Lipertance 20 mg. / 5 mg. / 5 mg. 30 tablets

What is Lipertance and what it is used for

Lipertance contains three active ingredients: atorvastatin, perindopril arginine and amlodipine in one tablet.

Atorvastatin belongs to a group of medicines called statins and 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, which makes your heart easier in pumping 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, which makes your heart easier in pumping 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 the sternum

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 hypercholesterolemia) or

- Concomitant elevated cholesterol and fat (triglycerides) (combined or mixed hyperlipemia).

Lipopertis is for patients who are already receiving 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 liver disease ,

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 medication containing aliskiren

if you are on dialysis or some other type of blood filtration. Depending on the device you are using, Lipertance may be inappropriate for you,

if you have kidney problems where the supply of your kidneys with blood is reduced (renal artery stenosis),

if you are being treated with saquitril / valsartan, a medicine used to treat heart failure. (see "Warnings and precautions" and "Other medicines and Lippertance").

if you are pregnant or planning to become pregnant, or if you are a woman of childbearing potential and you are not using a reliable method of contraception if you are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lipertance if:

have liver problems or have a history of liver disease, have moderate to severe kidney problems, consume large amounts of alcohol regularly,

if you are taking or have taken during the last 7 days a medicine called fusidic acid (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Lippertans can lead to serious muscle problems (rhabdomyolysis), you have repeated or unclear dull or sharp pain in your muscles, personal or family history of a history of muscle problems,

you or your close relative has muscle problems that are also found in other family members if you have had muscle problems in the past during treatment with other medicines (eg other medicines from the statins group "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, have diabetes (high blood glucose levels), have heart failure or other heart problems, have recently had a heart attack of the myocardium,
you have unusually elevated blood levels of the hormone called aldosterone (primary

aldosteronism),

you are elderly,

you have had a severe allergic reaction with swelling of the face, lips, tongue or throat, accompanied by difficulty 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,

you are of black background because you may be at greater risk for angioedema and this medicine may be less effective in lowering your blood pressure than in people who are not blacks,

if you are taking any of the following medicines, the risk of angioedema is greater:

racemadotril (used to treat diarrhea),

sirolimus, everolimus, temsirolimus and other medicines belonging to a class of medicines called mTOR inhibitors (to avoid rejection of transplanted organs)

saquinavir (available as a fixed dose combination with valsartan) used for long-term treatment of heart failure. You are going to have LDL apheresis (which means removing cholesterol from your body with the help of an apparatus),

you are going to be subjected to a desensitization treatment to reduce the allergic

effects to bee or ax sting, you are going to have anesthesia and / or a major surgery,

have collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma,

adhere to a diet with limited intake of salt or use substitutes of the salt that contain potassium,

You have been told by your doctor that you have an intolerance to some sugars,

take any of the following medicines used to treat high blood pressure:

- angiotensin II receptor blockers (ARB) (also known as sartans - for example, valsartan, telmisartan, irbesartan) and in particular - if you have kidney problems associated with diabetes.

- aliskiren.

If any of the above applies to you, talk to your doctor right away before taking Lipitorta or during treatment with it.

Your doctor may need to have a blood test during 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 at regular intervals, blood pressure, and the amount of electrolytes (eg potassium) in your blood. See also the information that you accept Lippertance. "

While you are being treated with this medicine, your doctor will monitor your condition carefully if you have diabetes or have a risk of developing diabetes. You may be at risk of developing

of diabetes, if you have high levels of sugars and fat in your blood, you 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 medicines 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. Alternatively, they may cause an increased risk or a greater severity of side effects including a muscle breakdown condition called rhabdomyolysis and is described in section 4. 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 for the treatment of bacterial infection), colchicine (used to treat gout - a 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 heart rhythm, 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), oral contraceptives, stiripentol (anticonvulsant for epilepsy), cimetidine (used in stomach acid and peptic ulcers) , phenazone (painkiller),

antacids (intake of products containing aluminum or magnesium
Alcohol

Avoid consuming large amounts of alcohol while you are being treated with this medicine. For details, see section 2: "Warnings and precautions4".

Pregnancy

Do not take Lipopertis if you are pregnant, planning to become pregnant, or if you have childbearing potential unless you apply reliable methods to prevent pregnancy (see "Do not take Lippertans").

If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. This medicine should not be taken during pregnancy.

Breastfeeding

You should not take Lipopertis if you are breast-feeding. Tell your doctor immediately if you are breast-feeding or intend to breast-feed.

Driving with machines

Lippertance may cause dizziness, headache, fatigue or nausea. If your medication affects you, your ability to drive or use machines may be impaired, especially at the beginning of treatment.

Lipopertha 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 can cause your blood pressure to drop even at dangerously low levels. You may feel dizzy, sleepy, headache, fainting or feeling weak. If this happens, it may help if you lie down and raise your legs up. If the fall in blood pressure is strong, shock can also occur. It is possible to 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 LIPRSTANE 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, redness of the skin of the whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson) or other allergic reactions (rare) (may affect up to 1 in 1,000 people)

weakness, tension or muscle pain and in particular, simultaneously with them malaise and possibly high temperature, which may be caused by abnormal muscle breakdown, which can be life-threatening and may lead to kidney problems (rare, may affect up to 1 per 1000 people),

hand or leg shakes or speech problems, which may indicate a possible stroke (very rare - may affect up to 1 in 10,000 people); 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 hectic or irregular heartbeat (uncommon, may affect up to 1 in 100 people),

feeling sick, trembling, fainting, falls, chest pain, general malaise, fever (fever), increased sweating, pain

tachycardia (increased heart rhythm), vasculitis (inflammation of the blood vessels)

increased number of eosinophils (a type of white blood cell)

urine tests that are positive for white blood cells

changes in laboratory performance: increased blood potassium levels, reversible upon stopping

intake, low sodium levels, hypoglycaemia (very low blood sugar levels)
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 tablet pack after EXP:

The tablets are stable up to 10 days after opening in the 10-tablet polypropylene container (available only for the 10/5/5 / mg unit dose).

The tablets are stable for up to 30 days after opening in the polypropylene container for 28 tablets. The tablets are stable for up to 30 days after opening in the 30 tablet polypropylene container. The tablets are stable for 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 container tightly closed in order to protect from moisture.

All dosage units, except those of 40/10/10 mg, are in a 100 tablet tablet container: No special storage conditions are required.

The 40/10/10 mg dose unit is in a 100-tablet tablet container: Store below 30 ° C.

Do not dispose of medicines in the sewage system 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 Lipertance

The active substances are atorvastatin, perindopril arginine and amlodipine.

One 10 mg / 10 mg film-coated tablet contains 10.82 mg of atorvastatin calcium trisodate equivalent to 10 mg of atorvastatin, 5 mg of perindopril arginine equivalent to 3.40 mg of perindopril and 6.94 mg of 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 benzylate equivalent to 5 mg amlodipine

One film-coated tablet of Lipitor 20/10/5 mg contains 21.64 mg atorvastatin calcium trisodate, 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 mg 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 A 40 mg / 10 mg film-coated tablet 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 (E 170), hydroxypropyl cellulose (E463), corn starch sodium glycolate (type A), cellulose, microcrystalline cellulose (E460), maltodextrin, magnesium stearate (E572).

film coating of the tablet: glycerol (E422), hypromellose (E464), macrogol 6000, magnesium stearate (E171), red iron dioxide (E572).

What Lipertance  looks like and what the package contains

Lipertance 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 the symbol.

Lipertance 20/5/5 mg: 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 "S" and the other side with the symbol "".

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