Atorvastatin Teva B.v.

Leaflet attached to the packaging: Information for the user

Atorvox, 10 mg, film-coated tablets

Atorvox, 20 mg, film-coated tablets

Atorvox, 40 mg, film-coated tablets

Atorvastatin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Atorvox and what is it used for
• 2. Important information before taking Atorvox
• 3. How to take Atorvox
• 4. Possible side effects
• 5. How to store Atorvox
• 6. Contents of the pack and other information

1. What is Atorvox and what is it used for

Atorvox belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
Atorvox is used to reduce the levels of lipids known as cholesterol and triglycerides in the blood, when a low-fat diet and lifestyle changes are not effective. Atorvox can also be used to reduce the risk of heart disease, even if cholesterol levels are normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking Atorvox

When not to take Atorvox

• if the patient is allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6),
• if the patient has or has had liver disease,
• if the patient has unexplained, abnormal liver function test results,
• in women of childbearing age who do not use effective methods of contraception,
• in pregnant or breastfeeding women,
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting treatment with Atorvox, the patient should discuss the following with their doctor or pharmacist:

• if the patient has severe respiratory failure,
• if the patient is taking or has taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Taking fusidic acid with Atorvox can lead to serious muscle problems (rhabdomyolysis),

and other conditions that may affect the patient's health.

• in case of a stroke with bleeding into the brain, or if there is a small amount of fluid in the brain from a previous stroke,
• in case of kidney problems,
• in case of hypothyroidism,
• in case of recurring or unexplained muscle pain, or muscle problems in the past, or similar problems in relatives,
• in case of muscle problems during previous treatment with other lipid-lowering medicines (e.g., other statins or fibrates),
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4),
• in case of regular consumption of large amounts of alcohol,
• in case of a history of liver disease,
• in patients over 70 years of age.

In patients with any of the above conditions, the doctor will order a blood test before starting treatment with Atorvox and, if possible, during treatment to monitor the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, is higher when certain medicines are taken at the same time (see section 2 "Atorvox and other medicines").
The doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
During treatment with Atorvox, the doctor will closely monitor the patient for the development of diabetes or the risk of diabetes. Patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

Atorvox and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Some medicines can change the effect of Atorvox or be affected by Atorvox. This type of interaction can lead to reduced efficacy of one or both medicines or increase the risk of serious side effects, including muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressants, such as cyclosporine,
• certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-lowering medicines, such as gemfibrozil, other fibrates, colestyramine,
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem, as well as medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus disease,
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with Atorvox, including ezetimibe

(which lowers cholesterol), warfarin (which reduces blood clotting),
oral contraceptives, stiripentol (an antiepileptic medicine used to treat epilepsy), cimetidine (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (a medicine used to treat gout) and antacids (medicines used for indigestion, containing aluminum or magnesium),

• over-the-counter medicines: St. John's Wort,
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).

Atorvox with food and drink

Information on the use of Atorvox can be found in section 3. However, the following information should be noted:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can change the effect of Atorvox.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
See section 2 "Warnings and precautions" for more information.

Pregnancy and breastfeeding

DO NOT take Atorvox if you are pregnant or plan to become pregnant.
DO NOT take Atorvox if you are of childbearing age and do not use effective methods of contraception.
DO NOT take Atorvox while breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
The safety of Atorvox during pregnancy and breastfeeding has not been established.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Atorvox usually does not affect the ability to drive or use machines. However, do not drive or use machines if the medicine affects your ability to do so.

Atorvox contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Atorvox

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Before starting treatment, your doctor will recommend a low-cholesterol diet, which should be continued during treatment with Atorvox.
The usual starting dose of Atorvox for adults and children over 10 years of age is 10 mg once daily. This dose may be increased by your doctor if necessary, up to a dose suitable for you. Your doctor will adjust the dose of Atorvox at intervals of at least 4 weeks. The maximum dose of Atorvox is 80 mg once daily.
Swallow the tablets whole with water; they can be taken at any time of day, with or without food. However, try to take the tablet at the same time each day.
Atorvox, 20 mg, 40 mg
The tablet can be divided into equal doses.

