ROSUVASTATIN ARISTO 10 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

1. what rosuvastatin aristo is and what it is used for

Rosuvastatin Aristo belongs to a group of medicines called statins.

• You have been prescribed Rosuvastatin Aristo because You have a high cholesterol level. This means you are at risk from a heart attack or stroke. Rosuvastatin Aristo is used in adults, adolescents and children 6 years or older to treat high cholesterol.

You have been advised to take a statin, because changing your diet and doing more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking Rosuvastatin Aristo.

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 build-up of fatty deposits in your arteries.

Why it is important to keep taking Rosuvastatin Aristo Rosuvastatin Aristo 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 Aristo 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. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, a stroke or related health problems.

You need to keep taking Rosuvastatin Aristo , 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 you have become pregnant.

2. what you need to know before you take rosuvastatin aristo

Do not take Rosuvastatin Aristo

• If you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Aristo stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Aristo 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 have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Rosuvastatin Aristo or other medicines containing rosuvastatin.
• 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 Aristo 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 cholesterol-lowering 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 Aristo: 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 cholesterol-lowering 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 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 treat the HIV infection e.g. ritonavir with lopinavir and/or atazanavir, please see section 2 “Other medicines and Rosuvastatin Aristo”.
• 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 Rosuvastatin Aristo can lead to serious muscle problems (rhabdomyolysis), please see section 2 “Other medicines and Rosuvastatin Aristo”.
• If you are over 70 (as your doctor needs to choose the right start dose of Rosuvastatin Aristo to suit you)
• If you have severe respiratory failure.
• 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 Aristo to suit you.

If any of the above applies to you (or if you are not sure):

• Do not take Rosuvastatin Aristo 40 mg (the highest dose) and check with your doctor or pharmacist before you actually start taking any dose of this medicine.

Serious skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with rosuvastatin treatment.

Stop using Rosuvastatin Aristo and seek medical attention immediately if you notice any of the symptoms described in section 4.

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 Aristo.

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.

Children and adolescents

If the patient is under 6 years old: Rosuvastatin Aristo should not be given to children younger than 6 years.

If the patient is below 18 years of age: The Rosuvastatin Aristo 40 mg tablet is not suitable for use in children and adolescents below 18 years of age.

Other medicines and Rosuvastatin Aristo 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 clopidogrel (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), fusidic acid (an antibiotic -please see below and section 2 “Warnings and precautions”) an oral contraceptive (the pill) regorafenib (used to treat cancer) hormone replacement therapy any of the following drugs used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (please see section 2 “Warnings and precautions”): ritonavir, lopinavir, atazanavir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medicines could be changed by Rosuvastatin Aristo or they could change the effects of Rosuvastatin Aristo.

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 Aristo. Taking Rosuvastatin Aristo with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4 “Possible side effects”.

Pregnancy and breast-feeding Do not take Rosuvastatin Aristo if you are pregnant or breastfeeding. If you become pregnant while taking this medicine, stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Aristo 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 taking this medicine – it will not affect their ability. However, some people feel dizzy during treatment with Rosuvastatin Aristo. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatin Aristo contains lactose

Each 5 mg film-coated tablet contains 96,8 mg lactose (as lactose monohydrate). Each 10 mg film-coated tablet contains 91,9 mg lactose (as lactose monohydrate).

Each 20 mg film-coated tablet contains 183,9 mg lactose (as lactose monohydrate).

Each 40 mg film-coated tablet contains 166,2 mg lactose (as lactose monohydrate). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. how to take

Rosuvastatin Aristo

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

Usual doses in adults

If you are taking Rosuvastatin Aristo for high cholesterol

Starting dose

• Your treatment with Rosuvastatin Aristo 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 starting dose will depend upon: Your cholesterol levels.
• 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 starting dose of Rosuvastatin Aristo 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 Aristo 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 Aristo 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 Aristo 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.

Use in children and adolescents aged 6 to 17 years

The dose range in children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual starting dose is 5 mg per day and your doctor may gradually increase your dose to find the right amount of Rosuvastatin Aristo for you. The maximum daily dose is 10 or 20 mg for children and adolescents aged 6 to 17 years depending on your underlying condition being treated. Take your dose once a day. Rosuvastatin Aristo 40 mg tablets should not be used by children and adolescents.

Taking your tablets

Swallow each tablet whole with a drink of water.

Take Rosuvastatin Aristo once daily. You can take it at any time of the day with or without food. 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 Aristo that is right for you.

If you take more Rosuvastatin Aristo 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 are taking Rosuvastatin Aristo.

If you forget to take Rosuvastatin Aristo

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

If you stop taking Rosuvastatin Aristo

Talk to your doctor if you want to stop taking Rosuvastatin Aristo. Your cholesterol levels might increase again if you stop taking the tablets.

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 Aristo 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).
• If you notice any of the following symptoms:
• Reddish non-elevated, targetlike or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can 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).
• If you have any unusual muscle aches, muscle weakness, tenderness, pain or red-brown discolouration of urine and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be lifethreatening and lead to kidney problems.Muscle symptoms are more common in children and adolescents than in adults. 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.
• If you experience muscle rupture.
• If you have lupus-like syndrome (including rash, joint disorders and effects on blood cells).

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

• 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 tablets (only Rosuvastatin Aristo 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 side effects (may affect up to 1 in 100 people):

• 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 tablets (only Rosuvastatin Aristo 5 mg, 10 mg and 20 mg).

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

• 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 Aristo and seek medical help immediately.
• Muscle damage in adults – as a precaution, stop taking Rosuvastatin Aristo 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.
• Bleeding or bruising more easily than normal due to low level of blood platelets.
• Lupus-like syndrome (including rash, joint disorders and effects on blood cells)

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

• 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
• Breast enlargement in men (gynaecomastia)

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

• Diarrhoea (loose stools)
• 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 or fever
• Tendon injury
• Muscle weakness that is constant
• Peripheral neuropathy

5. how to storerosuvastatin aristokeep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package in order to protect from light.

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 Aristo contains

The active substance is rosuvastatin.

Each film-coated tablet contains

5 mg, 10 mg, 20 mg or 40 mg rosuvastatin as rosuvastatin calcium, respectively.

The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone Type A, lactose monohydrate and magnesium stearate.

The tablet coating contains:

5 mg tablets:

Opadry II Yellow 33K12488 containing hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin and iron oxide yellow (E172).

10 mg tablets:

Opadry II Pink 33K94423 containing hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin and iron oxide red (E172).

20 mg tablets:

Opadry II Pink 33K94423 containing hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin and iron oxide red (E172).

40 mg tablets:

Opadry II Pink 33K94424 containing hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin and iron oxide red (E172).

What Rosuvastatin Aristo looks like and contents of the pack

5 mg tablets:

Yellow, round, biconvex, coated tablet, embossed ‘ROS’ over ‘5’ on one side and nothing on the other, with diameter 7 mm.

10 mg tablets:

Pink, round, biconvex, coated tablet, embossed ‘ROS’ over ‘10’ on one side and nothing on the other, with diameter 7 mm.

20 mg tablets:

Pink, round, biconvex, coated tablet, embossed ‘ROS’ over ‘20’ on one side and nothing on the other, with diameter 9 mm.

40 mg tablets:

Pink, oval, biconvex, coated tablet, embossed ‘ROS’ on one side and ‘40’ on the other side, with dimensions 6.8 × 11.4 mm.

Tablets are packed in OPA-Al-PVC/ Al blisters.

Pack sizes containing 10, 28, 30, 90 and 100 tablets in blisters are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Aristo Pharma GmbH

Wallenroder StraBe 8–10 13435 Berlin

Germany

ArIsto

This leaflet was last revised in 06/2021.

GI572000–08/UK/0621

Code 479

50001488/4