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

How to take Hydralazine tablets

^^^^14 Possible side effects

How to store Hydralazine tablets

H6 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

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•    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.

Continued over page

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

•    Diarrhoea

•    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

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•    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

•    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

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

^actavis

Actavis, Barnstaple, EX32 8NS, UK.