TORVALIPIN table. 10 mg. 30 tab
Torvalipin for use in reducing blood lipids, known as cholesterol and triglycerides as a diet low in fat and changes in life style is insufficient
TORVALIPIN table. 10 mg. 30 tab
TORVALIPIN WHAT IS AND WHAT IT IS USED
Torvalipin belongs to a group of medicines known as statins, which regulate lipid (fat).
Torvalipin for use in reducing blood lipids, known as cholesterol and triglycerides as a diet low in fat and changes in life style is insufficient. If you are at increased risk of heart disease Torvalipin can also be used to reduce this risk, even if your cholesterol levels are normal. You must maintain a standard diet to lower cholesterol during treatment.
2. BEFORE YOU TAKE TORVALIPIN
Do not take Torvalipin
if you are hypersensitive (allergic) to atorvastatin or a similar drug used to lower blood lipids, or any of the other ingredients of Torvalipin - for details, see Section 6;
if you have or have had a disease affecting the liver;
if you have unexplained abnormal blood tests of liver function;
if you are a woman who can not have children and not using reliable contraception;
if you are pregnant or trying to get pregnant;
if you are breastfeeding.
Take special care with Torvalipin
if you had a stroke or brain haemorrhage have small pockets of fluid in the brain prior stroke;
if you have kidney problems;
if you have underactive thyroid (hypothyroidism);
if you had multiple unexplained muscle pain, personal or family history of muscle problems;
if you have previously had muscle problems during treatment with other lipid-lowering drugs. (eg other "statin" or "fibrate-" drugs);
if you regularly consume large amounts of alcohol;
if you have a history of liver disease;
if you are over 70 years old.
Consult your doctor or pharmacist before you start taking Torvalipin if you have severe respiratory failure.
If any of these conditions apply to you, it may be necessary for your doctor to do blood tests before and possibly during your treatment with Torvalipin to predict your risk of muscle related side effects. It is known that the risk of muscle related side effects, e. rhabdomyolysis is increased by concomitant administration of certain drugs (see Chapter 2, "Using other medicines").
Using other medicines
There are some drugs that can alter the effect of Torvalipin or their effect can be changed by Torvalipin. This kind of interaction can make one or both drugs less effective. Eventually, it may increase the risk or severity of adverse effects, including important muscle-wasting condition known as rhabdomyolysis, described in Section 4:
Drugs used to modify the way your immune system works, such as cyclosporine;
Some antibiotics or antifungals such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampin, fusidic acid;
Other drugs for regulating lipid levels, e. gemfibrozil, other fibrates, colestipol;
Certain calcium channel blockers, used for the angina, or hypertension, for example. amlodipine, diltiazem, medications to regulate your heart rate, for example. digoxin, verapamil, amiodarone;
Drugs used in the treatment of AIDS, for example. ritonavir, lopinavir, agazanavir, indinavir, darunavir, etc.;
Other drugs with known to interact with Torvalipin include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (anticonvulsant for epilepsy), cimetidine (used to treat heartburn and peptic ulcers), phenoxazin (painkiller) and antacids (indigestion products containing aluminum or magnesium);
Medicines obtained without a prescription: St. John's wort.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Torvalipin with food and drink
See Section 3 for instructions on how to take Torvalipin. Please note the following:
Not take more than one or two small glasses of grapefruit juice per day, because large amounts of grapefruit juice may change the effect of Torvalipin.
Avoid drinking too much alcohol while taking this medicine. See section 2 "Take special care with Torvalipin" for details.
Pregnancy and lactation
Torvalipin not take during pregnancy or if you are trying to become pregnant.
Torvalipin do not take if it is possible to become pregnant unless using reliable contraception.
Torvalipin not take if you are breastfeeding.
Torvalipin safety in pregnancy and lactation has not been established.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Usually this medication affects your ability to drive and use machines. However, do not drive if this medicine affects your ability to drive. Do not use any tools or machines if your ability to use them will be affected by this medicine.
3. HOW TO TAKE TORVALIPIN
Before starting treatment, your doctor will put a diet low in cholesterol, you need to maintain and during therapy Torvalipin.
