Atorvastatin Sandoz GmbH: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Atorvastatine Sandoz GmbH 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

Generic medicine
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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:
1 What Atorvastatine Sandoz GmbH is and what it is used for
2 What you need to know before taking Atorvastatine Sandoz GmbH
3 How to take Atorvastatine Sandoz GmbH
4 Possible side effects
5 How to store Atorvastatine Sandoz GmbH
6 Contents of the pack and other information

1. What Atorvastatina Sandoz GmbH is and what it is used for

Atorvastatina Sandoz GmbH belongs to a class of medicines called statins, which regulate lipid (fat) levels.
Atorvastatina Sandoz GmbH is used to reduce lipid levels in the blood, known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes have not been successful. If you are at high risk of cardiovascular disease, Atorvastatina Sandoz GmbH may also be used to reduce this risk, even if cholesterol levels are normal. During treatment, you must continue to follow a standard cholesterol-lowering diet.

2. What you need to know before taking Atorvastatine Sandoz GmbH

Do not take Atorvastatine Sandoz GmbH

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 a 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 Sandoz GmbH if:

you suffer from severe respiratory insufficiency
you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and Atorvastatine Sandoz GmbH may cause serious muscle problems (rhabdomyolysis)
you have previously had a stroke with cerebral haemorrhage or if you have low levels of fluid in the brain 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 in 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

If any of these conditions apply to you, your doctor will need to perform a blood test before and possibly during treatment with Atorvastatine Sandoz GmbH to assess the risk of muscle-related side effects. It is known that the risk of muscle-related adverse effects (e.g. rhabdomyolysis) increases when certain medicines are taken concomitantly (see section 2 “Other medicines and Atorvastatine Sandoz GmbH”).
Additionally, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and treatments may be required to diagnose and manage this condition.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at 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 Sandoz GmbH
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines may alter the effect of Atorvastatine Sandoz GmbH, or the effect of these medicines may be altered by Atorvastatine Sandoz GmbH. Such interactions may reduce the effect of one or both medicines. Alternatively, they 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
Certain antibiotics or antifungals, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin
Other medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
Certain 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, letermovir, etc.
Certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir
Other medicines known to interact with Atorvastatine Sandoz GmbH include ezetimibe (a cholesterol-lowering agent), warfarin (reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach pain 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.
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 Sandoz GmbH. Taking Atorvastatine Sandoz GmbH with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For further information, read the section on rhabdomyolysis in section 4.

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

Grapefruit juice
You should 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 Sandoz GmbH.

Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For details, refer to section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Do not take Atorvastatine Sandoz GmbH if you are pregnant or planning to become pregnant.
Do not take Atorvastatine Sandoz GmbH if you think you could become pregnant unless you are using an effective method of contraception.
Do not take Atorvastatine Sandoz GmbH if you are breastfeeding.
The safety of Atorvastatine Sandoz GmbH during pregnancy and breastfeeding has not yet been established. Ask your doctor or pharmacist for advice before taking any medicine.

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

Atorvastatine Sandoz GmbH contains sodium. It contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Atorvastatina Sandoz GmbH

Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must follow both before and during therapy with Atorvastatina Sandoz GmbH.
The usual starting dose of Atorvastatina Sandoz GmbH is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose gradually until the required dose is reached. Your doctor will adjust the dosage at intervals of 4 weeks or more. The maximum dose of Atorvastatina Sandoz GmbH is 80 mg once daily.
Atorvastatina Sandoz GmbH tablets should be swallowed whole with 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.
Always take this medicine exactly as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with Atorvastatina Sandoz GmbH will be determined by your doctor.
If you feel that the effect of Atorvastatina Sandoz GmbH is too strong or too weak, consult your doctor.
If you take more Atorvastatina Sandoz GmbH than you should
If you accidentally take too many Atorvastatina Sandoz GmbH tablets (more than the prescribed dose), contact your doctor or the nearest hospital for advice immediately.
If you forget to take Atorvastatina Sandoz GmbH
If you forget to take a dose, take the next dose at the scheduled time. Do not take a double dose to make up for the missed tablet.
If you stop taking Atorvastatina Sandoz GmbH
If you have any questions about using this medicine or if you wish to discontinue treatment, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following serious side effects or symptoms, stop taking your tablets immediately and contact your doctor right away 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 windpipe, which may lead to significant breathing difficulties.
A serious condition associated with severe peeling and swelling of the skin, skin blisters, blisters in the mouth, eyes, and 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, pain, muscle breakdown, or red-brown discoloration of the urine, especially if you also feel unwell and have a high fever, this may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve after stopping atorvastatin and can potentially be fatal and lead to kidney problems.

