Atorvastatin Teva: detailed information

Patient Information Leaflet

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

Equivalent medicinal product
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Atorvastatin Teva is and what it is used for
What you need to know before taking Atorvastatin Teva
How to take Atorvastatin Teva
Possible side effects
How to store Atorvastatin Teva
Contents of the pack and other information

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

Atorvastatina Teva belongs to a group of medicines called statins, which are lipid-regulating (fat-regulating) drugs.
Atorvastatina Teva is used to reduce levels of 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 may also be used to reduce this risk, even if your cholesterol levels are normal.
During treatment, you must continue to follow a standard cholesterol-lowering diet.

2. What you need to know before taking Atorvastatin Teva

Do not take Atorvastatin 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 liver disease;
if you have had unexplained abnormal results in blood tests assessing liver function;
if you are a woman of childbearing age and are not using reliable contraceptive methods;
if you are pregnant or trying to become pregnant;
if you are breastfeeding;
if you are taking the combination glecaprevir/pibrentasvir for the treatment of hepatitis C.

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

if you have severe respiratory insufficiency;
if you are currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used for bacterial infections). The combination of fusidic acid and Atorvastatin Teva can cause serious muscle problems (rhabdomyolysis);
if you have previously had a stroke with bleeding into the brain or have small fluid-filled pockets in the brain as a consequence of prior strokes;
if you have kidney problems;
if your thyroid gland is underactive (hypothyroidism);
if you have had repeated or unexplained muscle pain, or if you have a personal or family history of muscle disorders;
if you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g. other "statin" or "fibrate" medicines);
if you have or have ever had myasthenia (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), since statins may sometimes worsen myasthenia or trigger its onset (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 old.

If any of the conditions described above apply to you, your doctor will perform a blood test before and possibly during your treatment with Atorvastatin Teva to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 “Other medicines and Atorvastatin Teva”).
Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be required to diagnose and manage this condition.
During treatment with this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are more likely to be at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure.

Other medicines and Atorvastatin Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may alter the effect of Atorvastatin Teva, or their effects may be altered by Atorvastatin Teva. Such interactions may reduce the effectiveness of one or both medicines. Alternatively, they may increase the risk or severity of adverse effects, including the serious condition of muscle breakdown known as rhabdomyolysis described in section 4:

medicines used to modify the immune system’s activity, e.g. cyclosporine;
certain 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, colestipol;
certain calcium channel blockers 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.;
certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir;
other medicines known to interact with Atorvastatin Teva include ezetimibe (a cholesterol-lowering medicine), warfarin (a blood thinner), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium);
non-prescription medicines: St John’s wort;
if you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment with Atorvastatin Teva. In rare cases, taking Atorvastatin Teva with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4;
daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).

Atorvastatin Teva with food and drink
For instructions on how to take Atorvastatin Teva, see section 3. Please note the following:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day. Large quantities of grapefruit juice may interfere with the effects of Atorvastatin Teva.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, see section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
DO NOT take Atorvastatin Teva if you are pregnant or planning to become pregnant.
DO NOT take Atorvastatin Teva if you are of childbearing age unless you are using reliable contraceptive methods.
DO NOT take Atorvastatin Teva if you are breastfeeding.
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of atorvastatin during pregnancy and breastfeeding has not yet been established.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Normally, this medicine does not affect your ability to drive or operate machinery.
However, do not drive if you notice that this medicine affects your ability to drive safely. Do not use tools or machinery if your ability to operate them is impaired by this medicine.

Atorvastatin 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 Atorvastatin Teva

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Before starting treatment, your doctor will advise you to follow a cholesterol-lowering diet, which you
must continue during treatment with Atorvastatin Teva.
The recommended starting dose of Atorvastatin Teva is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose gradually to the amount you need.
Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Atorvastatin Teva is
80 mg once daily.
Swallow the Atorvastatin Teva tablets whole with a glass of water. They can be taken at any time of day, with or without food. However, try to take the tablet at the same time every day.
[Atorvastatin Teva 20 mg, 40 mg and 80 mg]
The tablet may be divided into equal doses.
The duration of treatment with Atorvastatin Teva will be determined by your doctor.
Consult your doctor if the effect of Atorvastatin Teva seems too strong or too weak.
If you take more Atorvastatin Teva than you should
If you accidentally take too many Atorvastatin Teva tablets (more than your usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take Atorvastatin 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 the missed dose.
If you stop taking Atorvastatin Teva
If you have any doubts about using this medicine or if you wish 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 symptoms or serious side effects listed below,
stop taking the tablets and contact your doctor immediately or go to the nearest hospital emergency department.

