. What Hydralazine 25 mg Tablets are and what they are
used for
2. Before you take Hydralazine 25 mg Tablets
3. How to take Hydralazine 25 mg Tablets
4. Possible side effects
5. How to store Hydralazine 25 mg Tablets
6. Further Information
1. WHAT HYDRALAZINE 25 MG TABLETS ARE AND
WHAT THEY ARE USED FOR
The name of your medicine is Hydralazine 25 mg Tablets.
The active ingredient is hydralazine hydrochloride.
Hydralazine hydrochloride belongs to a group of medicines
called antihypertensives.
Hydralazine 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 HYDRALAZINE 25 MG TABLETS
Do not take Hydralazine 25 mg Tablets 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.
Hydralazine 25 mg Tablets are not recommended for
use in children.
Take special care with Hydralazine 25 mg Tablets 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 Hydralazine 25 mg 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 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 (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 anti-inflammatory
drugs (NSAIDs));
• 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 Hydralazine 25 mg Tablets.
Taking hydralazine with food and drink
It is advisable not to drink alcohol whilst taking hydralazine
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
hydralazine.
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 25 MG TABLETS
Always take hydralazine 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 200 mg) 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 75 mg
four times a day is often given as a long-term dose. Your
doctor will adjust the dose to suit you.
Children
Hydralazine is not recommended for use in children.
The tablets should be taken with a drink of water.
Ask your doctor before stopping treatment with hydralazine,
as treatment should be stopped gradually over several days.
If you take more Hydralazine 25 mg Tablets than you should
If you take more Hydralazine 25 mg Tablets than you
should, contact your doctor or go to your nearest hospital
emergency department immediately. Take the container
and any remaining tablets with you.

If you forget to take Hydralazine 25 mg Tablets
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 Hydralazine 25 mg Tablets 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:
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.

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.
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 imediately.
5. HOW TO STORE HYDRALAZINE 25 MG TABLETS
Store in the original package in order to protect from
moisture. Store below 30°C.
Do not use Hydralazine 25 mg Tablets 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 Hydralazine 25 mg Tablets 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 Hydralazine 25 mg Tablets look like and the
contents of the pack
Hydralazine 25 mg Tablets are pale yellow, round, sugar
coated tablets. The tablet is marked with GF on one side.
Hydralazine 25 mg Tablets are available in packs of 56, 84
or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
responsible for batch release:
Amdipharm Plc,
Regency House,
Miles Gray Road,
Basildon,
Essex SS14 3AF.
Manufacturer and Batch Release Site:
Rottendorf Pharma GmbH,
Ostenfelder Straße 51-61,
59320 Ennigerloh,
Germany.
Date of Preparation: September 2012

Very rare side effects
• 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;
• 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.

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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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