Lisinopril 5 Mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lisinopril 2.5 mg, 5 mg, 10 mg and 20 mg Tablets
Active substance: lisinopril
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Lisinopril is and what it is used 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 AND WHAT IT IS USED FOR
Lisinopril is used to treat:
• high blood pressure
• reduced heart pumping ability
• patients recovering from a heart attack
• kidney disease resulting from diabetes and high blood pressure.
Lisinopril should not be used in children with severe kidney impairment.
Lisinopril is recommended in children (above 6 years old) only for the treatment of high blood pressure (hypertension).
Lisinopril belongs to the ACE inhibitor medicine group (angiotensin-converting enzyme inhibitors). Lisinopril expands your blood vessels. This reduces your blood pressure and makes it easier for your heart to pump blood to all body parts.
2. BEFORE YOU TAKE LISINOPRIL
Do not take Lisinopril
• if you are allergic (hypersensitive) to
- lisinopril or,
- any of the other ingredients or,
- other ACE inhibitors.
• if during earlier ACE inhibitor use you had swelling of the face, lips, tongue and/or throat with difficulty swallowing, breathing or with joints.
Do not take Lisinopril if you had any of these reactions
- without a known cause or
- if it has been confirmed that you have a hereditary or
- other form of fluid accumulation (angiooedema).
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
• if you are more than 3 months pregnant. (It is also better to avoid Lisinopril in early pregnancy - see pregnancy section.)
Warnings and precautions
Talk to your doctor before taking Lisinopril
• if you suffer from dehydration due to treatment with „water tablets“ (diuretics), dialysis, a low salt diet, vomiting or diarrhoea.
if this applies to you, on starting medication you may frequently have a large drop in blood pressure.
• if you suffer from heart disorders such as heart failure, narrowing of the aortic or mitral valves (aortic or mitral stenosis), or an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy or ‘HOCM’) or if you have a condition involving the blood vessels in the brain.
• if you have kidney problems
• if you are undergoing dialysis treatment
- with high flux membranes
- blood separation treatment to remove cholesterol from your blood by machine with dextran sulphate
or
desensitisation treatment to reduce the effects of an allergy to a bee or wasp sting.
In these cases tell your doctor that you are taking Lisinopril. He may wish to interrupt your Lisinopril treatment to prevent a possible allergic reaction.
• if you have liver problems. If you develop jaundice during use of Lisinopril stop taking it and consult your doctor.
• if you have blood vessel disease, know as collagen vascular disease
• if you are Black of Afro Caribbean origin have a higher risk of having:
- sudden fluid accumulation in the skin and mucous membranes such as throat or tongue
- breathing difficulties
- itching and rash, often as an allergic reaction
- a reduction of Lisinopril’s effect.
• if you have a cough
Inform your doctor if this becomes worse.
• if you need to have surgery or an anaesthetic, remind your doctor or dentist that you are taking Lisinopril.
• if taking other medicines, such as potassium supplements, lithium (for mental disorders)
or medicines against diabetes.
• if you are taking any of the following medicines used to treat high blood pressure:
- an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.
- aliskiren.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Lisinopril”.
• if you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately
If you are unsure if any of the above apply to you, please discuss this with your doctor.
You must tell your doctor if you think that you are (or might become) pregnant. Lisinopril is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see Pregnancy section).
Other medicines and Lisinopril
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This particularly applies to:
• Diuretics (“water tablets”) which are used to treat high blood pressure including potassium-sparing diuretics such as spironolactone, triamterence or amiloride.
• Other medicines used to treat high blood pressure.
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Lisinopril” and “Warnings and precautions”).
• medicines to treat arthritis or muscle pain, such as acetylsalicylic acid doses over 3 grams daily or indomethacin
• Medicines for mental disorders or depressions such as
- lithium
- medicines to treat psychoses
- tricyclic antidepressants, such as amitriptiline
• Potassium containing supplements or salt substitutes.
• Blood sugar lowering medicines, such as insulin or those taken orally.
The antidiabetic medicine dose may need adjusting.
