ROSUHOL

Rosuhol 5 mg, 10 mg and 20 mg are prescription medicines containing rosuvastatin as rosuvastatin calcium. Rosuvastatin belongs to a group of medicines called statins and is used to regulate high cholesterol and other blood lipids.

Rosuvastatin reduces cholesterol production in the liver, increases the removal of LDL or “bad” cholesterol from the blood and may increase HDL or “good” cholesterol. In selected patients at high cardiovascular risk, it is also used to reduce the likelihood of a major cardiovascular event.

Rosuhol – strengths, uses, dosage and important warnings

What is Rosuhol used for?

Rosuhol is used together with an appropriate diet and other non-medicinal measures for:

• primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia;
• mixed dyslipidaemia involving abnormal cholesterol and other blood-lipid levels;
• homozygous familial hypercholesterolaemia as an addition to other lipid-lowering treatment;
• prevention of major cardiovascular events in adults assessed as being at high risk of a first event.

High cholesterol usually causes no symptoms. The benefit of treatment is therefore assessed through laboratory lipid tests rather than according to how the patient feels.

Rosuhol is not a weight-loss medicine and does not replace a balanced diet, physical activity, weight management, smoking cessation or appropriate treatment of high blood pressure and diabetes.

How is Rosuhol taken?

• Take the medicine once daily.
• It may be taken at any time of day.
• It may be taken with or without food.
• Swallow the tablet whole with sufficient water.
• Taking it at approximately the same time each day may help maintain regular use.

Continue taking Rosuhol even when cholesterol has reached the target level. A normal result commonly means that the prescribed treatment is working rather than that treatment is no longer needed.

Adult dosage

The usual starting dose for high cholesterol is 5 mg or 10 mg once daily. The doctor selects the starting dose according to cholesterol levels, cardiovascular risk, previous treatment and the likelihood of adverse effects.

When necessary, the dose may be increased at intervals of at least four weeks. A 20 mg dose may be used when lower doses do not achieve the target LDL-cholesterol level.

The maximum rosuvastatin dose of 40 mg daily is reserved for selected patients with severe hypercholesterolaemia and high cardiovascular risk who have not achieved the treatment goal with 20 mg. It requires closer specialist supervision. The registered Rosuhol packs covered on this page contain 5 mg, 10 mg or 20 mg tablets.

For prevention of major cardiovascular events, a daily dose of 20 mg is described in the official product information. A lower dose may be selected when risk factors for adverse effects are present.

Use in children and adolescents

Rosuhol may be prescribed from six years of age for certain forms of familial hypercholesterolaemia under specialist supervision.

• The usual starting dose is 5 mg once daily.
• The maximum dose for children aged 6–9 years is 10 mg daily.
• The maximum dose for children and adolescents aged 10–17 years is 20 mg daily.
• Use in children younger than six years is not recommended.

Children should continue the prescribed cholesterol-lowering diet during treatment. The dose must not be changed without medical instructions.

When is a 5 mg starting dose generally considered?

The lowest starting dose may be selected for:

• patients older than 70 years;
• moderate kidney impairment;
• an increased risk of myopathy;
• previous muscle problems during statin treatment;
• patients of Asian ancestry;
• concurrent use of medicines that increase rosuvastatin exposure.

Who must not take Rosuhol?

• people allergic to rosuvastatin or another ingredient;
• women who are pregnant or breastfeeding;
• patients with active liver disease or persistently and unexplainedly increased liver enzymes;
• patients with severe kidney impairment;
• patients with active myopathy or recurrent unexplained muscle pain;
• patients taking ciclosporin;
• patients receiving sofosbuvir/velpatasvir/voxilaprevir;
• patients who previously developed a severe skin reaction after rosuvastatin or a related medicine.

Additional restrictions apply to the maximum 40 mg dose, including moderate kidney impairment, an underactive thyroid gland, an increased risk of myopathy, regular consumption of large amounts of alcohol and concurrent fibrate treatment.

Muscle pain, weakness or cramps

Muscle pain is a possible adverse effect of rosuvastatin. Severe muscle injury is rare but may progress to rhabdomyolysis and kidney damage.

The risk may be increased by fibrates, systemic fusidic acid, ciclosporin, certain antiviral medicines and other treatments that increase rosuvastatin exposure.

When systemic fusidic acid treatment is necessary, the statin is generally interrupted temporarily according to medical instructions. Do not stop or restart Rosuhol independently.

Monitoring the liver, kidneys and blood glucose

The doctor may request tests before and during treatment, particularly:

• a lipid profile, including LDL, HDL, total cholesterol and triglycerides;
• liver-function tests;
• creatine kinase when muscle symptoms or risk factors are present;
• kidney-function tests in patients at increased risk;
• blood glucose or HbA1c in patients at risk of diabetes.

