Rosuvastatin 20 mg hard capsules

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

Why it is important to keep taking Rosuvastatin

Rosuvastatin 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 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 , 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.

Do not take Rosuvastatin

• 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 stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin 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 combination of sofosbuvir/velpatasvir/voxilaprevir (used for viral infection of the liver called hepatitis C)
• if you take a drug called ciclosporin (used, for example, after organ transplants)
• if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Rosuvastatin or other related medicines.

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 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.

• 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.
  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 “Other medicines and Rosuvastatin ”.
• 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 can lead to serious muscle problems (rhabdomyolysis), please see “Other medicines and Rosuvastatin”.
• if you are over 70 (as your doctor needs to choose the right start dose of Rosuvastatin 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 to suit you.

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

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

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.

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.

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

Children and adolescents

• if the patient is under 6 years old: Rosuvastatin should not be given to children younger than 6 years
• if the patient is below 18 years of age: The Rosuvastatin 40 mg capsule is not suitable for use in children and adolescents below 18 years of age.

Other medicines and Rosuvastatin

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, ticagrelor 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 Warnings and precautions)
• an oral contraceptive (the pill)
• regorafenib (used to treat cancer)
• darolutamide (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 Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

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

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

Rosuvastatin with food and drink

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

For a full list of ingredients, please see Contents of the pack and other information.

Rosuvastatin contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.

Usual doses in adults

If you are taking Rosuvastatin for high cholesterol

Starting dose

Your treatment with Rosuvastatin 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 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 start dose of Rosuvastatin 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 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 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 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 for you. The maximum daily dose of Rosuvastatin 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 capsule should not be used by children.

Taking your capsules

Swallow each capsule whole with a drink of water.

Take Rosuvastatin once daily. You can take it at any time of the day with or without food.

Try to take your capsule at the same time every day to help you to remember it.

Method of Administration

Taking Rosuvastatin with soft food (applesauce or chocolate/vanilla flavoured pudding).

For people who have difficulty in swallowing capsules, Rosuvastatin may be given with soft food (applesauce or chocolate/vanilla flavored pudding) as follows:

1. Carefully open the Rosuvastatin capsule.
2. Sprinkle the granules filled in the capsules on 1 teaspoonful of soft food (such as applesauce or chocolate/vanilla flavoured pudding).
3. Swallow the drug/food mixture within 60 minutes with drinking of at least 240 ml water (after ingestion of the sprinkled drug). Do not chew the granules.
4. Do not save the drug/food mixture for later use. Throw away any remaining drug/food mixture.

Giving Rosuvastatin through a nasogastric tube (NG tube) 8 French or larger, as prescribed by your doctor.

For people who have a nasogastric tube in place, Rosuvastatin may be given as follows:

1. The appropriate volume of syringe should be selected based on the dose of Rosuvastatin capsule to be administered.
2. The plunger should be removed from the syringe.
3. The Rosuvastatin capsule should be carefully opened and the granules should be emptied into the syringe barrel.
4. Water should be added to the granules in the syringe barrel. Do not use other liquids.
5. The plunger should be replaced and the syringe should be shaken vigorously for 15 seconds.
6. The tipped syringe should be attached to a nasogastric tube (≥8-French) depending on the patient age.
7. The mixture should be administered right away through the nasogastric tube into the stomach. The mixture should not be preserved for later use. Any remaining mixture should be thrown away.

After administering the mixture, the nasogastric tube should be flushed with additional water.

The recommended dose volume for mixing and flushing volume for each strength is as below:

1. For 5mg - Dosing volume to be used for mixing of granules is 5ml and Flushing volume to be used is 5ml

2. For 10mg - Dosing volume to be used for mixing of granules is 10ml and Flushing volume to be used is 5ml

3. For 20mg - Dosing volume to be used for mixing of granules is 20ml and Flushing volume to be used is 10 ml

4. For 40mg - Dosing volume to be used for mixing of granules is 40ml and Flushing volume to be used is 20 ml

The compatible NG tubes are PVC, PU and Silicone.

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 that is right for you.

If you take more Rosuvastatin 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 .

If you forget to take Rosuvastatin

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

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

Also, stop taking Rosuvastatin 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
• if you experience muscle rupture
• if you have lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).

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 capsules (only Rosuvastatin 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 hard capsules (only Rosuvastatin 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 and seek medical help immediately.
• muscle damage in adults – as a precaution, stop taking Rosuvastatin 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 disease syndrome (including rash, joint disorders and effects on blood cells).

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 and breast enlargement in men (gynaecomastia).

Side effects of unknown frequency may include

• 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 and muscle weakness that is constant.

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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

What Rosuvastatin contains

• The active substance in Rosuvastatin is rosuvastatin calcium.
  Rosuvastatin capsules contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
• The other ingredients are:
  Pellets: microcrystalline cellulose, crospovidone type B, mannitol, magnesium oxide, ferric oxide, sodium citrate, hypromellose, polyethylene glycol 4000, silica, colloidal hydrated
  Capsule shell
  5 mg (size 3): gelatin, sodium laurilsulfate, titanium dioxide (E171), iron oxide yellow, iron oxide red (E172)
  10 mg (size 3): gelatin, sodium laurilsulfate, titanium dioxide (E171), iron oxide black (E172)
  20 mg (size 1): gelatin, sodium laurilsulfate, titanium dioxide (E171), iron oxide red (E172)
  40 mg (size 0el): gelatin, sodium laurilsulfate, titanium dioxide (E171), FD & C Blue 1 (E133)
  Printing Ink
  Shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, purified water.

What Rosuvastatin looks like and contents of the pack

Rosuvastatin 5 mg hard capsules

Opaque hard gelatin capsule, size “3” with peach cap/off white body, imprinted with ”5” on body in black ink, filled with spherical and/or semi spherical yellow coloured pellets.

Rosuvastatin 10 mg hard capsules

Opaque hard gelatin capsule, size "3" cool grey cap/off white body, imprinted with ”10” on body in black ink, filled with spherical and/or semi spherical yellow coloured pellets.

Rosuvastatin 20 mg hard capsules

Opaque hard gelatin capsule, size "1" pink cap/off white body, imprinted with ”20” on body in black ink, filled with spherical and/or semi spherical yellow coloured pellets.

Rosuvastatin 40 mg hard capsules

Opaque hard gelatin capsule, size “0el” blue cap/off white body, imprinted with ”40” on body in black ink, filled with spherical and/or semi spherical yellow coloured pellets.

Rosuvastatin is available in blister packs containing 28, 30 and 90 hard capsules and in bottle packs containing 30 and 90 hard capsules.

Each bottle contains a silica gel desiccant canister which must be kept in the bottle to help protect your tablets and it should not be swallowed.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

This product is authorised in the Member States of the EEA under the following names

United Kingdom: Rosuvastatin