Package leaflet: Information for the patient 28055763 syringe, this is called an intravenous injection or; • A restriction of movement in part of the intestine; LF-117708-01 - it may be diluted further and injected very slowly • A deficiency of certain white blood cells which into your vein through a drip (intravenous infusion). can result in fever and ulceration of the mouth The recommended dose is 5 to 10 mg by and throat; intravenous injection, and will be repeated if • An increased number of white blood cells; necessary after 20 to 30 minutes. • Enlargement of the spleen; Hydralazine 20mg Powder for Concentrate for Solution for Injection/Infusion • A reduction in the number of red and white blood Your blood pressure will be taken whilst you cells and platelets in the blood; Hydralazine hydrochloride are receiving treatment and the dose adjusted • Depression; to make sure that you have gradual fall in your Read all of this leaflet carefully before you start • have been told you are a slow acetylator • Seeing or hearing things which are not really blood pressure to normal levels. taking this medicine because it (this means that your body handles some there (hallucinations); contains important information for you medicines more slowly than other people); If you are given more medicine than you should • Inflammation of the nerves which may cause weakness - Keep this leaflet. You may need to read it again. • suffer from any serious liver or kidney problems; As this medicine is given to you in hospital it is very or numbness especially in your fingers and toes; - If you have any further questions ask your • have blockage of one or more arteries that supply unlikely that an overdose will happen. • Tingling (pins and needles) in your hands or feet; doctor, pharmacist or nurse. blood to the heart (coronary heart disease). Should an overdose occur, the doctor will treat any • Disease of the lymph nodes; - This medicine has been prescribed for you only. If any of the above apply to you, or if you are not symptoms that follow. • Enlarged eye balls; Do not pass it on to others. It may harm them, • The inability to completely or partially empty the sure, tell your doctor before receiving 4. POSSIBLE SIDE EFFECTS even if their symptoms are the same as yours. bladder; Hydralazine Injection. Like all medicines, this medicine can cause side - If you get any side effects, talk to your doctor, • Opposite effect of medical treatment (episodes of effects, although not everybody gets them. pharmacist or nurse. This includes any possible Children high blood pressure); side effects not listed in this leaflet. See section 4. Hydralazine Injection is not recommended for use in Stop taking the medicine and seek immediate • An increase in other kinds of white blood cells. children. medical advice if you notice the following: The name of your medicine is Hydralazine 20mg If you feel very tired, experience unexpected • SLE-type syndrome, which can cause symptoms Powder for Concentrate for Solution for Other medicines and Hydralazine Injection bruising or bleeding, or more infections (e.g. colds such as joint pain, fever, change in blood count Injection/Infusion referred to from now as Tell your doctor or pharmacist if you are taking, and sore throats) than usual please tell your doctor. and skin rash. Hydralazine Injection. have recently taken or might take any other Your doctor may decide to conduct tests on your • Allergic reactions including itching, skin rash, medicines. blood periodically as a result of these symptoms. What is in this leaflet: inflammation of the walls of small blood vessels It is especially important that you tell your doctor if 1. What Hydralazine injection is and what it is and difficulty in breathing. If any of the side effects becomes severe, or you you are taking: used for • Yellowing of the skin and whites of the eyes, notice any side effects not listed in this leaflet, • medicines for high blood pressure, such as 2. What you need to know before you are given which may indicate problems with the liver please tell your doctor or pharmacist vasodilators (e.g. minoxidil, diazoxide); Hydralazine Injection such as jaundice and hepatitis. immediately. • ACE inhibitors (e.g. enalapril, lisinopril, captopril); 3. How Hydralazine Injection is given • Kidney failure (e.g. changes in urine, swelling of • beta-blockers (e.g. propranolol); Reporting of side