5 mg, 10 mg and 20 mg tablets
What Lisinopril Actavis is and what it is used for
Lisinopril Actavis is a blood pressure lowering medicine and belongs to a group of medicines called ACE inhibitors . Lisinopril Actavis works by dilating the blood vessels, which helps to lower blood pressure .
Lisinopril Actavis can be used for:
- treatment of high blood pressure
- treatment of heart failure
- short-term treatment after a heart attack
- treatment of kidney disease in patients with high blood pressure and non- insulin- dependent diabetes (type 2 diabetes ).
Lisinopril contained in Lisinopril Actavis may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you take Lisinopril Actavis
Do not take Lisinopril Actavis
- if you are allergic to lisinopril or any of the other ingredients of this medicine (listed in section 6) or other medicines of the same type ( ACE inhibitors ) as Lisinopril Actavis.
- if you have previously had angioneurotic edema (sudden accumulation of fluid under the skin, similar to hives) during treatment with ACE inhibitors
- if you have a history of hereditary or unexplained angioneurotic edema
- if you are pregnant. Pregnant women should not use Lisinopril Actavis during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Lisinopril Actavis, see Pregnancy and breast-feeding).
- if you have diabetes or renal impairment and are being treated with a blood pressure lowering medicine containing aliskiren.
- if you have taken or are taking sakubitril / valsartan, a medicine used to treat a type of long-term ( chronic ) heart failure in adults, as it increases the risk of angioedema (rapid swelling under the skin in an area such as the throat).
Warnings and cautions
Talk to your doctor before taking Lisinopril Actavis:
- if you have impaired liver or kidney function
- if you are taking diuretics
- if you are taking potassium supplements, medicines that increase the level of potassium in the blood such as spironolactone , amiloride, potassium-containing salt replacement or if you have been prescribed a low-salt diet
- if you have been informed that the blood vessels in one or both of your kidneys are narrow, especially if you have impaired kidney function
- if you have recently had a kidney transplant
- if you are on dialysis
- if you have impaired heart function
- if you have a heart disease, such as problems with the heart valves or an enlarged heart muscle
- if you have recently had a heart attack and your heart and circulation problems are not under control
- if you suffer from reduced blood flow to the heart or brain
- if you have a history of angioedema (an allergic reaction involving swelling of the face, arms, legs, lips, tongue, vocal cords and / or throat)
- if you are undergoing treatment with an allergy vaccine
- if you are undergoing treatment to remove bad cholesterol from the blood ( LDL afarés)
- if you are diabetic
- if you have a disease of the blood vessels ( collagen vascular disease, scleroderma, SLE (Systemic lupus erythematosus)
- if you are taking medicines containing allopurionol (for gout ), procainamide (for irregular heartbeat), or lithium (for mental illness)
- if you are taking immunosuppressive drugs (to prevent rejection of transplanted organs)
- if you have recently suffered from vomiting and diarrhea
- If you are going to have an operation or get anesthesia, you must inform your surgeon , anesthetist or dentist that you are being treated with Lisinopril Actavis
- in connection with blood or urine tests, always inform your medical staff that you are being treated with Lisinopril Actavis
- you may get a cough while taking Lisinopril Actavis. It is usually a dry cough and it will stop when you stop taking Lisinopril Actavis.
- the effect of Lisinopril Actavis may be impaired in people of African descent.
- if you are taking any of the following medicines used to treat high blood pressure:
- an angiotensin II receptor blocker (ARB) (also known as sartans – for example valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems.
- if you are taking any of the following medicines, the risk of angioedema may increase:
- racekadotril, a medicine used to treat diarrhea
- drugs used to prevent rejection of transplanted organs and against cancer (eg temsirolimus, sirolimus, everolimus)
- vildagliptin, a medicine used to treat diabetes
Your doctor may need to check your kidney function, blood pressure and the amount of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading ” Do not take Lisinopril Actavis”.
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Lisinopril Actavis is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects (see Pregnancy and breast-feeding).
Other medicines and Lisinopril Actavis
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor may need to change your dose and / or take other precautions:
If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the information under the headings “Do not take Lisinopril Actavis” and “Warnings and precautions”).
