Apo-atorva

Package Leaflet: Information for the Patient

Apo-Atorva, 10 mg coated tablets
Apo-Atorva, 20 mg coated tablets
Apo-Atorva, 40 mg coated tablets
Atorvastatinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Apo-Atorva and what is it used for
• 2. Important information before taking Apo-Atorva
• 3. How to take Apo-Atorva
• 4. Possible side effects
• 5. How to store Apo-Atorva
• 6. Contents of the pack and other information

1. What is Apo-Atorva and what is it used for

Apo-Atorva belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
Apo-Atorva is used to lower the levels of lipids, such as cholesterol and triglycerides, in the blood when a low-fat diet and lifestyle changes on their own have not been effective. Apo-Atorva may also be used to reduce the risk of heart disease, even if the cholesterol level is normal. During treatment, a standard cholesterol-lowering diet should be continued.

2. Important information before taking Apo-Atorva

When not to take Apo-Atorva

• if you are allergic to atorvastatin or any other ingredient of the 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 effective methods of 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 starting to take Apo-Atorva, discuss with your doctor or pharmacist:

• if 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,
• if you have kidney disease,
• if you have hypothyroidism,
• if you have had repeated or unexplained muscle pains or muscle weakness in the past,
• 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 may sometimes exacerbate symptoms or lead to myasthenia (see section 4);
• if you have had muscle pains during previous treatment with other lipid-lowering medicines (e.g. other statins or fibrates),
• if you regularly drink large amounts of alcohol,
• if you have liver disease,
• in patients over 70 years of age,
• in cases of severe respiratory failure,
• if you are currently taking or have taken within the last 7 days a medicine called fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection. Taking fusidic acid with Apo-Atorva can lead to serious muscle problems (rhabdomyolysis).

If any of the above situations apply to you, your doctor will order a blood test before starting treatment with Apo-Atorva and, if possible, during treatment to monitor the risk of muscle side effects. It is known that the risk of muscle side effects, such as rhabdomyolysis, is higher when certain medicines are taken at the same time (see section 2 "Apo-Atorva and other medicines").
You should also inform your doctor or pharmacist if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
If you have diabetes or are at risk of developing diabetes, your doctor will closely monitor your condition while you are taking Apo-Atorva. You may be at risk of developing diabetes if you have high blood sugar and lipid levels, are overweight, and have high blood pressure.

Apo-Atorva and 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 change the effect of Apo-Atorva or the effect of these medicines on the body may be changed by Apo-Atorva. 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, described in section 4:

• 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,
• other medicines that regulate lipid levels, such as gemfibrozil, other fibrates, colestyramine,
• certain calcium channel blockers used in angina or high blood pressure, such as amlodipine, diltiazem; medicines that regulate heart rhythm, 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, combination of tipranavir and ritonavir, etc.,

• certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and a combination of elbasvir and grazoprevir, ledipasvir and sofosbuvir,
• other medicines that are known to interact with Apo-Atorva 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 (used to treat gout), and antacids (medicines used to treat indigestion, containing aluminum or magnesium),
• over-the-counter medicines: St. John's Wort,
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).

If it is necessary to treat a bacterial infection with fusidic acid orally, you should temporarily stop taking Apo-Atorva. Your doctor will inform you when you can safely resume taking Apo-Atorva. Taking atorvastatin with fusidic acid can lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Apo-Atorva with food, drink, and alcohol

Information on the use of Apo-Atorva can be found in section 3. However, please note the following:

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 Apo-Atorva.
Alcohol
While taking this medicine, you should avoid excessive alcohol consumption. More information is provided in section 2 "Warnings and precautions".

Pregnancy and breast-feeding

Apo-Atorva should not be taken by pregnant or breast-feeding women.
Apo-Atorva should not be taken by women of childbearing age who do not use effective methods of contraception.
Apo-Atorva should not be taken during breast-feeding.
The safety of Apo-Atorva during pregnancy and breast-feeding has not been established.
If you are pregnant or breast-feeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Generally, 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 taking the medicine affects your ability to use them.

Apo-Atorva contains sodium

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

3. How to take Apo-Atorva

Before starting treatment, your doctor will recommend a low-cholesterol diet, which should be continued during treatment with Apo-Atorva.
Usually, the initial dose of Apo-Atorva for adults and children over 10 years of age is 10 mg once daily. This dose may be increased by your doctor if necessary, up to a dose suitable for you. Your doctor will adjust the dose of Apo-Atorva at intervals of at least 4 weeks. The maximum dose of Apo-Atorva is 80 mg once daily.
Apo-Atorva tablets should be swallowed whole with water and can 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.
This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

The duration of treatment with Apo-Atorva is determined by your doctor.

If you feel that the effect of Apo-Atorva is too strong or too weak, talk to your doctor.

Taking more than the recommended dose of Apo-Atorva

If you accidentally take more than the recommended dose of Apo-Atorva (more than your usual daily dose), contact your doctor or the nearest hospital for advice.

Missing a dose of Apo-Atorva

If you miss a dose, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Apo-Atorva

If you have any further questions about taking this medicine or stopping treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Apo-Atorva can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects or symptoms, stop taking Apo-Atorva and contact your doctor or go to the emergency department at your nearest hospital immediately.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can lead to severe breathing difficulties.
• Severe skin disease characterized by blistering and peeling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with reddish-purple spots, especially on the palms or soles, with possible blisters.
• Muscle weakness, tenderness, pain, or rupture, reddish-brown urine. If you also feel unwell or have a high fever, this may be due to muscle breakdown (rhabdomyolysis). Muscle breakdown does not always resolve, even after stopping atorvastatin, and can be a life-threatening condition that affects the kidneys.

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 Apo-Atorva:

Common: may affect up to 1 in 10 people

• nose and throat infections, sore throat, nosebleeds,
• allergic reactions,
• increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored), increased creatine kinase levels in the blood,
• headache,
• 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 the fingers of the hands and feet, decreased sensitivity to pain and touch, changes in taste, memory loss,
• blurred vision,
• ringing in the ears and/or head,
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain),
• liver inflammation,
• skin rash and 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 the urine.

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

• vision disorders,
• unexpected bleeding or bruising (bruises),
• jaundice (yellowing of the skin and whites of the eyes),
• tendon rupture,
• skin rash that may occur on the skin, or ulcers in the mouth (lichenoid drug reaction),
• purple spots on the skin (signs of 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: frequency 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). You should talk to your doctor if you experience muscle weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Other possible side effects reported during treatment with some statins (medicines from the same group as atorvastatin):

• sexual disorders
• depression
• breathing problems, including persistent cough and/or shortness of breath or fever
• diabetes. The risk of developing diabetes is higher in patients with high blood sugar and lipid levels, who are overweight, and have high blood pressure. Your doctor will monitor your condition while you are taking Apo-Atorva.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apo-Atorva

• Keep this medicine out of the sight and reach of children.
• There are no special storage instructions.
• Store in the original package to protect from moisture.
• Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.

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.

6. Contents of the pack and other information

What Apo-Atorva contains

The active substance of Apo-Atorva is atorvastatin.

• Apo-Atorva, 10 mg: each coated tablet contains atorvastatin calcium (solubilized with propylene glycol), equivalent to 10 mg of atorvastatin ( Atorvastatinum).
• Apo-Atorva, 20 mg: each coated tablet contains atorvastatin calcium (solubilized with propylene glycol), equivalent to 20 mg of atorvastatin ( Atorvastatinum).
• Apo-Atorva, 40 mg: each coated tablet contains atorvastatin calcium (solubilized with propylene glycol), equivalent to 40 mg of atorvastatin ( Atorvastatinum).

Other ingredients are: calcium acetate, microcrystalline cellulose (PH 102), silica colloidal anhydrous, sodium croscarmellose, magnesium stearate, sodium carbonate, hydroxypropylcellulose (Type LF), hypromellose 2910 E, macrogol 8000, and titanium dioxide (E171).

What Apo-Atorva looks like and contents of the pack

Apo-Atorva, 10 mg: white or almost white, oval, biconvex, coated tablets, with "APL" engraved on one side and "A10" on the other side.
Apo-Atorva, 20 mg: white or almost white, oval, biconvex, coated tablets, with "APL" engraved on one side and "ATV20" on the other side.
Apo-Atorva, 40 mg: white or almost white, oval, biconvex, coated tablets, with "APL" engraved on one side and "ATV40" on the other side.
The color of the tablets may change from white to almost white during storage.
Apo-Atorva is available in packs of 30 and 60 coated tablets for the 10 mg and 20 mg strengths.
Apo-Atorva is available in packs of 30 coated tablets for the 40 mg strength.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok. 27
01-909 Warszawa
Polska
Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000, Malta.
Date of last revision of the leaflet:10.2024