Atoris

Patient Information Leaflet: Information for the User

Atoris 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Atorvastatin
Equivalent medicine
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours. If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Atoris is and what it is used for

Atoris belongs to a group of medicines called statins, which are lipid-regulating drugs (fats).
Atoris is used to reduce lipids known as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes without other measures have failed. If you are at increased risk of heart disease, Atoris may also be used to reduce this risk even if your cholesterol levels are normal. A standard cholesterol-lowering diet must be continued during treatment.

2. What you need to know before taking Atoris

Do not take Atoris:

• If you are allergic to atorvastatin or to similar medicines used to lower blood fats, or to any of the excipients of this medicine (listed in section 6).
• If you have or have had any liver disease.
• If you have had unexplained abnormal blood test results indicating liver problems.
• If you are a woman who could become pregnant and you are not using a reliable method of contraception.
• If you are pregnant or trying 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 or pharmacist before taking Atoris.
Atoris may not be suitable for you for the following reasons:

• If you have previously had a stroke with brain haemorrhage, or if you have small fluid-filled pockets in the brain following previous strokes.
• If you have kidney problems.
• If your thyroid gland is underactive (hypothyroidism).
• If you have experienced recurrent or unexplained muscle pain, or if you or a family member have ever had muscle problems. Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.
• If you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g. other medicines known as “statins” or “fibrates”).
• If you regularly consume large amounts of alcohol.
• If you have a history of liver disease.
• If you are over 70 years old.

Talk to your doctor or pharmacist before taking Atoris

• if you suffer from severe respiratory failure.

If any of the above apply to you, your doctor may carry out blood tests before and probably during your treatment with Atoris, to assess the risk of muscle-related side effects. The risk of muscle-related side effects, such as rhabdomyolysis, is known to increase when certain medicines are taken at the same time (see section 2 “Other medicines and Atoris”).
While you are being treated with this medicine, your doctor will carefully 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, if you are overweight, and if you have high blood pressure.
Other medicines and Atoris
Some medicines may alter the effect of Atoris, or their effect may be altered by Atoris. Such interactions may make one or both medicines less effective. Conversely, this could also increase the risk or severity of side effects, including a serious condition involving muscle breakdown known as rhabdomyolysis, described in section 4:

• Medicines used to modify the activity of the immune system, e.g. cyclosporine.
• Certain antibiotic and antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• 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 used to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone.
• Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination tipranavir/ritonavir, etc.
• Certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medicines known to interact with Atoris include ezetimibe (a cholesterol-lowering medicine), warfarin (a blood thinner), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).
• Over-the-counter medicines: St. John’s wort.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Atoris with food and drink
See section 3 for instructions on how to take Atoris. 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 Atoris.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. See section 2 “Warnings and precautions” for further information.
Pregnancy and breastfeeding
Do not take Atoris if you are pregnant or trying to become pregnant.
Do not take Atoris if you are of childbearing age unless you are using reliable contraception.
Do not take Atoris while breastfeeding.
The safety of Atoris during pregnancy and breastfeeding has not been established.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine usually does not affect your ability to drive or use machines. Do not drive if this medicine affects your ability to drive. Do not use any tools or machinery if your ability to use them is affected by this medicine.
Atoris contains lactose and sodium
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to take Atoris

Always take this medicine exactly as instructed by your doctor or pharmacist. 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 both before and during therapy with Atoris.
The usual starting dose of Atoris is 10 mg once daily in adults and children above 10 years of age. If necessary, your doctor may increase this dose until you are taking the amount needed. Your doctor will adjust the dosage at intervals of 4 weeks or more. The maximum dose of Atoris is 80 mg once daily in adults and 20 mg once daily in children.
Atoris tablets must be swallowed whole with a glass of water and can be taken at any time of day, regardless of meals. However, try to take your tablet at the same time each day.
The duration of treatment with Atoris will be determined by your doctor.
Contact your doctor if you think the effect of Atoris is too strong or too weak.
If you take more Atoris than you should
If you accidentally take too many Atoris tablets (more than your usual daily dose), contact your doctor or the nearest hospital immediately.
If you forget to take Atoris
If you forget to take a dose, simply take the next dose at the correct time.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions about the use of this medicine or if you wish to stop treatment, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you notice any of the following serious side effects or 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 cause severe breathing difficulties.
• Severe illness with extensive peeling and swelling of the skin, blistering of the skin, mouth, eyes and genitals, and fever. Skin rash with red spots, particularly on the palms of the hands and soles of the feet, which may develop into blisters.
• Muscle weakness, tenderness, pain, muscle breakdown or red-brown coloured urine, particularly if you also feel unwell and have a high temperature. This may be due to abnormal muscle damage (rhabdomyolysis). Abnormal muscle damage does not always resolve even after stopping atorvastatin, and may be life-threatening and lead to 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. You should consult your doctor as soon as possible.
• Lupus-like syndrome (including skin rash, joint disorders and effects on blood cells).

