Lisinopril 5mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
LISINOPRIL 2.5 mg, 5 mg, 10 mg & 20 mg TABLETS
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, 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
THIS LEAFLET CONTAINS
1. What Lisinopril is for
2. Before you take Lisinopril
3. How to take Lisinopril
4. Possible side effects
5. How to store Lisinopril
6. Further information
1. WHAT LISINOPRIL IS FOR
Lisinopril belongs to a group of medicines called ACE inhibitors. These work by causing your blood vessels to relax, making it easier for your heart to pump blood around your body.
Lisinopril tablets can be used to treat:
• high blood pressure, also called hypertension
• heart failure, where the heart has difficulty pumping blood around your body
• patients who are stable but have had a heart attack within the last 24 hours (short term treatment)
• kidney disease in diabetic patients with high blood pressure
Lisinopril is recommended in children (above 6 years old) only for the treatment of high blood pressure (hypertension). Lisinopril should not be used in children with severe kidney impairment.
If you are not sure why you have been prescribed this medicine then please ask your doctor.
2. BEFORE YOU TAKE LISINOPRIL
Do not take Lisinopril and tell your doctor if you:
• are allergic (hypersensitive) to Lisinopril, other ACE inhibitors (such as captopril, ramipril), or any of the other ingredients in Lisinopril tablets (see section 6). The signs of an allergic reaction can include rash, swollen lips, face, throat or tongue, and difficulty in swallowing or breathing.
• or any of your family have experienced allergic symptoms, which may be unrelated to the use of medicines
• are more than 3 months pregnant, (it is also better to avoid Lisinopril in early pregnancy - see pregnancy section)
Do not take this medicine if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist.
Take special care with Lisinopril
Tell your doctor before you take this medicine if you:
• have been told to limit the amount of salt in your diet, are having kidney dialysis, or have recently had severe diarrhoea or sickness (vomiting)
• have recently had a heart attack (myocardial infarction)
• have a narrowing (stenosis) of the heart valve or aorta, or have a heart problem known as "hypertrophic cardiomyopathy". These all cause the blood to flow less freely away from the heart
• have kidney problems, including narrowing of the blood vessels supplying your kidneys (renal artery stenosis), or renovascular hypertension (high blood pressure due to a blockage in a blood vessel in the kidney), or have recently had a kidney transplant
• have ever had "angioneurotic oedema" or "angioedema" after taking other medicines. The signs include itching, red marks on the hands, feet and throat, swelling around the eyes and lips, difficulty breathing
• are having treatment to reduce your reaction to bee and wasp stings
• are having treatment of your blood by a machine to lower cholesterol (LDL apheresis)
• take extra potassium in your diet or a salt substitute that contains potassium
People who are of black race or African Caribbean origin
need to be aware that in this group of patients:
• Allergic reactions to Lisinopril are more common
• Lisinopril may not work as well
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Lisinopril.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines bought without a prescription. This is because Lisinopril can affect the way some medicines work. Also some medicines can affect the way Lisinopril works.
In particular, tell your doctor or pharmacist if you are taking any of the following:
• medicines to treat high blood pressure and heart problems, such as doxazosin, candesartan, diazoxide, hydralazine, methyldopa, minoxidil, moxonidine, sodium nitroprusside, propranolol or sotalol
• medicines to treat mental health problems, such as chlorpromazine, haloperidol, lithium, pimozide sulpiride or zuclophenthixol
• medicines to help you sleep or feel more relaxed, such as diazepam or temazepam
• medicines to treat chest pain, such as diltiazem, verapamil, or glyceryl trinitrate
• medicines to increase urine production, (diuretics), such as amiloride, furosemide or spironolactone
• medicines to stop your blood clotting
• medicines to treat diabetes, such as insulin, metformin or tolbutamide
• medicines to treat depression, called monoamine oxidase inhibitors (MAOIs), such as moclobemide and phenelzine
• medicines for pain and swelling, such as diclofenac, ibuprofen or indometacin
• medicines or supplements containing potassium, (including table salt substitutes)
• muscle relaxants, such as baclofen or tizanidine
• steroids, such as hydrocortisone or prednisolone, to treat swelling and allergies
• oestrogens used for contraception or hormone replacement therapy (HRT)
• antacids to treat indigestion or heartburn
• aldesleukin to treat cancer
• allopurinol to treat gout
• alprostadil for problems maintaining an erection
• ciclosporin to stop the rejection of organs after transplant
• clonidine to treat high blood pressure or migraine
• levodopa to treat Parkinson's disease
• moxisylyte to treat blood circulation problems like Raynaud's disease
Operations and Tests
If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking Lisinopril.
