Rozulip® Plus hard capsules are used as adjuvant therapy to the diet for patients with primary hypercholesterolemia, when it is advisable to use a combination drug:
- for patients who have not achieved the desired result when treated with statins only;
- replacement of therapy for patients with sufficient disease control when combined with rosuvastatin and ezetimibe in the same doses as the fixed combination Rozulip® Plus.
Compound
Active ingredients: rosuvastatin, ezetimibe. One capsule contains two tablets:
- one tablet of rosuvastatin - 10 mg (in the form of rosuvastatin zinc);
- one tablet of ezetimibe - 10 mg.
Excipients:
- for rosuvastatin tablets: microcrystalline silicon cellulose, colloidal anhydrous silicon dioxide, magnesium stearate;
- for ezetimibe tablet: povidone, croscarmellose sodium, microcrystalline cellulose, mannitol, sodium lauryl sulfate, low-substituted hydroxypropylcellulose, magnesium stearate;
- capsule composition: yellow iron oxide (E172), titanium dioxide (E 171), gelatin.
ROZULIP (tablets)
parathas that reduce cholesterol and triglyceride levels in the blood.
The tablets are available in an original box of 28 pieces per package. Dosage of 10, 20 and 40 mg. A high-quality product made in Hungary. Manufacturer LLC Pharmaceutical Plant EPS. Budapest. Active substance. Rosuvastin.
The expiration date of the drug is indicated on the packaging.
The tablets are packaged in blisters of 7 tablets.
Due to the fact that cases of counterfeiting of imported medical drugs have become more frequent on the market, I will give a detailed description of the tablets. Tablets of 10 mg are white, round, slightly convex, engraved with the number 592. The package contains detailed instructions for using the drug.
I will provide clinical characteristics and indications in the description.
Effect.
The drug was taken under the control and supervision of a cardiologist. Dosage of 10 mg per day for a long course of up to 12 months. Monitoring the effectiveness of drug treatment involves periodically taking a biochemical blood test every two months and monitoring blood cholesterol levels based on the test results. I can say right away that it brings little pleasure because blood for analysis needs to be taken from a vein, so a trip to the treatment room to see the nurse is guaranteed. The only good thing is that the analysis is not very expensive, costing 60 UAH, approximately 135 rubles.
From my own experience I can say that long-term use of the drug for several months and adherence to a strict diet are two MANDATORY conditions. If you actively take pills, but at the same time continue to actively engage in gluttony, this is “money thrown away.”
So be patient, buy a meat grinder and pressure cooker and switch to steaming meat and fish cutlets. More vegetables, fruits, hard cereals and victory over insidious cholesterol in six months will be guaranteed to you!
My blood cholesterol levels returned to normal after 5 months.
Safety.
Since long-term use of statins causes side effects, I want to note that I experienced two of them while taking the drug: - since I suffer from gouty arthritis, pain and swelling in the ankle joints periodically appeared, which had to be relieved by taking Nemisil; -I was also bothered by periodic sleep disturbances, which were eliminated by taking one Sonmila tablet at night.
— for those who like to drink well, I would also like to draw your attention to the fact that if you then long and persistently do not want to treat your liver, then drinking alcohol during treatment with statins is strictly PROHIBITED!!!
Availability.
The drug is available with a prescription. I bought the drug at the pharmacy for 115 UAH, approximately 255 rubles.
Thank you for your attention, don’t get sick, good luck and good luck!
Contraindications
- hypersensitivity to the active substances or to any of the excipients of the drug;
- active liver disease, including persistently elevated serum transaminase levels of unknown etiology and any increase in serum transaminase levels three times or more than the upper limit of normal (ULN);
- severe renal impairment (creatinine clearance <30 ml/minute);
- myopathy;
- simultaneous use of cyclosporine;
- childhood;
- pregnancy, breastfeeding period;
- Contraindicated in women of reproductive age who do not use effective methods of contraception.
Rosulip® Plus
Effect on skeletal muscles
In patients treated with all doses of rosuvastatin, and especially when taking doses >20 mg, effects of the drug on skeletal muscles were noted: for example, the development of myalgia, myopathy and (rarely) rhabdomyolysis. As with other HIG-CoA reductase inhibitors, the incidence of rhabdomyolysis with post-marketing use of rosuvastatin is higher when taking a dose of 40 mg.
