International Name (Active Ingredient): Rosuvastatin, Ezetimibe
Clinical-Pharmacological Group: Metabolic Disorders → Lipid Metabolism Modulators
Manufacturer: Atlantic Pharma
Country of Manufacture: Portugal
Dosage Form: 10 mg/10 mg 20/10 Capsules №30
Dispensing Category: Group III (Over-the-Counter)
Instructions for Use: Information for Patients
Rovezix, 10 mg + 10 mg, Capsules Rovezix, 20 mg + 10 mg, Capsules
Rosuvastatin + Ezetimibe
1. Rovezix and its Use
Rovezix contains two different active substances in one capsule. One active substance
is Rosuvastatin, which belongs to a group of drugs called statins, and the other active
substance is Ezetimibe.
Rovezix is a medication used to lower total cholesterol, so-called “bad” cholesterol
(LDL), and triglyceride levels in the blood. It also increases the level of “good”
cholesterol (HDL) in the blood. This medication reduces cholesterol in two ways: it
reduces the cholesterol absorbed from the gastrointestinal tract and the cholesterol
produced by the body.
Most people do not feel the effects of high cholesterol, as it does not cause symptoms.
However, if left untreated, fatty deposits may accumulate on the walls of blood vessels,
leading to narrowing.
Sometimes, these narrowed blood vessels may become blocked, resulting in a
cessation of blood supply to the heart or brain, leading to a heart attack or stroke.
Lowering cholesterol levels reduces the risk of developing heart attacks, strokes, or
related health problems.
Rovezix is prescribed for patients whose cholesterol levels cannot be controlled by a
cholesterol-lowering diet alone. During treatment with this medication, it is important to
continue following a cholesterol-lowering diet. The doctor may prescribe Rovexix if the
patient is already taking Rosuvastatin and Ezetimibe in the same doses.
Rovezix is used if the patient has:
• High cholesterol levels in the blood (primary hypercholesterolemia);
• Heart disease. Rovexix reduces the risk of heart attacks, strokes, and improves heart
blood supply, reducing the risk of hospitalization due to surgical intervention or chest
pain.
Rovexix does not promote weight loss.
2. Important Information Before Taking Rovezix
Rovezix should not be taken if:
• The patient is allergic to Rosuvastatin, Ezetimibe, or any other ingredients of the
medication (see the list in section 6);
• The patient has liver disease;
• The patient has severe kidney disease;
• The patient experiences unexplained recurrent muscle pain (myopathy);
• The patient is taking Cyclosporine (used, for example, in organ transplants);
• During pregnancy or breastfeeding. If pregnancy occurs during treatment with
Rovezix, the medication should be immediately discontinued, and the treating doctor
should be informed. Appropriate contraception should be used during treatment to
prevent pregnancy (see below: Pregnancy and Breastfeeding);
• The patient has a history of severe rash or skin peeling, blistering in the mouth, and/or
the development of ulcers after taking Rovezix or similar medications.
If any of the above applies to the patient (or if they are unsure), they should consult their
treating doctor.
Warnings and Precautions
Before starting treatment with Rovezix, it is necessary to consult with the doctor or
pharmacist:
• If the patient has kidney problems;
• If the patient has liver problems;
• If the patient has recurrent or unexplained muscle pain, personal or family history of
muscle problems, or has experienced muscle problems with other cholesterol-lowering
medications. Immediate consultation with a doctor is required if the patient experiences
unexplained muscle pain, especially if they also have weakness or fever. The doctor or
pharmacist should be informed if the patient has ongoing muscle weakness;
• If the patient has or had myasthenia (a disease that causes generalized muscle
weakness, including muscles involved in breathing in some cases) or ocular myasthenia
(a disease causing weakness of the eye muscles), as statins may worsen the condition
or lead to the development of myasthenia (see section 4);
• If the patient is of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or
Indian). In this case, the doctor will choose an appropriate dose of Rovezix for the
patient;
• If the patient is taking medications used to treat HIV or C hepatitis, such as
lopinavir/ritonavir and/or atazanavir or Simeprevir. See also “Other Medicines and
Rovezix”
• If the patient experiences severe breathing difficulty;
• If the patient is taking other cholesterol-lowering medications called fibrates. See
“Other Medicines and Rovezix”
• If the patient regularly consumes large amounts of alcohol;
• If the patient has thyroid dysfunction (hypothyroidism);
• If the patient is over 70 years old (in this case, the doctor will select the appropriate
dose of Rovezix);
• If the patient is taking or has taken a medication containing Fusidic acid (for bacterial
infections) in the last 7 days, either orally or by injection. Combining Fusidic acid with
Rovezix may lead to severe muscle damage (rhabdomyolysis).
