Ancilleg: detailed information

Package leaflet: Information for the patient

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

Ezetimibe/atorvastatin
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 other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Ancilleg is and what it is used for
What you need to know before taking Ancilleg
How to take Ancilleg
Possible side effects
How to store Ancilleg
Contents of the pack and other information

1. What Ancilleg is and what it is used for

Ancilleg contains two different active substances within one capsule. One of these active substances is
ezetimibe, the other is atorvastatin, which belongs to the group of medicines known as statins.
Ancilleg is a medicine used in adults to lower blood levels of total cholesterol, “bad” cholesterol (LDL
cholesterol), and fats called triglycerides. In addition, it increases levels of “good” cholesterol (HDL
cholesterol).
This medicine works in two ways to lower cholesterol: by reducing cholesterol absorbed in the digestive tract,
as well as cholesterol naturally produced by the body.
For most people, high cholesterol does not affect their general health, as it causes no symptoms. However, if
left untreated, fatty deposits can build up on the walls of blood vessels, causing them to narrow. Sometimes
narrowed blood vessels can become blocked, cutting off blood supply to the heart or brain, which may lead to
heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other related health
problems is reduced.
Ancilleg is used to treat patients for whom a cholesterol-lowering diet alone is not sufficient to control
cholesterol levels. While taking this medicine, you must still follow a cholesterol-lowering diet.
Your doctor may prescribe Ancilleg to you 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 liver disease
if you have had unexplained abnormal results in blood tests assessing liver function
if you are a woman of childbearing age and 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 medicine 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 an oral or injectable medicine called fusidic acid (a medicine for bacterial infection). The combination of fusidic acid and Ancilleg can lead to serious muscle problems (rhabdomyolysis). (See section “Other medicines and Ancilleg”.)
if you have previously had a stroke with cerebral haemorrhage or if there are small accumulations of fluid in the brain due to previous strokes
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, or if you have a personal or family history of muscle disorders
if you previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g., other “statin” or “fibrate” medicines)
if you regularly consume large amounts of alcohol
if you have a history of liver disease
if you are over 70 years old

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness
while taking Ancilleg.
This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage. It is known that atorvastatin can cause muscle problems, and cases of muscle problems have also been reported with ezetimibe.
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.
While being treated with this medicine, your doctor will monitor you closely if 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, or if you have high blood pressure.
Inform your doctor about all your medical conditions, including allergies.
The use of Ancilleg together with fibrates (medicines used to lower cholesterol) should be avoided, as the combination of Ancilleg with fibrates has not been studied.

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

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 alter the effect of Ancilleg or their effect may be altered by Ancilleg. This type of interaction could 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 serious condition of muscle breakdown known as “rhabdomyolysis”, described in section 4:

medicines used to modify the immune system function, e.g., cyclosporine
certain antibiotics, e.g., erythromycin, clarithromycin, telithromycin, rifampicin (medicines for bacterial infections)
certain 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, cholestyramine
certain calcium antagonists used for angina or hypertension, e.g., amlodipine and diltiazem
medicines used to regulate heart rhythm, e.g., digoxin, verapamil, amiodarone
Letermovir, a medicine that helps prevent cytomegalovirus infection
medicines used for the treatment of HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, efavirenz, fosamprenavir, delavirdine, the combination of tipranavir/ritonavir, etc.
certain medicines used for the treatment of hepatitis C (liver inflammation), e.g., telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir
Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart treatment with Ancilleg. Taking Ancilleg with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See further information on 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 used to treat epilepsy)
cimetidine (a medicine used to treat heartburn and peptic ulcers)
phenazone (a painkiller)
colchicine (used to treat gout)
antacids (medicines for digestive problems containing aluminium or magnesium)
St. John’s wort (a herbal medicine used to treat depression)

Ancilleg with food, drinks 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 per day, as large quantities of grapefruit juice may alter the effects of Ancilleg.
Alcohol
Avoid drinking excessive amounts of alcohol while being treated with this medicine. For further information, see section 2 “Warnings and precautions”.

Pregnancy, breastfeeding and fertility
Do not take Ancilleg if you are pregnant, planning to become pregnant, or suspect you may be pregnant.
Do not take Ancilleg if you are a woman of childbearing age unless you are using an effective method of contraception. If you become pregnant during treatment with Ancilleg, stop taking the medicine 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 established. If you are pregnant or breastfeeding, planning to become pregnant, or suspect you may be pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Ancilleg is not expected to affect your ability to drive or use machines. However, bear in mind that some people may experience dizziness after taking Ancilleg. If you experience dizziness, consult your doctor before driving or using machines.

Ancilleg contains sucrose and sodium
Each Ancilleg 10 mg/10 mg capsule contains 13 mg of sucrose, each Ancilleg 10 mg/20 mg capsule contains 26 mg of sucrose, and each Ancilleg 10 mg/40 mg capsule contains 51.5 mg of sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
During treatment with Ancilleg, you must continue to follow this cholesterol-lowering diet.
The recommended daily dose for adults is one capsule of the prescribed strength.
Take Ancilleg once daily.
The capsules may be taken at any time of day, with or without food. However, you may find it helpful
to take the capsule at the same time each day.
Swallow each capsule whole with a glass of water.
Ancilleg is not suitable for initiating treatment. Treatment initiation or dose adjustment, if
necessary, must only be carried out by administering the active substances separately. Only after the appropriate dose has been established should you switch to using Ancilleg at the corresponding strength.
If your doctor has prescribed Ancilleg in combination with other lipid-lowering medicines containing colestyramine or another bile acid sequestrant, you must 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 recommended (more than the recommended daily dose), contact your doctor or the nearest hospital immediately.
If you forget to take Ancilleg
If you miss a dose, take only the next dose at the usual time.
Do not take a double dose to make up for the missed capsule.
If you stop taking Ancilleg
Consult your doctor if you intend to stop treatment with Ancilleg. If you discontinue treatment with Ancilleg, your cholesterol levels may rise again.
If you have any doubts about how to use this medicine, 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 serious side effects or symptoms, stop taking this medicine 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 skin peeling and swelling, blistering of the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red patches, particularly on the palms of the hands or soles of the feet, which may develop blisters.
Muscle weakness, tenderness, pain, or injury, or change in urine color to red-brown; particularly if you also feel unwell and have high fever. This may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve after stopping treatment with Ancilleg and may be life-threatening, potentially leading to kidney problems.

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

In case of unexpected or unusual bleeding or bruising, which may indicate a liver disorder. You should contact your 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.
Nosebleeds.
Constipation.
Flatulence (excess gas in the intestinal tract).
Dyspepsia.
Feeling unwell (nausea).
Diarrhea.
Abdominal pain.
Muscle pain.
Joint pain.
Pain in arms and legs.
Muscle spasms.
Swelling of joints.
Back pain.
Feeling of tiredness (fatigue).
Increases in certain blood test values related to muscle function (CK).
Changes in liver function parameters, increases in certain blood test values indicating liver function (transaminases).

Uncommon (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 fingers of hands and feet.
Reduced sensitivity to pain or touch.
Altered sense of taste.
Memory loss.
Blurred vision.
Ringing in the ears.
Hot flush.
High blood pressure.
Cough.
Vomiting.
Belching.
Inflammation of the pancreas, which may cause severe abdominal pain extending 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.
Malaise (a feeling of general weakness).
Asthenia (lack of energy and strength).
Chest pain.
Pain.
Swelling, especially in hands and feet.
Fever.
Urine tests positive for white blood cells.
Increased levels of liver enzymes in the blood.

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

Reduced number of platelets in the blood, increasing the risk of bruising/bleeding (thrombocytopenia).
Nerve damage in arms and legs (such as numbness).
Visual disturbances.
Cholestasis (yellowing of the skin and whites of the eyes).
Skin erythema, sometimes with defined 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.
Breast enlargement in men (gynecomastia).

Not known (frequency cannot be estimated from the available data)

Depression.
Shortness of breath.
Gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting).
Persistent muscle weakness (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 levels of sugar and fats in the 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 Ancilleg

Keep this medicine out of the sight and reach of children.
Store below 30 °C in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date (Exp.) stated on the carton. 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. Contents of the pack and other information

What Ancilleg contains

The active substances are ezetimibe and atorvastatin (as atorvastatin calcium trihydrate). Each capsule contains 10 mg of ezetimibe and either 10 mg, 20 mg or 40 mg of atorvastatin.
The other components are:
Core: Calcium carbonate (E170), hydroxypropylcellulose (E463), polysorbate 80 (E433), sodium croscarmellose (E468), sugar spheres, talc (E553B), mannitol (E421), microcrystalline cellulose (E460(i)), low-substituted hydroxypropylcellulose (E463), povidone (E1201), sodium lauryl sulfate (E487), magnesium stearate (E572)
Capsule shell:
The cap of 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 cap of Ancilleg 10 mg/20 mg hard capsules: Titanium dioxide (E171), red iron oxide (E172), gelatin (E441)
The cap of 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 body of the capsule for all strengths: Titanium dioxide (E171), yellow iron oxide (E172), gelatin (E441)

Description of the appearance of Ancilleg and contents of the pack
Ancilleg 10 mg/10 mg hard capsules: Hard gelatin capsule of size 0 with unmarked closure, caramel-colored cap and yellow body, filled with pellets and a tablet.
Ancilleg 10 mg/20 mg hard capsules: Hard gelatin capsule of size 0 with unmarked closure, reddish-brown cap and yellow body, filled with pellets and a tablet.
Ancilleg 10 mg/40 mg hard capsules: Hard gelatin capsule of size 0 with unmarked closure, dark brown cap and yellow body, filled with pellets and a tablet.

Blister OPA/Al/PVC//Al containing 30, 60, 70, 80, 90, 100 or 120 hard capsules, packed in cardboard cartons.

Marketing Authorization 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 has been authorised in the European Economic Area Member States under the following names:
Netherlands: Ezetimibe/Atorvastatine Egis 10 mg/10 mg harde capsules
Ezetimibe/Atorvastatine Egis 10 mg/20 mg harde capsules
Ezetimibe/Atorvastatine Egis 10 mg/40 mg harde 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