Apo-atorva

Package leaflet: Information for the patient

Apo-Atorva, 10 mg film-coated tablets
Apo-Atorva, 20 mg film-coated tablets
Apo-Atorva, 40 mg film-coated tablets
Atorvastatinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, 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 levels of lipids known 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. You should continue to follow a cholesterol-lowering diet during treatment.

2. Important information before using Apo-Atorva

When not to use Apo-Atorva

• if the patient has hypersensitivity to atorvastatin or any of the other ingredients of the medicine (listed in section 6),
• if the patient has or has previously had liver disease,
• if the patient has unexplained, abnormal liver function test results,
• in women of childbearing age who are not using effective methods of contraception,
• in pregnant women or women planning to become pregnant,
• in breastfeeding women,
• if the patient is concurrently taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

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

• if the patient previously had a stroke with bleeding into the brain or if there is a small amount of fluid in the brain from a previous stroke,
• in case of kidney disease,
• in case of hypothyroidism,
• in case of recurrent or unexplained muscle pain or muscle disorders in the patient’s history or in family members,
• 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 eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4);
• in case of muscle disorders during previous treatment with other lipid-lowering medicines (e.g. other statins or fibrates),
• in case of regular consumption of large amounts of alcohol,
• in case of liver disease,
• in patients over 70 years of age,
• in case of severe respiratory insufficiency,
• if the patient is currently taking or has taken within the last 7 days a medicine called fusidic acid (used to treat bacterial infections) orally or by injection. Concomitant use of fusidic acid with Apo-Atorva may lead to serious muscle problems (rhabdomyolysis).

If any of the above conditions apply to the patient, the doctor will order a blood test before starting treatment with Apo-Atorva and, where possible, 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 higher when certain medicines are used concomitantly (see section 2 "Apo-Atorva and other medicines").
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and additional medicines may be necessary to diagnose and treat this condition.
If the patient has diabetes or is at risk of developing diabetes, the doctor will closely monitor the patient during treatment with Apo-Atorva. The patient may be at increased risk of developing diabetes if they have high blood sugar and lipid levels, overweight, and high blood pressure.

Apo-Atorva and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may alter the effect of Apo-Atorva or their effect on the body 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:

• immunosuppressive medicines, e.g. cyclosporine,
• certain antibiotics and antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, cholestyramine,
• certain calcium channel blockers used for angina or hypertension, e.g. amlodipine, diltiazem; medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus disease,
• medicines used to treat HIV infection, e.g.: ritonavir, lopinavir, atazanavir, indinavir, darunavir, combination of tipranavir and ritonavir, etc.,
• certain medicines used to treat hepatitis C, e.g.: telaprevir, boceprevir, and combination products containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with Apo-Atorva include ezetimibe (which reduces cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a painkiller), colchicine (used to treat gout), and medicines that neutralize stomach acid (medicines used for indigestion, containing aluminium or magnesium),
• over-the-counter medicines: St. John's wort,
• daptomycin (a medicine used to treat complicated skin and skin tissue infections and bloodstream infections caused by bacteria).

If treatment with oral fusidic acid is necessary for a bacterial infection, temporary discontinuation of Apo-Atorva is required. Your doctor will inform you when it is safe to resume treatment with Apo-Atorva. Concomitant use of atorvastatin and fusidic acid may rarely lead to muscle weakness, tenderness or muscle pain (rhabdomyolysis). More information about 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
Do not consume more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effect of Apo-Atorva.

Alcohol
Avoid excessive alcohol consumption while taking this medicine. Detailed information is provided in section 2 "Warnings and precautions".

Pregnancy and breastfeeding
Do not use Apo-Atorva in pregnant women or women planning to become pregnant.
Do not use Apo-Atorva in women of childbearing age who are not using effective methods of contraception.
Do not use Apo-Atorva during breastfeeding.
The safety of Apo-Atorva during pregnancy and breastfeeding has not been established.
If you are pregnant or breastfeeding, suspect you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

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

Apo-Atorva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine 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.
The usual starting dose of Apo-Atorva in adults and children aged 10 years or older is 10 mg once daily. This dose may be increased by your doctor as needed to reach the dose appropriate for the patient. Your doctor will adjust the dose 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, it is advisable 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 in doubt, consult 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, consult your doctor.
Taking more Apo-Atorva than prescribed
If you accidentally take too many Apo-Atorva tablets (more than your usual daily dose), contact your doctor or the nearest hospital for advice.
If you miss a dose of Apo-Atorva
If you miss a dose, take the next dose at your usual scheduled time. Do not take a double dose to make up for the missed dose.
Stopping Apo-Atorva
If you have any further questions about taking this medicine or about stopping treatment, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following serious adverse reactions or symptoms, the medicine should be discontinued immediately and the patient should contact a doctor without delay or go to the emergency department of the nearest hospital.
Rare: occurs in less than 1 in 1,000 patients

• Severe allergic reaction causing swelling of the face, tongue and throat, which may cause severe breathing difficulties.
• Serious illness characterized by skin peeling and swelling, skin blisters, and sores in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly with blisters.
• Muscle weakness, tenderness, pain or muscle rupture, red-brown discoloration of urine. If accompanied by malaise or high fever, this may be due to rhabdomyolysis (breakdown of striated muscle). Rhabdomyolysis does not always resolve even after discontinuation of atorvastatin and may be a potentially life-threatening condition leading to kidney problems.

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

• If the patient experiences unexpected or unusual bleeding or bruising, this may
  indicate liver problems. Medical advice should be sought as soon as possible.

• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible adverse reactions of Apo-Atorva:
Common: occurs in less than 1 in 10 patients

• Inflammation of nasal passages, sore throat, nosebleeds,
• Allergic reactions,
• Increased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be carefully monitored), increased creatine kinase levels in blood,
• Headache,
• Nausea, constipation, flatulence, indigestion, diarrhoea,
• Joint pain, muscle pain and back pain,
• Blood test results indicating abnormal liver function.

Uncommon: occurs in less than 1 in 100 patients

• Anorexia (loss of appetite), weight gain, decreased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be carefully monitored),
• Nightmares, insomnia,
• Dizziness, numbness or tingling in fingers and toes, reduced sensitivity to pain and touch, altered taste, memory loss,
• Blurred vision,
• Ringing in the ears and (or) in the head,
• Vomiting, belching, pain in upper and lower abdomen, pancreatitis (causing abdominal pain),
• Hepatitis,
• Skin rash and itching, urticaria, hair loss,
• Neck pain, muscle fatigue,
• Fatigue, malaise, weakness, chest pain, swelling especially of the ankles, elevated temperature,
• Presence of white blood cells in urine tests.

Rare: occurs in less than 1 in 1,000 patients

• Visual disturbances,
• Unexpected bleeding or bruising (bruises),
• Cholestasis (yellowing of the skin and whites of the eyes),
• Tendon rupture,
  • Rash which may appear on the skin or oral ulcers (lichenoid drug reaction),
  • Purple skin lesions (symptoms of vasculitis).

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

• Allergic reactions – symptoms may include sudden shortness of breath and chest pain or tightness, eyelid, facial, lip, oral cavity, tongue or throat swelling, breathing difficulties, collapse,
• Hearing loss,
• Gynaecomastia (excessive growth of glandular breast tissue in men).

Frequency not known: frequency cannot be estimated from available data

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

Other possible adverse reactions reported during treatment with some statins (medicines in the same group as atorvastatin):

• Sexual dysfunction
• 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 health during treatment with Apo-Atorva.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, the patient should inform their doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization 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 sight and reach of children.
• There are no special storage temperature requirements.
• Store in the original packaging to protect from moisture.
• Do not use this medicine after the expiry date stated on the carton and blister pack following the term "EXP". The expiry date refers to the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Apo-Atorva contains
The active substance is atorvastatin.

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

Other ingredients are: calcium acetate, microcrystalline cellulose (PH 102), colloidal anhydrous silica, sodium croscarmellose, magnesium stearate, sodium carbonate, hydroxypropyl cellulose (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 film-coated tablets, marked with "APL" on one side and "A10" on the other side.
Apo-Atorva 20 mg: white or almost white, oval, biconvex film-coated tablets, marked with "APL" on one side and "ATV20" on the other side.
Apo-Atorva 40 mg: white or almost white, oval, biconvex film-coated tablets, marked with "APL" on one side and "ATV40" on the other side.

The colour of the tablets may change from white to almost white during storage.

Apo-Atorva tablets in doses of 10 mg and 20 mg are available in packs of 30 and 60 film-coated tablets.
Apo-Atorva tablets in dose of 40 mg are available in packs of 30 film-coated tablets.
Not all pack sizes may be marketed.

Apo-Atorva film-coated tablets are available in strengths of 10 mg, 20 mg and 40 mg.

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

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000, Malta.