ATORVISTAT. 10 mg. 30 tablets
Atorvistat used for lowering lipid levels, cholesterol and triglycerides in the blood, where the lipid-lowering diet and change in life style is not sufficient. If you have an increased risk of developing heart disease .
ATORVISTAT. 10 mg. 30 tablets
ATORVISTAT WHAT IS AND WHAT IT IS USED
Atorvistat belongs to the group of medicines called statins that regulate lipid (fat).
Atorvistat used for lowering lipid levels, cholesterol and triglycerides in the blood, where the lipid-lowering diet and change in life style is not sufficient. If you have an increased risk of developing heart disease Atorvistat used as lekaretvo-lowering this risk even when cholesterol levels are normal. The standard diet aimed at lowering cholesterol is to be continued during the treatment.
Atorvistat is also intended as a supplement to other treatments (eg LDL-apheresis, a procedure that reduces the levels of lipids in the blood) or in cases of unsatisfactory outcome of treatment undertaken. Cholesterol is a natural substance in the blood necessary for normal growth. However, if there is too much cholesterol in the body, it is deposited on the walls of the blood vessels can eventually clog them. This is one of the most common causes of the disorder heart. It is believed that elevated levels of cholesterol lead to increased risk of heart disease. Other factors that increase the risk of developing heart disease are high blood pressure, diabetes, increased body weight, decreased physical activity, smoking, or family history of heart disease.
2. BEFORE YOU TAKE ATORVISTAT
Do not take Atorvistat if:
- You are allergic to atorvastatin or to any of the excipients. An allergic reaction may include rash, itching, swelling of the face, lips and throat and difficulty breathing.
- Have severe liver problems or have had
- Have any changes in the results of liver function tests
- Are of childbearing age and use adequate contraception
- You are pregnant, planning a pregnancy or breastfeeding
- You have a muscle disease called myopathy (repeated and unexplained muscle pain).
Take special care with Atorvistat
These are risk factors that can lead to impaired muscle function: unexplained muscle pain,
tenderness, or weakness (with or without the presence of pink colored urine), accompanied by fever and general discomfort or anxiety.
These are symptoms of a rare muscle disorder that can sometimes be serious and can lead to kidney problems. If you have some, please inform your doctor.
Reasons why Atorvistat may not be suitable for you:
if you have kidney disease
if you elabe active-shtiteviyana zhlozo (hyperthyroidism)
If you have repeated or unexplained muscle pain, personal or family history of muscle problems
if you had pre-existing muscle problems during treatment with other lipid-lowering drugs (eg other "statins" or "fibrates")
If you regularly receive large amounts of alcohol
if you have a history of liver disease
If you are over age 70
If any of these apply to you, your doctor should do blood tests before and possibly during treatment with Atorvistat, to control the risk of side effects affecting the muscles.
Taking other medicines
Some medicines may interact with Atorvistat. The risk of muscle damage may be greater if you are taking any of these medicines. Where necessary, co-administration of these drugs with Atorvistat, your doctor will determine the benefit / risk ratio when prescribing them to you.
It is important to tell your doctor if you are taking any of the following:
Products that affect the immune system, e. cyclosporine
Antibiotics or antifungals such as erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole
Other drugs that regulate lipid levels, e. gemfibrozil, other fibrates etsetimib, niacin, nicotinic acid, colestipol
Certain calcium channel blockers which are used for the treatment of angina pectoris or high blood pressure, for example. nifedipine, amlodipine
Products that control heart rate, such as digoxin
Products used for treatment of cardiac diseases (amiodarone, diltiazem, verapamil)
Some benzodiazepines, e. nafazodon used in states of anxiety or similar conditions
Herbs used for medicinal purposes, including treatment of depression (Hypericum perforatum)
Protease inhibitors used in the treatment of HIV, for example. efavirenz, nelfinavir
Other products that interact with Atorvistat such as warfarin (decreasing blood clotting). Oral contraceptives, phenytoin (anticonvulsant epilepsy) and antacid (products which are used for stomach ailments, and contain aluminum and magnesium).
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal or natural products.
Taking Atorvistat with food and drink
Atorvistat can be taken at any time of day with or without food.
Concomitant intake of large quantities of grapefruit juice (over 1.2 liters per day) may increase the effect of Atorvistat. You should avoid taking large amounts of this juice. while taking Atorvistat.
Avoid drinking large amounts of alcohol while taking this product. For details, see Section 2 particular care with Atorvistat.
Atorvistat not take if you are pregnant, may be pregnant or planning a pregnancy. Women of childbearing potential should take appropriate contraceptive. Ask your doctor or pharmacist for information before taking any medicine.
Do not take Atorvistat if breastfeeding
Ask your doctor or pharmacist for information before taking any medicine.
Driving and using machines
Atorvastatin has a negligible effect on the ability to drive and use machines.
Important information about some excipients in the composition of Atorvistat
Atorvistat contains milk sugar (lactose). If your doctor has mentioned that you have an intolerance to some sugars, contact your doctor before taking reception of the product.
3. HOW TO TAKE ATORVISTAT
Always take Atorvistat exactly as directed by your doctor. Please consult your doctor if you are unsure.
