Document: leaflet ALMUS PHARMACEUTICALS_PL 20395-0020 change
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Re ton 3 an
Lisinopril dihydrate
PACKAGE LEAFLET: INFORMATION FORTHE USER
Read all of this leaflet carefully before you start
taking these tablets
• Keep this leaflet. You may need to read it again.
• Ifyou have any further questions, askyour doctor or pharmacist.
• Your doctor has prescribed these tablets for you.Do not pass them on to others. They may harmthem even if their symptoms are the same asyours.
• If any of the side effects get serious, or if younotice any side effects not listed in the leaflet,please tell your doctor or pharmacist.
In this leaflet:
1. What Lisinopril Tablets are and what they areused for
2. Before you take Lisinopril Tablets
3. Howtotake Lisinopril Tablets
4. Possible side effects
5. Howto store Lisinopril Tablets
6. Further information
I. What Lisinopril Tablets are and what theyare used for
The active ingredient Lisinopril belongs to a group of medicines called ACE inhibitors (AngiotensinConverting Enzyme inhibitors). These allow bloodvessels to dilate, widening the blood vessels whichhelps reduce blood pressure and makes it easier forthe heart to pump blood through the body in patientswith heart failure or following a heart attack.
Your doctor has prescribed Lisinopril Tablets for one of the following reasons:
• High blood pressure (hypertension) where theycan be used on their own or with other bloodpressure lowering medicines.
• Heart failure where they are used with othertreatments.
• Within 24 hours of a heart attack as part of a longterm treatment.
• To treat kidney problems caused by Type IIdiabetes in people with high blood pressure.
2. Before you take Lisinopril Tablets
Do not take Lisinopril Tablets:
• If you have taken ACE inhibitors before andsuffered an allergic reaction (such asangioneurotic oedema/ angioedema); symptomsof a reaction may include sudden appearance ofnettle-like rash and swellings particularly of thelips, face or neck.
• If you are more than 3 months pregnant. (It is alsobetter to avoid Lisinopril in early pregnancy - seepregnancy section).
• If you are allergic to lisinopril or any of the otheringredients in these tablets.
• If you suffer from swellings particularly of thehands, feet, face, tongue or throat that have noapparent cause (angioedema) or a member ofyour family has had a similar reaction (hereditaryangioedema).
Take special care with Lisinopril Tablets:
Tell your doctor before you start taking these tablets:
• If you are undergoing a type of dialysis forremoving fats from your blood.
• If you have an aortic stenosis (abnormalnarrowing of the heart valve).
• If you have peripheral vascular disease or outflowtract obstruction (problems with your veins andarteries).
• If you have an enlarged heart (hypertrophiccardiomyopathy) or an enlarged right heartventricle (cor pulmonale).
• Ifyou have had a heart attack.
• Ifyou have low blood pressure
• If you have kidney problems or are undergoingdialysis treatment.
• Ifyou are on a low salt diet
• If you have recently had a bout of vomiting ordiarrhoea.
• Before treatments involving an anaesthetic.
• If you think you are (or might become) pregnant.Lisinopril is not recommended in early pregnancy,and must not be taken if you are more than 3months pregnant, as it may cause serious harm toyour baby if used at that stage (see pregnancysection).
Taking other medicines:
It is important to let your doctor know if you are taking or have recently taken any other medicinesincluding herbal remedies or supplements.
Please tell your doctor if you are taking any of the following medicines:
• Beta-Blockers (e.g propranolol, atenolol,bisoprolol) or other medicines for treating highblood pressure.
• Diuretics (water tablets) including potassiumsupplements and salt substitutes.
• NSAIDs (non steroidal anti-inflammatory drugs)when taken at a dose of 3g and above per day,such as aspirin, ibuprofen orindomethacin.
• Lithium (antidepressants).
• Immunosuppressants - medicines that suppressthe body's immune response e.g for an allergicreaction to wasp or bee stings.
