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Patient Information Leaflet GB727-0879LF-AM01

Apresoline®

Ampoules

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 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 Apresoline Ampoules 20 mg are and what they are used for

2.    Before you are given Apresoline Ampoules 20 mg

3.    How Apresoline Ampoules 20 mg are given

4.    Possible side effects

5.    How to store Apresoline Ampoules 20 mg

6.    Further information

1.    WHAT APRESOLINE AMPOULES 20 MG ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Apresoline Ampoules 20 mg.

The active ingredient is hydralazine hydrochloride in the form of a powder.

Hydralazine hydrochloride belongs to a group of medicines called antihypertensives.

Apresoline is used to treat very high blood pressure, particularly when this condition occurs in pregnancy or in people with kidney disease.

It works by relaxing blood vessels which increases the supply of blood and oxygen to the heart.

2.    BEFORE YOU ARE GIVEN APRESOLINE AMPOULES 20 MG

You should not be given this medicine 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.

Apresoline Ampoules 20 mg are not recommended for use in children.

Take special care with Apresoline Ampoules 20 mg if you:

•    have 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);

•    have been told that 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, tell your doctor before receiving Apresoline Ampoules 20 mg.

Taking with 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, 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 Apresoline Ampoules 20 mg.

Taking Apresoline Ampoules 20 mg with food and drink

It is advisable not to drink alcohol whilst taking Apresoline Ampoules 20 mg 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 being treated with Apresoline.

Driving and operating machinery

You can drive while being treated with Apresoline but do not drive until you know how it affects you.

It may make you feel dizzy. If it affects you in this way, do not drive or operate any machinery.

3. HOW APRESOLINE AMPOULES 20 MG ARE GIVEN

This medicine will be given to you in hospital.

Your doctor will decide when and how to treat you with this medicine. It can be given to you in one of 2 ways:

-    usually it is injected slowly into your vein using a syringe, this is called an intravenous injection or;

-    it may be diluted further and injected very slowly into your vein through a drip (intravenous infusion).

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The usual dosage is 5 to 10 mg by intravenous injection, and may be repeated if necessary after 20 to 30 minutes.

Your blood pressure will be taken whilst you are receiving treatment and the dose adjusted to make sure that you have gradual fall in your blood pressure to normal levels.

If you are given more medicine than you should As this medicine is given to you in hospital it is very unlikely that an overdose will happen.

Should an overdose occur, the doctor will treat any symptoms that follow.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Apresoline Ampoules 20 mg 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 suscetible 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.

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 if 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.

If any of the side effects becomes severe, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.

5. HOW TO STORE APRESOLINE AMPOULES 20 MG

The ampoules will be stored in the hospital and they will follow the instructions below.

The ampoules should be protected from light and stored below 30°C.

The doctor or nurse will check that the expiry date on the label has not passed before you are given the injection. The solution will be used as soon as it has been made up.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

5. FURTHER INFORMATION

What Apresoline Ampoules 20 mg contain

Each ampoule contains 20 mg of the active ingredient, hydralazine hydrochloride, as a powder. They also contain hydrochloric acid (as an inactive ingredient).

What Apresoline Ampoules 20 mg look like and the contents of the pack

Apresoline is provided as a powder in 2 ml clear glass ampoules.

Each pack contains 5 ampoules.

Marketing Authorisation Holder and Manufacturer

Amdipharm UK Limited,

Regency House,

Miles Gray Road,

Basildon,

Essex, SS14 3AF.

Apresoline is a registered trademark.

Date of leaflet August 2013.

REGULATORY AUTHORITY APPROVAL CONFIRMATION

Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, IMB, etc and that Amdipharm have license approval to distribute this component for sale in the relevent market

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Signature..........................................................................

Name ................................................................................

Date...................................................................................

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