Torvalipin usual starting dose is 10 mg once daily in adults and children over 10 years. If necessary, the dose may be increased by your doctor until you are taking the required amount. Your doctor may adjust the dose at intervals of 4 weeks or more. Torvalipin maximum dose is 80 mg per day for adults and 20 mg once daily in children.
Torvalipin tablets should be swallowed whole with water, and can be administered at any time of the day, with or without food. However, try to take the tablet at the same time each day.
Always take Torvalipin exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
The duration of treatment with Torvalipin determined by your doctor
Please consult your doctor if you think that the effect of Torvalipin is too strong or too weak.
If you take more than you should Torvalipin
If you have, take too many tablets Torvalipin (more than your usual daily dose), contact your doctor or nearest hospital for advice.
If you forget to take Torvalipin
If you forget to take a dose, just take your next dose when the time came for her.
Do not take a double dose to make up for a missed dose.
If you stop taking Torvalipin
If you have any further questions on the use of this drug or you want to stop your treatment, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Torvalipin can cause side effects, although not everybody gets them.
If any of the following serious side effects, stop taking the tablets and tell your doctor immediately or go to the emergency room of the nearest hospital.
Rare: affects 1 to 10 users in 10,000:
Serious allergic reaction that causes swelling of the face, tongue, and throat that may cause difficulties in breathing;
Serious disease with severe swelling and peeling of the skin, blistering of the skin, mouth, eyes, genitals and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet, which may form bubbles;
Muscle weakness, tenderness or pain, especially if at the same time you feel unwell or have a fever this may be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney problems.
Very rare: affects less than 1 in 10,000:
If you experience problems with unexpected or unusual bleeding or bruising, it may be a symptom of liver complaint. Check with your doctor as soon as possible.
Other possible side effects Torvalipin
Common side effects (affects 1 to 10 users in 100) include:
inflammation of the nasal passages, throat pain, bleeding from the nose;
raising the level of blood sugar (if you have diabetes keep careful track of your blood sugar levels), elevated creatine kinase in the blood;
nausea, constipation, flatulence, indigestion, diarrhea;
pain in the joints, muscles, and back;
results of blood tests showed abnormal liver function.
Uncommon side effects (affects 1 to 10 patients in 1000) include:
anorexia (loss of appetite), weight gain, decrease in blood sugar levels (if you have diabetes, keep careful monitoring of blood sugar);
dizziness, numbness or tingling in the fingers or toes, reducing the sensation of pain or touch, taste disturbances, loss of memory;
ringing in the ears and / or head;
vomiting, eructation, upper back pain or lower abdomen, pancreatitis (inflammation of the pancreas, leading to abdominal pain);
hepatitis (inflammation of liver);
rashes, skin rashes, itching, hives, hair loss;
neck pain, muscle weakness;
fatigue, malaise, weakness, chest pain, swelling, particularly of the ankles (edema), fever;
urine tests positive for white blood cells.
Rare side effects (affects 1 to 10 patients in 10000) include:
unexpected bleeding or bruising;
stagnation of bile (yellowing of the skin or whites of the eyes);
damage to the ligaments.
Very rare side effects (affects less than 1 user in 10,000) include:
allergic reaction - symptoms may include sudden wheezing and pain or tightness in the chest, swelling of eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse;
gynecomastia (breast enlargement in men and women).
Possible side effects reported with some statins (drugs of the same type):
Breathing problems including persistent cough and / or shortness of breath or fever.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE TORVALIPIN
Keep out of reach of children.
This medicinal product does not require any special storage conditions.
Torvalipin not use after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
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. ADDITIONAL INFORMATION
What does Torvalipin
The active substance is atorvastatin as atorvastatin calcium. Each tablet contains 10 mg, 20 mg or 40 mg of atorvastatin.
The other ingredients are:
Tablet core: mannitol, microcrystalline cellulose, crospovidone, sodium carbonate anhydrous, povidone, methionine, magnesium stearate;
Tablet coating: hypromellose 6cP, titanium dioxide (E171), macrogol 6000, talc.
Torvalipin looks like and contents of pack
10 mg; White, round, biconvex film-coated tablets marked with "10 on one side and A on the other";