• Central nervous system stimulative medicines, such as
- ephedrine or pseudoephedrine, which could be included in decongestants or cough/cold remedies or
- salbutamol, a medicine for treating asthma.
• Medicines to suppress the body’s immune system
• Allopurinol, a medicines to treat gout
• Procainamide, used to treat abnormal heartbeats
• Gold injections (sodium aurothiomalate), a medicine to injection against rheumatic arthritis
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicines.
Pregnancy
You must tell your doctor if you think that 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 it may cause serious harm to your baby if used after the third month of pregnancy.
Lactation
Tell y our doctor if you a re breast-feeding or about to start breast-feeding. Lisinopril is not recommended for m others who are breast-feeding, and your doctor may choose another treatment for y ou if you wish to breast-feed, espec ially if your baby is newbo rn, or was bo rn prematurely.
Driving and using machines
Dizziness or tiredness may occur when using Lisinopril. Do not drive or operate machinery if this affects you.
3. HOW TO TAKE LISINOPRIL
Always take Lisinopril for as long and exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Lisinopril should be taken once daily preferably every morning. Take the tablets whole with a glass of water independent of meal.
The tablets are not intended to be broken.
The usual dose is:
• For high blood pressure
The recommended starting dose is 4 tablets.
For severe conditions your doctor may decide to start you on between 1-2 tablets.
Once optimal control of blood pressure has been reached, the usual effective maintenance dose is 8* tablets as a single daily dose.
If within a period of 2-4 weeks your blood pressure is not under control, your doctor may increase your dose further up to maximum of 80 mg* daily.
Diuretic-Treated Patients
If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with lisinopril. Patients with high blood pressure who cannot discontinue the diuretic therapy, should begin Lisinopril treatment with 2 tablets.
• Heart conditions such as heart failure
The usual starting dose is 1 tablet once a day. Your doctor may increase this dose if required at intervals of 2 weeks or more and by increments of 4 tablets or less.
• Following a heart attack
The usual dose is 2 tablets on Day 1 and Day 2, then 4 tablets taken once a day.
• Diabetic patients with kidney problems
The usual dose is 4 tablets once a day which may be increased by your doctor to 8* tablets once a day.
Lisinopril 5mg tablets:
The tablets can be divided into equal halves.
The usual dose is:
• For high blood pressure
The recommended starting dose is 2 tablets.
For severe conditions your doctor may decide to start you on between 54-1 tablet.
Once optimal control of blood pressure has been reached, the usual effective maintenance dose is 4 tablets as a single daily dose.
If within a period of 2-4 weeks your blood pressure is not under control, your doctor may increase your dose further up to maximum of 80 mg1 daily.
* For this dosage, tablets with a higher content of active substance are available.
Diuretic-Treated Patients
If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with lisinopril. Patients with high blood pressure who cannot discontinue the diuretic therapy, should begin Lisinopril treatment with 1 tablet.
• Heart conditions such as heart failure
The usual starting dose is % tablet once a day. Your doctor may increase this dose if required at intervals of 2 weeks or more and by increments of 2 tablets or less.
• Following a heart attack
The usual dose is 1 tablet on Day 1 and Day 2, then 2 tablets taken once a day.
• Diabetic patients with kidney problems
The usual dose is 2 tablets once a day which may be increased by your doctor to 4 tablets once a day.
Lisinopril 10mg tablets:
The tablets can be divided into equal halves.
The usual dose is:
• For high blood pressure
The recommended starting dose is 1 tablet.
For severe conditions your doctor may decide to start you on between 2.5 mg1- % tablet.
Once optimal control of blood pressure has been reached, the usual effective maintenance dose is 2 tablets as a single daily dose.
If within a period of 2-4 weeks your blood pressure is not under control, your doctor may increase your dose further up to maximum of 81 tablets daily.
Diuretic-Treated Patients
If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with lisinopril. Patients with high blood pressure who cannot discontinue the diuretic therapy, should begin Lisinopril treatment with % tablet.
