ROSUVACARD FILM-COATED TBL.20MG N30

ATC code: C10AA07 

Active substances: Rosuvastatinum

Vendor, principal: Zentiva A.s.. 
ROSUVACARD FILM-COATED TBL.20MG N30 is compensated medicine in Latvia. 

 Prescription drug (℞) 

ROSUVASTATIN ACTAVIS 20MG N30

Package leaflet: Information for the user

Rosuvastatin Actavis 10 mg film-coated tablets,

Rosuvastatin Actavis 20 mg film-coated tablets,

rosuvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-   Keep this leaflet. You may need to read it again.
-   If you have any further questions, ask your doctor or pharmacist.
-   This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.   What Rosuvastatin Actavis is and what it is used for
2.   What you need to know before you take Rosuvastatin Actavis
3.   How to take Rosuvastatin Actavis
4.   Possible side effects
5.   How to store Rosuvastatin Actavis
6.   Contents of the pack and other information

1. What Rosuvastatin Actavis is and what it is used for

Rosuvastatin Actavis belongs to a group of medicines called statins. You have been prescribed Rosuvastatin Actavis because:
-   You have a high cholesterol level. This means you are at risk from a heart attack or stroke. You have been advised to take a statin, because changing your diet and taking more exercise were not enough to correct your cholesterol levels. You should continue with your cholestrol-lowering diet and exercise while you are taking Rosuvastatin Actavis
Or
-   You have other factors that increase your risk of having a heart attack, stroke or related health problems. Heart attack, stroke and other problems can be caused by a disease called atherosclerosis. Atherosclerosis is due to a build up of fatty deposits in your arteris.

Why it is important to keep taking Rosuvastatin Actavis

Rosuvastatin Actavis 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 found in the blood - “bad” cholesterol (LDL-C) and “good” cholesterol (HDL-C).
-   Rosuvastatin Actavis can reduce the “bad” cholesterol and increase the “good” cholesterol.
-   It works by helping to block your body’s production of “bad” cholesterol. It also improves your body’s ability to remove it from your blood.
For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels causing them to narrow.
Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain leading to a heart attack or a stroke. If you correct your cholesterol levels, you can reduce your risk of having a heart attack or stroke.
You need to keep taking Rosuvastatin Actavis, even if it has got your cholesterol to the right level, because it prevents your cholesterol levels from creeping up again and causing build up of fatty deposits. However, you should stop if your doctor tells you to do so, or if you have become pregnant.

2. What you need to know before you take Rosuvastatin Actavis

Do not take Rosuvastatin Actavis:

•   If you are allergic to rosuvastatin 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 Rosuvastatin Actavis stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Actavis by using suitable contraception.
•   If you have liver disease.
•   If you have severe kidney problems.
•   If you have repeated or unexplained muscle aches or pains.
•   If you take a drug called ciclosporin (used for example, after organ transplants).
If any of the above applies to you (or you are in doubt), please go back and see your doctor.

In addition, do not take Rosuvastatin Actavis 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 any repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterollowering medicines.
•   If you regularly drink large amounts of alcohol.
•   If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
•   If you take other medicines called fibrates to lower your cholesterol.
If any of the above applies to you (or you are in doubt), please go back and see your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rosuvastatin Actavis
•   If you have problems with your kidneys.
•   If you have problems with your liver.
•   If you have had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterollowering medicines. Tell your doctor immediately if you have unexplained muscle aches or pains especially if you feel unwell or have a fever. Also tell your doctor or pharmacist if you have a muscle weakness that is constant.
•   If you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and /... / can lead to serious muscle problems (rhabdomyolysis).
•   If you regularly drink large amounts of alcohol.
•   If your thyroid gland is not working properly.
•   If you take other medicines called fibrates to lower your cholesterol. Please read this leaflet carefully, even if you have taken other medicines for high cholesterol before.
•   If you take medicines used to fight the HIV infection e.g. ritonavir with lopinavir and/or atazanavir, please see “Other medicines and Rosuvastatin Actavis”.
•   If the patient is under 10 years old : Rosuvastatin Actavis should not be given to children younger than 10 years.
•   If the patient is below 18 years of age: The Rosuvastatin Actavis 40 mg tablet is not suitable for use in children and adolescents below 18 years of age.
•   If you are over 70 (as your doctor needs to choose the right start dose of Rosuvastatin Actavis to suit you).
•   If you are of Asian origin - that is Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor needs to choose the right start dose of Rosuvastatin Actavis to suit you.
If any of the above applies to you (or if you are not sure):
•   Do not take Rosuvastatin Actavis 40 mg (the highest dose) and check with your doctor or pharmacist before you actually start taking any dose of Rosuvastatin Actavis.
In a small number of people, statins can affect the liver. This is identified by a simple test which looks for increased levels of liver enzymes in the blood. For this reason, your doctor will usually carry out this blood test (liver function test) before and during treatment with Rosuvastatin Actavis.
While you are on 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, are overweight and have high blood pressure.

