LIPOCOMB 10 MG/10 MG HARD CAPSULES

2. What you need to know before you take 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 and unexplained muscle pains or cramps (myopathy),
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (medicines used to treat the viral infection of the liver called hepatitis C).
• you are taking a medicine called ciclosporin (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 sores in the mouth after taking Lipocomb or another medicine that contains rosuvastatin.

If you are 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 and unexplained muscle pains or cramps, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you have unexplained muscle pain or cramps, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you have constant muscle weakness,
• if 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 that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4),
• you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should establish the appropriate dose for you,
• if you are taking medicines to treat infections, including HIV (AIDS virus) or hepatitis C, such as ritonavir with lopinavir and/or atazanavir. See "Taking Lipocomb with other medicines",
• you have severe respiratory failure,
• you are taking other cholesterol-lowering medicines called fibrates, see "Taking Lipocomb with other medicines",
• you regularly consume large amounts of alcohol,
• your thyroid gland does not function properly (hypothyroidism),
• you are over 70 years old, (as your doctor should choose the appropriate dose of Lipocomb for you).
• you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic). The combination of fusidic acid and Lipocomb can cause serious muscle problems (rhabdomyolysis).

If you are in any of the above 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 medical attention immediatelyif you notice any of the symptoms described in section 4.

In a small 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 tests) during treatment with Lipocomb. It is essential that you go to the doctor 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 are likely to be at risk of developing diabetes if you have high levels of sugar and fat 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 medicines

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

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

• Ciclosporin (used after an organ transplant to prevent rejection of the transplanted organ. The effect of rosuvastatin increases with its combined use). Do not take Lipocomb if you are taking ciclosporin.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase while taking Lipocomb), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). The effect of rosuvastatin increases with its combined use.
• Colestyramine (a medicine also used to lower cholesterol), as it affects how ezetimibe works.
• Regorafenib (indicated for the treatment of 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 that contain aluminum and magnesium (used to neutralize stomach acid, as they reduce the level of rosuvastatin in the blood). This effect can be mitigated by taking these types of medicines 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases with its combined use.
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when you can safely take Lipocomb again. Taking Lipocomb with fusidic acid can rarely cause muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.
• An oral contraceptive (the pill). The levels of sex hormones absorbed from the pill are increased.
• Capmatinib (indicated for the treatment of 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 levels of uric acid in the blood).
• Teriflunomide (indicated for the treatment of multiple sclerosis).

If you go to the 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 use machines. However, some people may feel dizzy during treatment with Lipocomb. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Lipocomb contains sodium

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

3. How to take Lipocomb

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

You should continue to follow a cholesterol-lowering diet while taking Lipocomb.

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

Take Lipocomb once a day.

You can 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. The start of treatment or dose adjustments, if necessary, should only be done by taking the active substances separately, and once the appropriate doses have been adjusted, it is possible to switch to Lipocomb of the corresponding dose.

Regular cholesterol level checks

It is essential that you regularly visit your doctor to have your cholesterol levels checked, to ensure 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 nearest hospital emergency department, as you may need medical attention.

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

If you forget to take Lipocomb

Do not worry, simply take the next scheduled dose at the planned time. Do not take a double dose to make up for forgotten doses.

If you stop taking Lipocomb

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

If you have any further questions on 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 all people suffer from them.

It is essential that you know what these adverse effects can be.

Stop taking Lipocomb and seek medical attention immediately 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 can cause difficulty breathing and swallowing.
• Unexplained muscle pain and cramps that last longer than expected. In rare cases, this can lead to potentially life-threatening muscle damage known as rhabdomyolysis, which can cause general discomfort, fever, and kidney failure.
• Lupus-like syndrome (including rash, joint disorder, and effects on blood cells).
• Muscle rupture.

Adverse Effects of Unknown Frequency (cannot be estimated from available data):

• Reddish, non-elevated, target-like, or circular patches on the torso, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, elevated body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• Erythema multiforme (potentially life-threatening allergic reactions that affect the skin and mucous membranes).

Other Possible Adverse Effects

Common (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, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Abdominal pain (stomach pain);
• Diarrhea;
• Flatulence (excess gas in the intestinal tract);
• Feeling tired;
• High levels of certain liver function test results (transaminases).

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

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

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

• Pancreatitis, which causes severe stomach pain that can spread to the back;
• Decreased platelet count.

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

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

Frequency Not Known (cannot be estimated from available data):

• Breathing difficulties;
• Edema (swelling);
• Sleep disturbances, including insomnia and nightmares;
• Sexual dysfunction;
• Depression;
• Respiratory problems, including persistent cough and/or difficulty breathing or fever;
• Tendon injuries;
• Constant muscle weakness;
• Gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting);
• Severe myasthenia (a disease that causes generalized muscle weakness, which can affect the muscles used for breathing);
• Ocular myasthenia (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, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting Adverse Effects

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

By reporting adverse effects, you can contribute to providing 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.

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

Do not use this medicine after the expiration date shown on the box and blister pack after CAD. The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Lipocomb Composition

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

The other ingredients are:

Core

Silicified microcrystalline cellulose (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 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.

Product Appearance and Package Contents

Lipocomb 10 mg/10 mg hard capsules: Unmarked Coni Snap autoclosure, hard gelatin capsule with yellow cap and yellow body containing two tablets: one ezetimibe 10 mgtablet, white or almost white, round, flat, and beveled, with a stylized E sign on one face of the tablet and the code 612 on the other face; one rosuvastatin 10 mgtablet, white or almost white, round, with a mark on 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 20 mg/10 mg hard capsules: Unmarked Coni Snap autoclosure, hard gelatin capsule with caramel cap and yellow body containing two tablets: one ezetimibe 10 mgtablet, white or almost white, round, flat, and beveled, with a stylized E sign on one face of the tablet and the code 612 on the other face; one rosuvastatin 20 mgtablet, white or almost white, round, with a mark on 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).

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

Only certain package 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Laboratorios Servier S.L.

Avenida de los Madroños 33

28043 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet: November 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/