Atoris

Package Leaflet: Information for the User

Atoris, 30 mg, Film-Coated Tablets

Atoris, 60 mg, Film-Coated Tablets

Atoris, 80 mg, Film-Coated Tablets

Atorvastatin
Absolute Contraindication in Pregnancy

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, as You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed to a Specific Person. Do Not Pass it on to Others. The Medication may Harm Another Person, even if their Symptoms are the Same.
• If the Patient Experiences any Undesirable Effects, including those not Mentioned in this Package Leaflet, they Should Inform their Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Atoris and what is it Used for
• 2. Important Information Before Taking Atoris
• 3. How to Take Atoris
• 4. Possible Undesirable Effects
• 5. How to Store Atoris
• 6. Package Contents and Other Information

1. What is Atoris and what is it Used for

Atoris belongs to a Group of Medications called Statins, which Regulate Lipid Levels (Fats).
Atoris is Used to Lower Lipid Levels (Cholesterol and Triglycerides) in the Blood when a Low-Fat Diet and Lifestyle Changes have not Produced the Desired Effects. In Patients with an Increased Risk of Heart Disease, Atoris may also be Used to Reduce this Risk, even if Cholesterol Levels are Normal. During Treatment with Atoris, a Cholesterol-Lowering Diet should be Continued.

2. Important Information Before Taking Atoris

When Not to Take Atoris

• if the Patient is Allergic to Atorvastatin or any other Similar Medication Used to Lower Lipid Levels in the Blood, or any of the other Ingredients of this Medication (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 are not Using Effective 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 Atoris, 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 Used to Treat Bacterial Infections) Orally or by Injection within the Last 7 Days. Concurrent Use of Fusidic Acid with Atoris may Lead to Serious Muscle Problems (Rhabdomyolysis),
• if the Patient has had a Stroke with Bleeding into the Brain or has had Small Fluid-Filled Cavities in the Brain after Previous Strokes,
• Kidney Problems,
• Hypothyroidism,
• Recurring or Unexplained Muscle Pain or Muscle Problems in the Past or Similar Problems in Relatives,
• Muscle Problems during Previous Treatment with other Lipid-Lowering Medications (e.g., other Statins or Fibrates),
• Regular Consumption of Large Amounts of Alcohol,
• History of Liver Disease,
• Patient Age over 70 Years,
• 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 may Sometimes Exacerbate Symptoms of the Disease or Lead to the Development of Myasthenia (see Section 4).

If any of the Above Situations Apply to the Patient, the Doctor will Prescribe a Blood Test before Starting Treatment with Atoris and as Necessary during Treatment to Detect the Risk of Undesirable Effects related to Muscles. The Risk of Undesirable Effects related to Muscles, such as Rhabdomyolysis, Increases when Certain Medications are Taken Concurrently (see Section 2 "Atoris and other Medications").
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 Atoris, the Doctor will Closely Monitor the Patient for the Development of Diabetes or the Risk of Developing Diabetes. Patients with High Blood Sugar and Fat Levels, Overweight Patients, and those with High Blood Pressure may be at Risk of Developing Diabetes.

Atoris and other Medications

Certain Medications may Change the Effect of Atoris or their Effect may be Changed by Atoris. This Type of Interaction may Reduce the Effectiveness of one or both Medications.
It may also Increase the Risk or Severity of Undesirable Effects, including Serious Muscle Damage called Rhabdomyolysis, described in Section 4:

• Medications that Affect the Immune System, such as Cyclosporine,
• Certain Antibiotics or Antifungal Medications, such as Erythromycin, Clarithromycin, Telithromycin, Ketokonazole, Itraconazole, Voriconazole, Fluconazole, Posakonazole, Rifampicin, Fusidic Acid,
• Other Lipid-Lowering Medications, such as Gemfibrozil, other Fibrates, Cholestyramine,
• Certain Calcium Channel Blockers Used to Treat Angina or High Blood Pressure, such as Amlodipine, Diltiazem; Medications that Regulate Heart Rhythm, such as Digoxin, Verapamil, Amiodarone,
• Letermovir, a Medication Used to Prevent Cytomegalovirus Disease,
• Medications Used to Treat HIV Infection, such as Ritonavir, Lopinavir, Atazanavir, Indinavir, Darunavir, Tipranavir in Combination with Ritonavir, etc.,
• Certain Medications Used to Treat Hepatitis C, such as Telaprevir, Boceprevir, and a Combination Medication containing Elbasvir with Grazoprevir, Ledipasvir with Sofosbuvir,
• Other Medications Known to Interact with Atoris, including Ezetimibe (which Lowers Cholesterol), Warfarin (which Reduces Blood Clotting), Oral Contraceptives, Stiripentol (an Antiepileptic Medication), Cimetidine (Used to Treat Heartburn and Ulcers), Phenazon (a Pain Reliever), Colchicine (Used to Treat Gout), and Antacids (Medications that Neutralize Stomach Acid, containing Aluminum or Magnesium),
• Over-the-Counter Medications: Medications containing St. John's Wort,
• Daptomycin (a Medication Used to Treat Complicated Skin and Soft Tissue Infections and Bacterial Infections in the Blood).

