Package Insert: Information for the User

Twicor 10 mg/10 mg Film-Coated Tablets

rosuvastatina and 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 only for you and should not be given 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.

6. Contents of the pack and additional information

Twicor contains two different active principles in a film-coated tablet. One of the active principles is rosuvastatina, which belongs to the group of medications known as statins, the other active principle is ezetimiba.

Twicor is a medication used in adult patients to reduce elevated levels of cholesterol, the "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, Twicor increases the concentrations of the "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, elevated 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 stroke. By reducing cholesterol levels, the risk of having a heart attack, stroke, or other related health problems can be reduced.

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

This medication does not help with weight loss.

Do not take Twicor if:

• You are allergic to rosuvastatin, ezetimibe, or any of the other ingredients in 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 medication called ciclosporin (used, for example, after an organ transplant),
• You are pregnant or breastfeeding. If you become pregnant while taking Twicor, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with this medication using an appropriate contraceptive method,

• You have ever developed a severe skin rash or peeling, blisters, and/or mouth sores after taking Twicor or other related medications.

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 Twicor 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 experience unjustified muscle pain or cramps, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you experience constant muscle weakness,

• 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 (AIDS virus) or hepatitis C, such as lopinavir/ritonavir and/or atazanavir or simeprevir. See “Other medications and Twicor”,
• You have severe respiratory insufficiency,
• You are taking other medications called fibrates to lower cholesterol, see “Taking Twicor with other medications”,
• You regularly consume large amounts of alcohol,
• Your thyroid glanddoes not function correctly (hypothyroidism),
• You are over 70 years old, (since your doctor must choose the appropriate dose of Twicor for you).
• You are taking or have taken in the last 7 days a medication called fusidic acid (an antibiotic) by oral or injectable route. The combination of fusidic acid and Twicor may cause severe muscle problems (rhabdomyolysis),

• Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Twicor treatment. Stop taking Twicor and seek medical attention immediately if you notice any of the symptoms described in section 4.
• You have or have had myasthenia (a disease that involves generalized muscle weakness, which in some cases affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

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 this medication.

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 in the blood. For this reason, your doctor will usually perform blood tests (liver function test) during treatment with this medication. 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 blood sugar and fat levels, are overweight, and have high blood pressure.

Children and adolescents

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

Other medications and Twicor

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:

• Ciclosporin (used, for example, after an organ transplant to prevent organ rejection. The effect of rosuvastatin is increased with its use together).Do not take Twicor if you are taking ciclosporin.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase while taking this medication together), 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 is increased when gemfibrozil is used together with this medication.
• Colestiramine (a medication to lower cholesterol), as it affects how ezetimibe works.
• 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, simeprevir, 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.
• Erythromycin (an antibiotic). The effect of rosuvastatin is reduced with its use together.
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily interrupt taking this medication. Your doctor will indicate when you can safely take Twicor again. Taking this medication together with fusidic acid may cause rare muscle weakness, pain, or sensitivity (rhabdomyolysis). You can consult more information about rhabdomyolysis in section 4.
• Oral contraceptive (the pill). The levels of sex hormones absorbed from the pill are increased.
• Hormone replacement therapy (increased levels of hormones in the blood).
• Regorafenib (used to treat cancer).

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

Pregnancy and breastfeeding

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

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

Driving and operating machinery

This medication is not expected to interfere with your ability to drive or operate machinery. However, some people may experience dizziness after taking this medication. If you feel dizzy, do not drive or operate machinery.

Twicor contains sodium:This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

You should continue to maintain a low-cholesterol diet and exercise while taking Rozor.

The recommended daily dose for adults is one film-coated tablet.

Take ROZOR once a day.

You can take it at any time of the day, with or without food. Swalloweach film-coated tablet whole with water.

Take your medication at the same time every day.

This medication is not suitable for initiating 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 the appropriate dose ofRozor.

Regular cholesterol level checks

It is essential that you attend 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 Rozor than you should

Contact your doctor or the nearest hospital's emergency service 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 Rozor

Do not worry, omit the missed dose and 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 Rozor

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

Stop taking Twicor 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, lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells) and muscle rupture.

Unjustified muscle aches 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.

Unknown frequency (cannot be estimated from available data):

Reddish flat spots 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 flu-like symptoms (Stevens-Johnson syndrome).

Generalized rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Other side effects

Frequent side effects (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 medication;
• Stomach pain;
• Diarrhea;
• Flatulence (excess gas in the intestinal tract);
• Feeling tired;
• High levels in some blood test results for liver function (transaminases).

Rare side effects (may affect up to 1 in 100 people)

• Skin rash, itching, urticaria;
• High levels in some blood test results for muscle function(Creatine Kinase test);
• 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 side effects (may affect up to 1 in 1,000 people)

• Pancreatitis, which causes severe stomach pain that may extend to the back;
• Low platelet count in the blood.

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

• Icterus (yellowing of the skin and eyes);
• Liver inflammation (hepatitis);
• Blood in the urine;
• Nerve damage in the legs and arms (numbness);
• Memory loss;
• Enlargement of breast tissue in men (gynecomastia).

Unknown frequency (cannot be estimated from available data)

• Difficulty breathing;
• 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 that, in some cases, affects the muscles used for breathing). Myasthenia gravis (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 or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep in the original packaging to protect it from light and humidity.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the case or on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Twicor

• The active principles are rosuvastatina (as rosuvastatina calcium) and ezetimiba.
• Each film-coated tablet contains rosuvastatina calcium equivalent to 10 mg of rosuvastatina and 10 mg of ezetimiba.

• The other components are:

Rosuvastatina - Core

Pregelatinized maize starch; Microcrystalline cellulose (E460); Meglumina; Dihydrate calcium hydrogen phosphate (E-341); Crospovidone (E-1202); Anhydrous colloidal silica (E-551); Sodium stearate fumarate.

Ezetimiba - Core

Manitol (E-421); Butylhydroxyanisole (E-320); Sodium lauryl sulfate (E-487); Sodium croscarmellose (E-468); Povidone (K-30) (E-1201); Iron oxide red (E-172); Magnesium stearate (E470 b); Sodium stearate fumarate.

Coating

Hydroxypropyl methylcellulose (E-464); Titanium dioxide (E-171); Macrogol 4000; Iron oxide red (E-172).

Appearance of the product and contents of the package

Twicor are film-coated tablets of pink color, round, with a diameter of 10.0 mm, engraved with “AL” on one side.

Twicor is available in OPA/Al/PVC-Al blister packs of 10, 30, 60, 90 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola PLA3000

Malta

or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Slovenia:ROZOR 10 mg/10 mg film-coated tablets

Spain:Twicor 10 mg/10 mg film-coated tablets

Netherlands:TWICOR 10 mg/10 mg film-coated tablets

Poland:ROZOR 10 mg/10 mg coated tablets

Portugal:ROZOR 10 mg/10 mg coated tablets

Czech Republic:TWICOR 10 mg/10 mg coated tablets

Sweden:ROZOR 10 mg/10 mg film-coated tablets

Last review date of this leaflet: March 2023

Further information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/