Apo-Cilazapril/Hydrochlorothiazide Cilazapril 5Mg + Hydrochlorothiazide 12.5Mg Film Coated Tablets
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New Zealand Consumer Medicine Information Apo-Cilazapril/Hydrochlorothiazide cilazapril 5mg + hydrochlorothiazide 12.5mg film coated tablets What is in this leaflet Please read this leaflet carefully before you start using Apo-Cilazapril/Hydrochlorothiazide. This leaflet answers some common questions about Apo-Cilazapril/Hydrochlorothiazide. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Apo- Cilazapril/Hydrochlorothiazide against the benefits they expect it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. What Apo-Cilazapril/Hydrochlorothiazide is used for Apo-Cilazapril/Hydrochlorothiazide contains two active ingredients, cilazapril and hydrochlorothiazide. Cilazapril belongs to a group of medicines known as ACE (Angiotensin Converting Enzyme) inhibitors. Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics. Cilazapril and hydrochlorothiazide are both used to treat raised blood pressure. When used in combination they are more effective at lowering blood pressure than either medicine used alone. Cilazapril works by inhibiting (blocking) natural chemicals produced by the body which increase blood pressure. This inhibition leads to a reduction of blood pressure. When given together with diuretics (fluid tablets) this helps to reduce the blood pressure further. Your doctor may have prescribed Apo-Cilazapril/Hydrochlorothiazide for another reason. Ask your doctor if you have any questions about why Apo- Cilazapril/Hydrochlorothiazide has been prescribed for you. This medicine is available only with a doctor's prescription. Before you use Apo-Cilazapril/Hydrochlorothiazide When you must not use it Do not use Apo-Cilazapril/Hydrochlorothiazide if: • You are allergic to cilazapril or other blood pressure medicines of the same class (called ACE inhibitors) • You are allergic to hydrochlorothiazide, other thiazides or sulphonamide- derived medicines e.g. sulphamethoxazole (in co-trimoxazole, Deprim®, Trisul®) and sulphasalazine (Salazopyrin®) • You have diabetes and/or kidney problems and you are taking a medicine which contains aliskiren • You have previously suffered from angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing), when taking other ACE inhibitors. Some people may be more likely to experience this than others. • You are pregnant or breast feeding You should not take Apo-Cilazapril/Hydrochlorothiazide while pregnant. Your baby may absorb this medicine in the womb and therefore there is a possibility of harm to the baby. • You have no production or passing of urine (anuria) • You are allergic to any of the ingredients listed at the end of this leaflet • The package is torn or shows signs of tampering • The expiry date printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well. If you are not sure whether you should start using Apo-Cilazapril/Hydrochlorothiazide, talk to your doctor. Before you start to use it Tell your doctor if: 1. You are currently on haemodialysis or haemofiltration (kidney replacement therapy) 2. You are breast feeding or plan to breast feed You should not take Apo-Cilazapril/Hydrochlorothiazide if you are breast feeding. 1 3. You have any other health problems, especially the following: • liver disease • kidney disease • a heart condition • blood disorders • diabetes • gout or history of gout • you suffer from porphyria (a rare blood pigment disorder) 4. You are on a restricted salt diet 5. You are taking a medicine containing aliskiren, or are taking an Angiotensin II Receptor Blocker 6. You are taking potassium supplements or potassium-containing salt substitutes 7. You are allergic to any other medicines, foods, dyes or preservatives 8. You plan to have surgery (including dental surgery) Tell your doctor if you are about to have any form of operation that requires an anaesthetic. If you have not told your doctor about any of the above, tell them before you start using Apo- Cilazapril/Hydrochlorothiazide. Taking other medicines Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. You should also tell any health professional who is prescribing a new medication for you that you are taking Apo-Cilazapril/Hydrochlorothiazide. Some medicines may interfere with Apo-Cilazapril/Hydrochlorothiazide. These include: • medicines used to lower blood pressure e.g. ACE inhibitors