Atorvox

Package leaflet: Information for the user

Atorvox, 10 mg, coated tablets
Atorvox, 20 mg, coated tablets
Atorvox, 40 mg, coated tablets
Atorvastatinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Atorvox is and what it is 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 Atorvox is and what it is used for
Atorvox belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Atorvox is used to reduce blood levels of lipids known as cholesterol and triglycerides when a low-fat diet and lifestyle changes alone are not effective. Atorvox may also be used to reduce the risk of heart disease, even when cholesterol levels are within the normal range. A cholesterol-lowering diet should be maintained during treatment.

2. Important information before taking 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 previously had liver disease,
• if you have unexplained abnormal liver function test results,
• in women of childbearing potential who are not using effective contraception,
• in pregnant women or women planning to become pregnant,
• in breastfeeding women,
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions
Before starting Atorvox, discuss with your doctor or pharmacist if:

• you have severe respiratory failure,
• you are taking or have taken fusidic acid orally or by injection within the last 7 days (a medicine used to treat bacterial infections). Concomitant use of fusidic acid with Atorvox may lead to serious muscle problems (rhabdomyolysis),
• you have had a stroke with bleeding into the brain, or if there is a small amount of fluid in the brain from a previous stroke,
• you have kidney problems,
• you have hypothyroidism,
• you have a history of recurrent or unexplained muscle pain or muscle problems, or if such problems occurred in your family,
• you previously experienced muscle problems while taking other lipid-lowering medicines (e.g. other statins or fibrates),
• you have or have had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may sometimes worsen symptoms or trigger myasthenia (see section 4),
• you regularly consume large amounts of alcohol,
• you have a history of liver disease,
• you are aged 70 years or older.

If any of the above apply, your doctor may order blood tests before starting Atorvox and periodically during treatment to monitor for potential muscle-related side effects. The risk of muscle-related side effects, such as rhabdomyolysis, is known to increase when certain medicines are taken concomitantly (see section 2, "Atorvox with other medicines").
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and treatments may be required to diagnose and manage this condition.
While taking Atorvox, your doctor will closely monitor you for the development of diabetes or risk of diabetes. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at increased risk of developing diabetes.

Atorvox with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Some medicines may affect the action of Atorvox, or the effect of other medicines may be altered by Atorvox. Such interactions may reduce the effectiveness of one or both medicines and may increase the risk of serious side effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• Immunosuppressive medicines, e.g. cyclosporine,
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• Other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, cholestyramine,
• Certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem, and medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone,
• Letermovir, a medicine used to prevent cytomegalovirus infection,
• Medicines used to treat HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• Certain medicines used to treat hepatitis C virus infection, e.g. telaprevir, boceprevir, and combination products 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 used to treat epilepsy), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (used for indigestion, containing aluminium or magnesium),
• Over-the-counter medicines: St. John's wort (Hypericum perforatum),
• If you need to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking Atorvox. Your doctor will advise when it is safe to restart Atorvox. Taking Atorvox with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis is in section 4,
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).

Atorvox with food and drink
Information on how to take Atorvox is in section 3. However, please note the following:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger quantities may affect the action of Atorvox.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
For further information, see section 2, "Warnings and precautions".

Pregnancy and breastfeeding
DO NOT take Atorvox if you are pregnant or planning to become pregnant.
DO NOT take Atorvox if you are of childbearing age unless you are using effective contraception.
DO NOT take Atorvox while breastfeeding.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
The safety of Atorvox during pregnancy and breastfeeding has not been established.
Always consult your doctor or pharmacist before taking any medicine.

Driving and operating machinery
Atorvox usually does not affect the ability to drive or operate machinery. However, you should not drive if this medicine affects your ability to do so. Do not use tools or machines if taking this medicine affects your ability to operate them.

Atorvox contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Atorvox

Always take this medicine exactly as prescribed by your doctor. If you are unsure, 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 in adults and children aged 10 years and older is 10 mg once daily. Your doctor may increase this dose as needed to achieve the appropriate dose for you. Your doctor will adjust the dose at intervals of at least 4 weeks. The maximum dose of Atorvox is 80 mg once daily.
Swallow Atorvox tablets whole with water. They may be taken at any time of day, with or without food. However, it is advisable to take the tablet at approximately the same time each day.
Atorvox 20 mg, 40 mg
The tablet may be divided into equal doses.
The duration of treatment with Atorvox is determined by your doctor.
If you feel the effect of Atorvox is too strong or too weak, consult your doctor.

Taking more Atorvox than prescribed
If you accidentally take more tablets than the recommended daily dose, contact your doctor or nearest hospital for advice immediately.

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 missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the serious adverse reactions or symptoms listed below,
they should stop taking the medicine immediately and contact their doctor or go to the emergency department
at the nearest hospital.

Rare: may occur in no more than 1 in 1,000 people

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe breathing difficulties.
• Serious illness characterized by skin peeling and swelling, skin blisters, sores in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly with blisters.
• Muscle weakness, tenderness, muscle pain, or muscle rupture, or red-brown discoloration of urine. If accompanied by malaise or high fever, this may indicate rhabdomyolysis (breakdown of striated muscle). Rhabdomyolysis may not resolve even after discontinuation of atorvastatin, may be life-threatening, and may lead to kidney problems.

Very rare: may occur in no more than 1 in 10,000 people

• Unexpected or unusual bleeding or bruising, which may indicate liver abnormalities. Medical advice should be sought immediately.
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).

Other possible adverse reactions of Atorvox
Common: may occur in no more than 1 in 10 people

• Nasopharyngitis, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be closely monitored), increased blood creatine kinase levels
• Headaches
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain, and back pain
• Blood test results indicating abnormal liver function

Uncommon: may occur in no more than 1 in 100 people

• Anorexia (loss of appetite), weight gain, decreased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be closely monitored)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers and toes, reduced sensitivity to pain and touch, altered taste, memory loss
• Blurred vision
• Tinnitus and/or headache
• Vomiting, belching, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, skin eruptions and itching, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling (especially of the ankles), elevated body temperature
• Presence of white blood cells in urine analysis

Rare: may occur in no more than 1 in 1,000 people

• Visual disturbances
• Unexpected bleeding or bruising (bruises)
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon rupture
• Skin rash or oral ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis, inflammation of blood vessels)

Very rare: may occur in no more than 1 in 10,000 people

• Allergic reactions – symptoms may include sudden shortness of breath and chest pain or tightness, eyelid, facial, lip, oral, tongue or throat swelling, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive growth of glandular breast tissue in males)

Frequency not known: cannot be estimated based on available data

• Persistent muscle weakness
• Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)

Patients should speak to their doctor if they experience weakness in the arms or legs, worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Adverse reactions reported during treatment 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 likelihood of developing diabetes is higher in patients with high levels of blood sugar and fats, overweight patients, and those with high blood pressure. During treatment with this medicine, the doctor will perform appropriate tests.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, patients should inform their doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity or representative of the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Atorvox

Keep this medicine out of sight and reach of children.
Do not use Atorvox after the expiry date which is stated on the blister, carton, or bottle after "EXP:" or "Expiry date (EXP):". The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the packaging and other information

What Atorvox contains

• The active substance is atorvastatin. Each coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium salt). Each coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium salt). Each coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium salt).
• Other ingredients are:
  Tablet core: microcrystalline cellulose (E 460), calcium carbonate (E 170), maltose, sodium croscarmellose (E 466), polysorbate 80 (E 433), aluminum magnesium metasilicate, and magnesium stearate (E 470b).
  Tablet coating: hypromellose (E 464), hydroxypropyl cellulose (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" debossed on one side and smooth on the other. Dimensions: approximately 8 mm x 4 mm.
Atorvox 20 mg are white or almost white, elliptical, biconvex, film-coated tablets with "20" debossed on one side and a breakline on the other. Dimensions: approximately 10 mm x 6 mm.
Atorvox 40 mg are white or almost white, elliptical, biconvex, film-coated tablets with "40" debossed on one side and a breakline on the other. 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
The Netherlands

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

For further information, please contact the local representative of the Marketing Authorization Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, Poland
Tel.: (22) 345 93 00