GOLTOR 10 mg Tablet

Зміст інструкції

1. GOLTOR 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg or 10 mg/80 mg tablets
   1. What GOLTOR is and what it is used for
   2. What you need to know before taking GOLTOR
   3. How to take GOLTOR
   4. Possible side effects
   5. How to store GOLTOR
   6. Package Contents and Other Information

GOLTOR 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg or 10 mg/80 mg tablets

ezetimibe and simvastatin
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 their symptoms are the same as yours, as it could 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 GOLTOR is and what it is used for
• 2. What you need to know before you take GOLTOR
• 3. How to take GOLTOR
• 4. Possible side effects
• 5. How to store GOLTOR
• 6. Contents of the pack and other information

1. What GOLTOR is and what it is used for

GOLTOR contains the active ingredients ezetimibe and simvastatin.
GOLTOR is a medicine used to lower total cholesterol levels, “bad” cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. In addition, GOLTOR increases levels of “good” cholesterol (HDL cholesterol).
GOLTOR works in two ways to lower cholesterol. The active ingredient ezetimibe reduces cholesterol absorbed in the digestive tract. The active ingredient simvastatin, which belongs to the class of drugs called “statins”, inhibits the production of cholesterol synthesized by the body.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is mainly composed of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of arteries forming plaques. Over time, this build-up in the form of plaque 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. This blockage of blood flow can 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 protects against heart disease.
Triglycerides are another form of fat in the blood that can increase the risk of heart disease.
GOLTOR is used for patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you should still follow a diet to lower your cholesterol.
GOLTOR is used as an adjunct to diet therapy to lower cholesterol if you have:

• increased cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial and non-familial]) or high levels of fats in the blood (mixed hyperlipidemia):
• which are not well controlled by a statin alone,
• for which you have taken treatment with a statin and ezetimibe in separate tablets.
• an inherited disease (homozygous familial hypercholesterolemia) that increases your cholesterol levels in the blood. You may also be receiving other treatments
• heart disease, GOLTOR reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalisation for chest pain.

GOLTOR does not help with weight loss.

2. What you need to know before taking GOLTOR

Do not take GOLTOR if:

• you are allergic (hypersensitive) to ezetimibe, simvastatin or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information),
• you currently have liver problems,
• you are pregnant or breastfeeding,
• you are taking any medicine(s) containing one or more of the following active substances: ○ itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections), ○ erythromycin, clarithromycin or telithromycin (used to treat infections), ○ HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used to treat HIV infections), ○ boceprevir or telaprevir (used to treat hepatitis C virus infections), ○ nefazodone (used to treat depression), ○ cobicistat, ○ gemfibrozil (used to lower cholesterol), ○ cyclosporine (often used in patients undergoing organ transplantation), ○ danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus develops outside the uterus).
• you are taking or have taken, in the last 7 days, a medicine called fusidic acid (a medicine used to treat bacterial infection) orally or by injection. The combination of fusidic acid and GOLTOR may cause serious muscle problems (rhabdomyolysis). Do not take more than 10 mg/40 mg of GOLTOR if you are taking lomitapide (used to treat a severe and rare genetic condition of cholesterol).

Ask your doctor for advice if you are not sure whether the medicine you are taking is among those listed above.

Warnings and precautions
Tell your doctor:

• about all your medical conditions, including allergies,
• if you consume significant amounts of alcohol or if you have ever had a liver disease. In this case GOLTOR may not be suitable for you,
• if you are going to have surgery. You may need to stop taking GOLTOR tablets for a short period,
• if you are Asian, because a different dose may be appropriate for you.
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness including, in some cases, the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to appear (see section 4).

The doctor must have your blood tested before giving you GOLTOR and if you have symptoms of liver problems while taking GOLTOR. This test is done to know if the liver is working properly.
The doctor may prescribe blood tests to also check liver function after starting therapy with GOLTOR.
During treatment with this medicine, the doctor will carefully monitor that you do not have diabetes or 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 have high blood pressure.
Tell your doctor if you have a severe lung disease.
The administration of GOLTOR with fibrates (some types of medicines to lower cholesterol) should be avoided as the use of GOLTOR with fibrates has not been studied.

Contact your doctor immediately if you experience pain, tenderness or muscle weakness from undetermined causes, as muscle problems can, rarely, be serious and lead to muscle tissue damage that causes kidney damage and very rarely cases of death have occurred.
The risk of muscle damage is greater at higher doses of GOLTOR, especially with the 10 mg/80 mg dose. The risk of muscle damage is also greater in some patients. Tell your doctor if any of the following conditions apply to you:

• you have kidney problems,
• you have thyroid problems,
• you are 65 years of age or older,
• you are female,
• you have ever had muscle problems while taking cholesterol-lowering medicines called “statins” (such as simvastatin, atorvastatin and rosuvastatin) or fibrates (such as gemfibrozil and bezafibrato),
• you or your close family members suffer from an inherited muscle disease.

Also, tell your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines may be needed for diagnosis and treatment of this condition.

Children and adolescents

• The use of GOLTOR is not recommended in children under 10 years of age.

Other medicines and GOLTOR
Tell your doctor if you are taking, have recently taken or might take any other medicine with any of the following active substances. Taking GOLTOR with any of the following medicines may increase the risk of muscle problems (some have already been mentioned above in the “Do not take GOLTOR if” section).

• If you need to take fusidic acid orally to treat a bacterial infection, you will have to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart treatment with GOLTOR. Taking GOLTOR with fusidic acid can

rarely lead to weakness, tenderness or muscle pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

• cyclosporine (often used in patients receiving an organ transplant),
• danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus develops outside the uterus),
• medicines with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections),
• fibrates with active ingredients such as gemfibrozil and bezafibrato (used to reduce cholesterol),
• erythromycin, clarithromycin or telithromycin (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS),
• antiviral agents for hepatitis C such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• medicines with the active ingredient cobicistat,
• amiodarone (used to treat an irregular heartbeat),
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease or other heart diseases),
• lomitapide (used to treat a severe and rare genetic cholesterol condition),
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). It is possible that the side effects that affect the muscles may be greater when this medicine is taken during treatment with simvastatin (e.g., GOLTOR). Your doctor may decide to stop you from taking GOLTOR for a period of time,
• high doses (1 gram or more per day) of niacin or nicotinic acid (also used to lower cholesterol),
• colchicine (used to treat gout).

In addition to the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicine, including over-the-counter medicines. In particular, tell your doctor if you are taking any of the following:

• medicines with an active ingredient to prevent blood clots from forming, such as warfarin, fluindione, phenprocoumone or acenocoumarol (anticoagulants),
• cholestyramine (also used to lower cholesterol) as it affects how GOLTOR works,
• fenofibrate (also used to lower cholesterol),
• rifampicin (used to treat tuberculosis);
• ticagrelor (antiplatelet medicine).

You should also tell any doctor who is prescribing you a new medicine that you are taking GOLTOR.

GOLTOR with food and drink
Grapefruit juice contains one or more substances that alter the metabolism of some medicines, including GOLTOR. Consumption of grapefruit juice should be avoided, as it may increase the risk of muscle problems.

Pregnancy and breastfeeding
Do not use GOLTOR if you are pregnant, if you intend to become pregnant or if you suspect you are pregnant. If you become pregnant during therapy with GOLTOR, stop taking it immediately and contact your doctor. GOLTOR should not be used during breastfeeding as it is not known whether the medicine passes into human milk.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
GOLTOR is not expected to interfere with your ability to drive vehicles or operate machinery.
However, it should be noted that some people have experienced dizziness after taking GOLTOR.

GOLTOR contains lactose
GOLTOR tablets contain a sugar called lactose. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.

GOLTOR contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take GOLTOR

The doctor will determine the appropriate tablet dosage for you, based on your current treatment and your
risk profile.
The tablets do not have a score line and must not be divided.
Take this medicine following the instructions of your doctor or pharmacist exactly as given. If you
have any doubts, ask your doctor or pharmacist.

• Before starting to take GOLTOR, you should already have followed a diet to lower your cholesterol levels.
• During treatment with GOLTOR, you must continue to follow this diet to lower cholesterol. Adults: the dose is 1 tabletof GOLTOR orally once a day.

Use in adolescents(10 to 17 years of age): the dose is 1 tabletof GOLTOR orally once a
day (a maximum dose of 10 mg/40 mg once a day should not be exceeded).
The 10 mg/80 mg dose of GOLTOR is recommended only in adult patients with very high cholesterol levels and at high risk for heart disease who have not reached their ideal cholesterol level with lower doses.
Take GOLTOR in the evening. You can take it with or without food.
If your doctor has prescribed GOLTOR with another medicine to lower cholesterol containing the
active ingredient colestyramine or any other bile acid sequestrant, you must take GOLTOR
at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more GOLTOR than you should:

• Contact your doctor or pharmacist.

If you forget to take GOLTOR:

• Do not take a double dose to make up for a missed tablet, just take your normal dose of GOLTOR the next day at the usual time.

If you stop taking GOLTOR:

• Consult your doctor or pharmacist because your cholesterol may increase again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, GOLTOR can cause side effects, although not everybody gets them
(see section 2, What you need to know before you take GOLTOR).
The following side effects have been reported as common (may affect up to 1 in 10 people):

• muscle pain,
• increases in blood test values relating to liver function (transaminases) and/or muscles (CK).

The following side effects have been reported as uncommon (may affect up to 1 in 100 people):

• increases in blood test values relating to liver function; increases in uric acid levels in the blood; increases in the time it takes for blood to clot; presence of protein in the urine; decrease in body weight,
• dizziness; headache; tingling sensation,
• abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal bloating; diarrhoea; dry mouth; heartburn,
• skin rash; itching; hives,
• joint pain; pain, tenderness, weakness or muscle spasms; neck pain; arm or leg pain; back pain,
• unusual fatigue or weakness; feeling tired; chest pain; swelling, especially of the hands and feet,
• sleep disorder; difficulty falling asleep.

The following side effects have been reported with unknown frequency (frequency cannot be
estimated from the available data):

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

See your doctor if you experience weakness in your arms or legs that gets worse after periods of activity,
double vision or drooping eyelids, difficulty swallowing or shortness of breath.
Also, the following side effects have been reported in people taking GOLTOR or medicines
containing the active ingredients ezetimibe or simvastatin:

• low red blood cell count (anaemia); decreased number of blood cells, which can cause bruising/bleeding (thrombocytopenia),
• loss of sensation or weakness in the arms and legs; poor memory; memory loss; confusion,
• breathing problems including persistent cough and/or shortness of breath or fever,
• constipation,
• inflammation of the pancreas often with severe abdominal pain,
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes; itching; dark urine or pale stools, feeling tired or weak; loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea and vomiting),
• hair loss; raised, red skin rash, sometimes with target-like lesions (erythema multiforme),
• blurred vision and impaired vision (may affect up to 1 in 1,000 people),
• skin rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (may affect up to 1 in 10,000 people),
• hypersensitivity reactions including some of the following: allergic reactions including swelling of the face, lips, tongue and/or throat that can cause difficulty breathing or swallowing and requires immediate treatment (angioedema), pain or inflammation of the joints, inflammation of blood vessels, unusual bruising, skin rashes and swelling, sun sensitivity, fever, flushing, shortness of breath and feeling unwell, a collection of symptoms like lupus (which include skin rash, joint problems and effects on white blood cells). A very rare serious allergic reaction (may affect up to 1 in 10,000 people) that causes difficulty breathing or dizziness and requires immediate treatment (anaphylaxis),
• pain, tenderness, weakness or cramps in muscles; muscle injury; muscle rupture (may affect up to 1 in 10,000); tendon problems, sometimes complicated by tendon rupture,
• gynecomastia (enlargement of the breasts in men) (may affect up to 1 person in
• 10,000),
• loss of appetite,
• hot flushes; high blood pressure,
• pain,
• erectile dysfunction,
• depression,
• alteration of some blood test values relating to liver function.

Further possible side effects reported with some statins:

• sleep disturbances, including nightmares,
• sexual difficulties,
• diabetes. This is more likely if you have high levels of sugar and fats in your blood, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine,
• pain, tenderness or weakness in muscles that is constant and may not disappear after stopping treatment with GOLTOR (frequency not known).

Seek medical attention immediately in case of pain, tenderness or weakness in muscles of
unknown cause, as muscle problems can, rarely, be serious and lead to muscle tissue damage that causes kidney damage and very rarely cases of death.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national system
http://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 GOLTOR

• 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 package or container after the words “Scad”.
• Do not store GOLTOR tablets at a temperature above 30°C.

Blister: store in the original packaging to protect the medicine from moisture and light. Bottles:
keep the bottles tightly closed to protect the medicine from moisture and light.
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 GOLTOR contains
The active ingredients of GOLTOR are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe
and 10 mg, 20 mg, 40 mg or 80 mg of simvastatin.
The other ingredients are: butylated hydroxyanisole, citric acid monohydrate, sodium croscarmellose, hypromellose,
lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate.

Description of the appearance of GOLTOR and package contents
GOLTOR tablets are capsule-shaped off-white to white tablets with the code “311”, ”312”,
“313”, or “315” on one side. The tablets have no score line and must not be divided.
Pack sizes:
7, 10, 14, 28, 30, 50, 56, 84, 90, 98, multi-pack containing 98 (2 packs of 49), 100 or
300 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ADDENDA PHARMA Srl
Via Ragazzi del ’99, n. 5, 40133 Bologna (BO)

Distributor for the sale in Italy:
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5, 40133 Bologna (BO)

Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg,
Belgium

This medicinal product is authorised in the Member States of the European Economic Area under the following
name:
INEGY in Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden and United Kingdom.
VYTORIN in Germany, Italy, Portugal and Spain.
GOLTOR in Germany and Italy.