Hydralazine 20mg Powder for Concentrate for Solution for Injection/Infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions ask your doctor , pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Hydralazine 20mg Powder for Concentrate for Solution for Injection/Infusion referred to from now as Hydralazine Injection.

1. What Hydralazine injection is and what it is used for
2. What you need to know before you are given Hydralazine Injection
3. How you will be given Hydralazine Injection
4. Possible side effects
5. How to store Hydralazine Injection
6. Contents of the pack and other information

• if you are allergic to hydralazine or any of the other ingredients in this medicine (listed in section 6) (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);
• if you are allergic to dihydralazine;
• if you have or have ever had a condition called Systemic Lupus Erythematosus (SLE), an autoimmune condition which causes joint pain, skin rashes and fever;
• 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 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 heart function impaired (myocardial insufficiency);
• if you have a condition known as porphyria.
• if you have a condition called dissecting aortic aneurysm.

Talk to your doctor or pharmacist or nurse before using Hydralazine Injection

• if you have had a heart attack in the past three months;
• if you have coronary heart disease:
• if you have angina pectoris, which causes pain in the chest with exercise;
• if you have cerebrovascular disease (narrowing of the blood vessels in the brain);
• if you have been told you are a slow acetylator (this means that your body handles some medicines more slowly than other people);
• if you suffer from any serious liver or kidney problems;
• if you have blockage of one or more arteries that supply blood to the heart (coronary heart disease).
• if you have had blood tests before starting treatment

Hydralazine Injection is not recommended for use in children. In rare cases Hydralazine Injection may be used with extreme caution to treat children.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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 (MAOls) (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 (NSAlDs));
• corticosteroids (e.g. prednisolone or prednisone);
• 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 Injection.

It is advisable not to drink alcohol whilst taking Hydralazine Injection as it may affect you more than usual.

Taking Hydralazine Injection with food may decrease the amount of the medicine in your system, therefore, take it before food.

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 using this medicine.

You can drive while being treated with Hydralazine Injection but do not drive until you know how it affects you. It may make you feel dizzy or impair your reactions. If it affects you in this way, do not drive or operate any machinery.

Symptoms of overdose include a faster or irregular heartbeat, low blood pressure, feeling sick, dizziness, and sweating. Chest pain, headache, vomiting and losing consciousness are also possible symptoms. 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.

Very common (may affect more than 1 in 10 people)

• Abnormal heartbeat (palpitations);
• An unusually fast heartbeat;
• 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.

Rare (may affect up to 1 in 1,000 people)

• Heart failure, swelling;
• Increased levels of a substance called creatinine in the blood;
• Breathlessness, breathing difficulties or pain when breathing;
• Liver enlargement
• 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 (conjunctivitis);
• 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;
• Fever;
• Anxiety;
• Restlessness;
• Blocked or stuffy nose;
• Loss of appetite;
• Weight loss;
• Dizziness;
• Generally feeling unwell.

• A change in the amount of urine produced;
• A restriction of movement in part of the intestine;
• 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 and liver;
• 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;
• The inability to completely or partially empty the bladder;
• Opposite effect of medical treatment (episodes of high blood pressure);
• An increase in other kinds of white blood cells.

Not known (frequency cannot be estimated from the available data)

• Involuntary shaking or movement (tremors)

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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

Each ampoule contains 20 mg of the active ingredient, hydralazine hydrochloride as a powder.

They also contain hydrochloric acid , water for injection and nitrogen (as an inactive ingredient).

Hydralazine Injection is provided as a white to yellow powder in 2 ml clear glass ampoules.

Each pack contains 5 ampoules.