Hatteras

Package leaflet: Information for the user

Hatteras 10 mg/10 mg film-coated tablets, 10 mg/20 mg film-coated tablets, 10 mg/40 mg film-coated tablets, 10 mg/80 mg film-coated tablets

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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Hatteras is and what it is used for

Hatteras is a medicine used to lower elevated cholesterol levels. Hatteras contains
ezetimibe and atorvastatin.
Hatteras is used in adults to lower blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides. In addition, Hatteras increases levels of "good" cholesterol (HDL cholesterol).
Hatteras works in two ways to lower cholesterol. It reduces cholesterol absorbed in the digestive tract as well as cholesterol naturally produced by the body.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol consists mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such blockage of blood flow may cause a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent bad cholesterol from building up in the arteries and provides protection against heart disease.
Triglycerides are another form of fat in the blood that may increase the risk of heart disease.
Your doctor may prescribe Hatteras if you are already taking both atorvastatin and ezetimibe at the same doses, but as separate products, in addition to a cholesterol-lowering diet, if you have:

• elevated cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial and non-familial]) or elevated levels of fats in the blood (mixed hyperlipidemia)
• heart disease. Hatteras reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization for chest pain. Hatteras does not help with weight loss.

2. What you should know before taking Hatteras

Do not take Hatteras if:

• you are allergic to atorvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6)
• you have or have ever had liver disease
• you have had unexplained abnormal blood tests assessing liver function
• you are a woman of childbearing age and do not use a reliable contraceptive method
• you are pregnant, trying to become pregnant, or breastfeeding
• you are taking the combination glecaprevir/pibrentasvir for the treatment of hepatitis C

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

• you have previously had a stroke with cerebral bleeding or if there are small accumulations of fluid in the brain due to previous strokes
• you have kidney problems
• you have an underactive thyroid gland (hypothyroidism)
• you have had repeated or unexplained episodes of muscle discomfort or pain, or have a personal or family history of muscle disorders
• you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g. other "statin" or "fibrate" medicines)
• you are currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine for bacterial infection). The combination of fusidic acid and ezetimibe/atorvastatin-containing medicines may lead to serious muscle problems (rhabdomyolysis)
• you regularly consume large amounts of alcohol
• you have a history of liver disease
• you are over 70 years old
• you have or have had myasthenia (a disease characterized by generalized muscle weakness, sometimes affecting the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may occasionally worsen myasthenia or trigger its onset (see section 4).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness
while taking Hatteras. This is because, although rarely, muscle problems can be severe, 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.
Furthermore, inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.
Before taking Hatteras, check with your doctor or pharmacist:

• if you have severe respiratory insufficiency

If any of these conditions apply to you (or if you are unsure), consult your doctor or pharmacist before taking Hatteras, as your doctor may require you to have a blood test before and possibly during treatment to assess the risk of muscle-related side effects. It is known that the risk of developing muscle-related side effects, such as rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 “Other medicines and Hatteras”).
During treatment with this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. Risk factors for developing diabetes include high levels of sugar and fats in the blood, being overweight, and having high blood pressure.
Inform your doctor about all your medical conditions, including allergies.

Children
Hatteras is not recommended for children and adolescents.

Other medicines and Hatteras
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Fibrates (medicines used to lower cholesterol) should be avoided during treatment with Hatteras.
Some medicines may alter the effect of Hatteras or their effect may be altered by Hatteras (see section 3). Such interactions could reduce the effectiveness of one or both medicines. Alternatively, they could increase the risk or severity of side effects, including the serious condition of muscle breakdown known as "rhabdomyolysis" described in section 4:

• cyclosporine (a medicine often used in organ transplant patients)

• erythromycin, clarithromycin, telithromycin, fusidic acid**, rifampicin (medicines used to treat bacterial infections)

• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines used to treat fungal infections)

• gemfibrozil, other fibrates, nicotinic acid, derivatives, colestipol, cholestyramine (medicines used to regulate lipid levels)

• certain calcium antagonists used to treat angina or hypertension, e.g. amlodipine, diltiazem

• digoxin, verapamil, amiodarone (medicines used to regulate heart rhythm)

• letermovir (a medicine that helps prevent diseases caused by cytomegalovirus)

• medicines used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination tipranavir/ritonavir, etc. (medicines for the treatment of AIDS)

• certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir

• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia)

• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to resume Hatteras. Taking Hatteras with fusidic acid may rarely cause muscle weakness, soreness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Other medicines known to interact with Hatteras

• or oral contraceptives (medicines to prevent pregnancy)
• or stiripentol (an anticonvulsant medicine for the treatment of epilepsy)
• or cimetidine (a medicine used to treat heartburn and peptic ulcers)
• or phenazone (a painkiller)
• or antacids (medicines for digestive problems containing aluminium or magnesium)
• or warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines to prevent blood clots)
• or colchicine (used to treat gout)
• or St. John’s wort (a herbal remedy used to treat depression)

Hatteras with food, drinks and alcohol
For instructions on how to take Hatteras, 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 Hatteras.
Alcohol
Avoid excessive alcohol consumption during treatment with this medicine. For further information, see section 2 “Warnings and precautions”.

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

Driving and using machines
Hatteras is not expected to affect your ability to drive or use machines. However, you should be aware that some people may experience dizziness after taking Hatteras. If you feel dizzy after taking this medicine, do not drive or operate machinery.

Hatteras contains lactose
Hatteras 10 mg/10 mg film-coated tablets contain lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Hatteras 10 mg/20 mg film-coated tablets contain lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Hatteras 10 mg/40 mg film-coated tablets contain lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Hatteras 10 mg/80 mg film-coated tablets contain lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Hatteras contains sodium
Hatteras contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Hatteras

Take this medicine exactly as prescribed by your doctor. Your doctor will determine the appropriate tablet dosage for you based on your ongoing treatment and your individual risk profile. If in doubt, consult your doctor or pharmacist.

• Before starting treatment with Hatteras, you must have already started a cholesterol-lowering diet.
• During treatment with Hatteras, you must continue to follow this cholesterol-lowering diet.

What dose to take
The recommended dose is one Hatteras tablet once daily, preferably at the same time each day. The tablet should be swallowed with an adequate amount of liquid (for example, a glass of water).

When to take the dose
You may take Hatteras at any time of day. It can be taken with or without food.
If your doctor has prescribed Hatteras together with colestyramine or another bile acid sequestrant (medicines used to lower cholesterol levels), you must take Hatteras at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Hatteras than you should
Contact your doctor or pharmacist.

If you forget to take Hatteras
Do not take a double dose to make up for the missed dose. Take only your usual dose at the next scheduled time.

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 will experience them.
If you notice any of the following life-threatening side effects or symptoms, stop taking the tablets immediately and contact your doctor or go to the nearest hospital emergency department, taking the tablets with you.

• life-threatening allergic reaction causing swelling of the face, tongue, throat, and causing severe breathing difficulties
• life-threatening illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes, genitals, and fever; skin rash with pink-red pustules, particularly on the palms of the hands or soles of the feet, which may develop into blisters
• muscle weakness, tenderness, pain or muscle rupture, or red-brown discoloration of urine, especially if you also feel unwell and have high fever—this may be due to unusual muscle breakdown, which can be life-threatening and may lead to kidney problems
• lupus-like syndrome (including skin rash, joint problems, and effects on blood cells)

If you experience symptoms of unusual or unexpected bleeding or bruising, consult your doctor as soon as possible, as these may be signs of liver disorder.
Other possible side effects of Hatteras:
Common (may affect up to 1 in 10 people):

• diarrhoea
• muscle pain

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

• influenza
• depression; difficulty falling asleep; sleep disturbances
• dizziness; headache; tingling sensation
• slow heart rate
• hot flushes
• shortness of breath
• abdominal pain; bloating; constipation; indigestion; flatulence; frequent bowel movements
• stomach inflammation; nausea; stomach discomfort; stomach upset
• acne; urticaria
• joint pain; back pain; leg cramps; fatigue; muscle spasms or weakness; pain in arms and legs
• unusual weakness; feeling tired or unwell; swelling, especially in the ankles (oedema)
• increased liver or muscle (CK) function test values found in blood tests
• weight gain

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

• skin rash or inflammation of the oral mucosa (drug-induced lichenoid reaction)
• purple skin lesions (sign of blood vessel inflammation, vasculitis)

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

• myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing)
• ocular myasthenia (a disease causing weakness of the eye muscles)

Contact your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or laboured breathing.
In patients treated with statins and ezetimibe, or ezetimibe or atorvastatin tablets (medicines used to lower cholesterol), the following additional side effects have also been reported:

• allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing (a condition requiring immediate medical attention)
• raised, red rash, sometimes accompanied by "target-like" lesions
• liver problems
• cough
• heartburn
• decreased appetite; loss of appetite
• high blood pressure
• skin rash and itching; allergic reactions including skin rash and urticaria
• tendon injury
• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, and vomiting)
• pancreatitis, often with severe abdominal pain
• reduced number of blood cells, which may lead to bruising/bleeding (thrombocytopenia)
• nasal inflammation; nosebleeds
• neck pain; pain; chest pain; throat pain
• increased or decreased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels closely)
• nightmares
• numbness or tingling in fingers and toes
• reduced sensitivity to pain or touch
• altered sense of taste; dry mouth
• memory loss
• ringing in the ears and/or head; hearing loss
• vomiting
• belching
• hair loss
• increased body temperature
• urine tests positive for white blood cells
• blurred vision; visual disturbances
• gynaecomastia (enlargement of the breast in men)

Possible side effects reported with some statins:

• sexual dysfunction
• depression
• breathing problems including persistent cough and/or shortness of breath or fever
• diabetes. More likely if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.
• muscle pain, tenderness or weakness that is persistent, and especially if, at the same time, you feel unwell or have high fever, which may not resolve after stopping treatment with Hatteras (frequency not known)

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 Hatteras

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
Keep this medicine in the original packaging to protect it from light.
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 Hatteras contains
The active substances in this product are ezetimibe and atorvastatin.
Hatteras 10 mg/10 mg: each tablet contains 10 mg of ezetimibe and 10 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Hatteras 10 mg/20 mg: each tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Hatteras 10 mg/40 mg: each tablet contains 10 mg of ezetimibe and 40 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Hatteras 10 mg/80 mg: each tablet contains 10 mg of ezetimibe and 80 mg of atorvastatin (as
atorvastatin calcium trihydrate).

The other components are:

Tablet core
Hatteras 10 mg/10 mg: Lactose Monohydrate, Microcrystalline Cellulose, Sodium Croscarmellose, Iron Oxide Red (E172), Sodium Lauryl Sulfate, Povidone K30, Magnesium Stearate, Calcium Carbonate, Polysorbate 80
Hatteras 10 mg/20 mg: Lactose Monohydrate, Microcrystalline Cellulose, Sodium Croscarmellose, Iron Oxide Red (E172), Sodium Lauryl Sulfate, Povidone K30, Magnesium Stearate, Calcium Carbonate, Polysorbate 80
Hatteras 10 mg/40 mg: Lactose Monohydrate, Microcrystalline Cellulose, Sodium Croscarmellose, Iron Oxide Red (E172), Sodium Lauryl Sulfate, Povidone K30, Magnesium Stearate, Calcium Carbonate, Polysorbate 80
Hatteras 10 mg/80 mg: Lactose Monohydrate, Microcrystalline Cellulose, Sodium Croscarmellose, Iron Oxide Red (E172), Sodium Lauryl Sulfate, Povidone K30, Magnesium Stearate, Calcium Carbonate, Polysorbate 80

Tablet coating
Hatteras 10 mg/10 mg: Opadry White containing Hypromellose 2910 (E464), Titanium Dioxide (E171), Talc (E553b), Propylene Glycol (E1520)
Hatteras 10 mg/20 mg: Opadry White containing Hypromellose 2910 (E464), Titanium Dioxide (E171), Talc (E553b), Propylene Glycol (E1520)
Hatteras 10 mg/40 mg: Opadry White containing Hypromellose 2910 (E464), Titanium Dioxide (E171), Talc (E553b), Propylene Glycol (E1520)
Hatteras 10 mg/80 mg: Opadry White containing Hypromellose 2910 (E464), Titanium Dioxide (E171), Talc (E553b), Propylene Glycol (E1520)

Description of the appearance of Hatteras and package contents
Hatteras 10 mg/10 mg tablets: Film-coated, biconvex tablets, white and light pink in color, oval-shaped, with "10" engraved on one side and smooth on the other, approximately 13 mm (length) x 5 mm (width).
Hatteras 10 mg/20 mg tablets: Film-coated, biconvex tablets, white and light pink in color, oval-shaped, with "20" engraved on one side and smooth on the other, approximately 15 mm (length) x 6 mm (width).
Hatteras 10 mg/40 mg tablets: Film-coated, biconvex tablets, white and light pink in color, oval-shaped, with "40" engraved on one side and smooth on the other, approximately 16 mm (length) x 7 mm (width).
Hatteras 10 mg/80 mg tablets: Film-coated, biconvex tablets, white and light pink in color, oval-shaped, with "80" engraved on one side and smooth on the other, approximately 18 mm (length) x 8 mm (width).

Pack sizes of 30 film-coated tablets in cold-formed blisters (OPA/Al/PVC-Al).
Pack sizes of 60 film-coated tablets in cold-formed blisters (OPA/Al/PVC-Al).

Marketing Authorization Holder
I.B.N Savio S.r.l.
Via del Mare, 36
00071 Pomezia (RM)
Italy

Manufacturer
Factory Bennett Pharmaceuticals S.A.
Aigaiou 26, Thesi Karela
19441, Koropi Attiki, Greece
Rontis Hellas Medical and Pharmaceutical Products S.A.
Larissa Industrial Area, P.O. BOX 3012,
Larissa, 41500, Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Hatteras
Czech Republic: Hatteras