Package Insert: Information for the Patient

Rosuvastatina/ezetimiba Tecnigen5 mg/10 mgHard Capsules

Rosuvastatina/ezetimiba Tecnigen10 mg/10 mgHard Capsules

Rosuvastatina/ezetimiba Tecnigen20 mg/10 mg Hard Capsules

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it 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, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

This medication contains two different active principles in one capsule. One of the active principles is rosuvastatina, which belongs to the group of medications known as statins, the other active principle is ezetimiba.

Rosuvastatina/Ezetimiba is a medication used in adult patients to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, this medication also increases levels of "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 cerebral embolism. By reducing cholesterol levels, the risk of having a heart attack, cerebral embolism, 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 must follow a cholesterol-reducing diet. Your doctor may prescribe this medication if you are already taking rosuvastatina and ezetimiba at the same dosage level.

The capsules of this medication are used if you have:

• high levels of cholesterol in the blood (primary hypercholesterolemia)
• heart disease, this medication reduces the risk of myocardial infarction and cerebral accident, and is used in surgery to increase blood flow to the heart or hospitalization for chest pain.

This medication does not help with weight loss.

Do not takeRosuvastatina/ezetimiba Tecnigenif:

If you find yourself 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:

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 reduced 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 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.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with rosuvastatina/ezetimiba treatment.Stop using this medication and seek medical attention immediatelyif you notice any of the symptoms described in section 4.

Children and adolescents

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

Other medications andRosuvastatina/ezetimiba Tecnigen

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:

• Treatments for indigestion containing aluminum and magnesium (used to neutralize stomach acid, as they reduce the level of rosuvastatina in plasma). This effect can be mitigated by taking this type of medication 2 hours after rosuvastatina.
• • Eritromicina (an antibiotic). The effect of rosuvastatina is reduced with its use.
  • Ácido fusídico. If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily interrupt taking this medication. Your doctor will indicate when you can safely take this medication again. Taking this medication with fusidic acid can occasionally cause muscle weakness, pain, or sensitivity (rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.
  • A contraceptive pill (the pill).Levels of sex hormonesthat are absorbed fromthe pillare increased.
  • Hormone replacement therapy (increase of hormone levels in the blood).

If you visit a hospital or receive treatment for another condition, inform the medical staff that you are taking this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Do not take this 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 take this medication 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 feel dizzy during treatment with this medication. If you feel dizzy, do not drive or operate machinery.

Rosuvastatina/ezetimiba 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 is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated 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 this medication.

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

TakeRosuvastatina/ezetimiba Tecnigenonce a day.

You can take it at any time of the day, with or without food. Swallow each capsule whole with water. Try to take the capsules at the same time every day.

This medication is not suitable for starting treatment. The initiation of treatment or dose adjustments, if necessary, should only be made by taking the active principles separately, and once the appropriate doses have been adjusted, it is possible to switch to this medication at the corresponding dose.

If your doctor has prescribed rosuvastatina/ezetimiba along with another medication to reduce cholesterol that contains the active ingredient colestiramina 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 for cholesterol checks, in order to verify that your cholesterol levels have normalized and are maintained at appropriate levels.

If you take moreRosuvastatina/ezetimiba Tecnigenthan you should

Contact your doctor or the nearest hospital's emergency service as you may need medical assistance.

In the event of an 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 forgot to takeRosuvastatina/ezetimiba Tecnigen

Do not worry, simply 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 withRosuvastatina/ezetimiba Tecnigen

Consult your doctor if you want to interrupt 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 medicines, this medicine can cause side effects, although not everyone will experience them.

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

Stop takingRosuvastatina/ezetimiba Tecnigenand seek medical help immediately if you experience any of the following side effects:

• any unexplained muscle pain, tenderness or weakness that lasts longer than expected. This is due to muscle problems, including muscle fibre destruction that can damage the kidneys, which 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 urticaria). 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 a muscle rupture. This is rare (may affect up to 1 in 1,000 people).
• flat red patches on the trunk, often with blisters, peeling skin, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).The frequency of this is unknown (cannot be estimated from available data).
• generalised rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).The frequency of this is unknown (cannot be estimated from available data).

Other side effects

Frequent (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, obesity, and high blood pressure. Your doctor will monitor you while 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).

Occasional (may affect up to 1 in 100 people)

• Skin rash, itching, urticaria;
• Increased protein levels in urine, which usually returns to normal without the need to stop 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;
• Loss of appetite;
• Pain;
• Chest pain;
• Hot flushes;
• High blood pressure;
• Prickling sensation;
• Dry mouth;
• Stomach inflammation;
• Back pain;
• Muscle weakness;
• Pain in 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 may spread to the back;
• Reduced platelet levels in the blood.

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

• Icterus (yellowing of the skin and eyes);
• Hepatitis (inflammation of the liver);
• Traces of 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 generalised muscle weakness, which in some cases affects the muscles used for breathing); myasthenia ocular (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, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not require special storage conditions.

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

Do not use this medication 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 disposed of through drains or in the trash. Dispose of the packaging and themedicines that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition ofRosuvastatina/ezetimiba Tecnigen

The active principles are rosuvastatina (as rosuvastatina calcium) and ezetimiba.

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

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

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

The other components are:

• Hard capsule content: lactose monohydrate, hypromellose, croscarmellose sodium, sodium lauryl sulfate, microcrystalline cellulose, stearic acid fumarate and sodium, lactose, crospovidone, talc, anhydrous colloidal silica,

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

• Hard 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), indigo carmine (E132).

Appearance of the product and contents of the package

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

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

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

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

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

Rosuvastatina/ezetimiba Tecnigen20 mg/10 mg:is available in OPA/PVC/Al blister packs of 30 hard capsules.

Marketing authorization holder and responsible 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

Responsible manufacturer

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

2710-089 Abrunheira, Sintra

Portugal

Last review date of this leaflet: March 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Deviceshttp://www.aemps.es/