effects 4. Possible side effects legs, ankles or feet, shortness of breath, • calcium antagonists (e.g. nifedipine, diltiazem); If you get any side effects, talk to your doctor, 5. How to store Hydralazine Injection tiredness and nausea). • medicines for water retention (e.g. diuretics); pharmacist or nurse. This includes any possible side 6. Contents of the pack and other information • medicines for problems such as depression, Other side effects may include: effects not listed in this leaflet. You can also report 1. WHAT HYDRALAZINE INJECTION IS AND including monoamine oxidase inhibitors (MAOIs) Very common (may affect more than 1 in 10 side effects directly via the Yellow Card Scheme at: WHAT IT IS USED FOR (e.g. moclobemide, phenelzine, isocarboxazid, people) www.mhra.gov.uk/yellowcard or search for MHRA The name of your medicine is Hydralazine Injection. tranylcypromine), tricyclic antidepressants • Abnormal heart beat (palpitations); Yellow Card in the Google Play or Apple App Store The active ingredient is hydralazine hydrochloride (e.g. amitriptyline, clomipramine) or tranquillisers • An unusually fast heart beat; By reporting side effects you can help provide more in the form of a powder. Hydralazine hydrochloride (e.g. diazepam); • Headaches. information on the safety of this medicine. belongs to a group of medicines called • medicines to control pain and inflammation Common (may affect up to 1 in 10 people) 5. HOW TO STORE HYDRALAZINE INJECTION antihypertensives. (a group of medicines known as non-steroidal • Chest pains; Keep this medicine out of the sight and reach of anti-inflammatory drugs (NSAIDs)); Hydralazine Injection is used to treat very high blood • Swelling and/or pain in joints, muscle pain; children. • medicines to control psychoses; pressure, particularly when this condition occurs in • Low blood pressure; The ampoules will be stored in the hospital and they • a specific group of medicines known as nitrates, pregnancy or in people with kidney disease. • Feeling sick and being sick, particularly at will follow the instructions below. used to control blood pressure; It works by relaxing blood vessels which increases the beginning of the treatment or after The ampoules should be protected from light and • oestrogens (a group of female sex hormones the supply of blood and oxygen to the heart. an increase in dose; stored below 30°C. used in contraception and in treating the • Diarrhoea; Do not use this medicine after the expiry date which 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE menopause). • Flushing. is stated on the label. The expiry date refers to the GIVEN HYDRALAZINE INJECTION If you are going to have a general anaesthetic Rare (may affect up to 1 in 1,000 people) last day of the month. The solution will be used as You should not be given this medicine if you: you should tell the doctor or dentist in charge • Heart failure, swelling; soon as it has been made up. • are allergic to hydralazine, dihydralazine or that you are taking Hydralazine Injection. any of the other ingredients in this medicine • Increased levels of a substance called creatinine 6. CONTENTS OF THE PACK AND OTHER Hydralazine Injection with food, drink and in the blood; (listed in section 6) (allergic reactions include • Breathlessness, breathing difficulties or pain INFORMATION mild symptoms such as itching and/or rash. alcohol when breathing; What Hydralazine Injection contains More severe symptoms include swelling of the It is advisable not to drink alcohol whilst taking • Skin rash; Each ampoule contains 20 mg of the active face, lips, tongue and/or throat with difficulty in Hydralazine Injection as it may affect you more • Blood in the urine which may be associated with ingredient, hydralazine hydrochloride as a powder. swallowing or breathing); than usual. a disease of the kidneys; They also contain hydrochloric acid (as an inactive • Presence of protein in the urine; ingredient). • have or have ever had a condition called Pregnancy, breast-feeding and fertility • Inflammation or the abnormal functioning of the liver; Systemic Lupus Erythematosus (SLE), an If you are pregnant or breast-feeding, think you may • Watering or sore itchy eyes; What Hydralazine Injection looks like and autoimmune condition which causes joint pain, be pregnant or are planning to have a baby, ask • A reduction in the number of platelets in the blood contents of