Package leaflet: Information for the patient Hydralazine 25mg and 50mg tablets Read all of this leaflet carefully • have angina pectoris, which causes pain in the chest before you start taking this with exercise medicine because it contains • have cerebrovascular disease (narrowing of the blood vessels in the brain) important information for you. • have been told you are a slow acetylator (this means • Keep this leaflet. You may need to that your body handles some medicines more slowly read it again. than other people) • If you have any further questions, • suffer from any serious liver or kidney problems. ask your doctor or pharmacist. Tests • This medicine has been prescribed If you are taking long-term Hydralazine treatment, for you only. Do not pass it on to your doctor may want to carry out blood and urine others. It may harm them, even if tests every 6 months. their signs of illness are the same as yours. Other medicines and Hydralazine tablets • If you get any side effects, talk to Tell your doctor or pharmacist if you are taking, have your doctor or pharmacist. This recently taken or might take any other medicines. includes any possible side effects It is especially important to tell your doctor if you are not listed in this leaflet. See section taking: 4. • medicines for high blood pressure, such as vasodilators (e.g. minoxidil diazoxide) What is in this leaflet • ACE inhibitors (e.g. enalapril, lisinopril, captopril) • Beta-blockers (e.g. propranolol) 1 What Hydralazine tablets are • calcium antagonists (e.g. nifedipine or diltiazem) and what they are used for • medicines for water retention (e.g. diuretics) 2 What you need to know • medicines for problems such as depression, including monoamine oxidase inhibitors (MAOIs) before you take Hydralazine (e.g. moclobemide, phenelzine, isocarboxazid, tablets tranylcypromine) 3 How to take Hydralazine • tricyclic antidepressants (e.g. amitriptyline, clomipramine) or tranquillisers (e.g. diazepam) tablets • medicines to control pain and inflammation (a 4 Possible side effects group of medicines known as non-steroidal anti- inflammatory drugs (NSAIDs)) 5 How to store Hydralazine • medicines to control psychoses tablets • a specific group of medicines known as nitrates, used 6 Contents of the pack and to control blood pressure • oestrogens (a group of female sex hormones used in other information contraception and in treating the menopause) • muscle relaxants (e.g. baclofen, tizonidine) 1 What Hydralazine tablets are and what • medicines that stimulate the nervous system (e.g. they are used for adrenaline, norepinephrine) Hydralazine belongs to a group of medicines called • steroids. vasodilators. These medicines relax the muscles of artery walls and cause blood vessels to expand. If you are going to have general anaesthetic, you Hydralazine tablets are used to: should tell the doctor or dentist in charge that you • treat moderate to severe high blood pressure (with or are taking Hydralazine tablets. without a beta-blocker or diuretic medicine) Hydralazine tablets with alcohol • manage moderate to severe congestive heart failure It is advisable not to drink alcohol whilst taking (where use of other medicines alone is not enough). Hydralazine tablets as it may affect you more than 2 What you need to know before you usual. take Hydralazine tablets Pregnancy and breast-feeding Do not take Hydralazine tablets if you have: If you are pregnant or breast-feeding, think you may • an allergy to hydralazine, dihydralazine or any of the be pregnant or are planning to have a baby, please tell other ingredients in this medicine (listed in section 6) your doctor before taking Hydralazine Tablets. • a racing heart beat (tachycardia) Driving and using machines • heart failure caused by narrowing of blood vessels You can drive while taking Hydralazine but do not or heart valves (aortic or mitral stenosis), high drive until you know how the tablets affect you. They blood pressure in blood vessels supplying the lungs may make you feel dizzy. If they affect you in this way, (pulmonary hypertension) or inflammation of the do not drive or operate any machinery. heart (constrictive pericarditis) • heart failure with a normal or increased output of Hydralazine tablets and lactose blood from the heart (e.g. in thyrotoxicosis) If you have been told you have an intolerance to • systemic lupus erythematosus (SLE) or any related some sugars, contact your doctor before taking this disease medicine, as the 25mg tablets contain lactose. • swelling in a blood vessel wall (aortic aneurism) • (or a relative has) an inherited disorder of the red Hydralazine tablets and E122 blood pigment haemoglobin (porphyria). The 50mg tablets contain the colour E122 which may cause allergic reactions. Warnings and precautions Talk to your doctor or pharmacist before taking 3 How to take Hydralazine tablets Hydralazine tablets if you: Always take Hydralazine tablets exactly as your doctor • have had a heart attack in the past three months has told you. If you are not sure, check with your • have coronary heart disease doctor or pharmacist. Continued top of next column Continued over page 130x210 Leaflet Reel Fed Profile (BST) Hydralazine, Tablets, 25 & 50mg, Hydralazine 25 & 50 mg Tablets PIL - UK 56s - PL JDE No.: 50990760 approved for print/date Item number: BBBA8132 Colours Non Printing Colours 1. 