Before starting treatment with Atorvistat, your doctor will prescribe you lipid-lowering diet, which should be used during treatment with the drug.
Adults and the elderly:
The usual starting once daily dose is 10 mg. It can also be increased in case of necessity. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum daily dose is 80 mg Atorvistat.
Children should be treated by specialists.
Impaired renal function:
It is not necessary adaptation of the dose. Follow your doctor's instructions.
Impaired hepatic function:
Atorvistat should be used with caution in patients with impaired chernodsobna function.
Your lekyar will appoint liver function tests before starting treatment with Atorvistat, and periodically thereafter.
Atorvistat tablets should be swallowed whole with water or drink and can be taken at any time of day with or without food. However, take your tablet at the same time each day.
The duration of treatment with Atorvistat determined by your doctor.
If you take more than the required amount
Tell your doctor, pharmacist or go to the nearest emergency medical help immediately.
If you forget to take Atorvistat
Do not take a double dose to make up for forgotten doses. Continue treatment as prescribed by your doctor.
If you stop taking Atorvistat
Do not change or stop taking Atorvistat before checking with your doctor.
If you have questions regarding the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Atorvistat may cause side effects, although not everybody gets them. Typical side reactions are part of the gastrointestinal tract such as constipation, swell, indigestion and stomach pain normally disappears during therapy. Please note the following other side effects.
Very serious side effects
If one of the following, stop taking Atorvistat and tell your doctor immediately or go to the emergency center at your nearest hospital:
Very common side effects (reported in less than 1 in 10,000 patients):
Severe allergic reactions with swelling of the face, tongue, throat and mouth, which can cause difficulty in breathing (angioedema, anaphylaxis)
- Serious skin reactions with rash and skin redness, blistering of the skin and mucous membranes of the mouth, eyes and genitals
Rare (reported in 1 in 10,000 to 10 in 10,000 patients)
As with most such drugs Atorvistat affects the musculoskeletal system, in rare cases, causing muscle pain, inflammation and disorders that can develop into life-threatening disorder of muscle tissue.
Contact your doctor immediately if you experience pain or muscle weakness, especially if the condition is accompanied by a feeling of swelling or fever. In these cases, treatment with Atorvistat may require discontinuation or dose reduction.
These are very serious side effects. You may need urgent medical attention or hospitalization.
Serious side effects:
Tell your doctor immediately or go to the emergency center at your nearest hospital if you notice any of the following:
Uncommon serious adverse events (reported in 1 to 10 of 1000 patients)
-pancreatitis (inflammation of the pancreas, leading to abdominal pain)
Rare serious adverse events (reported in 1 to 10 of 10,000 patients)
- Inflammation of the liver
- Jaundice (yellowing of the skin and eyes eclairs)
- Inflammation of the muscles
- Infringement of muscle tissue
Very rare serious side effects (reported in less than 1 in 10,000 patients)
- Liver failure
- Tendon rupture (come with sipna pain, significant weakness, inability to move the affected arm or leg)
OTHER SIDE EFFECTS
Inforamirayte your doctor if you get any of these
Common side effects (reported in 1 to 10 of 100 patients)
swelling of the hands and feet
reduced skin sensitivity to light touch or pain
vkochenyavane or tingling in fingers and toes
Uncommon side effects (reported in 1 to 10 of 1000 patients)
increased or decreased glucose
ringing in the ears (tinnitus)
Feeling weak or down the loss of strength in the legs (peripheral neuropathy).
Very rare side effects (reported watered less than 1 in 10,000 patients)
growth of the abdomen or chest (gynecomastia)
decreased taste sensitivity (dysgeusia)
Effects on laboratory tests
- Change in the results of liver function tests (increased serum transaminases)
- Change in the results of studies of renal function (increase in serum creatinine phosphokinase).
If any of the side effects gets serious, or if you notice any not listed in this leaflet, please tell your doctor or pharmacist.
Atorvistat should not be used after the expiry date stated on the packaging. The expiry date is also printed on the blister after the indication "EXP" followed by the month and year.
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 does Atorvistat:
The active ingredient of atorvastatin Atorvistat is in the form of atorvastatin calcium. Each tablet contains 10 mg respectively, 20 mg, 40 mg or 80 mg of atorvastatin in the form of atorvastatin calcium.
The other ingredients are:
Tablet core: anhydrous lactose, microcrystalline cellulose, hydroxypropyl cellulose-L, anhydrous sodium carbonate, silica, colloidal anhydrous, sodium lauryl sulfate, butylated hydroxyanisole, butalhidroksitoluen, croscarmellose sodium and magnesium stearate.
Film coating: polyvinyl alcohol, titanium dioxide (E 171), talc, lecithin orasoye S-1-17823 and xanthan gum.
Atorvistat looks like:
10 mg: White to off white, film-coated, oval tablet with "KX 12" on one side and plain on the other.
20 mg: White to off white, film-coated, oval tablet with "KX 828" on one side and plain on the other.
40 mg: White to off white, film-coated, oval tablet with "KX 829" on one side and plain on the other.
80 mg: White to off white, film-coated, oval tablet with "KX 830" on one side and plain on the other.
Tablets in packs of: 7,10,14, 20, 28, 30, 56, 98 and 100 pieces tablets.