the pack skin rashes and fever; which can cause unexplained bruising or rashes; your doctor or pharmacist for advice before taking Hydralazine Injection is provided as a white to • suffer from severe tachycardia or right sided • A reduction in red blood cells, which can make this medicine. yellow powder in 2 ml clear glass ampoules. heart failure due to increased pressure in the you feel tired or breathless with physical exertion; Driving and using machines • A reduction in certain white blood cells which Each pack contains 5 ampoules. blood vessels of the lungs (cor pulmonale); may make you more susceptible to infections; • suffer from thyrotoxicosis (an excess of thyroid You can drive while being treated with Hydralazine Marketing Authorisation Holder and Injection but do not drive until you know how it affects • Fever; hormones in the blood that can cause a fast • Anxiety; Manufacturer heartbeat, sweating, trembling, anxiety, increased you. It may make you feel dizzy or impair your • Restlessness; Amdipharm UK Limited, appetite, loss of weight and intolerance of heat); reactions. If it affects you in this way, do not drive or • Blocked or stuffy nose; Capital House, • heart function impaired (myocardial insufficiency); operate any machinery. • Loss of appetite; 85 King William Street, • have a condition known as porphyria. • Weight loss; London EC4N 7BL, 3. HOW HYDRALAZINE INJECTION IS GIVEN • Dizziness; United Kingdom Warnings and precautions: Always take this medicine exactly as your doctor • Generally feeling unwell. Talk to your doctor or pharmacist or nurse before has told you. Check with your doctor if you are not Alternate Manufacturer Isolated cases taking Hydralazine Injection if you sure. Cenexi • A change in the amount of urine produced; • have had a heart attack in the past three months; This medicine will be given to you in hospital. Your 52 Rue Marcel ET Jacques Gaucher, • have angina pectoris, which causes pain in doctor will decide when and how to treat you with Fontenay Sous Bois, the chest with exercise; this medicine. It can be given to you in one of 2 F-94120, France ways: • have cerebrovascular disease (narrowing of Date of leaflet August 2019 the blood vessels in the brain); - usually it is injected slowly into your vein using a syringe, this is called an intravenous injection or; • A restriction of movement in part of the intestine; - it may be diluted further and injected very slowly • A deficiency of certain white blood cells which into your vein through a drip (intravenous infusion). can result in fever and ulceration of the mouth The recommended dose is 5 to 10 mg by and throat; intravenous injection, and will be repeated if • An increased number of white blood cells; necessary after 20 to 30 minutes. • Enlargement of the spleen; • A reduction in the number of red and white blood Your blood pressure will be taken whilst you cells and platelets in the blood; are receiving treatment and the dose adjusted • Depression; to make sure that you have gradual fall in your Read all of this leaflet carefully before you start • have been told you are a slow acetylator • Seeing or hearing things which are not really blood pressure to normal levels. taking this medicine because it (this means that your body handles some there (hallucinations); contains important information for you medicines more slowly than other people); If you are given more medicine than you should • Inflammation of the nerves which may cause weakness - Keep this leaflet. You may need to read it again. • suffer from any serious liver or kidney problems; As this medicine is given to you in hospital it is very or numbness especially in your fingers and toes; - If you have any further questions ask your • have blockage of one or more arteries that supply unlikely that an overdose will happen. • Tingling (pins and needles) in your hands or feet; doctor, pharmacist or nurse. blood to the heart (coronary heart disease). Should an overdose occur, the doctor will treat any • Disease of the lymph nodes; - This medicine has been prescribed for you only. If any of the above apply to you, or if you are not symptoms that follow. • Enlarged eye balls; Do not pass it on to others. It may harm them, • The inability to completely or partially empty the sure, tell your doctor before receiving 4. POSSIBLE SIDE EFFECTS even if their symptoms are the same as yours. bladder; Hydralazine