Hydralazine 25 Mg Tablets
Patient Information Leaflet
Apresoline® 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 Apresoline 25 mg Tablets are and what they are used for
2. Before you take Apresoline 25 mg Tablets
3. How to take Apresoline 25 mg Tablets
4. Possible side effects
5. How to store Apresoline 25 mg Tablets
6. Further Information
1. WHAT APRESOLINE 25 MG TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Apresoline 25 mg Tablets. The active ingredient is hydralazine hydrochloride. Hydralazine hydrochloride belongs to a group of medicines called antihypertensives. Apresoline 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 APRESOLINE 25 MG TABLETS
Do not take Apresoline 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.
Apresoline 25 mg Tablets are not recommended for use in children.
Take special care with Apresoline 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 Apresoline 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 Apresoline 25 mg Tablets.
Taking Apresoline with food and drink
It is advisable not to drink alcohol whilst taking Apresoline 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 Apresoline.
Driving and using machines
You can drive while taking Apresoline 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 APRESOLINE 25 MG TABLETS
Always take Apresoline 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 200mg) 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
Apresoline is not recommended for use in children. The tablets should be taken with a drink of water. Ask your doctor before stopping treatment with Apresoline, as treatment should be stopped gradually over several days.
If you take more Apresoline 25 mg Tablets than you should
If you take more Apresoline 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 Apresoline 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 Apresoline 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.
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.
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 immediately.
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 APRESOLINE 25 MG TABLETS
Protect from heat and moisture.
Do not store above 30°C.
Do not use Apresoline 25 mg Tablets after the expiry date shown on the container, after ‘EXP'. The expiry date refers to the last day of that month.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
If your tablets become discoloured, or if you notice any other signs of deterioration, please contact your pharmacist who will advise you what to do. 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 Apresoline 25 mg Tablets contain
Each sugar coated tablet contains 25 mg hydralazine hydrochloride.
The other ingredients are: colloidal anhydrous silica, cellulose, magnesium stearate (E572), povidone, maize starch, hypromellose, crospovidone, talc (E553b), macrogol 8000, sucrose. Colourants: iron oxide (E172), titanium dioxide (E171).
What Apresoline 25 mg Tablets look like and the contents of the pack Apresoline Tablets are pale yellow, round, sugar coated tablets. The tablet is marked in brown with GF on one side and plain on the other.
Apresoline 25 mg Tablets are available in bottles containing: 100 Tablets.
Manufactured by: Rottendorf Pharma GmbH, Ostenfelder Strasse 51-61, 59320 Ennigerloh, Germany.
Procured from within the EU by the Product Licence Holder: Expono Ltd, Cornwall Road, Smethwick, B66 2JT, UK.
Repackaged by: N.G. Ltd, West Midlands, B66 2JT, UK.
PL 22961/0170 - Apresoline® 25 mg Tablets Revision Date: 10.10.2016 POM
Apresoline® is a registered trademark of Amdipharm Ltd. Ref: 772
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 200mg) 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.
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.
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 immediately.
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 25 MG TABLETS
Protect from heat and moisture.
Do not store above 30°C.
Do not use Hydralazine 25 mg Tablets after the expiry date shown on the container, after ‘EXP'. The expiry date refers to the last day of that month.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
If your tablets become discoloured, or if you notice any other signs of deterioration, please contact your pharmacist who will advise you what to do. 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
Each sugar coated tablet contains 25 mg hydralazine hydrochloride.
The other ingredients are: colloidal anhydrous silica, cellulose, magnesium stearate (E572), povidone, maize starch, hypromellose, crospovidone, talc (E553b), macrogol 8000, sucrose. Colourants: iron oxide (E172), titanium dioxide (E171).
What Hydralazine 25 mg Tablets look like and the contents of the pack Hydralazine Tablets are pale yellow, round, sugar coated tablets. The tablet is marked in brown with GF on one side and plain on the other. Hydralazine 25 mg Tablets are available in bottles containing: 100 Tablets.
Manufactured by: Rottendorf Pharma GmbH, Ostenfelder Strasse 51-61, 59320 Ennigerloh, Germany.
Procured from within the EU by the Product Licence Holder: Expono Ltd, Cornwall Road, Smethwick, B66 2JT, UK.
Repackaged by: N.G. Ltd, West Midlands, B66 2JT, UK.
PL 22961/0170 - Hydralazine 25 mg Tablets Revision Date: 10.10.2016 I POM
Ref: 771