• Heart conditions such as heart failure
The usual starting dose is 2.5 mg1 once a day. Your doctor may increase this dose if required at intervals of 2 weeks or more and by increments of 1 tablet or less.
* For this dosage, tablets with a lower or higher content of active substance are available.
• Following a heart attack
The usual dose is % tablet on Day 1 and Day 2, then 1 tablet taken once a day.
Lisinopril 20mg tablets:
The tablets can be divided into equal halves.
The usual dose is:
• For high blood pressure
The recommended starting dose is % tablet.
For severe conditions your doctor may decide to start you on between 2.5 mg2-5 mg2.
Once optimal control of blood pressure has been reached, the usual effective maintenance dose is 1 tablet as a single daily dose.
If within a period of 2-4 weeks your blood pressure is not under control, your doctor may increase your dose further up to maximum of 4 tablets daily.
Diuretic-Treated Patients
If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with lisinopril. Patients with high blood pressure who cannot discontinue the diuretic therapy, should begin Lisinopril treatment with 5 mg2.
• Heart conditions such as heart failure
The usual starting dose is 2.5 mg2 once a day. Your doctor may increase this dose if required at intervals of 2 weeks or more and by increments of % tablet or less.
• Following a heart attack
The usual dose are 5 mg2 on Day 1 and Day 2, then % tablet taken once a day.
• Diabetic patients with kidney problems
The usual dose is % tablet once a day which may be increased by your doctor to 1 tablet once a day.
Patients with reduced kidney function
If you suffer from a kidney disorder, the doctor should prescribe the lowest possible dose and monitor your kidney function.
Children under 6 years
The use of Lisinopril is not recommended.
Children and adolescents aged 6-16 years
The dose depends on your weight. 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 or increase dosing interval. Your doctor will decide the correct dose for you.
Elderly, over 65 years
No special dosage adjustment is necessary. In case of reduced kidney function the dose should be adjusted carefully.
Patients following recent kidney transplant
The use of Lisinopril tablets is not recommended.
If you take more Lisinopril than you should
Contact your doctor or the nearest hospital casualty department immediately.
Take this leaflet or some tablets with you so that people will know what you have taken.
If you forget to take Lisinopril
Take the missed dose as soon as you remember but never take two doses in one day.
If you stop taking Lisinopril
Do not stop treatment before talking to your doctor, as this will reduce the treatments effect. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lisinopril can cause side effects, although not everybody gets them.
Allergic reaction signs and symptoms are:
• difficulties in breathing
• swelling of the face, hands, feets, lips, tongue and/or throat
• severe skin itch with raised lumps.
Stop taking Lisinopril and seek medical advice immediately, if you develop any of the
allergic reaction signs.
Side effects can occur with the following frequencies:
Common, occurs in 1 to 10 per 100 users:
• dizziness
• headache
• fall in blood pressure as a result e.g. of standing up rapidly from a sitting or lying
position, sometimes accompanied by dizziness
• cough
• diarrhoea
• vomiting
• kidney problems
Uncommon, occurs in 1 to 10 per 1000 users:
• mood changes
• the sensation of pins and needles
• vertigo
• taste abnormalities
• difficulty in sleeping
• possible heart attack or stroke in high risk patients
• increased heart rate
• heart palpitations
• numbness or tingling in the fingers and toes
• runny nose
• feeling sick (nausea)
• abdominal pain
• indigestion
• skin rash and/or itching
• sudden accumulation of fluid in the skin and mucous membranes (e.g. throat or tongue),
breathing difficulties and/or itching and rash, often as an allergic reaction (hypersensitivity/angioneurotic oedema)
• inability to maintain an erection (impotence)
• tiredness
• general weakness
• increase in blood urea, serum creatinin or liver enzyme values
• too much potassium in the blood, sometimes manifesting itself as muscle cramps, diarrhoea, nausea, dizziness, headache (hyperkalaemia)
Rare, occurs in 1 to 10 per 10 000 users:
• decrease of the red blood pigment haemoglobin and number of red blood cells (hamatocrit)
• mental confusion
• dry mouth
• nettle rash
• hair loss
• psoriasis, a skin disorder
• kidney failure leading to excessive urea in the blood
• enlargement of one or both breasts in men
• allergic reactions - See above!
