Atorvastatin EG

Package leaflet: Information for the user

Atorvastatin EG 30 mg film-coated tablets, 60 mg film-coated tablets

Please read 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 questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms
are the same as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor,
pharmacist or nurse. See section 4.
Contents of this leaflet

1. What Atorvastatin EG is and what it is used for
2. What you need to know before taking Atorvastatin EG
3. How to take Atorvastatin EG
4. Possible side effects
5. How to store Atorvastatin EG
6. Contents of the pack and other information

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

Atorvastatin EG contains the active substance atorvastatin, which belongs to a class of medicines known as statins, which regulate lipid (fat) levels.
Atorvastatin EG is used to reduce levels of lipids in the blood, known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes have not been effective. If you are at high risk of heart disease, Atorvastatin EG may also be used to reduce this risk, even if cholesterol levels are normal. You must continue a cholesterol-lowering diet during treatment.

2. What you need to know before taking Atorvastatine EG

DO NOT take Atorvastatine EG
if you are allergic to atorvastatin or to any of the other ingredients of this medicine
(listed in section 6);
if you have or have had liver disease;
if liver function tests have shown unexplained abnormal results;
if you are a woman of childbearing age and are not using a reliable method of contraception;
if you are pregnant or planning to become pregnant;
if you are breastfeeding;
if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Atorvastatine EG if:

• you suffer from severe respiratory insufficiency;
• you have previously had a stroke with cerebral haemorrhage or have low cerebrospinal fluid reserves due to previous strokes;
• you have kidney problems;
• you have an underactive thyroid gland (hypothyroidism);
• you have previously experienced repeated or unexplained muscle pain, or have a personal or family history of muscle disorders;
• you have previously had muscle problems while being treated with other lipid-lowering medicines (e.g. other medicines of the statin or fibrate class);
• you regularly consume large amounts of alcohol;
• you have a history of liver disease;
• you are over 70 years old;
• you are currently taking or, within the last 7 days, have taken orally or received by injection a medicine called fusidic acid (used to treat bacterial infections).

The combination of fusidic acid and Atorvastatine EG can cause serious muscle problems (rhabdomyolysis).

If any of the conditions listed above apply to you, your doctor should perform a blood test before and possibly during treatment with Atorvastatine EG to assess your risk of developing muscle-related side effects. It is known that the risk of muscle-related adverse effects (e.g. rhabdomyolysis) increases when certain medicines are taken concurrently (see section 2 “Other medicines and Atorvastatine EG”).

Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatments may be required to diagnose and manage this condition.

During treatment with this medicine, your doctor will carefully monitor whether you have diabetes or are at risk of developing diabetes. You are at increased risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.

Other medicines and Atorvastatine EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines can alter the effect of Atorvastatine EG, or the effect of these medicines can be altered by Atorvastatine EG. This type of interaction may reduce the effectiveness of one or both medicines. Alternatively, it may increase the risk or severity of side effects, including a condition involving muscle breakdown known as rhabdomyolysis, described in section 4:

• Medicines used to modify the way the immune system works, e.g. cyclosporine.
• Some antibiotics or antifungals, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
  • If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Atorvastatine EG. Taking Atorvastatine EG with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See section 4 for more information on rhabdomyolysis.
• Other medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol.
• Some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone.
• Medicines used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
• Some medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medicines known to interact with Atorvastatine EG include ezetimibe (a cholesterol-lowering agent), warfarin (reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium and magnesium).
• Over-the-counter medicines: St. John’s wort.

Atorvastatine EG with food, drinks and alcohol
See section 3 for instructions on how to take Atorvastatine EG. Please note the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice may alter the effects of Atorvastatine EG.

Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. See section 2 “Warnings and precautions”.

Pregnancy and breastfeeding

• Do not take Atorvastatine EG if you are pregnant or planning to become pregnant.
• Do not take Atorvastatine EG if you are of childbearing age unless you are using an effective method of contraception.
• Do not take Atorvastatine EG if you are breastfeeding. The safety of atorvastatin during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
This medicine usually does not affect your ability to drive or operate machinery. However, do not drive if this medicine impairs your ability to do so. Do not use tools or machinery if your ability to use them is impaired by this medicine.

Atorvastatine EG contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

Atorvastatine EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Atorvastatina EG

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must follow throughout your treatment with Atorvastatina EG.