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

Unexpected or unusual bleeding or bruising, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These symptoms may indicate a liver disorder. You should contact your doctor as soon as possible.
Lupus-like illness (including skin rash, joint problems, and effects on blood cells).

Other side effects that may occur with Atorvastatin Sandoz GmbH

Common (may affect up to 1 in 10 people):

Nasal airway inflammation, sore throat, nosebleeds
Allergic reactions
Increased blood glucose levels (if you have diabetes, you should continue to monitor your blood sugar levels closely), increased blood creatine kinase
Headache
Nausea, constipation, flatulence, indigestion, diarrhoea
Joint pain, joint swelling, muscle pain, muscle spasms, 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 closely)
Nightmares, insomnia
Dizziness, reduced sensitivity or tingling in the fingers and toes, reduced sensitivity to pain or touch, altered taste, memory loss
Blurred vision
Ringing in the ears and/or head
Vomiting, belching, abdominal pain, pancreatitis (inflammation of the pancreas with stomach pain)
Hepatitis (liver inflammation)
Skin rash, 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 leukocytes

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

Vision disorders
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 shortness of breath 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
Depression
Breathing difficulties including persistent cough and/or breathlessness 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 effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Atorvastatina Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister,
after the word "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
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 Sandoz GmbH contains
The active substance is atorvastatin (as dicalcium salt).
Each film-coated tablet contains 10 mg of atorvastatin (as calcium salt).
Each film-coated tablet contains 20 mg of atorvastatin (as calcium salt).
Each film-coated tablet contains 40 mg of atorvastatin (as calcium salt).
Each film-coated tablet contains 80 mg of atorvastatin (as calcium salt).
The other components are: sodium lauryl sulfate, microcrystalline cellulose, anhydrous colloidal silica, pregelatinized corn starch, tromethamine, yellow iron oxide (E 172), magnesium stearate, talc, sodium starch glycolate (type A), sodium croscarmellose, glycerol and hydroxyethylcellulose.

Description of the appearance of Atorvastatina Sandoz GmbH and package contents
10 mg film-coated tablets
Light yellow, mottled, shiny, round, biconvex, film-coated tablets, with the imprint “HLA 10” on one side, 7.2 mm in diameter.
20 mg film-coated tablets
Light yellow, mottled, shiny, round, biconvex, film-coated tablets, with the imprint “HLA 20” on one side, 9.2 mm in diameter.
40 mg film-coated tablets
Light yellow, mottled, shiny, round, biconvex, film-coated tablets, with the imprint “HLA 40” on one side, 11.2 mm in diameter.
80 mg film-coated tablets
Light yellow, mottled, shiny, oval, biconvex, film-coated tablets, with the imprint “HLA 80” on one side, 19.3 mm in length.

The film-coated tablets are packaged in aluminum/aluminum blisters contained in cardboard packaging.

Pack sizes:
10 mg film-coated tablets: 7, 14, 28, 30, 56, 60, 63, 90, 91, 100
20 mg film-coated tablets: 7, 14, 28, 30, 56, 60, 63, 90, 91, 100
40 mg film-coated tablets: 7, 14, 28, 30, 56, 60, 63, 90, 91, 100
80 mg film-coated tablets: 7, 28, 30, 50, 60, 90, 98, 100

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH – Biochemiestrasse 10 – 6250 Kundl (Austria)
Local representative in Italy: Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Responsible manufacturers for batch release
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia
Lek SA, Ul. Domaniewska 50 C, 02-672 Warsaw, Poland
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
AT Atorcall 10 mg – Filmtabletten
Atorcall 20 mg – Filmtabletten
Atorcall 40 mg – Filmtabletten
Atorcall 80 mg – Filmtabletten
Atorcall 30 mg – Filmtabletten
Atorcall 60 mg – Filmtabletten
BE Atorasat 10 mg filmomhulde tabletten
Atorasat 20 mg filmomhulde tabletten
Atorasat 40 mg filmomhulde tabletten
Atorasat 80 mg filmomhulde tabletten
Atorasat 30 mg filmomhulde tabletten
Atorasat 60 mg filmomhulde tabletten
FR ATORVASTATINE GNR 10 mg, comprimé pelliculé
ATORVASTATINE GNR 20 mg, comprimé pelliculé
ATORVASTATINE GNR 40 mg, comprimé pelliculé
ATORVASTATINE SANDOZ 80 MG, comprimé pelliculé
GR ROTACOR
IT ATORVASTATINA SANDOZ GMBH
NL Atorvastatine Sandoz tablet 10 mg, filmomhulde tabletten
UK Atorvastatin 10 mg Film-coated Tablets
Atorvastatin 20 mg Film-coated Tablets
Atorvastatin 40 mg Film-coated Tablets
Atorvastatin 80 mg Film-coated Tablets

This summary of product characteristics was last approved on