Other medicines and Rosuvastatin Actavis

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:
•   ciclosporin (used for example, after organ transplants),
•   warfarin (or any other drug used for thinning the blood),
•   fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe),
•   indigestion remedies (used to neutralise acid in your stomach),
•   erythromycin (an antibiotic),
•   an oral contraceptive (the pill),
•   hormone replacement therapy,
•   ritonavir with lopinavir, darunavir, tipranavir or atazanavir (used to fight the HIV infection -please see “Warnings and precautions”),
•   dronedarone (an antiarrhythmic),
•   itraconazole (an antifungal drug).
•   If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Rosuvastatin Actavis. Taking Rosuvastatin Actavis with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
The effects of these medicines could be changed by Rosuvastatin Actavis or they could change the effect of Rosuvastatin Actavis.

Rosuvastatin Actavis with food and drink

You can take Rosuvastatin Actavis with or without food.

Pregnancy and breast-feeding

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

Driving and using machines

Most people can drive a car and operate machinery while using Rosuvastatin Actavis - it will not affect their ability. However, some people feel dizzy during treatment with Rosuvastatin Actavis. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatin Actavis contains lactose

If you have been told by your doctor that you have an intolerance to some sugars (lactose or milk sugar), contact your doctor before taking Rosuvastatin Actavis.
For a full list of ingredients please see “Contents of the pack and other information” below.

3. How to take Rosuvastatin Actavis

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Recommended dose in adultsRosuvastatin Actavis

If you are taking for high cholesterol:

Starting dose:
Your treatment with Rosuvastatin Actavis must start with the 5 mg or the 10 mg dose, even if you have taken a higher dose of a different statin before. The choice of your start dose will depend upon:
•   Your cholesterol level.
•   The level of risk you have of experiencing a heart attack or stroke.
•   Whether you have a factor that may make you more sensitive to possible side effects.
Please check with your doctor or pharmacist which start dose of Rosuvastatin Actavis will best suit you.
Your doctor may decide to give you the lowest dose (5 mg) if:
•   You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
•   You are over 70 years of age.
•   You have moderate kidney problems.
•   You are at risk of muscle aches and pains (myopathy).

Increasing the dose and maximum daily dose

Your doctor may decide to increase your dose. This is so that you are taking the amount of Rosuvastatin Actavis that is right for you. If you started with a 5 mg dose, your doctor may decide to double this to 10 mg then 20 mg and then 40 mg if necessary. If you started on 10 mg, your doctor may decide to double this to 20 mg and then 40 mg if necessary. There will be a gap of four weeks between every dose adjustment.
The maximum daily dose of Rosuvastatin Actavis is 40 mg. It is only for patients with high cholesterol levels and a high risk of heart attacks or stroke whose cholesterol levels are not lowered enough with 20 mg.

If you are taking Rosuvastatin Actavis to reduce your risk of having a heart attack, stroke or related health problems:

The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.

Usual dose in children and adolescents aged 10-17 years

The usual start dose is 5 mg. Your doctor may increase your dose to find the right amount of Rosuvastatin Actavis for you. The maximum daily dose of Rosuvastatin Actavis is 20 mg. Take your dose once a day. Rosuvastatin Actavis 40 mg tablet should not be used by children.

Taking your tablets

Swallow each tablet whole with a drink of water.
Take Rosuvastatin Actavis once daily. You can take it at any time of the day.
Try to take your tablet at the same time every day to help you to remember it.

Regular cholesterol checks

It is important to go back to your doctor for regular cholesterol checks, to make sure your cholesterol has reached and is staying at the correct level.
Your doctor may decide to increase your dose so that you are taking the amount of Rosuvastatin Actavis that is right for you.

If you take more Rosuvastatin Actavis than you should

Contact your doctor or nearest hospital for advice.
If you go into hospital or receive treatment for another condition, tell the medical staff that you’re taking Rosuvastatin Actavis.

If you forget to take Rosuvastatin Actavis

Do not worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Rosuvastatin Actavis

Talk to your doctor if you want to stop taking Rosuvastatin Actavis. Your cholesterol levels might increase again if you stop taking Rosuvastatin Actavis.
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.
It is important that you are aware of what these side effects may be. They are usually mild and disappear after a short time.

Stop taking Rosuvastatin Actavis and seek medical help immediately if you have any of the

following allergic reactions:
•   Difficulty in breathing, with or without swelling of the face, lips, tongue and/or throat
•   Swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing
•   Severe itching of the skin (with raised lumps).
Also, stop taking Rosuvastatin Actavis and talk to your doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than you might expect. As with other statins, a very small number of people have experienced unpleasant muscle effects and rarely these have gone on to become a potentially life threatening muscle damage known as rhabdomyolysis.

Common possible side effects (may affect up to 1 in 10 users):

•   Headache
•   Stomach pain
•   Constipation
•   Feeling sick
•   Muscle pain
•   Feeling weak
•   Dizziness
•   An increase in the amount of protein in the urine - this usually returns to normal on its own without having to stop taking your Rosuvastatin Actavis tablets (only Rosuvastatin Actavis 40 mg).
•   Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Uncommon possible side effects (may affect up to 1 in 100 users):

•   Rash, itching or other skin reactions
•   An increase in the amount of protein in the urine - this usually returns to normal on its own without having to stop taking your Rosuvastatin Actavis tablets (only Rosuvastatin Actavis 5 mg, 10 mg and 20 mg).

Rare possible side effects (may affect up to 1 in 1,000 users):

•   Severe allergic reaction - signs include swelling of the face, lips, tongue and/or throat, difficulty in swallowing and breathing, a severe itching of the skin (with raised lumps). If you think you are having an allergic reaction, then stop taking Rosuvastatin Actavis and seek medical help immediately.
•   Muscle damage -as a precaution, stop taking Rosuvastatin Actavis and talk to your doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than expected.
•   A severe stomach pain (inflamed pancreas).
•   Increase in liver enzymes in the blood.
•   Reduction in platelets in the blood.

Very rare possible side effects (may affect up to 1 in 10,000 users):

•   Jaundice (yellowing of the skin and eyes)
•   Hepatitis (an inflamed liver)
•   Traces of blood in your urine
•   Damage to the nerves of your legs and arms (such as numbness)
•   Joint pain
•   Memory loss
•   Gynecomastia (breast enlargement in men)

Side effects of unknown frequency (frequency cannot be estimated from the available data):

•   Diarrhoea (loose stools)
•   Stevens-Johnson syndrome (serious blistering condition of the skin, mouth, eyes and genitals)
•   Cough
•   Shortness of breath
•   Oedema (swelling)
•   Sleep disturbances, including insomnia and nightmares
•   Sexual difficulties
•   Depression
•   Breathing problems, including persistent cough and/or shortness of breath
•   Tendon injury
•   A disorder of the nerves which can cause weakness, tingling or numbness (peripheral neuropathy)
•   Muscle weakness that is constant (immune-mediated necrotizing myopathy)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rosuvastatin Actavis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box/blisters/label after “EXP”. The expiry date refers to the last day of that month.
Do not store above 30°C
The tablet container contains oxygen absorber - Do not swallow
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.

6. Contents of the pack and other information What Rosuvastatin Actavis contains

-   The active substance in Rosuvastatin Actavis is rosuvastatin. Rosuvastatin Actavis film-coated tablets contain rosuvastatin calcium equivalent to 10 mg or 20 mg of rosuvastatin.
-   The other ingredients are: tablet core: microcrystalline cellulose, crospovidone type A, calcium hydrogen phosphate dihydrate, lactose monohydrate, magnesium stearate, tablet coat: hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin. Rosuvastatin Actavis 10 mg and 20 mg film-coated tablets also contain carmine (E120).

What Rosuvastatin Actavis looks like and contents of the pack

Rosuvastatin Actavis comes in two tablet strengths:
Rosuvastatin Actavis 10 mg film-coated tablets are pink, round, 7 mm, biconvex, film-coated tablets with “ST 2” engraved on one side.
Rosuvastatin Actavis 20 mg film coated tablets are pink, round, 9 mm, biconvex, film-coated tablets with “ST 3” engraved on one side.
Rosuvastatin Actavis comes in blister packs containing 20, 28, 30, 56, 60, 90, 98 and 100 tablets and tablet containers with 100 tablets and oxygen absorber ( Do not swallow the oxygen absorber).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 Hafnarfjöröur Iceland
Manufacturer Actavis Ltd.,
BLB 016 Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
UAB Sicor Biotech Estonian Branch,
Hallivanamehe 4 11317 Tallinn Tel: +372 661 0801

This leaflet was last revised in April 2018.