Atorvastatin Teva B.v.

Package Leaflet: Information for the User

Atorvox, 10 mg, film-coated tablets

Atorvox, 20 mg, film-coated tablets

Atorvox, 40 mg, film-coated tablets

Atorvastatin

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Atorvox is and what it is used for
• 2. What you need to know before you take 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 Atorvox is and what it is used for

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

2. What you need to know before you take Atorvox

When not to take Atorvox

• if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6),
• if you have or have had liver disease,
• if you have had unexplained abnormal liver function tests,
• in women of childbearing age who are not using reliable contraception,
• in pregnant or breast-feeding women,
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before taking Atorvox, tell your doctor or pharmacist:

• if you have severe respiratory failure,
• if you are taking or have taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Taking fusidic acid and Atorvox at the same time may lead to serious muscle problems (rhabdomyolysis),

if you have had a stroke with bleeding in the brain, or if there is a small amount of fluid in the brain from a previous stroke,

• if you have kidney problems,
• if you have hypothyroidism,
• if you have had repeated or unexplained muscle pain, muscle weakness, or muscle disease in the past, or similar problems in family members,
• if you have had muscle problems during previous treatment with other lipid-lowering medicines (e.g., other statins or fibrates),
• if you have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes worsen symptoms or cause myasthenia (see section 4),
• if you regularly drink large amounts of alcohol,
• if you have had liver disease in the past,
• if you are over 70 years old.

In patients with any of the above conditions, your doctor will order a blood test before starting treatment with Atorvox and possibly during treatment to monitor the risk of side effects related to the muscles. It is known that the risk of side effects related to the muscles, such as rhabdomyolysis, is higher when certain medicines are taken at the same time (see section 2 "Atorvox with other medicines").
Your 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, your doctor will closely monitor you for the development of diabetes or the risk of developing 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 with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect the way Atorvox works or may 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 severe muscle damage known as rhabdomyolysis, described in section 4:

• Immunosuppressants, such as cyclosporine,
• Certain antibiotics or antifungals, 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 heart rhythm regulators, 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 include 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,
• If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking Atorvox. Your doctor will tell you when you can safely restart Atorvox. Taking Atorvox with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• 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, pay attention to the following information:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may affect the action of Atorvox.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
See section 2 "Warnings and precautions" for more information.

Pregnancy and breast-feeding

DO NOT take Atorvox if you are pregnant or plan to become pregnant.
DO NOT take Atorvox if you are of childbearing age and not using reliable contraception.
DO NOT take Atorvox while breast-feeding.
If you are pregnant or breast-feeding, 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 breast-feeding has not been established.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Atorvox is not expected to affect your ability to drive or use machines. However, do not drive if this medicine affects your ability to drive. Do not use any tools or machines if taking Atorvox affects your ability to use them.

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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Before starting treatment with Atorvox, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvox.
The usual starting dose of Atorvox for adults and children over 10 years old is 10 mg once daily. This dose may be increased if necessary by your doctor, 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.
Atorvox tablets should be swallowed whole with water and can be taken at any time of day, with or without food. However, try to take your 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, talk to your doctor.

If you take more Atorvox than you should

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

If you forget to take 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 forgotten dose.

If you stop taking Atorvox

If you have any further questions on the use of this product, ask 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, stop taking Atorvox and contact your doctor immediately or go to the emergency department at your nearest hospital.

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

• severe allergic reaction causing swelling of the face, tongue, and throat, which may cause difficulty breathing.
• severe disease characterized by skin peeling, swelling, blisters, mouth, eye, genital, 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 reddish-brown urine. If you also feel unwell or have a high fever, this may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown does not always go away, even if you stop taking atorvastatin, and it can be life-threatening and cause kidney problems.

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

• if you experience unexpected or unusual bleeding or bruising, this may indicate liver problems. You should consult your 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 inflammation, 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 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, upper and lower abdominal pain, pancreatitis (causing abdominal pain)
• hepatitis
• skin rash, skin 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 urine tests

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 mouth ulcers (drug-induced lichenoid reaction)
• purple skin changes (symptoms of vasculitis, vasculitis)

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 muscle weakness in the eyes)

Talk to your doctor if you experience muscle weakness in your hands or feet, 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, your doctor will perform the necessary tests.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.
In Poland, you can report side effects to:
Department for Monitoring of Adverse Reactions to Medicinal Products,
Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych,
Al. Jerozolimskie 181C,
02-222 Warszawa,
Tel: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder or its representative.

5. How to store Atorvox

Keep this 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 stated.
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.

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 aluminometasilicate, 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
For more information, contact your local representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa,
tel.: (22) 345 93 00

Date of last revision of the leaflet: May 2025