In the post-registration period, cases of myopathy and rhabdomyolysis were observed with the use of ezetimibe. Rhabdomyolysis has been reported in very rare cases both with ezetimibe monotherapy and when ezetimibe is added to other medicinal products associated with an increased risk of rhabdomyolysis. If myopathy is suspected (based on muscle symptoms or increased CPK activity), ezetimibe, all statins, and any drugs known to be associated with increased rates of rhabdomyolysis should be immediately discontinued. At the beginning of treatment, all patients should be warned about the risk of myopathy and the need to promptly report any episodes of unreasonable muscle pain, muscle soreness or weakness (see section Adverse effects).
Effect on the liver
In controlled studies with co-administration of ezetimibe and a statin, consistent increases in transaminases (≥3 ULN) were observed.
It is recommended to determine liver function before starting treatment and 3 months after starting rosuvastatin therapy. Rosuvastatin should be discontinued or its dose reduced if serum transaminase activity is > 3x ULN. The incidence of serious liver events (mainly increased transaminase activity) during post-registration use is more often observed when taking a dose of rosuvastatin equal to 40 mg.
In patients with secondary hypercholesterolemia caused by hypothyroidism or nephrotic syndrome, treatment of the underlying disease is necessary before initiating therapy with Rozulip® Plus.
Due to the unknown effects of increased exposure to ezetimibe in patients with moderate or severe hepatic impairment, the use of Rozulip® Plus in them is not recommended (see Pharmacokinetics section).
Effect on the kidneys
Proteinuria, detected by rapid testing, predominantly of a tubular nature, was noted in patients receiving treatment with increased doses of rosuvastatin, in particular, a dose of 40 mg. In most cases, proteinuria was transient or inconsistent. Proteinuria has not been shown to signal the development of acute or progressive kidney disease (see Side Effects section). In the post-marketing period, serious renal adverse reactions were observed more frequently with the 40 mg dose. When monitoring patients taking a dose of 40 mg, consider monitoring renal function (at least every 3 months).
Determination of creatine phosphokinase activity
CPK activity should not be determined after intense physical activity or if there are other probable reasons for increased CPK activity, which may complicate the interpretation of the results.
If initially there is a significant increase in CPK activity (>5 ULN), a repeat measurement should be taken after 5-7 days. If repeated measurements confirm that CPK activity is >5 ULN, treatment should not be started.
Fusidic acid
Rosulip® Plus capsules should not be used in conjunction with fusidic acid for systemic use or within 7 days after discontinuation of fusidic acid treatment. In patients requiring treatment with fusidic acid, rosuvastatin should be discontinued throughout the entire treatment period. Rhabdomyolysis (in some cases fatal) has been reported in patients receiving rosuvastatin and fusidic acid together (see Interactions with Other Drugs). Patients should be informed that they should consult a physician immediately if they develop muscle weakness, pain, or tenderness.
7 days after the last dose of fusidic acid, treatment with rosuvastatin can be started again.
In exceptional cases, when long-term treatment with fusidic acid is necessary, for example, in severe infections, the decision on the need for combined use of fusidic acid and Rozulip® Plus should be made individually, weighing the potential risks of therapy and the possible benefits with careful monitoring of the patient's condition.
Before starting treatment
Rozulip® Plus, like other drugs that contain HMG-CoA reductase inhibitors, should be prescribed with caution to patients with factors predisposing to the development of myopathy or rhabdomyolysis:
— Kidney failure;
— Hypothyroidism;
— Hereditary muscle diseases in personal or family history;
- Toxic effect on muscles when using another HMG-CoA inhibitor or fibrate;
— Alcohol abuse;
— Age >70 years;
— Situations in which it is possible to increase the levels of active substances in plasma (see section “Pharmacokinetics”);
- Concomitant use of fibrates.
In such patients, the risks and possible benefits of treatment need to be assessed, and clinical monitoring is recommended. Treatment should not be started if there is a significant initial increase in CPK activity (>5 ULN).
During treatment
Patients should be asked to immediately report any unexplained muscle pain, weakness, or muscle spasms, especially if accompanied by general weakness or fever. CPK activity should be measured in these patients. Treatment should be discontinued if there is a noticeable increase in CPK activity (>5 ULN) or in the presence of severe symptoms that cause daily discomfort (even with CPK activity <5 ULN). Routine monitoring of CK activity is not required in asymptomatic patients.
