10 mg / 12.5 mg tablets
Lisinopril and hydrochlorothiazide
What Lisinopril / Hydrochlorothiazide Actavis is and what it is used for
This medicine contains two active substances – lisinopril and hydrochlorothiazide . These lower blood pressure in two different ways:
Lisinopril, a so-called ACE inhibitor , dilates blood vessels. This makes it easier for the heart to pump out the blood in the body and at the same time lowers blood pressure . Hydrochlorothiazide is a diuretic that lowers blood pressure by increasing urine output.
Lisinopril / Hydrochlorothiazide Actavis is used for treating high blood pressure when treatment with only one of the two substances, lisinopril and hydrochlorothiazide , has not been sufficiently effective.
Lisinopril and hydrochlorothiazide contained in Lisinopril / Hydrochlorothiazide Actavis may also be authorized for the treatment of other conditions not mentioned in this product information. 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 / Hydrochlorothiazide Actavis
Do not take Lisinopril / Hydrochlorothiazide Actavis
- if you are allergic to lisinopril or any of the other ingredients of this medicine (listed in section 6), or to any other ACE inhibitor .
- if you are allergic to hydrochlorothiazide or any of the other sulfonamide-type medicines (ask your doctor).
- Pregnant women should not use Lisinopril / Hydrochlorothiazide Actavis during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Lisinopril- Hydrochlorothiazide Actavis, see Pregnancy section).
- if you have had an allergic reaction with previous treatment with ACE inhibitors or diuretics with swelling of the face, lips, tongue and / or throat with difficulty swallowing or breathing (rare).
- if you have severe kidney or liver function.
- if you have hereditary or for unknown reasons swelling of the face, lips, throat or tongue ( angioedema ).
- if you suffer from suspended urinary excretion ( anuria ).
- if you have diabetes or renal impairment and are being treated with a blood pressure lowering medicine containing aliskiren.
- If you have been taking 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 or pharmacist before taking Lisinopril / Hydrochlorothiazide Actavis
- if your blood pressure is too low (you may experience it as dizziness or fainting when you stand up).
- if you use a low-salt diet and / or take potassium-sparing diuretics ( diuretics ) or use potassium supplements and / or potassium-containing salt substitutes.
- if you suffer from disorders of fluid or salt balance (eg low sodium or potassium levels in the blood).
- if you have diarrhea or vomiting.
- if you suffer from certain cardiovascular diseases (eg ischemic heart disease or cerebrovascular disease, ie reduced blood supply to the heart or brain).
- you have a heart condition that involves narrowing of the heart valves in the left ventricle, or if you have other outflow obstructions from the left ventricle.
- if you have a disease that causes thickening of the heart muscle ( hypertrophic cardiomyopathy ).
- if you have impaired kidney function, especially if you are suffering from certain vascular diseases at the same time or are being treated with medicines that reduce the activity of the immune system.
- if you are being treated with dialysis .
- if you have had a kidney transplant.
- if you have lupus (systemic lupus erythematosus).
- if you are going to undergo desensitization treatment because you are allergic or if you are allergic to e.g. insecticide.
- if you suffer from any liver disease.
- if you have diabetes ( dose one may need to be adjusted).
- if you have had gout .
- if you have previously had an allergic reaction with swelling of the face, arms or legs, lips, tongue and / or throat that caused difficulty in swallowing and breathing. You should be aware that black patients are at increased risk for these types of reactions when using ACE inhibitors .
- if you have a persistent cough.
- if you suffer from acute severe neutrophil deficiency (a type of blood cell ).
- if you are being treated with LDL afferences.
- if you are being treated with lithium (used for certain mental disorders).
- if you have elevated cholesterol levels.
- if you are pregnant or planning to become pregnant during treatment with Lisinopril / Hydrochlorothiazide Actavis.
- if after the first dose one suffers from a sharp drop in blood pressure, which can lead to symptoms such as dizziness or weakness.
- if you are being treated with diuretics . Treatment should be stopped 2-3 days before taking the first Lisinopril / Hydrochlorothiazide Actavis tablet.
- if you are going to have surgery or get anesthesia. You must tell your doctor or dentist if you are using Lisinopril / Hydrochlorothiazide Actavis.
- 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.
- aliskiren
- 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
- if you have had skin cancer or if you get an unforeseen skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses , may increase the risk of certain types of skin and lip cancer (non- melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Lisinopril / Hydrochlorothiazide Actavis.
- if you experience impaired vision or eye pain. This may be a symptom of fluid accumulation in the eye (between the choroid and retina) or an increase in pressure in the eye and may occur within a few hours to weeks after taking Lisinopril / Hydrochlorothiazide Actavis. This can lead to permanent visual impairment if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at a higher risk of developing this.
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 / Hydrochlorothiazide Actavis”.
If you think you may be pregnant (or become pregnant) during treatment, consult your doctor. Lisinopril / Hydrochlorothiazide Actavis is not recommended in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause fetal harm, see Pregnancy section.
Other medicines and Lisinopril / Hydrochlorothiazide Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Other medicines may affect the treatment effect of Lisinopril / Hydrochlorothiazide Actavis.
This is especially true if you also take:
- other antihypertensive drugs (eg beta-blockers ).
- angiotensin II receptor blockers (ARBs) or aliskiren (see also information under the headings “Do not take Lisinopril / Hydrochlorothiazide Actavis” and “Warnings and precautions”). Your doctor may need to change your dose and / or take other precautions.
- dialysis treatment.
- 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).
- lithium (used to treat certain mental illnesses).
- drugs to treat diabetes .
- non-steroidal anti-inflammatory drugs (eg ibuprofen , indomethacin, naproxen and sulindac) and acetylsalicylic acid .
- allopurinol (used to treat gout ).
- certain cholesterol-lowering drugs (cholestyramine and cholestipol).
- digitalis glycosides (used to treat heart failure ).
- sotalol (used to treat heart rhythm disorders).
- certain antidepressants ( tricyclic antidepressants , such as amitriptyline, clomipramine or nortriptyline).
- neuroleptics (medicines for psychosis ).
- calcium salts.
- certain laxatives (stimulant laxatives , eg bisacodyl).
- chemotherapy (used to treat cancer).
- immunosuppressive drugs that reduce the activity of the immune system (eg in organ transplantation).
- sympathomimetics (drugs that affect certain parts of the nervous system and are used to treat heart disease).
- amphotericin B in injection form (used to treat fungal infections).
- corticosteroids (used to treat inflammation )
- corticotropin (used to treat adrenal insufficiency ).
- carbenoxolone (used to treat ulcers and inflammation of the esophagus).
- certain muscle relaxants (eg tubocurarine chloride).
- anesthetics.
- drugs that can cause a certain type of very high heart rate disorder ( torsade de pointes ).
- procainamide (used to treat heart rhythm disorders).
- gold.
- other antihypertensive drugs.
- 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”.
If you have any further questions, ask your doctor or pharmacist.
Lisinopril / Hydrochlorothiazide Actavis with food and drink
Lisinopril / Hydrochlorothiazide Actavis can be taken with food and drink.
Pregnancy, breastfeeding and fertility
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.
Pregnancy
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 / Hydrochlorothiazide Actavis before pregnancy or as soon as you know you are pregnant and will recommend another medicine for you instead. Lisinopril / Hydrochlorothiazide 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.
Breast-feeding
Tell your doctor if you are breast-feeding or planning to start breast-feeding. Lisinopril / Hydrochlorothiazide 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
Like other antihypertensive drugs, this drug may affect your ability to drive or use machines. This is usually seen at the beginning of treatment, during dose adjustment or in combination with alcohol. Your receptivity determines how affected you become.
Make sure you are not affected by the treatment before driving or using machines. Be aware that temporary dizziness or fatigue may occur during treatment.
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 / Hydrochlorothiazide 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 / Hydrochlorothiazide Actavis
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is described below:
One to two tablets daily.
Take the tablets at about the same time each day.
Dose one may need to be adjusted if you have impaired kidney function.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Adverse reactions that have been observed and reported during treatment with Lisinopril / Hydrochlorothiazide Actavis are listed below.
IMMEDIATELY CANCEL LISINOPRIL / HYDROCHLORTIAZID ACTAVIS AND CONTACT DOCTORS IF YOU GET ANY OF THE FOLLOWING:
- Swelling of the face, lips, tongue and / or throat leading to difficulty swallowing and breathing.
- Swollen hands, feet and / or ankles.
- Severe itchy skin.
Serious side effects are
Uncommon (may affect up to 1 in 100 people):
Mood swings, symptoms of depression, heart attack or blood clot in the brain, possibly as a result of very low blood pressure in high-risk patients, altered heart rhythm or fast heart rhythm, increased amount of urea in the blood, increased amount of creatinine in the blood plasma, too high potassium levels in the blood (may show such as muscle aches and cramps), irregular heartbeat, abnormal fatigue or weakness.
