Rosuvastatin 40mg Film-Coated Tablets
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S. Gonzalez, s. I.
drtes giaficds
Mercurio 13 - Pol. Ind. "Coherman" 28970 Humanes (Madrid) *T. 91 697 65 02 - F. 91 697 18 03 artesgraficas@s-gonzalezsl.com
cn
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Prueba N.°: 11
Fecha: 11.10.2012
Cliente: BOTICALIA Codigo: CRES P/40 [0166] Edicion: 09.10.2012 Prospecto:
CRESTOR 40 MG TABLETS
Tamano: 150 x 540 mm
Plegado: 150 x 33,75 mm
N° de Colores: 1/1
Color: Negro
Cod. Barras: ---
Papel: Offset blanco 50 g/m2
Your medicine is known by the above name, but will be referred to as Crestor Tablets throughout this leaflet. Other strengths are also available.
Read all of this leaflet carefully before you start taking Crestor Tablets.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What are Crestor Tablets and what are they used for
2. Before you take Crestor Tablets
3. How to take Crestor Tablets
4. Possible side effects
5. How to store Crestor Tablets
6. Further information
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Crestor Tablets belongs to a group of medicines called ‘statins'.
You have been prescribed Crestor Tablets 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 cholesterol-lowering diet and exercise while you are taking Crestor Tablets.
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 is it important to keep taking Crestor Tablets?
Crestor Tablets are 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).
• Crestor Tablets 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 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 Crestor Tablets, 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 Crestor Tablets:
• If you have ever had an allergic reaction to Crestor Tablets or to any of its ingredients.
• If you are pregnant, or breast feeding. If you become pregnant while taking Crestor Tablets stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Crestor 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 Crestor 40mg Tablets (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 - that is 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.
Take special care with Crestor 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 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.
Additional tests and medicines may be needed to diagnose and treat this.
• 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. lopinavir / ritonavir, please see Taking other medicines'
• If the patient is under 10 years old: Crestor Tablets should not be given to children younger than 10 years
• If the patient is below 18 years of age: The Crestor 40mg 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 Crestor Tablets to suit you)
• If you have severe respiratory failure
• If you are of Asian origin - (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor needs to choose the right start dose of Crestor Tablets to suit you.
If any of the above applies to you (or if you are not sure):
• Do not take Crestor 40mg (the highest dose) and check with your doctor or pharmacist before you actually start taking any dose of Crestor 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 Crestor 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.
Taking other medicines
Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines including any you bought without a prescription.
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 or lopinavir/ ritonavir (used to fight the HIV infection -please see ‘Take special care with Crestor Tablets'). The effects of these medicines could be changed by Crestor Tablets or they could change the effects of Crestor Tablets.
Taking Crestor Tablets with food and drink
You can take Crestor Tablets with or without food.
Pregnancy and breast-feeding
Do not take Crestor Tablets if you are pregnant or breast-feeding. If you become pregnant while taking Crestor Tablets stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Crestor Tablets 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 Crestor Tablets - it will not affect their ability. However, some people feel dizzy during treatment with Crestor Tablets. If you feel dizzy, consult your doctor before attempting to drive or use machines.
Important information about some of the ingredients of Crestor Tablets
If you have been told by your doctor that you have an intolerance to some sugars (lactose or milk sugars), contact your doctor before taking. Crestor Tablets.
For a full list of ingredients please see ‘Further information’ below.
Always take Crestor Tablets as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Usual doses in adults
If you are taking Crestor Tablets for high cholesterol:
Starting dose:
Your treatment with Crestor Tablets must start with the 5mg or the 10mg dose, even if you have taken a higher dose of a different statin before. The choice of your start dose will depend upon:
I • your cholesterol level
A • the level of risk you have of experiencing a heart attack or stroke g • whether you have a factor that may make you more sensitive to possible side effects
S. Gonzalez, s. I.
drtes giaficds
Mercurio 13 - Pol. Ind. "Coherman" 28970 Humanes (Madrid) *T. 91 697 65 02 - F. 91 697 18 03 artesgraficas@s-gonzalezsl.com
Prueba N.°: 11
Fecha: 11.10.2012
Cliente: BOTICALIA Codigo: CRES P/40 [0166] Edicion: 09.10.2012 Prospecto:
CRESTOR 40 MG TABLETS
Tamano: 150 x 540 mm
Plegado: 150 x 33,75 mm
N° de Colores: 1/1
Color: Negro
Cod. Barras: ---
Papel: Offset blanco 50 g/m2
Tipografia
Helvetica Condensed Tamano: 9,5 pt.
Correcciones □ Aprobado □
Fecha y Firma
Reverso / Back
E
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LO
Please check with your doctor or pharmacist which start dose of Crestor Tablets will best suit you.
Your doctor may decide to give you the lowest dose (5mg) 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 Crestor Tablets that is right for you. If you started with a 5mg dose, your doctor may decide to double this to 10mg, then 20mg and then 40mg if necessary. If you started on 10mg, your doctor may decide to double this to 20mg and then 40mg if necessary. There will be a gap of four weeks between every dose adjustment. The maximum daily dose of Crestor Tablets is 40mg. 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 20mg.
If you are taking Crestor Tablets to reduce your risk of having a heart attack, stroke or related health problems:
The recommended dose is 20mg daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.
Usual doses in children aged 10-17 years
The usual start dose is 5mg. Your doctor may increase your dose to find the right amount of Crestor Tablets for you. The maximum daily dose of Crestor Tablets is 20mg. Take your dose once a day. Crestor 40mg tablets should not be used by children.
Taking your tablets:
Swallow each tablet whole with a drink of water. Take Crestor Tablets once daily. You can take it at any time of the day.
A translation of the days of the week on the blister strip is as follows:
LUN MAR MER GIO VEN SAB DOM
MON TUE WED THUR FRI SAT SUN
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 Crestor Tablets that is right for you.
If you take more Crestor Tablets 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 Crestor Tablets.
If you forget to take Crestor Tablets
Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.
If you stop taking Crestor Tablets
Talk to your doctor if you want to stop taking Crestor Tablets. Your cholesterol levels might increase again if you stop taking Crestor Tablets.
Like all medicines, Crestor Tablets 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 Crestor 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 Crestor 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 Crestor Tablets (only Crestor 40mg).
• 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 Crestor Tablets (only Crestor Tablets 5mg, 10mg and 20mg).
Rare possible side effects (these may affect between 1 in 1,000 and 1 in 10,000 patients):
• Severe allergic reactions - 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 Crestor Tablets and seek medical help immediately
• Muscle damage in adults - as a precaution, stop taking Crestor 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
• A severe stomach pain (inflamed pancreas)
• Increase in liver enzymes in the blood
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 arm (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
If any of the side effects become troublesome, or if you experience any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• Do not store above 30°C. Store in the original package.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is printed on the carton label. The expiry date refers to the last day of the month.
• If your doctor stops treatment return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.
• If your tablets show signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.
What Crestor Tablets contains:
The active substance in Crestor Tablets is rosuvastatin. Each film-coated tablet contains 40mg of the active ingredient rosuvastatin (as rosuvastatin calcium).
The tablets also contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate, glycerol triacetate, hypromel-lose, titanium dioxide (E171), and red iron oxide (E172).
What Crestor Tablets look like and content of the pack
Crestor 40mg Film-Coated Tablets are oval, pink, biconvex film-coated tablets with ‘ZD4522’ embossed on one face and ‘40’ on the other.
Crestor 40mg Film-Coated Tablets are available as calendar blister packs of 28 film-coated tablets.
Who manufactured your medicine
Crestor 40mg Film-Coated Tablets are manufactured by AstraZeneca GmbH,
Plankstadt, Germany. Procured from within the EU and repackaged by Product Licence Holder Boticalia Ltd., 27 Acton Park, The Vale, London W3 7QE.
PL 23038/0166 Leaflet date: 09.10 2012
POM
CRES P/40
Crestor is a trade mark of IPR Pharmaceuticals, Inc.
H.E.A.R.T UK - The Cholesterol Charity - provides information and advice for patients through a membership magazine, health and diet fact sheets and a helpline manned by nurses and dieticians. To become a member of H.E.A.R.T UK or for further information contact:
H.E.A.R.T UK
7 North Road, Maidenhead, Berkshire, SL6 1PE
Helpline number: 0845 450 5988 open 1000- 1600 from Mon-Fri.