• Antidiabetic drugs e.g insulin, metformin andsulphonylureas.
• Indometacin used in treatment for rheumatoiddisease.
• Inform your doctor that you are taking lisinopril ifyou are undergoing a desensitisation treatmentfor a wasp or bee sting.
Your doctor may monitor your blood pressure and kidney function prior to and during the treatmentwith lisinopril.
Pregnancy and Breastfeeding:
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normallyadvise you to stop taking Lisinopril before youbecome or as soon as you knowyou are pregnant andwill advise you to take another medicine instead ofLisinopril. Lisinopril is not recommended in earlypregnancy and must not be taken when more than 3months pregnant, as it may cause serious harm toyour baby if used afterthe third month of pregnancy.Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast-feeding Lisinopril is not recommendedfor mothers who are breast-feeding, and your doctormay choose another treatment for you if you wish tobreast-feed, especially if your baby is newborn, orwas born prematurely.
3. Howtotake Lisinopril Tablets
Always take Lisinopril Tablets exactly as your doctor has told you. Exactly how many tablets and how oftenyou must take them, will be written on the label.Please read it carefully. You should check with yourdoctor or pharmacist ifyou are not sure.
The recommended doses are given below. Swallow the tablets whole with water. Take the dose atapproximately the same time each day.
Adults and elderly patients over 65 years:
High blood pressure (Hypertension):
The recommended starting dose is 2.5mg once daily. This may be adjusted by your doctor until your bloodpressure is controlled. The usual effective dose rangeis lOmg to 20mg once daily. The maximumrecommended dose is 40 mg once daily.
If you are already taking water tablets (diuretics) for high blood pressure the doctor may discontinue thewater tablets, or reduce the dose several days beforestarting treatment with lisinopril.
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Heartfailure:
The recommended starting dose is 2.5mg. This may be adjusted by your doctor until effective control isachieved. The usual effective dose range is 5mg to20mg. Treatment should be started under closemedical supervision.
Ifyou are taking water tablets (diuretics), your doctor may reduce the dose before starting treatment withlisinopril.
Heart attack:
Treatment may be started within 24 hours of having a heart attack and dose is dependent on bloodpressure.
The usual dose is 5mg straight away, followed by 5mg after 24 hours, lOmg after 48 hours and then lOmgonce everyday.
If you have low blood pressure you may start treatment on 2.5mg each day.
Ifyou begin to get low blood pressure while taking the tablet the doctor may reduce your dose to 5mg or2.5mg. However, if you have continuous low bloodpressure the doctor may stop treating you withLisinopril Tablets.
Your treatment will usually last for about 6 weeks but if you have symptoms of heart failure, treatment willprobably be continued.
If you wish to stop treatment discuss this with your doctor first as your original symptoms will return.
Paediatric Patients aged 6-16 years:
Hypertension: The recommended initial dose is 2.5mg once daily. This may be adjusted by thedoctor.The maximum recommened dose is 40mgdaily.
Children:
Lisinopril Tablets are not recommended for children aged above 6 years in other indicatons thanhypertension.
Lisinopril is not recommended in children belowthe age of 6, or in children with severe renal impairment
If you take more Lisinopril Tablets than you should:
If you have taken one extra dose this is unlikely to cause problems. If you or someone else has takenmore than one extra dose or a large overdose ofLisinopril Tablets, contact your doctor or localhospital accident and emergency departmentimmediately.
Ifyou forget to take Lisinopril Tablets:
If you have forgotten to take your medicine, take the missed dose as soon as you remember. If the nextdose is due within 8 hours, take the missed dose nowand skip the next dose, then continue as before. Donot double the next dose to make up for the missedone. If you are concerned about this you shouldconsultyour doctor or pharmacist.
Ifyou stop taking Lisinopril Tablets:
Do not stop taking Lisinopril Tablets without first discussing it with your doctor.
If you have any further questions on the use of Lisinopril Tablets askyour doctor or pharmacist.
4. Possible Side Effects
Common: (>1/100, <1/10)
• Headache, dizziness and tiredness.
• Cough which normally resolves after stoppingtreatment.
• Feeling sick and diarrhoea.
• Afeeling of weakness/loss of strength.
• Low blood pressure (hypotension)
• Allergy-like reactions such as rash and wheezing.
Uncommon: (>1/1000 to <1/100)
• Irregular heartbeats and increased heart rate.There have been rare incidences of heart attacksor strokes in patients who have very low bloodpressure and blood vessel disorders.
• Abdominal pain, indigestion and dry mouth.
• Impotence (inability to sustain an erection).
• Mood changes, vertigo, mental confusion, sleepdisturbances and taste disturbances.
Rare: (>1/10000, <1/1000)
• Blood disorders may develop with a tendency tobruise easily, prolonged bleeding after injury,bleed from the gums or elsewhere, paleappearance and feel tired. Contact your doctor.
• Fever, mouth and throat ulcers. Contact yourdoctor or local hospital accident and emergencydepartment as soon as possible.
• One or more of the following symptomsoccurring together: fever, patchy swelling of smallblood vessels (symptoms: rash, bleeding into theskin, arthritis and kidney failure); muscle pain;joint pain or inflammation; changes to your blood;rash; sensitivity to sunlight; or other skinconditions.
• Yellowing of the skin and the whites of the eyes(jaundice) and sickness caused by inflammation ofthe liver (hepatitis).
• Low or no urine to pass, or blood in the urinecaused by kidney problems.
• Sinusitis (inflammation of the internal areas of thenose).
• Wheezing,runnynoseorsinusitis.
• Hair loss, excessive sweating, a scaly rash(psoriasis) and an itchy or raised rash may occur.
• loss of sense of smell
• Depression
Frequency not known: Syncope (fainting).
Ifyou develop any of these serious conditions, contact yourdoctoras soon as possible.
If you experience any adverse effects and they become severe or upsetting, or you have any otherunpleasant effects which you think could be due totaking Lisinopril Tablets, contact your doctor orpharmacist for advice.
5. Howto store Lisinopril Tablets
Keep out of the reach and sightof children.
Do not use Lisinopril Tablets after the expiry date which is stated on the carton.
Do not keep the tablets above 25°C.
6. Further information
What Lisinopril Tablets contain
Each tablet contains 2.5mg, 5mg, lOmg, or 20mg of lisinopril as the active ingredient lisinopril dihydrate.The other ingredients are mannitol, calciumhydrogen phosphate dihydrate, pregelatinised maizestarch, croscarmellose sodium and magnesiumstearate. The lOmg and 20mg tablets also containred, black and yellow oxide colourings (EI72).
Like all medicines, Lisinopril Tablets can cause side What Lisinopril Tablets look like and contents of effects, although not everyone gets them.the pack
Lisinopril 2.5mg and 5.0mg Tablets are white circular If you experience any of the following symptoms biconvex tablets. The Lisinopril lOmg and 20mgcontactyour doctor or hospital immediately:-Tablets are light pink circular biconvex tablets.
. Sudden signs of an allergic reaction such as rash, The tablets are supplied in packs of 28 or 50 tablets.
itching, swelling on the face, hands or lips or ... .«...
. T. Marketing Authorisation Holder and
problems breathing.
• Sudden severe pain in the upper abdomen and D i u i • j r-u u- i_i r- i
Relonchem Limited, Cheshire House, Gorsey Lane back caused by inflammation of the pancreas Widnes, Cheshire,WA80RR UK(pancreatitis).
. Serious skin reactions such as red itchy target Date leaflet last revised: September 2011
type marks on the skin and other more serious skin complaints with reddening, blistering or [pomIpeeling of the skin.
PL 20395/0019-0022
