Apo-atorva

Package leaflet: Information for the user

Apo-Atorva, 30 mg, film-coated tablets
Apo-Atorva, 60 mg, film-coated tablets
Atorvastatinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Apo-Atorva is and what it is used for
2. What you need to know 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 (fat) metabolism in the body.
Apo-Atorva is used to lower blood lipid levels such as cholesterol and triglycerides when a low-fat diet and lifestyle changes alone are not effective. Apo-Atorva may also be used to reduce the risk of heart disease even when cholesterol levels are normal. Standard cholesterol-lowering diet should be continued during treatment.

2. Important information before using Apo-Atorva

When not to use Apo-Atorva

• if the patient has a known allergy (hypersensitivity) to atorvastatin or any of the other ingredients of the medicine (listed in section 6);
• if the patient currently has or has previously had liver disease;
• if the patient has unexplained, abnormal liver function test results;
• if the patient is of childbearing age and is not using effective methods of contraception;
• if the patient is pregnant or intends to become pregnant;
• if the patient is breastfeeding;
• if the patient is taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions
Before starting treatment with Apo-Atorva, discuss the following with your doctor, pharmacist, or
nurse:

• if the patient has severe respiratory insufficiency;
• if the patient is taking or has taken within the last seven days a medicine called fusidic acid (used to treat bacterial infections), either orally or by injection. Concomitant use of fusidic acid and Apo-Atorva may lead to serious muscle disorders (rhabdomyolysis);
• if the patient has had a stroke with bleeding into the brain, or if there are small fluid-filled spaces in the brain from a previous stroke;
• if the patient has kidney problems;
• if the patient has hypothyroidism;
• if the patient has recurrent or unexplained muscle pain or discomfort, or if there has been a history of muscle disorders in the patient or in their family;
• if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4);
• if the patient has previously experienced muscle disorders during treatment with other lipid-lowering agents (e.g. other statins or fibrates);
• if the patient regularly drinks large amounts of alcohol;
• if the patient has previously had liver disease;
• if the patient is over 70 years old.

If any of the above conditions apply, the doctor will order a blood test before starting treatment with Apo-Atorva and possibly during treatment to monitor the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, is increased when certain other medicines are taken concomitantly (see section 2 "Apo-Atorva with other medicines").
You should also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatment may be necessary to diagnose and manage this condition.
Patients who have diabetes or are at risk of developing diabetes will be closely monitored while taking this medicine. The risk of developing diabetes is higher if the patient has high blood glucose and lipid levels, overweight, and high blood pressure.

Apo-Atorva with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Some medicines may alter the effect of Apo-Atorva, or the effect of those medicines may be altered by Apo-Atorva. This type of interaction may reduce the effectiveness of one or both medicines. It may also increase the risk of serious adverse effects, including severe muscle damage known as rhabdomyolysis, described in section 4.

• Medicines that modify the immune system, e.g. cyclosporine.
• Certain antibiotics and antifungal medicines, such as: erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other lipid-regulating medicines, such as: gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used for angina or hypertension, such as: amlodipine, diltiazem; and medicines regulating heart rhythm, such as: digoxin, verapamil, amiodarone.
• Medicines used in the treatment of HIV infection, such as: ritonavir, lopinavir, atazanavir,
  indinavir, darunavir, the combination of tipranavir and ritonavir, etc.
• Certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medicines known to interact with Apo-Atorva include: ezetimibe (a cholesterol-lowering agent), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (medicines for indigestion containing aluminium or magnesium).
• Over-the-counter medicines: St. John's wort.
• If oral fusidic acid is required to treat a bacterial infection, temporary discontinuation of Apo-Atorva is necessary. Your doctor will inform you when it is safe to restart Apo-Atorva. Taking Apo-Atorva together with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis in section 4.
• daptomycin (a medicine used to treat complicated skin and skin tissue infections and bloodstream infections caused by bacteria).

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

Apo-Atorva with food and drink
Information on how to take Apo-Atorva is provided in section 3. However, please pay attention to the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts may alter the effect of Apo-Atorva.

Alcohol
Avoid excessive alcohol consumption while taking this medicine. For further information, see section 2 "Warnings and precautions".

Pregnancy, breastfeeding and fertility
Do not take Apo-Atorva if you are pregnant or planning to become pregnant.
Do not use Apo-Atorva in women who may become pregnant unless effective contraception is used.
Do not take Apo-Atorva if you are breastfeeding.
The safety of atorvastatin during pregnancy or breastfeeding has not been established.
Consult your doctor or pharmacist before taking this medicine.

Driving and operating machinery
Generally, this medicine does not affect the ability to drive or operate machinery. However, patients should not drive if this medicine affects their ability to do so. Do not use tools or machinery if taking this medicine affects your ability to operate them safely.

Apo-Atorva contains lactose monohydrate and soya lecithin.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains soya lecithin. Do not use this medicine if a hypersensitivity to peanuts or soya has been diagnosed.

