Patient Leaflet Updated 07-Feb-2022 | Ranbaxy (UK) Limited a Sun Pharmaceutical Company
Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg hard capsules
Package leaflet: Information for the patient
Rosuvastatin 5 mg hard capsules
Rosuvastatin 10 mg hard capsules
Rosuvastatin 20 mg hard capsules
Rosuvastatin 40 mg hard capsules
rosuvastatin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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
1. What Rosuvastatin is and what it is used for
Rosuvastatin belongs to a group of medicines called statins.
You have been prescribed Rosuvastatin because
or
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).
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.
2. What you need to know before you take Rosuvastatin
Do not take Rosuvastatin
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 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 any of the above applies to you (or if you are not sure):
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
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
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’.
3. How to take Rosuvastatin
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 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:
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:
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.
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 and seek medical help immediately if you have any of the following allergic reaction
Also, stop taking Rosuvastatin and talk to your doctor immediately
Common possible side effects (these may affect between 1 in 10 and 1 in 100 patients)
Uncommon possible side effects (these may affect between 1 in 100 and 1 in 1,000 patients)
Rare possible side effects (these may affect between 1 in 1,000 and 1 in 10,000 patients)
Very rare possible side effects (these may affect less than 1 in 10,000 patients)
Side effects of unknown frequency may include
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.
5. How to store Rosuvastatin
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 label and carton after EXP. The expiry date refers to the last day of the month.
Blisters: Store below 30°C. Store in original pack in order to protect from light and moisture.
Containers: Store below 30°C. Store in original pack in order to protect from light and moisture.
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 contains
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
This leaflet was last revised in 10/2021
V002
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+44 (0) 208 848 8688
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