Package Insert: Information for the Patient

Lipocomb 1010 mg/10 mg Hard Capsules

Lipocomb 2010 mg/10 mg Hard Capsules

rosuvastatina / ezetimiba

Read this package insert carefully before starting to take this medication, as it contains important information for you

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Lipocomb contains two different active principles in one capsule. One of the active principles is rosuvastatina, which belongs to the group of statins, the other active principle is ezetimiba.

Lipocomb is a medication used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, Lipocomb increases the concentrations of "good" cholesterol (HDL cholesterol). This medication acts by reducing cholesterol in two ways: reducing the cholesterol absorbed in the digestive tract, as well as the cholesterol produced by the body itself.

For most people, high cholesterol levels do not affect how they feel since they do not produce any symptoms. However, if left untreated, fatty deposits can accumulate in the walls of blood vessels and narrow them. Sometimes, these narrowed blood vessels can become blocked, cutting off blood supply to the heart or brain, which would cause a heart attack or cerebral embolism. By reducing cholesterol levels, the risk of having a heart attack, cerebral embolism, or other related health problems can be reduced.

Thismedicationis used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you must follow a cholesterol-reducing diet. Your doctor may prescribe Lipocomb if you are already taking rosuvastatina and ezetimiba at the same dosage level.

This medication is used in patients with heart disease. Lipocomb reduces the risk of myocardial infarction, cerebral accident, coronary artery bypass surgery, or hospitalization for chest pain.

Lipocomb does not help with weight loss.

Do not take Lipocomb if:

• You are allergic to rosuvastatin, ezetimibe, or any of the other components of this medication (listed in section 6),
• You have liver disease,
• You have severe kidney problems,
• You have repeated or unjustified muscle pain and cramps (myopathy),
• You are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medications used to treat a viral liver infection called hepatitis C).
• You are taking a medication called ciclosporina (used, for example, after an organ transplant),
• You are pregnant or breastfeeding. If you become pregnant while taking Lipocomb, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Lipocomb using an appropriate contraceptive method.
• You have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Lipocomb or another medication containing rosuvastatin.

If you find yourself in any of the above situations (or are unsure), consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lipocomb if:

• You have kidney problems,
• You have liver problems,
• You have repeated or unjustified muscle pain and cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other medications to lower cholesterol levels. Inform your doctor immediately if you have unjustified muscle pain or cramps, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you have constant muscle weakness,
• You have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4),
• You are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must establish the appropriate dose for you,
• You are taking medications to treat infections, including HIV (human immunodeficiency virus) or hepatitis C, such as ritonavir with lopinavir and/or atazanavir. See "Taking Lipocomb with other medications",
• You have severe respiratory failure,
• You are taking other medications called fibrates to lower cholesterol, see "Taking Lipocomb with other medications",
• You regularly consume large amounts of alcohol,
• Your thyroid glanddoes not function correctly (hypothyroidism),
• You are over 70years old, (since your doctor mustchoosethe appropriate doseof Lipocomb for you).
• You are taking or have taken within the last 7days a medication called fusidic acid (an antibiotic) by oral or injectable route. The combination of fusidic acid and Lipocomb may cause severe muscle problems (rhabdomyolysis).

If you find yourself in any of these situations mentioned above (or are unsure): consult your doctor or pharmacist before starting to take any dose of Lipocomb.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with rosuvastatin treatment.Stop taking Lipocomband seek medical attention immediatelyif you observe any of the symptoms described in section 4.

In a reduced number of people, statins can affect the liver. This is detected by a simple test that detects increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function test) during treatment with Lipocomb. It is essential that you visit your doctor for the tests.

While taking this medication, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You may be at risk of developing diabetes if you have high sugarand fatlevels in your blood, are overweight, and have high blood pressure.

Children and adolescents

Lipocomb is not recommended for use in children and adolescents under 18 years of age.

