ANCILLEG 10 mg/10 mg Hard Capsules

Зміст інструкції

1. Ancilleg 10 mg/10 mg hard capsules, 10 mg/20 mg hard capsules, 10 mg/40 mg hard capsules
   1. What is Ancilleg and what is it used for
   2. What you need to know before taking Ancilleg
   3. How to take Ancilleg
   4. Possible side effects
   5. How to store Ancilleg
   6. Package contents and other information

Ancilleg 10 mg/10 mg hard capsules, 10 mg/20 mg hard capsules, 10 mg/40 mg hard capsules

Ezetimibe/atorvastatin

Read this leaflet carefully before you start taking 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Ancilleg and what is it used for

Ancilleg contains two different active ingredients within a capsule. One of the two active substances is
ezetimibe, the other is atorvastatin, which belongs to the group of so-called statins.
Ancilleg is a medicine used in adults to decrease the levels in the blood of total cholesterol, of
“bad” cholesterol (LDL cholesterol) and of fatty substances called triglycerides. Furthermore, it increases the levels of
“good” cholesterol (HDL cholesterol).
This medicine works in two ways to lower cholesterol: it reduces the cholesterol absorbed at the level of the
digestive tract, as well as the cholesterol produced naturally by the body.
For most people, high cholesterol does not change their state of health, as it does not cause
any symptoms. However, if left untreated, fat deposits can form on the walls of the
blood vessels causing their narrowing. Sometimes narrowed blood vessels can become blocked causing
a lack of blood supply to the heart or brain, which can lead to heart attack or stroke. By lowering the level
of cholesterol, the risk of heart attack, stroke or other related health problems is reduced.
Ancilleg is used to treat those patients in whom diet alone to reduce cholesterol is not sufficient
to keep cholesterol levels under control. While taking this medicine you should still
follow a diet to lower cholesterol.
Your doctor may prescribe Ancilleg if you are already taking both ezetimibe and atorvastatin at the same
dosage.
Ancilleg does not help with weight loss.

2. What you need to know before taking Ancilleg

Do not take Ancilleg

• if you are allergic to ezetimibe, atorvastatin or 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 blood test results, performed to assess liver function, inexplicably altered
• if you are a woman of childbearing potential and not using a reliable contraceptive method
• if you are pregnant or trying to become pregnant
• if you are breastfeeding
• if you are using the combination of medicines glecaprevir/pibrentasvir for the treatment of Hepatitis C

Warnings and precautions
Talk to your doctor or pharmacist before taking Ancilleg:

• if you have severe respiratory failure
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Ancilleg can lead to serious muscle problems (rhabdomyolysis). (See section “Other medicines and Ancilleg”.)
• if you have had a stroke with cerebral haemorrhage in the past or if there are small collections of fluid inside the brain resulting from strokes you have had in the past
• if you have kidney problems
• if you have an underactive thyroid gland (hypothyroidism)
• if you have had repeated or unexplained episodes of muscle discomfort or pain, a personal or family history of muscle problems
• if you have had muscle problems in the past while being treated with other medicines to lower lipid levels in the blood (e.g., other medicines based on “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

Immediately contact your doctor if you experience unexplained muscle pain, tenderness or weakness
while taking Ancilleg.
This is because, in rare cases, muscle problems can be serious, including muscle breakdown which
leads to kidney damage. Atorvastatin is known to cause muscle problems and cases of muscle problems have
also been reported with ezetimibe.
Also, tell your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines may be needed
for the diagnosis and treatment of this condition.
During treatment with this medicine, your doctor will carefully monitor you if you suffer from diabetes or if you are
at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugars and fats
in your blood, if you are overweight and if you have high blood pressure.
Tell your doctor about all your medical conditions, including allergies.
The administration of Ancilleg with fibrates (medicines used to lower cholesterol) should be
avoided as the use of Ancilleg with fibrates has not been studied.

Children and adolescents
The use of Ancilleg is not recommended in children and adolescents under the age of 18 years.

Other medicines and Ancilleg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Some medicines may change the effect of Ancilleg or their effect may be changed by
Ancilleg. This type of interaction may reduce the effectiveness of one or both medicines.
Alternatively, it could increase the risk of developing side effects or the severity of side
effects, including the important condition of muscle breakdown known as “rhabdomyolysis”,
described in section 4:

• medicines used to change the functioning of the immune system, e.g., cyclosporine
• some antibiotics e.g., erythromycin, clarithromycin, telithromycin, rifampicin (medicines for bacterial infections)
• some antifungal medicines e.g., ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole
• other medicines used to regulate lipid levels e.g., gemfibrozil, other fibrates, nicotinic acid derivatives, colestipol, colestyramine
• some calcium antagonists used for the treatment of angina or hypertension, e.g., amlodipine and diltiazem,
• medicines used to regulate heart rhythm e.g. digoxin, verapamil, amiodarone
• Leteremovir, a medicine that helps prevent you from getting sick with cytomegalovirus
• medicines used to treat HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, efavirenz, fosamprenavir, delavirdine, the combination of tipranavir/ritonavir etc.
• some medicines used to treat Hepatitis C (liver inflammation), e.g., telaprevir, boceprevir and the combination elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart treatment with Ancilleg. Taking Ancilleg with fusidic acid can rarely lead to weakness, tenderness or muscle pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Other medicines known to interact with Ancilleg
 warfarin, phenprocoumon, acenocoumarol or fluindione (medicines to prevent blood clots)

• oral contraceptives
• stiripentol (an anticonvulsant medicine for the treatment of epilepsy)
• cimetidine (a medicine used to treat heartburn and peptic ulcers)
• phenazone (a painkiller)
• colchicine (used to treat gout)
• antacids (medicines for the treatment of digestive problems containing aluminium or magnesium)
• St John's wort (a medicine for the treatment of depression)

Ancilleg with food, beverages and alcohol
For instructions on how to take Ancilleg see section 3. Pay attention to the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice a day as large amounts of grapefruit
juice can change the effects of Ancilleg.

Alcohol
Avoid drinking excessive amounts of alcohol during treatment with this medicine. For more
information see section 2 “Warnings and precautions”.

Pregnancy, breastfeeding and fertility
Do not take Ancilleg if you are pregnant, planning a pregnancy or suspect you may be
pregnant.
Do not take Ancilleg if you are a woman of childbearing potential unless you are using effective
contraception. If you become pregnant while taking Ancilleg, stop taking it immediately and
contact your doctor.
Do not take Ancilleg if you are breastfeeding.
The safety of Ancilleg during pregnancy and breastfeeding has not yet been demonstrated. If you are pregnant or
breastfeeding, planning a pregnancy or suspect you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It is not expected that Ancilleg will interfere with your ability to drive or operate machinery. However, you should
be aware that some people may experience dizziness after taking Ancilleg. If you experience
dizziness, ask your doctor for advice before driving or operating machinery.

Ancilleg contains sucrose and sodium
Each capsule of Ancilleg 10 mg/10 mg contains 13 mg of sucrose, each capsule of Ancilleg 10 mg/20 mg
capsules contains 26 mg of sucrose and each capsule of Ancilleg 10 mg/40 mg capsules contains 51.5 mg of
sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium
free’.

3. How to take Ancilleg

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
During treatment with Ancilleg, you must continue to follow this diet to reduce cholesterol levels.
The recommended daily dose for adults is one capsule of the prescribed dosage.

Take Ancilleg once a day.
The capsules can be taken at any time of the day with or without food. However, you may try
to take the capsule every day at the same time.
Swallow each capsule whole with a glass of water.
Ancilleg is not suitable for starting treatment. Starting treatment or adjusting the dose, if
necessary, must only be done by administering the active substances separately and, only after
establishing the correct dose, can you switch to using Ancilleg at the appropriate dosage.
If your doctor has prescribed Ancilleg in combination with other medicines used to lower cholesterol
levels containing colestyramine or another bile acid sequestrant as active ingredients, you should
take Ancilleg at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ancilleg than you should
If you accidentally take more capsules than you should (more than the recommended daily dose), contact
your doctor or the nearest hospital.

If you forget to take Ancilleg
If you forget to take a dose, take only the dose scheduled for the next day at the usual time.
Do not take a double dose to make up for the forgotten capsule.

If you stop taking Ancilleg
Contact your doctor if you intend to stop treatment with Ancilleg. If you stop
treatment with Ancilleg, your cholesterol levels may increase again.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects or symptoms, stop taking this medicine and immediately inform your doctor or go to the nearest hospital emergency room:
Rare (may affect up to 1 in 1,000 people)

• severe allergic reaction causing swelling of the face, tongue and throat, which can cause significant difficulty in breathing.
• severe illness with severe exfoliation and swelling of the skin, blistering of the skin, mouth, eyes, genitals and fever. Skin rash with pink-red patches, especially on the palms of the hands or soles of the feet, which may become covered with blisters.
• muscle weakness, tenderness, pain or rupture, or change in the color of urine to red-brown and especially if, at the same time, you do not feel well and have a high fever, this may be caused by abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always disappear after stopping treatment with Ancilleg, which can be life-threatening and lead to kidney problems.

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

• In case of unexpected or unusual bleeding or bruising, it may indicate a liver disorder. You should see a doctor as soon as possible.
• Lupus-like syndrome (including skin rash, joint disorders and effects on blood cells).

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

• common cold (nasopharyngitis).
• allergic reactions.
• high blood sugar levels.
• Headache.
• sore throat.
• nosebleed.
• constipation.
• flatulence (excess gas in the intestinal tract).
• Dyspepsia.
• feeling unwell (nausea).
• Diarrhea.
• abdominal pain.
• muscle pain.
• Joint pain.
• pain in the arms and legs.
• muscle spasms.
• swollen joints.
• back pain.
• feeling tired (fatigue).
• increases in some values ​​regarding muscle function (CK) revealed in the blood test.
• alteration of liver function parameters, increases in some values ​​regarding liver function revealed in the blood test (transaminases).

Not common (may affect up to 1 in 100 people)

• low blood sugar levels.
• weight gain.
• decreased or loss of appetite.
• Nightmares.
• Insomnia.
• Dizziness.
• numbness or tingling in the fingers of hands and feet.
• reduced sensitivity to pain or touch.
• alteration of the sense of taste.
• memory loss.
• blurred vision.
• ringing in the ears.
• hot flush.
• High blood pressure.
• Cough.
• Vomiting.
• Belching.
• inflammation of the pancreas, which can cause severe abdominal pain that can extend to the back.
• heartburn.
• dry mouth.
• inflammation of the stomach (gastritis).
• inflammation of the liver (hepatitis).
• Hives.
• Itching.
• skin rash.
• Hair loss.
• neck pain.
• muscle weakness.
• discomfort (a feeling of general weakness).
• asthenia (lack of energy and strength).
• chest pain.
• Pain.
• swelling, especially in the hands and feet.
• fever.
• urine tests that are positive for white blood cells.
• increased levels of liver enzymes in the blood.

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

• reduction in the number of platelets in the blood, which increases the risk of bruising/bleeding (thrombocytopenia).
• damage to the nerves of the legs and arms (such as numbness).
• visual disturbances.
• cholestasis (yellowing of the skin and the whites of the eyes).
• skin erythema, sometimes with delineated lesions (erythema multiforme)
• muscle disease accompanied by muscle weakness (myopathy).
• muscle inflammation.
• tendon injury.

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

• hearing loss.
• increased breast volume in men (gynecomastia).

Not known (frequency cannot be estimated based on available data)

• depression.
• shortness of breath.
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting)
• muscle weakness that is constant (immune-mediated necrotizing myopathy).

Possible side effects reported with some statins:

• sexual difficulties.
• breathing problems including persistent cough and/or shortness of breath or fever.
• diabetes. More likely if you have high sugar and fat levels in your blood, if you are overweight and if you 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, tell your
doctor or pharmacist. You can also report side effects directly through 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 Ancilleg

Keep this medicine out of the sight and reach of children.
Store at a temperature below 30 °C in the original packaging to protect the medicine
from humidity.
Do not use this medicine after the expiry date (Exp.) which is reported on the pack. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in 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 Ancilleg contains

• The active ingredients are ezetimibe and atorvastatin (as atorvastatin calcium trihydrate). Each capsule contains 10 mg of ezetimibe and 10 mg, 20 mg or 40 mg of atorvastatin.
• The other ingredients are: Core: Calcium carbonate (E170), hydroxypropylcellulose (E463), polysorbate 80 (E433), sodium croscarmellose (E468), sugar spheres, talc (E553B), mannitol (E421), microcrystalline cellulose (E460(i)), low substitution hydroxypropylcellulose (E463), povidone (E1201), sodium lauryl sulfate (E487), magnesium stearate (E572) Capsule coating: The head of the Ancilleg 10 mg/10 mg hard capsules: Titanium dioxide (E171), Yellow iron oxide (E172), Red iron oxide (E172), Black iron oxide (E172), Gelatin (E441). The head of the Ancilleg 10 mg/20 mg hard capsules: Titanium dioxide (E171), Red iron oxide (E172), Gelatin (E441) The head of the Ancilleg 10 mg/40 mg hard capsules: Titanium dioxide (E171), Yellow iron oxide (E172), Red iron oxide (E172), Black iron oxide (E172), Gelatin (E441)

The capsule body for all dosages: Titanium dioxide (E171), Yellow iron oxide (E172),
Gelatin (E441)

Description of the appearance of Ancilleg and package contents

Ancilleg 10 mg/10 mg hard capsules:Hard gelatin capsule with an unmarked closure of
size 0, with a caramel-colored head and a yellow body, filled with pellets and a tablet.

Ancilleg 10 mg/20 mg hard capsules:Hard gelatin capsule with an unmarked closure of
size 0, with a reddish-brown head and a yellow body, filled with pellets and a
tablet

Ancilleg 10 mg/40 mg hard capsules:Hard gelatin capsule with an unmarked closure of
size 0, with a dark brown head and a yellow body, filled with pellets and a
tablet.
OPA/Al/PVC//Al blisters of 30, 60, 70, 80, 90, 100 or 120 hard capsules packaged in cardboard boxes.

Marketing Authorisation Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturers
Egis Pharmaceuticals PLC
1165 Budapest, Bökenyföldi út 118-120.
Hungary
Egis Pharmaceuticals PLC
9900 Körmend, Mátyás Kiraly u 65.
Hungary
Lek Pharmaceuticals d.d.,
Verovškova ulica 57,
1526 Ljubljana, Slovenia

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Netherlands: Ezetimibe/Atorvastatine Egis 10 mg/10 mg hard capsules
Ezetimibe/Atorvastatine Egis 10 mg/20 mg hard capsules
Ezetimibe/Atorvastatine Egis 10 mg/40 mg hard capsules
Austria: Ezetimibe/Atorvastatine Egis 10 mg/10 mg Hartkapseln
Ezetimibe/Atorvastatine Egis 10 mg/20 mg Hartkapseln
Ezetimibe/Atorvastatine Egis 10 mg/40 mg Hartkapseln
Greece: Cholzet (10+10) καψάκια, σκληρά
Cholzet (10+20) καψάκια, σκληρά
Cholzet (10+40) καψάκια, σκληρά
Italy: Ancilleg
Norway: Ezetimibe/Atorvastatine Egis 10 mg/10 mg harde kapsler
Ezetimibe/Atorvastatine Egis 10 mg/20 mg harde kapsler
Ezetimibe/Atorvastatine Egis 10 mg/40 mg harde kapsler
Portugal: Ezetimibe/Atorvastatine Egis 10 mg/10 mg cápsulas
Ezetimibe/Atorvastatine Egis 10 mg/20 mg cápsulas
Ezetimibe/Atorvastatine Egis 10 mg/40 mg cápsulas