such as losartan (Cozaar®), candesartan (Atacand®); angiotensin receptor antagonists such as losartan (Cozaar®), candesartan (Atacand®); renin-inhibitors such as aliskiren (Rasilez); and diuretics including potassium sparing diuretics e.g. amiloride/hydrochlorothiazide (Moduretic®), amiloride/frusem ide (Frum il®), spironolactone (Spiractin®, Spirotone®) • other antihypertensive medicines e.g. amlodipine (Amlo®), clonidine (Catapres®), nifedipine (Adalat®) • Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) used for the relief of pain e.g. aspirin, ibuprofen (Nurofen®), diclofenac (Voltaren®), naproxen (Naprosyn SR®) • potassium supplements or potassium-containing salt substitutes used to reduce salt intake in the diet • antipsychotic medicines used for the treatment of mania, hypomania and bipolar depression such as lithium (Lithicarb®, Priadel®) 2 • cardiac medicines used for the treatment of heart failure and certain types of arrhythmias e.g. digoxin (Lanoxin®) • medicines used to treat irregular heart beat called class 1a or class III antiarrhythmics e.g. adenosine (Adenocor®, Leustatin®), lignocaine (Xylocaine®) • medicines used to reduce cholesterol, treat pruritus and relief diarrhoea following surgery e.g. cholestyramine/colestipol (Questran®/Colestid®) • medicines used to treat acute and chronic diarrhoea; ulcerative colitis; disease of the brain affecting movement; slow heart beat or to inhibit excessive saliva/mucous production pre surgery called anticholinergics e.g. atropine (Diastop®, Congentin®) • medicines used in the management of cardiac arrest; asthma; emphysema; narcolepsy or allergic disorders called sym pathom imetics e.g. adrenaline, salbutamol, ephedrine • medicines used for the treatment of Parkinson’s disease or infection caused by influenza e.g. amantadine (Symmetrel®) • medicines used to lower blood sugar in diabetes (anti-diabetic medicines such as insulin or vildagliptin (Galvus®)) • medicines used to prevent organ transplant rejection or medicines used for some cancers e.g. sirolim us (Rapam une®) and everolimus (Afinitor®) • desensitisation therapy with wasp or bee venom • medicines which reduce the body’s natural defences (immunosuppressive therapy) e.g. cyclosporine (Neoral®, Sandimmun®) • medicine used to treat certain mental and emotional conditions; or medicine used to put you to seep before surgery such as tricyclic antidepressants, antipsychotics, anaesthetics or narcotics • medicines used for the treatment of Rheumatoid Arthritis e.g. gold • medicines used to relax muscles called non-depolarizing muscle relaxants e.g. Atracurium, Mivacurium (Mivacron®) • medicines used for the treatment of osteoporosis e.g. calcium salts and vitamin D • medicines used for chemotherapy e.g. cytotoxic drugs such as methotrexate, cyclophosphamide, • medicines used for the treatment of gout, or high uric acid levels in the blood which may cause gout e.g. allopurinol These medicines may be affected by Apo-Cilazapril/Hydrochlorothiazide, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Apo-Cilazapril/Hydrochlorothiazide. Ask your doctor or pharmacist if you are not sure about this list of medicines. How to use Apo-Cilazapril/Hydrochlorothiazide Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet. 3 How much to take Take Apo-Cilazapril/Hydrochlorothiazide tablets exactly as your doctor has prescribed. The usual dose of Apo-Cilazapril/Hydrochlorothiazide is one tablet taken once daily. How to take it Swallow the tablet whole with a glass of water. Do not chew the tablets. When to take it Take Apo-Cilazapril/Hydrochlorothiazide tablets at about the same time every day. It does not matter whether you take Apo-Cilazapril/Hydrochlorothiazide tablets with food or not. Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take the tablets. How long to take it Continue taking Apo-Cilazapril/Hydrochlorothiazide tablets until your doctor tells you to stop. If you forget to take it Do not take two doses on the same day. If you remember your Apo-Cilazapril/Hydrochlorothiazide dose later on in the day you are meant to have taken it, then take the dose. If you remember the next day, skip the missed dose and take your next dose when you are meant to. If you are not sure what to do, ask your doctor or pharmacist. If you have trouble remembering your dose, ask your pharmacist for some hints. While you are using Apo-Cilazapril/Hydrochlorothiazide Things you must