Taking Lipocomb with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor if you are taking any of the following medications:

• Ciclosporina (used after an organ transplant to prevent organ rejection. The effect of rosuvastatin increases with its use together).Do not take Lipocomb if you are taking ciclosporina.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase while taking it together with Lipocomb), ticagrelor or clopidogrel.
• Other medications to lower cholesterol called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). The effect of rosuvastatin increases with its use together.
• Colestiramine (a medication also used to lower cholesterol), because it affects how ezetimibe works.
• Regorafenib (used to treat cancer).
• Darolutamida (used to treat cancer).
• Any of the following medications used to treat viral infections, including HIV or hepatitis C, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir,sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Medications for indigestion containing aluminum and magnesium (used to neutralize stomach acid, as they reduce the level of rosuvastatin in plasma). This effect can be mitigated by taking this type of medication 2 hours after rosuvastatin.
• Eritromicina (an antibiotic). The effect of rosuvastatin decreases with its use together.
• Fusidic acid.If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily interrupt taking this medication. Your doctor will indicate when you can safely take Lipocomb again. Taking Lipocomb with fusidic acid may occasionally cause severe muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.
• Oral contraceptive (the pill).Levels of sex hormonesabsorbed fromthe pillare increased.
• Capmatinib (used to treat cancer).
• Hormone replacement therapy (increased levels of hormones in the blood).
• Fostamatinib (used to treat low platelet count).
• Febuxostat (used to treat and prevent high uric acid levels in the blood).
• Teriflunomida (used to treat multiple sclerosis).

If you visit a hospital or receive treatment for another condition, inform the medical staff that you are taking Lipocomb.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication. If you become pregnant while taking Lipocomb, stop taking it immediately and inform your doctor. Women should use contraceptive methods during treatment with Lipocomb.

Do not take Lipocomb if you are breastfeeding, as it is unknown whether the medication passes into breast milk.

Driving and operating machinery

Lipocomb is not believed to interfere with your ability to drive or operate machinery. However, some people may feel dizzy during treatment with Lipocomb. If you feel dizzy, consult your doctor before attempting to drive or operate machinery.

Lipocomb contains sodium

This medication contains less than 1mmol of sodium (23mg) per hard capsule, that is, it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

You must continue to maintain a low-cholesterol diet and exercise while taking Lipocomb.

The recommended daily dose for adults is one capsule of the concentration in question.

Take Lipocomb once a day.

You can take it at any time of the day with or without food. Swallow eachcapsulewhole with water. Try to takethe capsulesat the same time every day.

Lipocomb is not suitable for starting treatment. The start of treatment or dose adjustments, if necessary, should only be made by taking the active ingredients separately, and once the appropriate doses have been adjusted, it is possible to switch to Lipocomb at the corresponding dose.

Regular cholesterol level checks

It is essential that you visit your doctor regularly for cholesterol checks, in order to verify that your cholesterol levels have normalized and are maintained at appropriate levels.

If you take more Lipocomb than you should

Contact your doctor or the emergency department of the nearest hospital as you may need medical assistance.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Lipocomb

Do not worry, simply take the next scheduled dose at the scheduled time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Lipocomb

Consult your doctor if you want to discontinue treatment with Lipocomb. Your cholesterol levels may increase again if you stop taking Lipocomb.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

It is essential that you know which side effects may occur.

Stop taking Lipocomb and seek medical assistance immediately if you experience any of the following side effects:

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

• Allergic reactions such as swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing and swallowing.
• Unjustified muscle pain and cramps that last longer than expected. In rare cases, this may become a potentially fatal muscle damage known as rhabdomyolysis, leading to general discomfort, fever, and kidney failure.
• Lupus-like syndrome (including rash, joint disorder, and effects on blood cells).
• Muscle rupture.

Side effects of unknown frequency (cannot be estimated from available data):

• Flat, red spots, in the shape of a target or circles on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and symptoms similar to the flu (Stevens-Johnson syndrome).
• Generalized rash, elevated body temperature, and increased lymph nodes (DRESS or drug hypersensitivity syndrome).
• Erythema multiforme (potentially fatal allergic reactions affecting the skin and mucous membranes).

Other possible side effects:

Frequent (may affect up to 1 in 10 people):

• Headache;
• Constipation;
• General discomfort;
• Muscle pain;
• Weakness;
• Dizziness;
• Diabetes. This is more likely if you have high blood sugar and lipid levels, being overweight, and high blood pressure. Your doctor will monitor you while taking this medicine.
• Abdominal pain (stomach pain);
• Diarhea;
• Flatulence (excess gas in the intestinal tract);
• Feeling tired;
• High levels in some blood test results for liver function (transaminases).

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

• Skin rash, itching, urticaria;
• Increased protein levels in urine, which usually returns to normal on its own without the need to stop treatment with rosuvastatin;
• High levels in some blood test results for muscle function (CK);
• Cough;
• Indigestion;
• Heartburn;
• Joint pain;
• Muscle spasms;
• Neck pain;
• Loss of appetite;
• Pain;
• Chest pain;
• Hot flashes;
• High blood pressure;
• Tickling sensation;
• Dry mouth;
• Stomach inflammation;
• Back pain;
• Muscle weakness;
• Pain in the arms and legs;
• Swelling, especially in the hands and feet.

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

• Pancreatitis, which causes severe stomach pain that may extend to the back;
• Reduction in platelet levels.

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

• Icterus (yellowing of the skin and eyes);
• Hepatitis (inflammation of the liver);
• Traces of blood in urine;
• Nerve damage in the legs and arms (such as numbness);
• Memory loss;
• Enlargement of the breasts in men (gynecomastia).

Unknown frequency (cannot be estimated from available data):

• Difficulty breathing;
• Edema (swelling);
• Sleep disturbances, including insomnia and nightmares;
• Sexual dysfunction;
• Depression;
• Respiratory problems, including persistent cough and/or difficulty breathing or fever;
• Tendon damage;
• Constant muscle weakness;
• Gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, and vomiting);
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing);
• Myasthenia ocular (a disease that causes weakness of the eye muscles);

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store below 30 °C.

Store in the original packaging to protect it from light and moisture.

Do not use this medication after the expiration date that appears on the box and on the blister packafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and unused medications at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Lipocomb

The active principles are rosuvastatina (as rosuvastatina zinc) and ezetimiba. The capsules contain rosuvastatina zinc equivalent to 10 mg or 20 mg of rosuvastatina. Each capsule contains 10 mg of ezetimiba.

The other components are:

Core

Microcrystalline cellulose silicified (microcrystalline cellulose (E460) and anhydrous colloidal silica (E551)), anhydrous colloidal silica (E551), magnesium stearate (E572), povidone (E1201), sodium croscarmellose (E468), microcrystalline cellulose (E460), mannitol (E421), sodium lauryl sulfate (E514), low-substituted hydroxypropyl cellulose (E463).

Capsule coating

Lipocomb 10mg/10mg hard capsules:

Cap and body: Yellow iron oxide (E172), titanium dioxide (E171), gelatin.

Lipocomb 20mg/10mg hard capsules:

Cap: Red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), gelatin.

Body: Yellow iron oxide (E172), titanium dioxide (E171), gelatin.

Appearance of the product and contents of the package

Lipocomb 10mg/10mg hard capsules: Unmarked Coni Snap type closure, hard gelatin capsule with yellow-colored cap and yellow-colored body containing two tablets: a tablet ofezetimiba 10 mgwhite or almost white, round, flat, and beveled-edge, with a stylized E sign on one face of the tablet and the code 612 on the other face; a tablet ofrosuvastatina 10 mgwhite or almost white, round, with a markon one face of the tablet and no mark on the other face. The length of the capsule is approximately 21.7 mm (± 0.5 mm).

Lipocomb 20mg/10mg hard capsules: Unmarked Coni Snap type closure, hard gelatin capsule with caramel-colored cap and yellow-colored body containing two tablets: a tablet ofezetimiba 10 mgwhite or almost white, round, flat, and beveled-edge, with a stylized E sign on one face of the tablet and the code 612 on the other face; a tablet ofrosuvastatina 20 mgwhite or almost white, round, with a markon one face of the tablet and no mark on the other face. The length of the capsule is approximately 21.7 mm (± 0.5 mm).

Packaging of 10, 28, 30, 56, 60, 84, 90 hard capsules in blister (OPA/Al/PVC // Al) within a folded cardboard box along with a leaflet.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Egis Pharmaceuticals PLC

1106 Budapest, Keresztúri út 30-38.

Hungary

Responsible manufacturer

Egis Pharmaceuticals PLC

1165 Budapest, Bökényföldi út 118-120.

Hungary

Egis Pharmaceuticals PLC

9900 Körmend, Mátyás király u. 65.

Hungary

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Laboratorios Servier S.L.

Avenida de los Madroños 33

28043 Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last revision date of this leaflet: November 2023

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/