ATORVASTATINA 10 mg Tabletki Powlekane

Treść ulotki

1. Atorvastatina Teva 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets
   1. What is Atorvastatina Teva and what is it used for
   2. What you need to know before taking Atorvastatina Teva
   3. How to take Atorvastatina Teva
   4. Possible side effects
   5. How to store Atorvastatina Teva
   6. Package Contents and Other Information

Atorvastatina Teva 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Atorvastatina Teva is and what it is used for
• 2. What you need to know before you take Atorvastatina Teva
• 3. How to take Atorvastatina Teva
• 4. Possible side effects
• 5. How to store Atorvastatina Teva
• 6. Contents of the pack and other information

1. What is Atorvastatina Teva and what is it used for

Atorvastatina Teva belongs to a group of medicines called statins, which are drugs that regulate
lipids (fats).
Atorvastatina Teva is used to reduce lipids known as cholesterol and triglycerides in the blood,
when a low-fat diet and lifestyle changes alone are not sufficient. If you
are at increased risk of developing heart disease, Atorvastatina Teva can also be
used to reduce this risk, even if your cholesterol levels are normal. During the
treatment you should continue to follow a standard diet to lower cholesterol.

2. What you need to know before taking Atorvastatina Teva

Do not take Atorvastatina Teva

• if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6);
• if you have or have ever had a liver disease;
• if you have had unexplained abnormal results in blood tests for liver function;
• if you are a woman of childbearing potential and not using reliable contraceptive methods;
• if you are pregnant or trying to become pregnant;
• if you are breastfeeding;
• if you are using the glecaprevir/pibrentasvir combination in the treatment of hepatitis C.

Warnings and precautions
Talk to your doctor or pharmacist before taking Atorvastatina Teva

• if you have severe respiratory failure;
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine used for bacterial infections) by mouth or by injection. The combination of fusidic acid and Atorvastatina Teva can cause serious muscle problems (rhabdomyolysis);
• if you have previously had a stroke with bleeding in the brain or have small pockets of fluid in the brain as a result of previous strokes;
• if you have kidney problems;
• if your thyroid gland is not working properly (hypothyroidism);
• if you have had repeated or unexplained muscle pain, or if you have a personal or family history of muscle problems;
• if you have previously had muscle problems while taking other medicines that lower cholesterol levels (e.g. other medicines based on “statins” or “fibrates”);
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness including, in some cases, the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to occur (see section 4);
• if you regularly consume large amounts of alcohol;
• if you have a history of liver disease;
• if you are over 70 years of age.

If any of the above conditions apply to you, your doctor will need to perform a
blood test before and possibly during your treatment with Atorvastatina Teva to
predict the risk of muscle-related side effects. It is known that the risk of muscle-related
side effects, e.g. rhabdomyolysis, increases when certain medicines are taken at the same time (see section 2 “Other medicines and Atorvastatina
Teva”).
Also tell your doctor or pharmacist if you suffer from persistent muscle weakness. Further
tests and medicines may be needed to diagnose and treat this condition.
During treatment with this medicine, your doctor will monitor you closely if you suffer from
diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes
if you have high levels of sugar and fat in your blood, if you are overweight and if you have high
blood pressure.

Other medicines and Atorvastatina Teva
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 Atorvastatina Teva or whose effect can
be altered by Atorvastatina Teva. This type of interaction could make one or
both medicines less effective. Alternatively, it could increase the risk of developing side effects or
the severity of such effects, including the serious condition of muscle breakdown known as
rhabdomyolysis described in section 4:

• medicines used to alter the functioning of the immune system, e.g. cyclosporine;
• some antibiotics or antifungals, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid;
• other medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, cholestipol;
• some calcium antagonists used for angina or high blood pressure, e.g. amlodipine, diltiazem, medicines used to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone;
• letermovir, a medicine that prevents infection by a virus called cytomegalovirus;
• medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination tipranavir/ritonavir, etc.;
• some medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir and the combination elbasvir/grazoprevir, ledipasvir/sofosbuvir;
• other medicines known to interact with Atorvastatina Teva include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used to treat gout) and antacids (products for indigestion containing aluminum or magnesium);
• non-prescription medicines: St John's wort;
• if you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can safely resume treatment with Atorvastatina Teva. In rare cases, taking Atorvastatina Teva with fusidic acid can cause weakness, tenderness or muscle pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4;
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and the presence of bacteria in the blood).

