Ezetimibe and atorvastatin Doc Generici

Patient Information Leaflet

EZETIMIBE AND ATORVASTATIN DOC 10 mg/10 mg hard capsules, mg/20 mg hard capsules, mg/40 mg hard capsules

Please read this entire leaflet carefully before 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, consult 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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What EZETIMIBE AND ATORVASTATIN DOC is and what it is used for
2. What you need to know before taking EZETIMIBE AND ATORVASTATIN DOC
3. How to take EZETIMIBE AND ATORVASTATIN DOC
4. Possible side effects
5. How to store EZETIMIBE AND ATORVASTATIN DOC
6. Package contents and other information

1. What EZETIMIBE AND ATORVASTATIN DOC is and what it is used for

EZETIMIBE AND ATORVASTATIN DOC 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.
EZETIMIBE AND ATORVASTATIN DOC is a medicine used in adults to lower blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances 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 gastrointestinal 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, interrupting blood flow to the heart or brain, which may lead to heart attack or stroke. Lowering cholesterol levels reduces the risk of heart attack, stroke, or other related health problems.
EZETIMIBE AND ATORVASTATIN DOC is used to treat patients in whom a cholesterol-lowering diet alone is not sufficient to control cholesterol levels. While taking this medicine, you must continue to follow a cholesterol-lowering diet.
Your doctor may prescribe EZETIMIBE AND ATORVASTATIN DOC if you are already taking ezetimibe and atorvastatin separately at the same dosage.
EZETIMIBE AND ATORVASTATIN DOC does not help with weight loss.

2. What you should know before taking EZETIMIBE E ATORVASTATINA DOC

Do not take EZETIMIBE E ATORVASTATINA DOC

• 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 performed to assess liver function
• if you are a woman of childbearing age 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 medicine glecaprevir/pibrentasvir for the treatment of hepatitis C

Warnings and precautions
Talk to your doctor or pharmacist before taking EZETIMIBE E ATORVASTATINA DOC:

• 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 EZETIMIBE E ATORVASTATINA DOC can lead to serious muscle problems (rhabdomyolysis). (See section “Other medicines and EZETIMIBE E ATORVASTATINA DOC”.)
• 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 have 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 EZETIMIBE E ATORVASTATINA DOC. This is because, in rare cases,
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.
Additionally, 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 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 the
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 EZETIMIBE E ATORVASTATINA DOC together with fibrates (medicines used to lower
cholesterol) should be avoided, as the use of EZETIMIBE E ATORVASTATINA DOC with fibrates has
not been studied.

Children and adolescents
The use of EZETIMIBE E ATORVASTATINA DOC is not recommended in children and adolescents
under 18 years of age.

Other medicines and EZETIMIBE E ATORVASTATINA DOC
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 EZETIMIBE E ATORVASTATINA DOC or its effect may be
altered by EZETIMIBE E ATORVASTATINA DOC. 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, colestyramine
• certain 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
• 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 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 restart treatment with EZETIMIBE E ATORVASTATINA DOC. Taking EZETIMIBE E ATORVASTATINA DOC with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

Other medicines known to interact with EZETIMIBE E ATORVASTATINA DOC
 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)

EZETIMIBE E ATORVASTATINA DOC with food, drinks and alcohol
For instructions on how to take EZETIMIBE E ATORVASTATINA DOC, 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 EZETIMIBE E ATORVASTATINA DOC.
Alcohol
Avoid drinking excessive amounts of alcohol during treatment with this medicine. For further information, see section 2 “Warnings and precautions”.

Pregnancy, breastfeeding and fertility
Do not take EZETIMIBE E ATORVASTATINA DOC if you are pregnant, planning to become pregnant, or suspect you may be pregnant.
Do not take EZETIMIBE E ATORVASTATINA DOC if you are a woman of childbearing age unless you are using an effective method of contraception. If you become pregnant while taking EZETIMIBE E ATORVASTATINA DOC, stop treatment immediately and consult your doctor.
Do not take EZETIMIBE E ATORVASTATINA DOC if you are breastfeeding.
The safety of EZETIMIBE E ATORVASTATINA DOC during pregnancy and breastfeeding has not yet been established. If you are pregnant or breastfeeding, planning a pregnancy or suspect you may be pregnant, consult your doctor or pharmacist before taking this medicine.

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

EZETIMIBE E ATORVASTATINA DOC contains sucrose and sodium.
Each capsule of EZETIMIBE E ATORVASTATINA DOC 10 mg/10 mg contains 13 mg of sucrose, each capsule of EZETIMIBE E ATORVASTATINA DOC 10 mg/20 mg contains 26 mg of sucruise, and each capsule of EZETIMIBE E ATORVASTATINA DOC 10 mg/40 mg 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 EZETIMIBE AND ATORVASTATIN DOC

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
During treatment with EZETIMIBE AND ATORVASTATIN DOC, you must continue to follow the cholesterol-lowering diet recommended by your doctor.
The recommended daily dose for adults is one capsule of the prescribed strength.
Take EZETIMIBE AND ATORVASTATIN DOC 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.
EZETIMIBE AND ATORVASTATIN DOC is not suitable for initiating treatment. Initiation of therapy or dose adjustment, if necessary, must be performed by administering the active substances separately. Only after the appropriate dose has been established should you switch to using EZETIMIBE AND ATORVASTATIN DOC at the corresponding strength.
If your doctor has prescribed EZETIMIBE AND ATORVASTATIN DOC in combination with other cholesterol-lowering medicines containing colestyramine or another bile acid sequestrant, you must take EZETIMIBE AND ATORVASTATIN DOC at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more EZETIMIBE AND ATORVASTATIN DOC than you should
If you accidentally take more capsules than prescribed (more than the recommended daily dose), contact your doctor or the nearest hospital immediately.

If you forget to take EZETIMIBE AND ATORVASTATIN DOC
If you forget to take a dose, take only the next scheduled dose at the usual time the following day. Do not take a double dose to make up for the missed capsule.

If you stop taking EZETIMIBE AND ATORVASTATIN DOC
Consult your doctor if you intend to stop treatment with EZETIMIBE AND ATORVASTATIN DOC. If you stop taking EZETIMIBE AND ATORVASTATIN DOC, your cholesterol levels may rise again.

If you have any further questions about the use of 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 notice 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 colour to red-brown, particularly if you also feel unwell and have a high fever, which may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve after stopping treatment with EZETIMIBE E ATORVASTATINA DOC, and may 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, this 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 digestive tract).
• Dyspepsia.
• Feeling unwell (nausea).
• Diarrhoea.
• 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).
• Alterations in liver function parameters, increases in certain blood test values related to liver function (transaminases).

Uncommon (may affect up to 1 in 100 people)

• Low blood sugar levels.
• Weight gain.
• Decreased 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 radiating to the back.
• Heartburn.
• Dry mouth.
• Inflammation of the stomach (gastritis).
• Inflammation of the liver (hepatitis).
• Hives.
• Itching.
• 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)

• Reduction in the 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).
• Red, raised rash, sometimes with target-shaped 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 (gynaecomastia).

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 sugars 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 EZETIMIBE AND ATORVASTATIN DOC

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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What EZETIMIBE AND ATORVASTATIN DOC 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 coating:
Capsule cap of EZETIMIBE AND ATORVASTATIN DOC 10 mg/10 mg hard capsules: Titanium
dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), gelatin (E441)
Capsule cap of EZETIMIBE AND ATORVASTATIN DOC 10 mg/20 mg hard capsules: Titanium
dioxide (E171), red iron oxide (E172), gelatin (E441)
Capsule cap of EZETIMIBE AND ATORVASTATIN DOC 10 mg/40 mg hard capsules: Titanium
dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), gelatin (E441)
Capsule body for all strengths: Titanium dioxide (E171), yellow iron oxide (E172), gelatin (E441)

Description of the appearance of EZETIMIBE AND ATORVASTATIN DOC and contents of the pack

EZETIMIBE AND ATORVASTATIN DOC 10 mg/10 mg hard capsules: Hard gelatin capsule, unmarked closure, size 0, with a caramel-colored cap and yellow body, filled with pellets and a tablet.

EZETIMIBE AND ATORVASTATIN DOC 10 mg/20 mg hard capsules: Hard gelatin capsule, unmarked closure, size 0, with a reddish-brown cap and yellow body, filled with pellets and a tablet.

EZETIMIBE AND ATORVASTATIN DOC 10 mg/40 mg hard capsules: Hard gelatin capsule, unmarked closure, size 0, with a dark brown cap and yellow body, filled with pellets and a tablet.

Blister OPA/Al/PVC//Al containing 30 hard capsules, packaged in cardboard cartons.

Marketing Authorization Holder

DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturers

Egis Pharmaceuticals PLC
Bokenyfoldi út 118-120.
Budapest
1165 Hungary

Egis Pharmaceuticals PLC
Matyas Kiraly Utca 65.
Kormend
Vas
9900 Hungary

This medicinal product has been authorised in the European Economic Area countries under the following names:

Netherlands: Ezetimibe/Atorvastatin DOC 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg hard capsules
Italy: EZETIMIBE E ATORVASTATINA DOC