Rosistat 10mg. 30 tablets

1. What Rosistat is and what it is used for
Rosistat belongs to a group of medicines called statins. Rosistat has been prescribed to you because:

You have high cholesterol levels. This means that you are at risk of having a heart attack or stroke.

You have been told to take a statin because changing your diet and getting more exercise have not been enough to control your cholesterol levels. You should continue your diet and exercise while you are taking Rosistat. Rosistat is used in adults, adolescents and children aged 6 years and over to treat high cholesterol.

There are other factors that increase your risk of having a heart attack, stroke or related health problems.

Heart attacks, strokes and other health problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by a build-up of fatty deposits in your arteries.

Why is it important to continue taking Rosistat?
Rosistat is used to correct the levels of fatty substances in the blood called lipids, the most common of which is cholesterol.
There are different types of cholesterol in the blood - "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

Rosistat can reduce "bad" cholesterol and increase "good" cholesterol. It works by helping to block the "bad" cholesterol that your body makes. It also improves the body's ability to remove it from the blood.
For most people, high cholesterol levels do not change the way they feel because they do not cause any symptoms. However, if they are not treated, fatty deposits thicken the walls of the blood vessels and cause them to narrow.

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

You should continue taking Rosistat even if your cholesterol levels have returned to normal, as this prevents a new increase in cholesterol, which leads to the build-up of fatty deposits. However, you should stop taking it if your doctor tells you to, or if you become pregnant.

2. What you need to know before you take Rosistat
Do not take Rosistat:
if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or breast-feeding. If you become pregnant while taking Rosistat, stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosistat and use an appropriate method of contraception;
if you have liver disease;
if you have severe kidney problems;
if you have had or have recurring and unexplained muscle or joint pain; if you are taking a medicine called ciclosporin (used e.g. after an organ transplant;
if you are taking the combination of medicines sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral infection of the liver called hepatitis C); if you have ever had a severe skin rash or peeling skin, blistering and/or mouth ulcers after taking Rosuvastatin or other medicines of this class called statins. If you think any of the above applies to you (or are in doubt), please tell your doctor.
In addition, do not take Rosuvastatin 40 mg (the highest dose):
if you have moderate kidney problems (if in doubt, please ask your doctor);
if your thyroid gland is not working properly;
if you have had recurrent and unexplained muscle pain, a personal or family history of muscle problems or a previous history of muscle problems when taking other cholesterol-lowering medicines;
if you regularly drink large amounts of alcohol;
if you are of Asian origin (Japanese, Chinese, Filipino, Korean or Indian);
if you are taking other medicines called fibrates to lower cholesterol.
If you think any of the above applies to you (or are not sure), please tell your doctor.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Rosistat: if you have kidney problems; if you have liver problems;

if you have had recurrent and unexplained muscle 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 straight away if you have unexplained muscle or joint pain and especially if you feel unwell or have a fever. Also tell your doctor or pharmacist if you have muscle weakness that is persistent. Additional tests and medicines may be needed to diagnose and treat this;
if you regularly drink large amounts of alcohol; if your thyroid gland is not working properly;
if you are taking other medicines called fibrates,
to lower cholesterol. Please read this leaflet carefully, even if you have already taken other medicines to lower cholesterol;
if you are taking medicines used to fight infection caused by human immunodeficiency virus (HIV), such as ritonavir with lopinavir and/or atazanavir, please see “Other medicines and Rosistat”;
if the patient is under 6 years of age: Rosistat should not be given to children under 6 years of age;
if the patient is under 18 years of age: the 40 mg dose is not suitable for use in children and adolescents under 18 years of age;
if you are over 70 years of age (your doctor should choose a starting dose that is right for you);
if you have severe respiratory failure;
if you are of Asian origin (Japanese, Chinese, Filipino, Korean and Indian). Your doctor should choose a starting dose that is right for you; if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine to treat bacterial infections) by mouth or injection. The combination of fusidic acid and Rosistat can lead to serious muscle problems (rhabdomyolysis). Please see “Other medicines and Rosistat”;
If you have or have ever had myasthenia gravis (a disease that causes general muscle weakness, sometimes including the muscles involved in breathing) or ocular myasthenia gravis (a disease that causes weakness of the eye muscle), as statins can sometimes make the condition worse or cause myasthenia gravis (see section 4).

If you think any of the above applies to you (or are in doubt), do not take Rosistat 40 mg (the highest dose) and talk to your doctor or pharmacist before taking any dose of Rosistat.