Tell your doctor if you are already taking any of the following:
- potassium supplements (including salt substitutes), potassium-sparing diuretic agent (diuretic), and other drugs that may increase the amount of potassium in your blood (such as trimethoprim and cotrimoxazole (trimethoprim / sulfamethoxazole) against infection s caused by bacteria, cyclosporine, an immunosuppressive drug which prevents the rejection of transplanted organs; and heparin , a drug used to thin the blood to prevent blood clots).
- potassium tablets or potassium-containing salt substitutes, diuretics ( diuretic tablets, especially those called potassium-sparing diuretics ), other medicines which may increase the potassium content of the body (eg heparin and the combination trimethoprim / sulfamethoxazole)
- lithium (for mental illness)
- certain types of medicines for the treatment of pain and swelling ( NSAIDs ) and acetylsalicylic acid (at daily doses above 3 g.)
- medicines containing gold
- other antihypertensive drugs
- certain types of antidepressant drugs ( tricyclic antidepressants )
- antipsychotics (medicines for psychosis and schizophrenia)
- drugs that affect the central nervous system ( sympathomimetics )
- drugs against diabetes
- immunosuppressive drugs such as cyclosporine (used in connection with organ transplantation)
- certain types of medicines used to treat gout (allopurinol)
- certain types of medicines to treat heart rhythm ( procainamide )
- drugs most commonly used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the group mTOR inhibitors). See section “Warnings and Precautions”.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Your doctor will usually suggest that you stop taking Lisinopril Actavis before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Lisinopril Actavis should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects.
Tell your doctor if you are breast-feeding or planning to start breast-feeding. Lisinopril Actavis is not recommended for breast-feeding and your doctor may choose another treatment for you if you want to breast-feed your baby, especially if your baby is newborn or born prematurely.
Driving and using machines
When taking Lisinopril Actavis, you should be aware that some side effects that may affect your ability to drive (eg dizziness and tiredness) may occur.
Avoid driving or using machines until you know how you react to the medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Lisinopril Actavis contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium -free’. is next to “sodium-free”.
How to take Lisinopril Actavis
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Lisinopril Actavis should be taken at about the same time each day. You can take Lisinopril Actavis with food or between meals.
You should take Lisinopril Actavis with a glass of water.
The tablet can be divided into two equal doses .
The recommended dose is:
In high blood pressure
The starting dose is 10 mg once daily. The dose for long-term treatment is usually 20 mg once daily. Your doctor may adjust the dose until your blood pressure is under control. The maximum dose is 80 mg daily.
If you are already taking diuretics, your doctor may discontinue or reduce the amount of these before starting treatment with Lisinopril Actavis.
Children and adolescents (between 6 and 16 years) with high blood pressure
The doctor will calculate the dose that is right for your child. Dose one is based on the weight of the child:
- The usual starting dose for children weighing between 20 and 50 kg is 2.5 mg once a day. Dose one can be increased to a maximum of 20 mg per day.
- The usual starting dose for children weighing more than 50 kg is 5 mg once a day. Dose one can be increased to a maximum of 40 mg per day.
Lisinopril Actavis is not recommended for children under 6 years of age or for children with severe kidney disease.
In case of heart failure
The starting dose is 2.5 mg once daily. Dose one will be increased gradually by a maximum of 10 mg at a time and at intervals of 2 weeks until a satisfactory effect is achieved. The maximum dose is 35 mg per day.
Short-term treatment after a heart attack
The starting dose is 5 mg on the first and second day, then 10 mg once daily.
Treatment of kidney disease associated with non-insulin dependent diabetes (type 2 diabetes ) and hypertension
The recommended dose is 10-20 mg once daily.
Impaired renal function
Dose one may need to be adjusted. Follow your doctor’s instructions.
Dose one may need to be adjusted. Follow your doctor’s instructions.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP TAKING LISINOPRIL ACTAVIS AND CONTACT A DOCTOR IMMEDIATELY IF YOU EXPERIENCE THE FOLLOWING:
- If you get symptoms such as swelling of the face, arms, legs, lips, tongue, vocal cords and / or throat ( angioedema ), contact your doctor immediately. People of African descent may be at higher risk of developing angioedema .
- if you get symptoms such as fever or general malaise, are prone to inflammation ( infections ), skin and mucous membrane bleeding, bruising, pallor and fatigue, contact a doctor immediately
- develops jaundice (yellowish tint on the skin and on the whites of the eyes), contact your doctor immediately.