Atorvastatina Teva with food and drink
For instructions on how to take Atorvastatina Teva, see section 3. Note the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day. High amounts of grapefruit
juice can alter the effects of Atorvastatina Teva.

Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For more
details, see section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
DO NOT take Atorvastatina Teva if you are pregnant or planning a pregnancy.
DO NOT take Atorvastatina Teva if you are of childbearing potential unless you are using reliable contraceptive methods.
DO NOT take Atorvastatina Teva if you are breastfeeding.
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
The safety of atorvastatin during pregnancy and breastfeeding has not yet been demonstrated.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
Normally, this medicine does not impair the ability to drive or operate machinery.
However, do not drive if you notice that this medicine affects your ability to drive. Do not use
tools or machinery if your ability to use them is altered by this medicine.

Atorvastatina Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e.
it is essentially “sodium-free”.

3. How to take Atorvastatina Teva

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Before starting treatment, your doctor will have you follow a low-cholesterol diet,
which you should then maintain even during therapy with Atorvastatina Teva.
The recommended initial dose of Atorvastatina Teva is 10 mg once a day in adults and in
children aged 10 years or older. If necessary, this dose may be increased by your
doctor up to the amount you need.
Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatina Teva is
80 mg once a day.
Atorvastatina Teva tablets should be swallowed whole with a glass of water and can be
taken at any time of day, with or without food. However, try to take the
tablet at the same time each day.
[Atorvastatina Teva 20 mg, 40 mg and 80 mg]
The tablet can be divided into equal doses.

The duration of treatment with Atorvastatina Teva is established by the doctor.
Consult your doctor if the effect of Atorvastatina Teva seems excessively strong or weak.

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

If you forget to take Atorvastatina Teva
If you forget to take a dose, take the next scheduled dose at the correct time.
DO NOT take a double dose to make up for a missed dose.

If you stop taking Atorvastatina Teva
If you have any doubts about the use of this medicine or if you want to stop treatment, consult
your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the serious symptoms or side effects listed below, stop taking the tablets and seek immediate medical attention or go to the nearest hospital emergency room.
Rare: may affect up to 1 in 1000 people

• severe allergic reaction causing swelling of the face, tongue and throat which can cause great difficulty in breathing
• severe illness with extensive skin peeling and blistering of the skin, in the mouth, eyes and genitals, and with fever. Skin rash with pink-red patches especially on the palms of the hands or soles of the feet, where blisters may form
• weakness, tenderness, pain or muscle breakdown or reddish-brown urine. In particular, if you simultaneously feel unwell or have a high fever, this could be caused by abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always disappear, even after stopping atorvastatin, and this can be life-threatening and cause kidney problems.

Very rare: may affect up to 1 in 10,000 people

• if you experience problems with unexpected or unusual bleeding or bruising, these could indicate a liver disorder. See your doctor as soon as possible.
• lupus-like syndrome (including rash, joint disorders and effects on blood cells)

Other possible side effects with Atorvastatina Teva
Common: may affect up to 1 in 10 people

• nasal cavity inflammation, sore throat, nosebleed
• allergic reactions
• increased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels), increased creatine kinase in the blood
• headache
• nausea, constipation, flatulence, indigestion, diarrhoea
• joint pain, muscle pain and back pain
• blood test results showing possible liver malfunction

Not common: may affect up to 1 in 100 people

• anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels)
• nightmares, insomnia
• dizziness, numbness or tingling in the hands and feet, reduced sensitivity to pain or touch, altered taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, eructation, pain in the upper and lower abdomen, pancreatitis (inflammation of the pancreas causing stomach pain)
• hepatitis (inflammation of the liver)
• skin rash, itchy skin rash, urticaria, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially of the ankles (edema), increased body temperature
• urine tests positive for the presence of white blood cells

