ROSUVASTATIN/EZETIMIBE TECNIGEN 5 mg/10 mg HARD CAPSULES

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

Do not takeRosuvastatin/Ezetimibe Tecnigenif:

• you are allergic to rosuvastatin, ezetimibe, or any of the other components of this medication (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 medication called cyclosporine (used, for example, after an organ transplant).
• you are taking a combination of medications called sofosbuvir/velpatasvir/voxilaprevir (used for the viral liver infection called hepatitis C).
• you are pregnant or breastfeeding. If you become pregnant while taking this medication, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with this medication 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 medication or other related medications.

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 medication 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 problems, or a history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unexplained muscle pain or cramps, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you have constant muscle weakness,
• you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should establish the appropriate dose of this medication for you,
• if you are taking medications 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 medications and Rosuvastatin/Ezetimibe Tecnigen",
• you have severe respiratory failure,
• you are taking other medications called fibrates to lower cholesterol, see "Other medications and Rosuvastatin/Ezetimibe Tecnigen",
• you are going to have surgery. You may need to stop taking rosuvastatin/ezetimibe for a short period of time,
• you regularly consume large amounts of alcohol,
• your thyroid gland does not function properly (hypothyroidism),
• you are over 70 years old, (as your doctor should choose the appropriate dose of this medication for you).
• you are taking or have taken in the last 7 days a medication called fusidic acid (an antibiotic). The combination of fusidic acid and this medication can cause serious muscle problems (rhabdomyolysis).
• you are taking regorafenib (a medication to treat cancer).
• If you have or have had myasthenia (a disease that causes generalized 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 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 (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function tests) during treatment with this medication. It is essential that you visit your doctor for these tests.

While taking this medication, 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.

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 medication and seek medical attention immediatelyif you notice any of the symptoms described in section 4.

Children and adolescents

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

Other medications andRosuvastatin/Ezetimibe Tecnigen

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

Tell your doctor if you are taking any of the following medications:

• Cyclosporine (used, for example, after an organ transplant to prevent organ rejection. The effect of rosuvastatin increases with its combined use). Do not take this medication if you are taking cyclosporine.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effects and the risk of bleeding may increase while taking this medication), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medications 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 medication to lower cholesterol), as it affects how ezetimibe works.
• Regorafenib (indicated for the treatment of cancer).
• Darolutamide (indicated for the treatment of cancer).
• 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.

• 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 medications 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 medication. Your doctor will indicate when you can safely take this medication again. Taking this medication 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 hormone levels in the blood).

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

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 medication.

Do not takethis medication if you are pregnant, trying to become pregnant, or think you may be 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 takethis medication if you are breastfeeding, as it is unknown whether the medication passes into breast milk.

Driving and using machines

This medication is not expected to interfere with your ability to drive or use machines. However, some people may feel dizzy during treatment with this medication. If you feel dizzy, do not drive or use machines.

Rosuvastatin/Ezetimibe Tecnigencontains lactose and sodium

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

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

3. How to take Rosuvastatin/Ezetimibe Tecnigen

Follow the administration instructions of this medication indicated by your doctor or pharmacist exactly. If you are unsure, consult your doctor or pharmacist again.

You should continue to follow a cholesterol-reducing diet and exercise while taking this medication.

The recommended daily dose for adults is one capsule of the corresponding concentration.

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 medication 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 are adjusted, it is possible to switch to this medication at the corresponding dose.

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

Regular cholesterol level checks

It is essential that you visit your doctor regularly to have your cholesterol levels checked, to ensure that your cholesterol levels have normalized and are maintained at appropriate levels.

If you take moreRosuvastatin/Ezetimibe Tecnigenthan you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeRosuvastatin/Ezetimibe Tecnigen

Do not worry, simply 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 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.

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 takingRosuvastatina/ezetimiba Tecnigenand seek immediate medical attention 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 trunk, 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).
• generalized 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 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;
• breast enlargement 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 Rosuvastatina/ezetimiba 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 that appears on the box and on the 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 SIGRE point in the pharmacy. 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 ofRosuvastatina/ezetimiba Tecnigen

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

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

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

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

The other components 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:

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

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

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

Appearance of the Product and Package Contents

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

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

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

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

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

Rosuvastatina/ezetimiba 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/