Statins may increase blood glucose in some patients. This is more likely in people with already elevated blood glucose or lipids, excess body weight or high blood pressure. Do not stop treatment independently because of a single abnormal result.

Severe skin reactions

Rare severe skin reactions, including Stevens–Johnson syndrome and DRESS syndrome, have been reported with rosuvastatin.

Interactions with other medicines

Tell the doctor and pharmacist about all medicines, supplements and herbal products being used. Important examples include:

• ciclosporin;
• warfarin, acenocoumarol, fluindione and other anticoagulants;
• ticagrelor and clopidogrel;
• gemfibrozil, fenofibrate and other fibrates;
• ezetimibe and other lipid-lowering medicines;
• oral or injectable fusidic acid;
• erythromycin;
• antacids used to neutralise stomach acid;
• darolutamide and regorafenib;
• oral contraceptives and hormone-replacement therapy;
• certain medicines for HIV or hepatitis C.

Do not independently add red yeast rice or monacolin K products to Rosuhol. These products may have statin-like effects and may increase the risk of muscle and liver problems.

Food and alcohol

Rosuhol may be taken independently of meals. Continue the recommended diet with less saturated and trans fat, sufficient dietary fibre and regular physical activity appropriate to the patient’s health.

Large amounts of alcohol increase the burden on the liver and may increase the risk of adverse effects. Tell the doctor about frequent alcohol consumption or a history of liver disease.

Pregnancy, breastfeeding and contraception

Rosuhol must not be used during pregnancy or breastfeeding.

Women who may become pregnant should use reliable contraception. If pregnancy occurs, stop taking the medicine and contact the doctor immediately.

Driving and using machines

Rosuhol does not significantly affect driving in most people. Do not drive or operate machinery if dizziness, weakness or another symptom affecting concentration occurs.

Possible side effects

Common adverse effects may include:

• headache and dizziness;
• nausea and abdominal pain;
• constipation;
• muscle pain;
• weakness or tiredness;
• increased blood glucose in predisposed patients.

Rash, itching and a temporary increase in urine protein may occur uncommonly.

Rare or very rare effects include severe allergy, muscle injury, inflammation of the pancreas, increased liver enzymes, reduced platelet counts, hepatitis, jaundice, blood in the urine, peripheral-nerve damage, tendon disorders and severe skin reactions.

Overdose, missed dose and stopping treatment

Contact a doctor, pharmacist or the nearest healthcare institution if more medicine than prescribed has been taken.

After a missed dose, take the next tablet at the normal time. Do not take a double dose.

Stopping treatment does not normally cause an acute withdrawal syndrome, but cholesterol and cardiovascular risk may rise again. Do not stop treatment without discussing it with the doctor.

Availability and price

Related category and education

Products intended to provide additional nutritional support are available in the High Cholesterol category.

Dietary supplements do not replace Rosuhol or another prescribed medicine. Products containing red yeast rice, monacolin K, high-dose niacin or complex cholesterol-lowering formulas must not be added to statin treatment without professional advice.

Related blog topic: What is good to drink for high blood lipids?

Composition, appearance and packaging

Each film-coated tablet contains 5 mg, 10 mg or 20 mg of rosuvastatin as rosuvastatin calcium.

The tablet core contains microcrystalline cellulose, lactose monohydrate, crospovidone and magnesium stearate.

• Rosuhol 5 mg: round, biconvex, yellowish tablet marked “5”; the coating contains E104.
• Rosuhol 10 mg: round, biconvex, light-pink tablet marked “10”; the coating contains E129.
• Rosuhol 20 mg: round, biconvex, dark-pink tablet marked “20”; the coating contains carmine E120.

Rosuhol contains lactose. Patients with an intolerance to certain sugars should consult their doctor before use.

Each pack contains three blisters of 10 tablets, providing 30 film-coated tablets in total.

Marketing authorisation holder and manufacturer: Pharmaswiss d.o.o. Belgrade, Batajnički drum 5A, Belgrade, Republic of Serbia.

Storage

Keep out of the sight and reach of children. Store in the original packaging to protect the medicine from light.

The shelf life is four years. Do not use after the expiry date stated on the packaging. Return unused tablets to a pharmacy that collects pharmaceutical waste.

Frequently asked questions

Official sources: ALIMS – Patient Information Leaflet | ALIMS – Summary of Product Characteristics | ALIMS – Packaging information.
Authorisation numbers: Rosuhol 5 mg – 515-01-02875-21-001; Rosuhol 10 mg – 515-01-02876-21-001; Rosuhol 20 mg – 515-01-02877-21-001, dated 7 July 2022. Official text revised in July 2022. Content checked: July 2026.