Twicor 20 mg/10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Twicor 20mg/10mg film-coated tablets

rosuvastatin and ezetimibe

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 and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Twicor is and what it is used for

Twicor contains two different active substances in a single 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 reduce elevated levels of cholesterol, specifically "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides circulating in the blood. In addition, this medicine increases levels of "good" cholesterol (HDL cholesterol). This medicine works in two ways to reduce cholesterol: by decreasing cholesterol absorbed from 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 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, leading 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 through diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet. Your doctor may prescribe Twicor if you are already taking rosuvastatin and ezetimibe at the same dose levels.

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

This medicine does not help you lose weight.

2. What you need to know before taking 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 pain or cramps (myopathy),
• you are taking a medicine called cyclosporine (used, for example, after 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 medicine by using an appropriate contraceptive method,
• if you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth sores after taking Twicor or other related medicines.

If you are in any of the situations mentioned above (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 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 are of Asian origin (e.g., 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 (human immunodeficiency virus) or hepatitis C, such as lopinavir/ritonavir and/or atazanavir or simeprevir. See “Other medicines and Twicor”,
• you have severe respiratory insufficiency,
• you are taking other medicines called fibrates to lower cholesterol; see “Taking Twicor 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 Twicor for you),
• you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine for bacterial infection). The combination of fusidic acid and Twicor may cause serious 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 immediate medical attention 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 causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

If you are in any of the above-mentioned 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 increased levels of liver enzymes. For this reason, your doctor will usually perform blood tests (liver function tests) during treatment with this medicine. It is important that you attend your doctor’s appointments for these tests.

While taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely at increased 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 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 need to take any other medicines.

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

• Cyclosporine (used, for example, after organ transplant to prevent organ rejection. The effect of rosuvastatin increases when taken together). Do not take Twicor if you are taking cyclosporine.
• Anticoagulants such as warfarin, acenocoumarol, or phenindione (their anticoagulant effects and risk of bleeding may increase when taken with 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 with this medicine.
• Cholestyramine (a medicine to lower cholesterol), as 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.
• Medicines 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.
• 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 should temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Twicor. Taking this medicine 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 from the pill are increased.
• Hormone replacement therapy (increased hormone levels in the blood).
• Regorafenib (used to treat cancer).

If you go to hospital or receive treatment for another condition, 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 should use contraceptive methods during treatment with this medicine.

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

Driving and use of machines

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

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

3. How to take Twicor

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

This medicine is not suitable for initiating treatment. Treatment initiation or dose adjustments, if necessary, should only be carried out by taking the active substances separately; once the appropriate doses have been established, switching to the appropriate dose of Twicor becomes possible.

You should follow a low-cholesterol diet and exercise while taking Twicor.

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

Take Twicor once a day.

You may take it at any time of day, regardless of meals. Take the medicine at the same time each day. Swallow the film-coated tablets whole with a glass of water.

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 Twicor than you should

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

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, stating the medicine and the amount ingested.

If you forget to take Twicor

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 Twicor

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 will experience them.

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

Stop taking Twicor and seek immediate medical attention 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 and/or swallowing; drug-induced lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells); and muscle rupture.

Unexplained muscle pain and cramps lasting longer than expected. In rare cases, this may progress to potentially life-threatening muscle damage known as rhabdomyolysis, leading to general malaise, fever, and kidney failure.

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

Red, non-elevated, target-shaped or circular skin lesions 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).

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

Other adverse effects

Frequent adverse 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 blood sugar and lipid levels, 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 gastrointestinal tract);
• Feeling tired;
• Elevated levels in certain blood tests indicating liver function (transaminases).

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

• Skin rash, itching, hives;
• Elevated levels in certain blood tests indicating muscle function (Creatine Kinase test);
• Cough;
• Indigestion;
• Heartburn;
• Joint pain;
• Muscle spasms;
• Neck pain;
• Loss of appetite;
• Pain;
• Chest pain;
• Hot flushes;
• High blood pressure;
• Tingling sensation;
• Dry mouth;
• Stomach inflammation;
• Back pain;
• Muscle weakness;
• Pain in arms and legs;
• Swelling, especially in hands and feet.

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

• Inflammation of the pancreas, causing severe stomach pain that may spread to the back;
• Reduced levels of blood platelets.

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

• Jaundice (yellowing of the skin and eyes);
• Liver inflammation (hepatitis);
• Blood traces in urine;
• Nerve damage in arms and legs (such as numbness);
• Memory loss;
• Enlargement of 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 disease causing generalized muscle weakness, which in some cases affects muscles used for breathing); Ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in 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 or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Twicor

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

Do not use this medicine after the expiry date stated on the carton or container following "EXP". The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, 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 Twicor

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

• Each film-coated tablet contains rosuvastatin calcium equivalent to 20 mg of rosuvastatin and 10 mg of ezetimibe.

• Other components are:

Rosuvastatin - Core

Pregelatinized starch (corn); Microcrystalline cellulose (E460); Meglumine; Calcium dihydrogen phosphate dihydrate (E-341); Crospovidone (E-1202); Colloidal anhydrous silica (E-551); Sodium stearyl fumarate.

Ezetimibe - Core

Mannitol (E-421); Butylated hydroxyanisole (E-320); Sodium lauryl sulfate (E-487); Sodium croscarmellose (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).

Nature of the product and contents of the pack

Twicor 20 mg/10 mg are pink, round, film-coated tablets with a diameter of 10.7 mm, smooth on both sides.

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

Only certain 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

or

McDermott Laboratories Limited T/A Gerard Laboratories T/A Mylan Dublin

Unit 35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

For further information about this medicinal product, 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:

ROSUVASTATINE/EZETIMIBE MYLAN HEALTHCARE – Netherlands

ROSUVASTATINE/EZETIMIBE MYLAN – Czech Republic

ROZOR – Bulgaria, Cyprus, Greece, Croatia, Hungary, Slovakia, Slovenia

ROZEIOND – Italy

TWICOR – Czech Republic, Denmark, Finland, France, Ireland, Malta, Portugal, Romania, United Kingdom, Spain

MYROSOR – Belgium, Luxembourg

Sorento – Poland

Date of the most recent review of this leaflet: May 2025

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