Mullusiem

Patient Information Leaflet

Mullusiem 10 mg film-coated tablets, 20 mg film-coated tablets, 30 mg film-coated tablets, 40 mg film-coated tablets, 60 mg film-coated tablets, 80 mg film-coated tablets

atorvastatin
Generic medicine
Please read all of this leaflet carefully before you start using this medicine, as 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, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Mullusiem is and what it is used for

Mullusiem belongs to a group of medicines called statins, which regulate lipid (fat) levels.
Mullusiem 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, Mullusiem may also be used to reduce this risk, even if your cholesterol levels are normal. During treatment, you must continue to follow a standard cholesterol-lowering diet.

2. What you need to know before taking Mullusiem

Do not take Mullusiem

• 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 ever had a liver disease
• if you have had unexplained abnormal results in liver function tests
• if you are a woman of childbearing age and do not use 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 Mullusiem

• if you suffer from severe respiratory insufficiency
• 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 Mullusiem can cause serious muscle problems (rhabdomyolysis).
• if you have previously had a stroke with cerebral haemorrhage or if you have small fluid-filled pockets in the brain due to previous strokes
• if you have kidney problems
• if you have an underactive thyroid (hypothyroidism)
• if you have had repeated or unexplained muscle pain, or a personal or family history of muscle disorders
• if you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g. other medicines in the statin or fibrate class)
• if you have or have had myasthenia (a disease causing generalised muscle weakness, including in some cases the muscles used for breathing), or ocular myasthenia (a disease causing weakness of the eye muscles), since statins may sometimes worsen this condition or lead to the onset of myasthenia (see section 4).
• if you regularly consume large amounts of alcohol
• if you have a history of liver disease
• if you are over 70 years old

If any of these conditions apply to you, your doctor should perform a blood test
before and possibly during treatment with Mullusiem to assess the risk of muscle-related
adverse effects. It is known that the risk of muscle-related adverse effects (e.g. rhabdomyolysis) increases
when certain medicines are taken at the same time (see section 2 “Other medicines and
Mullusiem”).
Also inform your doctor or pharmacist if you have persistent muscle weakness.
Further tests and medicines may be needed to diagnose and treat this condition.
During treatment with this medicine, your doctor will carefully monitor whether you have diabetes or are at
risk of developing diabetes. The risk of developing diabetes is higher if you have high levels of sugar and fats
in the blood, are overweight, and have high blood pressure.

Other medicines and Mullusiem
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine.
Some medicines can alter the effect of Mullusiem, or their effect can be altered by
Mullusiem. 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 condition of
muscle breakdown known as rhabdomyolysis described in section 4:
Medicines used to modify the activity of the immune system, e.g. cyclosporine.
Some 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.
Some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine,
diltiazem; medicines for regulating heart rhythm, e.g. digoxin, verapamil, amiodarone.
Letermovir, a medicine that helps prevent illness caused by cytomegalovirus.
Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir,
the combination of tipranavir/ritonavir, etc.
Some medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir and the combination of
elbasvir/grazoprevir, ledipasvir/sofosbuvir.
Other medicines known to interact with Mullusiem, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach pain or peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout) and antacids (products against indigestion 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 will need to temporarily stop
taking this medicine. Your doctor will tell you when it is safe to resume taking Mullusiem.
Taking Mullusiem with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).

Mullusiem with food and drink
See section 3 for instructions on how to take Mullusiem. Please note the following:
Grapefruit juice
You should not drink more than one or two small glasses per day of grapefruit juice, as large quantities of
grapefruit juice may alter the effects of Mullusiem.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, consult
section 2 “Warnings and Precautions”.

Pregnancy and breastfeeding
DO NOT take Mullusiem if you are pregnant or trying to become pregnant.
DO NOT take Mullusiem if you are of childbearing age unless you are using an effective method of contraception.
DO NOT take Mullusiem if you are breastfeeding.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
The safety of atorvastatin 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 the ability to drive or use machines. However, do not drive if you notice
that this medicine impairs your ability to drive. Do not use tools or machinery if your ability to use them is
impaired by this medicine.

Mullusiem contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take MULLUSIEM

Take this medicine exactly as directed 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 continue
throughout your therapy with Mullusiem.
The recommended starting dose of Mullusiem is 10 mg once daily in adults and children aged
10 years and older. If necessary, this dose may be increased by your doctor to reach the amount you need.
Your doctor will adjust the dose at intervals of 4 or more weeks.
The maximum dose of Mullusiem is 80 mg once daily.
Mullusiem tablets must 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.
Mullusiem 20 mg, 40 mg and 80 mg
The tablet may be divided into equal doses.
The duration of treatment with Mullusiem will be determined by your doctor.
If you feel that the effect of Mullusiem is too strong or too weak, consult your doctor.
If you take more Mullusiem than you should
If you accidentally take too many Mullusiem tablets (more than your usual dose), contact your doctor or the nearest hospital
for advice.
If you forget to take Mullusiem
If you forget to take a dose, take the next scheduled dose at the correct time. DO NOT take a double
dose to make up for the missed dose.
If you stop taking Mullusiem
If you have any doubts about taking 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 gets them.
If you notice any of the following serious side effects or symptoms listed below, 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 breathing difficulties.
• Severe illness associated with extensive peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with reddish spots, particularly on the palms of the hands or soles of the feet, which may develop into blisters.
• Weakness, tenderness, pain, or tearing of muscles, or red-brown discoloration of urine, especially if accompanied by feeling unwell and high fever. This may be due to unusual muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve 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 suggest a liver disorder. You should contact your doctor as soon as possible.
• Lupus-like disease syndrome (including skin rash, joint disorders, and effects on blood cells).

Other side effects that may occur with Mullusiem:

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 closely), 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 closely)
• Nightmares, insomnia
• Dizziness, reduced sensitivity 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)
• Rash, itchy rash, urticaria, 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 (white blood cells).

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

• Vision disorders
• Unexpected bleeding or bruising
• Jaundice (yellowing of the skin and whites of the eyes)
• Tendon damage
• Skin rash or mouth sores (drug-induced lichenoid reaction)
• Purple lesions on the skin (signs of blood vessel inflammation, vasculitis).

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

• Allergic reaction – symptoms may include sudden wheezing, 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.
• Severe myasthenia gravis (a condition causing generalised muscle weakness, including in some cases the muscles used for breathing)
• Ocular myasthenia (a condition causing weakness of the eye muscles)
• Contact your doctor if you experience worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

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. The risk of developing diabetes is higher if you have high levels of sugar and fats in the blood, are overweight, or 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, inform your doctor or pharmacist.
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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Mullusiem

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, packaging and bottle after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Mullusiem contains

• The active substance is atorvastatin. Each film-coated tablet contains 10 mg of atorvastatin. Each film-coated tablet contains 20 mg of atorvastatin. Each film-coated tablet contains 30 mg of atorvastatin. Each film-coated tablet contains 40 mg of atorvastatin. Each film-coated tablet contains 60 mg of atorvastatin. Each film-coated tablet contains 80 mg of atorvastatin.
• The other components are: Tablet core: microcrystalline cellulose, calcium carbonate (E170), maltose, sodium croscarmellose (E466), polysorbate 80 (E433), magnesium aluminium silicate, and magnesium stearate (E470b). Tablet coating: hypromellose (E464), hydroxypropylcellulose (E463), triethyl citrate (E1505), polysorbate 80 (E433), titanium dioxide (E171).

Description of the appearance of Mullusiem and contents of the pack
Mullusiem 10 mg are white to almost white, elliptical, biconvex, film-coated tablets,
with "10" printed on one side and smooth on the other side. Size: approximately 8 mm x 4 mm.
Mullusiem 20 mg are white to almost white, elliptical, biconvex, film-coated tablets,
with "20" printed on one side and a score line on the other side. Size: approximately 10 mm x 6 mm.
Mullusiem 30 mg are white to almost white, elliptical, biconvex, film-coated tablets,
with "30" printed on one side and smooth on the other side. Size: approximately 12 mm x 6 mm.
Mullusiem 40 mg are white to almost white, elliptical, biconvex, film-coated tablets,
with "40" printed on one side and a score line on the other side. Size: approximately 13 mm x 7 mm.
Mullusiem 60 mg are white to almost white, elliptical, biconvex, film-coated tablets,
with "60" printed on one side and smooth on the other side. Size: approximately 14 mm x 8 mm.
Mullusiem 80 mg are white to almost white, elliptical, biconvex, film-coated tablets,
with "80" printed on one side and a score line on the other side. Size: approximately 16 mm x 9 mm.
Mullusiem 10 mg is available in blister packs containing 30, 60 or 90 tablets.
Mullusiem 20 mg is available in blister packs containing 30, 60 or 90 tablets.
Mullusiem 30 mg is available in blister packs containing 28 tablets.
Mullusiem 40 mg is available in blister packs containing 30, 60 and 90 tablets.
Mullusiem 60 mg is available in blister packs containing 28 tablets.
Mullusiem 80 mg is available in blister packs containing 30, 60 and 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sigillata Limited
Inniscarra, Main Street
Rathcoole, Co. Dublin - D24 E029
Ireland

Manufacturer
TEVA PHARMA S.L.U.,
C/C, n. 4, Poligono Industrial Malpica,
50016 Zaragoza,
Spain
Teva Operations Poland Sp. z.o.o,
ul. Mogilska 80, 31-546
Krakow,
Poland

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria: Mullusiem 10 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg Filmtabletten
Italy: Mullusiem

Other sources of information
The most recently approved product information and educational material for this medicinal product are available by scanning the QR code included in the PIL and on the outer packaging with a smartphone or other device. The same information is available at the following URL: [URL to be included] and on the website of the national competent authority>.