Dosage

• The recommended starting dose of atorvastatin is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose until the required dose is reached.
• Your doctor will adjust the dose at intervals of 4 or more weeks.
• The maximum dose of atorvastatin is 80 mg once daily.

Method of administration
Atorvastatina EG tablets should be swallowed whole with a glass of water and may be taken at any time of day, with or without food. However, try to take the tablets at the same time each day.
The score line on the tablet is not intended for dividing the tablet.

The duration of treatment with Atorvastatina EG will be determined by your doctor.
If you feel that the effect of Atorvastatina EG is too strong or too weak, talk to your doctor.

If you take more Atorvastatina EG than you should
If you accidentally take too many Atorvastatina EG tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

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

If you stop taking Atorvastatina EG
If you have any doubts about using this medicine or wish to stop treatment, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects or serious symptoms, stop taking the tablets
immediately and contact your doctor or go to the nearest hospital emergency department.

Rare: may affect up to 1 in 1,000 people

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe difficulty in breathing.
• Serious condition associated with severe peeling and swelling of the skin, skin blisters, blisters in the mouth, eyes, or genital area, and fever. Skin rash with red spots, particularly on the palms of the hands or soles of the feet, which may develop into blisters.
• If you experience muscle weakness, tenderness, or pain, especially if you also feel unwell and have a high fever, this may be due to abnormal breakdown of muscles (rhabdomyolysis). Abnormal muscle breakdown may not always resolve even after stopping atorvastatin and can potentially be fatal and cause kidney problems.

Very rare: may affect up to 1 in 10,000 people

• If you experience unexpected or unusual bleeding or bruising, this may indicate a liver disorder. Consult your doctor as soon as possible.
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).

Other possible side effects of Atorvastatin EG

Common: may affect up to 1 in 10 people

• Nasal inflammation, sore throat, nosebleeds.
• Allergic reactions.
• Increased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully), increased creatine kinase in the blood.
• Headache.
• Nausea, constipation, flatulence, indigestion, diarrhoea.
• Joint pain, muscle pain, and back pain.
• Changes in liver function tests.

Uncommon: may affect up to 1 in 100 people

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully).
• Nightmares, insomnia.
• Dizziness, reduced sensation or tingling in fingers and toes, reduced sensitivity to pain or touch, altered taste, memory loss.
• Blurred vision.
• Ringing in the ears and/or head.
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas with stomach pain).
• Hepatitis (inflammation of the liver).
• Skin rash, skin exanthema and itching, hives, hair loss.
• Neck pain, muscle fatigue.
• Fatigue, malaise, weakness, chest pain, swelling, especially in the ankles (oedema), increased body temperature.
• Positive urine test for white blood cells.

Rare: may affect up to 1 in 1,000 people

• Vision disturbances.
• Unexpected bleeding or bruising.
• Cholestasis (yellowing of the skin and whites of the eyes).
• Tendon damage.

Very rare: may affect up to 1 in 10,000 people

• Allergic reaction – symptoms may include sudden wheezing and chest pain or tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse.
• Hearing loss.
• Gynaecomastia (enlargement of the breasts in men).

Not known: frequency cannot be estimated from the available data

• Persistent muscle weakness.

Possible side effects reported with some statins (medicines of the same type):

• Sexual difficulties.
• Breathing problems, including persistent cough and/or shortness of breath or fever.
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atorvastatin EG

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after the word
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Atorvastatina EG 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 components of Atorvastatina EG are:
Monohydrate lactose, microcrystalline cellulose, calcium carbonate, pregelatinized starch, hypromellose,
sodium croscarmellose, magnesium stearate.
The coating of Atorvastatina EG contains hypromellose, macrogol, titanium dioxide (E171), talc.

Description of the appearance of Atorvastatina EG and package contents
Film-coated tablet.
30 mg tablet: round, biconvex, film-coated tablets, white to off-white in colour, with a score line on one side and a diameter of 9 mm.
60 mg tablet: round, biconvex, film-coated tablets, white to off-white in colour, with a score line on one side and a diameter of 11 mm.
The score line is not intended to divide the tablet into equal doses.
Blister packs made of OPA/Al/PVC-Al containing 30, 50 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy

Manufacturer
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel, Germany

This medicinal product is authorized in the European Economic Area countries under the
following names:
DE Atorvastatin AL 30 mg Filmtabletten
IT ATORVASTATINA EG
NL Atorvastatine STADA 30 mg, filmomhulde tabletten