The duration of treatment with Atorvox is determined by your doctor.

If you feel that the effect of Atorvox is too strong or too weak, consult your doctor.

Taking more than the recommended dose of Atorvox

If you have accidentally taken too many Atorvox tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

Missing a dose of Atorvox

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

Stopping treatment with Atorvox

If you have any further questions about taking this medicine or are considering stopping it, consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects or symptoms, stop taking Atorvox and contact your doctor or go to the emergency department of your nearest hospital immediately.

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

• severe allergic reaction causing swelling of the face, tongue, and throat, which can lead to severe breathing difficulties.
• severe skin disease characterized by peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms or soles, with possible blisters.
• muscle weakness, tenderness, or pain, or muscle rupture, or brownish discoloration of the urine. If this is accompanied by malaise or high fever, it may be due to muscle breakdown (rhabdomyolysis). Muscle breakdown does not always resolve, even if the patient stops taking atorvastatin, and can be life-threatening and cause kidney problems.

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

• if the patient experiences unexpected or unusual bleeding or bruising, this may indicate liver problems. Consult a doctor as soon as possible.
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Atorvox

Common: may affect up to 1 in 10 people

• nasal congestion, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored), increased blood creatine kinase levels
• headaches
• nausea, constipation, bloating, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results indicating abnormal liver function

Uncommon: may affect up to 1 in 100 people

• loss of appetite, weight gain, decreased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers and toes, decreased sensitivity to pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)
• hepatitis
• skin rash, itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated temperature
• presence of white blood cells in the urine

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

• vision disorders
• unexpected bleeding or bruising (bruises)
• jaundice (yellowing of the skin and eyes)
• tendon rupture
• skin rash, which may occur on the skin or ulcers in the mouth (drug-induced lichenoid reaction)
• purple skin discolorations (symptoms of vasculitis, inflammation of blood vessels)

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

• allergic reactions - 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
• gynecomastia (excessive breast tissue growth in men)

Frequency not known: cannot be estimated from the available data

• persistent muscle weakness
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
• ocular myasthenia (a disease that causes weakness of the eye muscles)

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

• sexual disorders
• depression
• breathing problems, including persistent cough and/or shortness of breath or fever
• diabetes; the risk of developing this disease is higher in patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure. During treatment with this medicine, the doctor will perform the necessary tests on the patient.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Atorvox

Keep the medicine out of the sight and reach of children.
Do not use Atorvox after the expiry date stated on the blister, carton, or bottle after "EXP:" or "Expiry date (EXP):". The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6.

Contents of the pack and other information

What Atorvox contains

• The active substance of Atorvox 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).
• The other ingredients are: Tablet core: microcrystalline cellulose (E 460), calcium carbonate (E 170), maltose, sodium croscarmellose (E 466), polysorbate 80 (E 433), magnesium aluminum silicate and magnesium stearate (E 470b) Tablet coating: hypromellose (E 464), hydroxypropylcellulose (E 463), triethyl citrate (E 1505), polysorbate 80 (E 433), and titanium dioxide (E 171).

What Atorvox looks like and contents of the pack

Atorvox, 10 mg, are white or almost white, elliptical, biconvex film-coated tablets with "10" engraved on one side and smooth on the other side. Dimensions: approximately 8 mm x 4 mm.
Atorvox, 20 mg, are white or almost white, elliptical, biconvex film-coated tablets with "20" engraved on one side and a score line on the other side. Dimensions: approximately 10 mm x 6 mm.
Atorvox, 40 mg, are white or almost white, elliptical, biconvex film-coated tablets with "40" engraved on one side and a score line on the other side. Dimensions: approximately 13 mm x 7 mm.
Atorvox, 10 mg, is available in blisters of 30 tablets.
Atorvox, 20 mg, is available in blisters of 30 tablets.
Atorvox, 40 mg, is available in blisters of 30 tablets.

Marketing authorization holder

Teva B.V.
Swensweg 5,
2031 GA Haarlem
Netherlands

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Teva Pharma, S.L.U.
C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza
Spain
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw
phone: (22) 345 93 00

Date of last revision of the leaflet: May 2025