Atorvastatin aurovitas

Package leaflet: Information for the user

Atorvastatin Aurovitas, 10 mg, film-coated tablets
Atorvastatin Aurovitas, 20 mg, film-coated tablets
Atorvastatin Aurovitas, 40 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 Atorvastatin Aurovitas is and what it is used for
2. Before you take Atorvastatin Aurovitas
3. How to take Atorvastatin Aurovitas
4. Possible side effects
5. How to store Atorvastatin Aurovitas
6. Contents of the pack and other information

1. What Atorvastatin Aurovitas is and what it is used for

Atorvastatin Aurovitas belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Atorvastatin Aurovitas is used to lower blood levels of lipids known as cholesterol and triglycerides when diet low in fat and lifestyle changes alone are not effective.
Atorvastatin Aurovitas may also be used to reduce the risk of heart disease, even when cholesterol levels are normal. While taking this medicine, you should continue to follow a standard low-cholesterol diet.

2. Important information before using Atorvastatin Aurovitas

When not to use Atorvastatin Aurovitas

• if the patient is allergic to atorvastatin or any of the other ingredients of this 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,
• in women of childbearing age who are not using effective contraceptive methods,
• in pregnant women or women planning to become pregnant,
• in breastfeeding women,
• when co-administering glecaprevir/pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions
Before starting treatment with Atorvastatin Aurovitas, please discuss this with your doctor,
pharmacist, or nurse.

• in case of severe respiratory insufficiency,
• in case of haemorrhagic stroke, or if there is a small amount of fluid in the brain from a previous stroke,
• in case of kidney problems,
• in case of hypothyroidism,
• in case of recurrent or unexplained muscle pain or muscle problems in the past, or similar problems in family members,
• if the patient currently has or has previously 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 problems during previous treatment with other lipid-lowering medicines (e.g. other statins or fibrates),
• if the patient is taking or has taken within the last 7 days oral or injectable fusidic acid (a medicine used for bacterial infections). Cases of rhabdomyolysis have been reported in patients receiving statins concomitantly with fusidic acid.
• in case of regular consumption of large amounts of alcohol,
• in case of previous liver disease,
• in patients aged over 70 years.

In patients with any of the above conditions, the doctor will order a blood test before starting treatment with Atorvastatin Aurovitas 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 “Atorvastatin Aurovitas and other medicines”).
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and additional medicines may be required to diagnose and treat this condition.
During treatment, your doctor will closely monitor you for the development of diabetes or risk of developing diabetes. Patients with high blood sugar and fat levels, overweight patients, and those with high blood pressure may be at risk of developing diabetes.

Atorvastatin Aurovitas 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 Atorvastatin Aurovitas or the effect of these medicines on the body may be altered by Atorvastatin Aurovitas. 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 or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, colestyramine,
• certain calcium channel blockers used for angina or hypertension, e.g. amlodipine, diltiazem; and 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, tipranavir in combination with ritonavir, etc.,
• certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and combinations with elbasvir/grazoprevir, ledipasvir/sofosbuvir,
• other medicines known to interact with Atorvastatin Aurovitas include ezetimibe (which lowers cholesterol levels), 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 (a medicine used to treat gout), and antacids (medicines used for indigestion containing aluminium or magnesium),
• over-the-counter medicines: St John's wort,
• if the patient needs to take oral fusidic acid to treat a bacterial infection, they should temporarily stop taking Atorvastatin Aurovitas. The doctor will advise when it is safe to resume taking Atorvastatin Aurovitas. Concomitant use of Atorvastatin Aurovitas and fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis is provided in section 4.
• daptomycin (a medicine used to treat complicated skin and skin tissue infections and bloodstream infections caused by bacteria).

Atorvastatin Aurovitas with food and drink
Information on how to take Atorvastatin Aurovitas is provided in section 3. However, please pay attention to the following information:
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 Atorvastatin Aurovitas.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
Further details on this are provided in section 2, “Warnings and precautions”.

Pregnancy, breastfeeding and fertility
Do not use Atorvastatin Aurovitas if you are pregnant or planning to become pregnant.
Do not use Atorvastatin Aurovitas in women of childbearing age unless the patient is using effective contraceptive methods.
Do not use Atorvastatin Aurovitas during breastfeeding.
The safety of atorvastatin during pregnancy or breastfeeding has not been established. Consult your doctor or pharmacist before taking this medicine.

Driving and using machines
This medicine usually 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 any tools or machinery if taking this medicine affects your ability to operate them.

Atorvastatin Aurovitas 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 take this medicine if you have been diagnosed with hypersensitivity to peanuts or soya.