1. Profile Originator: RH Dimensions: 130x210 Black Dimensions: 130x210 (Reel Fed) Origination Date: 04-05-20 Min Body Text Size: 6.4 pt 2. 2. Revision Date: 11-05-20 Supplier: Accord Barnstaple 3. 3. Component: Leaflet for Bottles Revised By: RH 4. 5. Pharmacode: 2205 Proof Round Technical Date sent: n/a 6. 03 Approval Date received: n/a Date Sent: 28-04-20 [email protected] Technologist: RH FMD info NA (not a carton) No Yes Details Technically Approved * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 2 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 01.11.2017 Speak to your doctor before drinking alcohol with this • Blocked or stuffy nose medicine. • Loss of appetite • Weight loss Swallow these tablets with water. • Dizziness • Generally feeling unwell. The recommended dose is: Adults (including the elderly): Rare (may affect up to 1 in 1,000 people) Hypertension: Initially 25mg twice a day or 50mg once • Kidney failure a day. Your doctor may gradually increase this, up to a • A change in the amount of urine produced maximum of 200mg a day. Your doctor will decide on the • A restriction of movement in part of the intestine best dose for you. • A deficiency of certain white blood cells which can result in Chronic congestive heart failure: Treatment should be fever and ulceration of the mouth and throat started in hospital and dosages can vary. The maintenance • An increased number of white blood cells dose is 50mg - 75mg four times a day. • Enlargement of the spleen • A reduction in the number of red and white blood cells Use in children: Not recommended. and platelets in the blood If you take more Hydralazine tablets than you should • Depression If you (or someone else) swallow a lot of the tablets at the • Seeing or hearing things which are not really there same time, or if you think a child may have swallowed any, (hallucinations) contact your nearest hospital casualty department or tell • Inflammation of the nerves which may cause weakness or your doctor immediately. numbness especially in your fingers and toes Symptoms of an overdose include low blood pressure, • Tingling (pins and needles) in your hands or feet racing heart beat, decreased blood flow to the heart, • Disease of the lymph nodes irregular heart beat, coma. • Enlarged eye balls. If you forget to take Hydralazine tablets If you feel very tired, experience unexpected bruising or Do not take a double dose to make up for a forgotten dose. bleeding, or more infections (e.g. colds and sore throats) If you forget to take a dose, take it as soon as you remember than usual please tell your doctor. Your doctor may decide it and then take the next dose at the right time. to conduct tests on your blood periodically as a result of these symptoms. If you stop taking Hydralazine tablets Do not stop treatment early because an increase in blood Reporting of side effects pressure may occur. Talk to your doctor before you stop If you get any side effects, talk to your doctor, pharmacist taking the tablets and follow their advice. or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the If you have any further questions on the use of this Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or medicine, ask your doctor or pharmacist. search for MHRA Yellow Card in the Google Play or Apple App Store. 4 Possible side effects By reporting side effects you can help provide more Like all medicines, this medicine can cause side effects, information on the safety of this medicine. although not everybody gets them. 5 How to store Hydralazine tablets Stop taking the medicine and seek immediate medical Keep out of the sight and reach of children. advice if you notice the following: Do not store above 25°C. Store in the original container. • SLE-type syndrome, which can cause symptoms such as Do not use Hydralazine tablets after the expiry date stated joint pain, fever, change in blood count and skin rash. on the label/carton. The expiry date refers to the last day of • Allergic reactions including itching, skin rash, inflammation that month. of the walls of small blood vessels and difficulty in Do not throw away any medicines via wastewater or breathing.