Apo-atorva

Leaflet attached to the packaging: patient information

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

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• 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 as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging 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 reduce the levels of lipids, such as cholesterol and triglycerides, in the blood when a low-fat diet and lifestyle changes are not effective. Apo-Atorva 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 taking Apo-Atorva

When not to take Apo-Atorva

• if the patient is allergic to atorvastatin or any other ingredient of the medicine (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 do not use effective methods of 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 to take Apo-Atorva, the patient should discuss the following with their doctor or pharmacist:

• if the patient has had a stroke with bleeding in the brain or if there is a small amount of fluid in the brain from a previous stroke,
• if the patient has kidney disease,
• if the patient has hypothyroidism,
• if the patient has had recurring or unexplained muscle pain or muscle weakness in the past,
• 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 muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to the development of myasthenia (see section 4);
• if the patient has had muscle pain during previous treatment with other lipid-lowering medicines (e.g., other statins or fibrates),
• if the patient regularly consumes large amounts of alcohol,
• if the patient has liver disease,
• in patients over 70 years of age,
• in cases of severe respiratory failure,
• if the patient is currently taking or has 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 the patient, the doctor will order a blood test before starting treatment with Apo-Atorva and, if possible, during treatment to monitor the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, is higher when certain medicines are taken at the same time (see section 2 "Apo-Atorva and other medicines").
The patient should also inform their doctor or pharmacist if they experience muscle weakness that persists. To diagnose and treat this condition, additional tests and medications may be necessary.
If the patient has diabetes or is at risk of developing diabetes, the doctor will closely monitor their condition while taking Apo-Atorva. The patient may be at risk of developing diabetes if they have high blood sugar and lipid levels, are overweight, and have high blood pressure.

Apo-Atorva and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 lipid-lowering medicines, such as gemfibrozil, other fibrates, cholestyramine,
• certain calcium channel blockers used for 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), 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, the patient should temporarily stop taking Apo-Atorva. The doctor will inform the patient when it is safe to 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 taking Apo-Atorva can be found in section 3. However, the patient should pay attention to the following:

Grapefruit juice
The patient should not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can change the effect of Apo-Atorva.
Alcohol
The patient should avoid excessive alcohol consumption while taking this medicine. More information is provided in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Apo-Atorva should not be taken by pregnant or breastfeeding 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 breastfeeding.
The safety of Apo-Atorva during pregnancy and breastfeeding has not been established.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Generally, the medicine does not affect the ability to drive or use machines. However, the patient should not drive if the medicine affects their ability to drive.
The patient should not use any tools or machines if taking the medicine affects their 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, the doctor will recommend a low-cholesterol diet, which should be continued during treatment with Apo-Atorva.
The usual starting dose of Apo-Atorva for adults and children over 10 years of age is 10 mg once daily. 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 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: they can be taken at any time of day, with or without food. However, the patient should try to take the tablet at the same time every day.
This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

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

If the patient feels that the effect of Apo-Atorva is too strong or too weak, they should consult their doctor.

Taking a higher dose of Apo-Atorva than recommended

If the patient has taken too many Apo-Atorva tablets (more than their usual daily dose), they should contact their doctor or the nearest hospital for advice.

Missing a dose of Apo-Atorva

If the patient misses a dose, they should take the next dose at the scheduled time. They should not take a double dose to make up for the missed dose.

Stopping treatment with Apo-Atorva

If the patient has any further doubts about taking the medicine or stopping treatment, they should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects or symptoms, they should stop taking the medicine and contact their doctor or go to the emergency department of the nearest hospital immediately.

Rare: occurs in less than 1 in 1000 patients

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can cause severe breathing difficulties.
• Severe skin disease characterized by peeling and swelling of the skin, blisters, and fever. Skin rash with pink-red spots, especially on the palms or soles, with possible blisters.
• Muscle weakness, tenderness, pain, or rupture, reddish-brown urine. If the patient also feels unwell or has a high fever, it may be due to the breakdown of striated muscle (rhabdomyolysis). Rhabdomyolysis may not always resolve, even after stopping atorvastatin, and can be a life-threatening condition that causes kidney problems.

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

• If the patient experiences unexpected or unusual bleeding or bruising, it may indicate liver problems. They should consult their doctor as soon as possible.

• Systemic lupus erythematosus-like syndrome (including rash, joint disorders, effects on blood cells).

Other possible side effects of Apo-Atorva:

Common: occurs in less than 1 in 10 patients

• 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: occurs in less than 1 in 100 patients

• 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 and toes, 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: occurs in less than 1 in 1000 patients

• vision disorders,
• unexpected bleeding or bruising (bruises),
• cholestasis (yellowing of the skin and whites of the eyes),
• tendon rupture,
• skin rash that can occur on the skin or ulcers in the mouth (lichenoid drug reaction),
• purple skin changes (symptoms of vasculitis).

Very rare: occurs 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 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). The patient should talk to their doctor if they experience muscle weakness in their 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, overweight, and high blood pressure. The doctor will monitor the patient's condition while taking Apo-Atorva.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Apo-Atorva

• The medicine should be stored out of sight and reach of children.
• There are no special storage temperature requirements.
• The medicine should be stored in its original packaging to protect it from moisture.
• The medicine should not be taken after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging 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).

The other ingredients are calcium acetate, microcrystalline cellulose (PH 102), anhydrous colloidal silica, 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.
Apo-Atorva, 20 mg: white or almost white, oval, biconvex coated tablets, with "APL" engraved on one side and "ATV20" on the other.
Apo-Atorva, 40 mg: white or almost white, oval, biconvex coated tablets, with "APL" engraved on one side and "ATV40" on the other.
The color of the tablets may change from white to almost white during storage.
Apo-Atorva is available in 10 mg and 20 mg strengths in packs of 30 and 60 coated tablets.
Apo-Atorva is available in 40 mg strength in packs of 30 coated tablets.
Not all pack sizes may be marketed.
Apo-Atorva coated tablets are available in 10 mg, 20 mg, and 40 mg strengths.

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