Other possible side effects with Atoris:
Common side effects (may affect up to 1 in 10 people) include:

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully), increased creatine phosphokinase
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain and back pain
• Changes in blood test parameters indicating abnormal liver function

Uncommon side effects (may affect up to 1 in 100 people) include:

• Anorexia (loss of appetite), weight gain, decreased blood glucose levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers and fingertips, reduced sensitivity to pain or pressure, altered taste sensation, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing stomach pain)
• Hepatitis (inflammation of the liver)
• Rash, skin eruptions and itching, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, feeling unwell, weakness, chest pain, swelling, particularly of the ankles (oedema), high temperature
• Positive urine test for white blood cells

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

• Vision disorders
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon injury

Very rare side effects (may affect up to 1 in 10,000 people) include:

• Allergic reaction – symptoms may include shortness of breath and chest pain, chest tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• Hearing loss
• Gynaecomastia (breast enlargement 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
• Respiratory 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 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 Atoris

Keep this medicine out of the sight and reach of children.
Do not use Atoris after the expiry date stated on the pack and blister after EXP.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
No special storage temperature requirements apply to this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Atoris contains:

• The active substance is atorvastatin. Each film-coated tablet of Atoris contains 10 mg, 20 mg or 40 mg atorvastatin as atorvastatin calcium.
• The other components are: Tablet core: sodium hydroxide, sodium lauryl sulfate, hydroxypropylcellulose, monohydrate lactose (see section 2 "Atoris contains lactose and sodium"), microcrystalline cellulose, sodium croscarmellose, crospovidone, magnesium stearate. Film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3000 and talc in the film coating.

Description of the appearance of Atoris and contents of the pack
The 10 mg film-coated tablets are white, round, slightly convex, with bevelled edges, 6 mm in diameter.
The 20 mg film-coated tablets are white, round, slightly convex, with bevelled edges, 8 mm in diameter.
The 40 mg film-coated tablets are white, round, slightly convex, with bevelled edges, 10 mm in diameter.
Blister packs containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative in Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Package leaflet: Information for the user

Atoris 30 mg film-coated tablets, 60 mg film-coated tablets, 80 mg film-coated tablets

Atorvastatin
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 they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Atoris is and what it is used for

Atoris belongs to a group of medicines called statins, which are lipid-regulating (fat-regulating) drugs.
Atoris is used to reduce levels of lipids known as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes without other measures have failed. If you are at increased risk of heart disease, Atoris may also be used to reduce this risk, even if your cholesterol levels are normal. A standard cholesterol-lowering diet should be continued during treatment.

2. What you should know before taking Atoris

Do not take Atoris:

• If you are allergic to atorvastatin or to similar medicines used to reduce blood fats, or to any of the excipients of this medicine (listed in section 6).
• If you have or have had any liver disease.
• If you have had unexplained abnormal blood test results indicating liver problems.
• If you are a woman who could become pregnant and you are not using reliable contraception.
• If you are pregnant or trying 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 or pharmacist before taking Atoris.
Atoris may not be suitable for you for the following reasons:

• If you have previously had a stroke with bleeding into the brain, or if you have small pockets of fluid in the brain following previous strokes.
• If you have kidney problems.
• If your thyroid gland is underactive (hypothyroidism).
• If you suffer from recurrent or unexplained muscle pain, or if you or a family member have ever had muscle disorders. Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.
• If you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g. other drugs known as "statins" or "fibrates").
• If you regularly consume large amounts of alcohol.
• If you have a history of liver disease.
• If you are over 70 years of age.
• If you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used for bacterial infections). The combination of fusidic acid and Atoris can lead to serious muscle problems (rhabdomyolysis).

Check with your doctor or pharmacist before taking Atoris

• If you suffer from severe respiratory failure. If any of the above conditions apply to you, your doctor may need to perform blood tests before and probably during your treatment with Atoris, to assess the risk of muscle-related side effects. The risk of muscle-related side effects, such as rhabdomyolysis, is known to increase when certain medicines are taken at the same time (see section 2 “Other medicines and Atoris”).

Other medicines and Atoris
Some medicines may alter the effect of Atoris, or their effects may be altered by Atoris. This type of interaction may make one or both medicines less effective. Conversely, it could also increase the risk or severity of adverse effects, including a serious condition of muscle breakdown known as rhabdomyolysis, described in section 4:

• Medicines used to alter the activity of the immune system, 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, 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 in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
• Certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Other medicines known to interact with Atoris include ezetimibe (a cholesterol-lowering agent), warfarin (a blood thinner), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (dyspepsia remedies containing aluminium or magnesium).
• Over-the-counter medicines: St. John’s wort.
• If you need to take oral fusidic acid for the treatment of bacterial infections, you must temporarily stop taking this medicine. Your doctor will advise you when to restart Atoris. Taking Atoris with fusidic acid may lead to symptoms of muscle weakness, pain or tenderness (rhabdomyolysis). See further information on rhabdomyolysis in section 4. Inform your doctor or pharmacist if you are taking or have recently taken any other medicine.