• increase of bilirubin, a substance produced in the liver
• low sodium level in the blood (signs are tiredness, confusion and muscle twitching)
Very rare, occurs in less than 1 of 10 000 users:
• inhibition of the formation of blood in the bone marrow
• deficiency of red blood cells with signs such as looking pale or feeling tired
• unexpected bruising
• blood abnormality and abnormalities of the lymph glands
• low blood sugar levels
• difficulty in breathing, inflammation of nasal sinuses, certain forms of pneumonia
• inflammation of the pancreas
• allergic reaction in the small intestine (intestinal angioedema)
• inflammation of the liver (hepatitis) or other liver disorders such as jaundice (yellowing of the skin and/or the whites of the eyes)
• severe skin disorders including Stevens-Johnson Syndrome and aggregate of mature or abnormal looking lymphocytes in the dermis (cutaneous pseudolymphoma).
• excessive sweating (diaphoresis)
• production of less urine and/or passing urine less frequently.
Frequency unknown:
• depressive symptoms, syncope
Skin reactions may be accompanied by fever, inflammation of a blood vessel (vasculitis) , muscle pains (myalgia), pains in the joints (arthralgia) and inflammation of the joints (arthritis), increased quantity of antibodies (ANA), increased blood sedimentation rate, rash and increase in the number of white blood cells (eosinophilia and leukocytosis), rash, photosensitive to light or other skin reactions can occur.
Children
Safety data from clinical studies suggest that lisinopril is generally well tolerated in hypertensive children, and that the safety profile in this age group is comparable to that seen in adults.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE LISINOPRIL
5.
This medicinal product does not require any special storage conditions.
Keep out of the reach and sight of children.
Do not use Lisinopril after the expiry date which is stated on the Blister and on the carton after “Exp”. The expiry date refers to the last day of that month.
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 contains
• The active substance is lisinopril
One tablet contains 2.72 mg lisinopril dihydrate, equivalent to 2.5 mg lisinopril.
One tablet contains 5.44 mg lisinopril dihydrate, equivalent to 5 mg lisinopril.
One tablet contains 10.89 mg lisinopril dihydrate, equivalent to 10 mg lisinopril.
One tablet contains 21.78 mg lisinopril dihydrate, equivalent to 20 mg lisinopril.
• The other ingredients are calcium hydrogen phosphate dihydrate, mannitol, maize starch, croscarmellose sodium and magnesium stearate.
Additional Lisinopril 5mg, 10mg, 20 mg: Ferric oxide red
What Lisinopril looks like and contents of the pack
Lisinopril 2.5 mg is a round, convex and white tablet which is available in following packs: 14, 28, 30, 50 and 100 tablets.
Lisinopril 5 mg is a round, convex slightly red tablet with a score notch on one side which is available in following packs: 10,14, 28, 30, 30x1, 50, 56, 60, 98 and 100 tablets.
Lisinopril 10 mg is a round, convex slightly red tablet with a score notch on one side which is available in following packs: 10,14, 28, 30, 50, 98 and 100 tablets.
Lisinopril 20 mg is a round, convex, slightly red tablet with a score notch on one side which is available in following packs: 10,14, 28, 30, 50, 56, 98, 100 and 100x1 tablets.
Please note that not all pack sizes will be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Sandoz Limited Frimley Business Park,
Frimley,
Camberley,
Surrey GU16 7SR.
Manufacturer
Lek Pharmaceuticals d.d Verovskova 57 1526 Ljubljana, Slovenia
Salutas Pharma GmbH Otto-von-Guericke-Allee 1 391179 Barleben, Germany
This leaflet was last revised in 09/2014.
Diabetic patients with kidney problems
The usual dose is 1 tablet once a day which may be increased by your doctor to 2 tablets once a day.
For this dosage, tablets with a higher content of active substance are available.