There are very rare reports of the development of immune-mediated necrotizing myopathy during or after treatment with statins, including rosuvastatin. Clinically, this disease is characterized by proximal muscle weakness and increased serum CPK activity, which persist despite statin discontinuation.
In clinical studies, there was no evidence of increased effects on skeletal muscles in a small number of patients concomitantly taking rosuvastatin and other lipid-lowering drugs. An increased incidence of myositis and myopathy was observed in patients concomitantly taking other HMG-CoA reductase inhibitors and fibric acid derivatives (including gemfibrozil), cyclosporine, niacin, azole antifungals, protease inhibitors or macrolide antibiotics. Gemfibrozil increases the risk of myopathy when taken together with certain HMG-CoA reductase inhibitors. Therefore, the combination of Rozulip® Plus and gemfibrozil is not recommended. The benefits of further lowering lipid levels when taking Rosulip® Plus and fibrates or niacin in combination should be carefully weighed against the possible risks of this combination of drugs.
Rozulip® Plus should not be used in patients with serious acute conditions that are likely to have myopathy or that predispose to the development of renal failure due to rhabdomyolysis (for example, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine or electrolyte balance, with uncontrolled seizures).
Ethnicity of patients
Pharmacokinetic studies of rosuvastatin have shown increased drug exposure in Asian patients compared to Caucasian patients (see Dosage and Administration and Pharmacokinetics).
Protease inhibitors
Increased systemic exposure to rosuvastatin was observed in patients concomitantly taking rosuvastatin and various protease inhibitors in combination with ritonavir. Consideration should be given to both the lipid-lowering benefits of Rosulip® Plus in HIV-infected patients receiving protease inhibitors and the possibility of increased rosuvastatin plasma concentrations when initiating and titrating rosuvastatin dosages. Combined use of the drug with some protease inhibitors is recommended only with dose adjustment of Rozulip® Plus (see sections: Method of administration and dosage and Pharmacokinetics).
Interstitial lung diseases
In exceptional cases, the development of interstitial lung diseases has been reported with some statins, especially with long-term therapy. Symptoms of these illnesses include a nonproductive cough and poor general health (fatigue, weight loss, and fever). If a patient is suspected of developing interstitial lung disease, statin therapy should be discontinued.
Diabetes
Some data suggest that drugs of the statin class increase blood glucose concentrations and, in some patients at high risk of developing diabetes mellitus, may lead to hyperglycemia, the level of which meets the formal definition of diabetes mellitus and requires the initiation of antidiabetic therapy. This risk, however, is outweighed by the reduction in vascular risk with statins and should therefore not be a reason to discontinue statin therapy. In patients at risk (fasting glucose concentration - 5.6-6.9 µmol/l, BMI >30 kg/m2, increased TG concentrations, hypertension), clinical and biochemical monitoring of diabetes mellitus should be carried out in accordance with national guidelines.
In the JUPITER study, the overall incidence of diabetes mellitus was reported to be 2.8% in the rosuvastatin group and 2.3% in the placebo group (primarily in patients with fasting glucose concentrations of 5.6-6.9 mmol/L).
Fibrates
The safety and effectiveness of coadministration of ezetimibe and fibrates have not been established. If cholestasis is suspected in a patient taking Rosulip® Plus and fenofibrate, the gallbladder should be examined and this therapy should be discontinued (see sections Interactions with other medicinal products and Side effects).
Anticoagulants
If Rozulip® Plus is added to therapy with warfarin, another coumarin anticoagulant or fluindione, appropriate monitoring of the international normalized ratio (INR); see section Interactions with other medicinal products.
Cyclosporine
see sections Contraindications and Interactions with other drugs.
Pediatric patients
The safety and effectiveness of Rozulip® Plus in persons under 18 years of age have not yet been established, and therefore the use of the drug in this age group is not recommended.
Liver disease and alcohol use
Rozulip® Plus should be used with caution in patients with excessive alcohol consumption and/or a history of liver disease.
Mode of application
Before starting treatment, the patient should be prescribed a standard cholesterol-lowering diet, which should be followed during treatment. The dose should be selected individually, depending on the purpose of therapy and the effectiveness of treatment, taking into account the risk of adverse reactions and following current recommendations.
Combination treatment should be started only after determining the required dosage of rosuvastatin or both components of the drug.
Dose adjustments can be made after 4 weeks of therapy.
The recommended daily dose is one capsule, taken regardless of meals.
"Rozulip® Plus" is not used as first-line lipid-lowering therapy. Rosulip® Plus 10 mg/10 mg capsules are not used to treat patients who require a dose of rosuvastatin 40 mg.
The drug should be taken ≥ 2 hours before or ≥ 4 hours after taking a bile acid sequestrant.
Primary hypercholesterolemia. The drug is taken 1 time per day, in the evening, regardless of meals. The dose of the drug is selected individually, taking into account the initial level of LDL cholesterol, the purpose of treatment and the patient’s clinical response to the therapy being carried out.
The dose range is from 10 mg/10 mg to 40 mg/10 mg per day. Typically, the initial therapeutic dose is 20 mg/10 mg per day or 40 mg/10 mg per day. After starting treatment or at the stage of selecting the dose of the drug, blood lipid levels should be monitored at intervals of at least 4 weeks and, if necessary, dose adjustments should be made.
Instructions for use ROSULIP®
Effect on kidney function
Proteinuria has been observed in some patients taking high doses of rosuvastatin (especially the 40 mg dose). Proteinuria was diagnosed by urine test using test strips. In most cases, it was of tubular origin and was transient or intermittent. Proteinuria did not necessarily indicate the development of acute or progressive renal failure. In the post-registration period, serious renal dysfunction was more often observed in patients taking rosuvastatin at a dose of 40 mg. As part of the standard examination of patients receiving Rozulip® at a dose of 40 mg, it is necessary to periodically monitor renal function.
Effect on skeletal muscles
Side effects from skeletal muscles (for example, myalgia, myopathy, and, in rare cases, rhabdomyolysis) were observed in patients taking the drug at any dose, most often at doses exceeding 20 mg. Very rarely, rhabdomyolysis developed during concomitant therapy with ezetimibe and HMG-CoA reductase inhibitors. Since pharmacodynamic interactions cannot be excluded (see Drug Interactions), caution should be exercised when using these drugs simultaneously. As in the case of therapy with other HMG-CoA reductase inhibitors, rhabdomyolysis developed more often when using the drug at a dose of 40 mg.
Determination of creatine kinase
Serum creatine kinase testing should not be performed after intense exercise or when there are other possible reasons for increased creatine kinase concentrations, as this may make the results difficult to interpret. If the baseline creatine kinase level is significantly elevated (5 times the upper limit of normal), a repeat measurement should be performed after 5 to 7 days. Therapy should not be initiated if a repeat test confirms baseline creatine kinase levels (more than 5 times the upper limit of normal).
Fusidic acid
Rosulip® tablets should not be used in conjunction with fusidic acid for systemic use or within 7 days after discontinuation of fusidic acid treatment. In patients requiring treatment with fusidic acid, rosuvastatin should be discontinued throughout the entire treatment period. Rhabdomyolysis (in some cases fatal) has been reported in patients receiving rosuvastatin and fusidic acid together (see Drug Interactions). Patients should be informed that they should consult a physician immediately if they develop muscle weakness, pain, or tenderness.
7 days after the last dose of fusidic acid, treatment with rosuvastatin can be started again.
In exceptional cases, when long-term treatment with fusidic acid is necessary, for example, in severe infections, the decision on the need for combined use of fusidic acid and rosuvastatin should be made individually, weighing the potential risks of therapy and the possible benefits with careful monitoring of the patient's condition.
Before starting therapy
Like other HMG-CoA reductase inhibitors, Rozulip® should be administered with caution to patients with factors predisposing to the development of myopathy (rhabdomyolysis). These factors include:
- renal dysfunction;
- hypothyroidism;
- hereditary pathology of the muscular system in the patient or his close relatives;
- myopathy effect associated with a history of taking another HMG-CoA reductase inhibitor or fibrate;
- alcohol abuse;
- age over 70 years;
- situations in which an increase in the concentration of rosuvastatin in the blood plasma may be observed (see sections Dosage regimen, Drug interactions and Pharmacokinetics);
- simultaneous use of fibrates.
When prescribing the drug to such patients, it is necessary to carefully weigh the potential risks of therapy and possible benefits. In addition, clinical monitoring is recommended.
If creatine kinase levels are significantly elevated at baseline (>5 x ULN), rosuvastatin therapy should not be initiated.
During therapy
The patient should be informed to immediately report to the doctor the unexpected onset of muscle pain, muscle weakness or cramps, especially if accompanied by malaise and fever. In such patients, serum creatine kinase levels should be determined. Therapy should be discontinued if creatine kinase levels are significantly elevated (more than 5 times the upper limit of normal) or if muscle symptoms are severe and cause daily discomfort (even if creatine kinase levels are less than 5 times the upper limit of normal) . If symptoms disappear and creatine kinase levels return to normal, re-prescribing Rozulip® or other HMG-CoA reductase inhibitors in lower doses should be considered with careful monitoring of the patient. Routine monitoring of creatine kinase in the absence of symptoms is not advisable.
There are very rare reports of the development of necrotizing myopathy of immunological origin, with characteristic clinical manifestations in the form of prolonged weakness of the proximal muscles and increased serum creatine kinase levels during or after cessation of treatment with statins (including rosuvastatin). In such cases, further evaluation of neuromuscular function, serologic testing, and immunosuppressive therapy may be necessary.
In clinical studies involving a small number of patients, there was no evidence of increased effects on skeletal muscle when taking rosuvastatin with concomitant therapy. At the same time, an increase in the incidence of myositis and myopathy was reported in patients taking other HMG-CoA reductase inhibitors in combination with fibric acid derivatives, including gemfibrozil, cyclosporine, nicotinic acid, azole antifungals, protease inhibitors and macrolide antibiotics. Gemfibrozil increases the risk of myopathy when co-administered with certain HMG-CoA reductase inhibitors. Therefore, co-administration of rosuvastatin and gemfibrozil is not recommended. When using rosuvastatin concomitantly with fibrates or niacin, the benefit of further lowering lipid levels must be carefully weighed against the risk of using such combinations. During concomitant therapy with fibrates, taking Rozulip® at a dose of 40 mg is contraindicated (see sections Contraindications, Drug interactions and Side effects).
Rosulip® should not be used to treat patients with acute, serious disorders indicating the development of myopathy or the possibility of developing renal failure caused by rhabdomyolysis (for example, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine or electrolyte disturbances that cannot be controlled convulsions).
Effect on liver function
Like other HMG-CoA reductase inhibitors, rosuvastatin should be used with caution in the treatment of alcohol abusers and patients with underlying liver pathology.
Before starting therapy and 3 months after starting treatment, it is recommended to perform liver function tests. If the level of transaminases in the blood serum exceeds the upper limit of normal by more than three times, rosuvastatin should be discontinued or its dose reduced.
In the post-registration period (use in a wide range of patients), serious adverse events from the liver (mainly increased levels of transaminases in the blood serum) were more often observed in patients receiving the drug at a dose of 40 mg.
In patients with secondary hypercholesterolemia due to hypothyroidism or nephrotic syndrome, underlying diseases should be treated before starting treatment with rosuvastatin.
Ethnicity
The results of pharmacokinetic studies indicate that in people of Asian origin, the bioavailability of rosuvastatin is higher than in Europeans (see sections Dosage regimen, Contraindications and Drug interactions).
Protease inhibitors
When rosuvastatin was combined with various proteolytic enzyme inhibitors and ritonavir, an increase in the systemic exposure of rosuvastatin was observed. In HIV patients receiving protease inhibitors, the benefit of lowering lipid levels when prescribing rosuvastatin should be weighed against the possibility of increasing rosuvastatin plasma levels at the beginning of treatment and with further titration of the drug dosage in these patients. Combination with certain protease inhibitors is not recommended, except in cases where rosuvastatin doses are adjusted (see sections Dosage regimen, Special instructions and Drug interactions).
Interstitial lung disease
In very rare cases, patients receiving some statin drugs have developed interstitial lung disease (see Side effects section). Typically, these cases were observed during long-term statin therapy. Interstitial lung disease is characterized by shortness of breath, nonproductive cough, and deterioration of general condition (fatigue, weight loss, and fever). If interstitial lung disease is suspected, statin therapy should be discontinued.
Lactose intolerance
Rozulip® tablets contain lactose. The drug is not recommended for patients with rare hereditary galactose intolerance, lactase deficiency and glucose-galactose malabsorption syndrome.
