TWICOR 10 MG/10 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Twicor 10 mg/10 mg film-coated tablets

rosuvastatin and ezetimibe

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Twicor and what is it used for
2. What you need to know before you take Twicor
3. How to take Twicor
4. Possible side effects
5. Storage of Twicor

1. Contents of the pack and further information

1. What is Twicor and what is it used for

Twicor contains two different active substances in one film-coated tablet. One of the active substances is rosuvastatin, which belongs to a group of medicines called statins, the other active substance is ezetimibe.

Twicor is a medicine used in adult patients to lower high levels of cholesterol, the "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides circulating in the blood. In addition, Twicor raises the levels of the "good" cholesterol (HDL cholesterol). This medicine works by reducing cholesterol in two ways: it reduces the cholesterol absorbed in the gut and the cholesterol produced by the body itself.

For most people, high cholesterol levels do not affect how they feel because they do not produce 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 can become blocked, cutting off the blood supply to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, you can reduce your risk of having a heart attack, stroke, or other health problems related to it.

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

This medicine is used in patients with heart disease. Twicor reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

This medicine does not help you lose weight.

2. What you need to know before you take Twicor

Do not take Twicor 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 pains or cramps (myopathy),
• you are taking a medicine called ciclosporin (used, for example, after an organ transplant to prevent rejection of the transplanted organ),
• you are pregnant or breastfeeding. If you become pregnant while taking Twicor, stop taking it immediately and inform your doctor. Women must use a suitable contraceptive method during treatment with this medicine,

• if you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking Twicor or other related medicines.

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 Twicor if:

• you have kidney problems,
• you have liver problems,
• you have repeated or unexplained muscle pains or cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you have unexplained muscle pain or cramp, especially if you also feel unwell or have a fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness,

• you are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should determine the appropriate dose for you,

• if you are taking medicines to treat infections, including HIV (AIDS virus) or hepatitis C, such as lopinavir/ritonavir and/or atazanavir or simeprevir. See "Other medicines and Twicor",
• you have severe respiratory failure,
• you are taking other cholesterol-lowering medicines called fibrates, see "Taking Twicor with other medicines",
• you regularly drink large amounts of alcohol,
• your thyroid gland does not work properly (hypothyroidism),
• you are over 70 years old (since your doctor should choose the appropriate dose of Twicor for you).
• you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and Twicor can cause serious muscle problems (rhabdomyolysis),

• serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Twicor treatment. Stop taking Twicor and seek medical attention immediately if you notice any of the symptoms described in section 4.
• 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), since statins can sometimes worsen the disease or cause myasthenia (see section 4).

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

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 normally perform blood tests (liver function tests) during treatment with this medicine. It is important 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

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

Other medicines and Twicor

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, for example, after an organ transplant to prevent rejection of the transplanted organ. The effect of rosuvastatin increases with its combined use). 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 medicine), 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 when gemfibrozil is used in combination with this medicine.
• Colestyramine (a medicine to lower cholesterol), because it affects how ezetimibe works.
• 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, simeprevir, 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 this type of medicine 2 hours after rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin decreases with its combined use.
• Fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when you can safely take Twicor again. Taking this medicine 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.
• Hormone replacement therapy (increased levels of hormones in the blood).
• Regorafenib (indicated for the treatment of cancer).

If you go to the hospital or receive treatment for another illness, tell 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 plan to become pregnant. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women must use a suitable contraceptive method during treatment with this medicine.

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

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines. However, some people may feel dizzy after taking this medicine. If you feel dizzy, do not drive or use machines.

Twicor contains sodium:this medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Rozor

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of 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. Swallow each film-coated tablet whole with water.

Take your medicine at the same time every day.

This medicine is not suitable for starting 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 the appropriate dose of Rozor.

Regular cholesterol level checks

It is important that you regularly visit your doctor to have your cholesterol levels checked, in order to verify that your cholesterol levels have normalized and are being maintained at appropriate levels.

If you take more Rozor than you should

Contact your doctor or the emergency department of the nearest hospital, 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, telephone 91 562 04 20, indicating the medicine 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 planned time. Do not take a double dose to make up for missed doses.

If you stop taking Rozor

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

It is important that you know what these side effects can be.

Stop taking Twicor and seek medical attention 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 can cause difficulty breathing and swallowing, lupus-like syndrome (which includes skin rash, joint disorders, and effects on blood cells), and muscle rupture.

Unexplained muscle pain or cramp that lasts longer than expected. In rare cases, this can become a potentially life-threatening muscle damage known as rhabdomyolysis, leading to general malaise, fever, and kidney failure.

Frequency not known (cannot be estimated from the available data):

Red, target-like, or circular patches on the trunk, often with central blisters, peeling of the skin, 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, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Other side effects

Common side effects (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 levels of sugar and fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine;
• Stomach pain;
• Diarrhea;
• Flatulence (excess gas in the intestines);
• Feeling tired;
• High levels in some blood test results of liver function (transaminases).

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

• Skin rash, itching, hives;
• High levels in some blood test results of 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;
• Feeling of tingling;
• Dry mouth;

• Gastritis;
• Back pain;
• Muscle weakness;
• Pain in the arms and legs;
• Swelling, especially of the hands and feet.

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

• Pancreatitis, which causes severe stomach pain that can extend to the back;
• Decrease in blood platelet levels.

Very rare side effects (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;
• Increased breast size in men (gynecomastia).

Frequency not known (cannot be estimated from the 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;
• Persistent muscle weakness;
• Gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting).
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects 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 of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rozor

Keep in the original package 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 that appears on the carton or on the 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. Deposit the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Twicor

• The active ingredients are rosuvastatin (as rosuvastatin calcium) and ezetimibe.
• Each film-coated tablet contains rosuvastatin calcium equivalent to 10 mg of rosuvastatin and 10 mg of ezetimibe.

• The other components are:

Rosuvastatin - Core

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

Ezetimibe - Core

Mannitol (E-421); Butylhydroxyanisole (E-320); Sodium lauryl sulfate (E-487); Croscarmellose sodium (E-468); Povidone (K-30) (E-1201); Red iron oxide (E-172); Magnesium stearate (E470 b); Sodium stearyl fumarate.

Coating

Hypromellose (E-464); Titanium dioxide (E-171); Macrogol 4000; Red iron oxide (E-172).

Appearance of the Product and Container Content

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

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 under 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 film-coated tablets

Czech Republic: TWICOR 10 mg/10 mg coated tablets

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

Date of the last revision of this leaflet: May 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/