ROSUVASTATIN/EZETIMIBE TECNIGEN 20 mg/10 mg HARD CAPSULES

2. What you need to know before you take Rosuvastatin/ezetimibe Tecnigen

Do not takeRosuvastatin/ezetimibe Tecnigenif:

• 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).
• you are taking a combination of medicines called sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C virus infection).
• you are pregnant or breastfeeding. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with this medicine using an appropriate contraceptive method (see below: Pregnancy and breastfeeding).
• if you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking this medicine 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, pharmacist, or nurse before starting to take this medicine 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 feel unwell or have a 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 of this medicine for you,
• you are taking medicines to treat infections, including HIV (AIDS virus) or hepatitis C, such as ritonavir with lopinavir and/or atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, and/or pibrentasvir, see "Other medicines and Rosuvastatin/ezetimibe Tecnigen",
• you have severe respiratory failure,
• you are taking other cholesterol-lowering medicines called fibrates, see "Other medicines and Rosuvastatin/ezetimibe Tecnigen",
• you are going to have surgery. You may need to stop taking rosuvastatin/ezetimibe for a short time,
• you regularly drink large amounts of alcohol,
• your thyroid gland does not work properly (hypothyroidism),
• you are over 70 years old, (as your doctor should choose the appropriate dose of this medicine 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 this medicine can cause serious muscle problems (rhabdomyolysis).
• you are taking regorafenib (a medicine to treat cancer).
• If you have or have had myasthenia (a disease that causes general muscle weakness, which 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).

If you are in any of these 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 blood test that checks for 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 this medicine. 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 fats in your blood, are overweight, and have high blood pressure.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with rosuvastatin/ezetimibe treatment. Stop using this medicine and seek medical attention immediatelyif 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 andRosuvastatin/ezetimibe Tecnigen

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

Tell 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 this medicine 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 with its combined use.
• Colestyramine (a medicine 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, 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 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 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 this medicine 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).

If you go to the hospital or receive treatment for another condition, inform the medical staff that you are taking this medicine.

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.

Do not takethis medicine if you are pregnant, trying to become pregnant, or think you may be pregnant.If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor. Women must use contraceptive methods during treatment with this medicine.

Do not takethis medicine 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 during treatment with this medicine. If you feel dizzy, do not drive or use machines.

Rosuvastatin/ezetimibe Tecnigencontains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Rosuvastatin/ezetimibe Tecnigen

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist again.

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

The recommended daily dose for adults is one capsule of the relevant strength.

TakeRosuvastatin/ezetimibe Tecnigenonce 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.

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 this medicine of the corresponding dose.

If your doctor has prescribed rosuvastatin/ezetimibe along with another cholesterol-lowering medicine that contains the active substance colestyramine or any other medicine that contains a bile acid sequestrant, you should take this medicine at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Regular checks of cholesterol levels

It is essential that you go to your doctor regularly for cholesterol checks to ensure that your cholesterol levels have returned to normal and remain at appropriate levels.

If you take moreRosuvastatin/ezetimibe Tecnigenthan you should

Contact your doctor or the nearest hospital emergency department immediately, as you may need medical attention.

In the event of an 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 taken.

If you forget to takeRosuvastatin/ezetimibe Tecnigen

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

If you stop takingRosuvastatin/ezetimibe Tecnigen

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 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 takingRosuvastatin/ezetimibe Tecnigenand seek medical attention immediately if you experience any of the following adverse effects:

• any unexplained muscle pain, tenderness, or weakness that lasts longer than expected. This is because muscle problems, including muscle fiber destruction that damages the kidneys, can be severe and potentially life-threatening (rhabdomyolysis). This is rare (may affect up to 1 in 1,000 people);
• severe allergic reactions (angioedema) whose signs include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, and intense itching of the skin (with hives). This is rare (may affect up to 1 in 1,000 people);
• if you have a lupus-like syndrome (which includes skin rash, joint disorders, and effects on blood cells). This is rare (may affect up to 1 in 1,000 people).
• if you experience muscle rupture. This is rare (may affect up to 1 in 1,000 people).
• red, non-raised spots on the torso, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). The frequency of this is unknown (cannot be estimated from available data).
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome). The frequency of this is unknown (cannot be estimated from available data).

Other Adverse Effects

Frequent (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 intestinal tract);
• Feeling tired;
• High levels in some blood test results for liver function (transaminases).

Infrequent (may affect up to 1 in 100 people)

• Skin rash, itching, hives;
• Increased amount of protein in the urine, which usually reverses on its own without the need to interrupt treatment with rosuvastatin;
• High levels in some blood test results for muscle function (Creatine Kinase test);
• Cough;
• Indigestion;
• Heartburn;
• Joint pain;
• Muscle spasms;
• Neck pain;
• Decreased appetite;
• Pain;
• Chest pain;
• Hot flashes;
• High blood pressure;
• Tingling sensation;
• 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;
• reduction of blood platelet levels.

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).

Unknown Frequency(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;
• constant 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); myasthenic ocular (a disease that causes weakness of the eye muscles). Consult your doctor if you experience weakness in the 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. 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 Rosuvastatin/ezetimibe Tecnigen

This medicine does not require special storage conditions.

Keep this medicine out of sight and reach of children.

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 thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofRosuvastatin/ezetimibe Tecnigen

The active ingredients are rosuvastatin (as rosuvastatin calcium) and ezetimibe.

Rosuvastatin/ezetimibe Tecnigen5 mg/10 mg: Each hard capsule contains 5 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.

Rosuvastatin/ezetimibe Tecnigen10 mg/10 mg: Each hard capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.

Rosuvastatin/ezetimibe Tecnigen20 mg/10 mg: Each hard capsule contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.

The other ingredients are:

• Capsule content: lactose monohydrate, hypromellose, sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose, sodium stearyl fumarate, lactose, crospovidone, talc, anhydrous colloidal silica,

• Coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, iron oxide red (E172).

• Capsule composition:

Rosuvastatin/ezetimibe Tecnigen5 mg/10 mg: gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).

Rosuvastatin/ezetimibe Tecnigen10 mg/10 mg: gelatin, titanium dioxide (E171), iron oxide yellow (E172).

Rosuvastatin/ezetimibe Tecnigen20 mg/10 mg: gelatin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide black (E172), indigotine (E132).

Product Appearance and Package Contents

Rosuvastatin/ezetimibe Tecnigen5 mg/10 mg: Hard gelatin capsules with orange body and cap, filled with 1 film-coated pink tablet and 2 white tablets.

Rosuvastatin/ezetimibe Tecnigen10 mg/10 mg: Hard gelatin capsules with yellow body and cap, filled with 2 film-coated pink tablets and 2 white tablets.

Rosuvastatin/ezetimibe Tecnigen20 mg/10 mg: Hard gelatin capsules with green cap and white body, filled with 4 film-coated pink tablets and 2 white tablets.

Rosuvastatin/ezetimibe Tecnigen5 mg/10 mg: available in OPA/PVC/Al blister packs of 30 hard capsules.

Rosuvastatin/ezetimibe Tecnigen10 mg/10 mg: available in OPA/PVC/Al blister packs of 30 hard capsules.

Rosuvastatin/ezetimibe Tecnigen20 mg/10 mg: available in OPA/PVC/Al blister packs of 30 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A. Rua da Tapada Grande, n.º 2,

2710-089 Abrunheira, Sintra

Portugal

Date of the Last Revision of this Prospectus: March 2023

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