Atoris with Food, Drink, and Alcohol

Recommendations for Taking Atoris are Presented in Section 3.
Note:
Grapefruit Juice
Do Not Consume more than one or two Small Glasses of Grapefruit Juice per Day, as Large Amounts may Change the Effect of Atoris.
Alcohol
Avoid Excessive Alcohol Consumption while Taking Atoris. More Information can be Found in Section 2 "Warnings and Precautions".

Pregnancy and Breastfeeding

Do Not Take Atoris during Pregnancy or if Planning to Become Pregnant.
Taking Atoris is Contraindicated in Women of Childbearing Age who do not Use Effective Contraception.
Do Not Take Atoris while Breastfeeding. The Safety of Atoris during Breastfeeding has not been Established.
Consult a Doctor or Pharmacist before Taking this Medication.

Driving and Operating Machinery

Atoris Usually Does not Affect the Ability to Drive or Operate Machinery.
However, if Atoris Affects the Ability to Drive, Do Not Drive.
Do Not Use Tools or Machinery if the Ability to Operate them is Impaired by Atoris.

Atoris contains Lactose and Sodium

If the Patient has been Diagnosed with an Intolerance to some Sugars, they Should Consult their Doctor before Taking this Medication.
The Medication contains less than 1 mmol (23 mg) of Sodium per Dose, which means it is Considered "Sodium-Free".

3. How to Take Atoris

Before Starting Treatment with Atoris, the Doctor will Recommend a Low-Cholesterol Diet, which Should also be Followed during Treatment with Atoris.
The Usual Initial Dose in Adults and Children aged 10 Years or Older is 10 mg once Daily. If Necessary, the Doctor may Increase the Dose to the one that is Suitable for the Patient. The Doctor will Adjust the Dose every Four Weeks or Less Frequently. The Maximum Dose of Atoris in Adults is 80 mg once Daily, in Children 20 mg once Daily.
Tablets Should be Swallowed Whole with Water. Tablets can be Taken at any Time of Day, with or without Food. However, it is Recommended to Take the Tablets at the Same Time every Day.
This Medication Should always be Taken as Directed by the Doctor or Pharmacist. In Case of Doubts, Consult a Doctor or Pharmacist.

The Doctor Determines the Duration of Treatment with Atoris.

If the Patient Feels that the Effect of Atoris is too Strong or too Weak, they Should Consult their Doctor.

Taking a Higher than Recommended Dose of Atoris

In Case of Accidental Overdose (Taking more than the Recommended Daily Dose), Consult a Doctor or Go to the Nearest Hospital.

Missing a Dose of Atoris

If the Patient has Missed a Dose, they Should Take the Next Dose at the Normal Time.
Do Not Take a Double Dose to Make up for the Missed Dose.

Stopping Treatment with Atoris

In Case of Further Doubts about Taking this Medication, Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Atoris can Cause Undesirable Effects, although not everybody gets them.

If any of the Following Undesirable Effects or Symptoms Occur, Stop Taking Atoris and Consult a Doctor or Go to the Nearest Hospital Immediately.

Rare Undesirable Effects (may Occur in up to 1 in 1000 Patients):

• Severe Allergic Reaction with Swelling of the Face, Tongue, and Throat, which can Cause Difficulty Breathing.
• Severe Condition Characterized by Intensive Skin Peeling and Swelling, Blisters on the Skin, in the Mouth, on the Eyelids, Genital Organs, and Fever. Skin Rash with Pink-Red Spots, especially on the Palms of the Hands or Soles of the Feet, sometimes with Blisters.
• Muscle Weakness, Sensitivity, Muscle Pain, Muscle Tear, or Brownish Discoloration of Urine, especially if they Occur Together with Malaise or High Fever. These Symptoms may be Caused by Muscle Damage (Rhabdomyolysis). Muscle Breakdown does not always Reverse, even if the Patient Stops Taking Atorvastatin, and may also be Life-Threatening and Cause Kidney Problems.

Very Rare Undesirable Effects (may Occur in up to 1 in 10,000 Patients):

• If Unexpected or Unusual Bleeding or Bruising Occurs, it may Indicate Abnormal Liver Function. In this Case, Consult a Doctor Immediately.
• Lupus-Like Syndrome (including Rash, Joint Disorders, and Effects on Blood Cells).

