Rosver – composition, action, indications and contraindications. Roswer and cholesterol

Proven content

Roswera is a medicinal preparation that belongs to a group of drugs called statins. It contains rosuvastatin, the action of which lowers cholesterol. It is used in adults and children over 6 years of age, and is available in pharmacies upon presentation of a doctor’s prescription. What are the indications and contraindications for the use of Roswera? How to properly dose the drug and what precautions should be taken when using it? Can the use of Roswera cause side effects in a patient? How much does the drug Rosvera cost?

Rosver – general characteristics of the drug

Roswera is a blood lipid-lowering medicine. The use of this preparation allows you to control the concentration of cholesterol and lipoproteins in the blood, and also prevents atherosclerotic changes.

The active substance in Roswera is rosuvastatin with complex antiatherosclerotic effects. This preparation is mainly used in cardiac patients.

Roswera is available by prescription and comes in the form of tablets. Roswera film-coated tablets are white, round and slightly biconvex. They also have bevelled edges and an embossed dose of medicine on one side. The diameter and size of the tablet depend on the dose of the drug:

1. 5 mg – diameter 7 mm;
2. 10 mg – diameter 7,5 mm;
3. 15 mg – diameter 9 mm; 
4. 20 mg – diameter 10 mm; 
5. 30 mg – dimensions 15 mm x 8 mm;
6. 40 mg – dimensions 16 mm x 8,5 mm.

The two largest tablets have a score line on their surface to help the patient break up the medicine for ease of swallowing it, but it does not divide into equal doses. The drug is packed in blisters in a cardboard box. Each pack of the medicine contains 10, 14, 20, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets.

The entity responsible for the production and distribution of Roswera is Krka dd Krka is a Slovenian pharmaceutical company that produces medicines, cosmetics and veterinary preparations. The company was founded in 1954 as a pharmaceutical laboratory, then expanded to include the production of medicinal and cosmetic preparations. The production facilities were located in Ločna and a significant part of the production is still taking place there. In 1997, the company was transformed into a joint-stock company and listed on the Ljubljana Stock Exchange. Since 2012, it has also been listed on the Warsaw Stock Exchange. The factory in Poland was opened on October 30, 2001, and its headquarters is in Warsaw, Italy.

Are Poles satisfied with the activities of Polish pharmaceutical companies? Check: Customer satisfaction from Polish pharmaceutical companies: which is the most convincing?

Rosver – composition and mechanism of action of the drug

The main ingredient and active ingredient of Roswera is rosuvastatin. It is a lipid-lowering drug belonging to the group of statins. The most important property of rosuvastatin is the normalization of blood lipids. It is a very important property for our health, because the increased concentration of lipids in the blood affects the risk of cardiovascular diseases. LDL cholesterol levels greater than or equal to 3 mmol / L (115 mg / dL) are considered abnormal. Increased levels of LDL cholesterol and total cholesterol in the blood are known as hypercholesterolaemia.

Statins, including rosuvastatin, inhibit the activity of a key enzyme that is involved in the process of cholesterol synthesis. By inhibiting this activity, cholesterol synthesis is reduced, and the liver cells are stimulated to increase the uptake of LDL cholesterol particles from the blood. The effect of this action is to effectively reduce the concentration of LDL cholesterol in the blood.

Rosuvastatin is metabolised only to a minor extent. The biological half-life of this substance is approximately 19 hours. The reduction in serum cholesterol is visible after approx. 1-2 weeks, and the maximum effect occurs after approx. 4 weeks and is sustained during further treatment. Withdrawal of statins, cholesterol levels return to pre-treatment levels.

In addition to the active substance, Roswera uses other substances that make up the tablet’s core and coating.

Auxiliary components of the tablet core of the drug Roswera:

1. lactose;
2. microcrystalline cellulose;
3. crospovidone;
4. magnesium stearate;
5. colloidal anhydrous silica.

Auxiliary components of the Roswer tablet shell:

1. lactose jednowodna;
2. titanium dioxide (E 171);
3. macrogol 6000;
4. basic butyl methacrylate copolymer.

What are statins and how do they work? Read on: Statins – action, indications, contraindications, side effects

Rosver – indications for application

Roswera is primarily a drug that reduces blood lipids. On the one hand, the active substance of the drug reduces the concentration of “bad” LDL cholesterol and increases the concentration of “good” HDL cholesterol. In addition, it inhibits the production of cholesterol in the body and improves the ability to remove this substance from the blood.

The indications for the use of this preparation are:

1. treatment of hypercholesterolaemia, which is high blood cholesterol;
2. prevention of atherosclerosis;
3. reducing the likelihood of a heart attack or stroke in patients at risk.

How to recognize and treat familial hypercholesterolaemia? Check: Symptoms of familial hypercholesterolaemia that everyone should know [EXPLAINED]

Rosver – contraindications to use

Despite its effectiveness in lowering blood cholesterol, Roswera cannot be used by every patient struggling with this type of ailments.

Contraindications to the use of the drug Roswera are:

1. allergy to rosuvastatin or any of the other excipients of the drug;
2. pregnancy or breastfeeding;
3. liver disease;
4. severe kidney disease;
5. repeated or unexplained muscle pain;
6. use of cyclosporine.

The two highest doses of Roswera, 30 and 40 mg, should also not be used in the following cases:

1. you have moderate kidney disease;
2. you have thyroid disease;
3. if you have frequent or unexplained problems or muscle pain, if you or your family members have had muscle problems, or have had muscle problems before while taking medicines that lower fatty substances;
4. the patient regularly consumes large amounts of alcohol;
5. the patient is of Asian descent;
6. you are taking medicines from the group of fibrates.

In these cases, there are factors that increase the risk of myopathy or rhabdomyolysis.

What should you know about drug hypersensitivity? Check: Drugs are also allergenic

Rosver – precautions

Before and during the use of Roswera, follow the precautions included in the package leaflet.

Particular precautions should be taken especially if the patient:

1. struggles with kidney and / or liver problems;
2. suffer from recurring or unexplained muscle pain, or you or your family have had problems with your muscles in the past;
3. regularly consumes large amounts of alcohol;
4. is diagnosed with thyroid disease;
5. uses drugs from the group of fibrates;
6. is taking medicines to treat HIV infection;
7. has taken in the past 7 days or is fusidic acid;
8. is under 6 years old;
9. are under 18 years of age for the 30 mg and 40 mg doses;
10. is over 70 years old;
11. is of Asian descent;
12. suffers from severe respiratory failure;
13. diagnosed with or at risk of developing diabetes.

It should also be remembered that:

1. store the drug in the original package in order to protect from moisture;
2. no special recommendations regarding the storage temperature of the medicinal product;
3. the drug should be kept out of the reach of children;
4. the medicine should not be used after the expiry date which is stated on the carton. The expiry date refers to the last day of that month;
5. this medicine should not be disposed of via wastewater or household waste. It’s best to ask your pharmacist how to dispose of medicines you no longer use.

What should you know about proper drug storage? Check: Medications that are stored wrongly are poisonous

Roswer – the correct dosage

Always use Roswera exactly as described in the package leaflet or as directed by your doctor or pharmacist.

In adults, it is recommended to start treatment with to lower high cholesterol 5 mg or 10 mg doses even if the patient has taken other statins in the past at higher doses. The starting dose of Roswera depends on your cholesterol levels, the size of the risk of a heart attack or stroke, and the presence of a factor that may be contributing to side effects.

Your doctor may prescribe you the lowest possible dose (5 mg) if:

1. the patient is of Asian descent (Japan, China, Philippines, Vietnam, Korea and India);
2. the patient is over 70 years of age;
3. you have moderate kidney problems;
4. you are at risk of muscle pain and problems with muscles (myopathy).

In order to achieve normal blood cholesterol levels, your doctor may increase the dosage of your medicine, up to a maximum dose of 40 mg once a day. Each dose increase is made at intervals of four weeks. The maximum daily dose of Roswera is 40 mg. This dose is only used in patients with high cholesterol, who are at high risk of developing a heart attack or stroke, whose cholesterol levels have not dropped sufficiently with lower doses.

A starting dose of 20 mg is recommended to reduce the risk of heart attack, stroke or other similar health problems.

For and adolescents between 10 and 17 years of age, the usual starting dose is 5 mg. Your doctor may increase the dose until you reach the dose that is right for you. The maximum daily dose for patients in this age group is 20 mg. Take the dose once a day. Roswera 30 mg and 40 mg should not be used in children.

The Roswera tablet should be swallowed whole with a drink of water. To remember to take your medicine on a regular basis, take it at the same time each day.

How to take medication correctly? Check: How to take medications effectively?

Rosver – side effects of the drug

Roswera, like any other drug, may cause side effects in patients. It is important to report any suspected adverse reactions after authorization of the medicinal product so that the benefit / risk balance of the medicinal product can be monitored.

The frequency classification of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare (≥ 100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

Common side effects of taking Roswera (may affect up to 1 in 10 to 1 in 100 people):

1. Headache;
2. abdominal pain;
3. constipation;
4. nausea;
5. muscle pain;
6. weakness;
7. dizziness;
8. increase in urine protein levels – this parameter usually returns to normal on its own without the need to stop taking Roswera;
9. diabetes, especially in patients whose blood glucose is in the upper limit of the normal range.

Uncommon side effects of taking Roswera (may affect up to 1 in 100 to 1 in 1000 people):

1. rash, itching or other skin reactions;
2. increase in urine protein concentration – this parameter usually returns to normal on its own without the need to stop taking Roswera.

Rare side effects of taking Roswera (may affect between 1 in 1000 and 1 in 10 patients):

1. severe allergic reaction which includes swelling of the face, tongue and / or throat that may cause difficulty in swallowing and breathing;
2. severe itching of the skin (with lumps);
3. muscle damage in adults;
4. severe stomach pain (pancreatitis);
5. increase in liver enzymes in the blood.

Very rare side effects of taking Roswera (may affect up to 1 in 10 patients):

1. jaundice (yellowing of the skin and eyes);
2. hepatitis;
3. trace amounts of blood in the urine;
4. damage to the nerves of the lower and upper extremities (numbness);
5. arthralgia;
6. memory loss. 

Side effects from the use of the drug Roswera of unknown frequency:

1. diarrhea;
2. Stevens-Johnson syndrome (a serious condition with severe blisters on the skin, mouth, eyes and genitals);
3. cough;
4. shortness of breath (dyspnoea);
5. edema;
6. sleep disturbances including insomnia and nightmares;
7. sexual dysfunction;
8. depression;
9. breathing problems including persistent cough and / or shortness of breath;
10. fever.

How can you recognize high blood cholesterol? Check: Symptoms of high cholesterol

Roswer and pregnancy and breastfeeding

The use of any medications or dietary supplements during pregnancy requires consultation with the attending physician. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Roswera.

Roswera must not be used during pregnancy. If pregnancy occurs during treatment, treatment with Roswera should be discontinued immediately. Additionally, women of childbearing age should use effective contraception while taking the drug.

Roswera must also not be used during breast-feeding.

What is worth knowing about proper supplementation during pregnancy? Check: Conscious choices. Diet and supplementation in pregnancy

Roswer – interactions with other drugs

Before starting treatment with Roswera, please inform your doctor or pharmacist about all the medicines you are taking or have taken recently. You should also inform what medications the patient plans to take in the near future.

The use of Roswera precludes the simultaneous use of:

1. cyclosporins;
2. fibratams (for Roswera 30 mg and 40 mg doses).

However, if you are taking any of the following medicines, tell your doctor before taking Roswera:

1. warfarin or clopidogrel (or any other blood thinner);
2. fibrates (e.g. gemfibrozil, fenofibrate) or any other cholesterol-lowering drug (e.g. ezetimibe);
3. indigestion remedies (used to neutralize the acid in your stomach);
4. erythromycin (an antibiotic);
5. oral contraceptives;
6. fusidic acid – if you need fusidic acid, stop taking Roswera until your doctor decides if you can restart taking the statins.
7. Hormone Replacement Therapy;
8. regorafenib (used to treat cancer);
9. any of the following medicines used to treat viral infections, including HIV or hepatitis C infection, taken alone or in combination with other medicines: ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

Which drugs should never be combined with each other? Check: Dangerous interactions

Rosver – price

The price of the drug Roswer may differ depending on the city in which the preparation will be purchased or the pharmacy chosen by the patient. The price of the product also depends on the amount of active substance and the number of tablets contained in the package.

Roswera prices without reimbursement:

1. dose of 5 mg 28 tablets – approx. 5 zlotys;
2. dose of 5 mg 90 tablets – approx. 13 zlotys;
3. dose of 10 mg 28 tablets – about PLN 9-10;
4. dose of 10 mg 90 tablets – approx. 25 zlotys;
5. dose of 15 mg 28 tablets – about PLN 13-14;
6. dose of 15 mg 56 tablets – approx. 23 zlotys;
7. dose of 15 mg 90 tablets – approx. 36 zlotys;
8. dose of 20 mg 28 tablets – approx. 18 zlotys;
9. dose of 20 mg 90 tablets – approx. 47 zlotys;
10. dose of 30 mg 28 tablets – approx. 26 zlotys;
11. dose of 30 mg 56 tablets – approx. 44 zlotys;
12. dose of 30 mg 90 tablets – approx. 68 zlotys; 
13. dose of 40 mg 28 tablets – approx. 34 zlotys;
14. dose of 40 mg 90 tablets – about PLN 90.

It is worth mentioning that the drug Roswera is issued free of charge for all indications specified in the decision on reimbursement, for eligible persons who are 75 years of age. In addition, the drug is dispensed at a payment of 30% up to the limits for all registered indications as at the date of the decision.

How much money does the average Pole spend on treatment? Check: The Pole is not expected to see a doctor

Before use, read the leaflet, which contains indications, contraindications, data on side effects and dosage as well as information on the use of the medicinal product, or consult your doctor or pharmacist, as each drug used improperly is a threat to your life or health. Do you need a medical consultation or an e-prescription? Go to halodoctor.pl, where you will get online help – quickly, safely and without leaving your home.