Hydralazine 25 Mg Tablets
Hydralazine
25mg and 50mg Tablets
Hydralazine Hydrochloride
Read all of this leaflet carefully before
you start taking this 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
3. How to take Hydralazine Tablets
4. Possible side effects
5. How to store Hydralazine Tablets
6. Contents of the pack and other information
Hydralazine Tablets contain the active substance hydralazine hydrochloride. Hydralazine hydrochloride belongs to a group of medicines called antihypertensives. These medicines relax the muscles of artery walls and cause blood vessels to expand and help to reduce high blood pressure.
You have been prescribed Hydralazine Tablets by your doctor. The following information will help you get the best results with Hydralazine Tablets. If you have any further questions please ask your doctor or pharmacist.
Do not take Hydralazine Tablets Tell your doctor if any of the following are true for you as patients with these conditions should not take Hydralazine Tablets
• if you are allergic to hydralazine, dihydralazine or any of the other ingredients of this medicine (listed in section 6),
• if you have lupus (also called systemic lupus erythematosus or SLE) or a related disease,
• 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 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),
• 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 have 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 liver or kidney problems,
• if you are at risk of having a stroke,
• if you are recovering from a heart attack,
• if you need surgery.
If you are taking long-term Hydralazine treatment, your doctor may want to carry out blood and urine tests every 6 months.
Children
Do not give this medicine to children.
Other medicines and Hydralazine Tablets
Some medicines can affect the way other medicines work.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines especially:
• other antihypertensives including Diazoxide, beta-blockers (e.g. Propranolol), an ACE inhibitor (e.g. Captopril), ‘water’ tablets (diuretics),
• medicine to treat depression e.g. Dosulepin,
• monoamine oxidase inhibitors (MAOIs) such as Phenelzine; or medicines to treat mental illness (e.g. Chlorpromazine); or tranquilisers (e.g. Diazepam),
• non-steroidal anti-inflammatory drugs (NSAIDs) e.g. Indometacin,
• a specific group of medicines called nitrates such as isosorbide mononitrate tablets,
• medicines containing oestrogens e.g. HRT, the combined oral contraceptive pill.
Hydralazine Tablets with food and alcohol Hydralazine Tablets may be taken without food. Alcohol may increase the effects of Hydralazine Tablets causing side effects such as dizziness. Pregnancy, breast-feeding and fertility Hydralazine Tablets should only be used in the last few months of pregnancy and only when the benefits to mother outweigh the risk to the baby.
Hydralazine can pass into breast milk. Breast-fed babies of mothers taking Hydralazine Tablets should be monitored closely by the doctor.
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 taking this medicine.
Driving and using machines You should be aware of how you react to Hydralazine Tablets before you drive or operate machinery. If you feel dizzy or drowsy or unable to concentrate after taking Hydralazine Tablets, do not drive or operate machinery until these effects wear off.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will start you on a low dose of the tablets and gradually increase the dose depending on your condition. The usual doses are:
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.
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: Hydralazine Tablets is for ^ adults only, it is not for use in children.
If you take more Hydralazine Tablets than you should
You should not take more tablets than your doctor tells you to. If you take too many tablets contact your doctor, pharmacist or hospital and take your medicine with you. Symptoms of an overdose include low blood pressure, racing heartbeat, decreased blood flow to the heart, irregular heart-beat and coma.
If you forget to take Hydralazine Tablets If you forget to take a tablet, take it as soon as you remember. Do not take a double dose to make up for forgotten doses.
If you stop taking Hydralazine Tablets Suddenly stopping your treatment with Hydralazine Tablets may lead to an increase in your blood pressure. 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, stop taking Hydralazine Tablets and tell your doctor immediately:
If you have:
• an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty in breathing,
• SLE-type syndrome, which can cause symptoms such as joint pains, fever and anaemia,
• a skin reaction such as rash, blistering or peeling of the skin,
• inflammation of the liver or jaundice (your skin or the whites of your eyes look yellow).
Very common: may affect more than 1 in 10 people
• increase in heart beats,
• feeling of fast or irregular heart beat (pounding, racing, skipping beats),
• headaches.
Common: may affect up to 1 in 10 people
• flushing,
• low blood pressure,
• suffocating pain in the chest (angina),
• pain or swelling of joints, muscles or nerves,
• nausea (feeling sick) or vomiting,
• diarrhoea.
Uncommon: may affect up to 1 in 100 people
• heart failure, swelling,
• dizziness,
• increased levels of a substance called creatinine in your blood,
• presence of protein or blood in your urine which may be associated with diseases of the kidney,
• liver damage or enlargement causing a hepatitis like syndrome (yellowing of the skin or eyes),
• anaemia (changes in red blood cells that can cause fatigue and breathlessness),
• reduced number of white blood cells (which help protect the body from infection) and blood platelets (increased chance of bleeding or bruising),
• feeling anxious or agitated,
• feeling generally unwell, loss of appetite or weight loss,
• blocked or stuffy nose,
• red, swollen or teary eyes,
• shortness of breath or breathing difficulties or pain on breathing.
Rare: may affect up to 1 in 1,000 people
• increase in blood pressure,
• kidney failure,
• difficulty passing urine,
• nerve problems. Tell your doctor if you notice any pins and needles, tingling or numb sensations while you are taking this medicine,
• depression,
• hallucinations,
• enlarged eye ball,
• a restriction or reduction in movement of part of the intestine,
• enlarged spleen,
• changes in number of red or white blood cells with possible increased risk of infection,
• disease of the lymph nodes.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP’. The expiry date refers to the last day of that month.
Do not store above 25°C.
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.
What Hydralazine Tablets contain
• The active substance is hydralazine hydrochloride. Each tablet contains 25 mg or 50 mg hydralazine.
• The other ingredients (excipients) are: microcrystalline cellulose, dicalcium phosphate anhydrous, polyvinyl pyrrolidone, sodium starch glycolate, stearic acid, colloidal anhydrous silica and quinoline yellow aluminium lake.
What Hydralazine Tablets look like and contents of the pack
The 25mg tablets are round, flat, yellow to light yellow in colour, with ‘C’ and ‘1’ de-bossed on either side of break-line on one side and plain on the other side with diameter of 6.5 mm.
The 50mg tablets are round, flat, yellow to light yellow in colour, with ‘C’ and ‘2’ de-bossed on either side of break-line on one side and plain on the other side with diameter of 8.0 mm. Hydralazine Tablets are available in blisters of 7, 10, 14, 28, 30, 56, 60, 84, 90, 100 and 112. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Morningside Healthcare Ltd 115 Narborough Road Leicester, UK Manufacturer
Morningside Pharmaceuticals Ltd 5 Pavilion Way Loughborough, UK
This leaflet was last revised in October 2015.
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