Active ingredient
- simvastatin
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00427/00231.
Simvastatin Rosemont 40mg/5ml Oral Suspension
Patient Information Leaflet
Simvastatin Rosemont 40mg/5ml Oral Suspension
Simvastatin
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 Simvastatin Rosemont is and what it is used for
2. What you need to know before you take Simvastatin Rosemont
3. How to take Simvastatin Rosemont
4. Possible side effects
5. How to store Simvastatin Rosemont
6. Contents of the pack and other information
1. What Simvastatin Rosemont is and what it is used for
The name of your medicine is Simvastatin Rosemont 40mg/5ml Oral Suspension (called simvastatin in this leaflet). This belongs to a group of medicines called HMG-CoA reductase inhibitors (also known as statins).
This medicine works by lowering the amount of cholesterol and fatty substances called triglycerides in your blood.
Simvastatin can be used along with diet for:
In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor.
2. What you need to know before you take Simvastatin Rosemont
Do not take Simvastatin if:
Do not take more than 40 mg simvastatin if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition).
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking simvastatin.
Warnings and precautions
Talk to your doctor or pharmacist before taking simvastatin if:
Your doctor should do a blood test before you start taking simvastatin and if you have any symptoms of liver problems while you take simvastatin. This is to check how well your liver is working.
Your doctor may also want you to have blood tests to check how well your liver is working after you start taking simvastatin.
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.
Tell your doctor if you have severe lung disease.
Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
The risk of muscle breakdown is greater at higher doses of simvastatin, particularly the 80 mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:
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 are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking simvastatin.
Other medicines and Simvastatin
It is particularly important to tell your doctor if you are taking any of the following medicines. Taking simvastatin with any of these medicines can increase the risk of muscle problems (some of these have already been listed in the above section ‘Do not take Simvastatin’):
As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
This includes medicines bought without a prescription, including herbal medicines.
In particular tell your doctor if you are taking any of the following medicines:
Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and are Chinese.
Also tell any doctor who is prescribing a new medicine for you that you are taking simvastatin.
Having operations and tests
If you are going to have an operation, tell the doctor that you are taking simvastatin as it should be stopped a few days before.
Simvastatin with food and drink
Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including simvastatin.
Consuming grapefruit juice should be avoided.
Pregnancy and Breast-feeding
Do not use simvastatin if you are pregnant or planning to become pregnant. If you become pregnant while on this medicine, stop taking it and talk to your doctor straight away.
Do not use simvastatin if you are breast-feeding.
Children and adolescents
Safety and effectiveness have been studied in 10 -17 year old boys and in girls who had started their menstrual period at least one year before (see How to take Simvastatin Rosemont). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.
Driving and using machines
This medicine should not affect your ability to drive or operate machinery. However, this medicine may cause dizziness. If you feel this, take extra care when driving or using tools or machines.
Simvastatin Rosemont contains methyl parahydroxybenzoates, ethyl parahydroxybenzoate and propyl parahydroxybenzoate:
3. How to take Simvastatin Rosemont
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
You should stay on a cholesterol-lowering diet while taking simvastatin.
Taking this medicine
The usual doses are given below. Your doctor may change these.
Adults including older people
The usual dose range is 5mg to 80mg each day. The 80mg dose is only recommended in patients with very high cholesterol levels and at high risk of heart disease problems. The dose will be decided by your doctor depending upon what you are being treated for.
This product should not be used for doses of 20mg or below. For doses of 20mg or below use the 20mg/5ml strength product.
Treatment of high cholesterol levels:
Treatment of high cholesterol levels if there is a family history of this:
Prevention of coronary heart disease (CHD):
People with kidney problems
Use in children and adolescents (10 – 17 years old)
If you take more Simvastatin than you should
If you take more of this medicine than you should, talk to your doctor or go to your nearest hospital straight away. Take the medicine pack with you.
If you forget to take Simvastatin
If you stop taking Simvastatin
Do not stop taking simvastatin unless your doctor tells you to. It may make your cholesterol levels rise again.
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.
The following terms are used to describe how often side effects have been reported:
The following rare serious side effects were reported.
If any of these serious side effects happen, stop taking simvastatin and tell your doctor immediately or go to the emergency room at your nearest hospital:
The following very rare serious side effect was reported:
The following side effects have also been reported rarely:
The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):
Additional possible side effects reported with some statins:
Laboratory Values
Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
5. How to store Simvastatin Rosemont
6. Contents of the pack and other information
What Simvastatin Rosemont 40mg/5ml Oral Suspension contains
What Simvastatin Rosemont 40mg/5ml Oral Suspension looks like and contents of the pack
A white to off-white suspension with a flavour and odour of lime.
It comes in a brown glass bottle 150ml with HDPE, EPE wadded, tamper evident, child resistant closure.
A double-sided dosing spoon is provided to measure 1.25ml, 2.5ml and 5ml doses as prescribed.
Marketing Authorisation Holder and Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
Greece KYMORAL Πόσιμο εναιώρημα 40 mg/5 ml
United Kingdom Simvastatin Rosemont 40mg/5ml Oral Suspension
This leaflet was last updated in: 03/2019
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