Rare: may affect up to 1 in 1000 people

• visual disturbance
• unexpected bleeding or bruising
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon injury
• skin rash that may affect the skin or sores in the mouth (drug-induced lichenoid reaction)
• purple skin lesions (signs of inflammation of blood vessels, vasculitis)

Very rare: may affect up to 1 in 10,000 people

• an allergic reaction - symptoms can include sudden wheezing and pain or tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (enlargement of the breasts in men)

Not known: frequency cannot be estimated based on available data

• persistent muscle weakness
• myasthenia gravis (a disease that causes generalized muscle weakness including, in some cases, the muscles used for breathing)
• ocular myasthenia (a disease that causes weakness of the eye muscles)

See your doctor if you experience weakness in your arms or legs that worsens after periods of
activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
Possible side effects reported with some statins (medicines of the same type):

• sexual dysfunction
• depression
• breathing problems, including persistent cough and/or shortness of breath or fever
• diabetes. The risk of developing diabetes is higher if you have high sugar and fat levels in your blood, if you are overweight and if you have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at
By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Atorvastatina Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, on the carton and on the
bottle after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Atorvastatina Teva Contains

• The active ingredient is atorvastatin. Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium). Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium). Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium). Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium).
• The other ingredients are: Tablet core: microcrystalline cellulose (E460), calcium carbonate (E170), maltose, sodium croscarmellose (E466), polysorbate 80 (E433) and magnesium aluminium metasilicate and magnesium stearate (E470b). Film coating: hypromellose (E464), hydroxypropylcellulose (E463), triethyl citrate (E1505), polysorbate 80 (E433), titanium dioxide (E171).

Description of the appearance of Atorvastatina Teva and contents of the pack
Atorvastatina Teva 10 mg consists of film-coated tablets of colour from white to off-white, of
elliptical shape, biconvex, with imprinted “10” on one side and smooth on the other side. Dimensions: approximately 8 mm
x 4 mm.
Atorvastatina Teva 20 mg consists of film-coated tablets of colour from white to off-white, of
elliptical shape, biconvex, with imprinted “20” on one side and with a score line on the other side.
Dimensions: approximately 10 mm x 6 mm.
Atorvastatina Teva 40 mg consists of film-coated tablets of colour from white to off-white, of
elliptical shape, biconvex, with imprinted “40” on one side and with a score line on the other side.
Dimensions: approximately 13 mm x 7 mm.
Atorvastatina Teva 80 mg consists of film-coated tablets of colour from white to off-white, of
elliptical shape, biconvex, with imprinted “80” on one side and with a score line on the other side.
Dimensions: approximately 16 mm x 9 mm.
Atorvastatina Teva 10 mg is available in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or
105 tablets, in divisible blisters for a single dose of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1,
60x1, 90x1, 98x1, 100x1 or 105x1 tablets and in bottles of 28, 30, 50, 90, 100, 250 or 500 tablets.
Atorvastatina Teva 20 mg is available in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or
105 tablets, in divisible blisters for a single dose of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1,
60x1, 90x1, 98x1, 100x1 or 105x1 tablets and in bottles of 28, 30, 50, 90, 100, 250, 500 or
1 000 tablets.
Atorvastatina Teva 40 mg is available in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 105
tablets, in divisible blisters for a single dose of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1,
90x1, 98x1, 100x1 or 105x1 tablets and in bottles of 28, 30, 50, 90, 100, 250 or 500 tablets.
Atorvastatina Teva 80 mg is available in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 105
tablets, in divisible blisters for a single dose of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1,
90x1, 98x1, 100x1 or 105x1 tablets and in bottles of 28, 30, 50, 90, 100 or 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
TEVA B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

Manufacturer

Teva Pharma, S.L.U.
C/C, n.4, Poligono Industrial Malpica, 50016 Zaragoza (Spain)

Teva Operations Poland Sp. Z.oo
Ul. Mogilska 80, 31-546 krakòw (Poland)