In a small number of people, statins can affect the liver. This is checked by a simple test to see if the levels of liver enzymes in the blood are increased. For this reason, your doctor will order a blood test (liver function test) before and during treatment with Rosistat.

While you are taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, if you are overweight, and if you have high blood pressure.

Serious skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRHSS) have been reported with Rosistat treatment. Stop taking Rosistat and seek medical help immediately if you notice any of the symptoms described in section 4.

Other medicines and Rosistat
You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking any of the following medicines:
ciclosporin (used, for example, after an organ transplant);
warfarin; clopidogrel, ticagrelor (or other blood thinners); fibrates (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medicines (such as ezetimibe); indigestion remedies - antacids (used to neutralise stomach acid); erythromycin (an antibiotic); fusidic acid (an antibiotic - see “Warnings and precautions”); medicines taken by mouth to prevent unwanted pregnancy; regorafenib, darolutamide or capmatinib (used to treat cancer); hormone replacement therapy; fostamatinib (used to treat low platelet counts); febuxostat (used to treat and prevent high levels of uric acid in the blood); teriflunomide (used to treat multiple sclerosis); any the following medicines used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (please see “Warnings and precautions”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
The effect of these medicines may be affected by Rosuvastatin or vice versa.

If you need to take oral fusidic acid to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when it is safe to continue taking Rosuvastatin. Taking Rosuvastatin and fusidic acid together may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.
Rosistat with food, drink and alcohol
You can take Rosistat with or without food.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Rosistat if you are pregnant or breast-feeding. If you become pregnant while taking Rosistat, stop taking it immediately and tell your doctor. Women should avoid becoming pregnant by using appropriate contraception while taking Rosistat. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Most people can drive and use machines while taking Rosistat. It does not affect their ability. However, some people may feel dizzy when taking Rosistat. If you feel dizzy, talk to your doctor before driving or using machines.

Rosistat contains lactose

If your doctor has told you that you have an intolerance to or cannot digest some sugars (lactose or milk sugar), talk to him/her before taking this medicine.

3. How to take Rosistat

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

Usual adult doses

If you are taking Rosistat for high cholesterol

Starting dose
Your treatment with Rosistat should start with a dose of 5 mg or 10 mg, even if you have previously taken a high dose of another medicine. The choice of your starting dose will depend on:

your cholesterol level;

your risk of heart attack or stroke;
any factors that make you more sensitive to possible side effects. Please ask your doctor or pharmacist which starting dose of Rosistat would be most suitable for you.

Your doctor will prescribe the lowest dose (5 mg) if:
You are of Asian origin (Japanese, Chinese, Filipino, Korean and Indian);
You are over 70 years of age;
You have moderate kidney problems;
You are at risk of muscle disease (myopathy).
Increasing the dose and maximum daily dose
Your doctor may decide to increase your dose. This is to ensure that you are taking the dose that is right for you. If you start with a dose of 5 mg, your doctor may decide to double it to 10 mg, then to 20 mg and, if necessary, to 40 mg. If you start with 10 mg, your doctor may decide to double it to 20 mg and, if necessary, to 40 mg. There will be a period of 4 weeks between each dose adjustment.

The maximum daily dose of Rosistat is 40 mg. It is only for patients with high cholesterol levels and a high risk of heart attack or stroke whose cholesterol levels are not lowered enough with a dose of 20 mg.

If you are taking Rosistat to reduce the risk of heart attack, stroke or other related health problems

The recommended dose is 20 mg a day. Your doctor may decide to use a lower dose if any of the factors mentioned above apply to you.

Use in children and adolescents aged 6-17 years
The recommended dose is 5 mg. Your doctor may increase your dose to find the right amount of Rosistat for you. The maximum daily dose of Rosistat is 10 or 20 mg for children aged 6 to 17 years depending on the underlying condition being treated. Take your dose once a day. The 40 mg dose should not be used in children.

Take Rosistat once a day. You can take the tablet at any time of the day. Try to take your tablet at the same time each day. This will help you remember to take it.

Swallow the tablets whole with water.

Regular cholesterol monitoring

It is important to see your doctor for regular cholesterol monitoring to make sure that your cholesterol has reached and remains at the right level.

Your doctor may decide to increase your dose. This is to ensure that you are taking the dose that is right for you.

If you take more Rosistat than you should

If you take more Rosistat than you should, contact your doctor or the nearest hospital immediately for advice.

If you go into hospital or are given treatment for other reasons, tell the medical staff that you are taking Rosistat.

If you forget to take Rosistat
Don’t worry, just take your next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Rosistat
Talk to your doctor if you want to stop taking Rosistat. Your cholesterol levels may rise again if you stop taking Rosistat.

If you have any further questions on 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 Rosistat and seek medical help immediately if you have any of the following allergic reactions:
difficulty breathing, with or without swelling of the
face, lips, tongue and/or throat;
swelling of the face, lips, tongue and/or throat, which may make it difficult to swallow;
severe itching of the skin (with rash);
red, flat, target-like or circular spots on the body, often with central 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);
widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Also stop taking Rosistat and contact your doctor immediately if you have unusual muscle pain that lasts longer than you would expect. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people experience unpleasant effects on the muscles, which rarely cause abnormal muscle breakdown, which can lead to kidney problems (rhabdomyolysis).

Stop taking Rosistat and contact your doctor immediately if you experience any of the following symptoms:
lupus-like syndrome (including rash, inflammation of the joints and changes in blood cells);
muscle fiber tearing.
Other possible side effects
The frequency of side effects is defined using the following convention:
very common (may affect more than 1 in 10 people);
common (may affect up to 1 in 10 people);
uncommon (may affect up to 1 in 100 people);
rare (may affect up to 1 in 1,000 people);
very rare (may affect up to 1 in 10,000 people);
not known (frequency cannot be estimated from the available data).
Common
headache;
stomach pain;
constipation;
feeling sick;
muscle pain;
feeling weak;
dizziness;
increased amount of protein in the urine - usually normalises on its own without the need to stop taking Rosistat (only for Rosistat 40 mg dose)
diabetes, especially in people with blood sugar and blood fat levels close to the upper limit of normal, as well as in people who are overweight and/or have high blood pressure. Your doctor will monitor you while you are taking this medicine.
Uncommon
rash, itching or other skin reactions;
increased amount of protein in the urine - usually normalizes on its own without the need to stop taking Rosistat (only for Rosistat doses 5 mg, 10 mg and 20 mg)
Rare
severe allergic reaction - includes swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with rash). If you think you are having an allergic reaction, stop taking Rosistat and seek medical help immediately;
muscle damage in adults - as a precaution, stop taking Rosistat and contact your doctor immediately if you have unusual muscle pain that lasts longer than expected;
acute stomach pain (inflamed pancreas);
increased blood test values ​​that show changes in how the liver is working;
reduction in the number of platelets, which increases the risk of bleeding or bruising;
lupus-like disease (including rash, joint disorders and effects on blood cells).
Very rare
jaundice (yellowing of the skin and eyes); hepatitis (inflamed liver);
traces of blood in the urine;
nerve damage in the arms and legs (such as numbness);
joint pain;
memory loss;
breast enlargement in men (gynaecomastia).
Not known:
diarrhoea;
cough;
shortness of breath;
swelling;
sleep disorders, including insomnia and nightmares;
sexual difficulties;
depression;
breathing problems, including persistent cough and/or shortness of breath or fever;
tendon injury;
permanent muscle weakness;
myasthenia gravis (a disease causing general muscle weakness, in some cases
also involving the muscles involved in breathing);
myasthenia gravis (a disease causing weakness of the eye muscle).
Talk to your doctor if you experience weakness in your arms or legs that gets worse after periods of activity, have double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
5. How to store Rosuvastatin
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Does not require any special storage conditions.

6. Contents of the pack and other information
What Rosuvastatin contains
Active substance: rosuvastatin 10 mg or 20 mg (as rosuvastatin calcium).
Other ingredients: lactose monohydrate (DCL-11), microcrystalline cellulose (PH-112), crospovidone (type B), magnesium stearate, lactose monohydrate, hypromellose 2910 (6 cps), triacetin, titanium dioxide (E171), red iron oxide (E172).
What Rosistat looks like and contents of the pack
Rosistat 10 mg film-coated tablets
Light pink, round, biconvex film-coated tablets, with a score line on both sides, separating “11” and “36” on one side and “10” on the other side.

Rosistat 20 mg film-coated tablets
Light pink, round, biconvex film-coated tablets, with a score line on both sides, separating “11” and “37” on one side and “20” on the other side.

Rosistat 10 mg or 20 mg film-coated tablets are available in blister packs of 28 (2 x 14) or 30 (3 x 10) tablets.

 

Write a review

Your Name:

Your Review: Note: HTML is not translated!

Rating: Bad           Good

Enter the code in the box below: