Lipertance 10 mg. / 5 mg. / 5 mg. 30 tablets
Lipertance contains three active ingredients: atorvastatin, perindopril arginine and amlodipine in one tablet.
Atorvastatin belongs to a group of medicines called statins, and are medicines that regulate lipids (fats).
Perindopril arginine is an angiotensin converting enzyme (ACE) inhibitor. In patients with high blood pressure it works by expanding the blood vessels, making it easier for your heart to pump blood through them.
Amlodipine belongs to a group of medicines called calcium antagonists. In patients with high blood pressure it works by relaxing the blood vessels, making it easier for your heart to pump blood through them. In patients with angina pectoris (which causes chest pain), it works by improving the blood supply to the heart muscle which, thanks to this, gets more oxygen and the result is prevention of chest pain.
Lipertance is used to treat high blood pressure (hypertension) and / or stable coronary heart disease (a condition where blood flow to the heart is reduced or blocked) in adults who also suffer from one of the following conditions:
Elevated cholesterol levels (primary hypercholesterolaemia);
Concomitant elevated cholesterol and fat (triglycerides) (combined or mixed hyperlipemia).
Lipopertis is for patients already on treatment with atorvastatin, perindopril arginine and amlodipine in the form of separate tablets. Instead of taking atorvastatin, perindopril and amlodipine as separate tablets, you will take a single tablet of Lippertans, which contains all three active ingredients in the same amount.
2. What you need to know before you take Lippertans
Do not take Lipertance
if you are allergic (hypersensitive) to atorvastatin or other statins, to perindopril or another ACE inhibitor, to amlodipine or other calcium antagonists or any of the other ingredients of this medicine (listed in section 6);
if you have a disease that affects the liver;
if you have any abnormalities in the blood test results of a liver function for an undetermined cause;
if you have very low blood pressure (hypotension);
if you have cardiogenic shock (a condition where the heart can not supply the body with enough blood);
if you have blocked left ventricular blood flow (eg hypertrophic obstructive cardiomyopathy and high grade aortic stenosis);
if you suffer from heart failure after myocardial infarction;
if you have experienced symptoms such as whistling, swelling of the face, tongue or throat, intense itching or severe skin rashes with ACE inhibitors in the past, or if you or a member of your family have experienced similar symptoms in any other circumstances called angioedema);
if you have diabetes or have impaired kidney function and are being treated with a blood pressure lowering drug containing aliskiren;
if you are pregnant or planning to become pregnant, or if you are a woman of childbearing potential and do not use a reliable method of contraception;
if you are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lipoperza if:
have liver problems or have had a history of liver disease;
have moderate to severe kidney problems;
you consume large amounts of alcohol regularly;
have a repetitive or unclear blunt or painful muscle pain, a personal or family history of muscle problems;
you or your close relative has muscle problems that are found in other family members;
if you have had muscle problems in the past during treatment with other lipid-lowering medicines (eg other statins or fibrates);
if you have decreased thyroid function (hypothyroidism);
have a condition or a case leading to elevated levels of atorvastatin in your blood;
develop symptoms of severe respiratory failure during treatment;
you have diabetes (high blood glucose levels);
have heart failure or other heart problems;
you have recently had a myocardial infarction;
you have recently had diarrhea or vomiting, or if you are dehydrated;
have a non-severe stenosis of the aortic or mitral valve (narrowing of a major blood vessel leading from the heart or from the mitral valve of the heart);
have kidney problems; you recently had a kidney transplant or if you were on dialysis;
you are elderly;
you have had a severe allergic reaction with swelling of the face, lips, tongue or throat, accompanied by difficulty in swallowing or difficulty in breathing (angioedema). This can happen at any time during the course of treatment. If you develop such symptoms, you should stop taking Lipopertis and go to a doctor immediately;
are of black background because you may have a greater risk of angioedema and this medicine
If any of these apply to you, talk to your doctor immediately before taking Lipitorta or during treatment with it.
Your doctor may need to have a blood test during your treatment to check your muscles (see section 2 "Other medicines and Lippertance").
Tell your doctor or pharmacist if you have a muscle weakness that is lasting. Additional studies and medications may be needed to diagnose and treat this.
Your doctor may 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 Lippertance".
While you are being treated with this medicine, your doctor will monitor your condition carefully if you have diabetes or a risk of developing diabetes. You may have a risk of developing diabetes if you have high blood sugar and fat levels, have overweight and high blood pressure.
Children and adolescents
Lipopertis is not recommended for use in children and adolescents under the age of 18 years.
Other drugs and Lippertans
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There are some medicines that can alter the effect of Lippertone or whose effects could change from Lippertans. This type of interaction may cause a reduction in the effect of either or both of these drugs. Alternatively, they can cause an increased risk or a greater severity of side effects, including a muscle breakdown condition, called rhabdomyolysis, and is described in section 4.
Be sure to tell your doctor if you are taking any of the following medicines:
immunosuppressants (medicines that reduce the body's defense mechanism) used to treat autoimmune disorders or after transplant surgery (eg ciclosporin, tacrolimus);
ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medications against fungal diseases);
rifampicin, erythromycin, clarithromycin, telithromycin, fusidic acid, trimethoprim (antibiotics);
colchicine (used to treat gout - a disease with painful swelling of the joints caused by uric acid crystals);
other medicines for regulating lipid levels, e.g. gemfibrozil, other fibrates, colestipol, ezetimibe;
some calcium antagonists used for angina or high blood pressure, e.g. diltiazem;
medicines to regulate your heartbeat, e.g. digoxin, verapamil, amiodarone;
medicines used to treat HIV, e.g. delavirdine, efavirenz, ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc .;
warfarin (which reduces blood clotting);
stiripentol (anticonvulsant for epilepsy);
cimetidine (used in stomach acids and peptic ulcers);
fenazone (pain reliever);
antacids (intake of products containing aluminum or magnesium preparations);
over-the-counter medicines: hypericum perforatum or St John's wort (herbal medicine used in depression);
daprolene (infusion of severe body temperature abnormalities);
other medicines for high blood pressure, including aliskiren, angiotensin II receptor blockers (eg valsartan), see also the information under the heading "Do not take Lippertance" and "Warnings and precautions");
potassium-sparing medicines (e.g., triamterene, amiloride, eplerenone, spironolactone), potassium supplements or potassium-containing salt substitutes;
estramustine (used to treat cancer);
lithium for the treatment of manias and depressions;
medicines for the treatment of diabetes (such as insulin, metformin and gliptins);
baclofen (used to treat muscle stiffness in some diseases such as multiple sclerosis);
non-steroidal anti-inflammatory drugs (eg ibuprofen) to relieve pain or treat inflammation (eg rheumatoid arthritis) or high doses of aspirin;
vasodilators, including nitrates (products that enlarge blood vessels);
heparin (a medicine used to thin the blood);
medicines to treat mental disorders such as depression, anxiety, schizophrenia, etc. (eg tricyclic antidepressants, antipsychotic drugs);
medicines used to treat low blood pressure, shock or asthma (eg ephedrine, noradrenaline or adrenaline);
gold salts, especially when given intravenously (used to treat rheumatoid arthritis symptoms);
allopurinol (for gout);
procaine (for the treatment of irregular heart rhythm).
Lippertans with food and drinks and alcohol
It is preferable to take Lipopertis before a meal.
Grapefruit and grapefruit juice
People who take Lippertans should not consume grapefruit and grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in blood levels of the active ingredient amlodipine, which in turn may
Driving and using machines
Lippertance may cause dizziness, headache, fatigue or nausea. If your medicine impacts you this way, your ability to drive or use machines may be impaired, especially at the beginning of treatment.
Lippertone contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Lippertans
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one tablet once a day. Take your tablet with a glass of water, preferably at the same time each day, in the morning before a meal.
Children and adolescents
Lipopertis is not recommended for use in children and adolescents under the age of 18 years.
If you take more Lipoperthan than you should
If you take more tablets than you prescribed, contact your nearest emergency department or tell your doctor immediately. Taking too many tablets may cause your blood pressure to drop even at dangerously low levels. You may feel dizzy, drowsy, headache, fainting or feeling weak. If this happens, it may help if you lie down and raise your legs up. If the drop in blood pressure is high, shock can also occur. You may feel your skin cold and sticky, and you may lose consciousness.
If you forget to take Lippertans
It is important to take your medicine every day, as regular treatment is more effective. If you forget to take a dose of Lippertone, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Lippertans
Because treatment with Lipopertha usually lasts for long, you should discuss with your doctor before stopping taking this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking this medicine and go to your doctor immediately if you experience any of the following side effects, which may be serious:
swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (uncommon - may affect up to 1 in 100 people) (see section 2 "Warnings and Precautions");
severe skin reactions including intense skin rash, hives, skin reddening of the whole body, severe itching, blistering, peeling and swelling of the skin, mucosal membrane inflammation (Stevens-Johnson syndrome), or other allergic reactions (rarely) (may affect up to 1 in 1,000 people);
weakness, tension or muscle pain and, in particular, at the same time a general malaise and possibly a high temperature which may be caused by anomalous muscle breakdown, which may be life-threatening and lead to kidney problems (rare, may affect 1 in 1,000 people);
hand or leg shakes or speech problems, which could indicate a possible stroke (very rare - may affect up to 1 in 10,000 people);
severe dizziness or fainting (common - may affect up to 1 in 10 people) or fainting (uncommon, may affect up to 1 in 100 people) due to low blood pressure;
unusually hepatic or irregular heartbeat, chest pain (angina) or myocardial infarction (very rare - may affect up to 1 in 10,000 people);
sudden breathing, chest pain, shortness of breath or difficulty breathing (bronchospasm) (uncommon - may affect up to 1 in 100 people);
an inflamed pancreas that can cause severe abdominal pain and back pain accompanied by a feeling of being very unwell (uncommon - may affect up to 1 in 100 people);
if you have problems with unexpected or abnormal bleeding or bruising (bruising), this may lead to liver complaints (very rare - may affect up to 1 in 10,000 people);
yellowing of the skin or eyes (jaundice), which could be a sign of hepatitis (very rare - may affect up to 1 in 10,000 people);
skin rash, which often begins with red itchy spots on the face, arms or legs (erythema multiforme) (very rare - may affect up to 1 in 10,000 people).
Tell your doctor if you notice any of the following side effects:
Common (may affect up to 1 in 10 people):
inflammation of the nasal passages, sore throat, nasal bleeding;
allergic reactions (such as skin rashes, pruritus);
increase blood sugar (if you have diabetes, continue to closely monitor your blood sugar levels), increase blood creatine kinase;
headache, dizziness, dizziness, and dizziness
How to Store Lipertance
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister pack after EXP.
The tablets are stable until 30 days after opening in the 30 tablet polypropylene container.
The tablets are stable up to 100 days after opening in the container for 100 tablets of high density polyethylene.
The expiry date refers to the last day of that month.
Keep the container tightly closed in order to protect from moisture.
All dosage units except 40/10/10 mg are in a 100 tablet tablet container: No special storage conditions required.
The 40/10/10 mg unit dose is in a 100 tablet tablet: Store below 30 ° C.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What contains Lippertans
The active substances are: atorvastatin, perindopril arginine and amlodipine.
One 10 mg / 10 mg film-coated tablet contains 10.82 mg atorvastatin calcium trihydrate equivalent to 10 mg atorvastatin, 5 mg perindopril arginine equivalent to 3.40 mg perindopril and 6.94 mg amlodipine besylate equivalent to 5 mg amlodipine.
One film-coated tablet of Lippertans 20/5/5 mg contains 21.64 mg atorvastatin calcium trihydrate equivalent to 20 mg atorvastatin, 5 mg perindopril arginine equivalent to 3.40 mg perindopril and 6.94 mg amlodipine besylate equivalent to 5 mg amlodipine.
One film-coated tablet of Lippertans 20/10/5 mg contains 21.64 mg atorvastatin calcium trihydrate equivalent to 20 mg atorvastatin, 10 mg perindopril arginine equivalent to 6.79 mg perindopril and 6.94 mg amlodipine besylate equivalent to 5 mg amlodipine.
One film-coated tablet of Lippertans 20/10/10 mg contains 21.64 atorvastatin calcium trihydrate equivalent to 20 mg atorvastatin, 10 mg perindopril arginine equivalent to 6.79 mg perindopril and 13.87 mg amlodipine besylate equivalent to 10 mg amlodipine .
One film-coated tablet of Lipitor 40/10/10 mg contains 43.28 mg atorvastatin calcium trihydrate equivalent to 40 mg atorvastatin, 10 mg perindopril arginine equivalent to 6.79 mg perindopril and 13.87 mg amlodipine besylate equivalent to 10 mg amlodipine.
The other ingredients are:
Tablet core: lactose monohydrate, calcium carbonate (E170), hydroxypropylcellulose (E463), corn starch sodium glycolate (type A), cellulose, microcrystalline cellulose (E460), maltodextrine, magnesium stearate (E572);
film coating of the tablet: glycerol (E422), hypromellose (E464), macrogol 6000, magnesium stearate (E171), red iron dioxide (E572).
What Lippertans looks like and what the package contains
Lippertans 10/5/5 mg: Yellow, round, film-coated tablet 7 mm in diameter with a radius of curvature of 25 mm, engraved on one side with the symbol "1" and on the other side with a symbol.
Lippertans 20/5/5 mg: A yellow, round, film-coated tablet 8.8 mm in diameter, with a radius of curvature of 32 mm, engraved on one side with the symbol "2" and on the other side with a symbol.
Lippertans 20/10/5 mg: A yellow, square film-coated tablet of 9 mm long, 16 mm long, engraved on one side with the symbol "3" and on the other side with a symbol.
LIPRSTANTS 20/10/10 mg: Yellow, oblong film-coated tablet 12.7 mm long and 6.35 mm wide, engraved on one side with the symbol "4" and on the other side with a symbol.
Lipoperta 40/10/10 mg: A yellow, oblong film-coated tablet 16 mm in length and 8 mm in width, engraved on one side with the symbol "5" and on the other side with a symbol.
The tablets are available in 30-tablet and 100-pack containers. A secondary pack containing 90 (3 30-compartment) tablets is also available.
30 film-coated tablets in a closure container. The stopper contains a desiccant.
100 film-coated tablets in a container with a screw cap. The screw cap contains a desiccant. The tablet container contains 1-4 drying capsules.
Desiccant capsules should not be removed and should not be swallowed.
Not all pack sizes may be marketed.