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

Patient leaflet - ROSUVASTATIN 10 MG FILM-COATED TABLETS

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

Do not take Rosuvastatin tablets:

– If you have ever had an allergic reaction to rosuvastatin or to any of its ingredients.

– If you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatin tablets stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin tablets 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 tablets 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 tablets:

- 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 for example ritonavir with lopinavir and/or atazanavir, please see Other medicines and Rosuvastatin tablets.

- 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 tablets can lead to serious muscle problems (rhabdomyolysis). Please see Other medicines and Rosuvastatin tablets.
- If you are over 70 (as your doctor needs to choose the right start dose of Rosuvastatin tablets 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 tablets to suit you.

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

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

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 tablets.

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 tablets should not be given to children younger than 6 years.
- If the patient is below 18 years of age: The Rosuvastatin 40 mg tablets are not suitable for use in children and adolescents below 18 years of age.

Other medicines and Rosuvastatin tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

– regorafenib (used to treat cancer)

of the

used to treat viral infections

including HIV or hepatitis C infection, alone or in combination (please see Warnings and precautions): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

Tell your doctor if you are taking any of the following: ciclosporin (used for example, after organ transplants), warfarin or clopidogrel (or any other medicine 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 warnings and precautions), an oral contraceptive (the pill), hormone replacement therapy or anti-viral medicines such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat infections, including the HIV or hepatitis C infection – please see Warnings and precautions). The effects of these medicines could be changed by Rosuvastatin tablets or they could change the effects of Rosuvastatin tablets.

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 tablets. Taking Rosuvastatin tablets with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

Pregnancy and breast-feeding

Do not take Rosuvastatin tablets if you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatin tablets stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin tablets by using suitable contraception.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Rosuvastatin tablets contain 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 tablets.

For a full list of ingredients, please see Section 6, '

Contents of the pack and other information.

3. How to take Rosuvastatin tablets

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

Usual doses in adults

If you are taking Rosuvastatin tablets for high cholesterol:

Starting dose

Your treatment with Rosuvastatin tablets 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 starting dose of Rosuvastatin tablets 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 tablets 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 tablets 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 tablets 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 6–17 years

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

Taking your tablets

Swallow each tablet whole with a drink of water.

Take Rosuvastatin tablets 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.

co Regular cholesterol checks

B It is important to go back to your doctor for regular

3 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 tablets that is right for you.

If you take more Rosuvastatin tablets than you should

Contact your doctor or nearest hospital for advice.

f you go into hospital or receive treatment for another ondition, tell the medical staff that you're taking osuvastatin tablets.

590 mm

If you forget to take Rosuvastatin tablets

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 tablets

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

^^“If you have any further questions on the use of this ^^ ^medicine, ask your doctor or pharmacist.

=M=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 tablets 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 tablets 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. 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.

Common possible side effects (these may affect between 1 in 10 and 1 in 100 patients):

– 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 tablets (only Rosuvastatin tablets 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 (these may affect between 1 in 100 and 1 in 1,000 patients):

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

Rare possible side effects (these may affect between 1 in 1,000 and 1 in 10,000 patients):

– 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 tablets and seek medical help immediately
– Muscle damage in adults – as a precaution, stop taking Rosuvastatin tablets and talk to your doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than expected

t___________________________________________

– 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.

Very rare possible side effects (these may affect less

than 1 in 10,000 patients):

– 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 unknown frequency may include:

– 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 or fever
– Tendon injury
– Muscle weakness that is constant.

Reporting of side effects:

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

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5. how to store rosuvastatin tablets

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.

For OPA/Al/PVC-Al blisters: Do not store above 30°C.

For HDPE bottles: This medicinal product does not require any special storage conditions.

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 tablets contain:

– The active substance is rosuvastatin.

Rosuvastatin film-coated tablets contain rosuvastatin

calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.

– The other ingredients are:

What Rosuvastatin tablets look like and contents of the pack

Rosuvastatin tablets come in following pack sizes.

Blisters:

For 5 mg, 10 mg and 20 mg: OPA/Al/PVC-Al blisters in pack-sizes of 14, 28, 30, 90 or 100 film-coated tablets.

For 40 mg: OPA/Al/PVC-Al blisters in pack-sizes of 7, 14, 28, 30, 90 or 100 film-coated tablets.

Bottles:

For 5 mg, 10 mg, 20 mg and 40 mg: White opaque HDPE container having white opaque PP closure containing a silica gel desiccant in pack size of 30 or 90 film-coated tablets.

Not all pack sizes may be marketed.

Rosuvastatin tablets come in four tablet strengths:

Rosuvastatin 5 mg film-coated tablets are yellow, round, biconvex, coated tablets of approximately 7.1 mm in diameter, debossed with ‚5‘ on one side and ‚B‘ on other side.

Rosuvastatin 10 mg film-coated tablets are pink, round, biconvex, coated tablets of approximately 7.1 mm in diameter, debossed with ‚10‘ on one side and ‚B‘ on other side.

Rosuvastatin 20 mg film-coated tablets are pink, round, biconvex, coated tablets of approximately 9.1 mm in diameter, debossed with ‚20‘ on one side and ‚B‘ on other side.

Rosuvastatin 40 mg film-coated tablets are pink, oval, biconvex, coated tablets of approximately 11.6 mm in length and 7.1 mm in width, debossed with ‚40‘ on one side and ‚B‘ on other side.

Marketing Authorisation Holder

Biocon Pharma UK Limited

16, Great Queen Street, Covent Garden, London, WC2B 5AH, United Kingdom

Manufacturer