Apo-Atorva contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to use Apo-Atorva
Before starting treatment, your doctor will recommend a low-cholesterol diet, which should be continued throughout treatment with Apo-Atorva.
The usual starting dose of Apo-Atorva in adults and children aged 10 years or older is 10 mg once daily. If necessary, this dose may be increased by the doctor up to the dose appropriate for the patient. The doctor will adjust the dose at intervals of 4 weeks or longer. The maximum dose of Apo-Atorva is 80 mg once daily.
Apo-Atorva tablets should be swallowed whole with water; they may be taken at any time of day, with or without food. However, it is advisable to take the tablet at approximately the same time each day.
This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The duration of treatment with Apo-Atorva is determined by the doctor.
If you feel that the effect of Apo-Atorva is too strong or too weak, consult your doctor.

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

Missing a dose of Apo-Atorva
If you miss a dose, simply take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

Stopping Apo-Atorva
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the following serious adverse reactions, they should
stop taking the medicine immediately and contact their doctor or go to the emergency
department of the nearest hospital.
Rare (may affect up to 1 in 1,000 patients):

• severe allergic reactions causing swelling of the face, tongue and throat, and which may lead to difficulty breathing;
• serious skin diseases with severe peeling and swelling of the skin, skin blisters, in the mouth, eyes, genital organs, accompanied by fever. Skin rash with pink-red spots, which may be blistering, especially on the palms and soles of the feet;
• muscle weakness, muscle tenderness, red-brown discoloration of urine, muscle pain or muscle rupture, particularly if associated with malaise or high temperature; this may be due to rhabdomyolysis (breakdown of striated muscles). Breakdown of striated muscles does not always resolve, even if the patient stops taking atorvastatin. It may be life-threatening and may lead to kidney problems.

Very rare (may affect up to 1 in 10,000 patients):

• unexpected or unusual bleeding or bruising, which may indicate liver dysfunction. In such cases, contact a doctor as soon as possible;
• lupus-like syndrome (including rash, joint disorders and effects on blood cells).

Other possible adverse reactions of Apo-Atorva:

Common adverse reactions (may affect up to 1 in 10 patients):

• inflammation of the nasal mucosa, sore throat, nosebleeds;
• allergic reactions;
• increased blood glucose levels (if the patient has diabetes, blood glucose levels should be carefully monitored), increased creatine kinase activity;
• headache;
• nausea, constipation, bloating with gas release, indigestion, diarrhoea;
• joint pain, muscle pain and back pain;
• blood test results indicating abnormalities in liver function.

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• loss of appetite, weight gain, decreased blood glucose levels (if the patient has diabetes, blood glucose levels should be carefully monitored);
• nightmares, insomnia;
• dizziness, numbness or tingling in fingers of hands and feet, reduced sensitivity to pain or touch, changes in taste perception, memory loss;
• blurred vision;
• ringing in the ears and/or head;
• vomiting, belching, pain in the upper and lower abdomen, pancreatitis (inflammatory condition causing abdominal pain);
• hepatitis (liver inflammation);
• rash, skin eruptions and itching, urticaria, hair loss;
• neck pain, muscle fatigue;
• fatigue, malaise, weakness, chest pain, swelling, especially around the ankles, elevated temperature;
• presence of white blood cells in urine.

Rare adverse reactions (may affect up to 1 in 1,000 patients):

• vision disorders;
• unexpected bleeding or bruising;
• cholestasis (yellowing of the skin and whites of the eyes);
• tendon damage;
• rash, which may appear on the skin, or oral ulcers (lichenoid drug reaction);
• purple skin lesions (symptoms of vasculitis).

Very rare adverse reactions (may affect up to 1 in 10,000 patients):

• 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;
• gynaecomastia (enlargement of the breasts in men and women).

Adverse reactions with unknown frequency:

• persistent muscle weakness;
• myasthenia (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing); ocular myasthenia (a disease causing weakness of the eye muscles). If the patient experiences weakness in arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath, they should speak to their doctor.

Possible adverse reactions observed with some statins (medicines in the same group):

• sexual dysfunction;
• depression;
• breathing difficulties, including persistent cough and/or shortness of breath or fever;
• diabetes; this is more likely if the patient has high levels of glucose and fats in the blood, is overweight and has high blood pressure. The doctor will monitor the patient during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Apo-Atorva

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Apo-Atorva contains

• The active substance is atorvastatin. Each coated tablet contains 30 mg of atorvastatin (as atorvastatin calcium trihydrate). Each coated tablet contains 60 mg of atorvastatin (as atorvastatin calcium trihydrate).
• Other ingredients are: tablet core: mannitol, copovidone, sodium carbonate, sodium croscarmellose, microcrystalline cellulose silicified (containing colloidal anhydrous silica and microcrystalline cellulose), lactose monohydrate, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate;
  tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), talc, soya lecithin, xanthan gum.

What Apo-Atorva looks like and contents of the pack

Apo-Atorva, 30 mg
White, round coated tablets [10.1 mm], embossed with the identification mark "N" on one side and "30" on the other side.

Apo-Atorva, 60 mg
White, oval coated tablets [17.6 mm x 9.3 mm], embossed with the identification mark "N" on one side and "60" on the other side.

Pack sizes:
Blister packs made of PA/Aluminum/PVC/Aluminium in cardboard boxes containing 28, 30, 50, 60 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D lok. 27
01-909 Warsaw
Poland

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 authorised in 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