Lipocomb 20 mg/10 mg hard capsules

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Lipocomb 10 mg/10 mg hard capsules

Lipocomb 20 mg/10 mg hard capsules

rosuvastatin / ezetimibe

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Lipocomb is and what it is used for
2. What you need to know before taking Lipocomb
3. How to take Lipocomb
4. Possible side effects
5. How to store Lipocomb

Pack contents and other information

1. What Lipocomb is and what it is used for

Lipocomb contains two different active substances in one capsule. One of the active substances is rosuvastatin, which belongs to a group of medicines called statins; the other active substance is ezetimibe.

Lipocomb is a medicine used to reduce blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, Lipocomb increases levels of "good" cholesterol (HDL cholesterol). This medicine works by reducing cholesterol in two ways: it reduces both the cholesterol absorbed from the digestive tract and the cholesterol produced by the body itself.

For most people, high cholesterol levels do not affect how they feel, as they cause no symptoms. However, if left untreated, fatty deposits can build up 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 could lead to a heart attack or stroke. By lowering cholesterol levels, your risk of having a heart attack, stroke, or other related health problems can be reduced.

This medicine is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet. Your doctor may prescribe Lipocomb if you are already taking rosuvastatin and ezetimibe at the same dose levels.

This medicine is used in patients with heart disease. Lipocomb reduces the risk of myocardial infarction, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Lipocomb does not help you to lose weight.

2. What you need to know before taking Lipocomb

Do not take Lipocomb if:

• you are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6),
• you have liver disease,
• you have severe kidney problems,
• you have repeated or unexplained muscle pain or cramps (myopathy),
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medicines used for the viral liver infection called hepatitis C),
• you are taking a medicine called cyclosporine (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 by using an appropriate contraceptive method,
• you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking Lipocomb or another medicine containing rosuvastatin.

If you are in any of the situations listed above (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 unexplained muscle pain or cramps, a personal or family history of muscle disorders, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if you also have general malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness,
• you have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4),
• you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must determine the appropriate dose for you,
• you are taking medicines to treat infections, including HIV (human immunodeficiency virus) or hepatitis C, such as ritonavir with lopinavir and/or atazanavir. See "Taking Lipocomb with other medicines",
• you have severe respiratory insufficiency,
• you are taking other medicines called fibrates to lower cholesterol; see "Taking Lipocomb with other medicines",
• you regularly consume large amounts of alcohol,
• your thyroid gland is not functioning properly (hypothyroidism),
• you are over 70 years of age (as your doctor must choose the appropriate dose of Lipocomb for you),
• you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (an antibiotic for bacterial infection). The combination of fusidic acid and Lipocomb may cause serious muscle problems (rhabdomyolysis).

If you are in any of the above-mentioned situations (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 Lipocomb and seek immediate medical attention if you experience any of the symptoms described in section 4.

In a small number of people, statins may affect the liver. This is detected through a simple blood test showing increased levels of liver enzymes (transaminases). For this reason, your doctor will usually perform blood tests (liver function tests) during treatment with Lipocomb. It is important that you attend your appointments for these tests.

While taking this medicine, 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 levels of sugar and fats in your blood, are overweight, and have high blood pressure.

Children and adolescents

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

Taking Lipocomb with other medicines

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

Tell your doctor if you are taking any of the following medicines:

• Cyclosporine (used after organ transplantation to prevent organ rejection. The effect of rosuvastatin increases when taken together). Do not take Lipocomb if you are taking cyclosporine.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and risk of bleeding may increase when taken with Lipocomb), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct blood triglyceride levels (e.g., gemfibrozil and other fibrates). The effect of rosuvastatin increases when taken together.
• Colestipol (a medicine also used to lower cholesterol), as it affects how ezetimibe works.
• Regorafenib (used to treat cancer).
• Darolutamide (used to treat cancer).
• Any of the following medicines 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.
• Treatments for indigestion containing aluminum and magnesium (used to neutralize stomach acid, as they reduce plasma levels of rosuvastatin). This effect can be minimized by taking these medicines 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases when taken together.
• Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to resume Lipocomb. Taking Lipocomb with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• An oral contraceptive (the pill). Absorbed levels of sex hormones are increased.
• Capmatinib (used to treat cancer).
• Hormone replacement therapy (increased hormone levels in the blood).
• Fostamatinib (used to treat low platelet count).
• Febuxostat (used to treat and prevent high levels of uric acid in the blood).
• Teriflunomide (used to treat multiple sclerosis).

If you go to a hospital or receive treatment for another illness, tell the medical staff that you are taking Lipocomb.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. 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 medicine passes into breast milk.

Driving and using machines

Lipocomb is not expected to affect your ability to drive or operate machinery. However, some people may experience dizziness during treatment with Lipocomb. If you feel dizzy, consult your doctor before attempting to drive or use machinery.

Lipocomb contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, i.e., essentially "sodium-free".

3. How to take Lipocomb

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The recommended daily dose for adults is one capsule of the corresponding strength.

Take Lipocomb once daily.

You may take it at any time of day, with or without food. Swallow each capsule whole with water. Try to take the capsules at the same time each day.

Lipocomb is not suitable for initiating treatment. Initiation of treatment or dose adjustments, if necessary, should only be performed using the active substances separately. Once the appropriate doses have been established, switching to the corresponding strength of Lipocomb is possible.

Regular monitoring of cholesterol levels

It is important that you visit your doctor regularly for cholesterol checks, to ensure that your cholesterol levels have normalized and remain at appropriate levels.

If you take more Lipocomb than you should

Contact your doctor or the nearest hospital emergency department, as you may require medical attention.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 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 usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Lipocomb

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

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

4. Possible adverse effects

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

It is important that you are aware of what these adverse effects may be.

Stop taking Lipocomb and seek immediate medical help if you experience any of the following adverse effects:

Rare adverse 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 or swallowing.
• Unexplained muscle pains and cramps lasting longer than expected. In rare cases, this may lead to potentially life-threatening muscle damage known as rhabdomyolysis, resulting in general malaise, fever, and kidney failure.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).
• Muscle rupture.

Adverse effects with frequency not known (cannot be estimated from available data):

• Non-elevated red, target-shaped or circular skin rashes on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Erythema multiforme (potentially life-threatening allergic reactions affecting the skin and mucous membranes).

Other possible adverse effects:

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

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

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

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

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

• Inflammation of the pancreas, causing severe stomach pain that may spread to the back;
• Reduction in blood platelet levels.

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

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

Frequency not known (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 injuries;
• Persistent muscle weakness;
• Gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting);
• Myasthenia gravis (a condition causing generalized muscle weakness, which in some cases affects the muscles used for breathing);
• Ocular myasthenia (a condition causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lipocomb

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

Store below 30 °C.

Keep in the original packaging to protect from light and moisture.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lipocomb

The active substances are rosuvastatin (as rosuvastatin zinc) and ezetimibe. The capsules contain rosuvastatin zinc equivalent to 10 mg or 20 mg of rosuvastatin. Each capsule contains 10 mg of ezetimibe.

The other components are:

Core

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

Capsule shell

Lipocomb 10 mg/10 mg hard capsules:

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

Lipocomb 20 mg/10 mg hard capsules:

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

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

Nature of the product and contents of the container

Lipocomb 10 mg/10 mg hard capsules: Unmarked Coni Snap closure, hard gelatin capsule with yellow cap and yellow body containing two tablets: one ezetimibe 10 mg tablet, white or almost white, round, flat, with bevelled edges, bearing a stylized E on one side and the code 612 on the other side; one rosuvastatin 10 mg tablet, white or almost white, round, marked on one side and unmarked on the other side. The capsule length is approximately 21.7 mm (± 0.5 mm).

Lipocomb 20 mg/10 mg hard capsules: Unmarked Coni Snap closure, hard gelatin capsule with caramel-coloured cap and yellow body containing two tablets: one ezetimibe 10 mg tablet, white or almost white, round, flat, with bevelled edges, bearing a stylized E on one side and the code 612 on the other side; one rosuvastatin 20 mg tablet, white or almost white, round, marked on one side and unmarked on the other side. The capsule length is approximately 21.7 mm (± 0.5 mm).

Pack sizes of 10, 28, 30, 56, 60, 84, 90 hard capsules in blisters (OPA/Al/PVC // Al) inside a folding cardboard box with a package leaflet.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Egis Pharmaceuticals PLC

1106 Budapest, Keresztúri út 30-38.

Hungary

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 under the following names:

Date of the most recent review of this leaflet: November 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/