Other Possible Undesirable Effects of Atoris:

Common Undesirable Effects (may Occur in up to 1 in 10 Patients):

• Nasal Congestion, Sore Throat, Nosebleeds
• Allergic Reactions
• Increased Blood Sugar Levels (Patients with Diabetes should Monitor their Blood Sugar Levels Closely), Increased Creatine Kinase Activity in the Blood
• Headache
• Nausea, Constipation, Flatulence, Indigestion, Diarrhea
• Joint Pain, Muscle Pain, and Back Pain
• Abnormal Liver Function Test Results

Uncommon Undesirable Effects (may Occur in up to 1 in 100 Patients):

• Loss of Appetite (Anorexia), Weight Gain, Decreased Blood Sugar Levels (Patients with Diabetes should Closely Monitor their Blood Sugar Levels)
• Nightmares, Insomnia
• Dizziness, Numbness or Tingling in the Fingers of the Hands and Feet, Reduced Sensation of Pain and Touch, Changes in Taste, Memory Loss
• Blurred Vision
• Tinnitus and (or) Head Noise
• Vomiting, Belching, Upper and Lower Abdominal Pain, Pancreatitis (causing Abdominal Pain)
• Hepatitis
• Skin Rash, Itchy Skin Rash, Urticaria, Hair Loss
• Neck Pain, Muscle Fatigue
• Fatigue, Malaise, Weakness, Chest Pain, Edema, especially of the Ankles, Increased Body Temperature
• Presence of White Blood Cells in Urine Test

Rare Undesirable Effects (may Occur in up to 1 in 1000 Patients):

• Visual Disturbances
• Unexpected Bleeding or Bruising
• Jaundice (Yellowing of the Skin and Whites of the Eyes)
• Tendon Damage
• Skin Rash, which may Occur on the Skin, or Ulcers in the Mouth (Lichenoid Drug Reaction)
• Purple Skin Changes (Symptoms of Vasculitis)

Very Rare Undesirable Effects (may Occur in up to 1 in 10,000 Patients):

• Allergic Reaction, which may Include Sudden, Wheezing Breathing and Pain or Pressure in the Chest, Swelling of the Eyelids, Face, Lips, Mouth, Tongue, or Throat, Difficulty Breathing, Fainting
• Hearing Loss
• Gynecomastia (Breast Enlargement in Men)

Unknown (Frequency cannot be Estimated from 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)

Consult a Doctor if the Patient Experiences Weakness in the Arms or Legs, Worsening after Periods of Activity, Double Vision, or Drooping Eyelids, Difficulty Swallowing or Shortness of Breath.
Possible Undesirable Effects Reported for some Statins (Medications of the same Type):

• Sexual Dysfunction
• Depression
• Breathing Problems, including Persistent Cough and (or) Shortness of Breath or Fever
• Diabetes. The Development of Diabetes is more Likely in Patients with High Fasting Blood Sugar Levels, Overweight Patients, and those with High Blood Pressure. The Doctor will Closely Monitor the Patient while Taking this Medication.

Reporting Undesirable Effects

If any Undesirable Effects Occur, including those not Mentioned in this Package Leaflet, Inform a Doctor or Pharmacist. Undesirable Effects can be Reported Directly to the Department of Monitoring of Undesirable Effects of Medicinal Products, 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
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Help to Gather more Information on the Safety of the Medication.

5. How to Store Atoris

Store the Medication out of Sight and Reach of Children.
Do Not Use this Medication after the Expiration Date Stated on the Packaging after "EXP". The Expiration Date refers to the Last Day of the Month.
The Batch Number is Stated on the Packaging after "Lot".
Store in the Original Packaging to Protect from Moisture.
No Special Precautions for Storage Temperature.
Medications Should not be Disposed of via Wastewater or Household Waste. Ask a Pharmacist how to Dispose of Medications that are no longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Atoris Contains

• The Active Substance of Atoris is Atorvastatin. 30 mg, Film-Coated TabletsEach Film-Coated Tablet contains 30 mg of Atorvastatin in the form of Atorvastatin Calcium. 60 mg, Film-Coated TabletsEach Film-Coated Tablet contains 60 mg of Atorvastatin in the form of Atorvastatin Calcium. 80 mg, Film-Coated TabletsEach Film-Coated Tablet contains 80 mg of Atorvastatin in the form of Atorvastatin Calcium.
• Other Ingredients (Excipients) are: Sodium Hydroxide, Hydroxypropyl Cellulose (E 463), Lactose Monohydrate, Microcrystalline Cellulose (E 460), Croscarmellose Sodium,

Crosspovidone (Type A), Magnesium Stearate (E 572), and Polysorbate 80 in the Tablet Core, and Opadry II White 85F28751: Polyvinyl Alcohol, Titanium Dioxide (E 171), Macrogol 3000, and Talc (E 553b) in the Tablet Coating. See Section 2 "Atoris contains Lactose and Sodium".

What Atoris Looks Like and Contents of the Package

Film-Coated Tablets 30 mg: White to Almost White, Round, Slightly Convex Film-Coated Tablets with a Diameter of 9 mm
Film-Coated Tablets 60 mg: White to Almost White, Oval, Biconvex Film-Coated Tablets with Dimensions of 16 mm x 8.5 mm
Film-Coated Tablets 80 mg: White to Almost White, Biconvex Film-Coated Tablets in the Shape of a Capsule with Dimensions of 18 mm x 9 mm
Packaging:14, 30, 60, or 90 Film-Coated Tablets in Blisters in a Cardboard Box

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To Obtain more Detailed Information about the Names of Medications in other European Economic Area Member States, Contact the Representative of the Marketing Authorization Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

Date of Last Revision of the Package Leaflet: 15.01.2025