Diabetes
Based on available evidence, statins as a class increase blood sugar levels and may also cause hyperglycemia requiring antidiabetic treatment in patients at high risk of developing diabetes mellitus. However, in such cases, discontinuation of statins is not justified, since the benefits associated with reducing the risk of developing vascular diseases outweigh the risk of developing hyperglycemia. Patients at risk (fasting glucose concentration 5.6-6.9 mmol/l, body mass index >30 kg/m2, elevated triglyceride levels, hypertension) should undergo clinical and biochemical monitoring in accordance with existing national recommendations.
In the JUPITER study, the overall incidence of diabetes mellitus reported was 2.8% and 2.3%, respectively, in the rosuvastatin and placebo groups, particularly in subjects with fasting glucose levels of 5.6–6.9 mmol/L.
Children and teenagers
In children aged 6 to 17 years treated with rosuvastatin, determination of height, weight, body mass index, and assessment of puberty based on the development of secondary sexual characteristics according to Tanner was limited to a period of two years. After treatment for two years, no effect of the drug on height, body weight, body mass index and puberty was observed (see section Pharmacological action).
In a clinical study in which children received rosuvastatin for 52 weeks, increases in creatine kinase levels (10 times the upper limit of normal) and muscle symptoms were observed more frequently than in studies in adults (see section 4.4). section Side effects).
Preclinical safety data
Traditional preclinical safety, pharmacology, genotoxicity and carcinogenicity studies have not identified a specific risk associated with rosuvastatin therapy in the human population. Special tests assessing the effect of the drug on the gene for specific potassium channels of the human heart (Human Ether-a-Go-go Related Gene, hERG) have not been carried out. The following describes reactions that were not observed in clinical studies but were observed in animals at clinical bioavailability levels. Repeated dose toxicity studies in mice and rats revealed histopathological changes in liver tissue that were likely due to the pharmacological effects of rosuvastatin. Less pronounced changes in liver tissue, along with changes in the gallbladder, were found in dogs. Monkeys had no such reactions. In addition, when rosuvastatin was used in higher doses in monkeys and dogs, toxic effects of the drug on the testes were observed. Clear reproductive toxicity has been observed in rats. When the drug was administered in doses toxic to the mother's body (when systemic exposure is several times higher than the therapeutic level), a decrease in the number of cubs in the litter was observed, as well as a decrease in body weight and survival of the cubs.
Impact on the ability to drive vehicles and operate machinery
Studies evaluating the effect of Rozulip® on the ability to drive vehicles and machines have not been conducted. When driving a car or working with potentially dangerous mechanisms, you should be aware that dizziness may occur during therapy.
Features of application
Pregnant
Rozulip® Plus is contraindicated during pregnancy or breastfeeding. Women of reproductive age should use appropriate contraception. If it is necessary to treat a woman who is breastfeeding, the issue of stopping breastfeeding should be decided.
Children
The safety and effectiveness of the drug in children have not been studied. Contraindicated for use.
Drivers
No studies have been conducted on the effect of Rozulip® Plus on the ability to drive a car or operate machinery. When driving vehicles or working with other mechanisms, the possibility of dizziness during treatment should be taken into account.
Side effects
From the blood and lymphatic system: thrombocytopenia.
From the immune system: hypersensitivity reactions, including angioedema.
Endocrine disorders: diabetes mellitus.
Mental disorders: depression.
From the nervous system: headache, dizziness, polyneuropathy, memory loss; peripheral neuropathy, sleep disorders (including insomnia and nightmares).
From the respiratory system, chest and mediastinum: cough, shortness of breath.
From the digestive system: constipation, nausea, abdominal pain, pancreatitis, diarrhea.
From the hepatobiliary system: increased levels of liver transaminases, jaundice, hepatitis.
From the skin and subcutaneous tissue: itching, rash, urticaria, Stevens-Johnson syndrome.
From the skeletal muscles and connective tissue: myalgia, myopathy (including myositis), rhabdomyolysis, arthralgia, tendon disorders, sometimes complicated by ruptures, immune-mediated necrotizing myopathy.
From the kidneys and urinary system: hematuria.
From the reproductive system and mammary glands: gynecomastia.
Note!
Description of the drug Rozulip Plus caps. hard 10mg/10mg No. 30 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.