Atorvox

PATIENT INFORMATION LEAFLET: USER INFORMATION

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Atorvox (Atorvastatin Teva), 40 mg, film-coated tablets

Atorvastatinum
Atorvox and Atorvastatin Teva are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Atorvox and what is it used for
• 2. Important information before using Atorvox
• 3. How to use 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, such as cholesterol and triglycerides, in the blood when a low-fat diet and lifestyle changes are not effective. Atorvox may 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 using Atorvox

When not to use Atorvox

• in women of childbearing age who do not use effective methods of contraception,
• in pregnant or breastfeeding women.

Warnings and precautions

The following are reasons why Atorvox may not be suitable for the patient

• 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),
• 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 creatine kinase activity in the blood, which persists despite discontinuation of statin treatment.

Consult a doctor or pharmacist before using Atorvox:

• in case of severe respiratory failure.

In patients who experience any of the above situations, the doctor will order a blood test before starting treatment with Atorvox and, if possible, 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 used at the same time (see section 2 "Atorvox and other medicines").

Atorvox and other medicines

Some medicines may change the effect of Atorvox, or the effect of these medicines on the body may be changed by Atorvox. This type of interaction can lead to reduced efficacy of one or both medicines. At the same time, it can increase the risk of serious side effects, including severe muscle damage known as rhabdomyolysis:

• medicines that modify the immune system, such as cyclosporine,
• certain antibiotics and antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.

Atorvastatin should not be taken at the same time as systemic fusidic acid or within 7 days of stopping fusidic acid treatment. In patients for whom systemic fusidic acid is considered necessary, statin treatment should be discontinued during fusidic acid treatment. There have been reports of rhabdomyolysis (including some cases that were fatal) in patients treated with fusidic acid in combination with statins. If symptoms such as weakness, pain, or tenderness of the muscles occur, the patient should immediately consult a doctor.
Statin treatment can be resumed 7 days after the last dose of fusidic acid.
In exceptional circumstances, when long-term systemic fusidic acid treatment is necessary, e.g., for the treatment of severe infections, the need for concomitant use of atorvastatin and fusidic acid can only be considered after a detailed analysis of the individual case and under close medical supervision.

• other lipid-lowering medicines, such as gemfibrozil, other fibrates, colestyramine,
• certain calcium channel blockers used in angina or high blood pressure, such as amlodipine, diltiazem; as well as medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone,
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.,
• certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir;
• 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), and medicines

that neutralize stomach acid (medicines used for indigestion, containing aluminum or magnesium),

• over-the-counter medicines: St. John's Wort. You should tell your doctor about all medicines you have taken recently, including those that are available without a prescription.

Atorvox with food and drink

Information on the use of Atorvox can be found in section 3. However, you should pay attention to the following information:
Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may change the effect of Atorvox.
Alcohol
You should avoid drinking excessive amounts of alcohol while taking Atorvox.
For more information, see section 2.

Pregnancy and breastfeeding

The use of Atorvox by women who are pregnant or plan to become pregnant is contraindicated.
The use of Atorvox by women of childbearing age is contraindicated if they do not use effective methods of contraception.
The use of Atorvox during breastfeeding is contraindicated.
The safety of Atorvox during pregnancy and breastfeeding has not been established.
Before using any medicine, you should consult a doctor or pharmacist.

Driving and using machines

Normally, the medicine does not affect the ability to drive or use machines. However, you should not drive if the medicine affects your ability to drive. You should not use any tools or machines if the use of the medicine affects your ability to use them.

The medicine contains sodium

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

3. How to use Atorvox

Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvox.
The usual dose of Atorvox is 10 mg per day. This dose may be increased by the doctor if necessary, up to a dose suitable for the patient. The doctor will adjust the dose of Atorvox at intervals of 4 weeks or more. The maximum dose of Atorvox is 80 mg once a day.
Atorvox tablets should be swallowed whole, with a glass of water; they can be taken at any time of day, with or without food. However, you should try to take the tablet at the same time every day.
Atorvox should always be used as directed by the doctor. In case of doubts, you should consult the doctor or pharmacist again.

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

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

Using more than the recommended dose of Atorvox

In case of accidental ingestion of too many Atorvox tablets (more than the typical daily dose), you should consult a doctor or the nearest hospital for advice.

Missing a dose of Atorvox

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

Stopping treatment with Atorvox

In case of doubts about the use of the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the serious side effects or symptoms, they should stop using the medicine and immediately consult a doctor or go to the emergency department of the nearest hospital.

Rare: occurs in 1 to 10,000 patients:

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can cause severe breathing difficulties.
• Severe disease characterized by peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Rash with pink-red spots, especially on the palms or soles, with possible blisters.
• Weakness, tenderness, muscle pain, or reddish-brown urine. If there is also a feeling of illness or high fever, it may be caused by a life-threatening disease that causes kidney problems - muscle breakdown.

Very rare: occurs in less than 1 in 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, it may indicate liver problems. The patient should consult a doctor as soon as possible.

Other possible side effects of Atorvox:

Common side effects (occurring in 1 to 10 patients per 100):

• nasal congestion, 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, bloating, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results indicating abnormal liver function

Uncommon side effects (occurring in 1 to 10 patients per 1,000):

• 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 of the fingers and toes, decreased sensitivity to pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears or head
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)

Rare side effects (occurring in 1 to 10 patients per 10,000):

• vision disorders
• unexpected bleeding or bruising (bruises)
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon rupture,

Very rare side effects (occurring in less than 1 in 10,000 patients):

• 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 growth of breast tissue in men and women)

Other 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

Frequency not known

• immunomediated necrotizing myopathy characterized by persistent muscle weakness

If any of the side effects worsen or if you experience any side effects not listed in the leaflet, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Atorvox

Store in a place out of sight and reach of children.
Store at a temperature 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 given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Atorvox contains

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

What Atorvox looks like and what the pack contains

White or almost white, elliptical, biconvex, and smooth film-coated tablets. The dimensions of each tablet are approximately 15.6 mm x 8.3 mm.
The pack contains 28 film-coated tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Ireland, the country of export:

Teva Pharma B.V.
Swensweg 5
2031GA Haarlem
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
Merckle GmbH
Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem, Netherlands

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Ireland export license number: PA 749/110/3

Parallel import license number: 150/22 Date of approval of the leaflet: 05.04.2022

[Information about the trademark]