Rare (may affect up to 1 in 1,000 people):
Changes in the chemical composition of the blood, changes in the body’s salt balance, prolonged use can lead to disturbances in the body’s fluid and salt balance (decreased hemoglobin – and hematocrit values), swelling of the face, arms and legs, lips, tongue, esophagus and throat (hypersensitivity / angioneurotic edema ), itchy skin rash, hair loss, baldness, psoriasis , kidney failure , coma , any seizures or edema caused by severe kidney failure .
Very rare (may affect up to 1 in 10,000 people):
Decreased bone marrow , decreased oxygen transporting pigment ( hemoglobin ) in blood, leading to weakness or dizziness ( anemia ), decreased platelets in the blood, decreased white blood cells , severe acute lack of neutrophil s (a type of blood cell s), anemia , lymph node disease , autoimmune disease, respiratory tract contractions (eg asthma ), sinusitis, allergic pneumonia , difficulty breathing including pneumonia , inflammationin the pancreas, liver disease and liver failure, conditions that cause swelling around the intestines, jaundice (liver disease that causes yellow skin and yellow whites of the eyes), sweating, severe skin disease with blisters, cell or tissue death or skin detachment, severe form of skin redness ( Stevens-Johns syndrome ), skin rash, inflammatory reaction ( cutaneous pseudolymphoma), abnormally small or no urine production.
Has been reported (occurs in unknown number of users):
Skin and lip cancer (Non- melanoma skin cancer).
Shortness of breath (caused by, among other things, pneumonia and pulmonary edema ), Lupus erythematosus-like reactions in the skin, recurrence of lupus erythematosus (an autoimmune disease that causes rashes on the face and red scaly spots on the skin), photosensitivity reactions, anaphylactic reactions (allergic shocks ), fever, nephritis, vasculitis.
Non-serious adverse event is
Common (may affect up to 1 in 10 people):
Dizziness, headache, fainting, fainting sensation when getting up due to low blood pressure (orthostatic effects, including orthostatic hypotension ), cough, diarrhea, vomiting, renal impairment.
Uncommon (may affect up to 1 in 100 people):
Numbness, tingling, dizziness, taste changes, sleep disturbances, Raynaud’s syndrome (numbness, cold, blue fingers with pain), runny nose, nausea, abdominal pain and indigestion, elevated liver enzyme levels and liver bilirubin, skin rash, itching , impotence , weakness, fatigue.
Rare (may affect up to 1 in 1,000 people):
Mental confusion, dry mouth , enlarged mammary glands in men, imbalance in the body’s salinity ( hyponatremia ), a condition called SIADH (syndrome with increased secretion of antidiuretic hormone ).
Very rare (may affect up to 1 in 10,000 people):
Low blood sugar
Has been reported (occurs in unknown number of users):
Inflammation of the salivary glands ( sialadenitis ), restlessness, irritated stomach, constipation, anorexia , sugar in the urine, high blood sugar, high levels of uric acid (hyperuricemia) in the blood (eg gout ), disturbances in the salt balance (including low levels of sodium, potassium , chloride and magnesium), increase in cholesterol and triglycerides, muscle cramps, muscle weakness, loss of appetite, intoxication, temporary blurred vision, jaundice, decreased vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma ), redness , weakness.
How to store Lisinopril / Hydrochlorothiazide Actavis
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
The drug should not be disposed of via wastewater. 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
Content declaration
- The active substances are 10 mg lisinopril and 12.5 mg hydrochlorothiazide
- The other ingredients are: mannitol, calcium hydrogen phosphate dihydrate, pregelatinized maize starch, croscarmellose sodium, magnesium stearate, yellow and red iron oxide (dye E 172).
What the medicine looks like and contents of the pack
Peach-colored, round tablets (6 mm diameter), without notch, marked with “LH” on one side.
Lisinopril / Hydrochlorothiazide Actavis is available in blisters (PVC / PVDC / aluminum) in pack sizes:
10, 28, 30, 50, 98 and 100 tablets
Lisinopril hydrochlorothiazide Actavis is available in cans (HDPE cans) in pack sizes:
10 mg / 12.5 mg: 30, 100 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegur 76-78
220 Hafnarfjörður
Iceland
T anufacturers
Actavis Ltd., BLB016 Bulebel Industrial Estate, Zejtun 3000, Malta
Balkanpharma Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria