Rosuvastatin/ezetimibe Sandoz 5 mg/10 mg film-coated tablets

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Rosuvastatin/Ezetimibe Sandoz 5 mg/10 mg film-coated tablets

Rosuvastatin/Ezetimibe Sandoz 10 mg/10 mg film-coated tablets

Rosuvastatin/Ezetimibe Sandoz 20 mg/10 mg film-coated tablets

Rosuvastatin/Ezetimibe Sandoz 40 mg/10 mg film-coated tablets

Read the entire leaflet carefully before you start 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Rosuvastatin/Ezetimibe Sandoz is and what it is used for
2. What you need to know before taking Rosuvastatin/Ezetimibe Sandoz
3. How to take Rosuvastatin/Ezetimibe Sandoz
4. Possible side effects
5. How to store Rosuvastatin/Ezetimibe Sandoz
6. Contents of the pack and other information

1. What Rosuvastatina/Ezetimiba Sandoz is and what it is used for

Rosuvastatina/Ezetimiba Sandoz contains two different active substances in one tablet. One of the active substances is rosuvastatin, which belongs to the group of medicines called statins; the other active substance is ezetimibe.

Rosuvastatina/Ezetimiba Sandoz is a medicine used in adult patients to reduce total cholesterol levels, "bad" cholesterol (LDL cholesterol), and fatty substances circulating in the blood called triglycerides. In addition, it also increases levels of "good" cholesterol (HDL cholesterol). This medicine works by reducing cholesterol in two ways: by decreasing the cholesterol absorbed in the digestive tract and by reducing cholesterol produced by the body itself.

For most people, high cholesterol levels do not affect how they feel, as they do not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels and narrow them.

Sometimes, these narrowed blood vessels may become blocked, cutting off blood supply to the heart or brain, which could lead to a heart attack or stroke. By lowering cholesterol levels, the risk of having a heart attack, stroke, or other related health problems can be reduced.

Rosuvastatin/ezetimibe is used in patients whose cholesterol levels cannot be controlled by a cholesterol-lowering diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet. Your doctor may prescribe Rosuvastatina/Ezetimiba Sandoz if you are already taking rosuvastatin and ezetimibe at the same dose levels.

Rosuvastatin/ezetimibe is used if you have:

• high cholesterol levels in the blood (primary hypercholesterolemia).

This medicine does not help you lose weight.

2. What you need to know before taking Rosuvastatin/Ezetimibe Sandoz

Do not take Rosuvastatin/Ezetimibe Sandoz 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 to treat 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 rosuvastatin/ezetimibe, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with this medicine by using an appropriate contraceptive method.

In addition, do not take rosuvastatin/ezetimibe 40 mg/10 mg (the highest dose):

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland is not functioning properly (hypothyroidism).
• If you have had repeated or unexplained muscle pain or cramps, personal or family history of muscle problems, or previous history of muscle problems during treatment with other cholesterol-lowering medicines.
• If you regularly consume large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medicines called fibrates to lower cholesterol (see section “Other medicines and Rosuvastatin/Ezetimibe Sandoz”).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Rosuvastatin/Ezetimibe Sandoz if:

• you have kidney problems,
• you have liver problems,
• you have had repeated or unexplained muscle pain or cramps, a personal or family history of muscle problems, or 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 accompanied by 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, which 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 (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should determine the appropriate dose for you,
• you are taking medicines to treat infections, including HIV or hepatitis C, such as lopinavir, ritonavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir and/or pibrentasvir. See “Other medicines and Rosuvastatin/Ezetimibe Sandoz”,
• you have severe respiratory insufficiency,
• you are taking other medicines called fibrates to lower cholesterol. See “Other medicines and Rosuvastatin/Ezetimibe Sandoz”,
• you are about to undergo surgery. You may need to stop taking rosuvastatin/ezetimibe for a short period,
• you regularly consume large amounts of alcohol,
• you have hypothyroidism, meaning your thyroid gland is underactive,
• you are over 70 years old (as your doctor must choose the appropriate dose of rosuvastatin/ezetimibe for you),
• you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infection) taken orally or by injection. The combination of fusidic acid and rosuvastatin/ezetimibe may cause serious muscle problems (rhabdomyolysis),
• you are taking regorafenib (a medicine used to treat cancer),
• you have ever developed a severe skin rash, skin peeling, blisters and/or mouth sores after taking rosuvastatin/ezetimibe or other medicines containing rosuvastatin.

If you are in any of the above situations (or are unsure): consult your doctor or pharmacist before starting any dose of this medicine.

In a small number of people, statins may affect the liver. This is detected by a simple blood test showing elevated liver enzyme levels. For this reason, your doctor will perform regular blood tests (liver function tests) during treatment with this medicine. It is important that you attend your scheduled 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.

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin treatment. Stop using this medicine and seek immediate medical attention if you notice any of the symptoms described in section 4.

Children and adolescents

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

Other medicines and Rosuvastatin/Ezetimibe Sandoz

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

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

• Cyclosporine (used, for example, after an organ transplant to prevent organ rejection. The effect of rosuvastatin increases when taken concomitantly with cyclosporine). Do not take rosuvastatin/ezetimibe if you are taking cyclosporine.
• Anticoagulants, such as warfarin, acenocoumarol or phenindione (their anticoagulant effects and risk of bleeding may increase when taken concomitantly with this medicine), ticagrelor or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also correct blood triglyceride levels (e.g., gemfibrozil and other fibrates). During concomitant use, the effect of rosuvastatin increases. Do not take rosuvastatin/ezetimibe 40 mg/10 mg concomitantly with a fibrate.
• 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Treatments for indigestion containing aluminium 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/ezetimibe.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases when taken concomitantly.
• 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 rosuvastatin/ezetimibe. Concomitant use of this medicine and 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). Levels of absorbed sex hormones are increased.
• Hormone replacement therapy (increased hormone levels in the blood).

If you go to hospital or receive treatment for another condition, inform medical staff that you are taking rosuvastatin/ezetimibe.

Taking Rosuvastatin/Ezetimibe Sandoz with alcohol

Do not take rosuvastatin/ezetimibe 40 mg/10 mg (the highest dose) if you regularly consume large amounts of alcohol.

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.

Do not take rosuvastatin/ezetimibe if you are pregnant, think you may be pregnant, or plan to become pregnant. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women should use contraceptive methods during treatment with this medicine.

Do not take rosuvastatin/ezetimibe while breastfeeding, as it is unknown whether the medicine passes into breast milk.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machinery. However, bear in mind that some people may experience dizziness after taking this medicine. If you feel dizzy, do not drive or operate machinery.

Rosuvastatin/Ezetimibe Sandoz contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; hence, it is essentially “sodium-free”.

3. How to take Rosuvastatine/Ezetimibe Sandoz

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

You must continue to maintain a low-cholesterol diet and exercise regularly while taking rosuvastatin/ezetimibe.

The recommended dose in adults is one tablet daily.

You may take it at any time of day, with or without food. Swallow each tablet whole with a glass of water.

Try to take the tablet at the same time every day; this will help you remember to take it.

This medicine is not suitable for initiating treatment. The start of treatment or dose adjustment, if necessary, should only be done by taking the active substances separately. Once the appropriate doses have been established, switching to an appropriate dose of rosuvastatin/ezetimibe is possible.

If your doctor has prescribed rosuvastatin/ezetimibe to be taken concomitantly with another cholesterol-lowering medicine containing the active substance colestyramine, or with any other medicine containing a bile acid sequestrant, you must take rosuvastatin/ezetimibe at least 2 hours before or 4 hours after taking these medicines.

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 Rosuvastatine/Ezetimibe Sandoz 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 telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Rosuvastatine/Ezetimibe Sandoz

Do not worry. Skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Rosuvastatine/Ezetimibe Sandoz

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

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

Stop taking rosuvastatin/ezetimibe and seek immediate medical attention if you experience any of the following symptoms:

• any unexplained muscle pain, tenderness, or weakness lasting longer than expected. This is because muscle problems, including destruction of muscle fibres leading to kidney damage, can be serious and may lead to a potentially life-threatening condition (rhabdomyolysis) causing malaise, fever, and kidney failure. This is rare (may affect up to 1 in 1,000 people),
• severe allergic reaction (angioedema) – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, and intense itching of the skin (with lumps). This is rare (may affect up to 1 in 1,000 people),
• severe skin reactions, including reddish, flat spots on the trunk, often target-shaped or circular, sometimes with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or erythema multiforme [potentially life-threatening adverse reactions affecting the skin and mucous membranes]). The frequency of this is unknown (cannot be estimated from available data),
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome),
• lupus-like syndrome (includes rash, joint disorders, and effects on blood cells),
• muscle rupture.

Other known adverse effects

Common (may affect up to 1 in 10 people)

• headache
• constipation
• general malaise
• muscle pain
• feeling weak
• dizziness
• diabetes. This is more likely if you have high levels of blood sugar and lipids, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine
• abdominal pain (stomach ache)
• diarrhoea
• flatulence (excess gas in the gastrointestinal tract)
• feeling tired
• elevated levels in certain liver function blood tests (transaminases)
• increased levels of protein in urine, which usually returns to normal on its own without the need to discontinue treatment with rosuvastatin/ezetimibe (only for rosuvastatin doses of 40 mg).

Uncommon (may affect up to 1 in 100 people)

• skin rash, itching, hives, or other skin reactions
• elevated levels in certain muscle function blood tests (Creatine Kinase test)
• cough
• indigestion
• heartburn
• joint pain
• muscle spasms
• neck pain
• decreased 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
• increased levels of protein in urine – this usually returns to normal on its own without the need to discontinue treatment with rosuvastatin/ezetimibe (only for rosuvastatin doses of 10 mg and 20 mg).

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

• inflammation of the pancreas, causing severe stomach pain that may spread to the back
• reduced platelet levels in the blood, which may cause bruising/bleeding (thrombocytopenia)
• lupus-like syndrome (includes rash, joint disorders, and effects on blood cells)
• muscle rupture

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 (gynaecomastia)

Frequency not known (cannot be estimated from available data)

• difficulty breathing
• oedema (swelling)
• sleep disturbances, including insomnia and nightmares
• sexual dysfunction
• depression
• respiratory problems, including persistent cough and/or difficulty breathing or fever
• tendon injury
• persistent muscle weakness
• raised red spots, sometimes target-shaped (erythema multiforme)
• muscle tenderness
• gallstones or inflammation of the gallbladder (which may cause stomach pain, nausea, vomiting)
• myasthenia gravis (a condition causing generalized muscle weakness, which in some cases affects 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 effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rosuvastatin/Ezetimibe Sandoz

This medicine does not require any special storage temperature. Keep in the original packaging to protect it from light and moisture.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin/Ezetimibe Sandoz

• The active substances are rosuvastatin (as rosuvastatin calcium) and ezetimibe.

Rosuvastatin/Ezetimibe Sandoz 5 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium equivalent to 5 mg of rosuvastatin and 10 mg of ezetimibe.

Rosuvastatin/Ezetimibe Sandoz 10 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium equivalent to 10 mg of rosuvastatin and 10 mg of ezetimibe.

Rosuvastatin/Ezetimibe Sandoz 20 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium equivalent to 20 mg of rosuvastatin and 10 mg of ezetimibe.

Rosuvastatin/Ezetimibe Sandoz 40 mg/10 mg: Each film-coated tablet contains rosuvastatin calcium equivalent to 40 mg of rosuvastatin and 10 mg of ezetimibe.

• The other components are:

Tablet core

Lactose monohydrate, croscarmellose sodium (E468), povidone, sodium lauryl sulfate (E487), microcrystalline cellulose 102, hypromellose 2910 (E464), anhydrous colloidal silica, magnesium stearate (E470).

Tablet coating

Rosuvastatin/Ezetimibe Sandoz 5 mg/10 mg: Opadry Yellow 02F220026 consisting of: hypromellose 2910 (E464), titanium dioxide (E171), yellow iron oxide (E172), talc (E553b), red iron oxide (E172), macrogol 4000 (E1521).

Rosuvastatin/Ezetimibe Sandoz 10 mg/10 mg: Opadry Beige 02F270003 consisting of: hypromellose 2910 (E464), titanium dioxide (E171), yellow iron oxide (E172), macrogol 4000 (E1521), talc (E553b).

Rosuvastatin/Ezetimibe Sandoz 20 mg/10 mg: VIVACOAT PC-2P-308 consisting of: hypromellose 6 (E464), titanium dioxide (E171), talc (E553b), macrogol 4000 (E1521), yellow iron oxide (E172).

Rosuvastatin/Ezetimibe Sandoz 40 mg/10 mg: Opadry White OY-L-28900 consisting of: lactose monohydrate, hypromellose 2910 (E464), titanium dioxide (E171), macrogol 4000 (E1521).

Appearance of the product and pack contents

Rosuvastatin/Ezetimibe Sandoz 5 mg/10 mg

Light yellow film-coated, round, biconvex tablets with a diameter of approximately 10 mm, marked with "EL 5" on one side.

Rosuvastatin/Ezetimibe Sandoz 10 mg/10 mg

Beige film-coated, round, biconvex tablets with a diameter of approximately 10 mm, marked with "EL 4" on one side.

Rosuvastatin/Ezetimibe Sandoz 20 mg/10 mg

Yellow film-coated, round, biconvex tablets with a diameter of approximately 10 mm, marked with "EL 3" on one side.

Rosuvastatin/Ezetimibe Sandoz 40 mg/10 mg

White film-coated, round, biconvex tablets with a diameter of approximately 10 mm, marked with "EL 2" on one side.

Blister packs made of OPA/Al/PVC//Al containing 30 and 90 film-coated tablets.

Single-dose perforated blister packs made of OPA/Al/PVC//Al containing 30 x 1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Centre

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

or

Elpen Pharmaceutical Co Inc

Marathonos Ave. 95

Pikermi Attiki, 19009

Greece

Date of the most recent revision of this package leaflet: October 2022

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).