Atoris 30 mg. 30 tablets

WHAT ATORIS IS AND WHAT IT IS USED FOR
Atoris belongs to a group of medicines known as statins - medicines that regulate lipids (fats).
Atoris is used to reduce lipids, known as cholesterol and triglycerides in the blood, when a low-fat diet and lifestyle changes alone are insufficient. If you have an increased risk of heart disease, you may also reduce this risk even if your cholesterol levels are normal. The standard cholesterol-lowering diet should be continued during treatment.

2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE ATORIS
Do not take Atoris:

if you are hypersensitive (allergic) to Atoris or any other similar medicines used to lower lipids in the blood or any of the other ingredients of the medicine - point 6 for more information;
if you have or have ever had a disease that affects the liver;
if you have unclear blood test abnormalities for liver function;
if you are a woman of childbearing age and you are not using safe contraception;
if you are pregnant or trying to become pregnant;
if you are breast-feeding.
Take special care with Atoris
Here are the reasons why Atoris may not be suitable for you:

if you have had a previous stroke with bleeding in the brain or small areas of fluid in the brain from previous strokes;
if you have kidney problems;
if you have a reduced thyroid gland (hypothyroidism);
if you have recurrent or unexplained muscle pain, personal or family history of muscle problems;
if you have had previous muscle problems during treatment with other lipid-lowering medicines (eg other statins or fibrates);
if you regularly drink a lot of alcohol;
if you have a history of liver disease;
if you are older than 70 years old.
Ask your doctor or pharmacist for advice before taking Atosis:

if you have severe respiratory failure.
If any of these apply to you, your doctor will perform blood tests before and probably during your treatment with Atoris to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, rhabdomyolysis is increased when certain medicines are taken concomitantly (see section 2 "Taking other medicines").

Taking other medicines
There are some medicines that can alter the effect of Atoris or their effect can be changed by Atoris. This type of interaction could reduce the effectiveness of either or both drugs. Conversely, it could increase the risk or severity of side effects, including the severe muscle wasting condition known as rhabdomyolysis described in section 4:

Medicines used to alter the way your immune system works, for example, cyclosporin;
Certain antibiotics or antifungal drugs, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampin, fusidic acid;
Other drugs controlling lipid levels, e.g. gemfibrozil, other fibrates, colestipol;
Some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem;
Medicines that regulate your heart rhythm, digoxin, verapamil, amiodarone;
Drugs used to treat AIDS, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc .;
Other medicines known to interact with Atoris, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (anticonvulsant for the treatment of epilepsy), cimetidine (used in heartburn and ulcers) fenazone (an analgesic product) and antacids (digestive products containing aluminum or magnesium);
Prescription Drugs: 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.

While you are taking this medicine, your doctor will monitor you closely if you suffer from diabetes or are at risk of developing diabetes. You are more likely to be at an increased risk of developing diabetes if you have high blood sugar and fat, overweight and have high blood pressure.

Take Atoris  with food, drink and alcohol
See section 3 for instructions on how to take Atoras. Please note the following:

Grapefruit juice
Do not take more than one or two small glasses of grapefruit juice a day because large amounts of grapefruit juice can alter the effects of Atos.

Alcohol
Avoid taking too much alcohol while taking this medicine.
See section 2 "Take special care with Atosis" for details.

Pregnancy, breastfeeding and fertility
Do not take Atoris if you are pregnant or if you are planning to become pregnant.
HOW TO ACCEPT ATORIS
Before you start treatment, your doctor will prescribe a low-cholesterol diet that you should continue on during treatment with Atoris.
The usual starting dose of Atoris is 10 mg once daily in adults and children over 10 years of age. It may be increased if necessary by your doctor until you start taking the amount you need. Your doctor will adjust the dosage at intervals of 4 weeks or more. The maximum dose of Atoris is 80 mg once a day for adults and 20 mg once a day for children.
Atoris tablets should be swallowed whole with water and can be taken at any time of the day, with or without food. However, try to take your tablets at the same time each day.
Always take Atoris exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The duration of treatment with Atoris is determined by your doctor.
Please ask your doctor if you think the effect of Atos is too strong or too weak.

If you take more Atoris than you should
If you accidentally take too many Atoris tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.