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, if you are overweight, or if you have high blood pressure.

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

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

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

Pregnancy and breastfeeding
Do not take Atoris if you are pregnant or trying to become pregnant.
Do not take Atoris if you are of childbearing age unless you are using reliable contraception.
Do not take Atoris while breastfeeding.
The safety of Atoris during pregnancy and breastfeeding has not been established. Ask your doctor or pharmacist for advice before taking this medicine.

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

Atoris contains lactose and sodium
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to take Atoris

Always take this medicine exactly as instructed by your doctor or pharmacist. 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 also during therapy with Atoris.
The usual starting dose of atorvastatin is 10 mg once daily in adults and children over 10 years of age. If necessary, this dose may be increased by your doctor until the required amount is reached. Your doctor will adjust the dosage at intervals of 4 weeks or more. The maximum dose of Atoris is 80 mg once daily in adults and 20 mg once daily in children.
Atoris tablets must be swallowed whole with a glass of water and may be taken at any time of day, regardless of meals. However, try to take your tablet at the same time each day.
The duration of treatment with Atoris will be determined by your doctor.
Contact your doctor if you think that the effect of Atoris is too strong or too weak.
If you take more Atoris than you should
If you accidentally take too many Atoris tablets (more than your usual daily dose), contact your doctor or the nearest hospital immediately.
If you forget to take Atoris
If you forget to take a dose, simply take the next dose at the correct time.
Do not take a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine or if you wish to discontinue treatment, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this one may cause side effects, although not everybody gets them.
If you notice any of the serious side effects or symptoms listed below, stop taking the tablets immediately and contact your doctor or go to the nearest hospital emergency department straight away.

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

• Severe allergic reaction causing swelling of the face, tongue and throat, which may cause severe breathing difficulties.
• Severe illness with extensive peeling and swelling of the skin, blistering on the skin, mouth, eyes and genitals, fever. Skin rash with red spots, particularly on the palms of the hands and soles of the feet, which may develop into blisters.
• Muscle weakness, fragility, pain, muscle breakdown or red-brown discoloration of urine, especially if accompanied by feeling unwell and high temperature. This may be due to abnormal muscle damage (rhabdomyolysis). Abnormal muscle damage may not always resolve even after stopping atorvastatin, and can be life-threatening and lead to 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. You should consult your doctor as soon as possible.
• Lupus-like syndrome (including skin rash, joint disorders and effects on blood cells).

Other possible side effects with Atoris:
Common side effects (may affect up to 1 in 10 people):

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully), increased creatine kinase
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain and back pain
• Changes in blood test parameters indicating abnormal liver function

Uncommon side effects (may affect up to 1 in 100 people):

• Anorexia (loss of appetite), weight gain, decreased blood glucose levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers and fingertips, reduced sensitivity to pain or pressure, altered taste sensation, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing stomach pain)
• Hepatitis (inflammation of the liver)
• Rash, skin eruption and itching, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, feeling unwell, weakness, chest pain, swelling, especially of the ankles (oedema), high temperature
• Positive urine test for white blood cells

Rare side effects (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 injury

Very rare side effects (may affect up to 1 in 10,000 people):

• Allergic reaction – symptoms may include shortness of breath, chest pain and chest tightness, 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
• Respiratory problems including persistent cough and/or shortness of breath or fever
• Diabetes. This is more likely if you have high levels of sugar and fat 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 get 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 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 Atoris

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from moisture.
This medicine does not require any special temperature conditions for storage.
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 month indicated.
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 Atoris contains:

• The active substance is atorvastatin. Each film-coated Atoris tablet of 30 mg, 60 mg or 80 mg contains 30 mg, 60 mg or 80 mg of atorvastatin as atorvastatin calcium, respectively.
• The other ingredients are: sodium hydroxide, hydroxypropylcellulose (E463), monohydrate lactose (see section 2 "Atoris contains lactose and sodium"), microcrystalline cellulose (E460), sodium croscarmellose, crospovidone type A, magnesium stearate (E470b) and polysorbate 80 in the tablet core; polyvinyl alcohol, titanium dioxide (E171), macrogol 3000 and talc (E553b) in the coating film.

Description of the appearance of Atoris and pack sizes
The 30 mg film-coated tablets are white to almost white, round, slightly biconvex, with bevelled edges and 9 mm in diameter.
The 60 mg film-coated tablets are white to almost white, oval, biconvex, 16 mm x 8.5 mm in size.
The 80 mg film-coated tablets are white to almost white, capsule-shaped, biconvex, 18 mm x 9 mm in size.
Blister packs containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets are available.
Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative in Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany