APO-ATORVA 30 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the leaflet:
2. What Apo-Atorva is and what it is used for
3. Important information before taking Apo-Atorva
   1. When not to take Apo-Atorva
   2. Warnings and precautions
   3. Apo-Atorva and other medicines
   4. Apo-Atorva with food and drink
   5. Pregnancy, breast-feeding, and fertility
   6. Driving and using machines
   7. Apo-Atorva contains sodium.
4. How to take Apo-Atorva
   1. Duration of treatment with Apo-Atorva is determined by your doctor.
   2. Taking more than the recommended dose of Apo-Atorva
   3. Forgetting to take Apo-Atorva
   4. Stopping treatment with Apo-Atorva
5. Possible side effects
   1. If you experience any of the following serious side effects, stop taking Apo-Atorva and contact your doctor or go to the emergency department at your nearest hospital immediately.
   2. Other possible side effects of Apo-Atorva:
   3. Side effects with unknown frequency:
   4. Possible side effects observed with some statins (medicines from the same group):
   5. Reporting side effects
6. How to store Apo-Atorva
7. Contents of the pack and other information
   1. What Apo-Atorva contains
   2. What Apo-Atorva looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer/Importer:
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the leaflet: 10.2024

Leaflet accompanying the packaging: information for the user

Apo-Atorva, 30 mg, film-coated tablets
Apo-Atorva, 60 mg, film-coated tablets
Atorvastatinum

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

• Keep this 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 tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

Apo-Atorva belongs to a group of medicines called statins, which regulate lipid metabolism (fats) 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 changes in lifestyle are not effective on their own. Apo-Atorva can also be used to reduce the risk of heart disease even if cholesterol levels are normal. During treatment, you should continue a standard low-cholesterol diet.

2. Important information before taking Apo-Atorva

When not to take Apo-Atorva

• if you are allergic (hypersensitive) to atorvastatin or any of the other ingredients of this medicine (listed in section 6);
• if you have or have had liver disease;
• if you have had unexplained, abnormal liver function tests;
• if you are a woman of childbearing age and are not using effective contraception;
• if you are pregnant or planning to become pregnant;
• if you are breast-feeding;
• if you are taking a combination of glecaprevir and pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before taking Apo-Atorva, discuss with your doctor, pharmacist, or nurse:

• if you have severe respiratory failure;
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic) by mouth or by injection. The combination of fusidic acid and Apo-Atorva can cause serious muscle damage (rhabdomyolysis);
• if you have had a stroke with bleeding into the brain, or if there are small fluid-filled spaces in the brain from a previous stroke;
• if you have kidney problems;
• if you have hypothyroidism (an underactive thyroid gland);
• if you have had repeated or unexplained muscle aches or pains, or previously had muscle problems;
• if you have or have had myasthenia gravis (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenic syndrome (a disease that causes muscle weakness in the eyes), as statins can sometimes worsen the symptoms of these diseases or cause myasthenia;
• if you have previously had muscle problems while taking other medicines to lower cholesterol or triglycerides;
• if you regularly drink large amounts of alcohol;
• if you have previously had liver problems;
• if you are over 70 years old.

If any of the above applies to you, your doctor will order a blood test before and possibly during treatment with Apo-Atorva 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").
You should also inform your doctor if you experience persistent muscle weakness. Additional tests and treatment may be needed to diagnose and treat this condition.
While taking this medicine, patients with diabetes or at risk of developing diabetes will be closely monitored. The risk of developing diabetes is more likely if you have high blood glucose and lipid levels, are overweight, and have high blood pressure.

Apo-Atorva and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Some medicines may affect the way Apo-Atorva works or Apo-Atorva may affect the way other medicines work. This type of interaction can lead to reduced efficacy of one or both medicines or may increase the risk of serious side effects, including a serious muscle condition called 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 for angina or high blood pressure, such as amlodipine, diltiazem, and certain medicines used to regulate heart rhythm, such as digoxin, verapamil, amiodarone.
• Medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir, etc.

indinavir, darunavir, combination of tipranavir and ritonavir, etc.

• Certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medicines 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), fenazon (a pain reliever), colchicine (used to treat gout), and antacids (medicines used to treat heartburn, containing aluminum or magnesium).
• Over-the-counter medicines: St. John's Wort.
• If it is necessary to take fusidic acid by mouth to treat a bacterial infection, you should temporarily stop taking Apo-Atorva. Your doctor will tell you when you can safely restart taking Apo-Atorva. Taking Apo-Atorva at the same time as fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• 4.
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia).

Tell your doctor about all the medicines you have taken recently, including those obtained without a prescription.

Apo-Atorva with food and drink

Information on taking Apo-Atorva can be found in section 3. However, pay attention to the following information:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may affect the action of Apo-Atorva.
Alcohol
Avoid excessive alcohol consumption while taking this medicine. For more information, see section 2 "Warnings and precautions".

Pregnancy, breast-feeding, and fertility

Do not take Apo-Atorva if you are pregnant or planning to become pregnant.
Do not take Apo-Atorva if you are a woman who can become pregnant, unless you are using effective contraception.
Do not take Apo-Atorva if you are breast-feeding.
The safety of atorvastatin during pregnancy and breast-feeding has not been established.
Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Generally, this medicine does not affect the ability to drive or use machines. However, do not drive if this medicine affects your ability to drive. Do not use tools or machines if taking this medicine affects your ability to use them.
Apo-Atorva contains lactose monohydrate and soybean lecithin.
If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.
This medicine contains soybean lecithin. Do not take this medicine if you are allergic to peanuts or soy.