Atorvastatin Aurovitas 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 Atorvastatin Aurovitas

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atorvastatin Aurovitas.
The usual starting dose of Atorvastatin Aurovitas in adults and children aged 10 years or older is 10 mg once daily. This dose may be increased by your doctor as needed, up to the dose appropriate for the patient. Your doctor will adjust the dose at intervals of at least 4 weeks. The maximum dose of Atorvastatin Aurovitas is 80 mg once daily.
Atorvastatin Aurovitas 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 used exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with Atorvastatin Aurovitas is determined by your doctor.
If you feel that the effect of Atorvastatin Aurovitas is too strong or too weak, consult your doctor.
Taking more Atorvastatin Aurovitas than prescribed
If you accidentally take too many Atorvastatin Aurovitas tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
Missing a dose of Atorvastatin Aurovitas
If you forget to take your dose, simply take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
Stopping Atorvastatin Aurovitas
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 serious adverse reactions or symptoms, they should
stop taking the medicine immediately and contact a doctor or go to the emergency department
of the nearest hospital.
Rare (may occur in 1 out of 1,000 patients):

• Severe allergic reaction causing swelling of the face, tongue and throat, which may cause severe breathing difficulties.

• Severe illness characterized by skin peeling and swelling, skin blisters, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms or soles, possibly with blisters.

• Muscle weakness, tenderness, pain or muscle tears, or red-brown discoloration of urine, especially if accompanied by malaise or high fever,
  may be due to rhabdomyolysis (breakdown of skeletal muscle). Rhabdomyolysis does not always resolve even after the patient stops taking atorvastatin,
  and may be life-threatening and cause kidney problems.
  Very rare (may occur in 1 out of 10,000 patients):

• If the patient experiences unexpected or unusual bleeding or bruising, this may indicate liver abnormalities. 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 Atorvastatin Aurovitas:
Common (may occur in 1 out of 10 patients):

• Nasal congestion, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be carefully monitored), increased blood creatine kinase levels
• Headaches
• Nausea, constipation, bloating, indigestion, diarrhoea
• Joint pain, muscle pain and back pain
• Blood test results indicating abnormal liver function

Uncommon (may occur in 1 out of 100 patients):

• Anorexia (loss of appetite), weight gain, decreased blood glucose levels (in diabetic patients, 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 head
• Vomiting, belching, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, skin eruptions and itching, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling especially in the ankles, elevated temperature
• Presence of white blood cells in urine analysis

Rare (may occur in 1 out of 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 (may occur in 1 out of 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 (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). The patient should consult a doctor if they experience weakness in arms or legs worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Other possible adverse reactions reported during treatment with some statins (medicines of the
same type):

• Sexual dysfunction
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Diabetes; the likelihood of developing this condition is higher in patients with high blood sugar and fat levels, overweight patients, and those with high blood pressure. During treatment with this medicine, the doctor will perform appropriate tests on the patient.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Atorvastatin Aurovitas

Keep this medicine out of the sight and reach of children.
Dose 10 mg, 20 mg and 40 mg (PA/Aluminium/PVC/Aluminium):
No special storage precautions are required for this medicinal product.
Dose 10 mg and 20 mg (PVC/PE/PVdC/Aluminium):
No special storage precautions are required for this medicinal product.
Dose 40 mg (PVC/PE/PVdC/Aluminium):
Do not store above 30°C.
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 the stated month.
Medicines should 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 Atorvastatin Aurovitas contains

• The active substance is atorvastatin. Each coated tablet contains 10 mg of atorvastatin (as calcium trihydrate salt). Each coated tablet contains 20 mg of atorvastatin (as calcium trihydrate salt). Each coated tablet contains 40 mg of atorvastatin (as calcium trihydrate salt).
• Other ingredients are: mannitol, copovidone, sodium carbonate, sodium croscarmellose, microcrystalline cellulose with silicon dioxide (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 Atorvastatin Aurovitas looks like and contents of the pack
Film-coated tablet.
Atorvastatin Aurovitas 10 mg film-coated tablets:
White, elliptical [9.8 mm x 5.2 mm], film-coated tablets, embossed with "AS" on one side and "10" on the other side.
Atorvastatin Aurovitas 20 mg film-coated tablets:
White, elliptical [12.3 mm x 6.5 mm], film-coated tablets, embossed with "AS" on one side and "20" on the other side.
Atorvastatin Aurovitas 40 mg film-coated tablets:
White, elliptical [15.5 mm x 8.1 mm], film-coated tablets, embossed with "AS" on one side and "40" on the other side.
Atorvastatin Aurovitas film-coated tablets are available in blisters made of
Polyamide/Aluminium/PVC/Aluminium.
Atorvastatin Aurovitas is also available in blisters made of PVC/PE/PVdC/Aluminium, as an alternative packaging type.
Pack sizes:
Blisters: 14, 20, 28, 30, 50, 56, 84, 90, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
Poland
Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
This medicinal product is authorised in the European Economic Area under the following names:
Belgium: Atorvastatin AB 10 mg/20 mg/40 mg/80 mg filmomhulde tabletten
Poland: Atorvastatin Aurovitas
Portugal: Atorvastatina Aurovitas
Spain: Atorvastatina Aurovitas Pharma 10 mg/20 mg/40 mg/80 mg comprimidos recubiertos con película EFG