Taking Lisinopril may affect the results of some blood tests. These include tests on: the blood cells or other parts of it, potassium levels, creatine or urea, sodium, liver enzymes or bilirubin.
If you are going to have a blood test, it is important to tell your doctor that you are taking Lisinopril.
Pregnancy and breast-feeding
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Lisinopril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Lisinopril.
Lisinopril is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as they may cause serious harm to your baby if used after the third month of pregnancy.
Tell your doctor if you are breast-feeding or about to start breast-feeding. Lisinopril is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
You may feel tired or dizzy while taking Lisinopril. If this happens, do not drive or use any tools or machines and tell your doctor.
3. HOW TO TAKE LISINOPRIL
Always take Lisinopril tablets exactly as your doctor has told you.
The dose of Lisinopril will depend on the condition being treated and any other medicines you are taking. You should check with your doctor or pharmacist if you are not sure.
Swallow the tablets with a glass of water, with or without food. They should be taken at the same time each day.
The first Lisinopril tablets you take might make you feel dizzy or light-headed. This is because the first dose may make your blood pressure fall by more than the doses you take after that. It may help to lie down until you feel better.
Adults
For high blood pressure
• The starting dose is usually 10 mg daily. This may be increased gradually to a maintenance dose of usually 20 mg each day. The maximum daily dose is 80 mg.
• The actual dose, decided by your doctor, will depend on your blood pressure and other medical conditions.
• If you are taking a high dose of water tablets (diuretics), your doctor may ask you to stop taking them for 2 to 3 days before you start taking Lisinopril.
For heart failure
• Lisinopril will usually be given with a diuretic (water tablet) and where necessary, medicines used to reduce heart function.
• The starting dose is usually 2.5 mg each day.
• It can be increased to as much as 35 mg once daily; your doctor will decide this depending on how your condition changes with Lisinopril. Any change will be done gradually over a number of weeks.
After a heart attack
• Treatment may be started within 24 hours of having a heart attack
• The usual starting dose of 5 mg each day for 2 days may be increased to 10 mg on the third day.
• Treatment may continue for about 6 weeks after your heart attack.
For kidney disease in diabetic patients with high blood pressure
• The usual maintenance dose is 10 mg - 20 mg once daily.
People with kidney problems
• If you have kidney problems, the doctor will alter the amount of Lisinopril you take depending on how well your kidneys are working
• If you are on kidney dialysis your dosage will vary day by day. Your doctor will let you know what your dose should be.
• Lisinopril should not be used in patients who have recently had a kidney transplant
Elderly
Your dose will be decided by your doctor. It will depend on how well your kidneys are working.
Children and adolescents aged 6 to 16 years with high blood pressure:
The dose depends on the child’s bodyweight. The usual starting dose is between 2.5mg and 5mg once daily, which can be increased to a maximum of 20mg to 40mg once daily. Patients with kidney problems should take a lower dose. Your doctor will decide the correct dose for you.
Children under 6 years:
Lisinopril is not recommended for use in children under 6 years.
If you take more Lisinopril than you should
Contact your doctor or go to the nearest hospital casualty department straight away. Take the medicine pack with you so the doctor knows what you have taken.
If you forget to take Lisinopril
If you miss a dose do not worry. Take your normal dose when it is next due. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Lisinopril
Take your medicine until your doctor tells you to stop. If you feel better, do not stop taking the tablets. If you stop them, your condition may get worse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lisinopril can cause side effects, although not everybody gets them.
If you get any of the following side effects, STOP TAKING Lisinopril and tell your doctor immediately or go to the nearest hospital emergency department:
• Swelling of the hands, feet, ankle, face, lips, tongue or throat which may cause difficulty in swallowing or breathing, itching of the skin and nettle rash.
• Red, swollen or scalded skin with blisters on the lips, eyes, mouth, nose and/or genitals, you may also have a high temperature swollen glands or joint pain.
This may mean you are having an allergic reaction.
Talk to your doctor straight away if you notice any of the following serious side effects:
• Severe stomach or back pain. These could be signs of pancreatitis, (an inflammation of the pancreas).
• Blood disorders including the bone marrow problems and anaemia. Symptoms include bruising more easily, bleeding longer after injury, bleeding from the gums or elsewhere, purple spots or blotching on the skin (caused by damage to small blood vessels), and a greater chance of infection.
• High temperature, tiredness, loss of appetite, stomach pain, feeling sick (nausea), yellowing of the skin or eyes (jaundice) and liver failure. These are symptoms of hepatitis (inflammation of the liver).
• 'Symptom complex', a condition which may include some or all of the following: high temperature, inflamed blood vessels, painful inflamed muscles and joints, blood problems detected by a blood test, rash, being very sensitive to sunlight, or other skin reactions.
Tell your doctor or pharmacist if you notice any of the following side effects:
Common (affects less than 1 in 10 people)
• Dizziness, headache, or cough
• Feeling faint or light-headed when standing up quickly, this could be due to low blood pressure
• Diarrhoea, being sick (vomiting)
• Impaired kidney function, (shown in a blood test).
Uncommon (affects less than 1 in 100 people)
• Mood changes, a feeling of dizziness or "spinning" (vertigo), change in the way things taste, sleep problems, unusual skin sensations such as numbness, tingling, pricking, burning, or creeping on the skin (paraesthesia)
• Heart problems including increased heart rate, uneven heart beat, chest pain and more serious conditions including heart attack and stroke
• Raynaud's phenomenon. Symptoms include toes or fingers that change colour when exposed to the cold or when pressure is put on them, pain in the fingers or toes when cold, tingling or pain on warming
• Runny nose, itching, sneezing and stuffy nose (rhinitis)
• Itchy, lumpy rash
• Difficulty in getting an erection or ejaculating (impotence)
• Tiredness, lack or loss of strength (weakness)
Rare side effects (affects less than 1 in 1,000 people)
• Feeling confused
• Dry mouth
• Hair loss or balding
• Breast enlargement in men
• Pale or red irregular raised patches with severe itching (hives)
• Psoriasis (itchy scaly pink patches on the elbows, knees, scalp and other parts of the body)
• High levels of urea and other waste products in the blood due to kidney failure, acute kidney failure
• Decreases in haemoglobin and haematocrit, increases in blood levels of bilirubin, decreases in blood levels of sodium, (shown in a blood test)
Very rare side effects (affects less than 1 in 10,000 people, including isolated reports)
• Low blood sugar levels (hypoglycaemia). You may feel a sense of nervousness, shaky or sweaty.
• Narrowing of the airways, blocked or runny nose (sinusitis), inflammation or infection of the lungs due to an allergy (allergic alveolitis or eosinophilic pneumonia)
• Swelling of the intestines (intestinal angioedema), symptoms are stomach pain with or without feeling sick or being sick (vomiting)
• Excessive sweating
• Passing less urine than usual over the day
• Severe difficulty breathing, wheezing, tightness in the chest
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE LISINOPRIL
Keep out of the reach and sight of children.
Do not use the tablets after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Lisinopril tablets contain
The active substance (the ingredient that makes the tablets work) is Lisinopril dihydrate.
The other ingredients are calcium hydrogen phosphate dehydrate (E341), magnesium stearate, maize starch, mannitol (E421), and croscarmellose sodium.
The 10 mg and 20 mg tablets also contain iron oxide (E172).
What Lisinopril tablets look like and contents of the pack
The 2.5 mg tablets are circular white tablets.
The 5 mg tablets are circular white tablets.
The 10 mg tablets are circular light pink tablets.
The 20 mg tablets are circular pink tablets.
All four strengths of Lisinopril tablets come in blister packs of 28, 30, 50, 84 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Activase Pharmaceuticals Limited,
Boumpoulinas 11,3rd Floor, Nicosia, PC. 1060 Cyprus Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road, London SW5 9JQ
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last approved in 01/2011
LSN0018&0019&0020&0021/00025&0005&0010&0020T/LEA002