Apo-Atorva contains sodium.

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

3. How to take Apo-Atorva

Before starting treatment, your doctor will recommend a low-cholesterol diet, which you should continue during treatment with Apo-Atorva.
The usual starting dose of Apo-Atorva for adults and children over 10 years old is 10 mg once daily. If necessary, this dose may be increased by your doctor until the appropriate dose for you is reached. Your doctor will adjust the dose at intervals of at least 4 weeks. The maximum dose of Apo-Atorva is 80 mg once daily.
Swallow the tablets whole with water; they can be taken at any time of day, with or without food. However, try to take your tablet at the same time each day.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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 too many Apo-Atorva tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

Forgetting to take Apo-Atorva

If you forget to take a dose, just take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Apo-Atorva

If you have any further questions on the use of this product, 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, stop taking Apo-Atorva and contact your doctor or go to the emergency department at your nearest hospital immediately.

Rarely(may affect up to 1 in 1000 people):

• severe allergic reactions, which cause swelling of the face, tongue, and throat, and may cause difficulty breathing;
• serious diseases with severe skin peeling and swelling, blisters on the skin, in the mouth, on the eyes, genitals, and with fever. Skin rash with reddish-purple spots, which may be blistering, especially on the hands and soles of the feet;
• muscle weakness, tenderness, or pain, especially if you also feel unwell or have a high temperature; this could be a sign of a rare condition called rhabdomyolysis, which can lead to serious kidney problems and can be life-threatening. Rhabdomyolysis can occur even if you stop taking atorvastatin. It can lead to kidney problems and can be life-threatening.

Very rarely(may affect up to 1 in 10,000 people):

• unexplained or unusual bleeding or bruising, which may indicate liver problems. In this case, contact 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 side effects(may affect up to 1 in 10 people):

• nasal inflammation, sore throat, nosebleeds;
• allergic reactions;
• increased blood glucose levels (if you have diabetes, you should carefully monitor your blood glucose levels), increased creatine kinase activity;
• headache;
• nausea, constipation, bloating with gas, indigestion, diarrhea;
• joint pain, muscle pain, and back pain;
• blood test results indicating liver problems.

Uncommon side effects(may affect up to 1 in 100 people):

• loss of appetite (loss of appetite), weight gain, decreased blood glucose levels (if you have diabetes, you should carefully monitor your blood glucose levels);
• nightmares, insomnia;
• dizziness, numbness or tingling in the fingers of the hands and feet, decreased sensitivity to pain or touch, changes in taste, memory loss;
• blurred vision;
• ringing in the ears and/or head;
• vomiting, belching, abdominal pain, pancreatitis (inflammation of the pancreas);
• liver inflammation;
• skin rash, skin rash and itching, hives, hair loss;
• neck pain, muscle fatigue;
• fatigue, malaise, weakness, chest pain, swelling, especially around the ankles, increased temperature;
• presence of white blood cells in the urine.

Rare side effects(may affect up to 1 in 1000 people):

• vision 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 spots on the skin (signs of vasculitis).

Very rare side effects(may affect up to 1 in 10,000 people):

• allergic reactions - symptoms may include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, loss of consciousness;
• hearing loss;
• gynecomastia (breast enlargement in men and women).

Side effects with unknown frequency:

• persistent muscle weakness;
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing); myasthenic syndrome (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.

Possible side effects observed with some statins (medicines from the same group):

• sexual disorders;
• depression;
• breathing difficulties, including prolonged coughing and/or shortness of breath or fever;
• diabetes; This is more likely if you have high blood glucose and lipid levels, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. 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, tel.: +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 for this medicine.
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 is atorvastatin. Each film-coated tablet contains 30 mg of atorvastatin (as atorvastatin calcium trihydrate). Each film-coated tablet contains 60 mg of atorvastatin (as atorvastatin calcium trihydrate).
• The other ingredients are: tablet core:mannitol, copovidone, sodium carbonate, croscarmellose sodium, microcrystalline cellulose (contains silicon dioxide and microcrystalline cellulose), lactose monohydrate, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate;
  tablet coating:polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), talc, soybean lecithin, xanthan gum.

What Apo-Atorva looks like and contents of the pack

Apo-Atorva, 30 mg
White, round, film-coated tablets [10.1 mm], with "N" engraved on one side and "30" on the other side.
Apo-Atorva, 60 mg
White, oval, film-coated tablets [17.6 mm x 9.3 mm], with "N" engraved on one side and "60" on the other side.
Pack sizes:
Blisters of PA/Aluminum/PVC/Aluminum foil in a cardboard box
28, 30, 50, 60, or 100 film-coated tablets.
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 Warsaw

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF 26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica S.A.,
Rua João de Deus, no 19,
Venda Nova, 2700-487 Amadora,
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands:
Atorvastatine Aurobindo 30 mg/ 60 mg, filmomhulde tabletten
Germany:
Atorvastatin PUREN 30 mg/60 mg Filmtabletten
Poland
Apo-Atorva

Date of last revision of the leaflet: 10.2024