Rare: may affect up to 1 in 1,000 people

severe allergic reaction causing swelling of the face, tongue and throat, which may cause severe breathing difficulties
severe illness with extensive peeling and swelling of the skin, blistering of the skin, mouth, eyes and genitals, and fever. Skin rash with red or pink patches, especially on the palms of the hands or soles of the feet, where blisters may form
weakness, tenderness, pain or muscle breakdown, or red-brown colouration of the urine. In particular, if you also feel unwell or have a high fever, this could be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve 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 bleeding or unexpected or unusual bruising, these may indicate a liver disorder. Consult your doctor as soon as possible.
lupus-like syndrome (including skin rash, joint disorders and effects on blood cells)

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

inflammation of the nasal passages, sore throat, nosebleeds
allergic reactions
increased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully), 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 dysfunction

Uncommon: 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 monitor your blood sugar levels carefully)
nightmares, insomnia
dizziness, numbness or tingling in the fingers and toes, reduced sensitivity to pain or touch, altered taste, memory loss
blurred vision
ringing in the ears and/or head
vomiting, belching, pain in the upper and lower abdomen, pancreatitis (inflammation of the pancreas causing stomach pain)
hepatitis (inflammation of the liver)
rash, itchy rash, urticaria, hair loss
neck pain, muscle fatigue
fatigue, malaise, weakness, chest pain, swelling, especially of the ankles (oedema), increased body temperature
urine tests positive for white blood cells

Rare: may affect up to 1 in 1,000 people

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

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

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

Not known: frequency cannot be estimated from the available data

persistent muscle weakness
myasthenia gravis (a condition causing generalized muscle weakness, including in some cases the muscles used for breathing)
ocular myasthenia (a condition causing weakness of the eye muscles)

Contact your doctor if you experience weakness in your arms or legs that worsens with 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
respiratory problems, including persistent cough and/or shortness of breath or fever
diabetes. The risk of developing diabetes is higher if you have high levels of sugars and fats in your blood, are overweight, or have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address
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 stated on the blister, the box, and 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 medicines via wastewater 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 Atorvastatin Teva contains

The active substance 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 components are: Tablet core: microcrystalline cellulose (E460), calcium carbonate (E170), maltose, croscarmellose sodium (E466), polysorbate 80 (E433), 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 Atorvastatin Teva and contents of the pack
Atorvastatin Teva 10 mg consists of white to off-white, film-coated, elliptical, biconvex tablets, with "10" engraved on one side and smooth on the other side. Size: approximately 8 mm x 4 mm.
Atorvastatin Teva 20 mg consists of white to off-white, film-coated, elliptical, biconvex tablets, with "20" engraved on one side and a score line on the other side. Size: approximately 10 mm x 6 mm.
Atorvastatin Teva 40 mg consists of white to off-white, film-coated, elliptical, biconvex tablets, with "40" engraved on one side and a score line on the other side. Size: approximately 13 mm x 7 mm.
Atorvastatin Teva 80 mg consists of white to off-white, film-coated, elliptical, biconvex tablets, with "80" engraved on one side and a score line on the other side. Size: approximately 16 mm x 9 mm.
Atorvastatin Teva 10 mg is available in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 105 tablets, in divisible unit-dose blisters of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1 or 105x1 tablets, and in bottles containing 28, 30, 50, 90, 100, 250 or 500 tablets.
Atorvastatin Teva 20 mg is available in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 105 tablets, in divisible unit-dose blisters of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1 or 105x1 tablets, and in bottles containing 28, 30, 50, 90, 100, 250, 500 or 1,000 tablets.
Atorvastatin Teva 40 mg is available in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 105 tablets, in divisible unit-dose blisters of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1 or 105x1 tablets, and in bottles containing 28, 30, 50, 90, 100, 250 or 500 tablets.
Atorvastatin Teva 80 mg is available in blisters of 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 105 tablets, in divisible unit-dose blisters of 10x1, 14x1, 15x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 98x1, 100x1 or 105x1 tablets, and in bottles containing 28, 30, 50, 90, 100 or 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Manufacturer
Teva Pharma, S.L.U.
C/C, n.4, Poligono Industrial Malpica, 50016 Zaragoza (Spain)
Teva Operations Poland Sp. z o.o.
Ul. Mogilska 80, 31-546 Kraków (Poland)