If you forget to take Atoris
If you forget to take a dose, just take your next scheduled dose at the right time. Do not take a double dose to make up for the missed dose.

If you stop taking Atoris
If you have any further questions on the use of this product or want to stop treatment, please ask your doctor or pharmacist.

4. POSSIBLE Atoris  PERSPECTIVES
Like all medicines, Atoris can cause side effects, although not everyone gets them.

If you experience any of the following serious side effects, stop taking your tablets and tell your doctor immediately or go to a nearby hospital or emergency room.
Rare (affects 1 to 10 patients in 10,000):

Serious allergic reactions that cause swelling of the face, tongue and throat resulting in great difficulty in breathing;
Serious disease with severe bruising and swelling of the skin, with blistering of the skin, mouth, eyes, genitals, and fever. Skin rash in the form of pink-red spots, most commonly on the palms of the hands and feet, with possible blistering;
Muscle weakness, tenderness or pain, especially if you feel unwell or have high fever at the same time; this may be caused by increased muscle breakdown, which is life-threatening and leads to kidney problems.
Very rare (affects less than 1 patient in 10,000):

If you have problems with unexpected or abnormal bleeding or bruising, this may suggest a liver complaint. You should consult your doctor as soon as possible.
Other possible side effects with Atoris:
Common side effects (affects 1 to 10 patients in 100) include:

inflammation of the nose, sore throat, nasal bleeding;
allergic reactions;
increased blood glucose (if you have diabetes, continue to monitor your blood sugar levels), elevated blood creatinine phosphokinase levels;
headache;
nausea, constipation, gas, indigestion, diarrhea;
joint pain, muscle pain and back pain;
abnormal blood counts for hepatic function.
Uncommon side effects (affects 1 to 10 patients in 1,000) include:

anorexia (loss of appetite), weight gain, lowering of blood sugar (if you have diabetes, continue to monitor your blood sugar levels);
nightmares, insomnia;
dizziness, numbness and tingling in the fingers and toes, decreased sensitivity to pain and touch, change in taste, loss of memory;
blurred vision;
ringing in the ears and / or the head;
vomiting, eructation, upper and lower abdominal pain, pancreatitis (inflammation behind the stomach gland resulting in stomach pain);
hepatitis (hepatic inflammation);
rash, skin rash and pruritus, urticaria, hair loss;
neck pain, muscle weakness;
fatigue, general malaise, weakness, chest pain, swelling of the ankles (edema), fever;
white blood cells in the urine during the tests.
Rare side effects (affects 1 to 10 patients in 10,000) include:

visual disturbances;
unexpected bleeding or bruising;
cholestasis (yellowing of the skin and eyes);
tendon trauma.
Very rare side effects (affects less than 1 patient in 10,000) include:

allergic reaction - Symptoms may include sudden breathlessness and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue and throat, difficulty in breathing, fainting;
hearing loss;
gynecomastia (breast enlargement in men and women).
Possible side effects reported with certain statins (medicines of the same type):

sexual disorders;
depression;
breathing problems, including prolonged cough and / or shortness of breath, and fever;
diabetes: It is more likely if your blood sugar and fat levels are elevated and you have high blood pressure. Your doctor will monitor you while taking this medicine.
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 ATORIS
Keep out of the reach and sight of children.
Store in the original package in order to protect from moisture.
Do not use Atoris after the expiry date which is stated on the carton and the outer carton. 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 your unnecessary medicines. These measures will help to protect the environment.

6. CONTENTS OF THE PACKAGE AND ADDITIONAL INFORMATION
What Atoris contains
The active substance is atorvastatin (atorvastatin). Each film-coated tablet of 30 mg, 60 mg or 80 mg contains 30 mg, 60 mg or 80 mg of atorvastatin, such as atorvastatin calcium.
The other ingredients are: sodium hydroxide, hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, crospovidone, magnesium stearate, and polysorbate 80 in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000 and talc in the film coat.

What it looks like and what the pack contains
30 mg tablets: white, round, slightly protruding film-coated tablets with bevelled edges.
60 mg tablets: white, oval, biconvex, film-coated tablets.
80 mg tablets: white, capsule-like, biconvex, film-coated tablets.

Packs of 14, 30, 60, 90 film-coated tablets are available in blisters.
Not all packs may be marketed.

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