Serious Skin Reactions
Serious skin reactions have been described with the use of Rovezix, including Stevens-
Johnson Syndrome and drug reactions with eosinophilia and systemic symptoms
(DRESS). Rovezix treatment should be stopped, and immediate medical attention
should be sought if any of the symptoms described in section 4 occur.
If any of the above applies (or if the patient is unsure), they should consult their doctor
or pharmacist before taking any dose of Rovezix.
A small number of patients using statins may experience liver effects, which are
determined by a simple blood test checking liver enzyme levels. Therefore, regular
blood tests (liver function tests) should be performed before and during treatment with
Rovezix.
Monitoring During Treatment
During treatment, the patient’s condition should be closely monitored if they have or are
at risk of developing diabetes. The risk of diabetes development is higher if the patient
has high blood sugar levels, is overweight, and has high blood pressure.
If the patient is hospitalized or receiving treatment for another condition, medical staff
should be informed that the patient is taking Rovezix.
Children and Adolescents
Rovezix is not recommended for children and adolescents under 18 years old.
Other Medicines and Rovezix
The doctor or pharmacist should be informed of any other medications the patient is
currently taking, has taken recently, or plans to take.
Pregnancy, Breastfeeding, and Reproductive Health
During pregnancy or breastfeeding, it is important to consult with the doctor or
pharmacist before taking this medication.
Pregnancy
Rovezix should not be taken during pregnancy, planning for pregnancy, or if pregnancy
is suspected. If pregnancy occurs during treatment with Rovezix, the medication should
be immediately stopped, and the treating doctor should be informed. Appropriate
contraception should be used during treatment to avoid pregnancy.
Breastfeeding
Rovezix should not be taken during breastfeeding as it is not known whether the
medication is excreted in breast milk.
Driving and Using Machines
It is unlikely that Rovezix will affect the ability to drive or operate machinery. However,
some patients may experience dizziness after taking Rovezix. If dizziness occurs, it is
important to consult a doctor before driving or operating machinery.
Rovezix Contains Lactose
If the patient is intolerant to certain sugars, they should consult a doctor before using
this medication.
Rovezix Contains Sodium
This medication contains less than 1 mmol (23 mg) of sodium per capsule, which
means it is essentially “sodium-free”
3. How to Take Rovezix
The medication should always be taken exactly as instructed by the doctor or
pharmacist. If the patient is unsure, they should consult the treating doctor or
pharmacist.
During treatment with Rovezix, a cholesterol-lowering diet and physical activity should
be maintained.
For adults, the recommended daily dose is one tablet of the indicated dose. Rovezix is taken once a day, at any time of the day, regardless of meals. Each tablet
should be swallowed whole with a glass of water. The medication should be taken every
day at the same time.
Rovezix is not intended for initial treatment. The treatment should begin with individual
active substances and appropriate doses, after which the doctor may consider
transitioning to Rovezix with the appropriate dosage.
Regular Cholesterol Control
It is important to visit the doctor regularly for cholesterol level control to ensure the
desired cholesterol levels are achieved and maintained.
Overdose
If an overdose occurs, it is important to contact the doctor or visit the nearest hospital's
emergency department, as medical attention may be required.
Missed Dose
If a dose is missed, the patient should not worry and should take the next scheduled
dose as usual. Do not double the dose to make up for the missed one.
Discontinuation of Treatment
If the patient wishes to stop taking Rovezix, they should consult their doctor. Stopping
the medication may cause cholesterol levels to rise again.
For any additional questions regarding this medication, the patient should consult their
treating doctor or pharmacist.
4. Possible Side Effects
Like other medications, this medication may cause side effects, although not everyone
will experience them.
It is important for the patient to know what side effects may occur. Rovezix treatment
should be stopped, and immediate medical assistance should be sought if any of the
following occur:
• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing
or swallowing;