Injection. Like all medicines, this medicine can cause side - If you get any side effects, talk to your doctor, • Opposite effect of medical treatment (episodes of effects, although not everybody gets them. pharmacist or nurse. This includes any possible Children high blood pressure); side effects not listed in this leaflet. See section 4. Hydralazine Injection is not recommended for use in Stop taking the medicine and seek immediate • An increase in other kinds of white blood cells. children. medical advice if you notice the following: The name of your medicine is Hydralazine 20mg If you feel very tired, experience unexpected • SLE-type syndrome, which can cause symptoms Powder for Concentrate for Solution for Other medicines and Hydralazine Injection bruising or bleeding, or more infections (e.g. colds such as joint pain, fever, change in blood count Injection/Infusion referred to from now as Tell your doctor or pharmacist if you are taking, and sore throats) than usual please tell your doctor. and skin rash. Hydralazine Injection. have recently taken or might take any other Your doctor may decide to conduct tests on your • Allergic reactions including itching, skin rash, medicines. blood periodically as a result of these symptoms. What is in this leaflet: inflammation of the walls of small blood vessels It is especially important that you tell your doctor if 1. What Hydralazine injection is and what it is and difficulty in breathing. If any of the side effects becomes severe, or you you are taking: used for • Yellowing of the skin and whites of the eyes, notice any side effects not listed in this leaflet, • medicines for high blood pressure, such as 2. What you need to know before you are given which may indicate problems with the liver please tell your doctor or pharmacist vasodilators (e.g. minoxidil, diazoxide); Hydralazine Injection such as jaundice and hepatitis. immediately. • ACE inhibitors (e.g. enalapril, lisinopril, captopril); 3. How Hydralazine Injection is given • Kidney failure (e.g. changes in urine, swelling of • beta-blockers (e.g. propranolol); Reporting of side effects 4. Possible side effects legs, ankles or feet, shortness of breath, • calcium antagonists (e.g. nifedipine, diltiazem); If you get any side effects, talk to your doctor, 5. How to store Hydralazine Injection tiredness and nausea). • medicines for water retention (e.g. diuretics); pharmacist or nurse. This includes any possible side 6. Contents of the pack and other information • medicines for problems such as depression, Other side effects may include: effects not listed in this leaflet. You can also report 1. WHAT HYDRALAZINE INJECTION IS AND including monoamine oxidase inhibitors (MAOIs) Very common (may affect more than 1 in 10 side effects directly via the Yellow Card Scheme at: WHAT IT IS USED FOR (e.g. moclobemide, phenelzine, isocarboxazid, people) www.mhra.gov.uk/yellowcard or search for MHRA The name of your medicine is Hydralazine Injection. tranylcypromine), tricyclic antidepressants • Abnormal heart beat (palpitations); Yellow Card in the Google Play or Apple App Store The active ingredient is hydralazine hydrochloride (e.g. amitriptyline, clomipramine) or tranquillisers • An unusually fast heart beat; By reporting side effects you can help provide more in the form of a powder. Hydralazine hydrochloride (e.g. diazepam); • Headaches. information on the safety of this medicine. belongs to a group of medicines called • medicines to control pain and inflammation Common (may affect up to 1 in 10 people) 5. HOW TO STORE HYDRALAZINE INJECTION antihypertensives. (a group of medicines known as non-steroidal • Chest pains; Keep this medicine out of the sight and reach of anti-inflammatory drugs (NSAIDs)); Hydralazine Injection is used to treat very high blood • Swelling and/or pain in joints, muscle pain; children. • medicines to control psychoses; pressure, particularly when this condition occurs in • Low blood pressure; The ampoules will be stored in the hospital and they • a specific group of medicines known as nitrates, pregnancy or in people with kidney disease. • Feeling sick and being sick, particularly at will follow the instructions below. used to control blood pressure; It works by relaxing blood vessels which increases the beginning of the treatment or after The ampoules should be protected from light and • oestrogens (a group of female sex