Rozetin 10 mg/10 mg. 30 tablets

What is Rosetin and what it is used for

Rosetin contains two different active substances in 1 tablet. One of the active substances is rosuvastatin, which belongs to the group of so-called statins, the other active substance is ezetimibe.

Rosetin lowers the levels of total cholesterol, "bad" cholesterol (LDL-cholesterol) and fatty substances called triglycerides in the blood. In addition, Rosetin increases the levels of "good" cholesterol (HDL-cholesterol).

Rosetin works to lower cholesterol in two ways: it reduces cholesterol absorbed in the digestive tract as well as cholesterol made by the body itself.

Cholesterol is one of several fatty substances found in the blood. Your total cholesterol consists mainly of LDL- and HDL-cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can build up on artery walls, forming plaque. Over time, this plaque build-up can cause arteries to narrow, slowing or blocking blood flow to vital organs such as the heart and brain.This blockage of blood flow can lead to a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent bad cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another form of fat in the blood that can increase the risk of heart disease.

This medicinal product is used in patients who cannot control their cholesterol levels through diet alone. You should always be on a cholesterol-lowering diet while taking this medicine.

Rosetin is used in addition to your cholesterol-lowering diet if you have:

Elevated blood cholesterol (primary hypercholesterolaemia [heterozygous familial and non-familial])

for which you used a statin and ezetimibe as separate tablets.

due to a hereditary disease (homozygous familial hypercholesterolemia) that increases the level of cholesterol in the blood. You may also receive other treatments.

Rosetin does not help you lose weight.

For most people, high cholesterol doesn't affect how they feel because it doesn't cause any symptoms. However, if left untreated, fatty deposits can build up on the walls of your blood vessels, causing them to narrow.

Sometimes these narrowed blood vessels can become blocked, which can cut off blood supply to the heart or brain, leading to a heart attack or stroke. If you correct your cholesterol levels, you can reduce your risk of heart attack, stroke or related health problems.

You should continue to take Rosetin even if it lowers your cholesterol to the correct level, because it prevents cholesterol levels from rising again, leading to the formation of fat deposits.

However, you should stop taking Rosetin if your doctor tells you to, or if you become pregnant.

2. What you need to know before taking Rosetin

Do not take Rosetin if:

you are allergic to ezetimibe, rosuvastatin or any of the other ingredients of this medicine (listed in section 6);

you have liver disease;

you are pregnant or breastfeeding. If you become pregnant while taking Rosetin, stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosetin by using appropriate contraception;

you have severe kidney problems;

you have recurrent or unexplained muscle soreness or pain (myopathy);

you are taking the combination medicine sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral infection of the liver called hepatitis C).

you are taking a medicine called cyclosporine (used, for example, after an organ transplant).

If any of the circumstances listed above apply (or you suspect that they apply) to you, please go back and consult your doctor again.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rosetin if:

you have kidney problems

you consume large amounts of alcohol or have ever had liver disease. Rosetin may not be right for you.

you have had recurring or unexplained muscle soreness or pain, a personal or family history of muscle problems, or a previous history of muscle problems while taking other cholesterol-lowering medicines. Tell your doctor right away if you have unexplained muscle soreness or pain, especially if you feel sick or have a fever. Also tell your doctor or pharmacist if you have persistent muscle weakness.

your thyroid gland is not functioning properly.

you have severe respiratory failure.

you are taking medicines used to fight HIV infection, for example ritonavir with lopinavir and/or atazanavir (please see 'Other medicines and Rosetin').

you are over 70 years old (as your doctor must choose

Rosetin and alcohol

Do not take Rosetin 40 mg/10 mg tablets (highest dose) if you regularly consume large amounts of alcohol.

Pregnancy and breastfeeding

Do not take Rosetin if you are pregnant, breast-feeding or think you may be pregnant. If you become pregnant while taking Rosetin, stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosetin by using appropriate contraception.

Do not take Rosetin while breastfeeding, as it is not known whether the drug passes into breast milk.

Driving and using machines

Rosetin is not expected to affect your ability to drive or use machines. However, it should be noted that some people may experience dizziness after taking Rosetin. If you feel dizzy, talk to your doctor before driving or using machines.

Rosetin contains lactose monohydrate (a type of sugar) and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it can be said to be practically sodium-free.

3. How to take Rosetin

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Before starting treatment with Rosetin, you must be on a cholesterol-lowering diet

You must adhere to a cholesterol-lowering diet while taking Rosetin.

Your doctor will determine the appropriate dosage of the tablet for you, depending on your current treatment and your personal risk status.

The recommended dose is one Rosetin tablet once a day.

Rosetin is not suitable for starting treatment. The initiation of treatment or adjustment of the dose, if necessary, should be carried out only by applying the active substances separately as monocomponents, and after determining the appropriate doses, it is possible to switch to Rosetin in the appropriate dosage.

The maximum daily dose of rosuvastatin is 40 mg. It is only intended for patients with high cholesterol levels and a high risk of heart attack or stroke, whose cholesterol levels are not sufficiently reduced by the daily dose of 20 mg.

Try to take the tablet at the same time each day so that you remember to take it. You can take it with or without food. Swallow each tablet whole with water.

If your doctor has prescribed Rosetin together with another cholesterol-lowering medicine containing the active ingredient cholestyramine or another medicine containing a bile acid sequestrant, you should take Rosetin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Regular cholesterol checks

It's important to see your doctor for regular cholesterol checks to make sure your cholesterol has reached and stays at the right level. Your doctor may decide to increase your dose so that you are taking the right amount of medicine for you.

If you have taken more than the required dose of Rosetin

Contact your doctor or the emergency department of the nearest hospital as you may need medical attention

If you forget to take Rosetin

Don't worry, just take your next scheduled dose at the right time. Do not take a double dose to make up for a missed dose.

If you have stopped taking Rosetin

Talk to your doctor as your cholesterol levels may rise again if you stop taking Rosetin.

If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Rosetin and seek medical help immediately if you experience any of the following side effects:

Difficulty breathing with or without swelling of the face, lips, tongue and/or throat; the face, lips, tongue and/or throat, which may cause difficulty swallowing; severe itching of the skin (with bumps). These can be symptoms of a severe allergic reaction.

Any unexplained muscle pain, soreness, or weakness. This is because, in rare cases, muscle problems, including muscle breakdown leading to kidney damage, can be serious and become a potentially life-threatening condition.

lupus-like syndrome (including rash, joint disorders and effects on blood cells).

Muscle tearing.

Reddish, unraised, target-like or round spots on the body, often centrally located blisters, peeling skin, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).

An extensive rash, high body temperature and enlarged lymph nodes

5. How to store Rosetin

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date corresponds to the last day of the specified month.

Store in the original package to protect from moisture and light. This medicinal product does not require special temperature storage conditions.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Rosetin contains

The active substances are: rosuvastatin and ezetimibe. Each tablet contains 10 mg or 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.

The other ingredients are: microcrystalline cellulose (E460), silicon dioxide, colloidal anhydrous (E551), magnesium stearate (E572), povidone (E 1201), croscarmellose sodium (E468), sodium lauryl sulfate (E514), lactose monohydrate, hypromellose,

Opadray Beige (10 mg/10 mg): hypromellose (E464), titanium dioxide (E171), macrogol 4000 (E 1521), iron oxide, yellow (E172), talc (E553b),

Vivacoat Yellow (20 mg/10 mg): hypromellose (E464); titanium dioxide (E171); talc (E553b), macrogol 4000 (E 1521), iron oxide, yellow (E172).

What Rosetin looks like and what it contains in the package

Rosetin 10 mg/10 mg: Beige, round, biconvex, film-coated tablets approximately 10 mm in diameter and debossed with "EL4" on one side.

Rosetin 20 mg/10 mg: Yellow, round, biconvex, film-coated tablets approximately 10 mm in diameter and debossed with "EL3" on one side.

Rosetin 10 mg/10 mg film-coated tablets

Packs of: 10, 15, 30, 60 and 100 film-coated tablets.

Rosetin 20 mg /10 mg

Packs of: 30, 60 and 100 film-coated tablets.

Not all types of packaging can be put on sale.