Atorvox

Warning! Keep the package leaflet. Information on the immediate packaging is in a foreign language.
Atorvox (Atorvastatin Teva), 40 mg, coated tablets
Atorvastatinum
Atorvox and Atorvastatin Teva are different trade names for the same medicine.
Please read the leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms of illness are the same.
• If any adverse effects occur in the patient, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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 lower 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 normal. A standard low-cholesterol diet should be continued during treatment.

2. Important information before using Atorvox

When not to use Atorvox

• if the patient has hypersensitivity (allergy) to Atorvox or to any other similar medicine used to lower blood lipid levels, or to any of the other ingredients of the medicine – detailed information is provided in section 6,
• if the patient currently has or has previously had liver disease,
• if the patient has unexplained abnormal liver function test results,
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection,
• in women of childbearing age who are not using effective contraception methods,
• in pregnant women or women planning to become pregnant,
• in breastfeeding women.

Warnings and precautions
The following are reasons why Atorvox may not be suitable for the patient:

• in case of hemorrhagic stroke, 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 recurrent or unexplained muscle pain or muscle problems in the past, or similar problems in family members,
• in case of muscle problems during previous treatment with other lipid-lowering medicines (e.g. other statins or fibrates),
• in case of regular consumption of large amounts of alcohol,
• in case of liver disease,
• in patients over 70 years of age,
• in case of persistent muscle weakness and elevated serum creatine kinase activity, which persists despite discontinuation of statin therapy.

Consult your doctor or pharmacist before using Atorvox:

• in case of severe respiratory insufficiency.

In patients with any of the above conditions, the doctor may order a blood test before starting treatment with Atorvox and, whenever possible, during treatment, to monitor the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, is increased when certain medicines are taken concomitantly (see section 2 "Atorvox and other medicines").

Atorvox and other medicines
Some medicines may alter the effect of Atorvox, or the effect of those medicines on the body may be altered by Atorvox. This type of interaction may reduce the effectiveness of one or both medicines. It may also increase the risk of serious adverse effects, including severe muscle damage known as rhabdomyolysis:

• immunosuppressive medicines, e.g. cyclosporine,
• certain antibiotics and antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.

Atorvastatin must not be co-administered with medicinal products containing fusidic acid administered systemically, or within 7 days after discontinuation of fusidic acid treatment. In patients for whom systemic fusidic acid administration is considered necessary, statin therapy should be discontinued throughout the duration of fusidic acid treatment. Cases of rhabdomyolysis (including some fatal cases) have been reported in patients treated with fusidic acid in combination with statins. If any symptoms such as muscle weakness, pain or tenderness occur, the patient should seek medical advice immediately.

Statin treatment may be resumed 7 days after the last dose of fusidic acid.

In exceptional circumstances, when prolonged systemic fusidic acid therapy is required, e.g. for the treatment of severe infections, the need for concomitant use of atorvastatin and fusidic acid may be considered only after a detailed individual assessment and under strict medical supervision.

• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, cholestyramine,
• certain calcium channel blockers used for angina or hypertension, e.g. amlodipine, diltiazem; and medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone,
• medicines used to treat HIV infection, e.g.: ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.,
• certain medicines used to treat hepatitis C virus infection, e.g. telaprevir, boceprevir, and the fixed-dose combination containing elbasvir with grazoprevir;
• other medicines known to interact with Atorvox include ezetimibe (which lowers cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (used to treat heartburn and stomach ulcers), phenazone (an analgesic), and antacids (medicines used for indigestion, containing aluminium or magnesium),
• over-the-counter medicines: St. John's wort. Inform your doctor about all medicines you are currently taking, including those available without a prescription.

Atorvox with food and drink
Information on the use of Atorvox is provided in section 3. However, please pay attention to the following:

Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effect of Atorvox.

Alcohol
Avoid excessive alcohol consumption while taking this medicine.
For further details, see section 2.

Pregnancy and breastfeeding
The use of Atorvox in women who are pregnant or planning to become pregnant is contraindicated.
The use of Atorvox in women of childbearing age is contraindicated if they are not using effective contraception methods.
The use of Atorvox during breastfeeding is contraindicated.
The safety of Atorvox during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult your doctor or pharmacist.

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

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

3. How to use Atorvox

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvox.
The usual dose of Atorvox is 10 mg once daily. If necessary, your doctor may increase this dose up to the dose appropriate for the patient. Your doctor will adjust the dose at intervals of 4 weeks or longer. The maximum dose of Atorvox is 80 mg once daily.
Atorvox tablets should be swallowed whole with water; they may be taken at any time of day, with or without food. However, you should try to take the tablet at the same time each day.
Atorvox should always be taken exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist again.
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, you should consult your doctor.
Taking more Atorvox than prescribed
If you accidentally take 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 Atorvox
If you have any doubts about taking Atorvox, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Atorvox can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the serious adverse reactions or symptoms listed below, treatment should be discontinued immediately and the patient should contact a doctor or go to the emergency department of the nearest hospital without delay.
Rare: occurs in 1 out of 10,000 patients:

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe breathing difficulties.
• Severe illness characterized by skin peeling and swelling, skin blisters, blisters in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on palms or soles, possibly with blisters.
• Muscle weakness, tenderness, pain, or red-brown discoloration of urine. If accompanied by malaise or high fever, this may indicate a life-threatening condition causing kidney problems – rhabdomyolysis.

Very rare: occurs in less than 1 out of 10,000 patients:

• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells)
• If the patient experiences unexpected or unusual bleeding or bruising, this may indicate liver abnormalities. Medical advice should be sought as soon as possible.

Other possible adverse reactions of Atorvox:
Common adverse reactions (occurring in 1 to 10 patients out of 100):

• Nasopharyngitis, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be carefully 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 adverse reactions (occurring in 1 to 10 patients out of 1,000):

• Anorexia (loss of appetite), weight gain, decreased blood glucose levels (in diabetic patients, blood glucose levels should continue to be carefully monitored)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers and toes, reduced sensitivity to pain and touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears or head
• Vomiting, belching, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, skin rash 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 adverse reactions (occurring in 1 to 10 patients out of 10,000):

• Visual disturbances
• Unexplained bleeding or bruising (bruises)
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon rupture

Very rare adverse reactions (occurring in 1 out of 10,000 patients):

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

Other possible 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

Frequency not known:

• Immune-mediated necrotizing myopathy, manifesting, among others, as persistent muscle weakness

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

5. How to store Atorvox

Keep the medicine out of sight and reach of children.
Store below 30°C.
Do not use Atorvox after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Atorvox contains

• The active substance is atorvastatin (in the form of atorvastatin calcium) in a quantity of 40 mg. The other ingredients are: core: microcrystalline cellulose, sodium carbonate, maltose, sodium croscarmellose, magnesium stearate; coating: hypromellose (E 464), hydroxypropylcellulose, triethyl citrate, polysorbate 80, titanium dioxide (E 171).

What Atorvox looks like and contents of the pack
White or almost white, elliptical, biconvex, smooth coated tablets. Each tablet measures approximately 15.6 mm x 8.3 mm.
The pack contains 28 coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Ireland, the country of export:
Teva Pharma B.V.
Swensweg 5
2031GA 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
Merckle GmbH
Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem, The Netherlands
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Irish licence number in the country of export: PA 749/110/3
Parallel import licence number: 150/22