hormones the supply of blood and oxygen to the heart. an increase in dose; stored below 30°C. used in contraception and in treating the • Diarrhoea; Do not use this medicine after the expiry date which 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE menopause). • Flushing. is stated on the label. The expiry date refers to the GIVEN HYDRALAZINE INJECTION If you are going to have a general anaesthetic Rare (may affect up to 1 in 1,000 people) last day of the month. The solution will be used as You should not be given this medicine if you: you should tell the doctor or dentist in charge • Heart failure, swelling; soon as it has been made up. • are allergic to hydralazine, dihydralazine or that you are taking Hydralazine Injection. any of the other ingredients in this medicine • Increased levels of a substance called creatinine 6. CONTENTS OF THE PACK AND OTHER Hydralazine Injection with food, drink and in the blood; (listed in section 6) (allergic reactions include • Breathlessness, breathing difficulties or pain INFORMATION mild symptoms such as itching and/or rash. alcohol when breathing; What Hydralazine Injection contains More severe symptoms include swelling of the It is advisable not to drink alcohol whilst taking • Skin rash; Each ampoule contains 20 mg of the active face, lips, tongue and/or throat with difficulty in Hydralazine Injection as it may affect you more • Blood in the urine which may be associated with ingredient, hydralazine hydrochloride as a powder. swallowing or breathing); than usual. a disease of the kidneys; They also contain hydrochloric acid (as an inactive • Presence of protein in the urine; ingredient). • have or have ever had a condition called Pregnancy, breast-feeding and fertility • Inflammation or the abnormal functioning of the liver; Systemic Lupus Erythematosus (SLE), an If you are pregnant or breast-feeding, think you may • Watering or sore itchy eyes; What Hydralazine Injection looks like and autoimmune condition which causes joint pain, be pregnant or are planning to have a baby, ask • A reduction in the number of platelets in the blood contents of the pack skin rashes and fever; which can cause unexplained bruising or rashes; your doctor or pharmacist for advice before taking Hydralazine Injection is provided as a white to • suffer from severe tachycardia or right sided • A reduction in red blood cells, which can make this medicine. yellow powder in 2 ml clear glass ampoules. heart failure due to increased pressure in the you feel tired or breathless with physical exertion; Driving and using machines • A reduction in certain white blood cells which Each pack contains 5 ampoules. blood vessels of the lungs (cor pulmonale); may make you more susceptible to infections; • suffer from thyrotoxicosis (an excess of thyroid You can drive while being treated with Hydralazine Marketing Authorisation Holder and Injection but do not drive until you know how it affects • Fever; hormones in the blood that can cause a fast • Anxiety; Manufacturer heartbeat, sweating, trembling, anxiety, increased you. It may make you feel dizzy or impair your • Restlessness; Amdipharm UK Limited, appetite, loss of weight and intolerance of heat); reactions. If it affects you in this way, do not drive or • Blocked or stuffy nose; Capital House, • heart function impaired (myocardial insufficiency); operate any machinery. • Loss of appetite; 85 King William Street, • have a condition known as porphyria. • Weight loss; London EC4N 7BL, 3. HOW HYDRALAZINE INJECTION IS GIVEN • Dizziness; United Kingdom Warnings and precautions: Always take this medicine exactly as your doctor • Generally feeling unwell. Talk to your doctor or pharmacist or nurse before has told you. Check with your doctor if you are not Alternate Manufacturer Isolated cases taking Hydralazine Injection if you sure. Cenexi • A change in the amount of urine produced; • have had a heart attack in the past three months; This medicine will be given to you in hospital. Your 52 Rue Marcel ET Jacques Gaucher, • have angina pectoris, which causes pain in doctor will decide when and how to treat you with Fontenay Sous Bois, the chest with exercise; this medicine. It can be given to you in one of 2 F-94120, France • have cerebrovascular disease (narrowing of ways: - usually it is injected slowly into your vein using a Date of leaflet August 2019 the blood vessels in the brain); 28055763