Common (may affect up to 1 in 10 people):
- dizziness, headache
- drop in blood pressure when traveling rapidly to a standing position
- diarrhea, vomiting
- renal impairment
Uncommon (may affect up to 1 in 100 people):
- mood swings, numbness, tingling and stinging sensation in fingers, balance disorders, taste disorders, sleep disorders
- blood clots in the heart or brain that may be caused by very low blood pressure in high-risk patients, palpitations, fast pulse , decreased blood flow in fingers and toes (Raynaud’s syndrome)
- Runny nose
- nausea, abdominal pain, indigestion
- rash, itching
- fatigue, weakness
- changes in the composition of the blood related to kidney function, elevated liver values, elevated potassium levels in the blood.
Rare (may affect up to 1 in 1,000 people):
- decreased or increased blood levels
- low sodium content in the blood
- mental disorders
- dry mouth
- hives , hair loss, psoriasis
- swelling of the face, arms, legs, lips, tongue, throat and / or vocal cords caused by an allergic reaction (angioedema / hypersensitivity), acute renal failure , increased amount of slag products in the body caused by severe renal impairment
- insufficient secretion of a hormone in the brain that regulates water balance in the body (inadequate ADH secretion / SIADH)
- abnormal breast augmentation in men.
Very rare (may affect up to 1 in 10,000 people):
- decreased bone marrow function which causes changes in blood cell formation, bleeding, bruising or inflammation (may be caused by too few blood cells ), severe anemia
- swollen / enlarged lymph nodes , autoimmune disease (a condition in which the immune system attacks the blood cells )
- cramps in the muscles of the trachea, allergy-related inflammation in the ends of the branches of the trachea (alveoli) in the lungs and sinusitis.
- inflamed pancreas or liver with jaundice (yellowish tint on the skin and whites of the eyes), liver failure
- swollen intestines, sweating
- low blood sugar
- inflammation of the bile duct
- severe skin diseases with blisters and redness ( Stevens-Johnson syndrome and pemphigus ), dandruff and rejection of the skin ( toxic epidermal necrolysis ) or fever, rash on the face and arms and legs (erytheme multiforme)
- psoriasis -like skin reactions
- reduced or no urination.
Has been reported (occurs in an unknown number of users):
– symptoms of depression, fainting.
A symptom complex of fever, muscle aches, joint pain, inflammation of the vascular one, increased lower, changes in blood counts, rash, and / or photophobia have been reported.
Stop taking Lisinopril Actavis and contact your doctor immediately if you experience shortness of breath, difficulty swallowing, swelling of the face, arms / legs, lips, mucous membranes, tongue and / or throat or hives .
Side effects in children appear to be similar to those seen in adults.
How to store Lisinopril Actavis
Keep out of sight and reach of children.
Do not store above 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton, blister or label after “EXP.” The expiry date refers to the last day of that month.
The medicine 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.
Contents of the pack and other information
- The active substance is lisinopril dihydrate equivalent to 5 mg, 10 mg and 20 mg lisinopril.
- The other ingredients are mannitol, calcium hydrogen phosphate dihydrate, pregelatinized maize starch, croscarmellose sodium and magnesium stearate.
Lisinopril Actavis 10 mg tablets contain: Pigment Blend BP-24823 (pregelatinised maize starch, red iron oxide, black iron oxide and yellow iron oxide (E172)).
Lisinopril Actavis 20 mg tablets contain: Pigment Blend BP-24824 (pregelatinised maize starch, red iron oxide, black iron oxide and yellow iron oxide (E172)).
What the medicine looks like and contents of the pack
Lisinopril Actavis 5 mg: white, round, flat, uncoated 8 mm tablet with a score line on both sides.
Lisinopril Actavis 10 mg: light pink, round, uncoated, biconvex, 7 mm tablet with a score line.
Lisinopril Actavis 20 mg: pink, round, non-film-coated, biconvex tablet, 9 mm with a score line.
Lisinopril Actavis 5 mg, 10 mg and 20 mg are available in packages of PVC / Al blister and / or white HDPE can with a white PP cap and with silica gel as desiccant: 14, 28, 30, 50, 98, 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf.