Goltor: detailed information

Package leaflet: Information for the patient

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

ezetimibe and simvastatin
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 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:

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

1. What GOLTOR is and what it is used for

GOLTOR contains the active substances ezetimibe and simvastatin.
GOLTOR is a medicine used to lower levels of total cholesterol, “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 substance ezetimibe reduces cholesterol absorbed in the gastrointestinal tract. The active substance simvastatin, which belongs to the class of drugs known as “statins”, inhibits the body's production of cholesterol.
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. This 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 protects against heart disease.
Triglycerides are another form of fat in the blood that may 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 must still follow a cholesterol-lowering diet.
GOLTOR is used as an add-on to diet to lower cholesterol if you have:

elevated levels of cholesterol in the blood (primary hypercholesterolemia [heterozygous familial and non-familial]) or elevated levels of fats in the blood (mixed hyperlipidemia):
that are not well controlled by a statin alone,
for which you have previously been treated with separate tablets containing a statin and ezetimibe.
a hereditary disease (homozygous familial hypercholesterolemia) that increases your blood cholesterol levels. You may also be receiving other treatments.
heart disease; GOLTOR reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalization due to chest pain.

GOLTOR does not help with weight loss.

2. What you should 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 a 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 who have had an organ transplant),
○ danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).
you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infection). The combination of fusidic acid and GOLTOR may lead to serious muscle problems (rhabdomyolysis). Do not take more than 10 mg/40 mg of GOLTOR if you are taking lomitapide (used to treat a rare, severe genetic cholesterol condition).

Ask your doctor for advice if you are unsure 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 large amounts of alcohol or have ever had liver disease. In such cases, GOLTOR may not be suitable for you,
if you are scheduled for surgery. You may need to temporarily stop taking GOLTOR tablets,
if you are of Asian descent, as 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 causing weakness of the eye muscles), as statins may occasionally worsen myasthenia or trigger its onset (see section 4).

Your doctor should perform a blood test before you start taking GOLTOR and if you develop symptoms of liver problems while taking GOLTOR. This test is to check whether your liver is functioning properly.

Your doctor may also order blood tests to monitor liver function after starting treatment with GOLTOR.

While taking this medicine, your doctor will closely monitor whether 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 if you have a serious lung disease.

The use of GOLTOR together with fibrates (a type of cholesterol-lowering medicine) should be avoided, as the combination has not been studied.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, as muscle problems can rarely be severe and lead to muscle tissue damage causing kidney injury, and very rarely, death.

The risk of muscle damage is higher with higher doses of GOLTOR, particularly the 10 mg/80 mg dose. The risk of muscle damage is also increased in certain patients. Inform 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 previously experienced muscle problems while taking cholesterol-lowering medicines known as “statins” (such as simvastatin, atorvastatin, and rosuvastatin) or fibrates (such as gemfibrozil and bezafibrate),
you or your close family members have a hereditary muscle disease.

Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatments may be needed to diagnose and manage this condition.

Children and adolescents

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

Other medicines and GOLTOR

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

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 restart GOLTOR. Taking GOLTOR with fusidic acid may rarely lead to muscle weakness, pain, or tenderness (rhabdomyolysis). See further 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 grows outside the uterus),
medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
fibrates containing active substances such as gemfibrozil and bezafibrate (used to lower 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 containing the active substance cobicistat,
amiodarone (used to treat irregular heartbeat),
verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions),
lomitapide (used to treat a rare, severe genetic cholesterol condition),
daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). The risk of muscle-related side effects may be increased when this medicine is taken during treatment with simvastatin (e.g., GOLTOR). Your doctor may decide that you should temporarily stop taking GOLTOR,
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, inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription. In particular, tell your doctor if you are taking any of the following:

medicines containing active substances to prevent blood clots, such as warfarin, fluindione, phenprocoumon, or acenocoumarol (anticoagulants),
colestyramine (also used to lower cholesterol), as it may affect how GOLTOR works,
fenofibrate (also used to lower cholesterol),
rifampicin (used to treat tuberculosis),
ticagrelor (an antiplatelet medicine).

You should also inform any doctor prescribing you a new medicine that you are taking GOLTOR.

GOLTOR with food and drinks

Grapefruit juice contains one or more substances that alter the metabolism of certain 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, planning to become pregnant, or suspect you may be pregnant. If you become pregnant while taking GOLTOR, stop taking it immediately and contact your doctor. GOLTOR must not be used during breastfeeding, as it is unknown 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 affect your ability to drive or operate machinery. However, you should be aware that some people have experienced dizziness after taking GOLTOR.

GOLTOR contains lactose

GOLTOR tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult 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

Your doctor will determine the appropriate tablet dosage for you, based on your current treatment and your individual risk profile.
The tablets do not have a score line and must not be divided.
Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Before starting GOLTOR, you should already have adopted a cholesterol-lowering diet.
During treatment with GOLTOR, you must continue to follow this cholesterol-lowering diet.
Adults: The dose is 1 tablet of GOLTOR taken orally once daily.

Use in adolescents (aged 10 to 17 years): The dose is 1 tablet of GOLTOR taken orally once daily (the maximum dose must not exceed 10 mg/40 mg once daily).
The GOLTOR dose of 10 mg/80 mg is recommended only for adult patients with very high cholesterol levels and a high risk of heart disease who have not reached their target cholesterol level with lower doses.
Take GOLTOR in the evening. You may take it with or without food.
If your doctor has prescribed GOLTOR together with another cholesterol-lowering medicine containing the active ingredient cholestyramine 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 the missed tablet. Take only your usual normal dose of GOLTOR the following day at the regular time.

If you stop taking GOLTOR:

Consult your doctor or pharmacist, as 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, GOLTOR may cause side effects, although not everybody gets them (see section 2, What you need to know before taking GOLTOR).

The following common side effects have been reported (may affect up to 1 in 10 people):

muscle pain,
increases in blood laboratory test values related to liver function (transaminases) and/or muscle function (CK).

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

increases in blood test values related to liver function; increases in blood uric acid levels; prolonged blood clotting time; presence of protein in urine; decrease in body weight,
dizziness; headache; tingling sensation,
abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal bloating; diarrhoea; dry mouth; heartburn,
skin rash; itching; urticaria,
joint pain; muscle pain, tenderness, weakness or spasms; neck pain; arm or leg pain; back pain,
unusual tiredness or weakness; feeling of fatigue; 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 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 arm or leg weakness that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
In addition, the following side effects have been reported in patients taking GOLTOR or medicines containing the active substances ezetimibe or simvastatin:

reduction in red blood cell count (anaemia); decrease in blood cells, which may lead to bruising/bleeding (thrombocytopenia),
loss of sensation or weakness in 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,
liver inflammation with the following symptoms: yellowing of the skin and eyes; itching; dark-coloured urine or pale-coloured stools; feeling of tiredness or weakness; loss of appetite; liver failure; gallstones or gallbladder inflammation (which may cause abdominal pain, nausea and vomiting),
hair loss; red, raised skin rash, sometimes with target-like lesions (erythema multiforme),
blurred vision and visual impairment (may affect up to 1 in 1,000 people),
skin rash which may appear on the skin or ulcers in the mouth (lichenoid drug eruptions) (may affect up to 1 in 10,000 people),
hypersensitivity reactions including some of the following: allergic reactions such as swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing and require immediate treatment (angioedema); joint pain or inflammation; inflammation of blood vessels; abnormal bruising; skin rashes and swelling; urticaria; increased skin sensitivity to sunlight; fever; hot flushes; shortness of breath; feeling unwell; lupus-like symptoms (including skin rash, joint problems and effects on white blood cells). A very rare severe allergic reaction (may affect up to 1 in 10,000 people) may occur, causing difficulty breathing or dizziness and requiring immediate treatment (anaphylaxis),
muscle pain, tenderness, weakness or cramps; muscle injury; muscle breakdown (may affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture,
gynaecomastia (enlargement of breast tissue in men) (may affect up to 1 in 10,000 people),
decreased appetite,
hot flushes; high blood pressure,
pain,
erectile dysfunction,
depression,
changes in certain blood test values related to liver function.

Additional possible side effects reported with some statins:

sleep disorders, including nightmares,
sexual difficulties,
diabetes. This is 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,
muscle pain, tenderness or weakness that is persistent and may not resolve after stopping treatment with GOLTOR (frequency not known).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness,
as muscle problems can, rarely, be serious and lead to muscle tissue damage causing kidney injury,
and very rare cases of death have been reported.

Reporting of side effects
If you experience any side effects, 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: 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 carton or container after the word “Exp”.
Do not store GOLTOR tablets above 30°C.

Blister packs: store in the original packaging to protect the medicine from moisture and light.
Bottles: keep bottles tightly closed to protect the medicine from moisture and 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 GOLTOR contains
The active substances 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 components are: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium,
hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate.

Description of the appearance of GOLTOR and contents of the pack
GOLTOR tablets are white to off-white, capsule-shaped tablets with the code “311”, “312”,
“313”, or “315” on one side. The tablets do not have a score line and must not be divided.
Pack sizes:
7, 10, 14, 28, 30, 50, 56, 84, 90, 98, multiple 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)
Concessionaire for 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
The Netherlands

Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

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